With ODYSSEY Results in Hand, Talks With Payers Begin to Jump Start Praluent Sales

News that Sanofi and Regeneron’s alirocumab (Praluent), had cut the risk of all-cause death by 29% among patients with the highest cholesterol levels—those above 100 mg/dL—seemed almost an afterthought after reports came that the drug makers were ready to deal: Stop making things miserable for doctors prescribing our PCSK9 inhibitor to high-risk patients, and we’ll cut prices.

Some reports said this was a gambit to boost sales, after results of the ODYSSEY Outcomes trial, presented at the American College of Cardiology (ACC) meeting, fell short of what analysts had hoped. Sanofi and Regeneron’s focus was not on the overall finding—an all-cause death reduction of 15%—but on patients with the highest cholesterol levels, who are most at-risk of heart attacks or strokes. This includes those with rare genetic conditions who would seem obvious candidates for a proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor, but who have reportedly struggled to gain access.

The offer to drop the $14,000 price tag by 40% or more was based on updated findings of the Institute for Clinical and Economic Review (ICER), which had previously panned the cholesterol-fighting antibody class, but gained a chance to privately review the data ahead of Saturday’s presentation.

ICER’s preliminary finding, which the group said will be finalized in May, set 2 new value-based benchmarks. Prices for alirocumab, net of rebates and discounts should be:

• $2300 to $3400 per year, if used to treat all patients with a recent acute coronary event
• $4500 to $8000 a year, if used to treat high-risk patients with recent acute coronary syndrome who have low-density lipoprotein 100 mg/dL or higher despite intensive statins. This second group is the focus of the Sanofi—Regeneron olive branch.

“There are too many patients in urgent need of additional treatment options who have faced tremendous hurdles to gain access to Praluent,” Sheldon Koenig, head of Cardiovascular Franchise, Diabetes and Cardiovascular Global Business Unit, Sanofi, said Tuesday.

“Beginning this week, Sanofi and Regeneron will meet with US health plans to discuss potential net price adjustments for those that agree to provide straightforward access for high-risk patients,” he said. “The [pharmaceutical] companies also plan to work with cardiology healthcare professionals to define best practices in terms of reducing barriers to access in order to ensure that patients in need have their prescriptions filled quickly and efficiently.”

The offer is quite unlike Amgen’s money-back guarantee of a year ago, if patients had a heart attack while taking evolocumab (Repatha). That PCSK9 inhibitor reduced overall cardiac events but failed to show a mortality benefit. The alirocumab offer isn’t tied to the drug’s performance, but rather, to the behavior of the payers themselves.

Still, it’s acknowledgment of what FDA Commissioner Scott Gottlieb, MD, last week described as the “Kabuki drug-pricing constructs,” a system of official and unofficial prices, rebates, and coupons that some patients get and others subsidize. The Sanofi—Regeneron offer signals that the murky system is collapsing under its own weight, having left patients and their doctors to run a gauntlet for life-saving drugs, while a would-be blockbuster barely gets out of the gate.

While discussing ODYSSEY on Saturday, Valentin Fuster, MD, of Mount Sinai, was visibly angry recounting 3 years of frustration he’s faced trying to fill PCSK9 inhibitor prescriptions, despite attending seminars and investing staff time. Fuster described a war of attrition, which he suggested is designed to get cardiologists to give up. “They try to make the patient ineligible,” he said of payers. “It’s very, very hard.”

Days before the ACC meeting, while discussing challenges in the biosimilars market to America’s Health Insurance Plans (AHIP), Gottlieb chastised the current milieu of co-payments and pharmacy chain actors as one that has the “sick subsidizing the healthy.”

He said: “Patients shouldn’t face exorbitant out-of-pocket costs, and pay money where the primary purpose is to help subsidize rebates paid to a long list of supply chain intermediaries, or is used to buy down the premium costs for everyone else.”

Asked to comment on Gottlieb’s statement, Koenig said, “We believe a new approach is needed in how the healthcare industry collaborates to ensure patients can affordably access medicine they need.”

Of special concern are those with familial hypercholesterolemia (FH), a group of genetic conditions that cause abnormally high levels of LDL cholesterol, putting patients at high risk of heart attack at young ages even if they eat healthily and exercise. During the FDA approval process, an expert panel hotly debated indications for patients with atherosclerotic cardiovascular disease, but found consensus that FH patients needed these drugs right away.

Yet access has not been easy, according to both the FH Foundation and Sanofi officials. “The FH Foundation believes that [the] ODYSSEY results are exciting for the FH community because we now know that PCSK9 inhibitors can increasingly play an important role in reducing morbidity and mortality in those with heart disease and at highest risk,” said Katherine Wilemon, FH Foundation founder and CEO.