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Drug - Piqray® (alpelisib) [Novartis Pharmaceuticals Corporation]

January 2020

Therapeutic area - Oncology, Oral- Breast Cancer

Initial approval criteria

  • Patient must be ≥ 18 years of age; AND
  • Patient has hormone receptor-positive, HER2-negative advanced breast cancer; AND
  • Patient has a PIK3CA-mutation as detected by the therascreen PIK3CA RGQ PCR kit, an FDA-approved companion diagnostic; AND
  • Patient does not have inflammatory breast cancer; AND
  • If female, patient is postmenopausal; AND
  • Patient has experienced disease progression on or after an endocrine-based regimen for advanced disease OR has relapsed disease within 12 months after completion of adjuvant endocrine therapy; AND
  • Patient has not received chemotherapy for advanced breast cancer; AND
  • Patient has not previously been treated with fulvestrant; AND
  • Patient has not been treated with another PI3K inhibitor or mTOR (mammalian target of rapamycin) inhibitor; AND
  • Alpelisib Is being given in combination with fulvestrant; AND
  • Patient does not have a diagnosis of type 1 diabetes OR uncontrolled type 2 diabetes (fasting plasma glucose level >140 mg/dL or glycosylated hemoglobin level of > 6.4%); AND
  • Patient does not have uncontrolled central nervous system metastases; AND
  • Patient does not have a currently documented pneumonitis.
  • Initial approval is for 3 months

Renewal criteria

  • Patient continues to meet above criteria; AND
  • Patient has tumor response with stabilization of disease or decrease in the size of tumor or tumor spread; AND
  • Patient does not have unacceptable toxicity such as severe cutaneous reaction or pneumonitis (adverse effects resolve following outlined dosing recommendations and no permanent discontinuation of the medication is required according to labeling).
  • Renewal approval is for 6 months

Quantity limits

  • 50 mg tablets: 28 tablets/28 days
  • 150 mg tablets: 56 tablets/28 days
  • 200 mg tablets: 28 tablets/28 days


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

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