Pharmacy Prior Authorization Criteria

Ayvakit (avapritinib)

Indications for Prior Authorization

Ayvakit (avapritinib)

• For diagnosis of Gastrointestinal Stromal Tumor (GIST)
  Indicated for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (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 advanced systemic mastocytosis (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 /L.

• For diagnosis of Indolent Systemic Mastocytosis (ISM)
  Indicated for the treatment of adult patients with indolent systemic mastocytosis (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
AND
• Presence of platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations

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)
AND
• Platelet count is greater than 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

If patient meets criteria above, please approve at GPI-14

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 50 x 10^9/L

Ayvakit 25 mg

If patient meets criteria above, please approve at GPI-14

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

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

1. Ayvakit Prescribing Information. Blueprint Medicines Corporation. Cambridge, MA. May 2023.

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Revision History

• 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.

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