We are actively involved in a range of methodological research and other projects.
Our projects and partnerships help us to keep improving how NICE works. They also help us anticipate and adapt to policy developments, including changes in health and social care delivery.
IMI and H2020 Grant funded projects
Development and Harmonisation of Methodologies for Assessing Digital Health Technologies in Europe (ASSESS-DHT)
ASSESS-DHT is a European project that aims to increase the adoption of trustworthy and effective digital health technologies (DHTs) across Europe. The project will address the challenges with assessing DHTs by streamlining existing methods and developing a new assessment framework and toolkit. As a partner in the ASSESS-DHT consortium, NICE is leading the development of a European tool that will help developers of DHTs to identify evidence gaps and optimise their evidence development plans. We are also working with partners to develop the interim manual for DHT assessment and pilot its use in assessing an artificial intelligence (AI)-based digital health application.
Support the Utilisation of Sustainable and Tailored Innovative methods for HTA (SUSTAIN-HTA)
The aim of SUSTAIN-HTA is to support the use of innovative methods for European health technology assessment (HTA). It will generate a framework to continuously understand the most pressing needs of HTA bodies, and identify cutting-edge research, methods and tools to address those needs. It will also establish support for HTA organisations to implement new methods. NICE will lead on tasks to review the methods used in existing HTA practices in Europe and prioritise areas where innovative methods and tools should be implemented or developed further.
Revolutionising Alzheimer's Disease Detection and Treatment Across Europe (AD-RIDDLE)
AD-RIDDLE aims to bridge the gap between Alzheimer's research, implementation science and precision medicine. The project will offer healthcare professionals a suite of validated solutions for timely detection and diagnosis of Alzheimer's disease and dementias, to match individuals with the right interventions at the right time, enabling people to better understand what they can do to reduce risk and prevent cognitive decline.
European Digital Health Technology Assessment (EDiHTA)
The aim of EDiHTA is to develop a HTA framework for Digital Health Technologies (DHTs) that integrates existing assessment domains and methods with new ones to inform decision-making. An online platform will allow HTA assessments to be performed digitally in a standardised format that can be customised according to the type and lifecycle stage of the DHT and decision-making process. The digital framework will be piloted in five major European hospitals and through an open piloting scheme with European DHT developers.
PREDICTOM: Early Dementia Detection
PREDICTOM will aim to develop an Artificial Intelligence (AI) screening platform that can identify individuals at risk of developing dementia, even before symptoms manifest. NICE’s role in the project will be to assess current clinical guidelines on early dementia and support the development of recommendations for future guidelines based on the potential step-change in dementia detection intended by the project.
EHDEN: European Health Data and Evidence Network
The EHDEN project aims to set up a European federated network of data sources standardised to a common data model.
The network will enable observational research and the generation of high quality, real world evidence through open collaboration.
ERA4TB: a European Regimen Accelerator for Tuberculosis
The ERA4TB project's main objective is to create a European open platform to accelerate the development of new regimens for the treatment of tuberculosis. The project consortium will do this through a new community-focused platform on tuberculosis translational research and knowledge integration.
During the project, NICE will act as an interface with key stakeholders to maximise uptake and impact of ERA4TB's results. The stakeholders are mainly:
- HTA agencies
- regulatory authorities
- patients.
The project activity will complement our ongoing work in the area of antimicrobial resistance.
HARMONY PLUS
HARMONY PLUS, launched in October 2020, builds on the success of HARMONY in using big data and analytics to deliver knowledge that will improve the care of patients with several blood cancers.
The project expands the focus to additional blood diseases that were not covered by HARMONY and further deploys artificial intelligence techniques on an expanded big data platform.
HTx: Next Generation Health Technology Assessment
The project aims to create and test a framework for ‘next generation’ health technology assessment to support patient-centred, societally oriented, real-time decision-making on access to and reimbursement for health technologies throughout Europe.
The framework will provide solutions for a broad range of challenges, such as:
- personalised medicine
- combination therapies
- big data and artificial intelligence (AI).
IDERHA: Integration of Heterogeneous Data and Evidence towards Regulatory and HTA Acceptance
In recent years, there has been an exponential growth in the generation of data that could be harnessed for use in healthcare delivery and research. However, accessing, integrating, and analysing these data to maximise their value for patient care and research is extremely challenging.
IDERHA aims to create a scalable platform for the seamless integration or linkage of diverse data at scale to support healthcare professionals, patients, and researchers with new capabilities to improve patient outcomes. With an initial focus on Lung Cancer, the project aims for its outputs to be applicable across multiple disease settings in the future.
NICE is leading on tasks focused on engaging key internal and external stakeholder to develop consensus on policy recommendations to improve both access to data and the acceptability of heterogenous evidence for regulatory and HTA use.
VALUE-Dx: The value of diagnostics to combat antimicrobial resistance by optimising antibiotic use
VALUE-Dx will facilitate and accelerate the rigorous assessment and implementation of diagnostic technologies into healthcare settings. It will do this by establishing the methods, processes and approaches needed to understand, evaluate, and assess the value of diagnostics in the context of optimising antibiotic use. VALUE-Dx has a particular focus on community-acquired acute respiratory tract infections (CA-ARTI).
The project will produce recommendations on how to improve existing pricing and funding policies to ensure timely accessibility of cost-effective diagnostics to reduce antimicrobial resistance .
Science policy projects
Review of NICE recommendations for outpatient follow-up after elective care
The health and care system continues to operate under exceptional pressures, with more patients than ever waiting for elective treatment. Using alternatives to traditional face-to-face outpatient follow-up may be one way to reduce pressure on the system. To check that NICE recommendations are not contributing to system pressures, in late 2023 we conducted a comprehensive review of our recommendations on outpatient follow-up after elective care.
We found that there are approximately 500 recommendations in 140 elective care guidelines on outpatient follow-up. Approximately 70% of these recommendations explicitly state that a follow-up appointment is required, 70% also say that follow-up ‘should’ occur, which indicates the recommendation is based on clear evidence of cost-effectiveness and patient benefit. 4% of follow-up recommendations suggest alternatives to face-to-face follow-up (such as virtual or patient initiated).
The assessment concluded that NICE has followed robust processes to formulate recommendations on follow-up. NICE will continue to base follow-up recommendations on evidence of patient benefit and value for money; document the rationale for recommending follow-up; and outline the evidence-base for changes to follow-up timing or delivery method, with due consideration of equity and access to care.
Environmental sustainability
NICE has a strategic objective to examine the potential to include environmental impact data in our guidance to reduce the carbon footprint of health and care. We have been working with academic partners to help us scope a framework for considering environmental sustainability information. We are also working closely with system partners to ensure our environmental sustainability work complements other similar work undertaken across the healthcare landscape.
Evaluation and purchasing models for antimicrobials
In collaboration with NHS England and NHS Improvement (NHSE&I) and Department of Health and Social Care (DHSC), we’re working on a project to develop and test models that pay companies for antimicrobials based primarily on assessment of their value to the NHS as opposed to the volumes used.
EQ-5D-5L valuation set for England
We’re advising on a valuation study to generate a new EQ-5D-5L value set for the UK. The study is being undertaken by a research team comprising investigators from across the UK, and is being overseen by a steering group which includes representatives from EuroQol, NICE, the Department of Health and Social Care, and NHS England.
EQ-HWB
EQ-HWB (EQ Health and Wellbeing instrument) is a new standardised measure of of health and wellbeing that was created following the Extending the QALY research project that NICE contributed to.
The EQ-HWB has not been developed as a replacement for the EQ-5D, but as a different instrument that captures a broader range of impacts on people, their families and carers. Research is underway to validate the EQ-HWB and compare it with existing instruments. NICE supports this important research, which will help us to decide whether and how to use EQ-HWB to inform NICE evaluations in the future.
MHRA-NICE Effective Regulation and Evaluation of Digital Mental Health Technologies
We are collaborating with the MHRA on a Wellcome-funded project to explore issues around regulation and evaluation of digital mental health technologies, ranging from diagnostic and monitoring tools, self-help CBT apps and websites, and virtual reality and AI based therapies.
There has been a large increase in the number of digital mental health tools on the market in recent years. However, these products present challenges for regulation and health technology assessment, including whether technologies are medical devices, how they should be classified, and higher levels of uncertainty around effectiveness and cost-effectiveness.
Across five work packages, the project will explore the digital mental health landscape and consider issues around qualification and classification, clinical evaluation, and post-market surveillance and lifecycle assessment. At each stage, we will engage with and learn from people with lived experience and other subject experts, as well as working with international partners to help drive shared learning and international consensus.
NICE Listens
NICE Listens is our new programme of deliberative public engagement. It's been developed to give us an understanding of public opinion on moral, ethical and social value issues.
Using best practice methods, we work with external contractors who specialise in public engagement.
A new sample of members of the public is invited to take part in each project. They are given time to learn and become familiar with the topic area, before discussing it in detail and making recommendations. These recommendations are then be used by our executive team and board to inform various aspects of our work.
Societal perspective
NICE methods guidance states that the default perspective for economic evaluations should be that of the NHS and personal social services, but a broader set of effects can be included in exceptional circumstances when they are deemed especially relevant and when requested by the Department of Health and Social Care in the remit for the evaluation.
The aim of this project is to explore the need for and challenges of adopting a societal perspective in NICE’s assessments.
International collaboration
Australia, Canada, New Zealand and United Kingdom HTA collaboration
NICE has a collaboration arrangement with eight partner organisations in Australia, Canada, New Zealand and the United Kingdom. This arrangement preserves the governance arrangements and independence of each of the agencies, whilst creating greater opportunities to explore collaboration in five priority areas:
- COVID 19-related intelligence sharing
- future-proofing of HTA systems
- collaborating with regulators
- work-sharing and efficiency gains
- digital and AI.
The collaborating HTA agencies are:
- National Institute for Health and Care Excellence (NICE) in England.
- Canadian Agency for Drugs and Technologies in Health (CADTH).
- Australian Government Department of Health, together with the Pharmaceutical Benefits Advisory Committee (PBAC) and the Medical Services Advisory Committee (MSAC).
- Health Improvement Scotland, including the Scottish Medicines Consortium (SMC) and the Scottish Health Technologies Group (SHTG).
- Health Technology Wales (HTW), hosted by Velindre University NHS Trust.
- All Wales Therapeutics and Toxicology Centre
- Institut national d’excellence en santé et en services sociaux
- Pharmac.
Read our collaboration arrangement (PDF)
Handling confidential clinical data
Health technology evaluations must strike a critical balance between ensuring transparency of the evidence and decision-making and protecting confidential information. NICE has worked with HTA agencies in Canada (CADTH) and the US (ICER) to create a more consistent approach to handling clinical data.
The agencies have published a joint position statement on the confidentiality of clinical data. The principles in the statement are operationalised in NICE health technology evaluations: the manual.
Read the position statement (Word)
Sharing knowledge and collaborating on the modelling treatment pathways within a disease area
NICE is working with a group of international organisations to share learning about the development of reference models. The reference models span a disease pathway and can be used to assess multiple technologies across the pathway.
The group is also providing a simple way for organisations to exchange information, share developed pathway models, discuss best practice, give feedback, and overcome any technical and administrative issues.
The international organisations NICE is collaborating with are:
- Canadian Agency for Drugs and Technologies in Health (CADTH), from Canada
- the National Healthcare Institute (ZIN), from the Netherlands
- Institute for Clinical and Economic Review (ICER), from the United States.
The group is open to collaboration with other international organisations.
Past research and projects
ADAPT-SMART
ADAPT-SMART aimed to design new collaborative approaches to the development of medicines, known as Medicines Adaptive Pathways to Patients (MAPPs).
We've played a leading role in this and other projects, and we now engage with pharmaceutical companies via our Office for Market Access and the Accelerated Access Collaborative.
DO->IT (Big Data for Better Outcomes)
The DO->ITproject was launched to provide a coordination platform for the BD4BO programme, exploiting synergies across the projects and maximising its impact on healthcare systems. It aimed to:
- aggregate learnings and disseminate findings from the projects
- develop minimum data privacy standards
- engage with key stakeholders
- recommend areas for future collaborative research.
The project delivered a toolkit for the identification, selection and measurements of outcomes (PDF) to support the other BD4BO projects.
Exploring the assessment and appraisal of regenerative medicines and cell therapy products
In April 2015, we launched an exploratory study to highlight key issues in the evaluation of regenerative medicines (PDF) and consider the suitability (or otherwise) of current methods. The study responds to recommendations from the Department of Health Regenerative Medicine Expert Group (RMEG).
NICE has worked in collaboration with the Centre for Reviews and Dissemination and Centre for Health Economics, University of York, who have produced an extensive independent report (PDF).
The NICE Regenerative Medicines and Cell Therapy report (PDF) summarises key findings from the study, considers implications for NICE and makes a number of recommendations.
Extending the QALY (E-QALY)
The E-QALY project aimed to develop a broad measure of quality of life for use in economic evaluations across health and social care, for both patients and carers.
It explored the importance of non-health aspects (such as social and emotional wellbeing) in addition to physical and mental health so that important benefits, other than those related to health, are captured.
Flatiron Health
The partnership between NICE and Flatiron Health aimed to explore if and how real world evidence can inform the clinical and cost effectiveness of health technologies. An initial research project compared survival estimates from clinical trials to survival data observed in actual patient records to evaluate opportunities to reduce uncertainty in the estimation of long-term outcomes.
The collaboration tested how additional sources of evidence could complement trial and research data in NICE's technology appraisals, especially in helping to resolve uncertainty in the evidence.
GetReal Initiative
The GetReal Initiative was an Innovative Medicines Initiative (IMI) project which aimed to develop tangible solutions to key challenges associated with using real world data in drug development and subsequent regulatory and health technology assessment.
The project established a real world evidence Think Tank, which gathered international thought leaders to discuss, assess and give recommendations on the opportunities and barriers to the generation, use and acceptability of real world evidence.
This project followed on from successful completion of the IMI GetReal project on the use of real world evidence in effectiveness research.
HARMONY: Healthcare Alliance for Resourceful Medicines Offensive against Neoplasms in Haematology
The HARMONY alliance aimed to use big data and big data analytics to deliver knowledge to improve the care of patients with several blood cancers.
A key output from this project was the HARMONY BigData platform. As of April 2023, this held datasets of approximately 156,000 patients. This platform harmonises and analysis these data sets, with the aim of accelerating the development of more effective treatments for people with blood cancer.
Histology independent cancer drugs
The European Medicines Agency approved the first histology independent cancer drug in 2019. The clinical evidence on the effectiveness of these drugs makes it hard to assess:
- the level of benefit to patients
- if the drug provides value for money to health systems such as the NHS.
We initiated methods research through the National Institute for Health Research health technology assessment programme. This addressed the following questions:
- Can we apply our existing technology appraisal approaches and are any changes required?
- What evidence will be available at the point of initial marketing authorisation for these drugs?
- What guidance is needed to establish the evidence and analyses required to inform our recommendations?
Read the pre-publication report and recommendations (Word) from researchers at the University of York and the University of Sheffield.
IMI GetReal
GetReal aimed to develop a clearer understanding of how real-world evidence (RWE) can contribute to pharmaceutical research and development and healthcare decision-making.
As part of GetReal, we worked with the University of Manchester and the Association of British Pharmaceutical Industry (ABPI) to publish a report of recommendations for advancing the UK's capability for data science research in healthcare.
We also developed the RWE Navigator, an online platform to support better understanding of the potential of real world evidence in the development and assessment of new drugs.
IMPACT HTA
IMPACT HTA proposed new and improved methods, tools and guidance for decision-makers across 10 research areas in the context of health technology assessment and health system performance measurement. This contributed to the understanding of:
- costs and health outcomes variations within and across countries
- costs and health outcomes data integration from different sources.
Our role in the project included:
- assessing the performance of a range of statistical methods used to analyse non-randomised studies
- providing recommendations on which methods are likely to produce valid and unbiased estimates of relative effectiveness of interventions.
The methodological recommendations produced in this project will be useful for informing future updates of our methods guides in relation to the use of non-randomised studies, sometimes referred to as ‘real world studies’.
NEURONET: Efficiently Networking European Neurodegeneration Research
NEURONET was a coordination and support action project setup to provide support to a broad portfolio of IMI projects on neuro-degenerative diseases.
A key output from the project is an interactive Knowledge Base. This brings together key information about the 18 projects in the IMI neuro-degenerative diseases portfolio, including links to project publications, tools, and deliverable reports.
The Knowledge Base is an integral part of NEURONET's endeavour to boost collaboration across the research portfolio and enhance its visibility with related initiatives in Europe and worldwide.
NICE led work on the Regulatory and HTA Decision Tool, which provides a clickable overview of the processes and procedures for HTA and regulatory interactions at different stages of the development pipeline. This will help ensure that the outputs being developed by projects are relevant for regulatory and HTA settings, where applicable.
Patient Preferences
We worked in partnership with Myeloma UK to explore potential quantitative methods for capturing and using patient preferences within health technology assessment decision-making. This initial ‘proof of concept’ project was funded by Myeloma UK and focused on patients with multiple myeloma.
ROADMAP (Big Data for Better Outcomes)
The ROADMAP project worked on improving real world evidence in Alzheimer's disease.
The project launched the Data Cube in 2019, which provides an interactive overview of European data sources that capture outcomes relevant for Alzheimer's disease.
Our partners
EuroQol
We are involved in several EuroQol-funded projects. As well as jointly overseeing and advising on the new UK EQ-5D-5L valuation study, and contributing to the development of the new EQ-HWB instrument, we are participating in a number of research studies seeking to improve methods for measuring and valuing health-related quality of life.
Medical Research Council: Better Methods, Better Research (BMBR) panel
The Better Methods, Better Research (BMBR) panel is a partnership co-funded by the Medical Research Council (MRC) and the Department of Health and Social Care’s National Institute for Health and Care Research (NIHR). The aim of BMBR is to ensure, via provision of funding, that optimal research methods are being used to advance biomedical-, health- and care-related research and policies. NICE has an advisory role at panel meetings, highlighting proposals of interest that align with our research priorities or address current methodological challenges in guideline development. NICE can partner with researchers applying for funding from the MRC BMBR panel in several ways.
National Institute for Health and Care Research (NIHR)
NICE meets regularly with NIHR to share information about our respective research priorities, and seeks NIHR’s input to ensure our research recommendations are clear and actionable. We also work closely to fast-track, co-produce and advertise research briefs which are jointly agreed as key priorities. In addition to these fast-tracked key priorities, NIHR also reviews all NICE guidance and advertises research calls against NICE research recommendations through individual programme commissioned workstreams. NIHR has been screening NICE guidance for nearly 20 years to identify topics suitable for commissioning research. In 2021, NIHR launched a researcher-led rolling funding call, which will complement existing commissioning workstreams. The rolling research call aims to build on the success of the relationship between NIHR and NICE, and further develop the evidence base supporting guidance development.
New Drug Development Paradigms (NEWDIGS) programme
NICE is part of a global group of organisations who want to speed up the development and delivery of new, effective and affordable drugs.
The programme brings together pharmaceutical companies, academic researchers, patient advocacy groups, government agencies and other experts.