UCB’s Bimekizumab Gets Fast-Track Funding For Severe Psoriasis In England
New HTA Route For “Low-Risk” Products Offers Rapid Patient Access
Executive Summary
It may not yet be approved for marketing, but UCB’s potential blockbuster psoriasis drug has already got the all-clear from NICE, the health technology body that appraises new products for use in England and Wales.
UCB S.A.’s plaque psoriasis therapy, bimekizumab, has become the first product to be cleared for use on the National Health Service in England by the health technology appraisal (HTA) body NICE via a new approach to the fast-track cost-comparison review process.
The fast-track appraisal (FTA) procedure was originally introduced in April 2017 for assessing products that offered “exceptional value for money,” for example where a cost comparison showed that they were likely to provide similar or greater benefits at similar or lower cost than products that had already been recommended by NICE for the same indication.
NICE is now piloting a new approach to the FTA for “selected low-risk appraisals,” whereby a subset of its appraisal committee compares a new product with similar therapies that have already been appraised by NICE and is able to make a recommendation without the need for a full committee meeting.
After an initial recommendation has been made (based on evidence in the company’s initial submission and a review of that submission by NICE’s Evidence Review Group), the recommendation is considered by the entire appraisal committee before it is released. If any concerns arise, a full meeting can be scheduled.
NICE said the new approach to the FTA had been spurred by the need to find new ways to develop and publish guidance that was hit by the decision to pause the work program in 2020 as a result of the coronavirus pandemic.
“We are taking this opportunity to introduce new measures to address the impact of the pandemic, including this pilot program for a limited fast-tracked process” – NICE
“The urgency of the pandemic led to necessary changes to the way NICE prioritized guidance production throughout 2020,” said Meindert Boysen, director of NICE’s Centre for Health and Technology Evaluation. “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 program for a limited fast-tracked process.”
First Product Through The Pilot
Bimekizumab, which is the first product to undergo this new approach, has been recommended for treating severe plaque psoriasis because it is more effective than the three comparator products and its cost-effectiveness estimates are in line with what is considered an acceptable use of NHS resources, NICE said. The draft guidance (in the form of a final appraisal document, or FAD) was issued on 2 August and is open to appeal until 16 August. The final guidance is expected in September.
“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,” commented Claire Brading, UCB’s managing director for the UK & Ireland. “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,” Brading added.
Victoria Barrett, head of HTA and market access policy at the Association of the British Pharmaceutical Industry, said the new approach by NICE was “good news, especially for the patients that stand to benefit.” It was important, she said, that NICE and its committees had the capacity to issue timely guidance to the NHS; this was “one way to help, given the success of the pilot exercise.”
An Unmet Need
UCB said that about one million people in the UK have psoriasis, of whom 90% have the plaque version. Of those, about 2.55%, or some 18,000 people, have severe disease. “Unfortunately, the unmet need remains in psoriasis with the visible symptoms impacting the day-to-day lives of those living with the condition, including employment, significant physical, psychological, social isolation and economic burden which may result in failure to achieve full life potential,” the company declared.
NICE’s decision meant that bimekizumab would be the first 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, UCB continued. IL-17A and IL-17F are key drivers of chronic tissue inflammation, so neutralizing both cytokines is believed to suppress inflammation in patients, it added.
Bimekizumab, which will be marketed as Bimzelx, is expected to be a “mega-blockbuster” product, despite the existence of strong competition in the form of AbbVie Inc.’s adalimumab (Humira), Johnson & Johnson’s ustekinumab (Stelara) and Novartis AG’s secukinumab (Cosentyx). (Also see "UCB And Analysts Believe Bimekizumab Will Be Super-Blockbuster" - Scrip, 30 Jul, 2021.)
“Once the MHRA approval is received, NICE will issue final technology appraisal guidance and bimekizumab will become available to patients in England and Wales” – UCB
The product does not yet have a marketing authorization. It received a positive opinion from the European Medicines Agency in June, and a decision on pan-EU approval is expected from the European Commission shortly. (Also see "EMA OKs BMS/bluebird bio’s CAR-T Abecma For Multiple Myeloma" - Pink Sheet, 25 Jun, 2021.)
In the UK, UCB said a decision on marketing authorization from the UK regulator, the MHRA, should come in the next few months. It told the Pink Sheet that it was seeking approval of the product via the post-Brexit “reliance” route, where the MHRA relies on the EU marketing authorization when issuing its own approval for Great Britain (the EU approval will be valid in Northern Ireland).
“Once the MHRA approval is received, NICE will issue final technology appraisal guidance (TAG) and bimekizumab will become available to patients in England and Wales,” the company said.
The product is also under assessment by the US Food and Drug Administration, with a PDUFA (Prescription Drug User Fee Act) date of 15 October, as well as by regulators in Australia, Canada and Japan.
The NICE Appraisal
NICE said that evidence from clinical trials had shown that bimekizumab was more effective than adalimumab, secukinumab and ustekinumab, and that indirect comparisons suggested it was “similarly or more effective than” other biological treatments.
It was directly compared in clinical trials with placebo (the BE READY study), placebo and ustekinumab (BE VIVID), adalimumab (BE SURE) and secukinumab (BE RADIANT).
“In these trials, bimekizumab showed higher response rates compared with placebo, ustekinumab, adalimumab and secukinumab for both PASI 90 (90% reduction in PASI score) and PASI 100 (100% reduction in PASI score) at week 16,” according to the FAD (PASI stands for Psoriasis Area and Severity Index).
“The committee concluded that the total costs associated with bimekizumab were similar to or lower than those associated with brodalumab, risankizumab and ixekizumab” – NICE
For the cost-comparison exercise, UCB presented a comparison with three NICE-recommended products: LEO Pharma A/S’s brodalumab, AbbVie’s risankizumab and Eli Lilly and Company’s ixekizumab. NICE said this was appropriate because these drugs were “relevant comparators” and “adequately represent the NICE-recommended biological treatments for plaque psoriasis overall.”
NICE said the total costs associated with bimekizumab were similar to or lower than those associated with brodalumab, risankizumab and ixekizumab. The guidance does not reveal the price of bimekizumab, but notes that a commercial arrangement will make it available to the NHS with a confidential discount.
“Considering the confidential patient access schemes for bimekizumab and the comparators, the committee concluded that the total costs associated with bimekizumab were similar to or lower than those associated with brodalumab, risankizumab and ixekizumab (the exact results cannot be reported here because the discounts are confidential).”
The appraisal committee therefore recommended bimekizumab as an option for severe plaque psoriasis in adults that has not responded to systemic non-biological treatments, or if these are contraindicated or not tolerated.
Because bimekizumab had been recommended through the fast track appraisal process, NHS England and commissioning groups have agreed to provide funding to implement the guidance 30 days after it is published, NICE noted.
In Wales, when a NICE technology appraisal recommends the use of a product, the NHS must usually provide funding and resources for it within two months of the first publication of the FAD.