NICE has opened public consultation on new draft guidance that recommends against abemaciclib (Verzenios) with an aromatase inhibitor for the treatment of locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer as first endocrine-based therapy.
The draft guidance concludes that abemaciclib is as effective as both palbociclib and ribociclib which are already recommended by NICE and when the patient access schemes are taken into account, abemaciclib is not cost-effective relative to the other CDK 4/6 inhibitors.
The application for approval of abemaciclib was supported by clinical evidence from the MONARCH 3 double blind, placebo-controlled, randomised trial comparing abemaciclib with placebo (both taken with letrozole or anastrozole) in 493 postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer who had not had any treatment for advanced disease.
In the interim investigator-assessed progression-free survival (PFS) analysis, median PFS was not reached for abemaciclib and was 14.7 months for placebo (HR 0.54; 95% CI 0.41-0.72). Similarly, in the interim independent review, median PFS was not reached for abemaciclib and was 19.2 months for placebo (HR 0.51, 95% CI 0.36 to 0.72). The final PFS analysis was presented to the committee, but the results are confidential until publication.
At the interim analysis, overall survival was similar between the treatment groups with 32 (9.8%) deaths in the abemaciclib group and 17 (10.3%) in the placebo group (HR 0.97; 95% CI not reported).
Based on list prices for all three CDK 4/6 inhibitors, abemaciclib dominated ribociclib and palbociclib. However, using the patient access scheme agreed price, the incremental cost-effectiveness ratios (ICERs) for abemaciclib are significantly higher than £30,000 per quality-adjusted life year (QALY) gained. NICE concluded that abemaciclib is not a cost-effective use of NHS resources.
The draft guidance is open for public consultation until Tuesday 8 November.
