On 27 February 2019, NICE issued Technology appraisal guidance [TA563] with evidence based recommendations on abemaciclib (Verzenios, Eli Lilly) for treating locally advanced or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adults who have not had endocrine-based therapy before.
Abemaciclib with an aromatase inhibitor is recommended, within its marketing authorisation, as an option for treating locally advanced or metastatic, HR-positive, HER2-negative breast cancer as first endocrine-based therapy in adults. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Abemaciclib is recommended only if the company provides it according to the commercial arrangement.
The recommended dose is 150 mg taken orally, twice daily, alongside treatment with an aromatase inhibitor. Treatment should be continued as long as the patient is having clinical benefit or until unacceptable toxicity occurs.
Some adverse reactions may need to be managed by temporary dose reductions, dose interruptions, or permanently stopping the treatment.
Price is 2,950 GBP for 56×150 mg tablets (excluding VAT; MIMS online, accessed December 2018). The company has a commercial arrangement. This makes abemaciclib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.
Why the appraisal committee made these recommendations?
Palbociclib or ribociclib, taken with an aromatase inhibitor, are usually the first treatments for locally advanced or metastatic, HR-positive, HER2-negative breast cancer. They are cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors, as is abemaciclib.
Clinical trial evidence shows that abemaciclib with an aromatase inhibitor increases progression-free survival, compared with an aromatase inhibitor alone. It is not known whether abemaciclib increases the overall survival, because the final trial results are not available yet.
Abemaciclib, palbociclib and ribociclib have different side effects, but they all appear to work as well as each other.
Taking into account the commercial arrangements for all the CDK 4/6 inhibitors, abemaciclib is a cost-effective use of NHS resources and it can be recommended.