Sanofi blockbuster-to-be skin drug Dupixent fails to win gatekeeper's backing

Sanofi's new atopic dermatitis launch Dupixent has hit a roadblock with the influential cost-effectiveness gatekeepers in England. The National Institute for Health and Care Excellence rejected the blockbuster hopeful, despite finding that it's an innovative drug for patients who have a strong need for new treatments.

The obstacle? It's likely price, if NICE history holds. The agency found that Dupixent is a "step change" in managing the disease, Sanofi said Tuesday, but couldn't sign off on its use because of cost-effectiveness concerns. The guidance isn't final, and the process now goes to a consultation period until April 24. 

Initial NICE denials often spur drugmakers to offer discounts or other "access schemes" to win NICE backing, which not only confers routine use in England and Wales, but also inspires coverage in other countries that rely on NICE's recommendations to make their own reimbursement decisions.

Jessamy Baird, Sanofi's patient access director in the U.K. and Ireland, said in a statement that Dupixent's initial rejection is "disappointing news," but that it's "only the first step in the NICE appraisal process and we are currently reviewing NICE’s recommendations and the details that led to this initial assessment." 

"We appreciate there will be complexities when assessing the cost-effectiveness of such a new treatment approach and will be submitting a formal response to the draft NICE guidance in the next few weeks," Baird added. 

RELATED: Sanofi, Regeneron ready to roll with $3B-plus Dupixent approval 

The drug boasts a "Promising Innovative Medicine" designation by the Medicines and Healthcare Products Regulatory Agency in the U.K. and a positive "Early Access to Medicines" opinion. Sanofi said the EAMS designation demonstrates that officials in the U.K. recognize that the drug is innovative for a patient group with high unmet need.

The NICE decision doesn't affect patients already on the drug through NHS England, the drugmaker said. 

Dupixent is a critical new launch for Sanofi as its diabetes business comes under growing pressure in the U.S. and as the drugmaker's Dengvaxia launch has faltered. Last year, the company reported that U.S. diabetes sales were down 22.8% after formulary exclusions by CVS Health and UnitedHealthcare.

RELATED: Want numbers on formulary pain? Sanofi's diabetes sales are Exhibit A 

Dupixent, on the other hand, is on an upward trajectory the drugmaker wants to continue. Sanofi and partner Regeneron launched the drug in the U.S. in March and in Germany in December. Dupixent hauled in €219 million for the year for Sanofi, on a path to expected blockbuster revenue. Analysts have said the drug could climb to $3 billion or more in annual sales. European markets represent a key component of that peak sales figure. Dupixent won European approval in September 2017.