2 Information about alpelisib

Marketing authorisation indication

2.1 Alpelisib (Piqray, Novartis Pharmaceuticals UK) has a marketing authorisation for use 'in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine-based therapy'.

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics for alpelisib.


2.3 The company's list price is £4,082.14 per 56‑pack of 150 mg film-coated tablets (excluding VAT; BNF online, accessed May 2022). The average cost of a course of combination treatment at list price is £6,170.70 for the loading dose and £5,126.42 for the following cycles.

2.4 The company has a commercial arrangement. This makes alpelisib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)