| Medical Drug Policy Name | Revised Criteria |
|---|---|
| Afamitresgene autoleucel (Tecelra®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Allogeneic Processed Thymus Tissue-agdc (Rethymic®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Added Gene/Cellular Therapy distribution channel management language according to benefit booklet for clarity. Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Atidarsagene autotemcel (Lenmeldy®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Beremagene geperpavec-svdt (Vyjuvek®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Betibeglogene autotemcel (Zynteglo®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| CAR-T Therapy "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Added Gene/Cellular Therapy distribution channel management language according to benefit booklet for clarity. Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Delandistrogene moxeparvovec-rokl (Elevidys®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Denosumab (Prolia®, Xgeva®) and Denosumab Biosimilars "Notification" (PDF) | Changed requirement for trial and failure of preferred denosumab (Prolia) biosimilar products to include Bildyos in addition to existing preferred Jubbonti and Stoboclo; adjusted non-preferred denosumab (Prolia) biosimilar products to include Prolia, Boncresa, Bosaya, Conexxence, Enoby, Ospomyv, and Osvyrti. Changed requirement for trial and failure of preferred denosumab (Xgeva) biosimilar products to include Bilprevda in addition to existing preferred Osenvelt and Wyost; adjusted non-preferred denosumab (Xgeva) biosimilar products to include Xgeva, Aukelso, Bomyntra, Jubereq, Oziltus, Xbryk, and Xtrenbo. Added Site of Care medical necessity criteria. Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Donislecel-jujn (Lantidra™) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026 |
| Eladocagene exuparvovec-tneq (Kebilidi™) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Elivaldogene autotemcel (Skysona®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Etranacogene dezaparvovec-drlb (Hemgenix®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Exagamglogene autotemcel (Casgevy®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Fidanacogene elaparvovec-dzkt (Beqvez™) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Immunoglobulin Therapy "Notification" (PDF) | For Guillain-Barré syndrome indication, added requirements that patient has severe disease requiring aid to walk and that treatment initiation is within 4 weeks of onset of neuropathic symptoms; and adjusted equivalent alternative to plasma exchange verbiage to require no concurrent use with plasma exchange. For chronic ITP indication, reformatted criteria to allow for either a platelet count ≤ 30 x 109/L OR a platelet count < 50 x 109/L with symptomatic bleeding and/or an increased risk for bleeding (with listed examples); adjusted trial and failure requirements for intolerance/ FDA labeled contraindication/ hypersensitivity to be applicable to all corticosteroids and splenectomy, and listed examples of corticosteroids; updated ITP disease state terminology for clarity. Reference added. Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Lifileucel (Amtagvi™) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Lovotibeglogene autotemcel (Lyfgenia®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Nadofaragene firadenovec-vncg (Adstiladrin®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Added Gene/Cellular Therapy distribution channel management language according to benefit booklet for clarity. Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Omidubicel-onlv (Omisirge®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy remains on notice since 1/1/2026 for effective date 4/1/2026. Additional notification for coding changes given 2/1/2026 for effective date 4/1/2026. |
| Onasemnogene abeparvovec (Itvisma®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Onasemnogene abeparvovec (Zolgensma®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Prademagene zamikeracel (Zevaskyn™) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Remestemcel-L-rknd (Ryoncil®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Added Gene/Cellular Therapy distribution channel management language according to benefit booklet for clarity. Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Revakinagene taroretcel-lwey (Encelto™) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Romiplostim (Nplate®) "Notification" (PDF) | For chronic ITP indication, reformatted criteria to allow for either a platelet count ≤ 30 x 109/L OR a platelet count < 50 x 109/L with symptomatic bleeding and/or an increased risk for bleeding (with listed examples); adjusted trial and failure requirements to include trial of a prior ITP treatment or intolerance/ FDA labeled contraindication/ hypersensitivity to all other ITP treatment, and listed additional examples of ITP treatments; removed allowance for insufficient response to or not a candidate for splenectomy, and included splenectomy as an option within prior ITP trial agents; extended ITP duration of approval to 90 days (3 months); and updated ITP disease state terminology for clarity. Updated continuation criteria to differentiate between diagnoses and added redirection to initial criteria for HSARS indication. Within continuation criteria for ITP indication, added allowance for doubled platelet count from baseline, and made other minor adjustments to criteria verbiage. Added requirement to be prescribed by or in consultation with a specialist within initial and continuation sections. Added requirement within initial and continuation sections that Nplate will not be used in combination with another thrombopoietin receptor agonist or mimetic (with listed examples). Adjusted maximum units. Reference added. Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Treatment of Hereditary Angioedema "Notification" (PDF) | Reformatted diagnostic criteria to align HAE type I and type II with updated guidelines. Renamed HAE type III to HAE with normal C1-INH per updated guidelines and adjusted diagnostic requirements to allow for either documented genetic confirmation or presence of recurring angioedema attacks refractory to high-dose second generation H1 antihistamines in addition to family history of angioedema. For acute treatments, removed requirement that patient must be experiencing at least one symptom of a moderate or severe HAE attack, and adjusted placement of examples of HAE attack symptoms within criteria for each product. Added Sajazir (branded generic of Firazyr [icatibant]) to policy for clarity under existing J1744 HCPCS code. For brand Firazyr, Sajazir, and Ruconest, added requirement of trial and failure of generic icatibant within initial and continuation criteria. Added requirement for use of the self-administered product within initial and continuation criteria unless certain criteria are met. For Cinryze continuation criteria, added required medical record documentation for confirmation of prophylactic use and demonstration of clinical benefit, and added examples of clinical benefit. Added requirement that medications known to cause angioedema have been evaluated and discontinued if appropriate. Added requirement to be prescribed by or in consultation with a specialist. Added examples of medications not to be used in combination for clarity. Adjusted maximum units. Added references. Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Valoctocogene roxaparvovec-rvox (Roctavian®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Voretigene Neparvovec-rzyl (Luxturna®) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
| Zopapogene imadenovec-drba (Papzimeos™) "Notification" (PDF) | Added the following applicable revenue codes associated with policy HCPCS code(s): 0891 (Special Processed Drugs – FDA Approved Cell Therapy) and 0892 (Special Processed Drugs – FDA Approved Gene Therapy). Policy notification given 2/1/2026 for effective date 4/1/2026. |
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