- In the wake of their skin medication's approval, Sanofi and Regeneron signaled confidence that pre-market work with payers and physicians would lead to strong pickup of the drug.
- The Food and Drug Administration gave an OK to Dupixent (dupilumab) on Tuesday as a treatment for moderate-to-severe atopic dermatitis. Following that decision, Sanofi and Regeneron revealed they were setting the annual wholesale acquisition cost (WAC) for their drug at $37,000.
- "We sought the input and feedback of payers in advance of the Dupixent launch in order to ensure timely access and secure streamlined and reasonable utilization management criteria," Regeneron CEO Leonard Schleifer said during a March 28 investor call. "Additionally, we worked proactively with organizations such as ICER to convey our thoughts and share our analyses on cost effectiveness."
Higher ups from both companies said they weighed many factors, such as Dupixent's status as the first FDA-approved biologic targeting eczema in adults who weren't responding to topical treatments, when coming up with the medication's list price.
Furthermore, Sanofi and Regeneron noted the net price for Dupixent would be closer to the low $30,000s due to discounts, rebates and patient assistance programs.
While that price tag is much lower than other anti-inflammatories used to treat skin conditions, it isn't likely to win over critics who have lambasted the pharmaceutical industry for the high cost of their prescription medications. Mylan, Marathon and Eli Lilly are just a few of the names who have made the hitlist of lawmakers and consumer advocacy groups.
Another hurdle for Dupixent is the market it's entering.
"Atopic dermatitis is not an organized market yet," Bill Sibold, global franchise head of multiple sclerosis, oncology and immunology at Sanofi Genzyme, said on the investor call, adding that therapeutic areas like psoriasis have had more than a decade to streamline how patients receive treatment.
What will help Dupixent's adoption by doctors, payers and pharmacy benefit managers (PBMs) is that it doesn't need to be prescribed with topical corticosteroids.
"Generally speaking, we're not expecting prior authorization of the nature where you have to send in a documented lab value like you might for cholesterol or a picture and somebody would have to count how much of their body is affected by this," Schleifer said.
"All we're expecting is a physician to attest that the patient has moderate-to-severe atopic dermatitis and that ... they have not been adequately controlled with a topical," he added.
The companies also said they considered the potential for Dupixent to lock down additional indications when crafting its list price, but that the WAC wouldn't change with future approvals — rather, the amount of discounts offered would. The drug is currently in mid- and late-stage trials for a few other illnesses, including asthma, eosinophilic esophagitis and nasal polyposis.