1 Recommendations

1.1 Abemaciclib plus fulvestrant is recommended as an option for treating hormone receptor‑positive, human epidermal growth factor receptor 2 (HER2)‑negative, locally advanced or metastatic breast cancer in adults who have had endocrine therapy only if:

  • exemestane plus everolimus is the most appropriate alternative to a cyclin‑dependent kinase 4 and 6 (CDK 4/6) inhibitor and

  • the company provides abemaciclib according to the commercial arrangement.

Why the committee made these recommendations

This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement for abemaciclib plus fulvestrant for treating hormone receptor‑positive, HER2‑negative, locally advanced or metastatic breast cancer after endocrine therapy (see NICE's technology appraisal guidance 579). The usual treatment for this is exemestane plus everolimus.

Additional clinical trial evidence was collected while abemaciclib plus fulvestrant was in the Cancer Drugs Fund. Some people in the trial had a higher dose of abemaciclib than would normally be used, so it is uncertain how well the drug will work in clinical practice. But an indirect comparison suggests that people having abemaciclib plus fulvestrant have longer before their disease progresses and live longer than people having exemestane plus everolimus.

The cost‑effectiveness estimates vary. But, even with the uncertainty around the estimates, abemaciclib plus fulvestrant is considered a cost‑effective use of NHS resources. Therefore, abemaciclib plus fulvestrant is recommended.

  • National Institute for Health and Care Excellence (NICE)