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Injectable and Healthcare Administered Oncology Drugs

Commercial Utilization Management Policy

Last Review: April 2025

Restricted Product(s) for administration by a healthcare professional:

  • Abraxane® [paclitaxel (protein bound)] 
  • Adcetris® (brentuximab vedotin) 
  • Alimta® (pemetrexed) 
  • Anktiva® (nogapendekin alfa inbakicept-pmln) 
  • Arzerra® (ofatumumab) 
  • Bavencio® (avelumab) 
  • Besponsa® (inotuzumab ozogamicin) 
  • Bizengri® (zenocutuzumab-zbco)
  • Blincyto® (blinatumomab)
  • Columvi™ (glofitamab-gxbm) 
  • Danyelza® (naxitamab-gqgk) 
  • Darzalex® (daratumumab) 
  • Darzalex Faspro® (daratumumab and hyaluronidase-fihj) 
  • Datroway® (datopotamab deruxtecan-dlnk)
  • Elahere® (mirvetuximab soravtansine-gynx) 
  • Elrexfio™ (elranatamab-bcmm) 
  • Elzonris® (tagraxofusp-erzs)
  • Empliciti® (elotuzumab) 
  • Enhertu® (fam-trastuzumab deruxtecan-nxki) 
  • Epkinly® (epcoritamab-bysp) 
  • Erbitux® (cetuximab) 
  • Erwinaze™ (asparaginase Erwinia chrysanthemi) 
  • Fyarro® (sirolimus albumin-bound nanoparticles)
  • Gazyva® (obinutuzumab)
  • Halaven® (eribulin mesylate)
  • Hycamtin® (topotecan) 
  • Imdelltra™ (tarlatamab-dlle) 
  • Imfinzi® (durvalumab)
  • Imjudo® (tremelimumab-actl) 
  • Imlygic® (talimogene laherparepvec)
  • Jemperli® (dostarlimab-gxly)
  • Jevtana® (cabazitaxel)
  • Kadcyla® (ado-trastuzumab emtansine)
  • Keytruda® (pembrolizumab) 
  • Kimmtrak® (tebentafusp-tebn)
  • Kyprolis® (carfilzomib)
  • Libtayo® (cemiplimab-rwlc) 
  • Loqtorzi® (toripalimab-tpzi) 
  • Lunsumio™ (mosunetuzumab-axgb)
  • Lymphir™ (denileukin diftitox-cxdl) 
  • Margenza® (margetuximab-cmkb) 
  • Monjuvi® (tafasitamab-cxix)
  • Mylotarg™ (gemtuzumab ozogamicin)
  • Opdivo® (nivolumab) 
  • Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy)
  • Opdualag™ (nivolumab and relatlimab-rmbw)
  • Padcev® (enfortumab vedotin-ejfv) 
  • Pemfexy® (pemetrexed) 
  • Pemrydi RTU® (pemetrexed)
  • Perjeta® (pertuzumab)
  • Phesgo® (pertuzumab, trastuzumab, and hyaluronidase-zzxf) 
  • Polivy® (polatuzumab vedotin-piiq)
  • Portrazza™ (necitumumab) 
  • Poteligeo® (mogamulizumab-kpkc) 
  • Provenge® (sipuleucel-T)
  • Rybrevant® (amivantamab-vmjw)
  • Rylaze® [asparaginase Erwinia chrysanthemi (recombinant)- rywn] 
  • Sarclisa® (isatuximab-irfc) 
  • Sylvant® (siltuximab) 
  • Talvey™ (talquetamab-tgvs) 
  • Tecentriq® (atezolizumab) 
  • Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) 
  • Tecvayli® (teclistamab-cqyv)
  • Tevimbra® (tislelizumab-jsgr) 
  • Tivdak® (tisotumab vedotin-tftv) 
  • Trodelvy® (sacituzumab govitecan-hziy)
  • Unloxcyt® (cosibelimab-ipdl)
  • Vectibix® (panitumumab) 
  • Vyloy® (zolbetuximab-clzb) 
  • Vyxeos® (daunorubicin and cytarabine) 
  • Yervoy® (ipilimumab) 
  • Zepzelca® (lurbinectedin)
  • Ziihera® (zanidatamab-hrii)
  • Zynlonta® (loncastuximab tesirine-lpyl) 
  • Zynyz® (retifanlimab-dlwr)

FDA Approved Use:

  • Abraxane® [paclitaxel (protein bound)] 
    • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy (prior therapy should have included an anthracycline unless clinically contraindicated) 
    • Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy 
    • Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine 
  • Adcetris® (brentuximab vedotin) 
    • For treatment of adults with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine 
    • For treatment of pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide
    • For treatment of adults with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation 
    • For treatment of adults with classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
    • For treatment of adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone
    • For treatment of adults with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multiagent chemotherapy regimen 
    • For treatment of adults with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy 
  • Alimta® (pemetrexed) 
    • For initial treatment, in combination with pembrolizumab and platinum chemotherapy, of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations 
    • For initial treatment, in combination with cisplatin, of patients with locally advanced or metastatic, non-squamous NSCLC 
    • For maintenance treatment, as a single agent, of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy o For treatment, as a single agent, of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy 
    • Limitations of use: Not indicated for treatment of patients with squamous cell NSCLC 
    • For initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery 
  • Anktiva® (nogapendekin alfa inbakicept-pmln) 
    • For use with Bacillus Calmette-Guérin (BCG) for the treatment of adults with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors
  • Arzerra® (ofatumumab) 
    • For treatment of chronic lymphocytic leukemia (CLL) in the following situations: 
      • In combination with chlorambucil, for treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate 
      • In combination with fludarabine and cyclophosphamide for treatment of patients with relapsed CLL 
      • For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL 
      • For treatment of patients with CLL refractory to fludarabine and alemtuzumab
  • Bavencio® (avelumab)
    • Merkel cell carcinoma (MCC): For treatment of metastatic MCC in adults and pediatric patients 12 years and older 
    • Urothelial carcinoma (UC): 
      • For maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy 
      • For treatment of patients with locally advanced or metastatic UC who: 
        • Have disease progression during or following platinum-containing chemotherapy 
        • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy 
    • Renal cell carcinoma (RCC): For first-line treatment, in combination with axitinib, of patients with advanced RCC
  • Besponsa® (inotuzumab ozogamicin) 
    • For treatment of adult and pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) 
  • Bizengri® (zenocutuzumab-zbco)
    • For treatment of adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
    • For treatment of adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
  • Blincyto® (blinatumomab) 
    • For treatment of adult and pediatric patients 1 month and older with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% 
    • For treatment of adult and pediatric patients 1 month and older with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) 
    • For treatment of adult and pediatric patients 1 month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy 
  • Columvi™ (glofitamab-gxbm) 
    • For treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy 
  • Danyelza® (naxitamab-gqgk) 
    • For treatment, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), of pediatric patients 1 year of age and older and adults with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy 
  • Darzalex® (daratumumab) 
    • For treatment of adults with multiple myeloma in the following situations: 
      • in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory disease who have received at least one prior therapy
      • in combination with bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant 
      • in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant
      • in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy 
      • in combination with carfilzomib and dexamethasone in patients with relapsed or refractory disease who have received one to three prior lines of therapy 
      • in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor 
      • as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent 
  • Darzalex Faspro® (daratumumab and hyaluronidase-fihj) 
    • For treatment of adults with multiple myeloma in the following situations: 
      • In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant
      • in combination with bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant 
      • in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory disease who have received at least one prior therapy 
      • in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant 
      • in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy 
      • in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor 
      • in combination with carfilzomib and dexamethasone in patients with relapsed or refractory disease who have received one to three prior lines of therapy 
      • as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent 
    • For treatment of light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients 
      • Limitations of use: Not indicated and not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials
  • Datroway® (datopotamab deruxtecan-dlnk)
    • For treatment of adults with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease
  • Elahere® (mirvetuximab soravtansine-gynx) 
    • For treatment of adults with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. 
  • Elrexfio™ (elranatamab-bcmm) 
    • For treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody 
  • Elzonris® (tagraxofusp-erzs)
    • For treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older 
  • Empliciti® (elotuzumab) 
    • For treatment, in combination with lenalidomide and dexamethasone, for adults with multiple myeloma who have received one to three prior therapies 
    • For treatment, in combination with pomalidomide and dexamethasone, for adults with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor 
  • Enhertu® (fam-trastuzumab deruxtecan-nxki) 
    • For treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either:
      • in the metastatic setting, or 
      • in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy 
    • For treatment of adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy 
    • For treatment of adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy 
    • For treatment of adults with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen 
    • For treatment of adults with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options 
  • Epkinly® (epcoritamab-bysp) 
    • For treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy 
    • For treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
  • Erbitux® (cetuximab) 
    • For treatment of locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy 
    • For treatment of recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil 
    • For treatment of recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy 
    • For treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test: 
      • in combination with FOLFIRI for first-line treatment 
      • in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy 
      • as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan 
      • Limitations of use: Not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown. 
    • For treatment of BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combination with encorafenib, for the treatment of adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy
  • Erwinaze™ (asparaginase Erwinia chrysanthemi) 
    • For treatment of acute lymphoblastic leukemia (ALL), as a component of a multi-agent chemotherapeutic regimen, in patients who have developed hypersensitivity to E. coli-derived asparaginase 
  • Fyarro® (sirolimus albumin-bound nanoparticles) 
    • For treatment of adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa) 
  • Gazyva® (obinutuzumab) 
    • For treatment, in combination with chlorambucil, for patients with previously untreated chronic lymphocytic leukemia 
    • For treatment, in combination with bendamustine followed by Gazyva monotherapy, for patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen 
    • For treatment, in combination with chemotherapy followed by Gazyva monotherapy in patients achieving at least a partial remission, for adults with previously untreated stage II bulky, III or IV follicular lymphoma 
  • Halaven® (eribulin mesylate) 
    • For treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. 
    • For treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen
  • Hycamtin® (topotecan) 
    • For treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent 
    • For treatment of patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent 
    • For treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin 
  • Imdelltra™ (tarlatamab-dlle) 
    • For treatment of adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy 
  • Imfinzi® (durvalumab)
    • As neoadjuvant treatment in combination with platinum-containing chemotherapy, followed by continued use as a single agent as adjuvant treatment after surgery, for treatment of adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements 
    • For single-agent treatment of adults with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy 
    • For treatment, in combination with tremelimumab-actl and platinum-based chemotherapy, of adults with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations 
    • For first-line treatment, in combination with etoposide and either carboplatin or cisplatin, of adults with extensive-stage small cell lung cancer (ES-SCLC) 
    • For treatment, in combination with gemcitabine and cisplatin, of adults with locally advanced or metastatic biliary tract cancer (BTC) 
    • For treatment, in combination with tremelimumab-actl, of adults with unresectable hepatocellular carcinoma (uHCC) 
    • For treatment, in combination with carboplatin and paclitaxel, followed by use as a single agent, of adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) 
  • Imjudo® (tremelimumab-actl) 
    • For treatment, in combination with durvalumab, of adults with unresectable hepatocellular carcinoma (uHCC) 
    • For treatment, in combination with durvalumab and platinum-based chemotherapy, of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations
  • Imlygic® (talimogene laherparepvec) 
    • For local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery 
    • Limitations of use: Not shown to improve overall survival or have an effect on visceral metastases 
  • Jemperli® (dostarlimab-gxly) 
    • For treatment, in combination with carboplatin and paclitaxel followed by single-agent treatment, of adults with primary advanced or recurrent endometrial cancer 
    • For single-agent treatment of adults with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation 
    • For single-agent treatment of adults with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options 
  • Jevtana® (cabazitaxel) 
    • For treatment, in combination with prednisone, of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen 
  • Kadcyla® (ado-trastuzumab emtansine) 
    • For treatment, as a single agent, of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: 
      • received prior therapy for metastatic disease, or 
      • developed disease recurrence during or within six months of completing adjuvant therapy 
    • For adjuvant treatment, as a single agent, of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment 
    • Patient selection for therapy is based on an FDA-approved companion diagnostic for Kadcyla. Assessment of HER2 protein overexpression and/or HER2 gene amplification should be performed using FDA-approved tests specific for breast cancers by laboratories with demonstrated proficiency. 
  • Keytruda® (pembrolizumab) 
    • Melanoma 
      • For treatment of patients with unresectable or metastatic melanoma 
      • For adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection 
    • Non-small cell lung cancer (NSCLC)
      • For first-line treatment, in combination with pemetrexed and platinum chemotherapy, of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations 
      • As first-line treatment, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, of patients with metastatic squamous NSCLC
      • As a single agent for first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: 
        • stage III where patients are not candidates for surgical resection or definitive chemoradiation, or 
        • metastatic 
      • As a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. 
      • For treatment of patients with resectable (tumors ≥ 4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery 
      • As a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adults with stage IB (T2a ≥4 cm), II, or IIIA NSCLC 
    • Malignant Pleural Mesothelioma (MPM) 
      • For first-line treatment, in combination with pemetrexed and platinum chemotherapy, of adults with unresectable advanced or metastatic MPM 
    • Head and neck squamous cell cancer (HNSCC) 
      • For first-line treatment, in combination with platinum and FU, of patients with metastatic or with unresectable, recurrent HNSCC 
      • As a single agent for first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test 
      • As a single agent for treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy
    • Classical Hodgkin lymphoma (cHL) 
      • For treatment of adults with relapsed or refractory cHL 
      • For treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy 
    • Primary mediastinal large B-cell lymphoma (PMBCL) 
      • For treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy 
      • Limitations of use: Not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy
    • Urothelial cancer 
      • For treatment, in combination with enfortumab vedotin, of adults with locally advanced or metastatic urothelial cancer 
      • For treatment, as a single agent, of patients with locally advanced or metastatic urothelial carcinoma who: 
        • are not eligible for any platinum-containing chemotherapy, or 
        • have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy 
      • For treatment, as a single agent, of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy
    • Microsatellite instability-high or mismatch repair deficient cancer 
      • For treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options 
    • Microsatellite instability-high or mismatch repair deficient colorectal cancer (CRC) 
      • For treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA approved test 
    • Gastric cancer 
      • For first-line treatment, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test 
      • For first-line treatment, in combination with fluoropyrimidine- and platinum-containing chemotherapy, of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma 
    • Esophageal cancer 
      • For treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: 
        • in combination with platinum- and fluoropyrimidine-based chemotherapy, or 
        • as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test
    • Cervical cancer 
      • For treatment, in combination with chemoradiotherapy (CRT), of patients with FIGO 2014 Stage III-IVA cervical cancer 
      • For treatment as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test
      • For treatment, in combination with chemotherapy, with or without bevacizumab, of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test 
    • Hepatocellular carcinoma (HCC) 
      • For treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen 
    • Biliary Tract Cancer (BTC) 
      • For treatment, in combination with gemcitabine and cisplatin, of patients with locally advanced unresectable or metastatic biliary tract cancer 
    • Merkel cell carcinoma (MCC) 
      • For treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma 
    • Renal cell carcinoma (RCC) 
      • For first-line treatment, in combination with axitinib, of adults with advanced RCC
      • For first-line treatment, in combination with lenvatinib, of adults with advanced RCC
      • For adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
    • Endometrial carcinoma 
      • For treatment in combination with carboplatin and paclitaxel, followed by use as a single agent, of adults with primary advanced or recurrent endometrial carcinoma 
      • For treatment, in combination with lenvatinib, of adults with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation 
      • For treatment, as a single agent, of adults with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation 
    • Tumor mutational burden-high (TMB-H) cancer 
      • For treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options 
      • Limitations of use: Safety and effectiveness in pediatric patients with TMB-H central nervous system cancers have not been established 
    • Cutaneous squamous cell carcinoma (cSCC) 
      • For treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation
    • Triple-negative breast cancer (TNBC) 
      • For treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery 
      • For treatment, in combination with chemotherapy, of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test 
    • Keytruda is indicated for use at an additional dosing regimen of 400 mg every 6 weeks for adult classical Hodgkin lymphoma and adult primary mediastinal large B-cell lymphoma indications 
  • Kimmtrak ® (tebentafusp-tebn) 
    • For treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma
  • Kyprolis® (carfilzomib)
    • For treatment of adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with:
      • Lenalidomide and dexamethasone; or
      • Dexamethasone; or
      • Daratumumab and dexamethasone; or
      • Daratumumab and hyaluronidase-fihj and dexamethasone; or
      • Isatuximab and dexamethasone
    • For treatment, as a single agent, of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy 
  • Libtayo® (cemiplimab-rwlc) 
    • For treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation 
    • For treatment of basal cell carcinoma (BCC) in the following situations: 
      • in patients with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate 
      • in patients with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate 
    • For first-line treatment, in combination with platinum-based chemotherapy, of adults with non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations, and is: 
      • locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or 
      • metastatic
    • For first-line treatment as a single agent, of adults with non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is:
      • locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or
      • metastatic
  • Loqtorzi® (toripalimab-tpzi)
    • For first-line treatment, in combination with cisplatin and gemcitabine, of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC)
    • For treatment, as a single agent, of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy
  • Lunsumio™ (mosunetuzumab-axgb)
    • For treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
  • Lymphir™ (denileukin diftitox-cxdl)
    • For treatment of adults with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy
  • Margenza® (margetuximab-cmkb)
    • For treatment, in combination with chemotherapy, of adults with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease
  • Monjuvi® (tafasitamab-cxix)
    • For treatment, in combination with lenalidomide, for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT)
  • Mylotarg™ (gemtuzumab ozogamicin)
    • For treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older 
    • For treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older
  • Opdivo® (nivolumab)
    • Melanoma
      • For adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab
      • For adjuvant treatment of adult and pediatric (12 years and older) patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma
    • Non-small cell lung cancer (NSCLC)
      • For adults with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab
      • For adults with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy
      • For adults with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo.
      • For use in combination with platinum-doublet chemotherapy for neoadjuvant treatment of adults with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer
      • For use in combination with platinum-doublet chemotherapy for neoadjuvant treatment of adults with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, followed by use as single-agent adjuvant treatment after surgery
    • Malignant pleural mesothelioma
      • For adults with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab
    • Renal cell carcinoma (RCC)
      • For adults with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab
      • For adults with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib
      • For adults with advanced renal cell carcinoma who have received prior anti-angiogenic therapy 
    • Classical Hodgkin lymphoma (cHL)
      • For adults with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin; or after 3 or more lines of systemic therapy that includes autologous HSCT
    • Squamous cell carcinoma of the head and neck (SCCHN)
      • For adults with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy
    • Urothelial carcinoma
      • For adjuvant treatment of adults with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC
      • For first-line treatment, in combination with cisplatin and gemcitabine, of adults with unresectable or metastatic urothelial carcinoma (UC)
      • For adults with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy; or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
    • Colorectal cancer
      • For adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab
    • Hepatocellular carcinoma (HCC)
      • For adults with hepatocellular carcinoma who have been previously treated with sorafenib in combination with ipilimumab
    • Esophageal cancer
      • For adults with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT)
      • For adults with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy
      • For adults with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab
      • For adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy
    • Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
      • For adults with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy
  • Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy)
    • Renal cell carcinoma (RCC)
      • For first-line treatment of adults with intermediate or poor risk advanced RCC, following combination treatment with intravenous nivolumab and ipilimumab
        • Limitations of use: Not indicated in combination with ipilimumab for the treatment of RCC
      • For first-line treatment of adults with advanced RCC, in combination with cabozantinib
      • For treatment of adults with advanced RCC who have received prior anti-angiogenic therapy
    • Melanoma
      • For treatment of adults with unresectable or metastatic melanoma
      • For treatment of adults with unresectable or metastatic melanoma following combination treatment with intravenous nivolumab and ipilimumab
        • Limitations of use: Not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma
      • For adjuvant treatment of adults with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma
    • Non-small cell lung cancer (NSCLC)
      • For treatment of adults with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy
      • For treatment of adults with resectable (tumors ≥4 cm or node positive) NSCLC and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by use as monotherapy as adjuvant treatment after surgery
      • For treatment of adults with metastatic NSCLC and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo Qvantig
        • Limitations of use: Not indicated in combination with ipilimumab for the treatment of metastatic NSCLC
    • Squamous cell carcinoma of the head and neck (SCCHN)
      • For treatment of adults with recurrent or metastatic SCCHN with disease progression on or after a platinum-based therapy
    • Urothelial carcinoma (UC)
      • For adjuvant treatment of adults with UC who are at high risk of recurrence after undergoing radical resection of UC
      • For first-line treatment of adults with unresectable or metastatic UC, in combination with cisplatin and gemcitabine
      • For treatment of adults with locally advanced or metastatic UC who:
        • Have disease progression during or following platinum-containing chemotherapy
        • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
    • Colorectal cancer
      • For treatment of adults with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as monotherapy or as monotherapy following combination treatment with intravenous nivolumab and ipilimumab
        • Limitations of use: Not indicated in combination with ipilimumab for the treatment of MSI-H or dMMR metastatic CRC
    • Hepatocellular carcinoma (HCC)
      • For treatment of adults with HCC previously treated with sorafenib and following combination treatment with intravenous nivolumab and ipilimumab
        • Limitations of use: Not indicated in combination with ipilimumab for the treatment of HCC
    • Esophageal cancer
      • For treatment of adults with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT)
      • For treatment of adults with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy
        • Limitations of use: Not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC
      • For treatment of adults with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy
    • Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
      • For treatment of adults with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy
  • Opdualag™ (nivolumab and relatlimab-rmbw)
    • For the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma
  • Padcev® (enfortumab vedotin-ejfv)
    • For treatment, as a single agent, of adults with locally advanced or metastatic urothelial cancer who:
      • have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or
      • are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy
    • For treatment, in combination with pembrolizumab, of adults with locally advanced or metastatic urothelial cancer
  • Pemfexy® (pemetrexed) or Pemrydi RTU® (pemetrexed)
    • For initial treatment, in combination with pembrolizumab and platinum chemotherapy, of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations
    • For initial treatment, in combination with cisplatin, of patients with locally advanced or metastatic, non-squamous NSCLC
    • For maintenance treatment, as a single agent, of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
    • For treatment, as a single agent, of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy
      • Limitations of use: Not indicated for treatment of patients with squamous cell NSCLC 
    • For initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery 
  • Perjeta® (pertuzumab) 
    • For treatment, in combination with trastuzumab and docetaxel, of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease 
    • For neoadjuvant treatment, in combination with trastuzumab and chemotherapy, of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either > 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer 
    • For adjuvant treatment, in combination with trastuzumab and chemotherapy, of patients with HER2-positive early breast cancer at high risk of recurrence 
    • Assessment of HER2 protein overexpression and/or HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency 
  • Phesgo® (pertuzumab, trastuzumab, and hyaluronidase-zzxf) 
    • For neoadjuvant treatment, in combination with chemotherapy, of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either > 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer 
    • For adjuvant treatment, in combination with chemotherapy, of patients with HER2-positive early breast cancer at high risk of recurrence 
    • For treatment, in combination with docetaxel, of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease 
    • Assessment of HER2 protein overexpression and/or HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency 
  • Polivy® (polatuzumab vedotin-piiq) 
    • For treatment of adults, in combination with bendamustine and a rituximab product, for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies 
    • For treatment, in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP), of adults who have previously untreated DLBCL, not otherwise specified or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater
  • Portrazza™ (necitumumab) 
    • For first-line treatment, in combination with gemcitabine and cisplatin, of patients with metastatic squamous non-small cell lung cancer 
      • Limitations of use: Not for treatment of non-squamous non-small cell lung cancer 
  • Poteligeo® (mogamulizumab-kpkc) 
    • For treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy 
  • Provenge® (sipuleucel-T) 
    • For treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer 
  • Rybrevant® (amivantamab-vmjw) 
    • For single-agent treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy 
    • For first-line treatment, in combination with carboplatin and pemetrexed, of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test 
    • For treatment, in combination with carboplatin and pemetrexed, of adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor 
    • For first-line treatment, in combination with lazertinib, of adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test
  • Rylaze® [asparaginase Erwinia chrysanthemi (recombinant)-rywn] 
    • For treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL), as a component of a multi-agent chemotherapeutic regimen, in adults and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase 
  • Sarclisa® (isatuximab-irfc) 
    • For treatment, in combination with pomalidomide and dexamethasone, of adults with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor 
    • For treatment, in combination with carfilzomib and dexamethasone, of adults with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy 
    • For treatment, in combination with bortezomib, lenalidomide, and dexamethasone, of adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)
  • Sylvant® (siltuximab) 
    • For treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative 
    • Limitation of use: Not studied in patients with MCD who are HIV positive or HHV-8 positive because Sylvant did not bind to virally produced IL-6 in a nonclinical study 
  • Talvey™ (talquetamab-tgvs) 
    • For treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody 
  • Tecentriq® (atezolizumab) 
    • Non-small cell lung cancer (NSCLC) 
      • As adjuvant treatment following resection and platinum-based chemotherapy for adults with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test 
      • For first-line treatment of adults with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
      • For first-line treatment, in combination with bevacizumab, paclitaxel, and carboplatin, of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations 
      • For first-line treatment, in combination with paclitaxel protein-bound and carboplatin, of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations 
      • For treatment of adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq. 
    • Small cell lung cancer (SCLC)
      • For first-line treatment, in combination with carboplatin and etoposide, of adults with extensive-stage small cell lung cancer (ES-SCLC) 
    • Hepatocellular carcinoma (HCC) 
      • For treatment, in combination with bevacizumab, of adults with unresectable or metastatic HCC who have not received prior systemic therapy 
    • Melanoma 
      • For treatment, in combination with cobimetinib and vemurafenib, of adults with BRAF V600 mutation-positive unresectable or metastatic melanoma 
    • Alveolar soft part sarcoma (ASPS) 
      • For treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS
  • Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) 
    • Non-small cell lung cancer (NSCLC)
      • As adjuvant treatment following resection and platinum-based chemotherapy for adults with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test 
      • For first-line treatment of adults with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations 
      • For first-line treatment, in combination with bevacizumab, paclitaxel, and carboplatin, of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations 
      • For first-line treatment, in combination with paclitaxel protein-bound and carboplatin, of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations
      • For treatment of adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq Hybreza. 
  • Small cell lung cancer (SCLC) 
    • For first-line treatment, in combination with carboplatin and etoposide, of adults with extensive-stage small cell lung cancer (ES-SCLC) 
  • Hepatocellular carcinoma (HCC) 
    • For treatment, in combination with bevacizumab, of adults with unresectable or metastatic HCC who have not received prior systemic therapy 
  • Melanoma 
    • For treatment, in combination with cobimetinib and vemurafenib, of adults with BRAF V600 mutation-positive unresectable or metastatic melanoma as determined by an FDA-approved test 
  • Alveolar soft part sarcoma (ASPS) 
    • For treatment of adults with unresectable or metastatic ASPS
  • Tecvayli® (teclistamab-cqyv)
    • For treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody 
  • Tevimbra® (tislelizumab-jsgr) 
    • For treatment, as a single agent, in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor
    • For first-line treatment, in combination with platinum and fluoropyrimidine-based chemotherapy, in adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1)
  • Tivdak® (tisotumab vedotin-tftv) 
    • For treatment of adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  • Trodelvy® (sacituzumab govitecan-hziy) 
    • For treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease 
    • For treatment of adults with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting 
    • For treatment of adults with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor 
  • Unloxcyt® (cosibelimab-ipdl)
    • For treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation
  • Vectibix® (panitumumab) 
    • For treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC): 
      • In combination with FOLFOX for first-line treatment 
      • As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy 
    • Limitation of use: Not for treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown 
  • Vyloy® (zolbetuximab-clzb) 
    • For first-line treatment, in combination with fluoropyrimidine- and platinum-containing chemotherapy, of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test 
  • Vyxeos® (daunorubicin and cytarabine) 
    • For treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older
  • Yervoy® (ipilimumab) 
    • For treatment of melanoma in the following situations: 
      • Unresectable or metastatic melanoma in adults and pediatric patients 12 years and older, as a single agent 
      • Unresectable or metastatic melanoma in adults and pediatric patients 12 years and older, in combination with nivolumab 
      • Adjuvant treatment of adults with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy 
    • For treatment of adults with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab
    • For treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in combination with nivolumab 
    • For treatment of adults with hepatocellular carcinoma who have been previously treated with sorafenib, in combination with nivolumab 
    • For treatment of non-small cell lung cancer (NSCLC) in the following situations: 
      • Adults with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab 
      • Adults with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy
    • For treatment of adults with unresectable malignant pleural mesothelioma, as first-line treatment in combination with nivolumab 
    • For treatment of adults with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first-line treatment in combination with nivolumab
  • Zepzelca® (lurbinectedin) 
    • For treatment of adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy 
  • Ziihera® (zanidatamab-hrii)
    • For treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test
  • Zynlonta® (loncastuximab tesirine-lpyl) 
    • For treatment of relapsed or refractory large B-cell lymphoma in adults after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma
  • Zynyz® (retifanlimab-dlwr) 
    • For treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma

NOTE: This policy only addresses FDA labeled and compendia supported off-label oncologic indications for the above restricted agents. Any non-oncologic FDA labeled or compendia supported uses for the above restricted products are not addressed in this policy and may be addressed elsewhere.

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

  1. ALL of the following:
    1. ONE of the following:
      1. The patient has been treated with the requested agent within the past 180 days; OR
      2. The prescriber indicates the patient has been treated with the requested agent within the past 180 days AND is at risk if therapy is changed; OR 
  2. The patient has an FDA labeled indication for the requested agent and route of administration; AND 
    1. ONE of the following: 
      1. The requested indication does NOT require genetic/specific diagnostic testing (e.g., ALK, EGFR, HER2, KRAS) in FDA labeling; OR 
      2. The requested indication requires genetic/specific diagnostic testing in FDA labeling AND both of the following:
        1. Genetic/specific diagnostic testing has been performed; AND
        2. The results of the genetic/specific diagnostic testing indicate therapy with the requested agent is appropriate in FDA labeling; AND 
    2. ONE of the following:
      1. The requested agent will be used as a first-line agent AND is FDA labeled as a first-line agent for the requested indication, including any genomic aberrations (e.g., EGFR, ALK) and/or tumor expression factors [e.g., PD-L1 Tumor Proportion Score (TPS) values]; OR
      2. The patient has used the appropriate number and type(s) of prerequisite agent(s) listed in the FDA labeling for the requested indication, including any genomic aberrations (e.g., EGFR, ALK) and/or tumor expression factors [e.g., PD-L1 Tumor Proportion Score (TPS) values]; OR 
      3. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the required prerequisite agent(s) listed in the FDA labeling for the requested indication, indication including any genomic aberrations (e.g., EGFR, ALK) and/or tumor expression factors [e.g., PD-L1 Tumor Proportion Score (TPS) values]; AND 
    3.  ONE of the following:
      1. The requested agent is being used as monotherapy AND is approved for use as monotherapy in the FDA labeling for the requested indication, including any genomic aberrations (e.g., EGFR, ALK) and/or tumor expression factors [e.g., PD-L1 Tumor Proportion Score (TPS) values]; OR 
      2. The requested agent will be used in combination as combination therapy with all agent (s) and/or treatments (e.g., radiation) listed for concomitant use in the FDA labeling for the requested indication; AND
    4. ONE of the following:
      1. The FDA label does NOT include a performance status requirement; OR
      2. The patient meets the performance status requirement in the FDA labeling; OR
  3. The patient has an indication that is supported by ALL requirements in NCCN 1 or 2A recommended use for the requested agent [i.e., the indication must be supported by ALL requirements in the NCCN “Recommended Use” box (e.g., performance status, disease severity, previous failures, monotherapy vs combination therapy)]; AND
  4. The patient has not experienced disease progression or unacceptable toxicity on the same treatment as the requested agent or during treatment with another agent from the same drug class in a prior line of therapy (e.g., PD-L1/PD-1 inhibitors) unless there is acceptable supporting literature for use beyond progression in a different combination regimen; AND
  5. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication or NCCN 1 or 2A compendia supported recommendation for the requested agent; OR
    2. The prescriber has provided information in support of using the requested agent for the patient’s age; AND 
  6. The patient does NOT have any FDA labeled contraindications to the requested agent; AND
  7. The requested quantity (dose) and treatment duration (and maximum units) is within FDA labeled dosing for the requested indication or NCCN 1 or 2A compendia supported dosing for the requested indication.

Duration of Approval: 365 days (1 year) or for duration of treatment as supported in FDA labeling or in NCCN 1 or 2A recommendations for the requested indication, whichever is shorter

Continuation Criteria for Approval:

  1. The patient was approved through Blue Cross NC initial criteria for approval; OR 
  2. The patient would have met initial criteria for approval at the time they started therapy; AND
  3. The patient has continued clinical benefit while receiving the requested agent as demonstrated by tumor response or lack of disease progression, and an acceptable toxicity profile; AND
  4. The requested quantity (dose) and treatment duration (and maximum units) is within FDA labeled dosing for the requested indication or NCCN 1 or 2A compendia supported dosing for the requested indication. 

Duration of Approval: 365 days (1 year) or for duration of treatment as supported in FDA labeling or in NCCN 1 or 2A recommendations for the requested indication, whichever is shorter 

NOTE: Use of injectable and healthcare administered oncology agents may be considered medically necessary for clinical indications not listed above when the drug is prescribed for the treatment of cancer either: 

  1. In accordance with FDA label when clinical benefit has been established, and it is not determined to be investigational as defined in the Blue Cross NC Corporate Medical Policy (CMP), “Investigational (Experimental) Services.” [please refer to CMP “Investigational (Experimental) Services” for a summary of evidence standards from nationally recognized compendia]; OR
  2. In accordance with specific strong endorsement or support by nationally recognized compendia (e.g., National Comprehensive Cancer Network, NCCN), when such recommendation is based on the highest level of evidence (Level 1, 2A), and/or uniform consensus of clinical appropriateness has been reached.
FDA Label Reference 
MedicationIndicationDosingHCPCS
Abraxane® [paclitaxel (protein bound)] or generic paclitaxel protein-bound intravenous (IV) infusion
  • Metastatic breast cancer (MBC)
  • Locally advanced or metastatic NSCLC 
  • Metastatic adenocarcinoma of the pancreas
  • MBC: 260 mg/m2 IV every 3 weeks 
  • NSCLC: 100 mg/m2 IV on days 1, 8, and 15 of each 21- day cycle (administer carboplatin on day 1 of each 21-day cycle immediately after Abraxane) 
  • Adenocarcinoma of the pancreas: 125 mg/m2 IV on days 1, 8, and 15 of each 28-day cycle (administer gemcitabine immediately after Abraxane on days 1, 8, and 15 of each 28-day cycle) 
  • Do not substitute Abraxane for other paclitaxel products
J9264

Adcetris® (brentuximab vedotin) intravenous (IV) infusion

 

 

 

  • Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) in adults, in combination with doxorubicin, vinblastine, and dacarbazine
  • Previously untreated high risk cHL in pediatric patients
  • cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation
  • cHL after failure of auto-HSCT or after failure of ≥2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
  • Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL) in combination with cyclophosphamide, doxorubicin, and prednisone
  • sALCL after failure of at least one prior multiagent chemotherapy regimen
  • Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30- expressing mycosis fungoides (MF) who have received prior systemic therapy
  • Monotherapy for adults: 1.8 mg/kg IV up to a maximum of 180 mg every 3 weeks
  • In combination with chemotherapy for adults with previously untreated Stage III or IV cHL: 1.2 mg/kg IV up to a maximum of 120 mg every 2 weeks for a maximum of 12 doses
  • In combination with chemotherapy for pediatric patients ≥ 2 years old with previously untreated high risk cHL: 1.8 mg/kg IV up to a maximum of 180 mg every 3 weeks for a maximum of 5 doses
  • In combination with chemotherapy for adults with previously untreated PTCL: 1.8 mg/kg IV up to a maximum of 180 mg every 3 weeks for 6 to 8 doses

 

J9042 

Alimta® (pemetrexed) or Pemrydi RTU® (pemetrexed) or generic pemetrexed intravenous (IV) infusion

 

 

  • Non-squamous NSCLC
  • Mesothelioma
  • Non-squamous NSCLC:
    • Initial treatment of metastatic disease: 500 mg/m2 IV, administered after pembrolizumab and prior to carboplatin or cisplatin in patients with a CrCl of 45 mL/min or greater, on day 1 of each 21-day cycle for four cycles, until disease progression or unacceptable toxicity
    •  Initial treatment of locally advanced or metastatic disease: 500 mg/m2 IV, administered prior to cisplatin in patients with a CrCl of 45 mL/min or greater, on day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity 
    • Maintenance treatment: 500 mg/m2 IV on day 1 of each 21-day cycle, in patients with a CrCl of 45 mL/min or greater, until disease progression or unacceptable toxicity after 4 cycles of platinum-based first-line chemotherapy 
    • Recurrent disease: 500 mg/m2 IV on day 1 of each 21-day cycle, in patients with a CrCl of 45 mL/min or greater, until disease progression or unacceptable toxicity 
  • Mesothelioma: 500 mg/m2 IV on day 1 of each 21-day cycle, administered with cisplatin, in patients with a creatinine clearance of 45 mL/min or greater, until disease progression or unacceptable toxicity

J9305

J9324

J9292

J9294

J9296

J9297

J9314

J9322

J9323

 

 

Anktiva® (nogapendekin alfa inbakicept-pmln) intravesical instillationBacillus Calmette-Guérin (BCG)- unresponsive nonmuscle invasive bladder cancer (NMIBC) in adults with carcinoma in situ (CIS) with or without papillary tumors 

Administer by intravesical instillation at the following recommended dosing: 

  • For induction: 400 mcg administered with BCG once weekly for 6 weeks. A second induction course may be administered if complete response is not achieved at month 3.
  • For maintenance: 400 mcg administered with BCG once weekly for 3 weeks at months 4, 7, 10, 13, and 19. For patients with an ongoing complete response at month 25 and later, additional maintenance instillations with BCG may be administered once weekly for 3 weeks at months 25, 31, and 37.
J9028
Arzerra® (ofatumumab) intravenous (IV) infusion
  • Untreated CLL in combination with chlorambucil 
  • Relapsed CLL in combination with fludarabine and cyclophosphamide 
  • Extended treatment of recurrent or progressive CLL following partial or incomplete response after at least two lines of therapy 
  • CLL refractory to fludarabine and alemtuzumab 
  • Previously untreated CLL in combination with chlorambucil: 300 mg IV on day 1 followed by 1,000 mg on day 8, then 1,000 mg on day 1 of every subsequent 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles 
  • Relapsed CLL in combination with fludarabine and cyclophosphamide: 300 mg IV on day 1 followed by 1,000 mg on day 8, then 1,000 mg on day 1 of every subsequent 28-day cycle for a maximum of 6 cycles 
  • Extended treatment in CLL: 300 mg IV on day 1 followed by 1,000 mg on day 8, then 1,000 mg 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years
  • Refractory CLL: 300 mg IV on day 1 followed 1 week later by 2,000 mg weekly for 7 doses (infusions 2-8), followed 4 weeks later by 2,000 mg every 4 weeks for 4 doses (infusions 9-12)
J9302 
FDA Label Reference 
Medication IndicationDosing HCPCS
Bavencio® (avelumab)
intravenous (IV) infusion
  • Metastatic merkel cell carcinoma (MCC) in patients ≥ 12 years old
  • Locally advanced or metastatic urothelial carcinoma (UC): 
    • Maintenance treatment in patients who have not progressed with first-line platinum-containing chemotherapy
    • In patients with disease progression during or following platinum-containing chemotherapy
    • In patients with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Advanced renal cell carcinoma (RCC), first-line treatment in combination with axitinib
  • Metastatic MCC: 800 mg IV every 2 weeks until disease progression or unacceptable toxicity 
  • Locally advanced or metastatic UC: 800 mg IV every 2 weeks until disease progression or unacceptable toxicity 
  • RCC: 800 mg IV every 2 weeks in combination with axitinib until disease progression or unacceptable toxicity
J9023 
Besponsa™ (inotuzumab ozogamicin)
intravenous (IV) infusion		Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in patients ≥ 1 year old

First cycle: 0.8 mg/m2 IV on day 1, and 0.5 mg/m2 on days 8 and 15 for a total dose of 1.8 mg/m2 per 21-day cycle

Subsequent cycles (response dependent):

  • Complete response (CR) or complete remission with incomplete hematologic recovery (CRi) achieved: 0.5 mg/m2 IV on days 1, 8, and 15 for a total dose of 1.5 mg/m2 per 28-day cycle
  • CR or CRi not achieved: 0.8 mg/m2 IV on day 1, and 0.5 mg/m2 on days 8 and 15 for a total dose of 1.8 mg/m2 per 28-day cycle
  • Discontinue treatment if CR or CRi not achieved within 3 cycles
    Duration: 
  • If proceeding to HSCT: 2 cycles, consider third cycle if CR or CRi and minimal residual disease negativity are not achieved after 2 cycles
  • If not proceeding to HSCT: maximum of 6 cycles
J9229 
Bizengri® (zenocutuzumab-zbco) intravenous (IV) infusion
  • Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
  • Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
IV: 750 mg every 2 weeks until disease progression or unacceptable toxicity

C9399**

J3490**

J3590**

J9999**

Blincyto® (blinatumomab) intravenous (IV) infusion 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  • CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) ≥ 0.1% in patients ≥ 1 month old 
  • Relapsed or refractory CD19- positive B-cell precursor ALL in patients ≥ 1 month old 
  • CD19-positive Philadelphia chromosome-negative B-cell precursor ALL in the consolidation phase of multiphase chemotherapy in patients ≥ 1 month old

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  • MRD-positive B-cell precursor ALL: 
    • Patients weighing ≥ 45 kg receive a fixed-dose of 28 mcg/day; patients weighing < 45 kg receive weight-based dosing of 15 mcg/m2 /day (not to exceed 28 mcg/day)
    • A treatment course consists of 1 induction cycle followed by up to 3 additional consolidation cycles
    • A single treatment cycle of induction or consolidation consists of 28 days of continuous infusion followed by a 14-day treatment-free interval (total 42 days)
  • Relapsed or refractory B-cell precursor ALL: 
    • Weight-based dosing according to prescribing information 
    • A treatment course consists of up to 2 induction cycles followed by 3 additional consolidation cycles, and up to 4 additional cycles of continued therapy 
    • A single treatment cycle of induction or consolidation consists of 28 days of continuous infusion followed by a 14-day treatment-free interval (total 42 days)
    • A single treatment cycle of continued therapy consists of 28 days of continuous infusion followed by a 56-day treatment-free interval (total 84 days)
  • B-cell precursor ALL in the consolidation phase: 
    • Patients weighing ≥ 45 kg receive a fixed-dose of 28 mcg/day; patients weighing < 45 kg receive weight-based dosing of 15 mcg/m2 /day (not to exceed 28 mcg/day) 
    • A single treatment cycle of monotherapy in consolidation consists of 28 days of continuous infusion followed by a 14-day treatment-free interval (total 42 days)
J9039 
FDA Label Reference 
MedicationIndication  Dosing HCPCS 
Columvi™ (glofitamab-gxbm) intravenous (IV) infusionRelapsed or refractory diffuse large Bcell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, in adults who have received two or more prior lines of systemic therapy
  • Cycle 1: 
    • Day 1: Pretreatment with obinutuzumab 1000 mg 
    • Day 8: 1st step-up dose of 2.5 mg IV 
    • Day 15: 2nd step-up dose of 10 mg IV 
  • Cycles 2-12: o Day 1: 30 mg IV
  •  Each treatment cycle is 21 days
J9286 
FDA Label Reference 
MedicationIndication  Dosing HCPCS 
Danyelza® (naxitamab-gqgk)
 intravenous (IV) infusion		Relapsed or refractory high-risk neuroblastoma in the bone or bone marrow in pediatric patients 1 year of age and older and adults who have demonstrated a partial response, minor response, or stable disease to prior therapy

IV: 3 mg/kg/day (up to 150 mg/day) administered on days 1, 3, and 5 of each 28-day treatment cycle; repeat until complete or partial response, followed by 5 additional 28-day cycles. Subsequent cycles may be repeated every 8 weeks.

Discontinue for disease progression or unacceptable toxicity

J9348 
Darzalex® (daratumumab)
 intravenous (IV) infusion 		Multiple myelomaIV: 16 mg/kg actual body weight according to recommended schedule in prescribing information J9145
Darzalex Faspro™ (daratumumab and hyaluronidase-fihj) subcutaneous (SC) injection
  • Multiple myeloma 
  • Light chain (AL) amyloidosis
SC: (1,800 mg daratumumab and 30,000 units hyaluronidase) administered into the abdomen over approximately 3 to 5 minutes according to recommended schedule in prescribing information J9144

Datroway® (datopotamab deruxtecan-dlnk)

intravenous (IV) infusion

 

Unresectable or metastatic, HR-positive, HER2-negative breast cancer after receiving prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease

 

IV: 6 mg/kg once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity

 

C9399**

J3490**

J3590**

J9999**

FDA Label Reference 
MedicationIndication  Dosing HCPCS 
Elahere™ (mirvetuximab soravtansine-gynx) intravenous (IV) infusion FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who have received one to three prior systemic treatment regimensIV: 6 mg/kg adjusted ideal body weight every 3 weeks until disease progression or unacceptable toxicity J9063 
Elrexfio™ (elranatamab-bcmm) subcutaneous (SC) injectionRelapsed or refractory multiple myeloma in adults

SC: Following 2 step-up doses in Week 1, administered weekly for 24 weeks, then biweekly (every 2 weeks) in responding patients

  • Step-up dosing: 
    • Day 1: 1st step-up dose of 12 mg 
    • Day 4: 2nd step-up dose of 32 mg 
    • Day 8: 1st treatment dose of 76 mg 
  • Weekly dosing
    • One week after 1st treatment dose and weekly thereafter through week 24: 76 mg 
  • Biweekly (every 2 weeks) dosing: 
    • Week 25 and every 2 weeks thereafter (for responders only): 76 mg 
J1323
Elzonris™ (tagraxofusp-erzs) intravenous (IV) infusion
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older
IV: 12 mcg/kg over 15 minutes once daily on days 1 to 5 of a 21-day cycle

First cycle to be administered in the inpatient setting. Subsequent cycles may be administered in the inpatient or appropriate outpatient setting		J9269
Empliciti™ (elotuzumab) intravenous (IV) infusionMultiple myeloma
  • With lenalidomide and dexamethasone: 10 mg/kg IV every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity
  • With pomalidomide and dexamethasone: 10 mg/kg IV every week for the first two cycles and 20 mg/kg every 4 weeks thereafter until disease progression or unacceptable toxicity
J9176 
Enhertu® (fam-trastuzumab deruxtecan-nxki) intravenous (IV) infusion
  • Unresectable or metastatic HER2-positive breast cancer in adults who have received a prior anti-HER2-based regimen
  • Unresectable or metastatic HER2-low breast cancer in adults
  • Unresectable or metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have activating HER2 mutations and who have received a prior systemic therapy
  • Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in adults who have received a prior trastuzumab-based regimen
  • Unresectable or metastatic HER2-positive solid tumors in adults who have received prior systemic treatment and have no satisfactory alternative treatment options
  • HER2-positive or HER2-low metastatic breast cancer: 5.4 mg/kg IV once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity
  • HER2-mutant unresectable or metastatic NSCLC: 5.4 mg/kg IV once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity
  • HER2-positive locally advanced or metastatic gastric cancer: 6.4 mg/kg IV once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity
  • HER2-positive (IHC 3+) unresectable or metastatic solid tumors: 5.4 mg/kg IV once every 3 weeks (21- day cycle) until disease progression or unacceptable toxicity
  • Enhertu is not to be substituted for or with trastuzumab or ado-trastuzumab emtansine.
J9358 
Epkinly® (epcoritamab-bysp) subcutaneous (SC) injection

Relapsed or refractory diffuse large Bcell lymphoma (DLBCL) and highgrade B-cell lymphoma in adults after two or more prior lines of systemic therapy

Relapsed or refractory follicular lymphoma (FL) in adults after two or more lines of systemic therapy

DLBCL and High-grade B-cell Lymphoma 

  • Cycle 1: 
    • Day 1: 1st step-up dose of 0.16 mg SC 
    • Day 8: 2nd step-up dose of 0.8 mg SC 
    • Day 15: 1st full dose of 48 mg SC 
    • Day 22: 48 mg SC 
  • Cycles 2-3: 48 mg SC on days 1, 8, 15, and 22 
  • Cycles 4-9: 48 mg SC on days 1 and 15 
  • Cycle 10 and beyond: 48 mg SC on day 1 
  • Cycle length = 28 days

Follicular Lymphoma 

  • Cycle 1: 
    • Day 1: 1st step-up dose of 0.16 mg SC 
    • Day 8: 2nd step-up dose of 0.8 mg SC 
    • Day 15: 3 rd step-up dose of 3 mg SC 
    • Day 22: 1 st full dose of 48 mg SC 
  • Cycles 2-3: 48 mg SC on days 1, 8, 15, and 22 
  • Cycles 4-9: 48 mg SC on days 1 and 15 
  • Cycle 10 and beyond: 48 mg SC on day 1 
  • Cycle length = 28 days
J9321
Erbitux® (cetuximab)
intravenous (IV) infusion
  • Locally or regionally advanced squamous cell carcinoma of the head and neck
  • Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
  • K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
  • BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)
  • In combination with radiation therapy: 
    • Initial dose: 400 mg/m2 IV one week prior to initiating a course of radiation therapy 
    • Subsequent doses: 250 mg/m2 IV every week for the duration of radiation therapy (6–7 weeks) 
  • As single-agent or in combination with chemotherapy:
    • Weekly: Initial dose of 400 mg/m2 IV, and subsequent doses of 250 mg/m2 once weekly
    • Biweekly: 500 mg/m2 IV every two weeks 
    • Continue treatment until disease progression or unacceptable toxicity
J9055 
Erwinaze (asparaginase Erwinia chrysanthemi) intramuscular (IM) injection Acute lymphoblastic leukemia (ALL), as a component of a multi-agent chemotherapeutic regimen, in patients who have developed hypersensitivity to E. coli-derived asparaginaseIM: 25,000 IU/m2 three times weekly (Monday/Wednesday/Friday) for 6 doses for each planned pegaspargase dose, when replacing a long-acting asparaginase product. To substitute for a dose of native E. coli asparaginase, give 25,000 IU/m2 for each scheduled dose of native E. coli asparaginase J9019 
FDA Label Reference 
MedicationIndication  Dosing HCPCS 
Fyarro™ (sirolimus albumin-bound nanoparticles)
intravenous (IV) infusion 		Locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa) in adultsIV: 100 mg/m2 on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity J9331 
FDA Label Reference 
MedicationIndication  Dosing HCPCS 
Gazyva® (obinutuzumab) intravenous (IV) infusion 
  • Previously untreated chronic lymphocytic leukemia 
  • Follicular lymphoma in patients who relapsed after, or are refractory to, a rituximab-containing regimen 
  • Previously untreated stage II bulky, III or IV follicular lymphoma
  • Chronic lymphocytic leukemia: 100 mg IV on day 1 and 900 mg on day 2 of Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2– 6
  • Follicular lymphoma: 1000 mg IV on day 1, 8, and 15 of Cycle 1, 1000 mg on day 1 of Cycles 2-6 or Cycles 2-8, and then 1000 mg every 2 months for up to 2 years
J9301 
FDA Label Reference 
MedicationIndication  Dosing HCPCS 
Halaven® (eribulin mesylate) intravenous (IV) infusion
  • Metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease 
  • Unresectable or metastatic liposarcoma in patients who have received a prior anthracycline-containing regimen
IV: 1.4 mg/m2 on Days 1 and 8 of a 21-day cycle 
J9179
Hycamtin® (topotecan) intravenous (IV) infusion 
  • Metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent 
  • Small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent
  • Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin
  • Ovarian Cancer and SCLC: 1.5 mg/m2 IV daily for 5 consecutive days, starting on day 1 of a 21-day cycle 
  • Cervical Cancer: 0.75 mg/m2 IV on days 1, 2, and 3, with cisplatin 50 mg/m2 on day 1, of a 21-day cycle 
J9351 
FDA Label Reference 
MedicationIndication  Dosing HCPCS 
Imdelltra™ (tarlatamab-dlle) intravenous (IV) infusion Extensive stage small cell lung cancer (ES-SCLC) in adults with disease progression on or after platinum-based chemotherapyIV: Administer 1 mg step-up dose on day 1 of cycle 1, followed by 10 mg on days 8, 15, and every 2 weeks thereafter until disease progression or unacceptable toxicityJ9026
Imfinzi® (durvalumab) intravenous (IV) infusion
  • Resectable non-small cell lung cancer (NSCLC) in adults with no known EGFR mutations or ALK rearrangements, as neoadjuvant treatment in combination with platinum-containing chemotherapy followed by continued use as a single agent as adjuvant treatment after surgery
  • Unresectable, Stage III NSCLC in adults whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, as a single agent
  • Metastatic NSCLC in adults with no sensitizing EGFR mutations or ALK genomic tumor aberrations, in combination with tremelimumab-actl and platinum-based chemotherapy
  • Extensive-stage small cell lung cancer (ES-SCLC) in adults, as first-line treatment in combination with etoposide and either carboplatin or cisplatin
  • Locally advanced or metastatic biliary tract cancer (BTC) in adults, in combination with gemcitabine and cisplatin
  • Unresectable hepatocellular carcinoma (uHCC) in adults, in combination with tremelimumab-actl 
  • Primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) in adults, in combination with carboplatin and paclitaxel followed by use as a single agent
  • Resectable NSCLC (neoadjuvant and adjuvant settings): 
    • Wt ≥30 kg: 
      • Neoadjuvant: 1,500 mg IV in combination with chemotherapy every 3 weeks for up to 4 cycles prior to surgery
      • Adjuvant: 1,500 mg IV as a single agent every 4 weeks for up to 12 cycles after surgery
    • Wt <30 kg: 
      • Neoadjuvant: 20 mg/kg IV every 3 weeks in combination with chemotherapy for up to 4 cycles prior to surgery 
      • Adjuvant: 20 mg/kg IV every 4 weeks as a single agent for up to 12 cycles after surgery 
  • Unresectable Stage III NSCLC: 
    • Wt ≥30 kg: 10 mg/kg IV every 2 weeks or 1,500 mg every 4 weeks 
    • Wt <30 kg: 10 mg/kg IV every 2 weeks 
  • Metastatic NSCLC: 
    • Wt ≥30 kg: 1,500 mg IV every 3 weeks in combination with chemotherapy for 4 cycles, and then 1,500 mg every 4 weeks as a single agent 
    • Wt <30 kg: 20 mg/kg IV every 3 weeks in combination with chemotherapy, and then 20 mg/kg every 4 weeks as a single agent 
  • ES-SCLC: 
    • Wt ≥30 kg: 1,500 mg IV every 3 weeks in combination with chemotherapy, and then 1,500 mg every 4 weeks as a single agent 
    • Wt <30 kg: 20 mg/kg IV every 3 weeks in combination with chemotherapy, and then 10 mg/kg every 2 weeks as a single agent
  • BTC:
    • Wt ≥30 kg: 1,500 mg IV every 3 weeks in combination with chemotherapy, and then 1,500 mg every 4 weeks as a single agent 
    • Wt <30 kg: 20 mg/kg IV every 3 weeks in combination with chemotherapy, and then 20 mg/kg every 4 weeks as a single agent 
  • uHCC: 
    • Wt ≥30 kg: 1,500 mg IV in combination with chemotherapy as a single dose at cycle 1/day 1, and then as a single agent every 4 weeks
    • Wt <30 kg: 20 mg/kg IV in combination with chemotherapy as a single dose at cycle 1/day1, and then as a single agent every 4 weeks 
  • dMMR endometrial cancer: 
    • Wt ≥30 kg: 1,120 mg IV every 3 weeks in combination with chemotherapy for 6 cycles, and then 1,500 mg every 4 weeks as a single agent 
    • Wt <30 kg: 15 mg/kg IV every 3 weeks in combination with chemotherapy for 6 cycles, and then 20 mg/kg every 4 weeks as a single agent
 
J9173 
Imjudo® (tremelimumab-actl) intravenous (IV) infusion 
  • Unresectable hepatocellular carcinoma (uHCC) in adults, in combination with durvalumab
  • Metastatic NSCLC in adults with no sensitizing EGFR mutations or ALK genomic tumor aberrations, in combination with durvalumab and platinum-based chemotherapy
  • uHCC: 
    • Wt ≥30 kg: 300 mg IV as a single dose in combination with durvalumab 1,500 mg at cycle 1/day 1, and then durvalumab as a single agent every 4 weeks 
    • Wt <30 kg: 4 mg/kg IV as a single dose in combination with durvalumab 20 mg/kg at  cycle 1/day1, and then durvalumab as a single agent every 4 weeks 
  • Metastatic NSCLC: 
    • Wt ≥30 kg: 75 mg IV every 3 weeks in combination with durvalumab 1,500 mg and platinum-based chemotherapy for 4 cycles, and then durvalumab 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of Imjudo 75 mg in combination with durvalumab dose 6 at week 16 
    • Wt <30 kg: 1 mg/kg IV every 3 weeks in combination with durvalumab 20 mg/kg and platinum-based chemotherapy for 4 cycles, and then durvalumab 20 mg/kg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of Imjudo 1 mg/kg in combination with durvalumab dose 6 at week 16
J9347 
Imlygic® (talimogene laherparepvec) intralesional injection Local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgeryInitial dose is up to a maximum of 4 mL at a concentration of 106 (1 million) plaque-forming units (PFU) per mL. Subsequent doses should be administered up to 4 mL at a concentration of 108 (100 million) PFU per mLJ9325
FDA Label Reference 
MedicationIndication  Dosing HCPCS 
Jemperli® (dostarlimab-gxly) intravenous (IV) infusion
  • Primary advanced or recurrent endometrial cancer (EC) in adults
  • Mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen in any setting for adult patients who are not candidates for curative surgery or radiation
  • Mismatch repair deficient (dMMR) recurrent or advanced solid tumors that have progressed on or following prior treatment and in adult patients who have no satisfactory alternative treatment options

Combination Therapy

Adults with primary advanced or recurrent EC: 500 mg IV every 3 weeks for 6 cycles in combination with carboplatin and paclitaxel followed by 1,000 mg IV as monotherapy every 6 weeks for all cycles thereafter until disease progression, unacceptable toxicity, or up to 3 years 

Monotherapy

Adults with dMMR recurrent or advanced EC and dMMR recurrent or advanced solid tumors: 500 mg IV every 3 weeks for 4 cycles followed by 1,000 mg IV every 6 weeks for all cycles thereafter until disease progression or unacceptable toxicity

J9272 
Jevtana® (cabazitaxel) intravenous (IV) infusionMetastatic castration-resistant prostate cancer in patients previously treated with a docetaxel-containing treatment regimenIV: 20 mg/m2 every three weeks in combination with oral prednisone 10 mg daily throughout treatment. A dose of 25 mg/m2 can be used in select patients at the discretion of the treating healthcare provider.J9043 J9064
FDA Label Reference 
Medication  IndicationDosing HCPCS  
Kadcyla® (ado-trastuzumab emtansine) intravenous (IV) infusion
  • HER2-positive, metastatic breast cancer, as a single agent, in patients who previously received trastuzumab and a taxane, separately or in combination   
  • HER2-positive early breast cancer (EBC), as single-agent adjuvant treatment, in patients who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment 
  • IV: 3.6 mg/kg every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity, or a total of 14 cycles for patients with EBC
  • Do not administer at doses greater than 3.6 mg/kg 
  • Do not substitute for or with trastuzumab
J9354 
Keytruda® (pembrolizumab) intravenous (IV) infusion 
  • Melanoma 
  • Non-small cell lung cancer (NSCLC) 
  • Malignant pleural mesothelioma (MPM) 
  • Head and neck squamous cell cancer (HNSCC)
  • Classical Hodgkin lymphoma (cHL) 
  • Primary mediastinal large B-cell lymphoma (PMBCL) 
  • Urothelial cancer 
  • High-risk, BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) 
  • Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer
  • Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) 
  • Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) endometrial carcinoma
  • Gastric cancer 
  • Esophageal cancer 
  • Cervical cancer 
  • Hepatocellular carcinoma (HCC) 
  • Biliary tract cancer (BTC) 
  • Merkel cell carcinoma (MCC) 
  • Renal cell carcinoma (RCC) 
  • Endometrial carcinoma 
  • Tumor mutational burden-high (TMB-H) cancer 
  • Cutaneous squamous cell carcinoma (cSCC)
  • Triple-negative breast cancer (TNBC)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Monotherapy

  • Adults with unresectable or metastatic melanoma: 200 mg IV every 3 weeks, or 400 mg every 6 weeks until disease progression or unacceptable toxicity 
  • Adjuvant treatment of adults with melanoma, NSCLC, or RCC: 200 mg IV every 3 weeks, or 400 mg every 6 weeks until disease recurrence, unacceptable toxicity, or up to 12 months 
  • Adults with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic urothelial carcinoma, MSI-H or dMMR cancer, MSI-H or dMMR CRC, MSI-H or dMMR endometrial carcinoma, esophageal cancer, cervical cancer, HCC, MCC, TMB-H cancer, or cSCC: 200 mg IV every 3 weeks, or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months
  • Adults with high-risk BCG-unresponsive NMIBC: 200 mg IV every 3 weeks, or 400 mg every 6 weeks until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months 
  • Pediatric patients with cHL, PMBCL, MSI-H or dMMR cancer, MCC, or TMB-H cancer: 2 mg/kg IV every 3 weeks (up to a maximum of 200 mg) until disease progression, unacceptable toxicity, or up to 24 months 
  • Pediatric patients (12 years and older) for adjuvant treatment of melanoma: 2 mg/kg IV every 3 weeks (up to a maximum of 200 mg) until disease recurrence, unacceptable toxicity, or up to 12 months

Combination Therapy

  • Adults with resectable NSCLC: 200 mg IV every 3 weeks, or 400 mg every 6 weeks (administer Keytruda prior to chemotherapy when given on same day). Duration/timing of treatment: Neoadjuvant treatment in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with Keytruda as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity 
  • Adults with NSCLC, MPM, HNSCC, HER2-negative gastric cancer, esophageal cancer, or BTC: 200 mg IV every 3 weeks, or 400 mg every 6 weeks (administer Keytruda prior to chemotherapy when given on same day) until disease progression, unacceptable toxicity, or up to 24 months
  • Adults with locally advanced or metastatic urothelial cancer: 200 mg IV every 3 weeks, or 400 mg every 6 weeks (administer Keytruda after enfortumab vedotin when given on same day) until disease progression, unacceptable toxicity, or up to 24 months 
  • Adults with HER2-positive gastric cancer: 200 mg IV every 3 weeks, or 400 mg every 6 weeks (administer Keytruda prior to trastuzumab and chemotherapy when given on same day) until disease progression, unacceptable toxicity, or up to 24 months 
  • Adults with cervical cancer: 200 mg IV every 3 weeks, or 400 mg every 6 weeks (administer Keytruda prior to chemoradiotherapy or prior to chemotherapy with or without bevacizumab when given on same day) until disease progression, unacceptable toxicity, or (for Keytruda) up to 24 months 
  • Adults with RCC: 200 mg IV every 3 weeks, or 400 mg every 6 weeks (administer Keytruda in combination with axitinib 5 mg orally twice daily OR in combination with lenvatinib 20 mg orally once daily) until disease progression, unacceptable toxicity, or (for Keytruda) up to 24 months 
  • Adults with endometrial carcinoma: 200 mg IV every 3 weeks, or 400 mg every 6 weeks (administer Keytruda prior to carboplatin and paclitaxel when given on same day, or in combination with lenvatinib 20 mg orally once daily) until disease progression, unacceptable toxicity, or (for Keytruda) up to 24 months
  • Adults with high-risk early-stage TNBC: 200 mg IV every 3 weeks, or 400 mg every 6 weeks (administer Keytruda prior to chemotherapy when given on same day). Duration/timing of treatment: Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity, followed by adjuvant treatment with Keytruda as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicity 
  • Adults with locally recurrent unresectable or metastatic TNBC: 200 mg IV every 3 weeks, or 400 mg every 6 weeks (administer Keytruda prior to chemotherapy when given on same day) until disease progression, unacceptable toxicity, or up to 24 months
J9271 
Kimmtrak® (tebentafusp-tebn) intravenous (IV) infusionHLA-A*02:01-positive adults with unresectable or metastatic uveal melanomaIV: 20 mcg on day 1, 30 mcg on day 8, 68 mcg on day 15, and 68 mcg once every week thereafter. Administer until unacceptable toxicity or disease progression occur. J9274
Kyprolis® (carfilzomib) intravenous (IV) infusion
  • Relapsed or refractory multiple myeloma in adults who have received one to three lines of therapy, in combination with other chemotherapy
  • Single-agent treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
  • In combination with dexamethasone, or daratumumab and dexamethasone, or daratumumab and hyaluronidase-fihj and dexamethasone: 20/70 mg/m2 IV once weekly
  • In combination with dexamethasone, or daratumumab and dexamethasone, or daratumumab and hyaluronidase-fihj and dexamethasone, or isatuximab and dexamethasone, or monotherapy: 20/56 mg/m2 IV twice weekly
  • In combination with lenalidomide and dexamethasone, or monotherapy: 20/27 mg/m2 IV twice weekly
J9047
FDA Label Reference 
Medication  IndicationDosing HCPCS  
Libtayo® (cemiplimab-rwlc) intravenous (IV) infusion
  • Metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) in patients who are not candidates for curative surgery or curative radiation 
  • Locally advanced BCC (laBCC) or metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate 
  • First-line treatment, in combination with platinum-based chemotherapy, of adults with NSCLC with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic 
  • First-line treatment, as single agent, of adults with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%], with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or is metastatic
  • CSCC and BCC: 350 mg IV every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months
  • NSCLC: 350 mg IV every 3 weeks until disease progression or unacceptable toxicity 
J9119 
Loqtorzi™ (toripalimab-tpzi) intravenous (IV) infusion 
  • Metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) in adults, as first-line treatment in combination with cisplatin and gemcitabine
  • Recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy, as a single-agent treatment
  • In combination with cisplatin and gemcitabine: 240 mg IV every three weeks
  • As a single agent: 3 mg/kg IV every two weeks
J3263 
Lunsumio™ (mosunetuzumab-axgb) intravenous (IV) infusionRelapsed or refractory follicular lymphoma in adults after two or more lines of systemic therapy
  • Cycle 1 Day 1: 1 mg IV 
  • Cycle 1 Day 8: 2 mg IV 
  • Cycle 1 Day 15: 60 mg IV 
  • Cycle 2 Day 1: 60 mg IV 
  • Cycle 3+ Day 1: 30 mg IV 

  • Administer for 8 cycles unless patient experiences unacceptable toxicity or disease progression. For patients who achieve complete response, no further treatment beyond 8 cycles. For patients who achieve partial response or have stable disease in response to 8 treatment cycles, administer an additional 9 cycles of treatment (17 cycles total), unless a patient experiences unacceptable toxicity or disease progression.
J9350 
Lymphir™ (denileukin diftitox-cxdl) intravenous (IV) infusionRelapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) in adults, after at least one prior systemic therapyV: 9 mcg/kg/day on days 1 through 5 of a 21-day cycle, administered until disease progression or unacceptable toxicityJ9161
FDA Label Reference 
Medication  IndicationDosing HCPCS  
Margenza® (margetuximab-cmkb)

intravenous (IV) infusion
Metastatic HER2-positive breast cancer in adults who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease
IV: Initial dose of 15 mg/kg over 120 minutes, then over a minimum of 30 minutes every 3 weeks for all subsequent doses
J9353
Monjuvi® (tafasitamab-cxix) intravenous (IV) infusion Relapsed or refractory diffuse large Bcell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and in patients who are not eligible for autologous stem cell transplant (ASCT)
  • 12 mg/kg IV according to the following dosing schedule: 
    • Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle
    • Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle 
    • Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle 
  • Give in combination with lenalidomide for a maximum of 12 cycles and then continue Monjuvi as monotherapy until disease progression or unacceptable toxicity
J9349

Mylotarg™ (gemtuzumab ozogamicin intravenous (IV) infusion

 

 

 

 

 

 

  • Newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients ≥ 1 month old
  • Relapsed or refractory CD33- positive AML in adults and pediatric patients ≥ 2 years old 

 

 

 

 

 

 

  • Newly-diagnosed de novo AML (combination regimen)
    • Adults: Induction – 3 mg/ m2 (up to one 4.5 mg vial) on days 1, 4, and 7 in combination with daunorubicin and cytarabine; Consolidation – 3 mg/m2 on day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine
    • Pediatric patients 1 month and older: 3 mg/m2 for patients with body surface area (BSA) 0.6 m2 or greater; 0.1 mg/kg for patients with BSA less than 0.6 m2
  • Newly-diagnosed AML (single-agent regimen) 
    • Adults: Induction – 6 mg/m2 (not limited to one 4.5 mg vial) on day 1 and 3 mg/m2 (not limited to one 4.5 mg vial) on day 8; Continuation – For patients without evidence of disease progression following induction, up to 8 continuation courses of Mylotarg 2 mg/m2 (not limited to one 4.5 mg vial) on day 1 every 4 weeks
  • Relapsed/refractory AML (single-agent regimen): 3 mg/m2 (up to one 4.5 mg vial) on days 1, 4, and 7 
J9203 
FDA Label Reference 
Medication  IndicationDosing HCPCS  

Opdivo® (nivolumab) intravenous (IV) infusion

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  • Melanoma 
  • Non-small cell lung cancer (NSCLC) 
  • Malignant pleural mesothelioma
  • Renal cell carcinoma (RCC) 
  • Classical Hodgkin lymphoma (cHL) 
  • Squamous cell carcinoma of the head and neck (SCCHN)
  • Urothelial carcinoma 
  • Colorectal cancer 
  • Hepatocellular carcinoma (HCC) 
  • Esophageal cancer 
  • Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  • Unresectable or metastatic melanoma 
    • Adult and pediatric patients ≥ 40 kg: 240 mg IV every 2 weeks or 480 mg every 4 weeks
    • Pediatric patients < 40 kg: 3 mg/kg IV every 2 weeks or 6 mg/kg every 4 weeks
    • Adult and pediatric patients ≥ 40 kg: 1 mg/kg IV followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks
    • Pediatric patients < 40 kg: 1 mg/kg IV followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks
  • Adjuvant treatment of melanoma:
    • Adult and pediatric patients ≥ 40 kg: 240 mg IV every 2 weeks or 480 mg every 4 weeks
    • Pediatric patients < 40 kg: 3 mg/kg IV every 2 weeks or 6 mg/kg every 4 weeks
  • Neoadjuvant treatment of resectable (tumors ≥4 cm or node positive) NSCLC 
    • 360 mg IV with platinum-doublet chemotherapy on the same day every 3 weeks for 3 cycles 
  • Neoadjuvant and adjuvant treatment of resectable NSCLC
    • 360 mg IV with platinum-doublet chemotherapy on the same day every 3 weeks for up to 4 cycles, then continued as single-agent 480 mg IV every 4 weeks after surgery for up to 13 cycles (~1 year)
  • Metastatic NSCLC 
    • 360 mg IV every 3 weeks with ipilimumab 1 mg/kg every 6 weeks 
    • 360 mg IV every 3 weeks with ipilimumab 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy 
    • 240 mg IV every 2 weeks or 480 mg every 4 weeks
  • Malignant pleural mesothelioma: 360 mg IV every 3 weeks with ipilimumab 1 mg/kg every 6 weeks 
  • Advanced RCC 
    • 3 mg/kg IV followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks 
    • 240 mg IV every 2 weeks or 480 mg every 4 weeks administered in combination with cabozantinib 40 mg once daily without food
    • 240 mg IV every 2 weeks or 480 mg every 4 weeks
  • cHL: 240 mg IV every 2 weeks or 480 mg every 4 weeks
  • Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN): 240 mg IV every 2 weeks or 480 mg every 4 weeks
  • Adjuvant treatment of urothelial carcinoma: 240 mg IV every 2 weeks or 480 mg every 4 weeks
  • First-line unresectable or metastatic urothelial carcinoma: 360 mg IV every 3 weeks with cisplatin and gemcitabine on the same day for up to 6 cycles, then 240 mg every 2 weeks or 480 mg every 4 weeks
  • Previously treated locally advanced or metastatic urothelial carcinoma: 240 mg IV every 2 weeks or 480 mg every 4 weeks
  • MSI-H or dMMR metastatic colorectal cancer:  
    • Adult and pediatric patients ≥ 40 kg: 240 mg IV every 2 weeks or 480 mg every 4 weeks
    • Pediatric patients < 40 kg: 3 mg/kg IV every 2 weeks
    • Adult and pediatric patients ≥ 40 kg: 3 mg/kg IV followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks
  • HCC: 1 mg/kg IV followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks
  • Adjuvant treatment of resected esophageal or gastroesophageal cancer: 240 mg IV every 2 weeks or 480 mg every 4 weeks for total treatment duration of 1 year
  • Esophageal squamous cell carcinoma: 
    • 240 mg IV every 2 weeks or 480 mg every 4 weeks in combination with chemotherapy regimen of fluoropyrimidine- and platinum-containing chemotherapy
    • 3 mg/kg IV every 2 weeks or 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks
    • 240 mg IV every 2 weeks or 480 mg every 4 weeks 
  • Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC, GEJC, or EAC): 
    • 360 mg IV every 3 weeks with fluoropyrimidine- and platinum-containing chemotherapy every 3 weeks
    • 240 mg IV every 2 weeks with fluoropyrimidine- and platinum-containing chemotherapy every 2 weeks

J9299

 

 

Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy)

subcutaneous (SC) injection

 

  • Renal cell carcinoma (RCC)
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Squamous cell carcinoma of the head and neck (SCCHN)
  • Urothelial carcinoma (UC)
  • Colorectal cancer
  • Hepatocellular carcinoma (HCC)
  • Esophageal cancer
  • Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma

 

NOTE: Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) has a different dosage and administration than intravenous nivolumab products. Qpdivo Qvantig is for SC use only, and should be administered as a SC injection over 3-5 minutes.

  • Renal cell carcinoma
    • 600 mg/10,000 units every 2 weeks or 1,200 mg/20,000 units every 4 weeks
    • 600 mg/10,000 units every 2 weeks or 1,200 mg/20,000 units every 4 weeks administered in combination with cabozantinib 40 mg once daily without food
  • Melanoma
    • 600 mg/10,000 units every 2 weeks or 1,200 mg/20,000 units every 4 weeks
  • Neoadjuvant and adjuvant treatment of resectable (tumors ≥4 cm or node positive) non-small cell lung cancer
    • 900 mg/15,000 units with platinum-doublet chemotherapy on the same day every 3 weeks for 3 cycles, then use as a single-agent 1,200 mg/20,000 units every 4 weeks after surgery for up to 13 cycles
  • Metastatic non-small cell lung cancer
    • 600 mg/10,000 units every 2 weeks or 1,200 mg/20,000 units every 4 weeks
  • Squamous cell carcinoma of the head and neck
    • 600 mg/10,000 units every 2 weeks or 1,200 mg/20,000 units every 4 weeks
  • Urothelial carcinoma
    • 600 mg/10,000 units every 2 weeks or 1,200 mg/20,000 units every 4 weeks
  • First-line unresectable or metastatic urothelial carcinoma
    • 900 mg/15,000 units every 3 weeks with cisplatin and gemcitabine on the same day  for up to 6 cycles, then 600 mg/10,000 units every 2 weeks or 1,200 mg/20,000 units every 4 weeks
  • Colorectal cancer
    • 600 mg/10,000 units every 2 weeks or 1,200 mg/20,000 units every 4 weeks
  • Hepatocellular carcinoma
    • 600 mg/10,000 units every 2 weeks or 1,200 mg/20,000 units every 4 weeks
  • Esophageal cancer
    • 600 mg/10,000 units every 2 weeks or 1,200 mg/20,000 units every 4 weeks
    • 600 mg/10,000 units every 2 weeks or 1,200 mg/20,000 units every 4 weeks administered in combination with fluoropyrimidine- and platinum-containing chemotherapy
  • Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
    • 600 mg/10,000 units every 2 weeks in combination with fluoropyrimidine- and platinum-containing chemotherapy every 2 weeks
    • 900 mg/15,000 units every 3 weeks with fluoropyrimidine- and platinum-containing chemotherapy every 3 weeks

C9399**

J3490**

J3590**

J9999**

Opdualag™ (nivolumab and relatlimab-rmbw) intravenous (IV) infusion Unresectable or metastatic melanoma in adult and pediatric patients 12 years of age or older
IV: Adults and pediatric patients ≥ 12 years of age who weigh at least 40 kg: 480 mg nivolumab and 160 mg relatlimab every 4 weeks
J9298
FDA Label Reference 
Medication  IndicationDosing HCPCS  
Padcev™ (enfortumab vedotin-ejfv)intravenous (IV) infusion Locally advanced or metastatic urothelial cancer in adults
  • As single agent: 1.25 mg/kg (up to a maximum dose of 125 mg for patients ≥100 kg) given IV on days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity
  • In combination with pembrolizumab: 1.25 mg/kg (up to a maximum dose of 125 mg for patients ≥100 kg) given IV on days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity
J9177

Pemfexy® (pemetrexed) or Pemrydi RTU® (pemetrexed) or generic pemetrexed intravenous (IV) infusion

 

 

 

 

 

 

 

  • Non-squamous NSCLC 
  • Mesothelioma

 

 

 

 

 

 

 

 

  • Non-squamous NSCLC: 
    • Initial treatment of metastatic disease: 500 mg/m2 IV, administered after pembrolizumab and prior to carboplatin or cisplatin in patients with a CrCl of 45 mL/min or greater, on day 1 of each 21-day cycle for four cycles, until disease progression or unacceptable toxicity
    • Initial treatment of locally advanced or metastatic disease: 500 mg/m2 IV, administered prior to cisplatin in patients with a CrCl of 45 mL/min or greater, on day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity
    • Maintenance treatment: 500 mg/m2 IV on day 1 of each 21-day cycle, in patients with a CrCl of 45 mL/min or greater, until disease progression or unacceptable toxicity after 4 cycles of platinum-based first-line chemotherapy
    • Recurrent disease: 500 mg/m2 IV on day 1 of each 21-day cycle, in patients with a CrCl of 45 mL/min or greater, until disease progression or unacceptable toxicity 
  • Mesothelioma: 500 mg/m2 IV on day 1 of each 21-day cycle, administered with cisplatin, in patients with a creatinine clearance of 45 mL/min or greater, until disease progression or unacceptable toxicity

J9304

J9324

J9292

J9294

J9296

J9297

J9314

J9322

J9323

 

 

 

 

 

 

 

Perjeta® (pertuzumab) intravenous (IV) infusion 
  • HER2-positive metastatic breast cancer (MBC) in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
  • Neoadjuvant treatment of HER2-positive, locally advanced,  inflammatory, or early stage breast cancer (either > 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer 
  • Adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence
  • Initial dose is 840 mg IV, followed every 3 weeks thereafter by 420 mg
  • MBC: Administer with trastuzumab or trastuzumab hyaluronidase-oysk, and docetaxel every 3 weeks
  • Neoadjuvant: Administer with trastuzumab or trastuzumab hyaluronidase-oysk, and chemotherapy preoperatively every 3 weeks for 3 to 6 cycles
  • Adjuvant: Administer with trastuzumab or trastuzumab hyaluronidase-oysk, and chemotherapy postoperatively every 3 weeks for a total of 1 year (up to 18 cycles)
J9306 

Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) subcutaneous (SC) injection 

 

 

 

 

 

 

  • For neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either > 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer
  • For adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence 
  • HER2-positive metastatic breast cancer (MBC) in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease

 

  • Initial dose is 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase SC over approximately 8 minutes, followed every 3 weeks by a dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC over approximately 5 minutes
  • Neoadjuvant: Administer SC every 3 weeks and chemotherapy IV preoperatively for 3 to 6 cycles
  • Adjuvant: Administer SC every 3 weeks and chemotherapy IV postoperatively for a total of 1 year (up to 18 cycles)
  • MBC: Administer SC and docetaxel IV every 3 weeks
  • For SC use in thigh only, do not administer intravenously
  • Dosing and administration are different than IV pertuzumab and trastuzumab products 

J9316 

 

 

 

 

 

 

 

Polivy™ (polatuzumab vedotin-piiq) intravenous (IV) infusion

Relapsed or refractory diffuse large Bcell lymphoma (DLBCL), not otherwise specified, in adults, in combination with bendamustine and a rituximab product, after at least two prior therapies

Previously untreated DLBCL, not otherwise specified or high-grade Bcell lymphoma (HGBL) in adults, in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone 

IV: 1.8 mg/kg every 21 days for 6 cyclesJ9309
Portrazza™ (necitumumab) intravenous (IV) infusion First-line treatment of metastatic squamous non-small cell lung cancer, in combination with gemcitabine and cisplatinIV: 800 mg (absolute dose) on days 1 and 8 of each 3-week cycle. Continue until disease progression or unacceptable toxicity.J9295
Poteligeo® (mogamulizumab-kpkc) intravenous (IV) infusionRelapsed or refractory mycosis fungoides or Sézary syndrome in adults after at least one prior systemic therapyIV: 1 mg/kg on days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle. Continue until disease progression or unacceptable toxicity.J9204
Provenge® (sipuleucel-T) intravenous (IV) infusionAsymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancerIV: 3 complete doses at approximately 2-week intervals (each dose contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF) Q2043 
FDA Label Reference 
Medication  IndicationDosing HCPCS  

Rybrevant® (amivantamab-vmjw)

intravenous (IV) infusion

  • Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy, as a single agent
  • Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations in adults, as first-line treatment in combination with carboplatin and pemetrexed 
  • Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations in adults whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy, in combination with carboplatin and pemetrexed
  • Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations in adults, as first-line treatment in combination with lazertinib
Single-agent treatment or first-line treatment in combination with lazertinib: Given IV once weekly from weeks 1 to 5 (total of 5 doses), no dose given at week 6, then given every 2 weeks starting at week 7 onwards until disease progression or unacceptable toxicity, at the following dosing:
  • < 80 kg: 1050 mg 
  • ≥ 80 kg: 1400 mg 

Treatment in combination with carboplatin and pemetrexed: Given IV once weekly from weeks 1 to 4 (total of 4 doses), no dose given at weeks 5 and 6, then given every 3 weeks starting at week 7 onwards until disease progression or unacceptable toxicity, at the following dosing:

  • < 80 kg: 1400 mg weeks 1 to 4, then 1750 mg week 7 onwards 
  • ≥ 80 kg: 1750 mg weeks 1 to 4, then 2100 mg week 7 onwards
J9061 

Rylaze [asparaginase Erwinia chrysanthemi (recombinant)-rywn] intramuscular (IM) injection

Acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and pediatric patients ≥ 1 month old who have developed hypersensitivity to E. coli-derived asparaginase
  • When given every 48 hours: 25 mg/m2 IM every 48 hours, when replacing a long-acting asparaginase product 
  • When given Monday/Wednesday/Friday: 25 mg/m2 IM on Monday morning and Wednesday morning, and 50 mg/m2 on Friday afternoon, when replacing a long-acting asparaginase product 
J9021 
FDA Label Reference 
Medication  IndicationDosing HCPCS  

Sarclisa® (isatuximab-irfc) intravenous (IV) infusion

  • Multiple myeloma in adults who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor (in combination with pomalidomide and dexamethasone)
  • Relapsed or refractory multiple myeloma in adults who have received 1 to 3 prior lines of therapy (in combination with carfilzomib and dexamethasone)
  • Newly diagnosed multiple myeloma in adults who are not eligible for autologous stem cell transplant (in combination with bortezomib, lenalidomide, and dexamethasone)

In combination with pomalidomide and dexamethasone or with carfilzomib and dexamethasone:

  • Cycle 1 (28-day cycle): 10 mg/kg IV every week on days 1, 8, 15, and 22
  • Cycle 2 and beyond (28-day cycles): 10 mg/kg IV every 2 weeks on days 1 and 15 of each cycle until disease progression or unacceptable toxicity

In combination with bortezomib, lenalidomide, and dexamethasone:

  • Cycle 1 (42-day cycle): 10 mg/kg IV every week on days 1, 8, 15, 22, and 29 
  • Cycles 2 to 4 (42-day cycles): 10 mg/kg IV every 2 weeks on days 1, 15, and 29 of each cycle
  • Cycles 5 to 17 (28-day cycles): 10 mg/kg IV every 2 weeks on days 1 and 15 of each cycle
  • Cycle 18 and beyond (28-day cycles): 10 mg/kg IV every 4 weeks on day 1 of each cycle until disease progression or unacceptable toxicity
J9227

Sylvant® (siltuximab) intravenous (IV) infusion

Multicentric Castleman’s disease (MCD) in patients who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative
IV: 11 mg/kg every 3 weeks
J2860
FDA Label Reference 
Medication  IndicationDosing HCPCS  

Talvey™ (talquetamab-tgvs) subcutaneous (SC) injection

Relapsed or refractory multiple myeloma in adults

SC: Administered on a weekly or biweekly (every 2 weeks) dosing schedule following the step-up dosing schedule, until disease progression or unacceptable toxicity.

  • Weekly Dosing Schedule: 
    • Day 1: 1st step-up dose of 0.01 mg/kg 
    • Day 4: 2 nd step-up dose of 0.06 mg/kg 
    • Day 7: 1 st treatment dose of 0.4 mg/kg
    • One week after 1st treatment dose and weekly thereafter: 0.4 mg/kg once weekly
  • Biweekly Dosing Schedule: 
    • Day 1: 1 st step-up dose of 0.01 mg/kg
    • Day 4: 2nd step-up dose of 0.06 mg/kg 
    • Day 7: 3rd step-up dose of 0.4 mg/kg 
    • Day 10: 1st treatment dose of 0.8 mg/kg 
    • Two weeks after 1st treatment dose and every 2 weeks thereafter: 0.8 mg/kg every 2 weeks
J3055 

Tecentriq® (atezolizumab) intravenous (IV) infusion

  • Non-small cell lung cancer (NSCLC) 
  • Small cell lung cancer (SCLC) 
  • Hepatocellular carcinoma (HCC) 
  • Melanoma 
  • Alveolar soft part sarcoma (ASPS) 
  • NSCLC: 
    • Adjuvant setting: Administer following resection and up to 4 cycles of platinum-based chemotherapy as 840 mg IV every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks for up to 1 year
    • Metastatic setting: 840 mg IV every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks
  • SCLC: 840 mg IV every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks
  • HCC: 840 mg IV every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks
  • Melanoma: Following completion of a 28-day cycle of cobimetinib and vemurafenib, give 840 mg IV every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks with cobimetinib and vemurafenib
  • ASPS: 
    • Adults: 840 mg IV every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks
    • Pediatric patients ≥ 2 years old: 15 mg/kg (up to a maximum of 1200 mg) IV every 3 weeks
J9022 
Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) subcutaneous (SC) injection
  • Non-small cell lung cancer (NSCLC) in adults
  • Small cell lung cancer (SCLC) in adults
  • Hepatocellular carcinoma (HCC) in adults
  • Melanoma in adults 
  • Alveolar soft part sarcoma (ASPS) in adults 
  • NSCLC: 
    • Adjuvant setting: Administer following resection and up to 4 cycles of platinum-based chemotherapy as 1,875 mg atezolizumab and 30,000 units hyaluronidase (15 mL) SC every 3 weeks for up to 1 year 
    • Metastatic setting: 1,875 mg atezolizumab and 30,000 units hyaluronidase (15 mL) SC every 3 weeks 
  • SCLC: 1,875 mg atezolizumab and 30,000 units hyaluronidase (15 mL) SC every 3 weeks 
  • HCC: 1,875 mg atezolizumab and 30,000 units hyaluronidase (15 mL) SC every 3 weeks
  • Melanoma: Following completion of a 28-day cycle of cobimetinib and vemurafenib, give 1,875 mg atezolizumab and 30,000 units hyaluronidase (15 mL) SC with cobimetinib and vemurafenib
  • ASPS: 1,875 mg atezolizumab and 30,000 units hyaluronidase (15 mL) SC every 3 weeks 
  • Different recommended dosage and administration than IV atezolizumab; do not administer intravenously
J9024
Tecvayli™ (teclistamab-cqyv) subcutaneous (SC) injection Relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy


SC: Step-up doses of 0.06 mg/kg on day 1 and 0.3 mg/kg on day 4, followed by 1.5 mg/kg (on day 7) once weekly until disease progression or unacceptable toxicity



For patients who have achieved and maintained a complete response or better for a minimum of 6 months, dosing frequency may be decreased to 1.5 mg/kg every 2 weeks until disease progression or unacceptable toxicity.

J9380
Tevimbra® (tislelizumab-jsgr)  intravenous (IV) infusion

Unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-L1 inhibitor, as single agent treatment

Unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, as first-line treatment in combination with platinum and fluoropyrimidine-based chemotherapy

IV: 200 mg every 3 weeks until disease progression or unacceptable toxicity J9329
Tivdak® (tisotumab vedotin-tftv)
intravenous (IV) infusion		Recurrent or metastatic cervical cancer in adults with disease progression on or after chemotherapy IV: 2 mg/kg (up to a maximum of 200 mg) every 3 weeks until disease progression or unacceptable toxicityJ9273
Trodelvy™ (sacituzumab govitecan-hziy) intravenous (IV) infusion
  • Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in adults who have received two or more prior systemic therapies, at least one of them for metastatic disease
  • Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adults who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting
  • Locally advanced or metastatic urothelial cancer (mUC) in adults who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor
V: 10 mg/kg once weekly on days 1 and 8 of continuous 21- day treatment cycles until disease progression or unacceptable toxicityJ9317 
FDA Label Reference 
Medication  IndicationDosing HCPCS  
Unloxcyt® (cosibelimab-ipdl) intravenous (IV) infusionMetastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) in adults who are not candidates for curative surgery or curative radiation
IV: 1,200 mg every 3 weeks until disease progression or unacceptable toxicity

C9399**

J3490**

J3590**

J9999**

FDA Label Reference 
Medication  IndicationDosing HCPCS  

Vectibix® (panitumumab)
intravenous (IV) infusion

Wild-type RAS metastatic colorectal cancer (mCRC) 

IV: 6 mg/kg every 14 days over 60 minutes (≤ 1000 mg) or 90 minutes (> 1000 mg)

J9303 
Vyloy® (zolbetuximab-clzb) intravenous (IV) infusionLocally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive, as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapyIV: 800 mg/m2 initial dose followed by 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks until disease progression or unacceptable toxicity 

C9303

J3490**

J3590**

J9999**

Vyxeos™ (daunorubicin and cytarabine)
intravenous (IV) infusion

Newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older
  • Induction: Vyxeos (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 ) liposome IV on days 1, 3, and 5 and on days 1 and 3 for subsequent cycles of induction, if needed.
  • Consolidation: Vyxeos (daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 ) liposome IV on days 1 and 3
J9153
FDA Label Reference 
Medication  IndicationDosing HCPCS  

Yervoy™ (ipilimumab) intravenous (IV) infusion 

  • Unresectable or metastatic melanoma 
  • Adjuvant treatment of melanoma 
  • Advanced renal cell carcinoma 
  • MSI-H or dMMR metastatic colorectal cancer 
  • Hepatocellular carcinoma 
  • Metastatic non-small cell lung cancer 
  • Malignant pleural mesothelioma 
  • Esophageal squamous cell carcinoma 
  • Unresectable or metastatic melanoma:
    • 3 mg/kg IV every 3 weeks for a maximum of 4 doses
    • 3 mg/kg IV immediately after nivolumab 1 mg/kg on the same day, every 3 weeks for 4 doses
  • Adjuvant treatment of melanoma: 10 mg/kg IV every 3 weeks for 4 doses, followed by 10 mg/kg every 12 weeks for up to 3 years
  • Advanced renal cell carcinoma: 1 mg/kg IV immediately after nivolumab 3 mg/kg on the same day, every 3 weeks for 4 doses
  • MSI-H or dMMR metastatic colorectal cancer: 1 mg/kg IV immediately after nivolumab 3 mg/kg on the same day, every 3 weeks for 4 doses
  • Hepatocellular carcinoma: 3 mg/kg IV immediately after nivolumab 1 mg/kg on the same day, every 3 weeks for 4 doses
  • Metastatic non-small cell lung cancer: 1 mg/kg IV every 6 weeks with nivolumab 360 mg every 3 weeks; or 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks and 2 cycles of platinum-doublet chemotherapy
  • Malignant pleural mesothelioma: 1 mg/kg IV every 6 weeks with nivolumab 360 mg every 3 weeks
  • Esophageal squamous cell carcinoma: 1 mg/kg IV every 6 weeks with nivolumab 3 mg/kg every 2 weeks or 360 mg every 3 weeks
J9228 
FDA Label Reference 
Medication  IndicationDosing HCPCS  

Zepzelca™ (lurbinectedin) intravenous (IV) infusion

Metastatic small cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy
IV: 3.2 mg/m2 every 21 days 
J9223
Ziihera® (zanidatamab-hrii) intravenous (IV) infusionPreviously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC)IV: 20 mg/kg every 2 weeks until disease progression or unacceptable toxicity

C9302

J3490**

J3590**

J9999**

Zynlonta® (loncastuximab tesirinelpyl) intravenous (IV) infusion Relapsed or refractory large B-cell lymphoma in adults
Administered IV on day 1 of each cycle (every 3 weeks) 
  • 0.15 mg/kg every 3 weeks for 2 cycles 
  • 0.075 mg/kg every 3 weeks for subsequent cycles
J9359 
Zynyz™ (retifanlimab-dlwr) intravenous (IV) infusionMetastatic or recurrent locally advanced Merkel cell carcinoma in adultsIV: 500 mg every 4 weeksJ9345

**Non-specific assigned HCPCS codes, must submit requested product NDC

Other applicable oncology-specific HCPCS codes: S0353, S0354

Other ICD-10 codes that may be applicable to this policy: C00.0-C49.9, C4A.0-C4A.9, C50.011-C79.9, C7A.00-C7A.8, C7B.00-C7B.8, C80.0- C86.6, C88.2-C96.Z, D00.00-D09.9, Z51.11, Z51.12

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

April 2025: Coding change: For Lymphir, added HCPCS code J9161 to dosing reference table effective 4/1/2025; deleted C9399, J3490, J3590, and J9999 termed 3/31/2025. For Tecentriq Hybreza, added HCPCS code J9024 to dosing reference table effective 4/1/2025; deleted C9399, J3490, J3590, and J9999 termed 3/31/2025. For Vyloy, added HCPCS code C9303 to dosing reference table effective 4/1/2025; deleted C9399 termed 3/31/2025. For Ziihera, added HCPCS code C9302 to dosing reference table effective 4/1/2025; deleted C9399 termed 3/31/2025.

March 2025: Criteria change: Added newly approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) to policy for treatment of adults with renal cell carcinoma, melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table. Added newly approved Datroway (datopotamab deruxtecan-dlnk) to policy for treatment of adults with unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table. For Tevimbra, added new indication for first-line treatment, in combination with platinum and fluoropyrimidine-based chemotherapy, in adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1); added associated dosing in FDA label reference table.

February 2025: Criteria change: Added newly approved Bizengri (zenocutuzumab-zbco) to policy for treatment of adults with advanced, unresectable or metastatic NSCLC harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy, and for treatment of adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table. Added newly approved Unloxcyt (cosibelimab-ipdl) to policy for treatment of adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table.

January 2025: Criteria change: Added newly approved Ziihera (zanidatamab-hrii) to policy for treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table.

January 2025: Coding change: For Imdelltra, added HCPCS code J9026 to dosing reference table effective 1/1/2025; deleted C9170, J3490, J3590, and J9999 termed 12/31/2024. For Anktiva, added HCPCS code J9028 to dosing reference table effective 1/1/2025; deleted C9169, J3490, J3590, and J9999 termed 12/31/2024. Added HCPCS code J9292 (avyxa) for generic pemetrexed (Alimta) to dosing reference table effective 1/1/2025. For paclitaxel protein-bound particles, deleted HCPCS code J9259 (american regent) termed 12/31/2024, replaced by existing J9264 (Abraxane) effective 1/1/2025.

December 2024: Criteria change: Added newly approved Vyloy (zolbetuximab-clzb) to policy for first-line treatment, in combination with fluoropyrimidine- and platinum-containing chemotherapy, of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table.

November 2024: Criteria change: Added newly approved Lymphir (denileukin diftitox-cxdl) to policy for treatment of adults with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table. Added newly approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) to policy for treatment of the same indications as Tecentriq (atezolizumab) in adults; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table. For Darzalex Faspro: Added new indication for use in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant. For Enhertu: Added new indication for treatment of adults with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options; added associated dosing in FDA label reference table. For Epkinly: Added new indication for treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy; added associated dosing in FDA label reference table. For Imfinzi: Added new indication for neoadjuvant treatment in combination with platinum-containing chemotherapy, followed by continued use as a single agent as adjuvant treatment after surgery, for treatment of adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements; added new indication for treatment, in combination with carboplatin and paclitaxel, followed by use as a single agent, of adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR); added associated dosing in FDA label reference table. For Keytruda: Added new indication for treatment of patients with resectable (tumors ≥ 4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery; added new indication for first-line treatment, in combination with pemetrexed and platinum chemotherapy, of adults with unresectable advanced or metastatic malignant pleural mesothelioma; added new indication for first-line treatment, in combination with fluoropyrimidine- and platinum-containing chemotherapy, of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma; updated indication for locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma to clarify for tumors expressing PD-L1 (CPS ≥1) as determined by an FDA-approved test, according to FDA labeling update; added new indication for treatment, in combination with chemoradiotherapy (CRT), of patients with FIGO 2014 Stage III-IVA cervical cancer; updated HCC indication to HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen according to FDA labeling update; added new indication for treatment, in combination with gemcitabine and cisplatin, of patients with locally advanced unresectable or metastatic biliary tract cancer; added new indication for treatment in combination with carboplatin and paclitaxel, followed by use as a single agent, of adults with primary advanced or recurrent endometrial carcinoma; added associated dosing in FDA label reference table. For Opdivo: Added new indication for use in combination with platinum-doublet chemotherapy for neoadjuvant treatment of adults with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, followed by use as single-agent adjuvant treatment after surgery; adjusted completely resected malignant melanoma indication to include Stage IIB, Stage IIC, Stage III, or Stage IV disease according to FDA labeling updates; added associated dosing in FDA label reference table. For Padcev: Removed “who are not eligible for cisplatin-containing chemotherapy “ from indication for locally advanced or metastatic urothelial cancer in combination with pembrolizumab, according to updated FDA labeling. For Rybrevant: Added new indication for treatment, in combination with carboplatin and pemetrexed, of adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor; added new indication for first-line treatment, in combination with lazertinib, of adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test; added associated dosing in FDA label reference table. For Sarclisa: Added new indication for treatment, in combination with bortezomib, lenalidomide, and dexamethasone, of adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT); added associated dosing in FDA label reference table. Other minor edits made throughout policy for clarity with no change to policy intent.

October 2024: Criteria change: For Blincyto: Added newly approved indication for patients 1 month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy; expanded age for all indications to 1 month and older; added associated dosing in FDA label reference table. For Jemperli: Added newly approved indication in combination with carboplatin and paclitaxel, followed by as a single agent, for the treatment of adults with primary advanced or recurrent endometrial cancer; added associated dosing in FDA label reference table.

October 2024: Coding change: For Anktiva, added HCPCS code C9169 to dosing reference table effective 10/1/2024; deleted C9399 termed 9/30/2024. For Imdelltra, added HCPCS code C9170 to dosing reference table effective 10/1/2024; deleted C9399 termed 9/30/2024. For Tevimbra, added HCPCS code J9329 to dosing reference table effective 10/1/2024; deleted C9399, J3490, J3590, and J9999 termed 9/30/2024. For paclitaxel protein-bound particles, deleted HCPCS code J9258 (teva) termed 9/30/2024, replaced by existing J9264 (Abraxane) effective 10/1/2024.

August 2024: Criteria change: Added newly approved Anktiva to policy for use with Bacillus Calmette-Guérin (BCG) for treatment of adults with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table. Added newly approved Imdelltra to policy for treatment of adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table. Minor adjustments made throughout FDA label reference table with no change to policy intent. July 2024: Coding change: Added HCPCS code J3263 for Loqtorzi to dosing reference table effective 7/1/2024; deleted C9399, J3490, J3590, and J9999 termed 6/30/2024.

May 2024: Criteria change: Added newly approved Tevimbra to policy for treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-L1 inhibitor; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table. For Besponsa: Expanded relapsed/refractory CD22-positive B-cell precursor ALL indication to include patients aged 1 year and older per updated FDA label. For Keytruda: Updated wording of indication title for urothelial carcinoma to urothelial cancer and removed “who are not eligible for cisplatin-containing chemotherapy” from indication for locally advanced urothelial cancer in combination with enfortumab vedotin per updated FDA label. For Opdivo: Added new indication for first-line treatment of adults with unresectable or metastatic urothelial carcinoma, in combination with cisplatin and gemcitabine; updated FDA label reference table with corresponding dosing.

April 2024: Coding change: Added HCPCS code J1323 for Elrexfio to dosing reference table effective 4/1/2024; deleted C9165, J3490, J3590, and J9999 termed 3/31/2024. Added HCPCS code J3055 for Talvey to dosing reference table effective 4/1/2024; deleted C9163, J3490, J3590, and J9999 termed 3/31/2024.

April 2024: Criteria change: For Rybrevant: Added new indication for first-line treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, in combination with carboplatin and pemetrexed; added associated dosing in reference table. Updated dosing in reference table for single-agent treatment according to FDA label for clarity. For Tecvayli: Updated dosing information in reference table per update to FDA label to allow a decrease in dosing frequency to 1.5 mg/kg every 2 weeks until disease progression or unacceptable toxicity, in patients who have achieved and maintained a complete response or better for a minimum of 6 months.

March 2024: Criteria change: Added newly approved Loqtorzi to policy for treatment of adults with nasopharyngeal carcinoma (NPC); added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table. Removed Lumoxiti (moxetumomab pasudotox-tdfk) from policy due to manufacturer permanent market withdrawal based on very low clinical uptake (unrelated to safety or efficacy). Removed Aliqopa (copanlisib) from policy due to voluntary market withdrawal based on the confirmatory clinical trial not meeting the primary endpoint and requirements of FDA Accelerated Approval regulations. Policy notification given 1/11/2024 for effective date 3/11/2024.

January 2024: Coding change: Added J9286 for Columvi to dosing reference table effective 1/1/2024; deleted C9399, J3490, J3590, and J9999 termed 12/31/2023. Added J9321 for Epkinly to dosing reference table effective 1/1/2024; deleted C9155, J3490, J3590, and J9999 termed 12/31/2023. Added HCPCS code C9163 for Talvey to dosing reference table effective 1/1/2024; deleted C9399 termed 12/31/2023. Added HCPCS code C9165 for Elrexfio to dosing reference table effective 1/1/2024; deleted C9399 termed 12/31/2023. Added HCPCS code J9258 (teva) for generic paclitaxel protein-bound particles to dosing reference table effective 1/1/2024. Added HCPCS code J9234 for pemetrexed (pemrydi rtu) to dosing reference table effective 1/1/2024.

October 2023: Criteria change: Added newly approved Elrexfio and Talvey to policy for treatment of adults with relapsed or refractory multiple myeloma, after at least four prior lines of therapy; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table.

October 2023: Coding change: Added HCPCS code C9155 for Epkinly to dosing reference table effective 10/1/2023; deleted C9399 termed 9/30/2023. Added J9345 for Zynyz to dosing reference table effective 10/1/2023; deleted C9399, J3490, J3590, and J9999 termed 9/30/2023. Added HCPCS code J9064 (sandoz) for generic cabazitaxel to dosing reference table effective 10/1/2023.

September 2023: Criteria change: Added newly approved Columvi to policy for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table.

August 2023: Criteria change: Added newly approved Epkinly to policy for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy; added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table. 

July 2023: Coding change: Added HCPCS code J9063 for Elahere to dosing reference table effective 7/1/2023; deleted C9146, J3490, J3590, and J9999 termed 6/30/2023. Added J9347 for Imjudo to dosing reference table effective 7/1/2023; deleted C9147, J3490, J3590, and J9999 termed 6/30/2023. Added J9350 for Lunsumio to dosing reference table effective 7/1/2023; deleted C9399, J3490, J3590, and J9999 termed 6/30/2023. Added J9380 for Tecvayli to dosing reference table effective 7/1/2023; deleted C9148, J3490, J3590, and J9999 termed 6/30/2023. Added HCPCS codes J9322 (bluepoint) and J9323 for generic pemetrexed products to dosing reference table effective 7/1/2023. Added J9259 (american regent) for generic paclitaxel protein-bound particles to dosing reference table effective 7/1/2023.

July 2023: Criteria change: Added Pemfexy (pemetrexed) for treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) and for treatment of malignant pleural mesothelioma in patients whose disease is unresectable or who are otherwise not candidates for curative surgery, and added HCPCS code J9304 and associated dosing to FDA label reference table. Removed Blenrep (belantamab mafodotin-blmf) from policy due to FDA market withdrawal based on the confirmatory clinical trial not meeting requirements of FDA Accelerated Approval regulations; Blenrep is now only available for continued use through the manufacturer’s compassionate use program. Removed Zoladex (goserelin) from policy and added it to a separate individual policy (Gonadotropin Releasing Hormone Therapy). Policy notification given 4/1/2023 for effective date 7/1/2023.

May 2023: Criteria change: Added newly approved Zynyz to policy for treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma, added associated dosing and HCPCS codes C9399, J3490, J3590, and J9999 to FDA label reference table. For Keytruda: Added indication for adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy, in combination with enfortumab vedotin; added associated dosing in reference table. For Libtayo: Reformatted associated dosing in reference table into CSCC and BCC, or NSCLC for clarity. For Padcev: Added indication for adults with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy, in combination with pembrolizumab; adjusted formatting of associated dosing in reference table. For Polivy: Added indication for adults who have previously untreated DLBCL, not otherwise specified or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater, in combination with R-CHP.

April 2023: Coding update: Added HCPCS codes C9146 for Elahere, C9147 for Imjudo, and C9148 for Tecvayli to dosing reference table effective 4/1/2023; deleted C9399 for all three drugs termed 3/31/2023. Added HCPCS codes J9294 (hospira), J9296 (accord), and J9297 (sandoz) for generic pemetrexed products to dosing reference table effective 4/1/2023.

April 2023: Criteria update: For Darzalex: Updated indication for multiple myeloma in combination with pomalidomide and dexamethasone to patients who have received at least two prior therapies instead of one prior line of therapy. For Enhertu: Added FDA-approved testing within the indication for unresectable or metastatic HER2-low breast cancer for clarity according to label. For Jemperli: Updated indication for dMMR recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen to add in any setting or not candidates for curative surgery or radiation. For Keytruda: Added indication for use as a single agent for adjuvant treatment following resection and platinum-based chemotherapy for adults with stage IB (T2a ≥4 cm), II, or IIIA NSCLC; adjusted use at an additional dosing regimen of 400 mg every 6 weeks from all indications to specifically for adult classical Hodgkin lymphoma and adult primary mediastinal large B-cell lymphoma indications; adjusted wording according to label throughout for an FDA approved test where appropriate; and updated dosing reference table according to FDA label for clarity. For Opdivo: Added specification of use within adult and/or pediatric patients by indication according to label; and adjusted dosing by age and weight per indication within dosing reference table according to label. For Rylaze: Added additional dosing regimen option within dosing reference table according to label. For Tecentriq: Removed accelerated approval indication for urothelial carcinoma according to label; added indication for alveolar soft part sarcoma in adult and pediatric patients 2 years of age and older with unresectable or metastatic disease; and updated dosing and reference table according to label. For Trodelvy: Added indication for unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting; and updated dosing reference table according to label. For Yervoy: Added specification of use within adult and/or pediatric patients by indication according to label.

March 2023: Criteria change: Added newly approved Lunsumio to policy for treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, and added associated dosing to FDA label reference table.

March 2023: Coding update: Added HCPCS code J9314 (teva) for generic pemetrexed to dosing reference table effective 1/1/2023.

December 2022: Criteria update: Added newly approved Elahere to policy for treatment of adults with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens; and associated dosing to FDA label reference table. Added newly approved Imjudo to policy for treatment of adults with unresectable hepatocellular carcinoma (uHCC) and for treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitizing EGFR mutation or ALK genomic tumor aberrations; and associated dosing to FDA label reference table. Added newly approved Tecvayli for treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, and associated dosing to FDA label reference table.

November 2022: Criteria update: For Adcetris: Added indication for previously untreated high risk cHL in pediatric patients, and associated dosing to FDA label reference table. For Enhertu: Added indications for unresectable or metastatic HER2-positive breast cancer in the neoadjuvant or adjuvant setting, unresectable or metastatic HER2-low breast cancer, unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 mutations, and associated dosing to FDA label reference table. For Imfinzi: Added indications for metastatic NSCLC, locally advanced or metastatic biliary tract cancer, and unresectable hepatocellular carcinoma, and associated dosing to FDA label reference table. For Keytruda: Removed previously treated gastric cancer indication, adjusted endometrial carcinoma indications and associated dosing within FDA label reference table. For Kyprolis: Added indication for use in combination with isatuximab and dexamethasone, and adjusted associated dosing within FDA label reference table. For Libtayo: Added additional NSCLC indication and associated dosing to FDA label reference table. For Opdivo: Added additional esophageal cancer indications and associated dosing to FDA label reference table. For Yervoy: Added indications for unresectable advanced or metastatic esophageal squamous cell carcinoma and associated dosing to FDA label reference table, and adjusted dosing for melanoma and NSCLC. Removed tables with listed preferred and non-preferred bevacizumab, rituximab, and trastuzumab products, as these products are applicable to a separate individual medical policy (Preferred Injectable Oncology Program).

October 2022: Coding update: Added HCPCS codes J9274 for Kimmtrak and J9298 for Opdualag to dosing reference table effective 10/1/2022; deleted C9095, J3490, J3590, and J9999 for Kimmtrak and C9399, J3490, J3590, and J9999 for Opdualag termed 9/30/2022.

October 2022: Criteria change: Removed Herceptin Hylecta and Rituxan Hycela from policy and added them to a separate individual policy (Preferred Injectable Oncology Program). Policy notification given 8/4/2022 for effective date 10/1/2022.

July 2022: Coding update: Added HCPCS codes C9095 for Kimmtrak and J9331 for Fyarro to dosing reference table effective 7/1/2022, deleted C9399 for Kimmtrak and C9091, C9399, J3490, J3590, and J9999 for Fyarro termed 6/30/2022.

June 2022: Criteria change: Removed the following products from the policy and created individual policy for these products (Preferred Injectable Oncology Program): Avastin, Herceptin, Herzuma, Ontruzant, Riabni, Rituxan, Trazimera. The following products were removed from the policy and no longer require prior authorization for ONCOLOGY indications: Mvasi, Zirabev, Ruxience, Truxima, Kanjinti, Ogiviri.

May 2022: Criteria change: Added newly approved Opdualag with associated criteria and dosing to FDA label reference table. Added new indication for Opdivo for use in combination with platinum-doublet chemotherapy for neoadjuvant treatment of adult patients with resectable (tumors at least 4 cm or node positive) non-small cell lung cancer.

April 2022: Criteria change: Added newly approved Kimmtrak to policy for treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, and associated dosing to FDA label reference table. Addition of Erwinaze, Rybrevant, Rylaze, and Tivdak to remain on notice for effective date 4/1/2022. Additional policy notification given 2/15/2022 for effective date 4/1/2022.

April 2022: Coding update: Added HCPCS code J9273 for Tivdak,J9359 for Zynlonta, and C9091 for Fyarro to dosing reference table effective 4/1/2022, deleted C9086, J3490, J3590, J9999 for Tivdak and Zynlonta termed 3/31/2022.

February 2022: Criteria change: Added newly approved Fyarro to policy for treatment of locally advanced unresectable or metastatic malignant PEComa, and associated dosing to FDA label reference table. Added other applicable HCPCS and diagnosis codes for clarity

February 2022: Original medical policy criteria issued. Policy notification given 12/17/2021 for effective date 2/15/2022.

*Further historical criteria changes and updates for Corporate Medical Policies for each individual drug are available upon request from Medical Policy and/or Corporate Pharmacy.

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