Sanofi, Regeneron to cut price of Praluent

Alicia Farmer
March 12, 2018

"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.

Praluent (alirocumab), an anti-cholesterol drug being developed by Regeneron Pharmaceuticals and Sanofi, has succeeded in the Odyssey Outcomes trial by decreasing the risk of death and heart attack in high-risk patients. Participants in the trial, called Odyssey Outcomes, had recently had an acute coronary syndrome, which includes heart attack and unstable angina.

The drug, Praluent, also led to fewer deaths among high-risk patients, which could be the strongest argument for insurers to finally remove barriers that have severely constrained sales and frustrated physicians trying to get the medicine to patients.

After almost three years, 9.5 percent of those on Praluent and 11.1 percent of those on dummy medicine had suffered a heart attack, stroke, heart-related death or serious chest pain; 3.5 percent on Praluent and 4.1 percent on dummy medicine died.

"Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options due to their increased risk of another event".

And for patients at the highest risk - LDL, or "bad" cholesterol, of 100 mg/dL or higher - had a 24 percent reduction in cardiovascular events, including heart attack and stroke, compared with the placebo.

In a post-hoc analysis of this group, Praluent was associated with a lower risk of death from any cause by 29%. As a result, Regeneron and Sanofi will offer payers that agree to reduce onerous access restrictions for high-risk patients an even further reduced net price for the drug.

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"Not all patients with heart disease are the same".

"I've been unconvinced" of the drugs' benefits but now may prescribe them for certain very high risk patients, said Duke University cardiologist Dr. Christopher Granger.

Representatives from the two companies will meet with health plans to examine prospective net pricing adjustments for those that agree to provide straightforward access to high-risk patients.

Praluent and a similar drug, Amgen's Repatha, work in a different way and lower cholesterol much more. But preventing fewer than one heart problem a year at the drug's current price is not cost-effective, he said.

Sanofi also seems to have won over the doctors attending the conference, which will help it in the coming months as the battle with Amgen begins in earnest.

"In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk". Management sees population of 300K - 400K high-risk patients in US, only 38K being treated at present.

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. They have routinely rejected about 70 percent of prescriptions written, the companies have said. The analyses presented included the results from 730 patients (8%) in the Praluent group who continued to be assessed in the Praluent arm despite stopping therapy with the drug, as specified in the protocol for patients with persistent LDL-C readings below 15 mg/dL.

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