Express Scripts Holding Co. (NASDAQ:ESRX) is the first PBM to take Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) up on their offer of a reduced net price for Praluent alirocumab in exchange for lower utilization management criteria for the PCSK9 inhibitor. The PBM also awarded Praluent exclusive status on its National Preferred Formulary, with plans to pass the savings on to patients.
The new net price is undisclosed. However, Sanofi and Regeneron said that it fell within the $4,500-$8,000 per year cost-effectiveness threshold identified by the Institute for Clinical and Economic Review (ICER) in March.
Praluent's wholesale acquisition cost (WAC) is $14,600 annually.
ICER updated the analysis after Sanofi and Regeneron gave the institute an early look at cardiovascular outcomes data from the ODYSSEY OUTCOMES trial of Praluent. At the time, the partners said they would offer a lower net price in cases where payers were willing to reduce access barriers, such as laborious prior authorization requirements (see BioCentury Extra, March 10).
Since March, the partners have had "very productive and responsive discussions with Express Scripts," as well as other major and regional payers and PBMs, Regeneron's Michael Suesserman told BioCentury this week. He is VP of the company's cardiometabolic and opthalmology business unit.
Express Scripts CMO Steven Miller told BioCentury that the decision to give Praluent exclusive status “took the combination of a better price and better data.”
In ODYSSEY, Praluent lowered the relative risk of major cardiovascular adverse events (MACE) by 15% (HR=0.85, CI: 0.78, 0.93, p=0.0003) as well as a reduction in the risk of all-cause mortality (HR=0.85, CI: 0.73, 0.98, p=0.026). Miller noted that competing PCSK9 inhibitor Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) did not show a statistically significant effect on mortality.
The exclusive status, along with the new price and prior authorization requirements, will take effect on July 1. According to the companies, physicians will now be able to attest to the patient's eligibility for Praluent and will not be required to submit detailed laboratory results and treatment histories. Those processes were time-consuming and hindered uptake of the therapy, Suesserman said.
Additionally, while ICER's analysis for the cost-effectiveness threshold was in high-risk patients, Express Scripts will not restrict access to certain subgroups and instead will cover treatment for all patients included in Praluent's label.
Praluent is approved as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol.
Express Scripts' National Preferred Formulary represents 25 million covered lives.
The PBM also intends to pass one-third of the rebate it receives to patients and two-thirds to plan sponsors, Miller told BioCentury.
"We really believe that this announcement represents significant progress and will address the challenges patients are facing as well as demonstrate the commitment that Sanofi and Regeneron have to improving access and affordability," Sanofi's Sheldon Koenig told BioCentury. Koenig is the pharma's SVP and global head of its CV franchise.