CurrentCignaPolicy N/A

Avapritinib (Ayvakit) coverage

Defines prior authorization requirements and medical necessity criteria for coverage of Ayvakit (avapritinib) for Cigna-administered health benefit plans, addressing FDA-approved indications and select supportive-evidence uses for adults.

Policy Summary

PayerCigna

PolicyAvapritinib (Ayvakit) coverage

Policy CodePolicy N/A

Change TypeIndication added — indolent systemic mastocytosis

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age, diagnosis, mutation status, platelet count where applicable, and prior therapies as specified.

SourceLink

POLICY UPDATE CHANGES

Criterion was added for a patient who has indolent systemic mastocytosis based on new FDA approval.

3covered indications

1 yearapproval duration

≥18min patient age

≥50 x10^9/Lplatelet threshold

Coverage Criteria for Avapritinib (Ayvakit)

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GIST (FDA-approved): Approve for 1 year if the patient meets BOTH of the following (A and B): A) Patient is ≥ 18 years of age; AND B) Patient meets ONE of the following: i) The tumor is positive for PDGFRA exon 18 mutation (PDGFRA exon 18 includes D842V); OR ii) Patient has tried ALL of the following: a) imatinib; AND b) one of sunitinib or dasatinib; AND c) regorafenib; AND d) ripretinib.

Systemic Mastocytosis

Covered when ALL of the following are met

Systemic Mastocytosis (FDA-approved): Approve for 1 year if the patient meets ALL of the following (A, B, and C): A) Patient is ≥ 18 years of age; AND B) Patient has a platelet count ≥ 50 x 10^9/L (≥ 50,000/mcL); AND C) Patient meets ONE of the following: i) indolent systemic mastocytosis; OR ii) one of the following advanced subtypes: a) aggressive systemic mastocytosis; b) systemic mastocytosis with an associated hematologic neoplasm; c) mast cell leukemia.platelets >= 50 x 10^9/L

Indication includes indolent and advanced subtypes; policy notes limitation when platelets < 50 x 10^9/L.

Myeloid/Lymphoid Neoplasms (supportive evidence)

Covered when ALL of the following are met

Myeloid/Lymphoid Neoplasms with Eosinophilia: Approve for 1 year if the patient meets ALL of the following (A, B, and C): A) Patient is ≥ 18 years of age; AND B) Patient has eosinophilia; AND C) The tumor is positive for PDGFRA D842V mutation.

NCCN notes a clinical trial is preferred if available; this is supportive-evidence coverage.

Coding and Laboratory Requirements

Codingmixed

No CPT/HCPCS/NDC codes listed

The policy does not list specific procedure, supply, or NDC codes for avapritinib; references prescribing information.

inv-07: Platelet count — >= 50 x 10^9/L

Required platelet countPlatelet count ≥ 50 x 10^9/L (≥ 50,000/mcL)

ContextRequired for coverage of avapritinib in systemic mastocytosis indications (indolent and advanced subtypes)

Approval durationApprovals granted for 1 year when criteria are met

Provider Actions — Authorization, Documentation, and Step Therapy

Prior Authorization

Prior authorization required; approvals for 1 year

Prior authorization is recommended for Ayvakit (avapritinib). Approvals are granted for 1 year when the patient meets the specified criteria for the relevant indication.

Step Therapy

Step therapy required for non‑PDGFRA exon 18 GIST

For GIST without a PDGFRA exon 18 mutation, prior therapy with all of the following is required before approval: imatinib; one of sunitinib or dasatinib; regorafenib; and ripretinib.

Imatinib must have been tried.
One of sunitinib or dasatinib must have been tried.
Regorafenib (Stivarga) must have been tried.
Ripretinib (Qinlock) must have been tried.

Documentation Required

Required documentation for prior authorization

Prior authorization requests should include documentation supporting patient age, covered diagnosis, mutation status or prior therapies (as applicable), platelet count when required, and evidence of eosinophilia/mutation for myeloid/lymphoid neoplasms; approvals are provided for the duration noted (typically 1 year).

Patient age (≥ 18 years)
Diagnosis supporting the requested indication
PDGFRA exon 18/D842V mutation test results when applicable
Documentation of prior therapies for non‑PDGFRA GIST
Platelet count (≥ 50 x 10^9/L) for systemic mastocytosis
Evidence of eosinophilia for myeloid/lymphoid neoplasms

Denial Risk

Denials for uncovered codes or non‑policy uses

Claims submitted for services that are not accompanied by covered diagnosis or procedure codes will be denied as not covered; Ayvakit is considered not medically necessary for any uses not specified in this policy.

Line of Therapy Specifications

first-line | later-line

GIST line of therapy: Avapritinib is a primary treatment option for PDGFRA exon 18–mutant GIST (category 2A). For GIST without PDGFRA exon 18 mutation, avapritinib may be used after failure of imatinib, a second‑line agent (sunitinib or dasatinib), regorafenib, and ripretinib per the policy's step therapy requirements.

Definitions and Thresholds

inv-13: PDGFRA exon 18 mutation — A mutation in exon 18 of the platelet-derived growth factor receptor alpha gene; includes the D842V substitution which is insensitive to ...

DefinitionA mutation in exon 18 of the platelet-derived growth factor receptor alpha (PDGFRA) gene

IncludesSpecifically includes the D842V substitution, which is an indication for avapritinib in GIST

Clinical relevancePresence of PDGFRA exon 18 mutation (D842V) is required for FDA‑approved GIST coverage and supportive‑evidence myeloid/lymphoid neoplasms coverage

inv-14: Systemic mastocytosis platelet threshold — Policy requires a platelet count ≥ 50 x 10^9/L (≥ 50,000/mcL) for coverage of avapritinib in systemic mastocytosis indications.

Required platelet thresholdPlatelet count ≥ 50 x 10^9/L (≥ 50,000/mcL)

Applicable indicationsRequired for coverage of avapritinib in systemic mastocytosis (indolent and advanced subtypes)

Approval limitationPolicy notes Ayvakit is not recommended for systemic mastocytosis patients with platelet counts < 50 x 10^9/L

Background

Avapritinib is a selective tyrosine kinase inhibitor with FDA‑approved indications in adults for gastrointestinal stromal tumor (GIST) harboring PDGFRA exon 18 mutations (including D842V) and for systemic mastocytosis. It also has supportive evidence for use in PDGFRA D842V–positive myeloid/lymphoid neoplasms with eosinophilia. NCCN guidelines recognize avapritinib as a preferred option for PDGFRA exon 18–mutant GIST and as a preferred single‑agent therapy for systemic mastocytosis when the platelet threshold is met.

Covered Regimens and Dosing

Regimen	Indication	Approval duration
Avapritinib per prescribing information	Gastrointestinal stromal tumor (GIST) with PDGFRA exon 18 mutation (includes D842V) OR GIST after failure of imatinib, one of sunitinib or dasatinib, regorafenib, and ripretinib	Approve for 1 year

Regimen	Indication	Approval duration
Single-agent avapritinib	Systemic mastocytosis (indolent OR advanced subtypes including aggressive systemic mastocytosis, systemic mastocytosis with associated hematologic neoplasm, or mast cell leukemia) with platelet count ≥ 50 x 10^9/L	Approve for 1 year