Rival PCSK9 Makers Cut Prices to Get Approval from UK Health Service

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Even though prices for both drugs in Britain was less than half the list price in the United States, NICE demanded further discounts before issuing a draft guidance that the therapies were appropriate for those who cannot otherwise lower cholesterol.

The novel cholesterol-fighting drugs, PCSK9 inhibitors, gained the blessing of Britain’s healthcare watchdog agency after agreeing to cut prices to levels considered “cost-effective.”

The change was reported late Thursday by Reuters.

At around $5780 per year in US dollars, the drugs, Amgen’s evolocumab (Repatha), and Sanofi-Regeneron’s alirocumab (Praluent), were already less than half the price they are in the United States. Both came on the market in the summer of 2015 at more than $14,000 a year.

While health plans and pharmacy benefit managers (PBMs) expected the drugs to be expensive, the pricing stunned formulary managers, who have set up strict protocols for who can gain access to the injectable therapies. That’s easier to do in the United States, where the FDA limited its approval to only the most at-risk cardiovascular patients and those with genetic conditions that elevate cholesterol while it awaits long-term cardiovascular outcomes data.

In Europe, both drugs gained broader approval from a safety perspective, but Britain’s National Institute for Health and Care Excellence (NICE), separately decides whether the country’s health service will pay for drugs based on cost-effectiveness. The announcement of the price cut—the level was undisclosed—was key to getting NICE approval in a draft guidance.

Reuters reported that NICE called for both drugs to be considered for use by those whose low-density lipoprotein (LDL) cholesterol is still not under control despite trying other treatments.

Evolocumab and alirocumab both work by blocking proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme that when missing causes LDL cholesterol levels to drop by 55% to 60%, depending on the condition and whether it is used in combination with other therapy such as metformin.

Proponents of the drug see it as a therapy that could be used not only for the most high-risk patients—those who have been unable to control cholesterol on the most powerful statins—but also those who are statin-intolerant. So far, the FDA does not agree.

Cost concerns are a factor in why the drug class has thus far not achieved the sales levels once predicted. In September, the Institute for Clinical and Economic Review (ICER) found that PCSK9 inhibitors should cost 85% less than their list price, based on their value demonstrated over established therapies.

Absent a head-to-head clinical trial, ICER said it could not recommend 1 therapy over the other.