Amgen launching PCSK9 med Repatha in Europe at steep discount to US price
- Amgen's anti-cholesterol PCSK9 inhibitor, Repatha (evolocumab), is being launched in the U.K. for roughly $6,780 per year.
- The list price in the U.S. (before discounts) is slightly more than $14,000 per year.
- Prices for Repatha in Austria and Finland are $8,220 and $8,820 per year, respectively.
Repatha was cleared by the European Medicines Agency (EMA) in July and is currently being reviewed by the National Institute for Health and Care Excellence (NICE) in the U.K. Currently, Amgen is targeting patients with hard-to-treat hypercholesterolemia, which has not been controlled with conventional high-potency statins or ezetimbe. In addition, patients who suffer from statin-related side effects, such as joint pain, fatigue, and nausea, are also targets.
Given the strength of the efficacy evidence for Repatha—a reduction of LDL-C of 55% to 75% compared with placebo, and 35% to 45% compared with ezetimbe—it would seem that Repatha would be an option for many of the estimated 60% of high-risk patients across Europe who have hard-to-treat hypercholesterolemia.
However, the prevailing thought process is that NICE most likely will not approve Repatha for the vast majority of patients, even at prices that seem comparatively reasonable. NICE is known for its value-based considerations and tendency to focus on the most cost-effective treatment option given all available data.
In this case, that means that Repatha will most likely be reserved for patients with documented hypercholesterolemia that has not been adequately controlled despite medical intervention with statins, exetimbe and lifestyle modification. That being said, Repatha will probably not be approved for people who simply have a hard time taking statins because of bothersome side effects.
This is also the latest example of a major drug being available in other parts of the world for significantly lower prices than they are in the U.S. Much of that has to do with the far stronger pull of government agencies on drug price negotiations in European countries. While private payers in the U.S. have recently been flexing their muscles, major programs like Medicare do not have this direct negotiation power.