From today, 1st February 2022, the National Institute for Health and Care Excellence (NICE) will introduce changes that aim to simplify and speed up Health Technology Assessments (HTA) allowing greater flexibility so that it can keep pace with the continually evolving and ground-breaking advances in medicine. The reforms have been welcomed by the industry as they should support faster access to medicines as well as improve the ability to benefit from state-of-the-art therapies for patients with rare diseases.
In 2019 NICE embarked upon the project of conducting a reform of its methods, processes, and topic selection. For this purpose, NICE have conducted considerable analysis of existing protocols, engaged with 170 stakeholder groups, and comprehensively rethought all aspects of NICE’s health technology evaluations. This has resulted in the NICE board approving the updated guidance development manuals that were published on 31st January 2022 which will be implemented on any new evaluations from today.
The following changes will come into effect:
- Introduction of the severity modifier – Going forward NICE will cease using the end-of-life modifier and will instead begin to use the severity modifier. This will allow greater weight to be given to the QALYs gained by a new medicine if it treats a severe disease. Treatments for conditions deemed severe will be given a maximum weighting on 1.7 and a minimum of 1.2 to give appropriate value to the benefit that a treatment would provide. This will result in the maximum threshold for cost per QALY being raised from £30,000 to between £36,000 between £50,000 for a treatment for a severe disease.
- Greater flexibility – NICE is giving greater flexibility to independent committees at times when the collection of evidence is challenging. Whilst NICE will still demand the strongest evidence base as possible, to prevent access barriers to valuable treatments, committees will have greater jurisdiction over whether to accept uncertainties on a case-by-case basis. For example, where diseases are rare and there is a struggle to obtain mature data experts opinion may be more heavily considered.
- Adopting different approaches to evidence – NICE will expand on and improve how it considers real-world evidence from the lived experiences of patients. On top of this, clearer descriptions will be provided on how to measure health-related quality of life when using the preferred method of EQ-5D is not suitable.
- Adjustments for Highly Specialised Technologies (HST) programme – NICE has adopted clearer principles and routing criteria for rare diseases which it will evaluate under the HST programme. This will improve the predictability and clarity over which products will be suitable for this type of assessment. You can read our previous articles on the HST process here.
- Clarity on managed access – NICE will provide greater clarity around the circumstances when a managed access recommendation can be given. It will also ensure earlier engagement between NHS England or NHS Improvement and companies over managed access proposals to enable patients to have access to treatments while further data is collected.
Areas discussed that will remain unchanged:
- Discount rates – NICE state that they will collect evidence of the effects of discounting on future health technology evaluations for later discussions, however, no change will be made to the discount rate of 3.5% at this time.
- Health inequalities – No changes will come into effect currently on how NICE considers health inequalities when conducting HTAs. However, this is something that may be worked on in the future.
Future NICE updates will be modular
Going forward, NICE have committed to a modular approach to future updates to its methods and processes. They have already identified some potential topics to be explored in the modular updates including methods for digital, genomic, and antimicrobial technologies, and processes to enable rapid entry to managed access agreements. The updates will also address other issues with the methods such as health inequalities and the societal value of health benefits in severe diseases. This modular approach will enable NICE to remain agile and responsive to developments in the healthcare landscape ensuring that they stay ahead of the game when it comes to approving cutting edge treatments.
What do the changes mean?
On top of providing greater predictability to the industry and supporting rapid decision making for NICE’s independent committees, the changes published on 31st January in the updated guidance manuals would also give patients earlier access to innovative new treatments. Further to this, the changes will provide a robust foundation to NICE’s evaluations into the future permitting NICE to remain leaders in producing rapid HTAs.
- www.nice.org.uk, “Public board meeting agenda and papers: January 2022”, 19th January 2022
- www.nice.org.uk, “NICE signals commitment to greater flexibility in its evaluation of promising-new health technologies and making patient access fairer”, 20th January 2022