Pharmacy Prior Authorization Criteria

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

References

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

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Revision History

• 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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