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Sanofi and Regeneron to ‘improve access and affordability of Praluent’




Sanofi and Regeneron Pharmaceuticals announced plans to improve patient access to Praluent (alirocumab) by offering a reduced net price to payers that commit to reducing access barriers for high-risk patients. The company will meet with US health plans to discuss price adjustments and will work with cardiology healthcare professionals to establish best practices and ways to ensure prescriptions are filled quickly and efficiently. 

The announcement came following the release of a Preliminary New Evidence Update for alirocumab from the Institute for Clinical and Economic Review (ICER). Sanofi and Regeneron reached an agreement with ICER, allowing it to evaluate the evidence and update cost-effectiveness analyses and value-based price benchmarks for the drug. 

Praluent is a PCSK9 inhibitor used to lower cholesterol levels in patients whose high cholesterol is not controlled with dietary changes and treatment with  HMG-CoA reductase inhibitors, also called statins. It works by inhibiting the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor, lowering the levels of LDL-C in the blood. The updated value-based price benchmark was based on the results of an ODYSSEY outcomes clinical trial, which established patients whose cholesterol levels remained high despite intensive treatment with statins benefited the most from treatment with alirocumab. The trial showed the drug lowers levels of bad cholesterol and could reduce mortality rates among patients with a recent history of acute coronary events.

Leonard S Schleifer MD, PhD, president and chief executive officer of Regeneron, and Olivier Brandicourt, MD, the chief executive officer of Sanofi, highlighted the need to change the way patients gain access to vital medication such as Praluent. “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,” commented Schleifer. He described the move towards greater collaboration with payers as “unprecedented”, asserting it demonstrates the possibility of enabling easier patient access to innovation at a price “that aligns with the value delivered”. 

His views echoed those of Sanofi’s CEO, who committed to working with payers to enable appropriate access to Praluent among high-risk patients. “ We are prepared to improve access and affordability, eliminating burdensome barriers for high-risk patients in need,” Brandicourt stated. He observed that too many American patients faced “tremendous hurdles” in gaining access to certain additional treatments used alongside or on top of statins. 

ICER president Steven D Pearson, MD, commended Sanofi and Regeneron for seeking an independent assessment to ensure negotiations to establish a fair price with payers are well-informed. “We believe that responsible pricing aligned with value will generate reciprocal action from payers to ensure appropriate access for patients today while sustaining broader affordability for patients and the health system in the long term,” he added.

Statins, for example, Lipitor (atorvastatin) or Zocor (simvastatin), are among the most commonly prescribed medications in the United States, and work by reducing the production of LDL cholesterol in the liver. Centers for Disease Control and Prevention figures show nearly 37 percent of adults in the United States have low-density lipoprotein cholesterol levels within the range experts recommend treatment with cholesterol medicine, such as statins. Despite this, only around half of these patients currently take medication to treat the condition.