CurrentCignaPolicy N/A

Oncology - Imatinib Products Prior Authorization Policy

Cigna coverage policy governing prior authorization and medical necessity criteria for imatinib products (Gleevec tablets and Imkeldi oral solution) for members covered under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Imatinib Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMultiple material updates (product additionindication clarifications)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for Gleevec or Imkeldi with supporting documentation; approvals are typically for one year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

A new formulation of imatinib (Imkeldi [imatinib oral solution]) was added to the policy with the same criteria as imatinib.

Acute Lymphoblastic Leukemia approval option added: 'patient has ABL1-class translocation.'

Chronic Myeloid Leukemia approval option added: 'patient has BCR::ABL1-positive chronic myeloid leukemia.'

Systemic mastocytosis qualifier changed: 'Aggressive' removed; requirement added that disease is KIT D816V mutation negative or unknown.

Graft-versus-host disease examples updated to include Niktimvo (axatilimab-csfr) among systemic treatment examples; Melanoma regimen examples modified; Romvimza added for pigmented villonodular synovitis options.

≥1 yearstandard approval duration for covered indications

2imatinib products named

11listed indications

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1applies to Cigna-administered plans

Coverage and Medical Necessity Criteria

FDA-Approved Indications

Covered when criteria below are met for each indication; approvals for 1 year

FDA-approved indications

Acute Lymphoblastic Leukemia (ALL)
- ALL options: A) Patient has Philadelphia chromosome-positive acute lymphoblastic leukemia; OR B) Patient has ABL-class translocation.
Systemic Mastocytosis
- Age and mutation status: A) Patient is ≥ 18 years of age; AND B) the disease is KIT D816V mutation negative or unknown.
Chronic Myeloid Leukemia (CML)
- CML options: A) Patient has Philadelphia chromosome-positive chronic myeloid leukemia; OR B) Patient has BCR::ABL1-mutation positive chronic myeloid leukemia.
Dermatofibrosarcoma Protuberans: Approve for 1 year if patient is ≥ 18 years of age
Gastrointestinal Stromal Tumors (GIST): Approve for 1 year
Hypereosinophilic Syndrome and/or Chronic Eosinophilic Leukemia: Approve for 1 year if patient is ≥ 18 years of age
Myelodysplastic/Myeloproliferative Disease
- Age and PDGFR rearrangement: A) Patient is ≥ 18 years of age; AND B) the condition is associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements.

Note: Approvals for any covered FDA indication are for 1 year per policy.

Other Uses with Supportive Evidence

Covered when indication-specific criteria are met; approvals for 1 year

Chordoma: Approve for 1 year

Desmoid Tumors (Aggressive Fibromatosis): Approve for 1 year

Graft-Versus-Host Disease, Chronic: Approve for 1 year if the patient has tried at least one conventional systemic treatment for graft-versus-host disease (examples listed in policy).

Kaposi Sarcoma

Age: A) Patient is ≥ 18 years of age

Imatinib products (Gleevec® tablets and Imkeldi® oral solution) are considered not medically necessary for any uses not specifically listed in this policy. The policy will be updated as new published data become available.

Any use of imatinib products other than the FDA‑approved indications and the other uses with supportive evidence described in this policy is considered not medically necessary and therefore not covered.

Example systemic regimens
nivolumab + ipilimumab (Opdivo + Yervoy)
Opdualag (nivolumab/relatlimab)
pembrolizumab (Keytruda)
dabrafenib + trametinib (Tafinlar + Mekinist)
vemurafenib + cobimetinib (Zelboraf + Cotellic)
encorafenib + binimetinib (Braftovi + Mektovi)

Named Products and Coding Details

Named productsmixed

Gleevec	imatinib tablets - Novartis, generic
Imkeldi	imatinib oral solution - Shorla Oncology

Age requirement for select indications — ≥ 18 years

Age requirementPatient must be ≥ 18 years of age for specified indications (systemic mastocytosis, dermatofibrosarcoma protuberans, hypereosinophilic syndrome/chronic eosinophilic leukemia, myelodysplastic/myeloproliferative disease, Kaposi sarcoma, and cutaneous melanoma).

Approval durationApprovals for these indications are for 1 year when criteria are met.

Applies toAdults only for indications listing the ≥ 18 years requirement; pediatric approvals are specified elsewhere (e.g., ALL pediatric combination with chemotherapy).

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for prescription benefit coverage of imatinib products. All approvals are provided for the duration noted in the clinical criteria. This includes Gleevec (imatinib tablets) and Imkeldi (imatinib oral solution).

Products: Gleevec (imatinib tablets) and Imkeldi (imatinib oral solution)
Approvals limited to the duration specified in the policy criteria (typically 1 year for listed indications)

Step Therapy

Step Therapy Required for Chronic GVHD

For chronic graft-versus-host disease (GVHD), prior authorization approvals will be granted only if the patient has tried at least one conventional systemic therapy for chronic GVHD before initiating imatinib.

Examples of conventional systemic therapies: corticosteroids (methylprednisolone, prednisone); cyclosporine; tacrolimus; mycophenolate mofetil; Imbruvica (ibrutinib); low-dose methotrexate; sirolimus; Niktimvo (axatilimab-csfr infusion); Rezurock (belumosudil); Jakafi (ruxolitinib).

Background and Scope

Imatinib is a tyrosine kinase inhibitor available as Gleevec® (imatinib tablets) and Imkeldi® (imatinib oral solution). Coverage and medical necessity for imatinib are determined only for the specific indications and supportive‑evidence uses set forth in this policy; other uses are considered not medically necessary.

Key Definitions and Biomarker Terms

inv-12: Ph+ — Philadelphia chromosome-positive (Ph+)

DefinitionPhiladelphia chromosome-positive (Ph+): presence of the BCR::ABL1 fusion resulting from the Philadelphia chromosome, used to identify Ph+ ALL and Ph+ CML indications for imatinib.

Relevant FDA-approved indicationsPh+ acute lymphoblastic leukemia (ALL) and Ph+ chronic myeloid leukemia (CML) are specified FDA-approved indications for imatinib.

Coverage actionApprove for 1 year when documentation confirms Ph+ status as specified in the indication criteria.

inv-13: KIT D816V mutation status — KIT D816V mutation negative or unknown required for systemic mastocytosis approval

Requirement for systemic mastocytosisDisease must be KIT D816V mutation negative or mutation status must be unknown for approval of systemic mastocytosis.

Line of Therapy Requirements

salvage

Salvage: Patient must have tried at least one conventional systemic treatment prior to approval (applies to chronic graft-versus-host disease per policy).

Biomarker and Molecular Test Requirements

inv-15: KIT D816V — negative or unknown

MarkerKIT D816V

RequirementSystemic mastocytosis must be KIT D816V mutation negative or mutation status unknown for approval.

ContextThis biomarker requirement is listed under the FDA-approved systemic mastocytosis indication and is coupled with an adult age requirement.

inv-16: BCR::ABL1 — biomarker requirement

MarkerBCR::ABL1

RequirementPresence of BCR::ABL1-mutation (BCR::ABL1-positive) is an alternate approval pathway for chronic myeloid leukemia (CML).

Examples of Regimens and Prior Therapies

Example systemic regimens
nivolumab + ipilimumab (Opdivo + Yervoy)
Opdualag (nivolumab/relatlimab)
pembrolizumab (Keytruda)
dabrafenib + trametinib (Tafinlar + Mekinist)
vemurafenib + cobimetinib (Zelboraf + Cotellic)
encorafenib + binimetinib (Braftovi + Mektovi)

Policy Revisions and Effective Dates

2026-03-25revisionLatest

Systemic mastocytosis qualifier changed: 'Aggressive' removed and requirement added that disease is KIT D816V mutation negative or unknown; Kaposi sarcoma option expanded to include KSHV-associated inflammatory cytokine syndrome; operational examples updated (Graft-versus-host disease examples, melanoma regimen modification, Romvimza added for pigmented villonodular synovitis).

2025-01-08selected_revision

Imkeldi (imatinib oral solution) was added to the policy as a new formulation with the same criteria as imatinib and the policy name changed to 'Imatinib Products Prior Authorization Policy'.

2024-05-01annual_review

Policy Summary

PayerCigna

PolicyOncology - Imatinib Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMultiple material updates (product additionindication clarifications)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for Gleevec or Imkeldi with supporting documentation; approvals are typically for one year when criteria are met.

SourceLink

On This Page

Disease criteria: B) Patient meets ONE of the following: i) patient has tried at least one medication AND has relapsed or refractory disease; OR ii) patient has KSHV-associated inflammatory cytokine syndrome (KICS).

Melanoma, Cutaneous

Melanoma criteria: A) Patient is ≥ 18 years of age; AND B) patient has metastatic or unresectable disease; AND C) patient has an activating KIT mutation; AND D) patient has tried at least one systemic regimen.

Myeloid/Lymphoid Neoplasms with Eosinophilia

Age and molecular criteria: A) Patient is ≥ 18 years of age; AND B) tumor has an ABL1 rearrangement OR the tumor has an FIP1L1-PDGFRA or PDGFRB rearrangement.

Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor

PVNS/TGCT options: A) Patient has tried Turalio (pexidartinib) or Romvimza (vimseltinib); OR B) patient cannot take Turalio or Romvimza per prescriber (examples include elevated liver enzymes or concomitant hepatotoxic medications).

Documentation Required

Prior Authorization and Documentation Expectations

Prior authorization is recommended and approvals are provided for the duration noted. Coverage determinations require documentation of the covered diagnosis, supporting clinical information, and specification of the FDA-approved indication or supportive evidence for other uses.

Submit documentation supporting the indicated diagnosis, prior treatments tried, mutation status when required (e.g., KIT D816V, BCR::ABL1), and treatment history.
Approvals generally issued for 1 year for the indications listed in the policy unless otherwise specified.

Denial Risk

Coding-Based Denial Risk

Claims submitted without covered diagnosis or procedure codes that match the applicable coverage policy will be denied as not covered. Ensure billing uses the most appropriate codes current as of the date of submission.

Claims lacking a covered diagnosis/procedure code consistent with the policy will be denied.
Use current, appropriate ICD-10/CPT/HCPCS/NDC codes as of the submission date.

Systemic mastocytosis approval also requires the patient to be ≥ 18 years of age.

Approval durationApprovals are for 1 year when both age and KIT D816V status criteria are met.

Approve for 1 year when documentation confirms BCR::ABL1-positive CML as specified in the CML criteria.

inv-17: ABL1 rearrangement / FIP1L1-PDGFRA / PDGFRB — biomarker requirement

MarkersABL1 rearrangement; FIP1L1-PDGFRA rearrangement; PDGFRB rearrangement

RequirementMyeloid/lymphoid neoplasms with eosinophilia require presence of an ABL1 rearrangement OR a FIP1L1-PDGFRA or PDGFRB rearrangement for approval.

Age linkageThis indication also requires the patient be ≥ 18 years of age.

inv-18: activating KIT mutation — biomarker requirement

MarkerActivating KIT mutation

RequirementCutaneous (cutaneous) melanoma approval requires presence of an activating KIT mutation as part of the criteria.

Additional criteriaApproval for melanoma also requires patient be ≥ 18 years, have metastatic or unresectable disease, and have tried at least one systemic regimen.

Annual review recorded with no clinical criteria changes noted on this date.