6:36 AM
Mar 10, 2018
 |  BC Extra  |  Clinical News

Sanofi, Regeneron offer lower Praluent price on heels of ODYSSEY data

Editor's Note: This article was updated on Mar 12, 2018 at 12:14 PM PDT

Armed with cardiovascular outcomes data for Praluent alirocumab and a fresh cost-effectiveness analysis from the Institute for Clinical and Economic Review (ICER), Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) have a proposition for payers: reduce barriers to access in high-risk patients and the partners will offer up to a 69% discount to the PCSK9 inhibitor’s list price.

“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,” said Regeneron President and CEO Leonard Schleifer in a statement issued March 10 following the results of ODYSSEY OUTCOMES study.

Data from the 18,924-patient trial showed Praluent given on top of statins lowered the risk of major adverse cardiovascular events (MACE) by 15% (HR=0.85, CI: 0.78, 0.93, p=0.0003). The MACE composite endpoint includes patients who experienced a heart attack, stroke, death from coronary heart disease (CHD) or unstable angina requiring hospitalization. The data were presented at the American College of Cardiology (ACC) meeting.

Praluent was also associated with a lower risk of all-cause mortality (HR=0.85, CI: 0.73, 0.98, p=0.026). In a pre-specified analysis, the patients with baseline LDL-C levels at or above 100 mg/dL had a 24% reduction in the risk of MACE (HR=0.76, CI: 0.65, 0.87) and a 29% reduction in the risk of all-cause mortality (HR=0.71, CI: 0.56, 0.90). According to Sanofi, about one-third of patients in the trial met this criterion.

Patients in ODYSSEY were on a maximally tolerated dose of statins and had either LDL-C ≥70 mg/dL; non-high-density lipoprotein cholesterol ≥100 mg/dL; or apolipoprotein B ≥80 mg/dL. They also had experienced a heart attack or unstable angina requiring hospitalization within a year prior to enrollment.

Praluent's effect on MACE is similar to the benefit seen last year for competing PCSK9 inhibitor Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN). In the Phase III FOURIER trial, Repatha resulted in a 15% reduction in the relative risk of MACE, including hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death (HR=0.85, CI:0.79, 0.92, p<0.001). Repatha also showed a 20% relative risk reduction on a secondary composite endpoint that consisted only of heart attack, stroke and cardiovascular death (HR=0.80, CI:0.73, 0.88, p<0.001) (see BioCentury, March 24, 2017).

However, Repatha failed to reduce the risk of all-cause death (HR=1.04, CI:0.91, 1.19, p=0.54). Both outcomes trials enrolled patients with similar LDL and non-HDL characteristics as well as patients with a history of cardiovascular events, including heart attack, stroke or peripheral artery disease. FOURIER did not limit the history of CV events to one year. The median time from most recent MI or stroke for patients in FOURIER was three years.

An updated ICER analysis of Praluent's cost-effectiveness, also presented on March 10 at ACC, showed that the drug would be cost-effective at an annual price of $2,300-$3,400 per year if used to treat all patients who meet trial eligibility criteria, and $4,500-$8,000 per year if used to treat higher-risk patients with LDL cholesterol ≥100 mg/dL despite intensive statin therapy. The companies worked with ICER to provide it with the ODYSSEY data ahead of the presentation at ACC.

In a similar analysis of Repatha performed last year based on FOURIER's results, the group found that the cost-effectiveness range was $1,700-$2,200. ICER said Praluent's range was higher because it showed an effect on all-cause mortality and a trend towards improved clinical benefit in patients with higher LDL levels.

Praluent's wholesale acquisition cost (WAC) is $14,600 annually. Payers have restricted access to the therapy because of the high price.

However, Sanofi and Regeneron said Saturday that if payers lift those restrictions, they will offer via rebates a lower net price that is within ICER's latest cost-effectiveness range.

Whether the rebate would translate into lower co-pays would depend on whether the insurance plan moves Praluent to a more favorable tier, Sanofi said in a statement to BioCentury.

Sanofi and Regeneron said they will meet with U.S. payers to discuss the proposal.

Express Scripts Holding Co. (NASDAQ:ESRX) said it would review the ODYSSEY data and its coverage for the therapy.

“We will re-examine our coverage criteria to see if they are still relevant. Overall, we are encouraged to hear Regeneron and Sanofi are willing to reduce the price of this medication to make it more accessible for patients,” said spokesperson Jennifer Luddy in an emailed statement to BioCentury.

Regional payer Harvard Pilgrim Health Care Inc. (Boston, Mass.) said it would review the ODYSSEY data and might consider revising its policy to deliver a lower net cost, "if we thought the decision made sense from a clinical as well as economic lens," CMO Michael Sherman told BioCentury. However, the payer wouldn't remove all prior authorization requirements. "They would still need to check with us to ensure that their patients meet the hypothetically expanded policy," Sherman said.

Amgen is already offering discounts to payers. “Over the last several weeks, we have been in negotiations with insurers and have offered dramatic reductions in price for those who significantly improve access,” the company said in an email to BioCentury. Amgen would not disclose the size of the price reductions offered to payers.

The biotech has been trying to entice payers to reduce restrictions via outcomes-based arrangements that tie rebates for Repatha to CV events. If patients experience a heart attack or stroke after six months on Repatha, Amgen would pay an undisclosed rebate. Three payers, including Harvard Pilgrim, have agreed to the arrangement (see BioCentury Extra, May 2, 2017).

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

Purchase this article for limited one-time distribution and website posting

$750 USD