NICE approves first treatment through fast-tracked appraisal pilot

Bimekizumab, which is used for the treatment of severe plaque psoriasis, is the first treatment to be approved by a National Institute for Health and Care Excellence sub-committee in a trial fast-track appraisal process.

The National Institute for Health and Care Excellence (NICE) has approved the first treatment as part of a fast-tracked appraisal process pilot, which was introduced to clear a backlog of work caused by the COVID-19 pandemic.

The pilot is trialling a new approach to the organisation’s cost-comparison fast-track appraisal process by using a subset of the appraisal committee to assess low-risk treatments, comparing them with similar therapies that have already been assessed by NICE.

This sub-committee can then make a recommendation without requiring a full committee meeting, after which the guidance is then considered by the entire committee ahead of its release, and a full meeting can be scheduled if any concerns arise.

Bimekizumab (UCB Pharma) is the first treatment to have been approved through this new process, with NICE publishing draft guidance on 2 August 2021 on its use in treating severe plaque psoriasis.

According to a statement, NICE said clinical trial evidence shows that bimekizumab is more effective at treating the condition than three comparator treatments, which were all previously approved by NICE.

Bimekizumab is also considered to be cost-effective, with nearly 18,000 people eligible for the treatment.

Meindert Boysen, director of the Centre for Health and Technology Evaluation at NICE, said the COVID-19 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.”

Claire Brading, managing director for UK and Ireland at UCB Pharma, 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.”

UCB said in a statement that it was anticipating a decision on marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the next few months, which would make it one of the first medicines to be considered through the MHRA’s new post-Brexit approval pathway.

Assuming the MHRA approval is received, NICE will issue final technology appraisal guidance and bimekizumab will become available to patients in England and Wales on the NHS.

Last updated
The Pharmaceutical Journal, PJ, August 2021, Vol 307, No 7952;307(7952)::DOI:10.1211/PJ.2021.1.98973

    Please leave a comment 

    You may also be interested in