NICE approves UCB’s bimekizumab through expedited review process

pharmafile | August 3, 2021 | News story | Manufacturing and Production  

NICE has published draft guidance on the first treatment to use its new review process, recommending UCB’s bimekizumab for treating severe plaque psoriasis.

The process is NICE’s new Expedited Low Risk Fast Track Appraisal, a pathway developed in response to the pandemic to minimise delaying access to new innovative medicines.

The pilot programme works by using a subset of the appraisal committee to assess low-risk treatments, comparing them to similar therapies that have already been appraised by NICE. This sub-committee is then able to make a recommendation without requiring a full committee meeting.

After an initial recommendation has been made, the guidance is then considered by the entire committee ahead of its release, and a full meeting can be scheduled if any concerns arise. The pilot process does not impact the standard governance or appeal processes.

Claire Brading, Managing Director UK & Ireland, UCB said: “This fast-tracked NICE decision marks a significant moment for innovative medicines in the UK and reinforces our commitment to advancing science in immuno-dermatology. 

“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.”

Meindert Boysen, Director of the Centre for Health and Technology Evaluation at NICE, said: “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.

“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.

“It is our hope that we will continue to be able to follow this new process for eligible low-risk appraisals, and release capacity within our committees and the technology evaluation team.”

Lilly Subbotin

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