Sanofi and Regeneron to expand United States access to Praluent

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"I think that will impress the field and people who have to make (reimbursement) decisions", said Dr. Phillippe Steg, the study's co-chairman who presented the data at the American College of Cardiology meeting in Orlando, Florida.

Praluent, or alirocumab, a relatively new cholesterol drug, is effective at lowering heart attack and death risk, according to a study sponsored by manufactuers Sanofi and Regeneron Pharmaceuticals. Regeneron and Sanofi announced at the conference they would offer payers a discount on the drug if they agree to ease up on their restrictions when approving prescriptions.

It inactivates a specific protein in the liver, reducing the amount of harmful LDL, or bad cholesterol, in the blood. Months can go by before a patient gets them. The drugs have been sold since 2015 but cost more than $14,000 a year, and insurers have baulked at paying without proof that they reduce health problems, not just the cholesterol number.


All had LDL over 70 despite maximum statin use.

High-risk patients who were subjected to Praluent injection in combination with maximally-tolerated statins had significantly lesser major adverse cardiovascular events compared to patients treated on only maximally-tolerated statins.

With an LDL target range of 25-50, rather than taking it as low as possible, three-quarters of patients ended up on a lower dose of Praluent and some were taken off the drug if their LDL remained at 15 or lower. After almost three years, 9.5 per cent of those on Praluent and 11.1 per cent of those on dummy medicine had suffered a heart attack, stroke, heart-related death or serious chest pain; 3.5 per cent on Praluent and 4.1 per cent on dummy medicine died. The organization recommended a price range of $4,500 to $8,000 for those high-risk patients likely to gain the most benefit from Praluent therapy. Despite their striking ability to lower gobs of LDL-C or "bad" cholesterol, their sales have been meager compared to Wall Street analysts' initial bullish multi-billion dollar projections; alirocumab tallied $194 million past year worldwide, evolocumab $319 million.


"The hard data from the Odyssey Outcomes trial confirms. that treatment with Praluent does lead to a reduction of both cardiovascular and all-cause deaths, particularly for the higher-risk patient population", said David Whitrap, a spokesman for ICER, which conducted the review.

"We need to reset our expectations" and realize that benefits for any new drug are going to be fairly small when added to already good treatments such as statins, said Dr Jeffrey Kuvin, conference leader and cardiology chief at Dartmouth-Hitchcock Medical Centre.

On Saturday, the independent group said Praluent should cost, based on the new results, between $2,300 to $3,400 per year for people like those in the study. Regeneron will now focus its commercial efforts on those patients, and plans to reach out to payers with a deal: provide "straightforward access for high-risk patients", and it will lower the price of alirocumab, according to a press release.


From 300,000 to 400,000 people in the United States each year fall in that second category.

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