The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD), recommending UCB’s bimekizumab as an option for the treatment of adults with severe plaque psoriasis.
This recommendation is the first to follow NICE’s new Expedited Low Risk Fast Track Appraisal (FTA) process, a pathway developed in response to the COVID-19 pandemic to minimise delaying access to new innovative medicines.
NICE noted from the company network meta-analysis that bimekizumab was more effective than three comparator treatments (brodalumab, risankizumab and ixekizumab) in PASI 90 and 100 response (a way to measure severity and extent of psoriasis).
The recommendation is also supported by results from four Phase III studies, which demonstrated the superior efficacy and safety of bimekizumab in adults with moderate to severe plaque psoriasis against placebo, ustekinumab, secukinumab and adalimumab.
“Designed and developed here in the UK, bimekizumab has shown significant sustained improvements in psoriasis severity in both head-to-head and placebo controlled clinical trials. We’re proud to have worked so collaboratively with NICE throughout this process to help speed up access to this important treatment,” said Claire Brading, managing director UK & Ireland, UCB.
UCB is expecting a decision on marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the next few months, which would make bimekizumab available to patients in England and Wales.
This decision means bimekizumab will be the first NICE recommended treatment to selectively inhibit two key cytokines, IL-17A and IL-17F, which aid cell-to-cell communication in immune responses and drive inflammatory processes for severe plaque psoriasis.
“The urgency of the pandemic led to necessary changes to the way NICE prioritised guidance production throughout 2020. As part of our 2021 review into the health technology evaluation process, we are taking this opportunity to introduce new measures to address the impact of the pandemic, including this pilot programme for a limited fast-tracked process," commented Meindert Boysen, director of the Centre for Health and Technology Evaluation at NICE.
“Although our review is still underway, we are pleased to have been able to pilot this new approach to committee decision making to recommend bimekizumab as a treatment option for severe plaque psoriasis," he added.