In blow to Sanofi, UK's NICE reverses course & backs Amgen's PCSK9 med
- In draft guidance, the UK's National Institute for Health and Care Excellence (NICE) on Monday reversed its previous position of refusing to back Amgen's PCSK9 inhibitor cholesterol-lowering medication Repatha. The agency also dealt a significant blow to Sanofi/Regeneron's competing PCSK9 med Praluent, rejecting it for use by UK patients on cost-effectiveness grounds.
- While NICE did clear Repatha use in UK patients, it did so in a more restrictive manner than regulators in the U.S. Repatha will be available only to patients with a number of cholesterol-related health conditions such as primary non-familial hypercholesterolaemia or primary heterozygous-familial hypercholesterolaemia with progressive CVD and high LDL-cholesterol levels, among several other specific patient populations. It will also only be available at the 140 mg dose.
- The agency sounded concerns over Praluent's price and questioned its ability to lower CVD events. It's possible that Sanofi could elbow its way to a future NICE approval after further negotiations.
While this is an obvious and significant setback to Sanofi, Amgen also harbors its own objections to NICE's new guidance. The regulatory body has been waging an aggressive war on pricey new medications in an effort to contain healthcare costs.
"NICE has reviewed the technical responses to its initial appraisal, listened to patients and healthcare professionals and proposed a recommendation for the use of Repatha by the NHS in England and Wales," said Amgen UK & Ireland Executive Medical Director Tony Patrikios.
"However, beyond these draft recommendations, another priority will be patients with existing cardiovascular disease who fail to reduce their LDL-C to a satisfactory level despite the use of statins and who remain at high risk. For them, access to new treatment options is critically important to help avoid a heart attack or stroke."
In the U.S., Amgen and Sanofi/Regeneron have been splitting payers between the competing medications. The latter company scored a major victory in December when American health insurance giant UnitedHealth announced that its benefits manager unit OptumRx would make Praluent the preferred PCSK9 med on its formulary. But CVS Health struck an exclusive deal for Amgen's Repatha while benefits giant Express Scripts decided to cover both drugs.
Sanofi may ratchet up its efforts to strike a deal with NICE given the size of the market and the company's ongoing sales woes. On Tuesday, the firm said that, while it expects stability, it doesn't anticipate 2016 profits to grow as its flagship insulin Lantus continues to bleed sales to competitors such as Novo Nordisk's Levemir.
The French pharma's hope has been that uptake of new drugs such as Praluent and Lantus successor Toujeo will staunch the bleeding. But as NICE's draft guidance demonstrates, marketing these products will continue to be an uphill battle. Sanofi has announced a major restructuring effort that involves securing major savings and slashing jobs.
Sanofi shares fell to 52-week lows in U.S. and European markets in Tuesday trading.
UPDATE: Sanofi sent the following statement to BioPharma Dive expressing its disappointment in the decision while also praising NICE's recognition of Praluent on several other fronts. The company also emphasized that the NICE guidance is still preliminary and may change.
"Sanofi is disappointed that the National Institute for Health and Care Excellence (NICE) has not recommended the use of Praluent® q(alirocumab) for patients with high cardiovascular risk at the first draft stage," the company said.
"Sanofi is pleased, however, that our intention to focus upon those patient subgroups that are at risk of further cardiovascular events has been recognised by the Institute.
"The Appraisal Committee recommendation to NICE for Praluent is an appraisal consultation document (ACD) and is not a final recommendation. The Praluent draft recommendation is now open for consultation and feedback will be considered at a second Committee meeting which is likely to take place towards the end of February.
"Sanofi is committed to working with NICE to ensure that appropriate patients are able to access Praluent. This is why we offered a patient access scheme upfront including a confidential discount as a sign of our commitment to seeing patients in the UK benefit from this innovative treatment."