NICE rejects Dupixent for atopic dermatitis on cost grounds, Sanofi responds
pharmafile | April 4, 2018 | News story | Research and Development, Sales and Marketing | Dupixent, NICE, Sanofi, atopic dermatitis, eczema, pharma
UK drug watchdog NCIE has issued draft guidance rejecting the routine use of Sanofi’s Dupixent (dupilumab) for the treatment of moderate-to-severe atopic dermatitis on the NHS in adults when systemic therapy is suitable, citing, as usual, cost-effectiveness concerns. A consultation period has been opened to dispute the decision, ending 24 April.
Just last month, the MHRA granted the drug an Early Access to Medicines (EAMS) positive Scientific Opinion for use in severe atopic dermatitis, and while it was also awarded Promising Innovative Medicine (PIM) status in December 2015. Sanofi highlighted that, despite cost concerns, the draft guidance noted Dupixent’s effectiveness in treating moderate-to-severe atopic dermatitis following failure (or contraindication) of topical therapies and systemic immunosuppressant agents.
Responding to the decision, Jessamy Baird, Director of Patient Access UK & Ireland at Sanofi, remarked: “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. 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.”
The most common form of eczema, atopic dermatitis affects around 1.5 million people in the UK. The condition is characterised by rashes which can cover a large proportion of the body which can present persistent itching and dryness, cracking, crusting or oozing of skin.
Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme, also added: “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. 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.”
Matt Fellows
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