Regeneron Pharmaceuticals, Inc. and Sanofi announced they will lower the net price of Praluent® (alirocumab) Injection in exchange for straightforward, more affordable patient access from Express Scripts. Praluent will become the exclusive PCSK9 inhibitor therapy on the Express Scripts national formulary. The agreement significantly simplifies the documentation necessary to secure insurance coverage and may help reduce out-of-pocket costs for eligible patients. Despite having the broadest U.S. formulary coverage of any PCSK9 inhibitor, many patients have been unable to access Praluent because of the complicated utilization management process required by some insurance companies and high patient out-of-pocket costs.
The agreement takes effect on July 1, 2018 for commercial patients covered by the Express Scripts National Preferred Formulary (approximately 25 million individuals in total). Physicians will submit a simplified attestation form confirming that Praluent is appropriate for the patient based on the U.S. FDA-approved indication and patient history.
This is a significant simplification compared to many current utilization management processes that involve multiple steps and lengthy documentation, including submitting laboratory results and detailed patient histories.
"This paradigm-shifting agreement is designed to break the gridlock so that Praluent is finally able to reach patients most in need," said Leonard S. Schleifer, MD, PhD, President and Chief Executive Officer of Regeneron. "U.S. cardiologists have experienced unprecedented challenges in securing access for Praluent for patients who were clearly appropriate, but were denied coverage.
This agreement sets a new standard in industry and payer collaboration that we hope will serve as a model for how to make innovative medicines more accessible and affordable." Also beginning on July 1, 2018, Express Scripts will pass a portion of the Praluent rebates it receives from Regeneron and Sanofi directly to people enrolled in participating commercial health benefit plans, including many of those offered by employers. Praluent patients enrolled in such participating plans should see lowered out-of-pocket costs at the pharmacy.
"This patient-centric approach addresses head-on the frustrations caused by complex pre-authorization requirements that can hamstring physicians and restrict access to an important medicine," said Michelle Carnahan, Sanofi Senior Vice President, Head of North America Diabetes and Cardiovascular Business. "In this new era of shared responsibility across healthcare players, this collaboration with Express Scripts is a frontrunner by making Praluent both accessible and affordable to patients who may most benefit from it."
"We are proud to work with Regeneron and Sanofi to further expand access and deliver greater value to patients who need Praluent," said Steve Miller, M.D., Senior Vice President and Chief Medical Officer, Express Scripts. "Our specialized care team at Accredo pairs patients with expert specialist pharmacists who have deep understanding of cardiovascular disease and familial hypercholesterolemia. Our holistic approach to care ensures patients get the full benefit of innovative medicines like Praluent."
