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Manufacturer, pharmacy provider agree to alirocumab price drop, simplified access
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Sanofi and Regeneron announced that they have reached an agreement with pharmacy provider Express Scripts to offer the PCSK9 inhibitor alirocumab at a reduced price in exchange for “straightforward, more affordable access.”
Express Scripts’ formulary covers approximately 25 million individuals on commercial health plans, according to a press release from Sanofi and Regeneron.
The agreement, which will take effect July 1, also calls for alirocumab (Praluent) to be the exclusive PCSK9 inhibitor on the Express Scripts formulary, and simplifies the documentation required to guarantee insurance coverage of alirocumab, according to the release.
“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,” the companies stated in the release. “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 is the first agreement with a payer after Sanofi and Regeneron announced in March that they will offer alirocumab at a reduced net price to payers who agree to remove barriers to access for high-risk patients.
According to the prior announcement, results from ODYSSEY Outcomes, which found alirocumab was associated with reduced major adverse CV events in patients with ACS on maximally tolerated statin therapy, to the Institute for Clinical and Economic Review (ICER), so that ICER could conduct a new value assessment.
ICER announced it had determined new price benchmarks of alirocumab of $2,300 to $3,400 per year, net of rebates and discounts, if used to treat all patients who met the ODYSSEY Outcomes inclusion criteria of ACS within 1 year and LDL at least 70 mg/dL, and $4,500 to $8,000 per year, net of rebates and discounts, if used to treat high-risk patients with LDL at least 100 mg/dL.
The companies stated they would agree to prices based on the ICER benchmarks for “payers that agree to reduce burdensome access barriers for high-risk patients.”
The ODYSSEY Outcomes results, including the positive safety profile demonstrated, “translates into improved pharmacoeconomics,” Jay Edelberg, MD, PhD, vice president and head of cardiovascular development for Sanofi, told Cardiology Today. “It becomes much more cost-effective to target patients who have the highest need and get the highest benefit.”
Robert Pordy, MD, vice president of cardiovascular and metabolism therapeutics for Regeneron, said in an interview that “both companies really want value, and we want to get this drug to the patients who will benefit the most.”
A new indication will be pursued, according to Pordy. “These are very important results, and our goal is to get [an application for a CV outcomes indication] to the regulatory agencies in the U.S. and the rest of the world as soon as possible,” he said. “We’re aiming for the end of the second quarter.” – by Erik Swain
Disclosures: Edelberg is an employee of Sanofi. Pordy is an employee of Regeneron.
Perspective
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Seth J. Baum, MD, FASPC
If the arrangement between Sanofi/Regeneron and Express Scripts enables appropriate patients to receive alirocumab without enduring the extraordinary obstacles currently in place, that will be wonderful. If patients also pay less, better still. The attestation requirement may be viewed by some as an over-reach; a doctor’s signature on a prescription pad should be trusted. Also, the exclusivity bothers me. I’d always rather see clinicians and patients have the choice of any and all medications. On balance though, this will hopefully help patients and also save physicians’ offices countless hours of wasted time that will be better spent on patient care.
The system has yet to be implemented. If, however, it goes as proposed, patients such as those with familial hypercholesterolemia will be able to more widely and rapidly obtain alirocumab. This will dramatically lower patients’ LDL levels and hopefully avert MIs, strokes and even death.
If this goes well, I’d imagine many similar arrangements will follow. It would be nice to know the underpinnings of these deals, but I am not sure we will ever get that opportunity.
For nearly 3 years, payers have successfully blocked appropriate utilization of the PCSK9 inhibitors alirocumab and evolocumab (Repatha, Amgen). In my view, these two drugs are the greatest advance in lipid-lowering therapy in 30 years. With this in mind, imagine the angst of not being able to use them when necessary. I am hopeful that the established barriers will now completely crumble so that clinicians can do what we do best, treat our patients. Medication decisions must return to the doctor’s office where patients and their clinicians can make shared decisions about patient care. Payers are unquestionably vital, but they need to get out of our exam rooms.
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