Regeneron and Sanofi Slash Cost of Cholesterol-Lowering Drug

Express Scripts to offer Praluent at roughly 60% off list price

Frustrated by tepid sales and practical stumbling blocks, Regeneron and Sanofi are offering a huge discount on their treatment for bad cholesterol in exchange for a promise that health care’s biggest middleman will make it easier for patients to actually get the drug, according to a STAT report.

Starting in July, the two companies will sell their cholesterol-lowering drug alirocumab (Praluent), which carries a $14,600 list price, at roughly 60% off to clients of Express Scripts, the nation’s biggest pharmacy benefit manager. In exchange, Express Scripts will make their drug the only cholesterol-lowering injection available to the 25 million patients on its formulary, freezing out a rival therapy from Amgen. And, most important, Express Scripts will scrap the weeks of paperwork now required to approve a prescription, and implement a simple form that will allow doctors to get an immediate answer, STAT said.

The Institute for Clinical and Economic Review (ICER), an independent nonprofit that studies whether drugs are worth their price, concluded that Regeneron and Sanofi’s treatment is cost-effective at between $4,500 and $8,000 per year. Express Scripts has negotiated a price “on the low end” of that range, said Dr. Steve Miller, the company’s chief medical officer.

 “We think this is a new model,” Miller said. “You’ve got a company that looks at what fair drug price is, puts itself through an external evaluation, and then negotiates on that price with us. We believe that this can actually change the marketplace.”

Sanofi and Regeneron are making the pricing concession in hopes of jump-starting sales of alirocumab, which has been a commercial nonentity since winning approval in 2015. In clinical trials, the drug lowered bad cholesterol by as much as 60% in high-risk patients. Amgen’s similar treatment, evolocumab (Repatha), worked much the same way, and investors expected each to bring in billions of dollars a year.

But each medicine’s price tag proved too much for the system to bear. Despite the drugs’ dramatic effects on cholesterol, payers required doctors to supply pages and pages of documentation to prove patients actually needed the pricey drugs. The majority of prescriptions got rejected, the companies said, and that had a devastating effect on sales. Last year, Amgen booked just $319 million from its drug, while Regeneron and Sanofi generated just $195 million.

Now, with the Express Scripts agreement, Regeneron and Sanofi are working to change that.

“I think this really is a turning point in the story,” said Mike Suesserman, vice president of marketing at Regeneron. “We’ve come to the conclusion that this was one of the biggest reasons patients who are eligible for therapy just aren’t getting the drug or aren’t getting it in a timely way. Now it should be much easier for doctors and patients to get the medication that they’re eligible for.”

In March, Sanofi and Regeneron presented long-term data showing that alirocumab reduced the risk of heart attack, stroke, and death in patients with cardiovascular disease. The company will submit those data to the Food and Drug Administration in hopes of updating alirocumab’s label.

Amgen, which presented long-term data of its own in 2017, holds about 65% of the U.S. market. Last year, the company promised a money-back guarantee for patients who have heart attacks or strokes while taking evolocumab, but the offer is yet to have a marked effect on sales. Both drugs had safety profiles similar to placebo in those large trials.

Meanwhile, the two parties are locked in a patent dispute, with Amgen claiming that Regeneron infringed its intellectual property in developing alirocumab. Last year, a federal judge threw out an earlier ruling in favor of Amgen, and a new trial is expected this year.

Both drugs work by blocking a protein called proprotein convertase subtilisin/kexin type 9, thereby freeing up the body to clear out low-density lipoprotein-cholesterol in the blood.

Source: STAT; May 1, 2018.