CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Imatinib (Gleevec) — coverage criteria

Determines medical necessity, prior authorization, and documentation requirements for imatinib (Gleevec) for FDA‑approved and compendial oncology and hematology indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyImatinib (Gleevec) — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and provide molecular or cytogenetic test results confirming the relevant target (e.g., BCR::ABL, PDGFR, c‑KIT) to support coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration for most indications

7 monthsauthorization duration for certain CML initial therapy

16+indications enumerated (FDA and compendial combined)

6+documentation/testing required prior to authorization

Coverage Criteria for Imatinib (Gleevec)

Initial and compendial indications

Covered when ALL of the following are met (per indication-specific criteria below):

General coverage condition: Requested use is one of the FDA-approved indications or listed compendial uses and member has no exclusions to the prescribed therapy.

FDA‑Approved indications (any one qualifies when specific testing confirms diagnosis): FDA‑Approved indications (any one qualifies when appropriate diagnostic testing confirms the diagnosis). Examples include: newly diagnosed adult and pediatric Ph+ CML (chronic phase), Ph+ CML in accelerated/blast phase or after interferon failure, relapsed/refractory Ph+ ALL, pediatric newly diagnosed Ph+ ALL in combination with chemotherapy, MDS/MPD associated with PDGFR rearrangements, ASM without D816V or unknown c-KIT status, HES/CEL with FIP1L1‑PDGFRA, unresectable/recurrent/metastatic DFSP, KIT (CD117) positive unresectable/metastatic GIST, and adjuvant KIT+ GIST after resection.

Compendial uses (any one qualifies when supported by testing or clinical context). Examples include: primary treatment of advanced phase CML, follow-up therapy after HSCT for CML, Ph+ B-ALL/LL and maintenance after HSCT, GIST, desmoid tumors, PVNS/TGCT, recurrent chordoma, cutaneous melanoma, Kaposi sarcoma progressed on first-line therapy, CMML, chronic GVHD, relapsed/refractory pediatric T-cell ALL/LL with ABL-class translocation, and myeloid/lymphoid neoplasms with eosinophilia.

Documentation requirement: Provide specific molecular or cytogenetic testing results confirming the relevant target as applicable to the indication (e.g., Ph chromosome/BCR::ABL for CML or Ph+ ALL/LL; ABL-class translocation for T‑cell ALL/LL; PDGFR rearrangement for MDS/MPD and CMML; D816V c‑KIT status and FIP1L1::PDGFRA for ASM; c‑KIT activating mutation for melanoma; ABL1/FIP1L1::PDGFRA/PDGFRB for neoplasms with eosinophilia).

Initial CML special condition: For initial CML authorization, member must not have failed prior TKI therapy (unless failure due to intolerance); in these settings authorization of 7 months may be granted.

Continuation therapy

Covered for continuation when specified conditions are met:

CML continuation: Authorization may be granted for continued treatment of CML confirmed by detection of the Ph chromosome or BCR::ABL gene when either (a) BCR::ABL1 ≤ 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 (b) member has received HSCT and there is no evidence of disease progression or unacceptable toxicity. If member has completed < 6 months of therapy, authorization of up to 7 months may be granted.BCR::ABL1 ≤ 10%

ALL/LL continuation: 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 is met: Ph+ ALL/LL confirmed by Ph chromosome/BCR::ABL testing; T‑cell ALL/LL with confirmed ABL‑class translocation; or post‑HSCT follow-up.

Other tumor types continuation: 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 and the member is receiving clinical benefit.

Indications not expressly listed among the FDA‑approved or compendial uses in this document are considered experimental/investigational and not medically necessary.

Any request for imatinib for a diagnosis or clinical use that is not specifically enumerated in the FDA‑approved or compendial indications in this policy will be denied as not medically necessary because it is considered experimental/investigational.

Regimens and Combination Use

Indication	Allowed as single agent?	Allowed in combination?	Notes / required context
Cutaneous melanoma (metastatic or unresectable, c‑KIT activating mutation)	covered	not_covered	Authorization of 12 months when metastatic/unresectable, tumor has c‑KIT activating mutation, used as subsequent therapy after progression/intolerance/risk with BRAF‑targeted therapy
Kaposi sarcoma	covered	covered	Authorization of 12 months when used as subsequent therapy; may be single agent or in combination with antiretroviral therapy (ART)
Chronic graft‑versus‑host disease (cGVHD)	not_covered	covered	Authorization of 12 months when used as subsequent therapy in combination with systemic corticosteroids

Coding and Monitoring Thresholds

BCR::ABL1 monitoring threshold — continuation

Continuation thresholdBCR::ABL1 ≤ 10% with no evidence of disease progression or unacceptable toxicity for members on therapy ≥ 6 months

Alternate continuation conditionAuthorization may be granted if member received HSCT and there is no evidence of progression or unacceptable toxicity

Shorter authorization for early therapyIf member has completed < 6 months of therapy, authorization up to 7 months may be granted

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for imatinib (Gleevec) therapy. Typical authorization durations: initial CML may be authorized for 7 months (when prior TKI therapy has not been failed other than due to intolerance); most other covered indications may be authorized for 12 months.

Initial CML: authorization of 7 months may be granted when CML is confirmed by detection of the Ph chromosome or BCR::ABL gene and the member did not fail (other than due to intolerance) prior therapy with a TKI (e.g., dasatinib, nilotinib, bosutinib, ponatinib).
Most other indications (e.g., ALL/LL, GIST, desmoid tumors, PVNS/TGCT, HES/CEL, DFSP, chordoma, MDS/MPD, CMML, ASM, cutaneous melanoma, Kaposi sarcoma, cGVHD, myeloid/lymphoid neoplasms with eosinophilia) — authorization of 12 months may be granted when criteria for the specific indication are met.

Documentation Required

Required Diagnostic Documentation

Provide diagnostic test results relevant to the requested indication to initiate review. Documentation must include evidence of the molecular or cytogenetic alteration that supports the diagnosis and indication for imatinib.

For CML or Ph+ ALL/LL: results of cytogenetic and/or molecular testing for detection of the Ph chromosome or the BCR::ABL gene.
For T-cell ALL/LL: results of cytogenetic and/or molecular testing confirming ABL-class translocation.
For MDS/MPD and CMML: results of molecular testing confirming PDGFR gene rearrangement.
For ASM: results of molecular testing for D816V c-KIT mutation and FIP1L1::PDGFRA fusion gene (where applicable).
For cutaneous melanoma: results confirming c-KIT activating mutation.
For myeloid/lymphoid neoplasms with eosinophilia: results confirming ABL1, FIP1L1::PDGFRA, or PDGFRB rearrangement.

Documentation Required

Prior TKI Requirement for CML

Prior TKI requirement for CML initial authorization: member must not have previously failed prior therapy with a tyrosine kinase inhibitor (TKI) — examples include dasatinib, nilotinib, bosutinib, ponatinib — unless the failure was due to intolerance.

If prior TKI was not failed (other than intolerance), initial CML authorization may be granted for 7 months when Ph chromosome or BCR::ABL is confirmed.
Members who have failed prior TKI therapy (other than intolerance) do not meet the initial-authorization exception noted above and should have documentation of prior therapy and reason for discontinuation provided for review.

Line of Therapy Rules

First-line | subsequent

First-line / newly diagnosed: Newly diagnosed Ph+ CML in chronic phase and pediatric newly diagnosed Ph+ ALL in combination with chemotherapy are covered when diagnostic confirmation is documented.

Subsequent therapy: Use as subsequent therapy is permitted per indication-specific criteria (for example, cutaneous melanoma as subsequent therapy after progression/intolerance to BRAF-targeted therapy; Kaposi sarcoma as subsequent therapy, single agent or with ART; cGVHD in combination with systemic corticosteroids).

Biomarker and Diagnostic Requirements

BCR::ABL (Ph chromosome) — biomarker requirement

Required testCytogenetic and/or molecular testing confirming presence of Philadelphia (Ph) chromosome or BCR::ABL gene

Indications supportedRequired for diagnosis and coverage of CML and Ph+ ALL/LL

Documentation useProvide test results with prior authorization request to confirm eligibility

ABL‑class translocation — biomarker requirement

Required testCytogenetic and/or molecular testing confirming ABL‑class translocation

Indications supportedRequired for T‑cell ALL/LL and relapsed/refractory pediatric T‑cell ALL/LL coverage

Documentation useProvide test results with prior authorization request to confirm ABL‑class rearrangement

c‑KIT activating mutation (including KIT/CD117 positivity) — biomarker requirement

Required testMolecular testing confirming c‑KIT activating mutation (includes KIT/CD117 positivity)

Indications supportedRequired for coverage of KIT+ GIST and cutaneous melanoma with c‑KIT mutation

Documentation useProvide test results with prior authorization request to confirm c‑KIT activating mutation

PDGFR (including FIP1L1‑PDGFRA, PDGFRB) — biomarker requirement

Required testMolecular testing or analysis confirming PDGFR gene rearrangement (including FIP1L1‑PDGFRA or PDGFRB)

Indications supportedRequired for MDS/MPD, CMML, HES/CEL, and myeloid/lymphoid neoplasms with eosinophilia

Documentation useProvide test results with prior authorization request to confirm PDGFR rearrangement

D816V c‑KIT mutation — biomarker requirement

Required testMolecular testing for D816V c‑KIT mutation status

Coverage condition for ASMAuthorization may be granted when D816V c‑KIT mutation is negative or status is unknown

Related findingsASM coverage may also be granted for well‑differentiated systemic mastocytosis or eosinophilia with FIP1L1::PDGFRA fusion

Background

Imatinib (Gleevec) is a tyrosine kinase inhibitor used in a range of hematology and oncology indications, including treatment of myeloid/lymphoid neoplasms with eosinophilia and ABL1, FIP1L1::PDGFRA, or PDGFRB rearrangements, aggressive systemic mastocytosis (ASM), and dermatofibrosarcoma protuberans (DFSP), among other listed tumor types. Coverage is contingent on the indication being one of the FDA‑approved or compendial uses documented in this policy.