Ayvakit (avapritinib)
Indications for Prior Authorization
Ayvakit (avapritinib)
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For diagnosis of Gastrointestinal Stromal Tumor (GIST)
Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. -
For diagnosis of Advanced Systemic Mastocytosis (AdvSM)
Indicated for the treatment of adult patients with AdvSM. AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).Limitations of Use: Ayvakit is not recommended for the treatment of patients with AdvSM with platelet counts of less than 50 × 10^9/L.
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For diagnosis of Indolent Systemic Mastocytosis (ISM)
Indicated for the treatment of adult patients with ISM. Limitations of Use: Ayvakit is not recommended for the treatment of patients with ISM with platelet counts of less than 50 × 10^9/L.
Criteria
Ayvakit
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Gastrointestinal Stromal Tumor (GIST)
- Diagnosis of gastrointestinal stromal tumor (GIST) AND
- Disease is ONE of the following:
- Unresectable
- Metastatic
- Presence of platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations, as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
Ayvakit
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Advanced Systemic Mastocytosis (AdvSM)
- Diagnosis of advanced systemic mastocytosis (AdvSM) AND
- Patient has one of the following:
- Aggressive systemic mastocytosis (ASM)
- Systemic mastocytosis with an associated hematological neoplasm (SM-AHN)
- Mast cell leukemia (MCL)
- Platelet count is greater than or equal to 50 x 10^9/L
Ayvakit
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Gastrointestinal Stromal Tumor (GIST), Advanced Systemic Mastocytosis (AdvSM)
- Patient does not show evidence of progressive disease while on therapy
Ayvakit 25 mg
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Indolent Systemic Mastocytosis (ISM)
- Diagnosis of indolent systemic mastocytosis (ISM) AND
- Platelet count is greater than or equal to 50 x 10^9/L
Ayvakit 25 mg
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Indolent Systemic Mastocytosis (ISM)
- Patient does not show evidence of progressive disease while on therapy
P & T Revisions
2026-03-11, 2025-04-30, 2024-04-03, 2023-07-06, 2023-04-10, 2022-03-03, 2021-08-05, 2021-04-14, 2020-12-29, 2020-02-14
References
- Ayvakit Prescribing Information. Blueprint Medicines Corporation. Cambridge, MA. November 2024.
Revision History
- 2026-03-11: Annual Review 2026 - Revised AdvSM and ISM initial auth criteria to allow coverage for patients with platelet count = 50x10^9/L. Updated GIST initial auth criteria for standard genetic testing verbiage. Background updates.
- 2025-04-30: Annual review: No criteria changes. Updated references.
- 2024-04-03: 2024 Annual Review - no changes
- 2023-07-06: Addition of criteria for indolent systemic mastocytosis (ISM); addition of platelet count criterion to AdvSM criteria to align with labeled indication; removal of specialist requirement from GIST and AdvSM criteria.
- 2023-04-10: 2023 Annual Review - references updated
- 2022-03-03: 2022 Annual Review.
- 2021-08-05: Added new strength GPIs and criteria for new indication.
- 2021-04-14: Updated GPIs
- 2020-12-29: 2021 Annual Review: no changes
- 2020-02-14: New guideline created for Ayvakit.
HEALTHY LIVING