New NICE Manual for Health Technology Evaluations: A Critical Discussion on the Most Relevant Changes (or Lack Thereof)

OHE opens a series of blog posts on the NICE new health technology evaluation manual.

OHE opens a series of blog posts on the NICE new health technology evaluation manual. The blogs will provide a critical discussion around the topics, including the expected implications of the changes (or lack thereof) in the manual; what is still missing; and what further research is needed.

The National Institute for Health and Care Excellence (NICE) produces evidence-based guidance and advice for health, public health, and social care practitioners. In England and Wales, new health technologies are appraised based on NICE guidance to determine whether they should be made available on the National Health Service. This means that the methods used by NICE to develop that guidance have significant impact on the level and time to patient access to new interventions. NICE guidance on methods for health technology assessment (HTA) is of paramount importance because of its impact on the approach used by other HTA bodies internationally. NICE published the first HTA methods guideline in 2003 and has periodically updated it.

NICE has recently published a new HTA manual for health technology evaluations. The new manual is the result of more than two years of extensive work. In the first stage, NICE identified the evidence that supports a case for change in the methods, followed by a first consultation to identify the most relevant ones. NICE then moved to the analysis of the selected cases for change and set a second consultation to obtain feedback on the proposals for change.

OHE has contributed to the ‘methods review’ journey by producing evidence that is highly relevant to the topics discussed for the review (a few examples are: identify evidence on resource allocation inefficiencies driven by differences in methods and processes between NICE’s HTA programmes; provide a rationale supporting the need of a new outcomes-based value attribution framework for combination regimens in oncology; and clarify the meanings of absolute and proportional shortfall with examples, in early stages of the review). OHE has responded to both consultations, and in a previous blog, we discussed the most notable changes put forward in NICE’s methods first consultation (November – December 2020) and reflected on their potential consequences.

OHE welcomes a number of the changes that address current challenges of treatment evaluation, including the replacement of the end-of-life modifier with a severity modifier; additional flexibility in considering the uncertainty of certain interventions; the inclusion of productivity costs as additional information for the committee whenever such costs may be a critical component of the value of the intervention; broader scope to consider real-world evidence; and the intent to establish a hierarchy of preferred outcome measures to assist those developing technologies.

However, there are several aspects that we believe were not fully or satisfactorily addressed during the review. They are: the reluctance to switch to 1.5% as the discount rate; the continuation in the use of the EQ-5D-3L with utility tariffs dating from 1995; the lack of clear guidance on whether and how to capture health-related quality of life benefits for carers within appraisals; the reluctance of NICE to contemplate the use of the societal perspective as a potential case-for-change; the lack of evidence to set the categories of severity that tag along different values of the severity modifier;  and the lack of clarity on addressing the concept of ‘health inequalities’.

Through this blog, OHE opens a series of blog posts that provide a critical discussion of those topics. The research agenda that will be set as part of the next phase following the publication of the new manual will be critical to delivering an evidence-based change to the current approach.