Sanofi and Regeneron Slash Cost of New Cholesterol Drug Praluent

One of the reasons the new class of cholesterol-lowering medications, PCSK9 inhibitors, have had trouble gaining traction in the marketplace is because of cost. Compared to standard-of-care statins, which run around $50 per month, PCSK9 inhibitors, primarily Sanofi US and Regeneron Pharmaceuticals, Inc.’s Praluent and Amgen’s Repatha, run around $14,000 per year. Although PCSK9 inhibitors are considered appropriate for patients who just don’t respond to statins, payers have been reluctant to reimburse for the drugs for the wider market.

Now, leveraging data from the 18,924-patient Odyssey Outcomes clinical study, Regeneron and Sanofi are cutting deals with payers to drop the prices if they can gain broader market access. The two companies are also identifying a more targeted population, according to Seeking Alpha, "focusing efforts on high-risk patients most vulnerable for future cardiovascular (CV) events, such as those who have suffered a previous coronary event and are unable to reduce their LDL cholesterol (LDL-C) below 100 mg/dL despite maximally-tolerated statin therapy."

The negotiations align with the U.S. Institute for Clinical and Economic Review (ICER)’s new value assessment for high-risk patients. Sanofi and Regeneron gave ICER early access to date from the Odyssey Outcomes trial. ICER is an independent group that studies and evaluates prescription drugs’ value.

"Inventing innovative medicines only matters if the people who need these products are able to access them—and that is unfortunately not the case with Praluent today," said Leonard Schleifer, Regeneron’s president and chief executive officer, in a statement. "We believe a new paradigm is needed in how all members of the healthcare community collaborate to ensure that patients are able to affordably access medical treatments they need. We commit to working with all health plans that agree to remove access barriers for high-risk patients to offer a more cost-effective net price for Praluent. We hope that our unprecedented approach to collaborating with payers and other stakeholders demonstrates that it is possible to bring major innovation to patients at a price that aligns with the value delivered."

The Odyssey Outcomes data provide evidence that Praluent significant cuts the number of cardiovascular incidents by patients taking the drug, most of which are already on statins, but it also showed a clear reduction in deaths. That was something that Amgen’s similar study data released last summer was unable to prove.

Patients on Praluent had a drop of 3.4 points compared to placebo in Major Adverse Cardiac Events (MACE) in patients with an LDL level over 100 mg/dL, and the cardiovascular death rate fell from 4.2 percent to 2.9 percent. There was also a drop of overall death rates from 5.7 percent to 4.1 percent, which is a 29 percent decrease in risk. Or as John Carroll, writing for Endpoints News, describes it, for every 1,000 patients fitting the profile and taking the drug, 17 people would still be alive.

As a result, Sanofi and Regeneron are making a deal to lower the price of Praluent to $7,975, a decrease of $4,460, per year, for payers who will allow more access.

Carroll writes, "Just as Amgen won kudos for its work to convince payers to do the same with money-back guarantees, this new round marks the industry’s increasing willingness to negotiate over what it charges—a trend that is creating a sea change over some drugs that have to survive in a competitive scene."

At this time, Sanofi and Regeneron seem to have a bit of an edge over Amgen because of the mortality advantage for Praluent observed in the Odyssey Outcomes study. That may have largely been the result of focusing on a narrower patient population. Jay Edelberg, head of Sanofi’s cardio development, said in a statement, "Odyssey Outcomes studied Praluent in the highest risk patients. They remain at high risk of recurring heart attacks. By studying these highest risk patients, we were able to demonstrate reductions in MACE and a reduction in mortality."

This may mark the beginning of a price war for the cholesterol market, especially as more companies bring on alternatives to statins. Esperion Therapeutics Inc. has indicated the company plans to charge less than $4,000 for its late-stage cholesterol medication, which is in late-stage studies. The Medicines Company may also be forced to lower its prospective prices for its RNAi treatment for LDL cholesterol.

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