1 Recommendations
1.1 Alpelisib plus fulvestrant is recommended as an option for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated, locally advanced or metastatic breast cancer in adults, only if:
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their cancer has progressed after a CDK4/6 inhibitor plus an aromatase inhibitor and
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the company provides alpelisib according to the commercial arrangement).
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 after endocrine-based therapy with a CDK4/6 inhibitor plus an aromatase inhibitor includes everolimus with exemestane. Alpelisib with fulvestrant is a new treatment for this condition. The company has positioned alpelisib with fulvestrant after a CDK4/6 inhibitor plus an aromatase inhibitor, which is narrower than its marketing authorisation (licence).
Clinical evidence from indirect comparisons suggests that alpelisib plus fulvestrant is more effective than everolimus plus exemestane, but the analyses are uncertain. The clinical trial evidence presented only included a small number of people who would be eligible for alpelisib with fulvestrant in clinical practice.
Alpelisib plus fulvestrant meets NICE's criteria to be a life-extending treatment at the end of life. The most likely cost-effectiveness estimates are uncertain but within the range that NICE considers an acceptable use of NHS resources. So, alpelisib plus fulvestrant is recommended.