following a full submission assessed under the end of life and orphan equivalent medicine process:
alpelisib (Piqray®) is not recommended for use within NHSScotland.
Indication under review: 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.
The addition of alpelisib to fulvestrant significantly increased progression-free survival in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA mutation.
The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Download detailed advice885KB (PDF)
Medicine details
- Medicine name:
- alpelisib (Piqray)
- SMC ID:
- SMC2481
- Indication:
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.
- Pharmaceutical company
- Novartis Pharmaceuticals UK Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Not recommended
- Date advice published
- 12 December 2022