To help ensure more affordable and timely access to patients most in need, Sanofi and Regeneron Pharmaceuticals will offer U.S. payers that agree to reduce burdensome access barriers for high-risk patients a further reduced net price for Praluent (alirocumab) Injection in alignment with a new value assessment for high-risk patients from the U.S. Institute for Clinical and Economic Review (ICER).
The companies will take a precision medicine approach, to address the burden of cardiovascular disease, focusing efforts on high-risk patients most vulnerable for future cardiovascular (CV) events, such as those who have suffered a previous coronary event and are unable to reduce their LDL cholesterol (LDL-C) below 100 mg/dL despite maximally-tolerated statin therapy.
In keeping with ICER’s established “in confidence” procedures, Sanofi and Regeneron provided early access to data from the Odyssey Outcomes trial to ICER, an independent organization that evaluates the value of prescription drugs and other health care innovations, to enable a revised assessment of alirocumab value incorporating the Odyssey Outcomes results.
“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 and chief executive officer of 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.”
“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, chief executive officer of 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.”
Sanofi and Regeneron will be meeting with U.S. health plans to discuss potential net pricing adjustments for those that agree to provide straightforward access for high-risk patients. The companies 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.
Filed Under: Drug Discovery