CurrentCignaPolicy N/A

Oncology - Dasatinib Prior Authorization Policy

Prior authorization requirements for prescription benefit coverage of dasatinib for FDA‑approved indications and other uses with supportive evidence under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Dasatinib Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial clinical additions and minor editorial updates

Effective Date

Next Review Date

Key ActionSubmit prior authorization requests with applicable benefit plan reference and supporting clinical information, including prior therapies and relevant biomarker results.

SourceLink

POLICY UPDATE CHANGES

Approval option for Acute Lymphoblastic Leukemia was expanded to include patients with an ABL-class translocation.

Approval option for Chronic Myeloid Leukemia was expanded to include patients with BCR:ABL1-positive chronic myeloid leukemia.

Melanoma, cutaneous was added as an 'Other Use with Supportive Evidence' with specific eligibility conditions.

Policy text updated to reflect availability of generic dasatinib and changed references from Sprycel to dasatinib throughout.

FDA + 4Indications listed

1 yearTypical approval duration

NCCNGuideline source

Policy Summary

PayerCigna

PolicyOncology - Dasatinib Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial clinical additions and minor editorial updates

Effective Date

Next Review Date

Key ActionSubmit prior authorization requests with applicable benefit plan reference and supporting clinical information, including prior therapies and relevant biomarker results.

SourceLink

On This Page

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Coverage Criteria for Dasatinib

FDA-Approved Indications

Approve for 1 year if the patient meets ONE of the following for each numbered indication

Acute Lymphoblastic Leukemia (ALL): Approve for 1 year if ONE of: A) Patient has Philadelphia chromosome-positive acute lymphoblastic leukemia; OR B) Patient has ABL-class translocation.

Chronic Myeloid Leukemia (CML): Approve for 1 year if ONE of: A) Patient has Philadelphia chromosome-positive chronic myeloid leukemia; OR B) Patient has BCR::ABL1-positive chronic myeloid leukemia.

Other Uses with Supportive Evidence

Approve for 1 year when the specific criteria below are met for each condition

Bone Cancer: Patient is ≥ 18 years of age AND patient has chondrosarcoma or chordoma.age >= 18 years

Gastrointestinal Stromal Tumor (GIST): Patient is ≥ 18 years of age AND patient has tried imatinib or Ayvakit (avapritinib).age >= 18 years

Required prior therapy: imatinib or avapritinib.

Melanoma, Cutaneous: Patient is ≥ 18 years of age AND has metastatic or unresectable disease AND has an activating KIT mutation AND has tried at least one systemic regimen.age >= 18 years

Examples of systemic regimens are listed in the policy (e.g., immune checkpoint inhibitors, BRAF/MEK combinations).

Myeloid/Lymphoid Neoplasms with Eosinophilia: Patient is ≥ 18 years of age AND the tumor has an ABL1 rearrangement.age >= 18 years

Dasatinib (Sprycel® and generics) is considered experimental, investigational, or unproven for any indications or uses that are not explicitly listed as FDA‑approved or as “Other Uses with Supportive Evidence” in this policy. Requests for coverage for such non‑listed uses will not meet the policy’s coverage criteria and are excluded from coverage.

Regimen	Indication / Guideline context	Coverage stance
Dasatinib as monotherapy
Ph+ acute lymphoblastic leukemia (ALL): used per NCCN in induction, consolidation, maintenance, or relapsed/refractory settings (TKI may be combined with chemotherapy or corticosteroids)
Dasatinib as monotherapy or in combination with chemotherapy/corticosteroids per guideline-recommended regimens for Ph+ ALL
Dasatinib as monotherapy
Chronic myeloid leukemia (CML): recommended by NCCN as a 'Preferred' primary treatment for newly diagnosed chronic‑phase Ph+ or BCR::ABL1‑positive CML and as an alternative TKI in other settings
Dasatinib as monotherapy or in combination with chemotherapy/corticosteroids per guideline-recommended regimens for Ph+ CML

Provider Action Required / Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of dasatinib. All approvals are provided for the durations specified in the policy.

Approvals: typically 1 year for listed indications

Step Therapy

Required Prior Therapy for GIST

For gastrointestinal stromal tumor (GIST), the patient must have tried imatinib or avapritinib (Ayvakit) prior to approval of dasatinib.

Documentation Required

Benefit-plan and Clinical Documentation

Providers should reference the applicable benefit plan document when submitting coverage requests and supply all clinical information necessary for review, including diagnosis, prior therapies tried, relevant mutation or cytogenetic testing results, age, and treatment history.

Required Biomarker Findings and Genetic Definitions

KIT activating mutation — biomarker requirement

MarkerActivating KIT mutation

Required forMelanoma, cutaneous (metastatic or unresectable)

Age requirementPatient is ≥ 18 years of age

Additional clinical requirementPatient has tried at least one systemic regimen (per policy examples)

ABL1 rearrangement or ABL-class translocation — biomarker requirement

MarkerABL1 rearrangement or ABL-class translocation

Required for

Line of Therapy Definitions and Placement

first-line | second-line | salvage

NCCN context: Dasatinib is recommended across multiple lines including induction, consolidation, maintenance, relapsed/refractory settings for Ph+ ALL and as preferred or alternative TKI options in various CML settings; specific line depends on disease context and prior therapy.

Regimens and Combinations Covered

Regimen	Indication / Guideline context	Coverage stance
Dasatinib as monotherapy
Ph+ acute lymphoblastic leukemia (ALL): used per NCCN in induction, consolidation, maintenance, or relapsed/refractory settings (TKI may be combined with chemotherapy or corticosteroids)
Dasatinib as monotherapy or in combination with chemotherapy/corticosteroids per guideline-recommended regimens for Ph+ ALL
Dasatinib as monotherapy
Chronic myeloid leukemia (CML): recommended by NCCN as a 'Preferred' primary treatment for newly diagnosed chronic‑phase Ph+ or BCR::ABL1‑positive CML and as an alternative TKI in other settings
Dasatinib as monotherapy or in combination with chemotherapy/corticosteroids per guideline-recommended regimens for Ph+ CML

Background and Drug Information

Dasatinib is a tyrosine kinase inhibitor (TKI) with FDA‑approved indications that include Philadelphia chromosome‑positive (Ph+) acute lymphoblastic leukemia (ALL) and multiple phases of Ph+ chronic myeloid leukemia (CML). Guideline sources such as NCCN address dasatinib across disease contexts and list it as a preferred or recommended TKI option in settings for ALL and CML and in other tumor types; NCCN guidance also supports use in certain bone cancers, gastrointestinal stromal tumor (GIST), cutaneous melanoma with activating KIT mutations, and myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangements in selected circumstances.

Terminology and Abbreviations

Ph+, BCR::ABL1, ABL-class/ABL1 rearrangement — definitions

Ph+Indicates presence of the Philadelphia chromosome or BCR::ABL1 fusion

BCR::ABL1BCR::ABL1 (BCR-ABL1 positive) denotes the BCR-ABL1 fusion oncogene associated with Philadelphia chromosome-positive disease

ABL-class translocationRefers to translocations involving ABL-family genes (ABL1 and related) that can drive leukemias and are a separate molecular indication from classical Ph+ disease

ABL1 rearrangementSpecific rearrangement of the ABL1 gene; required biomarker for myeloid/lymphoid neoplasms with eosinophilia per policy

Policy Revision History

2025-03-26annual_revisionLatest

Added ABL-class translocation as an approval option for Acute Lymphoblastic Leukemia and added BCR::ABL1-positive option for Chronic Myeloid Leukemia; modified melanoma systemic regimen example (Opdualag replacement).

2024-10-02selected_revision

Updated policy to note availability of generic dasatinib and changed references from Sprycel to dasatinib throughout the document.

2023-05-31annual_revision

Reviewed policy (annual revision recorded).