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  • Question on Consultation

    Has all of the relevant evidence been taken into account?
  • Question on Consultation

    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?
  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?
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    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?

1 Recommendations

1.1 Abemaciclib plus fulvestrant is not recommended, within its marketing authorisation, for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in adults who have had endocrine therapy.

1.2 This recommendation is not intended to affect treatment with abemaciclib plus fulvestrant that was started in the Cancer Drugs Fund before final guidance was published. For those people, abemaciclib with fulvestrant will be funded by the company until they and their NHS clinician consider it appropriate to stop.

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 advanced breast cancer after endocrine therapy (NICE technology appraisal guidance 579). Abemaciclib with fulvestrant will no longer be available in the Cancer Drugs Fund for this indication after final guidance is published.

People with hormone receptor-positive, HER2-negative advanced breast cancer usually have exemestane plus everolimus after endocrine therapy.

Additional clinical trial evidence was collected while abemaciclib plus fulvestrant was in the Cancer Drugs Fund. But 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.

There is also uncertainty because there is no evidence directly comparing abemaciclib plus fulvestrant with exemestane plus everolimus. 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. Also, it is unclear how long people would have treatment for, and therefore how much the treatments would cost.

Because of these uncertainties the cost-effectiveness estimates vary. The most likely estimates are higher than what NICE considers a cost-effective use of NHS resources. Therefore, abemaciclib plus fulvestrant is not recommended.