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Capivasertib with fulvestrant for treating hormone receptor-positive HER2-negative advanced breast cancer after endocrine treatment

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1 Recommendations

1.1

Capivasertib plus fulvestrant is not recommended, within its marketing authorisation, for treating hormone receptor (HR)-positive HER2-negative (defined as immunohistochemistry [IHC]0 or IHC1 positive, or IHC2 positive or in situ hybridisation [ISH]1 negative) locally advanced or metastatic breast cancer in adults that has:

  • 1 or more PIK3CA, AKT1 or PTEN gene alterations

  • recurred after or progressed on endocrine treatment.

1.2

This recommendation is not intended to affect treatment with capivasertib 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 healthcare professional consider it appropriate to stop.

Why the committee made these recommendations

Usual treatment for HR-positive HER2-negative locally advanced or metastatic breast cancer with 1 or more PIK3CA, AKT1 or PTEN gene alterations that has recurred (come back) after or progressed (got worse) on endocrine treatment is:

  • alpelisib plus fulvestrant (for cancer with a PIK3CA alteration), or

  • exemestane plus everolimus.

For this evaluation, the company asked for capivasertib to be considered only for people whose cancer has recurred or progressed after a CDK 4 and 6 inhibitor plus an aromatase inhibitor (a type of endocrine treatment). This does not include everyone who it is licensed for.

Clinical trial evidence shows that capivasertib plus fulvestrant increases how long people have before their cancer gets worse compared with fulvestrant.

Capivasertib plus fulvestrant has not been directly compared in a clinical trial with alpelisib plus fulvestrant or everolimus plus exemestane. The results of indirect comparisons are uncertain because:

  • of differences in the populations in the clinical trials

  • there are problems with the methods used to compare these treatments.

There are also uncertainties in the economic model, including the assumptions about how long the treatment effect lasts.

Because of the uncertainties in the clinical evidence and economic model, it is not possible to determine the most likely cost-effectiveness estimates for capivasertib plus fulvestrant. So, capivasertib plus fulvestrant is not recommended.

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