Alpelisib with fulvestrant for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer

1 Recommendations

1.1 Alpelisib plus fulvestrant is not recommended, within its marketing authorisation, for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated, locally advanced or metastatic breast cancer in women after menopause, and men, who have disease progression after endocrine-based therapy.

1.2 This recommendation is not intended to affect treatment with alpelisib plus fulvestrant that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Current treatment for hormone receptor-positive, HER2-negative, PIK3CA-mutated, locally advanced or metastatic breast cancer is usually only everolimus with exemestane. Alpelisib with fulvestrant is a new treatment for this condition.

There is no direct evidence comparing alpelisib plus fulvestrant with everolimus plus exemestane. The clinical trial evidence presented either did not compare alpelisib plus fulvestrant with other treatments, or it only included a small number of people who would be eligible for alpelisib with fulvestrant in clinical practice. Indirect comparisons suggest that alpelisib plus fulvestrant may be more effective than everolimus plus exemestane, but these analyses are highly uncertain.

The results of the economic model show that alpelisib plus fulvestrant is not a cost-effective use of NHS resources. Also, the limitations in the clinical evidence mean that the results are very uncertain. So, alpelisib plus fulvestrant cannot be recommended for routine use.

Issues with the clinical evidence would not be resolved by ongoing studies. So, alpelisib plus fulvestrant cannot be recommended for use in the Cancer Drugs Fund.