18. Nov. 2015 in PharmaTimes
The National Institute for Health and Care Excellence has turned down Amgen’s Repatha – the world’s first approved PCSK9 inhibitor – as an option for people with high cholesterol and mixed dyslipidaemia.
Key reasons for the negative decision were: (1) no long-term outcomes data and thus, the question of whether reducing LDL cholesterol with Repatha (evolocumab) would reduce angina, heart attacks and strokes “remains unanswered”; (2) The company used the Framingham risk equations for calculating the risk of cardiovascular events rather than using the UK validated QRISK2 tool, which results in lower cardiovascular risk estimates (3) Repatha’s annual cost per patient comes in at around £4,448.60 for 140mg every two weeks, and £6123.60 for 420 mg monthly, which, given the high number patients that could be eligible for treatment, would heavily impact the NHS financial resources.
Full text in PharmaTimes: http://www.pharmatimes.com/Article/15-11-18/Amgen_s_cholesterol-buster_Repatha_turned_down_for_NHS_use.aspx