CurrentMass General Brigham Health PlanPolicy N/A

Imkeldi (imatinib) oral solution — Prior Authorization and Coverage Criteria

This policy governs prior authorization, quantity limits, and continuation criteria for Imkeldi (imatinib) oral solution under the Mass General Brigham Health Plan pharmacy benefit, affecting commercial/exchange and specialty pharmacy claims.

Policy Summary

PayerMass General Brigham Health Plan

PolicyImkeldi (imatinib) oral solution — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document that the member is currently receiving the medication (or provide a clinical rationale why the tablet cannot be used) for members new to the plan within 90 days.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsApproval duration

10 mL/dayQuantity limit

90 daysNew-to-plan grace

SpecialtyDispense channel

Coverage Criteria for Imkeldi (imatinib) oral solution

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inv-01: Initial Authorization

Authorization may be granted when ONE of the following is met

Pathway A - New to plan on therapy: Member is new to the plan within the past 90 days and is currently receiving the requested medication (excluding samples or manufacturer's patient assistance programs)90 days

Support with documentation of current therapy and source of medication

Pathway B - Clinical rationale for oral solution: A clinical rationale why the member cannot administer imatinib tablet is provided

Document specific reason tablet cannot be used; prescribing information may be referenced

inv-02: Continuation of Therapy

Requests for reauthorization will be approved when ALL of the following are met

Continuation of Therapy: Member has had a positive response to therapy and does not show evidence of disease progression or treatment-related toxicity

Clinical documentation of response and absence of progression/toxicity required

Authorizations using the "new to plan" pathway are not granted when the member obtained the product only as samples or through the manufacturer's patient assistance program. Support for a "new to plan" approval must document that the member is currently receiving the requested medication and that the product was obtained by means other than samples or patient assistance.

If the request is not eligible under the "new to plan" pathway, authorization may still be considered when the provider supplies a clinical rationale demonstrating why the member cannot administer imatinib tablets (see clinical criteria).

Indication	Dosing (per FDA prescribing information)	Coverage status
Newly diagnosed adult and pediatric Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) — chronic phase
Use FDA‑approved dosing for imatinib oral solution as specified in the prescribing information (dose varies by indication and patient age/weight); follow the PI for specific mg/kg or fixed‑dose regimens
Adult and pediatric Ph+ CML (chronic phase) — covered when dosing follows FDA PI and authorization criteria are met

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior authorization required; 90-day new-to-plan allowance

Prior authorization is required for Imkeldi (imatinib) oral solution. Authorizations may be granted for members new to the plan within the past 90 days who are currently receiving the requested medication (excluding product obtained only as samples or via manufacturer's patient assistance programs), or when all stated clinical criteria are met.

Step Therapy

Step therapy noted — no specific sequence provided

Step therapy is listed as a program type for this medication, but the policy does not specify any required step sequence or alternative agent requirements.

Documentation Required

Required documentation — current therapy and tablet rationale

Document the member's current treatment status when relying on the 'new to plan' pathway and provide a clinical rationale explaining why the member cannot use imatinib tablets; prescribing information may be referenced.

Denial Risk

Authorization may be denied if current therapy or rationale is not documented

Failure to document that the member is currently receiving the requested medication and is new to the plan within the past 90 days, or failure to provide a rationale why the member cannot use imatinib tablets, may trigger denial.

Line of Therapy Requirements

inv-10: mixed

Line-specific indications: Indication matches one of the FDA‑listed indications for imatinib oral solution (e.g., newly diagnosed Ph+ CML in chronic phase; Ph+ CML in BC, AP, or CP after interferon‑alpha failure; newly diagnosed pediatric Ph+ ALL in combination with chemotherapy; relapsed/refractory adult Ph+ ALL; adjuvant treatment post‑GIST resection; unresectable/recurrent/metastatic DFSP; KIT‑positive unresectable/metastatic GIST)

Indications as listed in prescribing information

Biomarker and Mutation Requirements

FIP1L1-PDGFRa — diagnostic requirement

BiomarkerFIP1L1-PDGFRa fusion kinase

Required demonstrationPositive by mutational analysis

Alternative demonstrationFISH demonstration of CHIC2 allele‑deletion

Applicable indicationHypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL)

c‑Kit D816V — diagnostic requirement

Biomarkerc‑Kit D816V mutation status

Allowed status for coverageAbsence of D816V mutation

Alternate acceptable statusc‑Kit mutational status unknown

Applicable indicationAggressive systemic mastocytosis (ASM)

Indications and Definitions

FDA‑approved indications for Imkeldi (imatinib) oral solution

IndicationNewly diagnosed adult and pediatric Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) — chronic phase

IndicationPh+ CML in blast crisis (BC), accelerated phase (AP), or chronic phase (CP) after interferon‑alpha failure

IndicationPediatric newly diagnosed Ph+ ALL in combination with chemotherapy

IndicationRelapsed or refractory adult Ph+ acute lymphoblastic leukemia (ALL)

IndicationMDS/MPD associated with PDGFR gene rearrangements

IndicationAggressive systemic mastocytosis (ASM) without D816V c‑Kit mutation or with c‑Kit mutational status unknown

IndicationHES and/or CEL with FIP1L1‑PDGFRa fusion kinase (or FIP1L1‑PDGFRa negative/unknown)

IndicationUnresectable, recurrent, or metastatic dermatofibrosarcoma protuberans (DFSP)

IndicationKit (CD117) positive unresectable and/or metastatic gastrointestinal stromal tumors (GIST)

IndicationAdjuvant treatment following resection of Kit (CD117) positive GIST

Indication	Dosing (per FDA prescribing information)	Coverage status
Ph+ CML in blast crisis (BC), accelerated phase (AP), or chronic phase (CP) after failure of interferon‑alpha therapy
Use FDA‑approved dosing for imatinib oral solution as specified in the prescribing information for the relevant disease phase and patient characteristics
Ph+ CML (BC/AP/CP post‑interferon failure) — covered when dosing follows FDA PI and authorization criteria are met

Background

Imatinib is a tyrosine kinase inhibitor with activity against BCR-ABL, PDGFR, and KIT kinases. The oral solution formulation provides an alternative route of administration for patients who cannot take tablets.

This policy applies to Imkeldi (imatinib) oral solution for the hematologic and solid tumor indications listed in the prescribing information; prior authorization is required and approvals may be granted either for members new to the plan within 90 days who are already receiving treatment, or when a clinical rationale is provided showing the member cannot use tablets.