SANOFI: Sanofi and Regeneron offer Praluent® (alirocumab) at a new reduced U.S. list price

Sanofi issued the following announcement on Feb. 11.

Praluent® (alirocumab) will be made available at a new reduced U.S. list price of $5,850 annually, a 60% reduction from the original price, for both the 75 mg and 150 mg doses, beginning in early March.

The new lower-priced Praluent is expected to result in lower patient out-of-pocket costs and represents another step in the companies' efforts to help improve patient affordability and access. This follows an earlier announcement in March 2018, when Sanofi and Regeneron committed to lower the U.S. net price for payers in return for helping to reduce burdensome access barriers for appropriate patients.

"We were encouraged to see improvements in accessibility following our collaboration with payers last year to provide more straightforward, affordable access to Praluent, but only some patients had reduced out-of-pocket costs," said Michelle Carnahan, North America Head of Primary Care Business Unit at Sanofi. "With today's announcement, we are looking to help bridge that gap, and have now made Praluent available at a price that is approximately 60% lower. We hope that payers will do their part to help ensure savings are directly passed on to more patients, through lower out-of-pocket costs."

With the new lower-priced Praluent, most Medicare Part D patients are expected to pay between $25 to $150 per month, a potential savings of up to $345*, depending on their insurance plan. Eligible commercial patients will continue to have access to copay assistance through MyPraluent®.

*For illustrative purposes only, this calculation of monthly savings (e.g., 2 Praluent doses) assumes a scenario where Praluent is on a specialty tier with 33% co-insurance and Praluent then moves to preferred brand tier co-pay of $25. Individual savings will vary according to plan.

"In 2018, we lowered the Praluent net price for health plans that were willing to improve patient access and affordability. While lowering the net cost to payers did improve access, seniors who were prescribed Praluent were often still unable to afford it due to high co-pay costs or co-insurance at many Medicare Part D plans," said Leonard S. Schleifer, MD, Ph.D., President and Chief Executive Officer, Regeneron. "Offering a lower-priced Praluent will help lower seniors' out-of-pocket costs and thereby remove another barrier to receiving this important medicine."

The new, lower-priced Praluent is expected to be available for pharmacies to order in early March, and the doses with the original list price will remain on the market at least through 2019. The lower-priced Praluent will be identical to the Praluent currently available, other than the list price.

To learn more about these changes, U.S. physicians and patients can contact 1-800-633-1610 (press option 7, then option 5).

About Praluent
Praluent® (alirocumab) Injection 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 to clear LDL, which lowers LDL-C levels in the blood. Praluent was developed by Regeneron and Sanofi under a global collaboration agreement.

Praluent is approved in more than 60 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico, Braziland the European Union. 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 or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-C. 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/safety/medwatch/ or call 1-800-FDA-1088.

Please click here for the full Prescribing Information.

Original source can be found here.

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