In unexpected setback, UK cost regulators reject Amgen's PCSK9 drug
- The National Institute for Health and Care Excellence (NICE) has decided to not include Repatha (evolocumab) on the UK's list of reimbursable drugs over cost concerns. Additionally, NICE expressed uncertainty in whether reducing LDL-C actually translates into fewer heart attacks and strokes.
- Repatha is a human monoclonal antibody that inhibits the PCSK9 protein—a protein that reduces the body's ability to remove LDL-C from the blood. In clinical trials, Repatha reduced LDL-C by 55% to 75% versus a placebo, and by 35% to 45% compared with Merck's exetimbe.
- The British list price for Repatha is $6,769, and Amgen offered further discounts. In the U.S., Repatha and its competitor Praluent from Sanofi/Regeneron, costs more than $14,000 at list price.
NICE is known for its conservative approach to determining which drugs are clinically needed for the National Health Services's (NHS) list of available drugs. This decision, however, comes as a surprise for many. Statistics have shown that 60% of high-risk patients in the EU with hypercholesterolemia are still unable to control their LDL-C with their current regimens.
Nonetheless, the issue highlights several concerns. Decreased LDL-C in the Repatha and Praluent (alirocumab) trials has not been definitively connected to decreased heart attacks. For its part, Amgen argues there is a very strong evidence base linking decreased LDL-C and decreased risk of heart attack and stroke.
Furthermore, Repatha in the UK costs less than half of the US list price, with Amgen willing to futher discount it. This suggests the determination of US-based PBMs, such as United Healthcare and Aetna, to rein in prices could have some results, given the vast flexibility seen in other markets.