The National Institute for Health and Care Excellence (NICE) has launched a public consultation on proposals for changes to the methods it uses to develop its guidance on medicines, medical devices and diagnostics. The consultation is an opportunity to ensure NICE’s methods remain at the very forefront of innovations and to sustain NICE’s reputation as a world leader in health technology evaluation.
The consultation is a key step in the review of current NICE methods to ensure that these are able to continue to support rapid patient access to the most innovative technologies with strong clinical and economic benefit. This includes ensuring methods align with current advances in methodologies thus enabling NICE to implement faster processes to respond to future technologies.
NICE hopes that any changes that are introduced will not only support patients and the NHS in accessing new technologies, but also align with the changing UK regulatory landscape. This will add to the attractiveness of the UK as a first-launch country and facilitate equitable access to new technologies.
The public consultation is open until 11:59 pm on 18 December 2020 and MAP will be developing a response to the consultation to which members will be invited to contribute. If members have any immediate feedback or priorities, we welcome them to complete the survey in order to inform our response.
The consultation document is divided into the following themes and includes the proposed changes set out below:
The retention of the perspective that health benefits are of equal value
A proposal to replace the modifier for life-extending treatments at the end-of-life with a disease severity modifier
Uncertainty should remain an important consideration, and a degree of risk and uncertainty should be accepted in defined circumstances, such as for rare diseases and innovative technologies
NICE recognises the evidence suggests there is a case to change the reference-case discount rate to 1.5% per year for both costs and health effects but this will be considered separately as it creates policy and affordability challenges
Consistent use of modifiers across programmes.
The methods guidance on sourcing, assessing and presenting evidence should be refreshed to include a fuller description of the circumstances whereby ‘real-world’ evidence is valuable with emphasis on its importance and its optimal use
A hierarchy of preferred sources for prices for medicines that should be used when commercial agreements are in place
The methods for including the costs of acquiring medical technologies, devices and diagnostics should be clarified
Evaluations should include an overall assessment of uncertainty including whether uncertainties can be addressed by additional evidence
Recommendation for further research for measuring and valuing health-related quality of life in children, young people and carers.
The allowance of pairwise comparisons for economic analyses where relevant and justified
The inclusion of absolute and relative treatment effects in methods for considering subgroups
Optimised decision making where committees are able to recommend a technology for a particular sub-group
In exceptional circumstances, for technologies that are not cost-effective at £0, non-reference case analyses that omit or adjust high-cost care can be presented
When recommending technologies, committees can specify what should be considered (including cost) when choosing between similar options
Further work is needed to consider how equality issues associated with implementing technologies in practice may feed into evaluation.
NICE recognises the challenges for rare diseases, ATMPs, histology-independent cancer treatments and other emerging technologies and proposes to address these challenges including considering unpublished evidence, post-marketing surveillance data, cure-proportion modelling and exploring assumptions about long-term benefits.
This will continue into the second stage of the review, and NICE is looking to develop a decision-making framework and a methods manual to support this to enable a single, consistent approach for cost-comparison analyses that include a thorough discussion of similarity and uncertainty.
The consultation document applies across all four of NICE’s health technology appraisal programmes and therefore includes technology appraisals, highly specialised technologies, medical technologies and diagnostics. Formal changes beyond NICE methods beyond these programmes are outside the scope of the review.
NICE will be hosting an online event to discuss the consultation at 4pm on 25 November 2020. The event will be recorded and published on NICE’s website afterwards. Questions will need to be submitted in advance.
At MAP BioPharma, our goal is to accelerate patient access to the medicines, devices and diagnostics they need. Our team have extensive experience of working with clients to respond to consultations and developing wider policy and public affairs strategies. Find out more about our range of services here and get in touch today by emailing firstname.lastname@example.org.
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