Since its creation over 20 years ago, the National Institute for Health and Care Excellence (NICE), the Health Technology Assessment (HTA) body for England and Wales, has forged a solid reputation as one of the world’s foremost HTA authorities. Speaking at the recent FT Global Pharma and Biotech Summit, NICE Chief Executive Samantha Roberts shared insights into how NICE is adapting to the UK’s disrupted life sciences landscape.
Adapting to Change
The UK’s healthcare and life sciences ecosystem is facing a unique set of challenges. Apart from the ongoing fallout from the COVID-19 pandemic and Brexit, the National Health Service (NHS) has long been confronted with chronic staff shortages while the country’s ageing population must contend with a series of increasingly complex health needs. “This is one of the toughest times we’ll ever see in the health sector,” said Roberts.
To confront these issues, NICE is attempting to adapt to the times. “Rather than being immobilized, thinking about what’s it going to look like on the other side, we are building our organisation for what that other side will look like.”
Home Care, Non-Traditional Workforce, Changing Role of Hospitals
According to Roberts one of the trends NICE sees on that “other side” is a tendency towards home care with patients visiting hospitals less and less as they become primarily for patients with life-threatening diseases. “For us, what does that mean? It means we need to get into remote diagnostics and digital care,” she claimed. To illustrate her point, Roberts said that NICE looked at 20 digital technologies last year whereas the year before the body had only examined one.
Due to understaffing, Roberts also predicted the expansion of a non-traditional clinical workforce including physician’s assistants and pharmacists. “This means that the advice that we give needs to be really simple, usable, and easy to access,” she maintained. One of NICE’s planned measures with respect to this will be to improve its website. “We need strip it down, arrange things according to therapeutic areas …. and put it in language that anybody could understand.”
Another new challenge for Roberts is a patient population progressively faced with multiple long-term conditions, a reality that not only NICE will need to adapt to. “All of us are going to have to collectively figure out how to deal with the challenge of multi morbidity and it’s not going to be by doing more of the same in the same way.”
Roberts contended that the HTA has also adjusted to the expectations of the life sciences industry by reducing its timelines. “We’ve improved our timeliness year on year by 17 percent,” she confirmed.
Incorporating the Innovative Licensing and Access Pathway
The UK life sciences ecosystem saw another modification to its modus operandi when in 2021 the UK government launched a new Innovative Licensing and Access Pathway (ILAP). Aimed at accelerating time to market and facilitating patient access, part of the new pathway’s intention was also to involve NICE at an early in the development process and for companies to receive immediate feedback for a better chance at a positive assessment.
For Roberts, despite what she called the pathway’s initial “teething problems,” incorporating ILAP has led to shorter timelines. “Medicines do go through faster than non-ILAP medicines,” she said. NICE’s chief executive also claimed that ILAP has led to better collaboration, and not just with respect to medicines going through that pathway, something she believes should be further assimilated. “I think the big focus for us now is on how can we systematize that working together.”
Roberts alleged that NICE and the UK’s Medicines and Healthcare products Regulatory Agency do not necessarily share their information. “Our technical teams across the regulator and the HTA agency don’t speak to each other,” she said. NICE aims to change this. “What we are aiming for is a consent-based process whereby the regulator and the HTA teams can share these experiences so that we can expedite the process and not duplicate anything.”
Real-World Data
Real-world evidence has also increasingly become an important focus for NICE, Roberts asserted. “We published the real-world evidence framework last year and have tracked how real-world evidence came back last year and incorporated some new rules around it in the methods that NICE committees use.”
As a result of this, according to Roberts, real-world evidence was a major topic for NICE committee discussion in 40 percent of appraisals and in 23 percent of all appraisals it was used as a primary source of evidence. She commended life sciences companies for their ability to provide this kind of data. “I think that there’s quite a good agreement between us and life science companies that are going through appraisals, that this is quite a success.”
Setting a Benchmark for HTA
NICE has often been looked to as a global example and a benchmark for health technology assessment and Roberts believes that this will continue to be the case. “17 other countries actually reference a NICE decision in their guidance,” she said, explaining that the body’s international counterparts take into account the UK body’s methods and processes.
NICE’s severity modifier is an example in the chief executive’s view. “We pay more if a medicine addresses a very severe problem. And we’ve defined severity by the length and quality of life lost,” she stated. “So for people who do follow cost effectiveness, I think our methods are quite influential.”
