Avapritinib (Ayvakit) coverage
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Defines medical necessity, prior authorization, and coverage criteria for avapritinib (Ayvakit) for commercial, HIM, and Medicaid lines of business at Peach State Health Plan.
For GIST, added Qinlock (ripretinib), Sutent (sunitinib), and Stivarga (regorafenib) as examples of prior lines of therapy.
For MLNE and FIP1L1-PDGFRA, revised criteria from 'failure of imatinib' to 'documentation of PDGFRA D842 mutation that is resistant to imatinib.'
Added documentation requirement of platelet count 950 x 10^9/L (950,000/mcL) for systemic mastocytosis.
Extended initial approval duration from 6 to 12 months for Medicaid/HIM line of business for maintenance medication in IL HIM per IL HB 5395.
Added oncology bypass language to existing redirections.
Coverage Criteria
Initial Therapy - GIST
Initial Approval Criteria — Gastrointestinal Stromal Tumor (must meet all):
Prior authorization may be required for imatinib, Qinlock, Sutent, or Stivarga
Initial Therapy - Advanced Systemic Mastocytosis
Initial Approval Criteria — Advanced Systemic Mastocytosis (must meet all):
Initial Therapy - Indolent Systemic Mastocytosis
Initial Approval Criteria — Indolent Systemic Mastocytosis (must meet all):
Initial Therapy - MLNE with FIP1L1-PDGFRA
Initial Approval Criteria — Myeloid/Lymphoid Neoplasm with Eosinophilia and Tyrosine Kinase Fusion Gene (off-label) (must meet all):
Off-label indication; prescriber must submit supporting evidence
Continued Therapy
Continued Therapy (all indications in Section I must meet all):
Requests for avapritinib to treat indications that are not FDA‑approved and are not explicitly addressed in this policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the referenced off‑label use policies. Such documentation should align with the plan's off‑label criteria and include supporting clinical evidence, guideline recommendations, or peer‑reviewed literature that justify use for the specific off‑label indication.
Appendix C notes that there are no contraindications or boxed warnings reported in this policy for avapritinib. Providers should continue to review product labeling and current safety information for any updates, but the policy itself does not list boxed warnings or contraindications.
Off‑label uses of avapritinib (those not FDA‑approved and not specifically covered by this policy) require submission of adequate supporting evidence. If sufficient off‑label documentation per the plan's off‑label use policies is not provided, the request will be considered not medically necessary and may be denied.
Initial Therapy — Indication-specific Rules
Initial Therapy
Initial therapy coverage rules by indication:
Initial dosing
Initial dosing — dosing rules by indication (must meet):
Policy lists AdvSM maximum of 200 mg/day (1 tablet) for advanced systemic mastocytosis
Continuation / Renewal Criteria
Continuation Therapy
Continuation Therapy — continued therapy requirements (general rules for ongoing use):
CONTINUATION CRITERIA
CONTINUATION CRITERIA — approval durations and line-of-business specific continuation rules:
Provider Actions / Authorization Requirements
Prior authorization required — submit diagnosis, prescriber specialty, age, and lab thresholds
Prior authorization is required for avapritinib; the provider must document the covered diagnosis, prescriber specialty, patient age, and any indication-specific laboratory thresholds (e.g., platelet counts where applicable) as part of the PA submission.
- Diagnosis per indication (e.g., unresectable/metastatic GIST; ASM/SM-AHN/MCL; ISM; MLNE with FIP1L1-PDGFRA).
- Prescribed by or in consultation with required specialist (oncologist; hematologist/oncologist for MLNE; oncologist/allergist/immunologist for mastocytosis).
- Patient age ≥ 18 years.
- Indication-specific platelet threshold for systemic mastocytosis (see required supporting documentation).
- Single-agent therapy, dosing and quantity limits per indication.
PA approval durations vary by line of business (IL HIM initial approval extended to 12 months)
Prior authorization is required and approval durations and continuation rules vary by line of business; for Medicaid/HIM in Illinois the initial approval duration for maintenance therapy has been extended to 12 months per IL HB 5395.
- Approval durations differ by line of business — check applicable LOB rules.
- IL HIM: initial approval extended to 12 months for maintenance medication per IL HB 5395 (effective for relevant requests).
Step therapy for GIST — document prior therapies or mutation
Step therapy may be required for GIST patients; the PA must document prior line(s) of therapy or mutation status per the GIST criteria.
- Either documentation of a PDGFRA exon 18 D842V mutation OR, for PDGFRA exon 18 mutations other than D842V, documentation of failure of prior therapies.
- Examples of prior lines of therapy include imatinib, ripretinib (Qinlock), sunitinib (Sutent), or regorafenib (Stivarga).
Step therapy redirection and oncology bypass; follow state exceptions
Step therapy redirection and oncology bypass provisions apply; state regulations may prohibit redirection for certain advanced/metastatic cancer settings — follow state-specific exceptions and oncology bypass language.
- Requests in states with regulations against step therapy redirection for advanced/metastatic cancer may be exempt (see Appendix D state list).
- Illinois HIM: step therapy requirements do not apply as of 1/1/2026 for IL HIM requests per policy text.
Required documentation — submit chart notes, labs, and clinical information
Providers must submit supporting clinical documentation with the PA — office chart notes, laboratory results, and other clinical information that demonstrate the member meets all approval criteria.
- Chart notes detailing diagnosis, treatment history, and specialist involvement.
- Relevant lab reports (e.g., platelet counts) and imaging or pathology reports as applicable.
- If dose or off-label use is requested, include supporting practice guideline or peer-reviewed literature when required.
Required supporting documentation — platelet count and molecular evidence
Include specific supporting documentation for systemic mastocytosis and molecular-driven indications: a platelet count ≥ 50 x 10^9/L (≥ 50,000/mcL) for ASM/ISM and molecular evidence (e.g., PDGFRA D842V or PDGFRA mutation resistant to imatinib) when applicable.
- Platelet count ≥ 50 x 10^9/L (≥ 50,000/mcL) is required for Advanced Systemic Mastocytosis and Indolent Systemic Mastocytosis.
- For MLNE with FIP1L1-PDGFRA, provide documentation of a PDGFRA D842V mutation that is resistant to imatinib (per criteria).
- When relying on prior therapy failure for GIST, document prior agents (imatinib, ripretinib/Qinlock, sunitinib/Sutent, regorafenib/Stivarga) and reason for failure/contraindication.
Denial triggers — failure to meet approval criteria or insufficient off-label evidence
Requests that do not meet the policy approval criteria or that request non‑FDA indications without sufficient off‑label evidence will be denied.
- Non‑FDA approved indications not addressed in the policy require sufficient documentation of efficacy/safety per off‑label use policies; otherwise they are not authorized.
- Ensure all approval criteria (diagnosis, specialist involvement, age, dose limits, quantity limits, lab thresholds, mutation or prior‑therapy documentation) are clearly met in the submission.
Documentation-based denials — missing platelet count or mutation/prior‑therapy evidence
Lack of required documentation may trigger a denial — specifically absence of the documented platelet count (≥ 50 x 10^9/L) for systemic mastocytosis or missing mutation/prior‑therapy evidence for MLNE or GIST.
- Failure to provide platelet count ≥ 50 x 10^9/L for ASM/ISM can result in denial.
- Failure to document PDGFRA mutation status or that a PDGFRA D842V is resistant to imatinib (for MLNE) or to document required prior therapy failures for GIST may result in denial.
Step Therapy / Redirection Rules
| Step | Requirement |
|---|---|
| 1 | |
| Failure of imatinib, ripretinib (Qinlock), sunitinib (Sutent), or regorafenib (Stivarga) unless contraindicated or clinically significant adverse effects are experienced; required for certain GIST requests unless exempt by state regulations or specific exceptions (e.g., Illinois HIM exemptions as noted). |
| Redirection / Bypass | Notes / State prohibitions |
|---|---|
| Oncology bypass added to existing redirections (redirection may be overridden per oncology bypass provisions). | |
| Some states prohibit step therapy redirection for advanced/metastatic cancer (see Appendix D). Examples: FL and GA — prohibited for stage 4 metastatic cancer; IN, LA, IA and others — prohibitions for advanced/metastatic or stage 4 cancer per Appendix D; Illinois HIM: step therapy redirection exceptions (IL HIM per IL HB 5395) apply. |
Coding and Clinical Thresholds
| No codes listed |
Quantity Limits
Site of Care Considerations
State restrictions may block redirection/step therapy for advanced/metastatic cancer
State‑level prohibitions on redirection/step therapy for advanced or metastatic cancer may affect whether step therapy redirection applies in the hospital outpatient or oncology setting; check state Appendix D for applicability.
- Appendix D lists states with regulations against redirections in cancer (examples include FL, GA, IA, IN, LA) with notes on scope (e.g., stage 4 metastatic cancer).
- Follow state rules when evaluating applicability of redirection or step therapy for advanced/metastatic cancer.
Definitions
Background
Avapritinib (Ayvakit) is an oral tyrosine kinase inhibitor indicated for select PDGFRA‑mutant gastrointestinal stromal tumors and for subtypes of systemic mastocytosis. For GIST, approval is targeted to tumors with PDGFRA exon 18 mutations (including D842V) and dosing is limited to a maximum of 300 mg once daily. For systemic mastocytosis indications (ASM, SM‑AHN, MCL, ISM), the recommended dosing and maximum is typically 25 mg once daily for indolent disease and 200 mg once daily for advanced systemic mastocytosis per indication‑specific criteria; platelet count thresholds apply for mastocytosis patients. Prescribers should follow FDA labeling or NCCN recommendations and ensure dosing, mutation documentation, and laboratory requirements are met when seeking coverage.
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