CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sprycel

Defines covered FDA-approved and compendial indications, required documentation for prior authorization, authorization durations for initial and continuation therapy, and criteria for approval of dasatinib products (Sprycel/Phyrago/generic).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySprycel

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must submit cytogenetic and/or molecular testing results confirming disease-specific genetic alterations (e.g., Ph chromosome/BCR::ABL, ABL-class fusions, PDGFRA exon 18, ABL1 rearrangement, c-KIT mutations) to initiate prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

5FDA-Approved Indications Listed

13Compendial Uses Listed

12 monthsCommon authorization length

7 monthsCML initial authorization (when applicable)

Coverage Summary & Indications

Indications (covered when ALL approval criteria met and no exclusions)

The following FDA-approved and compendial indications are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications

Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy
Pediatric patients 1 year of age and older with Ph+ CML in chronic phase
Pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy

Compendial Uses (covered)

Primary treatment of advanced phase CML (accelerated phase or blast phase)
Additional therapy for CML patients after hematopoietic stem cell transplant (HSCT)
Ph+ B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (Ph+ B-ALL/LL)
Maintenance therapy for Ph+ B-ALL/LL patients after HSCT
Relapsed or refractory Ph+ B-ALL/LL
Relapsed or refractory T-cell ALL/LL with ABL-class translocation

Exclusion: All other indications are considered experimental/investigational and not medically necessary

Coverage stance: covered with criteria. Scope: policy applies to dasatinib products (Sprycel, Phyrago, and generic dasatinib) and defines covered FDA-approved and compendial indications contingent on genetic/molecular confirmation of disease-specific alterations (e.g., Ph chromosome/BCR::ABL, ABL-class fusions, PDGFRA exon 18, ABL1 rearrangement, c-KIT mutations) and the member's prior tyrosine kinase inhibitor (TKI) therapy history (including no prior TKI, intolerance/toxicity, or resistance with required BCR::ABL1 mutational testing results where applicable).

Prior Authorization & Documentation Requirements

Documentation required for prior authorization

The following information is necessary to initiate the prior authorization review:

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

Provider actions

Note

Key thresholds & authorization lengths

BCR::ABL1 level for CML continuation<= 10%

Initial CML authorization duration7 months

Initial ALL/LL authorization duration12 months

Mutation testing panel requiredT315I/A, F317L/V/I/C, V299L

Initial Therapy Criteria (by disease)

Initial authorization criteria by disease

Authorization durations and disease-specific initial approval criteria

Chronic Myeloid Leukemia (CML) - Authorization up to 7 months

CML confirmed by detection of the Ph chromosome or BCR::ABL gene by cytogenetic and/or molecular testing
ANY of the following
- Member has not received prior therapy with a TKI (e.g., bosutinib, imatinib, nilotinib, ponatinib)
- Member experienced toxicity or intolerance to prior therapy with a TKI
- Member experienced resistance to prior therapy with a TKI and BCR::ABL1 mutational testing is negative for T315I/A, F317L/V/I/C, and V299L
- Member has received HSCT for CML and BCR::ABL1 mutational testing is negative for T315I/A, F317L/V/I/C, and V299L

Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LL) - Authorization 12 months

Disease confirmation (one of)
- Ph+ ALL/LL confirmed by detection of Ph chromosome or BCR::ABL gene
- Ph-like B-ALL/LL with ABL-class kinase fusion confirmed by testing
- T-cell ALL/LL with ABL-class translocation confirmed by testing and disease is relapsed or refractory
Prior therapy status (one of)
- Member has not received prior therapy with a TKI (e.g., bosutinib, imatinib, nilotinib, ponatinib)
- Member experienced toxicity or intolerance to prior therapy with a TKI

GIST - Authorization 12 months

Member has residual, unresectable, recurrent/progressive, or metastatic/tumor rupture disease
Disease harbors a PDGFRA exon 18 mutation
Member has received prior therapy with avapritinib
Requested medication will be used as a single agent

Bone Cancer (widespread metastatic chondrosarcoma or recurrent chordoma) - Authorization 12 months

Requested medication used as a single agent

Myeloid/Lymphoid Neoplasms with Eosinophilia - Authorization 12 months

ABL1 rearrangement in chronic phase or blast phase

Cutaneous Melanoma - Authorization 12 months

Disease is metastatic or unresectable
Tumor has c-KIT activating mutations
Requested medication will be used as subsequent therapy
Member has had disease progression, intolerance, or risk of progression with BRAF-targeted therapy
Requested medication will be used as a single agent

Continuation / Renewal Criteria

Continuation (renewal) criteria

Criteria for authorization renewal (continued treatment)

CML continuation

ANY of the following
- Authorization of 12 months may be granted when any of the following is met and member has been receiving the requested medication for 6 months or greater: BCR::ABL1 is less than or equal to 10% and there is no evidence of disease progression or unacceptable toxicity while on the current regimen<= 10%
  BCR::ABL1 level threshold
- Member has received HSCT and there is no evidence of unacceptable toxicity or disease progression while on the current regimen
Authorization of up to 7 months may be granted when the member has completed less than 6 months of therapy with the requested medication

ALL/LL continuation - Authorization 12 months

No evidence of unacceptable toxicity or disease progression while on the current regimen
ANY of the following
- Member has Ph+ ALL/LL confirmed by detection of Ph chromosome or BCR::ABL gene
- Member has Ph-like B-ALL/LL with ABL-class kinase fusion confirmed by testing
- Member has T-cell ALL/LL with ABL-class translocation confirmed by testing
- Member has received HSCT for ALL/LL

GIST, Bone Cancer, Myeloid/Lymphoid Neoplasms with Eosinophilia, Cutaneous Melanoma continuation - Authorization 12 months

No evidence of unacceptable toxicity or disease progression while on the current regimen

Evidence & References

Package insert sources: Sprycel [package insert] (February 2023); Phyrago [package insert] (December 2023); dasatinib (generic) [package insert] (September 2024).

Guideline/compendium sources: NCCN Drugs & Biologics Compendium (© 2024) and relevant NCCN guideline versions cited — Chronic Myeloid Leukemia (Version 2.2024), Acute Lymphoblastic Leukemia (Version 4.2023), and Gastrointestinal Stromal Tumors (Version 1.2024).

Background

Background: Dasatinib (Sprycel/Phyrago/generic) is indicated for multiple Philadelphia chromosome–positive leukemias (including newly diagnosed Ph+ CML in chronic phase, Ph+ CML with resistance or intolerance to prior therapy, and Ph+ ALL) and has numerous covered compendial oncology uses (e.g., advanced-phase CML, post-HSCT CML therapy, Ph-like and T-cell ALL/LL with ABL-class alterations, GIST, chordoma, chondrosarcoma, myeloid/lymphoid neoplasms with eosinophilia, and cutaneous melanoma). The policy aligns coverage to genetic/molecular confirmation of the relevant alteration and requires documentation of prior TKI history (no prior TKI, intolerance, or resistance with specified BCR::ABL1 mutation testing such as T315I/A, F317L/V/I/C, and V299L when applicable) to meet approval criteria.

Term	Definition
Ph+	Philadelphia chromosome-positive
TKI	Tyrosine kinase inhibitor (examples: bosutinib, imatinib, nilotinib, ponatinib)
HSCT	Hematopoietic stem cell transplant
BCR::ABL1 mutation testing	Testing for specific resistance mutations including T315I/A, F317L/V/I/C, and V299L