CurrentMass General Brigham Health PlanPolicy N/A

Imkeldi (imatinib) oral solution

Defines prior authorization, specialty pharmacy requirement, coverage criteria, continuation criteria, quantity limits, and fill/benefit details for Imkeldi (imatinib) oral solution for Commercial/Exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyImkeldi (imatinib) oral solution

Policy CodePolicy N/A

Change TypePolicy created

Effective DateMay 1, 2025

Next Review Date

Key ActionPrior authorization is required for Imkeldi (imatinib) oral solution under the pharmacy benefit for Commercial/Exchange members effective 05/01/2025.

SourceLink

POLICY UPDATE CHANGES

Policy created for February P&T and made effective 05/01/2025.

10FDA Indications Listed

12 monthsInitial/Reauthorization Approval Duration

10 mL/dayPer-day Quantity Limit

90 daysNew-to-plan Continuity Window

Coverage Summary

Coverage stance: covered with criteria for Imkeldi (imatinib) oral solution under the pharmacy benefit for Commercial/Exchange members. Medication is designated specialty and must be filled at a contracted specialty pharmacy. Effective date: 05/01/2025. Scope: defines prior authorization requirements, specialty pharmacy requirement, coverage and continuation criteria, quantity limits (10 mL/day), and approval durations (12 months) for Commercial/Exchange members.

Initial Authorization Criteria

Initial Authorization

Authorizations may be granted when ALL of the following criteria are met:

ALL of the following

Tablet trial or clinical rationale: Member has had a trial and failure, intolerance or contraindication to imatinib tablet OR a clinical rationale why the member cannot administer imatinib tablet is provided
New-to-plan continuity (operational): Member is new to the plan within the past 90 days and is currently receiving treatment with the requested medication (excluding when the product is obtained as samples or via manufacturer's patient assistance programs)
Authorizations may be granted for members new to the plan within the past 90 days who are currently receiving treatment

Indications / FDA-labeled Uses (Overview): - Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase - Patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy - Adult patients with relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) - Pediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy - Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements - Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown - 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 - Adult patients with unresectable, recurrent, or metastatic dermatofibrosarcoma protuberans (DFSP) - Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) - Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST

Continuation Therapy / Reauthorization Criteria

Continuation of Therapy / Reauthorization

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

ALL of the following

Positive response to therapy: Member had a positive response to therapy
No progression or toxicity: Member does not show evidence of disease progression or toxicity

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Reauthorization operational thresholds

Approval duration for reauthorization12 months

Required clinical evidencePositive response to therapy

Required clinical evidenceNo evidence of disease progression or treatment-related toxicity

Provider Actions and Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Imkeldi (imatinib) oral solution under the pharmacy benefit for Commercial/Exchange members effective 05/01/2025.

Documentation Required

Tablet trial or rationale required

Documentation must show trial and failure, intolerance, or contraindication to imatinib tablet OR a clinical rationale why the member cannot administer imatinib tablet.

Prior Authorization

New-to-plan continuity

Authorizations may be granted for members new to the plan within the past 90 days who are currently receiving the medication (excluding samples or manufacturer assistance programs).

New-to-plan window: 90 days

Prior Authorization

Reauthorization requirements

Reauthorization requests require evidence of positive response to therapy and absence of disease progression or toxicity.

Billing Rule

Quantity limit enforcement

Quantity limit for Imkeldi oral solution is set at 10 mL per day and initial and reauthorization approvals are for 12 months.

10 mL/day
approvals for 12 months

Documentation Required

Specialty pharmacy fill

Medication must be filled at a contracted specialty pharmacy; providers should route prescriptions accordingly.

Clinical Evidence & Background

Imkeldi (imatinib) oral solution is a kinase inhibitor with multiple hematologic and oncologic indications consistent with the FDA prescribing information, used across CML, ALL, GIST, DFSP, HES/CEL, ASM, and PDGFR-rearranged MDS/MPD populations. This policy governs pharmacy benefit prior authorization and specialty distribution for Commercial/Exchange members.

Prior authorization, specialty pharmacy fill requirements, coverage criteria (including tablet trial or clinical rationale exceptions), continuation criteria, quantity limits, and approval durations are specified in the policy for Commercial/Exchange members.

References: - Imkeldi (imatinib) oral solution [prescribing information]. Cambridge, MA: Shorla Oncology Inc.; November 2024.

Policy Summary

PayerMass General Brigham Health Plan

PolicyImkeldi (imatinib) oral solution

Policy CodePolicy N/A

Change TypePolicy created

Effective DateMay 1, 2025

Next Review Date

Key ActionPrior authorization is required for Imkeldi (imatinib) oral solution under the pharmacy benefit for Commercial/Exchange members effective 05/01/2025.

SourceLink

On This Page

OpenPayer

Imkeldi (imatinib) oral solution

Coverage Summary

Initial Authorization Criteria

Continuation Therapy / Reauthorization Criteria

Provider Actions and Requirements

Applicable Codes and Benefit Details

Clinical Evidence & Background

Definitions

Revision History