CurrentCignaPolicy N/A

Dasatinib (Sprycel) prior authorization

Prior authorization requirements and coverage criteria for dasatinib (Sprycel) for prescription benefit plans administered by Cigna companies, including FDA‑approved indications and select off‑label uses with supportive evidence.

Policy Summary

PayerCigna

PolicyDasatinib (Sprycel) prior authorization

Policy CodePolicy N/A

Change TypeMaterial updates to covered indications and criteria

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation showing the specific indication, relevant biomarkers, prior therapies, and benefit plan details; approvals are typically for 1 year.

SourceLink

POLICY UPDATE CHANGES

Bone Cancer condition of approval reworded to 'bone cancer' and criterion added specifying patient has chondrosarcoma or chordoma.

Melanoma, Cutaneous approval added to 'Other Uses With Supportive Evidence'.

Added option for approval in ALL for patients with ABL-class translocation.

Added option for approval in CML for patients with BCR::ABL1-positive disease.

Policy updated to note Sprycel is available as generic dasatinib and generic terminology added throughout.

1 yearapproval duration

6covered indications

NCCN citedguideline source

Coverage Criteria for Dasatinib (Sprycel)

FDA-Approved Indications

Covered when ONE of the following is met; approve for 1 year:

Acute Lymphoblastic Leukemia (ALL): Patient has Philadelphia chromosome-positive acute lymphoblastic leukemia OR patient has ABL-class translocation.

Approve for 1 year.

Chronic Myeloid Leukemia (CML): Patient has Philadelphia chromosome-positive chronic myeloid leukemia OR patient has BCR::ABL1-positive chronic myeloid leukemia.

Approve for 1 year.

Other Uses With Supportive Evidence

Covered when ALL specified conditions are met; approve for 1 year:

Bone Cancer:

Policy Summary

PayerCigna

PolicyDasatinib (Sprycel) prior authorization

Policy CodePolicy N/A

Change TypeMaterial updates to covered indications and criteria

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation showing the specific indication, relevant biomarkers, prior therapies, and benefit plan details; approvals are typically for 1 year.

SourceLink

On This Page

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Regimen / Setting	Details / NCCN role	Coverage status
Dasatinib as monotherapy for Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML)
NCCN: Recommended as a 'Preferred' primary treatment for newly diagnosed chronic‑phase Ph+ or BCR::ABL1‑positive CML (category 1); also an alternative TKI in subsequent settings (category 2A).
Approve per criteria for Ph+ CML; standard approval duration 1 year.
Dasatinib as monotherapy or combined with chemotherapy for Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL)
NCCN: Recommended for Ph+ ALL in multiple clinical circumstances (induction, consolidation, maintenance, relapsed/refractory) with TKIs used alone or in combination with chemotherapy/corticosteroids (mainly category 2A).
Approve per criteria for Ph+ ALL; standard approval duration 1 year.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for prescription benefit coverage of dasatinib. Approvals are provided for the duration noted (typically 1 year) when criteria are met.

Prior authorization recommended for dasatinib (Sprycel®).
Typical approval duration: 1 year, when criteria are met.

Step Therapy

Prior Therapy Requirements

For certain indications (e.g., gastrointestinal stromal tumor and cutaneous melanoma) specific prior therapy is required before dasatinib will be approved.

Gastrointestinal Stromal Tumor (GIST): patient must be ≥ 18 years of age and have tried imatinib or Ayvakit (avapritinib).
Cutaneous Melanoma: patient must be ≥ 18 years of age, have metastatic or unresectable disease with an activating KIT mutation, and have tried at least one systemic regimen (examples include immune checkpoint inhibitors and targeted BRAF/MEK combinations).

Documentation Required

Required Evaluation Prior to Coverage Determination

Coverage determinations require review of the member's specific benefit plan, applicable laws/regulations, and relevant collateral materials. Each request is reviewed on its own merits.

Verify the member's benefit plan language and any plan-specific exclusions.
Consider applicable federal/state mandates and delegated vendor guidelines where relevant.

Denial Risk

Denial Triggers

Requests that do not meet the listed criteria (FDA‑approved indications, specified other uses with supportive evidence, or required prior therapy) may be considered experimental/investigational and denied.

Uses not listed in FDA‑approved indications or the "Other Uses with Supportive Evidence" section are considered experimental/investigational.
Failure to meet prior‑therapy prerequisites (e.g., no trial of imatinib or avapritinib for GIST; no prior systemic regimen for KIT‑mutant melanoma) may trigger denial.

Biomarker and Genetic Requirement Details

inv-13: KIT — activating KIT mutation (biomarker requirement for some indications)

BiomarkerActivating KIT mutation

Required indicationMelanoma, Cutaneous (metastatic or unresectable)

Age requirementPatient is ≥ 18 years of age

Prior therapy requirementPatient has tried at least one systemic regimen

inv-14: PDGFRA exon 18 (including D842V) — noted as insensitive to imatinib

BiomarkerPDGFRA exon 18 mutations (including D842V)

Clinical contextGastrointestinal stromal tumor (GIST) with PDGFRA exon 18 mutations

Therapeutic noteThese PDGFRA exon 18 mutations are insensitive to imatinib

Approval conditionsPatient is ≥ 18 years of age and has tried imatinib or avapritinib (per GIST criteria)

inv-15: BCR::ABL1 / ABL1 rearrangement — biomarker requirement

BiomarkerBCR::ABL1 fusion or ABL1 rearrangement

Covered indicationsAcute lymphoblastic leukemia (ALL), Chronic myeloid leukemia (CML), and myeloid/lymphoid neoplasms with eosinophilia

Approval durationApprove for 1 year when criteria met

Guideline supportNCCN lists dasatinib as preferred or recommended therapy for disease with these rearrangements

Definitions and Terminology

inv-09: Ph+ — Philadelphia chromosome positive (BCR::ABL1 fusion) definition

DefinitionPresence of the BCR::ABL1 fusion (Philadelphia chromosome positive).

Associated diseasesPh+ acute lymphoblastic leukemia (ALL) and Ph+ chronic myeloid leukemia (CML).

Therapeutic implicationPresence of Ph+ disease is an FDA‑approved indication for dasatinib when criteria are met (approve for 1 year).

inv-10: ABL-class translocation / ABL1 rearrangement — genomic rearrangements involving ABL1 or related kinases

DefinitionGenomic rearrangements involving ABL1 or related kinases (ABL‑class translocations) that may confer sensitivity to ABL‑targeting TKIs.

Clinical relevanceIncluded as criteria for approval in ALL, CML, and myeloid/lymphoid neoplasms with eosinophilia when ABL1 rearrangement is present.

Guideline noteNCCN recommends dasatinib as a preferred or recommended therapy for diseases with ABL1 rearrangements (category 2A).

Approval durationApprove for 1 year when criteria are met.

OpenPayer

Dasatinib (Sprycel) prior authorization

Coverage Criteria for Dasatinib (Sprycel)

Provider Actions and Authorization Requirements

Biomarker and Genetic Requirement Details

Line of Therapy

Definitions and Terminology

Background