CurrentCignaPolicy N/A

Oncology - Imatinib Prior Authorization Policy

Defines Cigna's prior authorization requirements and coverage criteria for imatinib (Gleevec) tablets for FDA‑approved and select guideline‑supported oncology and related indications; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Imatinib Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMay 1, 2024

Key ActionObtain prior authorization; approvals are issued for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14indications listed

1 yearstandard approval

NCCN citedguideline source

Coverage Criteria for Imatinib (Gleevec)

Covered indications and criteria

Imatinib (Gleevec) is covered as medically necessary when ALL of the following for a given listed indication are met as specified:

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FDA-Approved Indications (1–7): 1. Acute Lymphoblastic Leukemia (Ph+): Approve for 1 year if the patient has Philadelphia chromosome-positive acute lymphoblastic leukemia. 2. Aggressive Systemic Mastocytosis: Approve for 1 year if the patient is ≥ 18 years of age. 3. Chronic Myeloid Leukemia (Ph+): Approve for 1 year if the patient has Philadelphia chromosome-positive chronic myeloid leukemia. 4. Dermatofibrosarcoma Protuberans: Approve for 1 year if the patient is ≥ 18 years of age. 5. Gastrointestinal Stromal Tumors: Approve for 1 year. 6. Hypereosinophilic Syndrome and/or Chronic Eosinophilic Leukemia: Approve for 1 year if the patient is ≥ 18 years of age. 7. Myelodysplastic/Myeloproliferative Disease: Approve for 1 year if the patient meets BOTH of the following (A and B): A) Patient is ≥ 18 years of age; AND B) The condition is associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements.

Other Uses with Supportive Evidence (8–14): 8. Chordoma: Approve for 1 year. 9. Desmoid Tumors (Aggressive Fibromatosis): Approve for 1 year. 10. 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 include corticosteroids, cyclosporine, tacrolimus, mycophenolate mofetil, ibrutinib, low‑dose methotrexate, sirolimus, belumosudil, and ruxolitinib). 11. Kaposi Sarcoma: Approve for 1 year if the patient meets ALL the following: A) Patient is ≥ 18 years of age; AND B) Patient has tried at least one medication (examples include liposomal doxorubicin, paclitaxel, pomalidomide, lenalidomide, etoposide, thalidomide); AND C) Patient has relapsed or refractory disease. 12. Melanoma, Cutaneous: Approve for 1 year if the patient meets ALL the following: 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 (examples include immune checkpoint inhibitors and BRAFi/MEKi combinations). 13. Myeloid/Lymphoid Neoplasms with Eosinophilia: Approve for 1 year if the patient meets BOTH of the following: A) Patient is ≥ 18 years of age; AND B) Patient meets ONE of the following: i) The tumor has an ABL1 rearrangement; OR ii) The tumor has an FIP1L1‑PDGFRA or PDGFRB rearrangement. 14. Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor (TGCT): Approve for 1 year if the patient meets ONE of the following: A) Patient has tried Turalio (pexidartinib); OR B) Patient cannot take Turalio according to the prescriber (examples include elevated liver enzymes or concomitant use of hepatotoxic medications).

Indication / Context	Recommended regimen / TKI options	Line of therapy
Gastrointestinal stromal tumor (GIST)	Imatinib monotherapy (preferred regimen)	First‑line (preferred; NCCN category 1)
Chronic myeloid leukemia (Ph+), chronic phase — low‑risk patients	Imatinib (first‑generation TKI) OR second‑generation TKIs (bosutinib, dasatinib, nilotinib) — imatinib and second‑generation TKIs listed as preferred options for low‑risk; for intermediate/high risk, second‑generation TKIs preferred and imatinib listed as other recommended regimen	First‑line (low‑risk: imatinib or second‑generation TKI per NCCN; intermediate/high‑risk: second‑generation preferred)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for prescription benefit coverage; approvals are issued for 1 year. Requests that do not meet the coverage criteria (FDA‑approved indications or other uses with supportive evidence and any applicable step-therapy requirements) may be denied.

Prior authorization recommended for prescription benefit coverage of imatinib tablets (Gleevec® and generics).
All approvals are provided for 1 year.

Step Therapy

Step Therapy / Prior Treatment Prerequisites

For certain indications (for example chronic graft‑versus‑host disease), a trial of at least one conventional systemic treatment is required before approval. Step therapy or other prior treatment prerequisites listed in the policy must be met.

Chronic Graft‑Versus‑Host Disease: Require trial of at least one conventional systemic treatment prior to approval (examples: corticosteroids such as methylprednisolone or prednisone; cyclosporine; tacrolimus; mycophenolate mofetil; ibrutinib; low‑dose methotrexate; sirolimus; belumosudil; ruxolitinib).
Kaposi Sarcoma and Melanoma, Cutaneous: see policy-specific prior medication or mutation requirements and prior systemic regimen trial requirements.

Documentation Required

Documentation for Coverage Review

Coverage review must consider the terms of the applicable benefit plan document, applicable laws and regulations, relevant collateral materials (including this coverage policy), and the specific clinical facts of the request. Submit documentation that supports the diagnosis, prior treatments tried, relevant mutation or genetic testing when required, age criteria, and rationale for use.

Include benefit plan information and date of service when submitting a request.
Provide clinical records documenting diagnosis, age, prior therapies and their outcomes, and test results (e.g., PDGFR, ABL1, FIP1L1‑PDGFRA, PDGFRB, KIT mutation testing) when indicated.
Document reasons a preferred therapy cannot be used when applicable (e.g., liver enzyme elevation or contraindicated concomitant medications for Turalio).

Denial Risk

Denial Risk — Criteria Not Met

Denials may be issued when the request does not meet the listed coverage criteria, such as use outside FDA‑approved indications or lacks supportive evidence, missing required prior therapy trials, or insufficient documentation.

Requests without meeting policy criteria (age limits, required mutation status, prior therapy trials, or other specified prerequisites) are at risk for denial.
Incomplete documentation (e.g., lacking diagnostic test results or prior treatment history) may result in denial or request for additional information.

Biomarker and Molecular Testing Requirements

inv-11: KIT (activating KIT mutation)

Required biomarkerActivating KIT mutation (required for Melanoma, Cutaneous indication)

Indication tied to biomarkerMelanoma, Cutaneous — approval requires an activating KIT mutation and other criteria (age ≥18, metastatic/unresectable disease, prior systemic therapy)

Approval duration when criteria metApprove for 1 year when all indication criteria are satisfied

inv-12: FIP1L1‑PDGFRA / PDGFRB

Required biomarkerFIP1L1‑PDGFRA fusion (FIP1L1‑PDGFRα) or PDGFRB rearrangement

Indications tied to biomarkerHypereosinophilic syndrome/chronic eosinophilic leukemia and Myeloid/Lymphoid Neoplasms with Eosinophilia — presence of FIP1L1‑PDGFRA or PDGFRB fusion supports imatinib use

Approval duration when criteria metApprove for 1 year when the indication-specific criteria are met

inv-13: ABL1 rearrangement

Required biomarkerABL1 rearrangement

Indication tied to biomarkerMyeloid/Lymphoid Neoplasms with Eosinophilia — an ABL1 rearrangement is an acceptable molecular criterion for approval

Guideline supportNCCN recommends imatinib for patients with ABL1 rearrangements in chronic or blast phase (category 2A)

inv-14: Philadelphia chromosome (BCR‑ABL/Ph+)

Required biomarkerPhiladelphia chromosome (BCR‑ABL/Ph+)

Indications tied to biomarkerAcute lymphoblastic leukemia (Ph+) and Chronic myeloid leukemia (Ph+) — both listed FDA indications for imatinib

Approval duration when criteria metApprove for 1 year when other indication-specific criteria are satisfied

Definitions

inv-08: Philadelphia chromosome positive (Ph+)

DefinitionPhiladelphia chromosome positive (Ph+) indicates presence of the BCR‑ABL fusion resulting from the t(9;22) translocation

Clinical contextPh+ designation is required for the ALL and CML indications listed for imatinib (adult and pediatric uses as specified)

Guideline referenceNCCN guidelines reference Ph+ disease in recommendations for imatinib across indications

inv-09: FIP1L1‑PDGFRA / PDGFRB rearrangement

DefinitionFIP1L1‑PDGFRA and PDGFRB are gene fusions/rearrangements involving PDGF receptor genes that can drive eosinophilic/myeloid neoplasms

Predictive rolePresence of FIP1L1‑PDGFRA or PDGFRB rearrangements predicts response to imatinib and is an explicit molecular criterion for approval in hypereosinophilic syndrome/chronic eosinophilic leukemia and myeloid/lymphoid neoplasms with eosinophilia

Testing methods notedMutation analysis or fluorescence in situ hybridization (FISH) demonstrating relevant rearrangements is referenced in the product labeling for FIP1L1‑PDGFRα

Background

Imatinib (Gleevec) is a tyrosine kinase inhibitor (TKI) used in multiple hematologic malignancies and select solid tumors where specific targetable mutations or gene rearrangements are present. The agent is recognized in guideline sources such as NCCN for use across indications including Philadelphia chromosome–positive leukemias, gastrointestinal stromal tumors (GIST), and other tumor types where molecular targets like BCR‑ABL (Ph+), KIT, PDGFRA, FIP1L1‑PDGFRA, PDGFRB, or ABL1 rearrangements predict response.

For coverage purposes under this policy, prior authorization is recommended for imatinib tablets and approvals are issued for a standard duration of 1 year when the listed indication-specific criteria are met. Clinical application and line‑of‑therapy placement (for example, imatinib as a preferred first‑line regimen for GIST) follow NCCN recommendations and the specific molecular and prior‑treatment requirements outlined in the coverage criteria.

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