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NICE rejects Sanofi’s Dupixent for atopic dermatitis at first call

Dupixent is still too expensive despite discount, says the UK’s cost effectiveness body


A proposal by Sanofi to discount the cost to the NHS of its Dupixent drug for atopic dermatitis has not been enough to sway NICE, which has said it cannot back routine use of the drug in draft guidance.

Despite the confidential discount on Dupixent’s list price of £1,264.89 per pack of two syringes of the IL-4 and IL-13 inhibitor - developed with Regeneron - the cost effectiveness watchdog has concluded that it is still too expensive in its approved indication. It’s accepting comments on its initial decision until 24 April.

Dupixent (dupilumab) was approved by the EMA last September for the treatment of moderate-to severe atopic dermatitis (also known as eczema) - a chronic skin condition characterised by skin blistering, cracking and often debilitating itching - and is the first targeted biologic drug for this purpose. NICE said clinical experts (and the company) advise it should be used mainly as a fifth-line drug after existing systemic therapies, including steroids and powerful immunosuppressants such as ciclosporin.

The agency said that while the clinical evidence shows that dupilumab is effective when used in this way, its cost-effectiveness estimates “compared with best supportive care are too high to consider it a good use of NHS resources”.

NICE’s initial verdict comes shortly after the Medicines and Healthcare Products Regulatory Agency (MHRA) made the therapy available to UK patients with atopic dermatitis via its Early Access to Medicines Scheme (EAMS).

“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,” commented Jessamy Baird, director of patient access UK & Ireland at Sanofi.

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

Dupixent is one of the most important drugs in Sanofi’s portfolio of new products, making €219m ($269m) in sales last year, and has been predicted to make up to $5bn a year at peak if it can also secure approvals in additional indications.

Sanofi took a step forward towards that objective this week after the EMA started its review of Dupixent as an add-on maintenance treatment in certain adults and adolescents with inadequately controlled moderate-to-severe asthma.

Article by
Phil Taylor

4th April 2018

From: Regulatory



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