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DrugAyvakit™ (avapritinib) [Bluepint Medicines Corporation]

September 2020

Therapeutic area - Oncology, Oral - Other

Initial approval criteria

  • Patient is 18 years or older AND
  • Patient has a diagnosis of gastrointestinal stromal tumors (GIST) AND
  • Patient’s disease is unresectable or metastatic AND
  • Patient’s BCR-ABL KD mutational analysis contains the presence of platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutations AND
    • Patient’s disease has a D842V mutation in the PDGFRA gene OR
    • Patient’s disease is progressive after prior therapies, consisting of a 3-month trial or longer, with ≥ 1 of the following: imatinib, regorafenib, sunitinib, sorafenib, nilotinib, dasatinib or pazopanib AND
  • Patient will avoid concomitant use with moderate and strong CYP3A inducer (e.g., rifampin, carbamazepine, St. John’s Wort)
  • Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet the initial criteria above AND
  • Treatment has resulted in disease response as defined by stabilization of disease or decrease in size of tumor or tumor spread AND
  • Patient has not had unacceptable toxicity from the drug (e.g., recurrent or severe intracranial hemorrhages or severe central nervous system [CNS] effects, such as cognitive impairment, dizziness, sleep disorders, mood disorders, speech disorders, hallucinations)
  • Renewal approval is for 6 months

Quantity limits

  • 34 tablets per 34 days


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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