ICER reports: November 2020
- PDF / 172,704 Bytes
- 1 Pages / 595.245 x 841.846 pts (A4) Page_size
- 36 Downloads / 172 Views
1
ICER reports: November 2020 The US Institute for Clinical and Economic Review (ICER) has released a Draft Evidence Report on bempedoic acid and incliseran for the management of high cholesterol,1 and an Evidence Report on supervised injection facilities (SIFs),2 and a Final Evidence Report on haemophilia A therapies,3 in November 2020.
Cholesterol therapies ICER has released a Draft Evidence Report assessing the comparative effectiveness and value of inclisiran [Novartis], bempedoic acid [Nexletol; Esperion Therapeutics] and bempedoic acid/ezetimibe [Nexlizet; Esperion Therapeutics] for the treatment of heterozygous familial hypercholesterolemia (HeFH) and for secondary prevention of atherosclerotic cardiovascular disease (ASCVD). Bempedoic acid and bempedoic acid/ezetimibe have been approved by the US FDA for adjunctive treatment of HeFH in adults on maximal HMG-CoA reductase inhibitor (statin) therapy or with ASCVD. The FDA is expected to release a regulatory decision on inclisiran in late 2020. Evidence from clinical trials showed that bempedoic acid was more effective than placebo, bempedoic acid/ ezetimibe was more effective than ezeteimibe, and inclisiran was more effective than placebo. ICER estimated that drug costs per year were $2856 [2020 values] for bempedoic acid/ezetimibe and $5644 for inclisiran. It estimated that the incremental cost-effectiveness ratio (ICER) for bempedoic acid + ezetimibe + statin compared with ezetimibe + statin was $183 000 per QALY gained, and the ICER for inclisiran + ezetimibe + statin versus ezetimibe + statin was $155 000 per QALY gained. Stakeholders are invited to submit comments on the Draft Evidence Report and Draft Voting Questions by 11 December 2020, after which those comments, ICER’s responses to the comments, and the Evidence Report will be posted. The Evidence Report will be discussed and voted on at a virtual public meeting of the Midwest CEPAC (Comparative Effectiveness Public Advisory Council) on 5 February 2021.
Supervised injection facilities ICER has released an Evidence Report assessing the effectiveness and economic value of SIFs for reducing harm in people who inject drugs (PWID). ICER has judged available evidence adequate to demonstrate that supervised injection facilities prevent overdose deaths and reduce costs by preventing emergency room visits and hospitalisation in communities with high rates of overdose. Evidence provides high certainty that SIFS prevent overdose deaths compared with syringe service programs (SSPs), and does not suggest that SIFS are associated with an increase in crime. The operational costs of SIFs were estimated to be higher than those of SSPs, but they were offset by cost savings from fewer overdose-related services. "A SIF is one of the rare interventions that is not only cost-effective, but cost-saving: in communities with high rates of overdose, SIFs save both lives and money," said ICER. The Evidence Report will be discussed at a virtual meeting of the New England CEPAC on 3 December 2020.
Haemophilia A therapies IC
Data Loading...
