by Thomas Meek
LONDON, 7 Feb (APM) - NICE recognises that the "pressure is on" for its review of its methodologies, according to Meindert Boysen, director of the body's centre of health technology evaluation.
Speaking on Thursday at a Westminster Health Forum event in London, Boysen discussed the review, which was launched last summer in order for NICE, which provides healthcare guidance for the National Health Service (NHS) in England and Wales, to update and review its methods in light of new technologies and changes in the healthcare environment (APMHE 63800
Proposed changes will be announced this summer, followed by a six-week consultation period. Final changes will be announced at the end of the year and will be implemented in 2021.
Boysen, who is on the steering group of the review, acknowledged the process is now beyond the halfway stage and that pharmaceutical companies are anticipating its outcomes.
"We of course absolutely recognise that that the pressure is on," he said. The process involves more than just NICE, however, he said.
"What we want from a methods update is that this is a conversation between all the relevant stakeholders."
This is seen in the make-up of the review
. Although there is a steering group made up of mainly NICE representatives, there is a methods working group consisting of representatives from industry, charity, academia, NHS and government.
This group is working across 11 'task and finish' groups
covering key areas identified by NICE, including exploring uncertainty, types of evidence, health-related quality of life, discounting and equality considerations in guidance development.
All these groups will "work through a case for change", said Boysen. And this must be evidence-based and relate to the future work of the body.
NICE has also been careful not to start this update with a "preconceived idea" about what it wants to achieve, said Boysen.
"That probably isn't how we function. We function on the basis of evidence."
He gave the example of the working group on 'modifiers'. These are factors, such as whether a drug is for end-of-life treatment, that are used to help decide whether to recommend a technology with an incremental cost effectiveness ratio above £20,000 per QALY.
"We're going to look back at all of the technology appraisal for the past year, we try and extract what the committee has been doing from the data we have on file from the documentation we know has being created and from that we might learn something about their historical approach to some of the concerns around innovation, children, rarity, end the life."
This group will also look forward at what is coming down the pipeline, he said.
Helen Knight, programme director for technology appraisal and highly specialised technologies at NICE, has previously said that rarity could potentially be a modifier (APMHE 65785
Hilary Hutton-Squire, general manager for Gilead's UK and Ireland business, said earlier in the conference that she hoped NICE's review could address more advanced technologies coming down the pipeline.
"What we need to see come from that is something that allows us to look ahead to the medicines that we think will be problematic in our pipelines, to be very open and transparent about the problems that we see coming before they are upon us, before we get to the situation where a patient is sitting waiting for a treatment while we're having a debate about how we value it."
However, Andrew Briggs, a professor of health economics at London School of Hygiene & Tropical Medicine, suggested that NICE's current model could accommodate these types of product, referencing a pilot study for the CAR-T cancer products that have come to market in the past couple of years.
The main issue is how to address the extra uncertainty in these products, which tend to come to market with more limited data and command high prices.
Briggs said that England's Cancer Drugs Fund, a managed access programme for new cancer drugs that allows conditional approval while more data are collected, is an attempt to reduce uncertainty.
"It will be interesting to see whether there's an increased focus on those. I wouldn't see that as being so much of methodological development as a practical response to uncertainties. I think we have the methodological tools but the practical implementation of them sometimes is difficult because it involves a lot of cooperation between different stakeholders."