Positive outcomes results will be required for the PCSK9 inhibitors to reach their maximum sales potential.
By Louisa Joseph, Analyst
12 August 2016
PCSK9 inhibitors will need to demonstrate significant improvements in cardiovascular (CV) outcomes in order to reach their maximum sales potentials. Datamonitor Healthcare surveyed 231 cardiologists and endocrinologists across the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK) to calculate the dyslipidemia treatment population and to gain an understanding of current and future prescribing patterns in dyslipidemia. To justify their high cost and use in the wider dyslipidemia population, the PCSK9 inhibitors will need to demonstrate substantial reductions in CV risk in comparison to current lipid-lowering therapies in their Phase III cardiovascular outcomes trials (CVOTs). Positive CV outcomes data will likely reduce reimbursement barriers and trigger increased uptake in their approved indications for high-risk patients. Additionally, significant positive results will help to convince regulators and physicians of their clinical benefits in the wider, more commercially lucrative dyslipidemia population. Datamonitor Healthcare forecasts the majority of PCSK9 inhibitor sales to be gained following the anticipated positive results in their CVOTs and subsequent label expansions for the treatment of dyslipidemia in the wider population.
PCSK9 inhibitor sales in dyslipidemia across the US, Japan and five major EU markets ($m), 2015–2017
Drug 2015 2016 2017
Praluent 11 159 431
Repatha 6 168 469
Grand total 17 327 900
Source: Datamonitor Healthcare’s dyslipidemia forecast, August 2016
Datamonitor Healthcare’s dyslipidemia: forecast covers the expected impact of newly branded therapies on the highly genericized dyslipidemia market, as well as a detailed look at the current dyslipidemia pipeline.
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