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Repatha versus Praluent: Will the approval of PCSK9 inhibitors trigger a new price war in the US?
With an FDA marketing authorisation decision date fast approaching, Amgen and Sanofi together with its partner Regeneron have recently published new results for their proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors. The two candidate medicines, Amgen's Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab) are expected to become the next cardiovascular blockbusters able to significantly lower low-density lipoprotein cholesterol (LDL-C), also known as the "bad" cholesterol, in high-risk patients suffering from hypercholesterolemia. This new class of medicines represents a promise for new therapy opportunities for patients with poorly controlled hypercholesterolemia.
PCSK9 inhibitors halve LDL-C levels
According to results reported by Amgen from the Phase II OSLER-1 and Phase III OSLER-2 studies, Repatha administered in combination with standard therapy lowered the LDL-C by 61% after 11 months of use vs standard therapy alone. Meanwhile, Sanofi / Regeneron Pharmaceuticals' Phase III ODYSSEY LONG TERM trial showed a 56 % reduction from baseline in LDL-C for Praluent versus placebo at week 78. Furthermore, data from the three trials demonstrated that PCSK9 inhibitors reduced risks of heart attack or stroke by approximately 50% for both investigational treatments. However, we still need to be cautious over drawing conclusions concerning cardiovascular-related outcomes, including heart attacks and strokes, as studies involving a greater number of patients are necessary to evaluate PCSK9 inhibitors efficacy in reducing cardiovascular events. In particular, Amgen has underlined that it will be necessary to await the conclusion of the cardiovascular outcomes trial, FOURIER, to have a better picture of the impact on major cardiovascular events.
Amgen and Sanofi head-to-head to enter US market
The US has become the battle ground for Amgen and Sanofi/ Regeneron to secure the first approval of a PCSK9 inhibitor. Amgen's application for Repatha was accepted by the FDA in November last year and a decision from the agency is expected to be issued by 27 August 2015. However, Sanofi and Regeneron managed to jump ahead of competition by purchasing a Priority Review voucher for their Biologics License Application (BLA) from BioMarin in July 2014 for USD67.5 million. Following the decision of the FDA to grant priority review of the BLA for Praluent, Sanofi/ Regeneron are now expecting a decision by 24 July 2015, one (potentially critical) month before Repatha.
PCSK9: A new headache for the payers?
While the two companies are preparing to enter the US market, US payers have already been raising concerns over potential costs of PCSK9 inhibitors. According to figures published by US pharmacy benefit manager CVS Health, the cost of a one-year treatment with these medicines is expected to reach between USD7,000 and USD12,000 per person, potentially surpassing costs of the new generation of therapeutics for hepatitis C virus (HCV) which have themselves created headlines over the last year. In light of the political and public backlash over pricing in HCV, it will be interesting to observe the price strategy that the manufacturers decide to adopt assuming Repatha and Praluent receive the FDA nod. Manufacturers of HCV treatments, including Gilead Sciences and AbbVie, have been pushed to compete on discounts, starting what has been defined as a price war, in order to secure exclusivity on drug formularies. Payors, therefore, may undertake a similar strategy with PCSK9 inhibitors and push manufacturers into similar discount competition in their bid to reduce costs.
Federica Benassi is a life sciences analyst for IHS
Published 6 April 2015
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