LONDON, UK — The National Institute for Health and Care Excellence (NICE) announced today in a draft that it is not recommending the PCSK9 inhibitor evolocumab (Repatha, Amgen) for patients with primary hypercholesterolemia and mixed dyslipidemia. NICE provides recommendations on whether the National Health Service should pay for treatment in the UK.
NICE program director Meindert Boysen noted in a release that although the committee believes that evolocumab does effectively reduce LDL-C in this patient population, there have been no long-term clinical-outcome trials. And whether reducing LDL-C really would lower angina, MI, and stroke is still up in the air.
He also reported that there were several limitations in the analyses presented by Amgen, "which called into question the reliability of the cost-effectiveness results."
This included the manufacturer not using the NICE-recommended QRISK2 assessment tool and instead using Framingham risk equations, "which have been shown to overestimate CVD risk in a UK population," said Boysen.
"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."
The one-year price for the medication in the UK is £4448.60/$6769, which is about half the $14,100 one-year treatment total in the US.
The FDA approved evolocumab in August, a month after the agency gave its approval to fellow PCSK9 inhibitor alirocumab (Praluent, Sanofi/Regeneron). As reported by heartwire from Medscape, the large US pharmacy benefits manager Express Scripts announced in October that it would pay for both medications.
NICE reported that comments from the public and the manufacturer on the evolocumab preliminary guidance will be open until December 8, 2015 and will be considered at its January 13, 2016 meeting, which will lead to the issuance of the next draft guidance. The committee has not yet assessed alirocumab.
Heartwire from Medscape © 2015 Medscape, LLC
Cite this: NICE Proposal Would Keep Evolocumab Out of UK National Health - Medscape - Nov 18, 2015.