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Repatha's price tag too rich for UK's NICE

HTAbody turns the cholesterol-lowering antibody down in draft guidance

Amgen Repatha evolocumab

Amgen's new cholesterol-lowering antibody Repatha has been turned down by the UK's National Institute of Health and Care Excellence (NICE) in draft guidance.

Despite the fact that Repatha (evolocumab) has been priced in Europe at a hefty discount to the US - reportedly around $7,000 a year, around half its US list price - NICE said it was not cost-effective enough for use within the National Health Service (NHS).

Moreover, the agency also raised questions about the PCSK9 inhibitor's efficacy in its draft guidance, acknowledging that it can cut low-density lipoprotein (LDL) cholesterol but pointing out that there is as yet no data on its ability to improve cardiovascular disease.

While reducing LDL cholesterol has been widely considered to be a key factor in reducing cardiovascular disease, regulators have started to ask for more evidence of a direct effect on CV outcomes.

Repatha and rival PCSK9 inhibitor Praluent (alirocumab) from Sanofi have been developed to complement other cholesterol-lowering drugs such as statins, particularly in people who are struggling to achieve treatment targets. Both drugs are biologics that require self-injection once every two or four weeks.

NICE's appraisal committee "felt the question of whether reducing LDL cholesterol with evolocumab would reduce angina, heart attacks and strokes remains unanswered", commented Meindert Boysen, the agency's programme director.

Amgen has completed patient enrolment in a CV outcomes trial called FOURIER, which is comparing Repatha plus statin therapy to statins and placebo, but this is not expected to generate results until 2017.

Meanwhile, Sanofi and partner Regeneron are carrying out the ODYSSEY OUTCOMES trial of Praluent - which was approved in the EU in September - with data also expected in 2017.

Cost-effectiveness in question

The panel also felt that the analyses presented by Amgen had "limitations which called into question the reliability of the cost-effectiveness results," Boysen added.

That verdict echoes a recent Institute for Clinical and Economic Review (ICER) report in the US, which suggested the price of Repatha and Praluent would have to be cut by a whopping 85% to make them cost-effective treatment options.

"The committee concluded that the degree of uncertainty in the cost-effectiveness evidence was too high for it to be able to make well-founded recommendations about evolocumab," said Boysen.

NICE is accepting comments on the draft guidance until December 8 and will review these at the next committee meeting on January 13.

Article by
Phil Taylor

19th November 2015

From: Sales

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