Prior Authorization Required

Prior authorization is required for Ayvakit (avapritinib) for covered members aged 19 and older. Providers must obtain prior authorization before dispensing; this requirement affects outpatient pharmacy benefits and medical-administered claims where applicable.

• Applies to members ≥ 19 years (members < 19 years process without coverage review).
• Authorization term: up to 12 months per approval.

GIST — Prior Therapies / Disease State Requirements

For the GIST indication, documentation must show prior systemic therapy unless the tumor harbors a qualifying PDGFRA exon mutation as specified below. If requesting Ayvakit for GIST after failure of other therapies, list prior agents and reason for discontinuation (e.g., progression or intolerance).

• Required prior therapies: imatinib, sunitinib, regorafenib, or ripretinib (unless contraindicated or not appropriate).
• If patient has unresectable, recurrent, metastatic disease, or disease with limited progression/gross residual disease/residual disease with significant morbidity, document clinical rationale for selecting Ayvakit.

Required Clinical and Laboratory Evidence

Provide the following clinical and laboratory documentation with the prior authorization request: tumor diagnosis and staging, prior systemic therapies with dates and reasons for discontinuation, and molecular testing results confirming PDGFRA exon mutation status where applicable. For hematologic/platelet safety, include a recent platelet count. Specific required items are listed below.

• Diagnostic documentation: pathology or oncology note confirming GIST or myeloid/lymphoid neoplasm with eosinophilia.
• Molecular testing: report demonstrating PDGFRA exon mutation (including D842V) for GIST cases when indicated, or FIP1L1-PDGFRA rearrangement for myeloid/lymphoid neoplasms with eosinophilia.
• Prior therapy documentation: names of prior systemic agents (e.g., imatinib, sunitinib, regorafenib, ripretinib) with treatment dates and reason for failure/intolerance.
• Laboratory evidence: platelet count ≥ 50 x 10^9/L documented within the last 30 days.
• Authorization duration: typical approvals issued for 12 months.

Documentation & Denial Risk — Missing Molecular Evidence or Low Platelets

Common reasons for denial or requests for clarification include missing or incomplete molecular diagnostic evidence (PDGFRA exon mutation report or FIP1L1-PDGFRA rearrangement) and platelet counts below the required threshold. To avoid delays, include full molecular pathology reports and recent CBC with platelet count; if platelets are <50 x 10^9/L, provide documentation of management plan or rationale if therapy is still being considered.

• Missing molecular report (PDGFRA exon mutation or FIP1L1-PDGFRA): submit full lab/pathology report, not just a statement.
• Platelet count < 50 x 10^9/L: documentation will prompt denial without evidence of mitigation or specialist recommendation.
• For GIST requests lacking documented prior therapies, provide treatment history or clinical justification for bypassing prior agents.