The National Institute for Health and Care Excellence has issued draft guidance rejecting Sanofi/Regeneron’s Dupixent (dupilumab) for the treatment of moderate-to-severe atopic dermatitis.

The draft guidelines highlight that Dupixent (dupilumab) is effective at treating moderate-to-severe atopic dermatitis (AD) following failure (or contraindication) of topical therapies and systemic immunosuppressant agents.

However, the Institute said cost-effectiveness estimates for the drug were uncertain, and higher than that normally considered an acceptable use of NHS resources.

“Whilst this is disappointing news, it is 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,” said Jessamy Baird, director of Patient Access UK & Ireland at Sanofi.

“Dupilumab is an innovative medicine that represents a step change in the management of atopic dermatitis, which the Appraisal Committee itself acknowledged. 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.”

Around 1.5 million (3 percent) adults in the UK have AD, a condition for which there is high unmet medical need.

Dupixent is a human monoclonal antibody designed to specifically inhibit overactive signaling of two key proteins - IL-4 and IL-13 -believed to be major drivers of the persistent underlying inflammation in AD, and certain other allergic or atopic diseases.

The drug was approved for AD in September last year, on the back of data from the Phase III LIBERTY AD CHRONOS trial, which showed that adding the drug to topical corticosteroids (TCS) significantly improved measures of overall disease severity compared to placebo/TCS.

After 16 weeks (the primary endpoint), 39 percent of patients who received dupilumab 300mg with TCS either weekly or every two weeks achieved clearing or near-clearing of skin lesions, compared to 12 percent of patients receiving placebo/TCS.

“We are fully committed to achieving a positive final outcome to ensure that dupilumab can be made available on the NHS for appropriate atopic dermatitis patients in England,” said Peter Kuiper, general manager UK & Ireland at Sanofi Genzyme, commenting on the decision.

“We encourage the atopic dermatitis and eczema community to review and comment on the guidance so that the real-life impact of atopic dermatitis and treatment with dupilumab can be fully understood and assessed.”