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NEWS
The National Institute for Health and Care Excellence (NICE) has developed the CHEERS-AI standards to enhance health economic evaluations for AI-based healthcare interventions, in collaboration with the EU-funded HTx project. A systematic review conducted by NICE identified significant gaps in reporting quality, such as lack of data transparency, potential biases, and unclear AI functionalities. CHEERS-AI will enhance transparency and quality in how cost-effectiveness studies of AI-enabled healthcare interventions are reported, which will help healthcare decision-makers understand the value of AI-enabled treatments and ensure patients gain faster access to favourable treatments. CHEERS-AI is also an extension of the CHEERS-2022 checklist and incorporates 28 original items and has now added eight tailored for AI contexts, and ten new AI-specific standards such as user autonomy.
NEWS
The National Institute for Health and Care Excellence (NICE) has announced the expansion of its HealthTech evaluation programme to include medical devices, diagnostics and digital tools, applying the same standards currently used to assess new medicines. The initiative is intended to place health technologies on equal footing with medicines, helping innovations such as wearable diabetes monitors and AI diagnostics reach patients quicker and consistently across the NHS.
NEWS
The National Institute for Health and Care Excellence's (NICE) Board has concluded that the new severity modifier, introduced in 2022 to enhance the evaluation of medicines for severe diseases, is functioning as intended during its September 2024 public board meeting. The Board was presented with a review which showed that following the modifier's application, positive recommendations rose to 84.4%, surpassing the previous end-of-life modifier's rate. The modifier has facilitated the recommendation of treatments for various severe conditions, including non-end-of-life cancers and cystic fibrosis. The NICE will continue to monitor its impact while researching societal preferences for valuing these medicines.
NEWS
The National Institute for Health and Care Excellence (NICE) has implemented revised cost-effectiveness thresholds for medicines and other technologies, following a government decision to raise the range used in technology appraisals to £25,000 to £35,000 per quality-adjusted life year (QALY) gained, and has updated its manual so that independent appraisal committees apply the change immediately to new and ongoing evaluations. NICE states that QALYs are used to measure both length and quality of life in order to compare new treatments with existing NHS care, and that the higher thresholds are intended to improve patient access to effective treatments while reflecting government choices on NHS spending and supporting the life sciences sector. NICE estimates that the change could allow an additional three to five medicines or new indications to be approved each year, on top of its current recommendation rate of around 91 per cent of medicines evaluated. Under the updated framework, committees continue to assess clinical effectiveness and value for money using evidence from studies, expert input and patient experience, while also considering uncertainty, disease severity, health inequalities, wider NHS effects and opportunity costs. Recommendations may range from routine use to restricted use, managed access, evidence generation or research-only use, but technologies will not be recommended where the evidence does not show sufficient benefit or value for NHS resources; NICE also states that decisions must be transparent and clearly justified by reference to the evidence, consultation responses and relevant legal and policy duties.
NEWS
The National Institute for Health and Care Excellence (NICE) has established the Medicines and Medical Devices Access Initiative (MMDAI), a new UK-wide cross-government collaboration arising from the 2024 voluntary scheme for branded medicines pricing, access and growth. The initiative, which is distinct from the Innovative Licensing and Access Pathway, aims to improve co-ordination of Health Technology Assessment activities across organisational boundaries. Operating through a steering committee with dedicated working groups for medicines and medical devices, the MMDAI brings together regulatory bodies, Health Technology Assessment agencies, and industry trade bodies from all four UK nations. The initiative focuses on developing aligned frameworks for innovative health technologies while facilitating intelligence sharing to ensure consistent and timely patient access across the UK.
NEWS
The National Institute for Health and Care Excellence (NICE) has announced the introduction of the National HealthTech Access Programme, aimed at providing faster and more consistent access to selected high‑impact HealthTech across the NHS. The programme will allow a limited number of high‑impact technologies to be reimbursed and adopted consistently across the health service. The initial technologies are capsule sponge tests for detecting abnormal cells associated with Barrett’s oesophagus and oesophageal cancer, and AI tools used to analyse tissue images for suspected prostate and breast cancer. The programme forms part of the government’s 10 Year Health Plan and is intended to support earlier diagnosis, increase service capacity and encourage more uniform availability of effective technologies.
NEWS
National Institute for Health and Care Excellence (NICE) has announced a partnership with the USA-based Institute for Clinical and Economic Review and the Canadian Drug Agency to establish the Health Economics Methods Advisory (HEMA). This international initiative aims to research and evaluate health technology assessment (HTA) methods. HEMA will examine selected topics, provide guidance to the HTA community, and coordinate publications. The collaboration includes a steering committee of patient representatives and life sciences professionals from the three countries, demonstrating NICE's commitment to improving healthcare decision-making through international cooperation.
NEWS
The National Institute for Health and Care Excellence (NICE) has published a blog post offering guidance to pharmaceutical companies considering the International Recognition Procedure (IRP) for UK market entry. The organisation has highlighted that even when using the IRP, companies may need to consult NICE in advance to ensure their clinical evidence meets required standards. NICE has provided five key areas of focus, including understanding the IRP landscape, aligning with NICE evidence requirements, addressing timeline challenges, managing evidence maturity, and navigating surrogate endpoints. The organisation has also directed companies to its report 'Implications of using the IRP for a NICE technology appraisal evidence submission' and emphasised the availability of its NICE Advice service to support companies through the process.
NEWS
The National Institute for Health and Care Excellence (NICE) has announced proposals to transform its HealthTech programme, aiming to drive more innovative technologies into the NHS (National Health Service). NICE has launched a consultation on significant changes, including removing the requirement for medical devices to be cost-saving and introducing cost-effectiveness assessments for all technologies. The reforms also involve merging three existing programmes into a single HealthTech programme, implementing a lifecycle evaluation approach, and making multi-tech assessments standard practice. These changes are designed to accelerate the adoption of effective devices, interventions, digital solutions, and diagnostic tools in the NHS. The consultation period for these proposals runs until 6 March 2025.
NEWS
The National Institute for Health and Care Excellence (NICE) has published a blog post by its programme director for healthtech strategy and development, Dr Sarah Byron, outlining efforts to accelerate the adoption of digital health technologies within the NHS. NICE is reforming its evaluation processes by focusing on cost-effectiveness rather than merely cost-saving measures. The proposed changes include merging three existing programmes into a single healthtech evaluation programme, adopting a lifecycle evaluation approach, and standardising multi-tech assessments. These measures are designed to simplify engagement for healthtech developers, ensure that recommendations align with NHS priorities, and help innovative treatments reach patients more efficiently.
NEWS
NICE has published new guidance, in collaboration with international health technology assessment agencies, on the use of surrogate endpoints in cost-effectiveness analyses for health technology assessments. The report outlines best practices for selecting and validating surrogate endpoints, choosing long-term benefits, and presenting evidence. This guidance aims to provide clarity for technology developers and support HTA decision-making. NICE will consider updating its methods based on these recommendations, which were developed using published HTA manuals, regulatory guidelines, and agency experience.
NEWS
National Institute for Health and Care Excellence (NICE) has announced that its scientific advice service can significantly reduce appraisal timelines for new technologies. A study examining guidance published between June 2020 and May 2023 found that products receiving scientific advice from NICE Advice progressed from marketing authorisation to guidance publication in a median of 312 days, compared to 400 days for those without such advice. The research, which included 230 guidance documents, reinforces the value of early engagement with NICE Advice's service in streamlining the evaluation process and potentially expediting patient access to innovative treatments.