Imatinib – NC Standard

Restricted Product(s)

Restriction applies to brand and generic products

• Imatinib (Gleevec®)
• Imatinib oral solution (Imkeldi)

FDA Approved Use

• Treatment of relapsed or refractory Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in adults. 
• Treatment of newly diagnosed Ph+ ALL in children (in combination with chemotherapy). 
• Treatment of aggressive systemic mastocytosis in adults without D816V c-kit mutation (as determined by an approved test) or with c-kit mutational status unknown 
• Treatment of Ph+ chronic myeloid leukemia (CML) in chronic phase (newly diagnosed) in adults and children 
• Treatment of Ph+ CML in blast crisis, accelerated phase, or chronic phase after failure of interferon-alfa therapy. 
• Treatment of unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans (DFSP) in adults. 
• Treatment of Kit (CD117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). 
• Adjuvant treatment of Kit (CD117)-positive GIST following complete gross resection. 
• Treatment of hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) in adult patients who have the FIP1L1-plateletderived growth factor (PDGF) receptor alpha fusion kinase (mutational analysis or fluorescent in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGF receptor alpha fusion kinase negative or unknown. 
• Treatment of myelodysplastic syndrome/myeloproliferative disease (MDS/MPD) associated with PDGF receptor gene rearrangements as determined by an approved test in adults.

Criteria for Approval of Restricted Product(s)

1. The patient is currently taking the requested medication for a cancer diagnosis; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is being managed by or in consultation with an oncologist; AND 
3. If the request is for brand Gleevec tablet, 
   1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic imatinib tablet (medical record documentation required); AND 
4. If the request is for Imkeldi (imatinib) oral solution:
   1. The patient is 11 years of age or younger; OR
   2. ALL of the following:
      1. The provider attests that the patient is unable to take the requested product in a standard formulation; AND
      2. The patient is not taking any other medication in a standard dosage form; AND
      3. If a patient is using an enteral feeding tube, the tablet formulation cannot be crushed for administration (via nationally recognized organization such as the Institute for Safe Medication Practices); AND
5. The patient has been diagnosed with one of the following diagnoses (medical record documentation required):
   1. Newly diagnosed Philadelphia chromosome positive chronic myeloid (Ph+ CML) (in adults and pediatrics); OR
   2. Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) of any stage after failure with interferon alpha therapy (in adults and pediatrics); OR 
   3. Newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy (in pediatrics); OR 
   4. Relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) (in adults); OR 
   5. Myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements (in adults); OR 
   6. Aggressive systemic mastocytosis (ASM) without the D816V c-KIT mutation or with cKIT mutational status unknown (in adults); OR 
   7. Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown (in adults); OR 
   8. unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans (DFSP) (in adults); OR 
   9. KIT(CD117)-positive gastrointestinal stromal tumors (GIST) that are either resectable, unresectable, recurrent, metastatic, or post resection of the KIT (CD117)-positive GIST (in adults); AND
6. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. Medical records and references / evidence must be provided; AND 
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of Approval: 365 days (1 year)

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.

January 2025: Criteria change: Added new to market Imatinib oral solution (Imkeldi) 80mg/mL. Added P&T statement. Updated name of policy to ‘Imatinib – NC Standard’.

July 2022: Criteria change: Require usage of generic medication unless patient has tried and failed, is intolerant to, or has a clinical contraindication to generic medication.

July 2020: Criteria update: Allow for approval if currently taking the requested medication for a cancer diagnosis and utilizing the generic formulation (if available).

October 2019: Reformatted criteria

April 2017: Original utilization management criteria issued.