Ayvakit™

Drug - Ayvakit™ (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

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

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