PIQRAY (alpelisib)
SELF ADMINISTRATION- ORAL
Indications for Prior Authorization:
- Indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Patients must meet the following criteria for the indication(s) above:
- Prescribed by or in consultation with a specialist (e.g. oncologist), AND
- Patient is a postmenopausal female or male, AND
- Diagnosis of advanced or metastatic HR+, HER2- breast cancer as confirmed by chart note documentation, AND
- Patient has PIK3CA-mutated breast cancer as detected by an FDA approved test, AND
- Patient has progressed on or after at least one prior endocrine-based regimen (e.g. anastrozole, letrozole, exemestane, Faslodex®, tamoxifen, toremifene), AND
- Piqray® will be used in combination with Fulvestrant, AND
- Piqray® will not be coadministered with strong CYP3A4 inducers. Coadministration of Piqray® with BCRP inhibitors should be avoided (if unable to use alternative drugs, closely monitor)
Dosing:
- Recommended dose: 300mg (two 150mg tablets) once daily
Approval:
- 1 year
Last review date: July 16, 2019