Piqray®

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

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

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