Regeneron and Sanofi Announce Plans to Make Praluent® (alirocumab) More Accessible and Affordable for Patients with the Greatest Health Risk and Unmet Need
Published: Mar 10, 2018
PARIS and TARRYTOWN, N.Y., March 10, 2018 /PRNewswire/ -- To help ensure more affordable and timely access to patients most in need, Sanofi (EURONEXT: SAN) (NYSE: SNY) 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. 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."
"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.
Praluent inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which lowers LDL-C levels in the blood. The use of Praluent to reduce the risk of major adverse CV events is investigational and has not been evaluated by any regulatory agency.
Praluent is approved in more than 60 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico and Brazil, as well as the European Union (EU).
In the U.S., Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C.
In the EU, Praluent is approved for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-C goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
The effect of Praluent on cardiovascular morbidity and mortality has not been determined.
Important Safety Information for the U.S.
Do not use Praluent if you are allergic to alirocumab or to any of the ingredients in Praluent.
Before you start using Praluent, tell your healthcare provider about all your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.
Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.
Praluent can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.
The most common side effects of Praluent include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Talk to your doctor about the right way to prepare and give yourself a Praluent injection and follow the "Instructions for Use" that comes with Praluent.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing Information.