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

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