Sanofi, Regeneron to Reduce Costs for PCSK9 Inhibitor for Value-Based Contracts

Sanofi and Regeneron Pharmaceuticals announced last week a plan to help ensure affordable and timely access to alirocumab (Praluent), a PCSK9 inhibitor, according to a press release.

The manufacturers plan to reduce the cost of alirocumab even further for payers who enter into a novel value assessment for high-risk patients.

Related Coverage: Challenges for Value-Based Contracting in Specialty Pharmacy

“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 S. Schleifer, MD, PhD, president, CEO, Regeneron. “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 precision medicine approach will focus on patients who are vulnerable to cardiovascular events, including those who have experienced a previous coronary event and are unable to reduce low-density lipoprotein (LDL) cholesterol levels despite maximum statin therapy and diet, according to the release.

To comply with procedures set by the US Institute for Clinical and Economic Review, the companies will provide early access to data from the ODYSSEY OUTCOMES clinical trial. The early access will support a value assessment for alirocumab to include new trial data, according to Sanofi.

Sanofi and Regeneron will meet with representatives from US health plans to discuss net pricing adjustments that are available for those that provide straightforward access to high-risk patients, according to the release.

The manufacturers also plan to work with cardiology providers to define practices that can reduce barriers to access and ensure that patients have their prescriptions in a timely manner, according to Sanofi.

“Too many patients in urgent need of additional treatment options on top of statins have faced tremendous hurdles to gain access to this important medicine. We are prepared to improve access and affordability, eliminating burdensome barriers for high-risk patients in need,” said Olivier Brandicourt, MD, CEO, Sanofi. “We will begin working with payers to ensure that high-risk patients have appropriate access. This is the right thing to do for patients.”

Alirocumab is indicated for use along with diet and maximally-tolerated statin therapy for patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease whose LDL-C levels are uncontrolled. Alirocumab is currently approved in more than 60 countries, including the United States, Japan, Canada, Switzerland, Mexican, Brazil, and the European Union.