14 Apr The FDA approved Dupixent for moderate-to-severe atopic dermatitis
The FDA approved Dupixent
On March 28th, the FDA approved Dupixent for moderate-to-severe atopic dermatitis. One of the most highly-anticipated approvals of 2017, Dupixent is the latest output of the collaboration between Sanofi and Regeneron. While Dupixent is exciting for several reasons, its pricing strategy is arguably the most intriguing and sheds light on some potentially valuable lessons for the rest of the biopharmaceutical industry.
Before diving into how Sanofi and Regeneron approached Dupixent’s price, it is first important to understand the atopic dermatitis market landscape. Prior to Dupixent, atopic dermatitis was mostly treated with topical products. While these products have varying levels of efficacy, as well as some safety concerns, they are inexpensive, mostly costing less than $400 per month. As a result, payers may choose to restrict access to any new, expensive product, such as Dupixent, through prior authorizations requiring pictures of patients’ skin or step therapy through topical products. Even with robust access support, these burdensome restrictions would make it difficult for any new product to gain traction in the market.
Sanofi and Regeneron chose to price Dupixent at an annual list price of $37,000 per patient, cheaper than many other biologic medications used to treat skin disorders. To set Dupixent’s price, Sanofi and Regeneron pursued the type of forward-looking strategy consistent with the evolving world of biopharmaceutical market access.
First, Sanofi and Regeneron held pre-approval meetings with various payers to gather feedback and discuss pricing scenarios. This was made possible by the FDA’s recent guidance titled “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities.” Among other things, this document clarifies that manufacturers are permitted to discuss pricing information for investigational products with payers. In today’s environment of exclusion lists, prior authorizations and step therapies, honing pricing based on feedback from payers can make all the differences in securing favorable access.
The other valuable thing that Sanofi and Regeneron did was engage the Institute for Clinical and Economic Review (ICER) in its assessment of the value of Dupixent. For those not familiar with ICER, it is a non-profit organization that primarily evaluates evidence on the value of biopharmaceutical treatments. As value continues to be a top buzz word in healthcare, organizations like ICER may gain increasing amounts of influence over the assessment of medications and therapies. Ultimately, ICER’s analysis of Dupixent showed value of $97,600 per additional quality-adjusted life year (QALY), well below the commonly-cited threshold of $150,000 per QALY—a big win for the Sanofi and Regeneron team.
While only time will tell if Sanofi and Regeneron got Dupixent’s price right, the early signs are positive. Steve Miller, Chief Medical Officer and outspoken critic of bipharma pricing recently said of Dupixent’s pricing, “This is really a great example of how it should work. Our plans would obviously like a lower price. [Regeneron’s] shareholders would like a higher price. I think the fact we disappointed everyone probably means this came in where it should have.”
Regardless of Dupixent’s outcome, manufacturers planning to launch their own new products can learn from this situation. As the ability to demonstrate value continues to drive the market success, companies must engage payers early in the development process and use these discussions to craft pricing. A drug’s price should not surprise stakeholders at launch. Additionally, working with external organizations like ICER to ensure that a new product shows value will help manufacturers make the case for their products. Biopharma companies have known for years that value is more than simply a list price, and well-crafted value frameworks can help demonstrate this. The success of each new product may very well depend on it.