The aim of this project, commissioned by NICE through the NIHR HTA Programme as part of the NICE’s Single Technology Appraisal process, was to review the submission of the pharmaceutical company (Sanofi and Regeneron Pharmaceuticals, Inc) on the evidence for the clinical and cost-effectiveness of Dupilumab (Dupixent®) for treating adults with moderate to severe atopic dermatitis (AD).
The clinical evidence submitted by the company consisted mainly of four RCTs from the LIBERTY AD clinical trial programme; two trials compared Dupilumab with placebo (SOLO 1 [16 weeks] and SOLO 2 [16 weeks]) and two trials Dupilumab plus concomitant topical corticosteroids (TCS) with TCS plus placebo (CHRONOS [52 weeks] and CAFÉ [16 weeks]).
The Aberdeen HTA Group acted as the Evidence Review Group (ERG) for the project and provided an independent critique of the clinical and cost-effectiveness evidence submitted by the company. Based on the findings of the company submission and of the ERG’s critique, NICE prepared evidence-based recommendations for the use of Dupilumab as an option for treating moderate to severe atopic dermatitis. NICE clinical guidance was published on 01 August 2018.
For more information see: http://www.nice.org.uk/guidance/ta534/chapter/1-Recommendations
Contacts
- Miriam Brazzelli; m.brazzelli@abdn.ac.uk