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Piqray (alpelisib tablets - Novartis)Cigna

Breast cancer

Initial criteria

  • Patient age ≥ 18 years
  • Patient meets ONE of the following (i or ii): i. Patient is a postmenopausal female or a male; OR ii. Patient is pre/perimenopausal and meets ONE of the following (a or b): a) Patient is receiving ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist; OR b) Patient has had surgical bilateral oophorectomy or ovarian irradiation
  • Patient has advanced or metastatic hormone receptor (HR)-positive disease
  • Patient has human epidermal growth factor receptor 2 (HER2)-negative disease
  • Patient has PIK3CA-mutated breast cancer as detected by an approved test
  • Patient has progressed on or after at least one prior endocrine-based regimen (e.g., anastrozole, letrozole, exemestane, tamoxifen, toremifene, or fulvestrant)
  • Piqray will be used in combination with fulvestrant injection

Approval duration

1 year