Subject: imatinib-Gleevec 2172-A SGM P2023

Drug

GLEEVEC  (imatinib mesylate)

imatinib mesylate

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and
          compendial uses are considered a covered benefit provided that
          all the approval criteria are met and the member has no
          exclusions to the prescribed therapy.

          A.  FDA-Approved Indications
               1.  Newly diagnosed adult and pediatric patients with
                    Philadelphia chromosome positive chronic myeloid
                    leukemia (Ph+ CML) in chronic phase
               2.  Patients with Ph+ CML in blast crisis, accelerated phase,
                    or in chronic phase after failure of interferon-alpha
                    therapy
               3.  Adult patients with relapsed or refractory Philadelphia
                    chromosome positive acute lymphoblastic leukemia (Ph+
                    ALL)
               4.  Pediatric patients with newly diagnosed Ph+ ALL in
                    combination with chemotherapy
               5.  Adult patients with myelodysplastic/myeloproliferative
                    diseases (MDS/MPD) associated with PDGFR (platelet-
                    derived growth factor receptor) gene re-arrangements
               6.  Adult patients with aggressive systemic mastocytosis
                    without the D816V c-Kit mutation or with c-Kit mutational
                    status unknown
               7.  Adult patients with hypereosinophilic syndrome (HES)
                    and/or chronic eosinophilic leukemia (CEL) who have the
                    FIP1L1-PDGFRα fusion kinase (mutational analysis or
                    FISH demonstration of CHIC2 allele deletion) and for
                    patients with HES and/or CEL who are FIP1L1-PDGFRα
                    fusion kinase negative or unknown
               8.  Adult patients with unresectable, recurrent and/or
                    metastatic dermatofibrosarcoma protuberans (DFSP)
               9.  Patients with Kit (CD117) positive unresectable and/or
                    metastatic malignant gastrointestinal stromal tumors
                    (GIST)
              10.  Adjuvant treatment of adult patients following complete
                     gross resection of Kit (CD117) positive GIST

          B.  Compendial Uses
               1.  Primary treatment of advanced phase CML (accelerated
                    phase or blast phase)
               2.  Follow-up therapy for CML patients after hematopoietic
                    stem cell transplant (HSCT)
               3.  Ph+ B-cell acute lymphoblastic leukemia or lymphoblastic
                    lymphoma (Ph+ B-ALL/LL)
               4.  Maintenance therapy for Ph+ B-ALL/LL patients after
                    HSCT
               5.  GIST
               6.  Desmoid tumors
               7.  Pigmented villonodular synovitis/tenosynovial giant cell
                    tumor
               8.  Recurrent chordoma
               9.  Cutaneous melanoma
              10. Kaposi sarcoma that has progressed on or not responded
                    to first-line systemic therapy
              11. Chronic myelomonocytic leukemia 
              12. Chronic graft versus host disease
              13. Relapsed or refractory pediatric T-cell ALL/LL with ABL-
                    class translocation
              14. Myeloid/lymphoid neoplasms with eosinophilia and the
                    ABL1, FIP1L1::PDGFRA, or PDGFRB rearrangement in
                    chronic phase or blast phase
              15. Aggressive Systemic Mastocytosis (ASM)
              16. Dermatofibrosarcoma Protuberans (DFSP)

          All other indications are considered experimental/investigational
          and not medically necessary.


    II.  DOCUMENTATION

          The following information is necessary to initiate the prior
          authorization review:
          1.  For treatment of CML or Ph+ ALL/LL: results of cytogenetic
               and/or molecular testing for detection of the Ph chromosome
               or the BCR::ABL gene.
          2.  For treatment of T-cell ALL/LL: results of cytogenetic and/or
               molecular testing confirming ABL-class translocation
          3.  For treatment of MDS/MPD and CMML: results of molecular
               testing or analysis confirming PDGFR gene rearrangement
          4.  For the treatment of ASM: results of molecular testing or
               analysis for D816V c-KIT mutation and FIP1L1::PDGFRA
               fusion gene (where applicable)
          5.  For treatment of melanoma: results of molecular testing or
               analysis confirming c-KIT activating mutation
          6.  For treatment of myeloid and/or lymphoid neoplasms with
               eosinophilia: results of testing or analysis confirming ABL1,
               FIP1L1::PDGFRA, or PDGFRB rearrangement


  III.  CRITERIA FOR INITIAL APPROVAL

          A.  Chronic Myeloid Leukemia (CML)
               Authorization of 7 months may be granted for treatment of
               CML that has been confirmed by detection of the Ph
               chromosome or BCR::ABL gene by cytogenetic and/or
               molecular testing when the member did not fail (other than
               due to intolerance) prior therapy with a TKI (e.g., dasatinib,
               nilotinib, bosutinib, ponatinib).

          B.  Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic
               Lymphoma (LL)
               Authorization of 12 months may be granted for treatment of
               ALL/LL when any of the following criteria is met:
               1.  Member has Ph+ ALL/LL that has been confirmed by
                    detection of the Ph chromosome or BCR::ABL gene by
                    cytogenetic and/or molecular testing
               2.  Member has T-cell ALL/LL with ABL-class translocation
                    that has been confirmed by cytogenetic and/or molecular
                    testing and the disease is relapsed or refractory
               3.  Member has received HSCT for Ph+ ALL/LL

          C.  Gastrointestinal Stromal Tumor (GIST), Desmoid
               Tumors, Pigmented Villonodular
               Synovitis/Tenosynovial Giant Cell Tumor
               (PVNS/TGCT), Hypereosinophilic Syndrome/Chronic
               Eosinophilic Leukemia (HES/CEL),
               Dermatofibrosarcoma Protuberans (DFSP), Chordoma
               Authorization of 12 months may be granted for treatment of
               GIST, desmoid tumors, PVNS/TGCT, HES/CEL, DFSP, or
               recurrent chordoma.

          D.  Myelodysplastic Syndromes/Myeloproliferative
               Diseases (MDS/MPD) and Chronic Myelomonocytic
               Leukemia (CMML)
               Authorization of 12 months may be granted for treatment of
               MDS/MPD or CMML when the member’s disease is associated
               with PDGFR (platelet-derived growth factor receptor) gene
               rearrangements.

          E.  Aggressive Systemic Mastocytosis (ASM)
               Authorization of 12 months may be granted for treatment of
               ASM when any of the following criteria is met:
               1.  D816V c-KIT mutation is negative
               2.  D816V c-KIT mutation status is unknown
               3.  Well-differentiated systemic mastocytosis (WDSM)
               4.  Eosinophilia is present with FIP1L1::PDGFRA fusion gene

          F.  Cutaneous Melanoma
               Authorization of 12 months may be granted for treatment of
               cutaneous melanoma when all of the following criteria are
               met:
               1.  The disease is metastatic or unresectable
               2.  The tumor has c-KIT activating mutations
               3.  The requested medication will be used as subsequent
                    therapy
               4.  Member has had disease progression, intolerance, or risk
                    of progression with BRAF-targeted therapy
               5.  The requested medication will be used as a single agent

          G.  Kaposi Sarcoma
               Authorization of 12 months may be granted for treatment of
               Kaposi sarcoma when the requested medication is used as
               subsequent therapy as a single agent or in combination with
               antiretroviral therapy.

          H.  Chronic Graft-Versus-Host Disease (cGVHD)
               Authorization of 12 months may be granted for treatment of
               cGVHD when the requested medication is used as
               subsequent therapy in combination with systemic
               corticosteroids.

          I.  Myeloid/Lymphoid Neoplasms with Eosinophilia
               Authorization of 12 months may be granted for treatment of
               myeloid and/or lymphoid neoplasms with eosinophilia and
               ABL1, FIP1L1::PDGFRA, or PDGFRB rearrangement in the
               chronic phase or blast phase.


   IV.  CONTINUATION OF THERAPY

          A.  CML
               Authorization may be granted for continued treatment of CML
               that has been confirmed by detection of Ph chromosome or
               BCR::ABL gene by cytogenetic and/ or molecular testing
               when either of the following criteria is met:
               1.  Authorization of 12 months may be granted when any of
                    the following criteria is met:
                    a.  BCR::ABL1 is less than or equal to 10% and there is
                         no evidence of disease progression or unacceptable
                         toxicity while on the current regimen for members
                         who have been receiving the requested medication for
                         6 months or greater
                    b.  Member has received HSCT and there is no evidence
                         of disease progression or unacceptable toxicity while
                         on the current regimen
               2.  Authorization of up to 7 months may be granted when the
                    member has completed less than 6 months of therapy
                    with the requested medication.

          B.  Acute Lymphoblastic Leukemia or Lymphoblastic
               Lymphoma (ALL/LL)
               Authorization of 12 months may be granted for continued
               treatment of ALL/LL when there is no evidence of
               unacceptable toxicity or disease progression while on the
               current regimen and any of the following criteria is met:
               1.  Member has Ph+ ALL/LL that has been confirmed by
                    detection of Ph chromosome or BCR::ABL gene by
                    cytogenetic and/ or molecular testing.
               2.  Member has T-cell ALL/LL with ABL-class translocation
                    that has been confirmed by cytogenetic and/or molecular
                    testing.
               3.  Member has received HSCT for ALL/LL

          C.  Desmoid Tumors, PVNS/TGCT, HES/CEL, DFSP,
               Chordoma, MDS/MPD, CMML, ASM, Cutaneous
               Melanoma, Kaposi sarcoma, cGVHD, or
               Myeloid/Lymphoid Neoplasms with Eosinophilia
               Authorization of 12 months may be granted for continued
               treatment of desmoid tumors, PVNS/TGCT, HES/CEL, DFSP,
               chordoma, MDS/MPD, CMML, ASM, cutaneous melanoma,
               Kaposi sarcoma, cGVHD, or myeloid/lymphoid neoplasms
               with eosinophilia when there is no evidence of unacceptable
               toxicity or disease progression while on the current regimen.

          D.  GIST
               Authorization of 12 months may be granted for continued
               treatment of GIST when the member is receiving clinical
               benefit and there is no evidence of unacceptable toxicity
               while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Gleevec [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; August 2022.
2. imatinib [package insert]. Cranbury, NJ: Sun Pharmaceuticals Industries, Inc.; September 2022.
3. The NCCN Drugs & Biologics Compendium^® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 18, 2023.
4. NCCN Clinical Practice Guidelines in Oncology^® Acute Lymphoblastic Leukemia (Version 1.2022). © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 19, 2023.
5. NCCN Clinical Practice Guidelines in Oncology^® Pediatric Acute Lymphoblastic Leukemia (ALL) (Version 2.2023). © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 19, 2023.
6. NCCN Clinical Practice Guidelines in Oncology^® Myelodysplastic Syndromes (Version 1.2023). © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 19, 2023.

 

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

November 20, 2023