CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Dasatinib (Sprycel) — Coverage Criteria

Policy governing prior authorization, coverage criteria, and documentation requirements for dasatinib (Sprycel) across FDA-approved and compendial oncology indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDasatinib (Sprycel) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit required molecular or cytogenetic test results (e.g., Ph/BCR::ABL, BCR::ABL1 mutation testing, PDGFRA exon 18, ABL1 rearrangement, or c-KIT) as specified for the indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA + compendialIndications included

12 moTypical auth length

7 moCML initial auth

BCR::ABL1 reqMutation testing

Coverage Criteria for Dasatinib (Sprycel)

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Initial Therapy — ALL/LL

Covered for Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LL) when ALL of the following are met

ALL/LL initial therapy: Member has any of: Ph+ ALL/LL confirmed by detection of Ph chromosome or BCR::ABL gene; OR Ph-like B-ALL/LL with ABL-class kinase fusion confirmed by testing; OR T-cell ALL/LL with ABL-class translocation confirmed by testing and the disease is relapsed or refractory; AND member meets any of: has not received prior TKI; OR experienced toxicity/intolerance to prior TKI; OR experienced resistance to prior TKI with BCR::ABL1 mutational testing negative for T315I/A, F317L/V/I/C, and V299L.

Authorization of 12 months may be granted; HSCT scenarios with negative mutation testing described separately.

Initial Therapy — Cutaneous Melanoma

Covered for Cutaneous Melanoma when ALL of the following are met

Cutaneous melanoma criteria: Disease is metastatic or unresectable; tumor has c-KIT activating mutations; the requested medication will be used as subsequent therapy and as a single agent; and member has had disease progression, intolerance, or risk of progression with BRAF-targeted therapy.

Authorization of 12 months may be granted.

Continuation Therapy

Continuation therapy — CML and ALL/LL

CML continuation: Authorization may be granted for continued treatment of CML confirmed by detection of Ph chromosome or BCR::ABL gene when any of the following are met: member has been receiving dasatinib for >=6 months and BCR::ABL1 is <=10% with no evidence of disease progression or unacceptable toxicity; OR member has received HSCT and there is no evidence of unacceptable toxicity or disease progression while on the current regimen. If the member has completed less than 6 months of therapy, authorization of up to 7 months may be granted.BCR::ABL1 <=10%

ALL/LL continuation: Authorization of 12 months may be granted for continued treatment of ALL/LL when there is no evidence of unacceptable toxicity or disease progression and any of the following diagnostic confirmations are met: Ph+ ALL/LL, Ph-like B-ALL/LL with ABL-class kinase fusion, or T-cell ALL/LL with ABL-class translocation; or member has received HSCT.

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required — Documentation & Diagnostic Testing

Prior authorization is required. The following documentation and testing must be submitted to initiate review and support medical necessity for treatment with the requested medication.

Results of cytogenetic and/or molecular testing confirming Philadelphia (Ph) chromosome and/or BCR::ABL gene for CML and Ph+ ALL/LL.
Results of cytogenetic and/or molecular testing confirming ABL-class kinase fusion for Ph-like B-ALL/LL and confirming ABL-class translocation for T-cell ALL/LL.
For members initiating therapy after resistance to prior TKI therapy: results of BCR::ABL1 mutation testing for T315I/A, F317L/V/I/C, and V299L.
For treatment of GIST: PDGFRA exon 18 mutation testing where applicable.
For myeloid/lymphoid neoplasms with eosinophilia: testing confirming ABL1 rearrangement.
For cutaneous melanoma: molecular testing confirming c-KIT activating mutations.

Documentation Required

Prior Therapy and Mutation-Testing Requirements

Coverage for the requested medication is contingent on prior therapy history and mutation testing where specified. Provide clear documentation of prior TKI use, intolerance/toxicity, resistance, or absence of prior TKI as applicable to the indication.

For CML and ALL/LL indications: document whether the member has not received prior TKI therapy, has experienced toxicity/intolerance to a prior TKI, or has experienced resistance to a prior TKI.
When coverage is requested based on resistance to prior TKI therapy, include BCR::ABL1 mutational test results that are negative for T315I/A, F317L/V/I/C, and V299L if required by the indication.
For GIST: document prior therapy with avapritinib as required by the GIST criteria.
For members post-hematopoietic stem cell transplant (HSCT): document HSCT and include mutation testing results when required by the indication.

Denial Risk

Experimental/Investigational Exclusions — Denial Risk

All indications not listed as FDA‑approved or compendial uses (including the enumerated CML, ALL/LL, GIST, chondrosarcoma, chordoma, myeloid/lymphoid neoplasms with eosinophilia, and cutaneous melanoma) are considered experimental or investigational and are not medically necessary. Requests for such uses will be denied unless there is documented FDA approval or accepted compendial support.

If an indication is not explicitly listed among the approved/compendial uses, attach supporting literature or FDA labeling; absence of such support will result in denial as experimental/investigational.

Biomarker and Molecular Testing Requirements

BCR::ABL (Ph chromosome/BCR::ABL gene) — testing requirements

Required testCytogenetic and/or molecular testing confirming presence of the Philadelphia (Ph) chromosome or the BCR::ABL gene is required to initiate therapy for CML.

When requiredTesting required at initiation and for continuation decisions per documentation requirements for CML treatment.

Supporting scenariosProvides confirmation for newly diagnosed Ph+ CML, post-HSCT status, or when assessing resistance/intolerance to prior TKIs.

PDGFRA exon 18 — GIST molecular testing requirement

Required testPDGFRA exon 18 mutation testing is required to document that the GIST harbors a PDGFRA exon 18 mutation prior to coverage.

Clinical contextDisease must be residual, unresectable, recurrent/progressive, or metastatic and member must have received prior avapritinib.

Regimen constraintDasatinib must be used as a single agent for this indication.

ABL1 rearrangement / ABL-class kinase fusion — testing requirement

Required testCytogenetic and/or molecular testing confirming ABL1 rearrangement or an ABL-class kinase fusion is required for myeloid/lymphoid neoplasms with eosinophilia and for Ph-like B-ALL/LL or T‑cell ALL/LL with ABL-class translocation.

IndicationsRequired for myeloid/lymphoid neoplasms with eosinophilia (chronic or blast phase), Ph-like B-ALL/LL, and relapsed/refractory T‑cell ALL/LL with ABL-class translocation.

Documentation useResults must be provided to initiate prior authorization review per documentation section.

c-KIT activating mutation — testing requirement for melanoma

Required testMolecular testing documenting c‑KIT activating mutations is required for coverage of cutaneous melanoma.

Clinical prerequisitesDisease must be metastatic or unresectable and dasatinib used as subsequent single‑agent therapy after progression/intolerance/risk with BRAF‑targeted therapy.

Authorization lengthAuthorization of 12 months may be granted when criteria met.

Covered Regimens and Regimen Notes

Indication	Regimen / Use	Coverage status
Gastrointestinal Stromal Tumor (GIST)	Dasatinib used as a single agent after prior therapy with avapritinib for residual, unresectable, recurrent/progressive, or metastatic disease harboring a PDGFRA exon 18 mutation.	Covered
Widespread metastatic chondrosarcoma or recurrent chordoma (Bone Cancer)	Dasatinib used as a single agent for treatment of widespread metastatic chondrosarcoma or recurrent chordoma.	Covered
Cutaneous Melanoma	Dasatinib used as a single agent as subsequent therapy for metastatic or unresectable disease in patients with tumor c-KIT activating mutations who have progressed on, are intolerant of, or are at risk of progression with BRAF-targeted therapy.	Covered

Definitions and Mutation Details

BCR::ABL1 mutational testing (T315I/A, F317L/V/I/C, V299L)

DefinitionBCR::ABL1 mutational testing refers to analysis for specific kinase domain mutations: T315I/A, F317L/V/I/C, and V299L.

When requiredRequired when initiating dasatinib after resistance to prior TKI therapy or post‑HSCT in CML and for resistant ALL/LL scenarios.

Use in decision makingNegative results for all listed mutations are required to qualify patients with prior TKI resistance for dasatinib.

PDGFRA exon 18 mutation (GIST) — definition

DefinitionPDGFRA exon 18 mutation refers to alterations in exon 18 of the platelet‑derived growth factor receptor alpha gene identified in GIST tumors.

Clinical rolePresence of a PDGFRA exon 18 mutation is required for dasatinib coverage in GIST after prior avapritinib therapy.

DocumentationTest results must be submitted as part of prior authorization documentation.

c‑KIT activating mutations (cutaneous melanoma) — definition

Definitionc‑KIT activating mutations are molecular alterations in the KIT gene that drive a subset of cutaneous melanomas.

Clinical roleConfirmation of a c‑KIT activating mutation is required for dasatinib coverage as subsequent single‑agent therapy in metastatic or unresectable melanoma after BRAF‑targeted therapy.

DocumentationMolecular testing results confirming the c‑KIT activating mutation must be provided with the prior authorization request.

Background

Dasatinib (Sprycel) is a tyrosine kinase inhibitor referenced in this policy for treatment of Philadelphia chromosome–positive leukemias and selected compendial oncology indications. The policy’s compendial list includes uses such as advanced-phase CML, post‑HSCT follow-up, Ph+ B‑ALL/LL (including maintenance or relapsed/refractory settings), Ph‑like B‑ALL/LL and T‑cell ALL/LL with ABL‑class alterations, select sarcomas (metastatic/widespread chondrosarcoma, recurrent chordoma), gastrointestinal stromal tumor (GIST), myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangement, and cutaneous melanoma. Coverage decisions and required documentation are tied to these specified indications; uses not on this list are treated as experimental/investigational and not medically necessary.