UCB's bimekizumab 'pre-approved' using NICE fast-track scheme

UCB's bimekizumab hasn't been approved for marketing in Europe yet, but has already been given the nod for NHS use in England and Wales under a new fast-track scheme introduced by NICE.

The IL-17 inhibitor is the first to go through a new process aimed at accelerating appraisals for drugs deemed to be low-risk, which is being piloted by NICE to help clear a work programme that has been held up by the COVID-19 pandemic.

The Final Appraisal Determination (FAD) recommends bimekizumab as a treatment option for adults with severe plaque psoriasis that hasn't responded to current systemic treatments, or for patients who can't tolerate them.

NICE said that the new fast-track appraisal is intended to minimise delaying access to new innovative medicines. It works by using a subset of the appraisal committee to assess low-risk treatments, which is then able to make an initial recommendation without a full panel meeting.

The guidance is considered by the entire committee ahead of its release, and a full meeting can be scheduled if any concerns arise, according to NICE. Nearly 18,000 people will be eligible for the treatment if approved, said the healthcare technology assessment agency.

UCB is bringing up the rear of the IL-17 inhibitor category with bimekizumab - proposed trade name Bimzelx - as the drug will be a latecomer if approved, coming behind drugs like Novartis' Cosentyx (secukinumab), Eli Lilly's Taltz (ixekizumab) and Bausch Health's Siliq/Kyntheum (brodalumab).

NICE notes however that clinical evidence has shown bimekizumab to be more effective at treating the condition than three comparators – Cosentyx, AbbVie's TNF inhibitor Humira (adalimumab) and Johnson & Johnson's IL-12/IL-23 inhibitor Stelara (ustekinumab) – which have all been previously approved by NICE for use by the NHS in psoriasis patients.

It also says that the costs associated with bimekizumab are "similar to or lower" to those associated with Kyntheum, Taltz, and AbbVie's IL-23 inhibitor Skyrizi (risankizumab).

"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," said Meindert Boysen, director of the Centre for Health and Technology Evaluation at NICE.

"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," he added.

UCB is expecting a decision on marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the next few months, and bimekizumab is also under review in the EU and US.

Analysts at Jefferies have previously said that the antibody could achieve peak sales of more than $2 billion a year if it's approved for psoriasis and follow-up indications psoriatic arthritis and ankylosing spondylitis, even though the categories are getting increasingly crowded.

That would help ease the pain of the forthcoming patent expiries for the Belgian drugmaker's current top-selling product Cimzia (certolizumab pegol), due in Europe in 2021 and in the US in 2024.