BURLINGTON, Mass., March 16, 2017 /PRNewswire/ --Decision Resources Group finds that the PCSK9 inhibitor agents are expected to become blockbusters on the back of positive outcomes data, but the high prices for these agents could mean that peak sales do not reach record heights. The results from FOURIER, the cardiovascular outcomes trial (CVOT) for Amgen's PCSK9 inhibitor Repatha (evolocumab) will shortly be presented at ACC.17.
Amgen have announced that the results are positive, so the big question is how positive? And how will practice change? Or will it? The high prices of Repatha and its direct competitor Sanofi/Regeneron Pharmaceutical's Praluent (alirocumab) have already contributed to slow uptake of these agents, despite their efficacy at reducing cholesterol levels. Furthermore, cost-effectiveness analyses suggest massive CV risk reductions are going to be required to make the PCSK9 inhibitors represent value for money.
With competition from numerous existing and emerging less expensive oral therapies, the treatment landscape for dyslipidemia and CV diseases, such as acute coronary syndromes (ACS), could change dramatically over the next few years, but this will all depend on the CVOT data.
Other key findings from Decision Resources Group's Disease Landscape & Forecast report entitled Dyslipidemia:
The dyslipidemia market is expected to grow from approximately $17 billion in 2015 to more than $24 billion in 2025. Patent expiration of key brands will hinder growth during the first half of the forecast period, but this will eventually be offset by the launch and uptake of several novel agents.
The results of several major CV outcomes trials should provide conclusive evidence of the place for several nonstatin therapies, including PCSK9 inhibitors and omega-3 fatty acid compounds, in the treatment paradigm.
The 2015 emergence of the PCSK9 inhibitors will provide great impetus to the dyslipidemia market, although use of this class will largely be restricted to patients with high CV risk initially.
Several new emerging therapies with novel MOAs will also stimulate market growth, despite being used in later lines of therapy. These products include Esperion Therapeutics' bempedoic acid (ETC-1002), Merck's anacetrapib, and Resverlogix's apabetalone (RVX-208).
Comments from Decision Resources Group Analyst Dr. Tim Blackstock, MB ChB, M Phil:
"Reducing CV morbidity and mortality is the ultimate goal of treating dyslipidemia. CVOT data will have a considerable impact on physicians' prescribing, as well as payer coverage and reimbursement."
"The PCSK9 inhibitors are likely to be limited to use in high CV-risk patients with uncontrolled LDL-cholesterol levels; the emergence of the novel oral once-daily LDL-cholesterol-lowering drugs bempedoic acid and anacetrapib, which are expected to be offered at a much lower price, will also limit use of the PCSK9 inhibitors."
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