Adults with moderate to severe atopic dermatitis are a step closer to being able to routinely access treatment with Sanofi’s Dupixent on the NHS, following a green light from cost regulators.
The National Institute for Health and Care Excellence has published final draft guidance backing the drug’s use when the disease has not responded to at least one other systemic therapy, such as ciclosporin, methotrexate, azathioprine and mycophenolate mofetil, or these are contraindicated or not tolerated.
Also, Sanofi must continue to provide Dupixent (dupilumab) as per the patient access scheme agreed with NHS England, and treatment should be stopped at 16 weeks if there has been no response.
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 made available to NHS patients with atopic dermatitis through the UK’s Early Access to Medicines Scheme in March last year before winning European regulatory approval in September, 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.
Atopic dermatitis (also known as atopic eczema) is a chronic, recurrently flaring, inflammatory skin condition estimated to affect around 2.5 percent of the adult population in the UK.
The condition “not only impacts the skin, but can have a detrimental effect on a patient’s mental wellbeing and quality of life,” said Professor Graham Ogg, Professor of Dermatology, University of Oxford and consultant dermatologist, Oxford University Hospitals NHS Trust.
“NICE’s recommendation for dupilumab represents a much needed step change in the management of moderate to severe atopic dermatitis and offers an important new treatment for those living with the disease.”
The decision also marks a turnaround from the Institute’s initial position that cost-effectiveness estimates for the drug were uncertain, and higher than that normally considered an acceptable use of NHS resources.