Neighborhood Health Plan RI dasatinib Coverage Update | OpenPayer
CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A
Dasatinib (Sprycel/Phyrago) — indications and prior authorization criteria
Defines medical necessity criteria, required diagnostic testing, and authorization durations for dasatinib (Sprycel, Phyrago, generic) 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/Phyrago) — indications and prior authorization criteria
Policy CodePolicy N/A
Change TypeNo material changes
Effective DateN/A
Next Review DateN/A
Key ActionObtain required diagnostic test results (e.g., Ph/BCR::ABL, ABL-class fusion, PDGFRA exon 18, c-KIT, or BCR::ABL1 mutation panel) and submit for prior authorization.
No material clinical or coverage changes in this revision.
7 monthsauthorization length for some initial CML approvals
12 monthsauthorization length for most ALL/LL and other indications
T315I/A, F317L/V/I/C, V299LBCR::ABL1 mutations that must be negative
PDGFRA exon 18mutation required for GIST coverage
c-KIT mutation
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required biomarker for melanoma coverage
Coverage Criteria for Dasatinib (Sprycel / Phyrago)
Initial therapy — CML
Covered for Chronic Myeloid Leukemia (CML) when ALL of the following apply:
CML initial therapy
CML qualifying conditions: Member has not received prior therapy with a TKI OR Member experienced toxicity or intolerance to prior TKI OR Member experienced resistance to prior TKI and BCR::ABL1 mutational testing negative for T315I/A, F317L/V/I/C, and V299L OR Member has received HSCT for CML and BCR::ABL1 mutational testing negative for T315I/A, F317L/V/I/C, and V299L
Initial therapy — ALL/LL
Covered for Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LL) when ALL of the following apply:
ALL/LL initial therapy: Member has one of: (a) Ph+ ALL/LL confirmed by detection of the Ph chromosome or BCR::ABL gene by cytogenetic and/or molecular testing; (b) Ph-like B-ALL/LL with ABL-class kinase fusion confirmed by cytogenetic and/or molecular testing; (c) T-cell ALL/LL with ABL-class translocation confirmed by cytogenetic and/or molecular testing AND the disease is relapsed or refractory
Authorization of 12 months may be granted
ALL/LL prior therapy conditions: Member has not received prior therapy with a TKI OR Member experienced toxicity/intolerance to prior TKI OR Member experienced resistance to prior TKI and BCR::ABL1 mutational testing negative for T315I/A, F317L/V/I/C, and V299L
Initial therapy — GIST
Covered for Gastrointestinal Stromal Tumor (GIST) when ALL of the following are met:
GIST criteria: Member has residual, unresectable, recurrent/progressive, or metastatic/tumor rupture disease AND disease harbors PDGFRA exon 18 mutation AND member has received prior therapy with avapritinib AND requested medication will be used as a single agent
Authorization of 12 months may be granted
Initial therapy — Bone Cancer
Covered for Bone Cancer (widespread metastatic chondrosarcoma or recurrent chordoma):
Bone cancer criteria: Requested medication used as a single agent for widespread metastatic chondrosarcoma or recurrent chordoma
Authorization of 12 months may be granted
Initial therapy — Myeloid/Lymphoid neoplasms with eosinophilia
Covered for Myeloid/Lymphoid Neoplasms with Eosinophilia when ALL of the following are met:
Myeloid/lymphoid neoplasms with eosinophilia: Myeloid and/or lymphoid neoplasm with eosinophilia and ABL1 rearrangement in the chronic phase or blast phase
Authorization of 12 months may be granted
Initial therapy — Cutaneous Melanoma
Covered for Cutaneous Melanoma when ALL of the following are met:
Melanoma criteria: Disease is metastatic or unresectable AND tumor has c-KIT activating mutations AND requested medication will be used as subsequent therapy AND member has had disease progression, intolerance, or risk of progression with BRAF-targeted therapy AND requested medication will be used as a single agent
Authorization of 12 months may be granted
Continuation therapy
Criteria for continued therapy (maintenance/renewal):
CML continuation: For members receiving the requested medication >= 6 months: BCR::ABL1 <= 10% and no evidence of disease progression or unacceptable toxicity OR member has received HSCT and there is no evidence of unacceptable toxicity or disease progression
Authorization of 12 months may be granted
CML short-term continuation: If member has completed < 6 months of therapy with the requested medication, authorization of up to 7 months may be granted
ALL/LL continuation: No evidence of unacceptable toxicity or disease progression while on current regimen AND member has Ph+ ALL/LL OR Ph-like B-ALL/LL with ABL-class fusion OR T-cell ALL/LL with ABL-class translocation OR has received HSCT
Authorization of 12 months may be granted
Other indications continuation:
All indications not explicitly listed in the FDA-approved indications or the enumerated compendial uses are considered experimental/investigational and are not covered. Requests for dasatinib (Sprycel, Phyrago, or generic dasatinib) for indications outside the listed FDA-approved or compendial uses will be denied as not medically necessary.
Use of dasatinib for indications other than those specified in the FDA-approved indications or the compendial uses section is considered not medically necessary. Providers should confirm the patient’s diagnosis matches one of the listed covered indications before submitting a prior authorization request.
Provider Requirements and Authorization Rules
Prior Authorization
Prior Authorization Required
Prior authorization is required. Authorization durations vary by indication (commonly 12 months; up to 7 months for certain initial CML approvals). Ensure complete documentation is submitted to avoid delays or denial.
Typical initial authorization: 7 months for some CML starts; 12 months for most other indications and for continuation when criteria met.
Documentation Required
Required Diagnostic Test Results
Submit documentation of diagnostic testing that confirms the molecular or cytogenetic abnormality relevant to the requested indication. Authorization cannot be completed without these results.
For CML or Ph+ ALL/LL: results of cytogenetic and/or molecular testing demonstrating the Philadelphia (Ph) chromosome or BCR::ABL gene
For Ph‑like B‑ALL/LL or T‑cell ALL/LL: results confirming ABL‑class kinase fusion or ABL‑class translocation, respectively
Biomarker and Mutation Requirements
inv-18: BCR::ABL / Ph chromosome — key biomarker requirement for several indications
DefinitionPhiladelphia chromosome–positive (Ph+) indicates detection of the Ph chromosome or BCR::ABL gene by cytogenetic and/or molecular testing.
Testing requirementCytogenetic and/or molecular testing results confirming Ph chromosome or BCR::ABL must be submitted for CML and Ph+ ALL/LL prior authorization requests.
Associated indicationsSupports FDA‑approved indications for newly diagnosed Ph+ CML and Ph+ ALL, and compendial uses including advanced‑phase CML and post‑HSCT therapy.
inv-19: ABL-class kinase fusion / ABL1 rearrangement — required biomarker for certain indications
DefinitionABL-class kinase fusion or ABL1 rearrangement is a genomic rearrangement involving ABL-family kinases detectable by cytogenetic and/or molecular testing.
First-line and Subsequent Therapy Rules
first-line | subsequent
Line of therapy considerations: Policy addresses newly diagnosed (first-line) Ph+ CML and Ph+ ALL (FDA indications) and also covers subsequent lines when member has intolerance, resistance, or post-HSCT scenarios as specified; prior TKI exposure is explicitly considered in criteria.
Key Definitions
inv-15: Ph+ — Philadelphia chromosome-positive definition and required testing
DefinitionPresence of the Philadelphia (Ph) chromosome or detection of the BCR::ABL gene by cytogenetic and/or molecular testing.
Required forChronic Myeloid Leukemia (CML) and Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia/lymphoblastic lymphoma (ALL/LL).
Documentation to submitResults of cytogenetic and/or molecular testing confirming Ph chromosome or BCR::ABL gene must be provided with the prior authorization request.
Related policy notesPh+ findings support FDA-approved indications for newly diagnosed Ph+ CML and Ph+ ALL and are incorporated in compendial uses for advanced-phase CML and post‑HSCT scenarios.
inv-16: ABL-class kinase fusion/translocation — definition and testing note
Definition
Background
Dasatinib is a BCR::ABL tyrosine kinase inhibitor with primary activity against Philadelphia chromosome–positive (Ph+) leukemias and additional activity in malignancies driven by ABL-class fusions or other actionable mutations. The clinical uses enumerated in the compendial section include advanced-phase CML, post‑HSCT scenarios, Ph+ B-ALL/LL (including maintenance and relapsed/refractory settings), Ph-like B-ALL/LL and T-cell ALL/LL with ABL-class rearrangements, GIST, myeloid/lymphoid neoplasms with ABL1 rearrangement, metastatic/widespread chondrosarcoma, recurrent chordoma, and cutaneous melanoma. Coverage under this policy is biomarker-driven and limited to these FDA-approved and compendial indications; all other uses are considered experimental/investigational and not medically necessary.
Policy Summary
PayerNeighborhood Health Plan of Rhode Island
PolicyDasatinib (Sprycel/Phyrago) — indications and prior authorization criteria
Policy CodePolicy N/A
Change TypeNo material changes
Effective DateN/A
Next Review DateN/A
Key ActionObtain required diagnostic test results (e.g., Ph/BCR::ABL, ABL-class fusion, PDGFRA exon 18, c-KIT, or BCR::ABL1 mutation panel) and submit for prior authorization.
For GIST, bone cancers, myeloid/lymphoid neoplasms with eosinophilia, or cutaneous melanoma: no evidence of unacceptable toxicity or disease progression while on the current regimen
Authorization of 12 months may be granted
For requests after prior TKI resistance: BCR::ABL1 mutation testing results specifically reporting T315I/A, F317L/V/I/C, and V299L status
For GIST: PDGFRA exon 18 mutation testing (when applicable)
For myeloid/lymphoid neoplasms with eosinophilia: results confirming ABL1 rearrangement
For cutaneous melanoma: molecular testing confirming c‑KIT activating mutations
Step Therapy
TKI Prior Therapy Considerations
Prior TKI therapy and mutation status affect eligibility. Provide treatment history and mutation testing results as applicable.
Document prior exposure to other TKIs (e.g., bosutinib, imatinib, nilotinib, ponatinib) — note whether member is TKI‑naïve, intolerant/toxic, or had resistance
If resistance to prior TKI is claimed, include BCR::ABL1 mutation testing negative for T315I/A, F317L/V/I/C, and V299L when required by the indication
For initial CML approvals, authorization of 7 months may be granted when member is TKI‑naïve, intolerant, or resistance is present with negative specified mutations
For ALL/LL indications, prior TKI history (naïve, intolerance, or resistant with documented mutation testing) is required to meet initial authorization criteria
Denial Risk
Not Covered Indications
Indications not specifically listed as covered are considered experimental/investigational and not medically necessary. Requests for these indications are at high risk for denial unless supporting evidence justifies coverage.
All indications other than the policy’s listed compendial/covered uses (e.g., CML, Ph+ ALL/LL, Ph‑like B‑ALL/LL with ABL‑class fusion, GIST with PDGFRA exon 18 mutation, myeloid/lymphoid neoplasms with ABL1 rearrangement, metastatic chondrosarcoma, recurrent chordoma, cutaneous melanoma with c‑KIT mutation) are not covered
Required forPh-like B-ALL/LL, relapsed/refractory T‑cell ALL/LL with ABL-class translocation, and myeloid/lymphoid neoplasms with eosinophilia (ABL1 rearrangement).
Testing requirementSubmit cytogenetic and/or molecular test results confirming the ABL-class fusion or ABL1 rearrangement with the prior authorization request.
Clinical applicationFor T‑cell ALL/LL the ABL-class translocation must be confirmed and disease should be relapsed or refractory per coverage criteria.
IndicationRequired biomarker for coverage of Gastrointestinal Stromal Tumor (GIST).
Documentation to submitPDGFRA exon 18 mutation testing results must be provided with the prior authorization request.
Clinical contextCoverage requires residual/unresectable/recurrent/metastatic disease, prior avapritinib therapy, and single‑agent use of the requested medication.
inv-21: c-KIT activating mutations — required biomarker for melanoma coverage
Required biomarkerPresence of c‑KIT activating mutations confirmed by molecular testing.
IndicationRequired biomarker for coverage of metastatic or unresectable cutaneous melanoma when used as subsequent single‑agent therapy after BRAF‑targeted therapy failure/intolerance/contraindication.
Documentation to submitMolecular testing demonstrating c‑KIT activating mutation must be provided with the prior authorization request.
Coverage conditionsTumor must be metastatic or unresectable and member must have progression, intolerance, or risk of progression with BRAF-targeted therapy.
inv-22: BCR::ABL1 mutation panel (T315I/A, F317L/V/I/C, V299L) — must be negative for listed mutations for some approvals
Panel componentsBCR::ABL1 mutational testing for T315I/A, F317L/V/I/C, and V299L.
When requiredRequired when initiating therapy after prior TKI resistance or in certain post‑HSCT scenarios per CML and ALL/LL criteria.
Interpretation for approvalResults must be negative for all listed mutations (T315I/A, F317L/V/I/C, V299L) to meet coverage criteria in the specified scenarios.
Documentation to submitProvide BCR::ABL1 mutation testing results with the prior authorization request when applicable.
Genomic rearrangement involving ABL-family kinases detectable by cytogenetic and/or molecular testing (ABL-class kinase fusion or ABL1 rearrangement).
Required forPh-like B-ALL/LL, T-cell ALL/LL with ABL-class translocation, and myeloid/lymphoid neoplasms with eosinophilia (ABL1 rearrangement).
Documentation to submitResults of cytogenetic and/or molecular testing confirming an ABL-class kinase fusion or ABL1 rearrangement must accompany the prior authorization request.
Clinical noteFor T‑cell ALL/LL the ABL-class translocation must be confirmed and the disease is relapsed or refractory per coverage criteria.