- The U.K.’s National Institute for Health and Care Excellence (NICE) has recommended coverage for new PCSK9 cholesterol drugs after winning discounts from the manufacturers.
- Amgen’s Repatha and Regeneron/Sanofi’s Praluent has both had weak launches after high expectations they could raise the standard of care for high cholesterol treatment. Both are pricey, however, listing for over $14,000 in the U.S. and nearly $6,000 in the U.K.
- NICE, a cost agency, recommended the drugs only for people whose cholesterol levels are not controllable using statins and only after the companies conceded further discounts.
NICE has a reputation for denying drugs which don't reflect value and negotiates with manufacturers for discounted prices to align with NICE's value-based analyses. Based on clinical trial data, both Repatha and Praluent lower LDL cholesterol levels by about 60 percent, with few side effects and excellent overall tolerance in the hardest-to-treat patients.
However, the population that can benefit from either of these drugs is very targeted—specifically patients who can't be controlled on high-potency statins, or those who can't tolerate statins. This population also includes certain patients with familial hypercholesterolemia. NICE has been very clear that patients must meet all of the criteria in order to be eligible, and only if the discounts agreed to by the companies are provided.
This is a win for the drug companies involved but legal troubles could present a serious risk to Sanofi and Regeneron’s Praluent. A U.S. district court recently ruled in favor of Amgen, upholding the validity of two Amgen patents on antibodies targeting the PCSK9 enzyme. Damages or royalties have not been set, however.