1 Recommendations

1 Recommendations

1.1 Abemaciclib with fulvestrant is recommended for use within the Cancer Drugs Fund as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer in people who have had endocrine therapy only if:

  • exemestane plus everolimus would be the most appropriate alternative and

  • the conditions in the managed access agreement for abemaciclib with fulvestrant are followed.

1.2 This recommendation is not intended to affect treatment with abemaciclib with 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 advanced hormone receptor-positive, HER2-negative breast cancer after endocrine therapy when chemotherapy is not needed immediately, is usually exemestane, tamoxifen, or exemestane plus everolimus. NICE does not recommend fulvestrant monotherapy.

Clinical trial evidence suggests that compared with fulvestrant alone, abemaciclib with fulvestrant increases the length of time before the disease progresses. However, it is uncertain whether people having abemaciclib with fulvestrant live longer, because people in the trial have not been followed-up for long enough. This uncertainty in the clinical benefit adds to the uncertainty about the cost-effectiveness estimates.

The cost-effectiveness estimates are based on an indirect comparison. Also, survival data are incomplete. Therefore the cost-effectiveness estimates are highly uncertain. Most of the plausible estimates are likely to be higher than what NICE normally considers an acceptable use of NHS resources, although the company's preferred estimate is lower. Therefore abemaciclib with fulvestrant is not recommended for routine commissioning in the NHS.

More evidence is needed to address clinical uncertainties. Longer follow-up data from the trial on how long people live are likely to reduce the uncertainty in the clinical- and cost-effectiveness results. Therefore abemaciclib with fulvestrant is recommended for use in the Cancer Drugs Fund, while these data are collected.

  • National Institute for Health and Care Excellence (NICE)