Piqray (alpelisib)

Indications for Prior Authorization

Piqray (alpelisib)
  • For diagnosis of Advanced or Metastatic Breast Cancer
    Indicated in combination with fulvestrant for the treatment of adults 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.

Criteria

Piqray

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of advanced or metastatic breast cancer
  • AND
  • Disease is hormone receptor (HR)-positive
  • AND
  • Disease is human epidermal growth factor receptor 2 (HER2)-negative
  • AND
  • Cancer is PIK3CA-mutated as detected by an FDA-approved test (therascreen PIK3CA RGQ PCR Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
  • AND
  • Used in combination with fulvestrant
  • AND
  • Disease has progressed on or after an endocrine-based regimen
Piqray

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient does not show evidence of progressive disease while on therapy
P & T Revisions

2024-07-02, 2024-03-06, 2023-06-07, 2022-07-05, 2021-07-23, 2021-05-21, 2020-06-09, 2019-07-02

  1. Piqray Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. January 2024.

  • 2024-07-02: 2024 Annual Review - no changes
  • 2024-03-06: Removed "postmenopausal woman or male" criteria
  • 2023-06-07: 2023 Annual Review - removed prescriber requirement
  • 2022-07-05: 2022 Annual Review- no criteria changes
  • 2021-07-23: 2021 Annual Review, no changes to criteria.
  • 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
  • 2020-06-09: 2020 Annual Review, no changes to clinical criteria.
  • 2019-07-02: New PA criteria created for Piqray. Criteria closely mirror FDA-approved indication with added prescriber requirement through an oncologist. Oncology specialist reviewed and approved of criteria as is. JM 7/2/2019

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