CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Dasatinib (Sprycel, Phyrago, generic) — Coverage Criteria

Defines medical necessity criteria, documentation, and authorization periods for dasatinib products for oncology indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDasatinib (Sprycel, Phyrago, generic) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and provide required molecular or cytogenetic testing results (e.g., Ph chromosome/BCR::ABL, ABL-class fusion, PDGFRA exon 18, c‑KIT, or specified BCR::ABL1 mutation testing) as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7 monthsinitial auth (some CML)

12 monthsauth (most indications)

T315I/A; F317L; V299Lrequired mutation testing

Coverage Criteria for Dasatinib (Sprycel / Phyrago / generic)

Covered Indications (FDA and Compendial)

Covered when criteria below are met (FDA-approved and compendial indications):

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Indications: Includes FDA-approved indications for Ph+ CML (newly diagnosed chronic phase; chronic/accelerated/blast phases with resistance/intolerance to prior therapy), Ph+ ALL with resistance or intolerance, and pediatric indications; plus compendial uses including advanced phase CML; additional therapy after HSCT; Ph+ B-ALL/LL (including maintenance and relapsed/refractory settings); Ph-like B-ALL/LL with ABL-class kinase fusion (induction/consolidation); relapsed/refractory T-cell ALL/LL with ABL-class translocation; metastatic/widespread chondrosarcoma; recurrent chordoma; GIST; myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangement; and cutaneous melanoma. All other indications are considered experimental/investigational and not medically necessary.

See FDA-approved indications (chunk 1) and compendial uses (chunk 2) for full list.

Initial Therapy — CML

Initial authorization criteria for Chronic Myeloid Leukemia (CML):

CML initial authorization: Authorization of 7 months may be granted when CML is confirmed by detection of the Ph chromosome or BCR::ABL by cytogenetic and/or molecular testing and ANY one of the following is met: (1) no prior therapy with a TKI (e.g., bosutinib, imatinib, nilotinib, ponatinib); (2) toxicity or intolerance to prior TKI therapy; (3) resistance to prior TKI therapy with results of BCR::ABL1 mutational testing negative for T315I/A, F317L/V/I/C, and V299L; (4) post-hematopoietic stem cell transplant (HSCT) with BCR::ABL1 mutational testing negative for T315I/A, F317L/V/I/C, and V299L.

Chunk 5

Initial Therapy — ALL/LL

Initial authorization criteria for Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LL):

ALL/LL initial authorization: Authorization of 12 months may be granted when BOTH: (i) the member has one of the following confirmed by cytogenetic and/or molecular testing: (a) Ph+ ALL/LL; (b) Ph-like B-ALL/LL with ABL-class kinase fusion; or (c) T-cell ALL/LL with ABL-class translocation in relapsed/refractory disease; AND (ii) the member meets ANY of: no prior TKI therapy (e.g., bosutinib, imatinib, nilotinib, ponatinib); intolerance/toxicity to prior TKI; or resistance to prior TKI with BCR::ABL1 mutational testing negative for T315I/A, F317L/V/I/C, and V299L. Authorization of 12 months may also be granted for members post-HSCT with negative BCR::ABL1 mutation testing for those same mutations.

Chunk 6

Continuation Therapy

Continuation (renewal) authorization criteria:

CML continuation: Authorization may be granted for continued CML treatment confirmed by Ph chromosome or BCR::ABL when EITHER: (1) BCR::ABL1 ≤ 10% with no evidence of disease progression or unacceptable toxicity while on the current regimen for members receiving the medication for ≥6 months (authorization of 12 months); OR (2) member has received HSCT and there is no evidence of unacceptable toxicity or disease progression while on the current regimen (authorization of 12 months). If the member has completed less than 6 months of therapy, authorization of up to 7 months may be granted.≤ 10% for BCR::ABL1

Chunk 11

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 while on the current regimen and any of the following apply: confirmed Ph+ ALL/LL; Ph-like B-ALL/LL with ABL-class kinase fusion; T-cell ALL/LL with ABL-class translocation; or member has received HSCT for ALL/LL.

Chunk 12

Other indications continuation: Authorization of 12 months may be granted for continued treatment of GIST, chondrosarcoma, chordoma, myeloid/lymphoid neoplasms with eosinophilia, or cutaneous melanoma when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Chunk 12

Indication	Required criteria	Coverage status
Gastrointestinal stromal tumor (GIST)	1) Residual, unresectable, recurrent/progressive, or metastatic/ruptured disease; 2) Tumor harbors PDGFRA exon 18 mutation; 3) Prior therapy with avapritinib; 4) Requested medication will be used as a single agent.	Covered with criteria
Widespread metastatic chondrosarcoma	Requested medication will be used as a single agent.	Covered with criteria
Recurrent chordoma	Requested medication will be used as a single agent.	Covered with criteria
Cutaneous melanoma (metastatic or unresectable)	1) Tumor has c-KIT activating mutations; 2) Requested medication will be used as subsequent therapy; 3) Member had progression, intolerance, or risk of progression with BRAF‑targeted therapy; 4) Requested medication will be used as a single agent.	Covered with criteria

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required and Authorization Durations

Prior authorization is required for the requested medication. Authorization durations vary by indication: CML initial requests may be authorized up to 7 months (longer for continuation requests as specified); ALL/LL, GIST, bone cancers, myeloid/lymphoid neoplasms with eosinophilia, and cutaneous melanoma initial and continuation authorizations may be granted for up to 12 months when criteria are met. Specific duration rules include: initial CML (up to 7 months), continued CML (12 months if on therapy ≥6 months with response or post‑HSCT; up to 7 months if <6 months on therapy), ALL/LL initial and continued (12 months), GIST, bone cancer, myeloid/lymphoid neoplasms with eosinophilia, and cutaneous melanoma initial and continued (12 months).

Initial CML authorization: up to 7 months when criteria met
Continued CML: 12 months if ≥6 months on therapy with response or post‑HSCT; up to 7 months if <6 months on therapy
ALL/LL (initial and continued): 12 months
GIST, bone cancer, myeloid/lymphoid neoplasms with eosinophilia, cutaneous melanoma (initial and continued): 12 months

Denial Risk

Experimental / Investigational Exclusions

Indications not listed in the policy’s compendial uses (e.g., all other diagnoses) are considered experimental and investigational and are not medically necessary. Requests for such indications will be denied.

All indications other than those enumerated (CML, Ph+ ALL/LL, Ph‑like B‑ALL/LL with ABL‑class fusion, T‑cell ALL/LL with ABL‑class translocation, GIST, metastatic/widespread chondrosarcoma, recurrent chordoma, myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangement, cutaneous melanoma) are experimental/investigational and not medically necessary.

Documentation Required

Required Documentation for Prior Authorization

Submit required documentation with the prior authorization request. Documentation must demonstrate the diagnosis and any molecular or cytogenetic findings referenced in the clinical criteria. Provide results of relevant testing and mutation analyses as applicable to the indication.

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

Step Therapy

Prior TKI Therapy / Step Requirements

Prior TKI therapy history and exceptions must be documented. Authorization criteria reference prior TKI exposure, intolerance/toxicity, or resistance (with mutation testing).

Document prior TKI therapy status: no prior TKI, prior TKI with intolerance/toxicity, or prior TKI with resistance
If resistance is cited, provide BCR::ABL1 mutational testing negative for T315I/A, F317L/V/I/C, and V299L when required by the criteria
HSCT recipients: document history of hematopoietic stem cell transplant and provide mutation testing results when indicated

Biomarker and Molecular Testing Requirements

inv-19: BCR::ABL (Ph chromosome) — diagnostic requirement; display as key/value

RequirementDetection of the Philadelphia (Ph) chromosome or BCR::ABL gene by cytogenetic and/or molecular testing is required to confirm Ph+ disease for CML or Ph+ ALL/LL.

Applicable indicationsRequired for newly diagnosed Ph+ CML (chronic phase), chronic/accelerated/blast phases with resistance/intolerance, and Ph+ ALL as listed under FDA-approved indications.

Documentation to supplyProvide results of cytogenetic and/or molecular testing showing Ph chromosome or BCR::ABL gene with prior authorization submission.

inv-20: ABL-class kinase fusion / ABL1 rearrangement — requirement confirmation by testing

RequirementConfirmation of an ABL-class kinase fusion or ABL1 rearrangement by cytogenetic and/or molecular testing is required for coverage in Ph-like B-ALL/LL, T-cell ALL/LL, and myeloid/lymphoid neoplasms with eosinophilia.

Applicable indicationsPh-like B-ALL/LL with ABL-class fusion; relapsed/refractory T-cell ALL/LL with ABL-class translocation; myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangement.

Documentation to supplyProvide cytogenetic and/or molecular test results confirming the specific ABL-class fusion or ABL1 rearrangement with the prior authorization request.

inv-21: BCR::ABL1 mutation testing (T315I/A, F317L/V/I/C, V299L) — specific mutations required/ruled out

Required mutation testingBCR::ABL1 mutational testing must document absence of T315I/A, F317L/V/I/C, and V299L in members with prior TKI resistance or post-HSCT when initiating or continuing therapy.

When requiredRequired for members requesting initiation of therapy after resistance to prior TKI and for some post-HSCT situations in CML and ALL/LL per criteria.

Documentation to supplySubmit BCR::ABL1 mutation testing results that explicitly address T315I/A, F317L/V/I/C, and V299L with the prior authorization request.

inv-22: PDGFRA exon 18 — mutation required for GIST coverage

RequirementPDGFRA exon 18 mutation testing is required and the tumor must harbor a PDGFRA exon 18 mutation for GIST coverage.

When requiredRequired for authorization of dasatinib in residual, unresectable, recurrent/progressive, or metastatic/ruptured GIST after prior avapritinib therapy.

Documentation to supplyProvide PDGFRA exon 18 mutation test results with the prior authorization submission for GIST cases.

inv-23: c-KIT activating mutation — required molecular feature for melanoma coverage

RequirementMolecular testing confirming a c-KIT activating mutation in the tumor is required for coverage of cutaneous melanoma.

When requiredRequired for metastatic or unresectable cutaneous melanoma when dasatinib is requested as subsequent single-agent therapy after progression/intolerance/risk with BRAF-targeted therapy.

Documentation to supplySubmit molecular testing results showing c-KIT activating mutation with the prior authorization request for melanoma indications.

Line of Therapy and Sequencing

first-line | subsequent (depends on indication)

Policy applies across lines: can be used as initial therapy for newly diagnosed Ph+ CML or Ph+ ALL, or after prior TKI therapy in cases of intolerance/toxicity or resistance (with mutation testing), and as subsequent therapy in melanoma after BRAF-targeted therapy failure.

Line of therapy notes: Use may be first-line for newly diagnosed Ph+ CML (chunk 1) or Ph+ ALL in specified pediatric setting, or subsequent therapy after prior TKI for CML/ALL when criteria for intolerance or resistance are met (see chunks 5 and 6). For melanoma, use is subsequent therapy after progression/intolerance to BRAF-targeted therapy (chunk 10).

Chunks 1,5,6,10

Covered Regimens and Single-Agent Use

Indication	Required criteria	Coverage status
Gastrointestinal stromal tumor (GIST)	1) Residual, unresectable, recurrent/progressive, or metastatic/ruptured disease; 2) Tumor harbors PDGFRA exon 18 mutation; 3) Prior therapy with avapritinib; 4) Requested medication will be used as a single agent.	Covered with criteria
Widespread metastatic chondrosarcoma	Requested medication will be used as a single agent.	Covered with criteria
Recurrent chordoma	Requested medication will be used as a single agent.	Covered with criteria
Cutaneous melanoma (metastatic or unresectable)	1) Tumor has c-KIT activating mutations; 2) Requested medication will be used as subsequent therapy; 3) Member had progression, intolerance, or risk of progression with BRAF‑targeted therapy; 4) Requested medication will be used as a single agent.	Covered with criteria

Background

Dasatinib (Sprycel, Phyrago, generic) is a BCR‑ABL tyrosine kinase inhibitor with approved and compendial oncology uses. Compendial indications include treatment of advanced‑phase CML (accelerated or blast phase); additional or maintenance therapy after hematopoietic stem cell transplant (HSCT) for CML and Ph+ B‑ALL/LL; induction, consolidation, or relapsed/refractory treatment for Ph+ B‑ALL/LL, Ph‑like B‑ALL/LL with ABL‑class fusions, and relapsed/refractory T‑cell ALL/LL with ABL‑class translocation; management of myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangement; and select solid tumor uses such as metastatic/widespread chondrosarcoma, recurrent chordoma, gastrointestinal stromal tumor (GIST), and cutaneous melanoma. All other uses are considered experimental/investigational and not medically necessary.

Definitions

inv-16: Ph+ (Philadelphia chromosome-positive) — definition and testing confirmation

DefinitionPhiladelphia chromosome-positive (Ph+) disease is defined by the presence of the BCR::ABL fusion gene or Ph chromosome confirmed by cytogenetic and/or molecular testing.

Testing confirmationCytogenetic and/or molecular testing results demonstrating the Ph chromosome or BCR::ABL gene must be provided for CML and Ph+ ALL/LL prior authorization.

Applicable settingsApplies to newly diagnosed Ph+ CML (chronic phase), chronic/accelerated/blast phase CML with resistance/intolerance, and Ph+ ALL per FDA-approved indications and compendial uses.

inv-17: ABL-class kinase fusion / ABL1 rearrangement — definition

DefinitionABL-class kinase fusion / ABL1 rearrangement refers to genetic alterations involving ABL-family kinases (including ABL1) that must be confirmed by cytogenetic or molecular testing for coverage in specified indications.

Applicable indicationsRequired for Ph-like B-ALL/LL with ABL-class fusion, relapsed/refractory T-cell ALL/LL with ABL-class translocation, and myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangement.

Documentation to supplyProvide cytogenetic and/or molecular testing results confirming the ABL-class fusion or ABL1 rearrangement with the prior authorization submission.