Written Evidence Submitted by the National Institute for Health and Care Excellence (NICE)
- The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing guidance on health and social care in England. We assess a wide range of complex evidence to help commissioners and frontline practitioners, patients and carers take better informed decisions. These decisions may be about the care that people receive, the safety of new procedures, or the use of scarce healthcare resources. We do this to increase the uptake of effective and cost effective new treatments and interventions to benefit the population as a whole.
- We are supporting the NHS and social care during the COVID-19 pandemic by providing guidance about COVID-19 and supporting efforts to get promising diagnostics and treatments to patients quickly. We are rapidly updating our guidance when new evidence comes out so that the health and care system can find current, reliable advice as it continues to respond to the pandemic.
NICE’s response and flexibility in our processes to the pandemic
- As part of the response to COVID-19, NICE produced a series of rapid guidelines making recommendations to help manage COVID-19 symptoms, complications and conditions that could increase the risk of poor outcomes and for the optimal delivery of services during the COVID-19 pandemic. Between mid-March and 27 July produced 21 pieces of guidance.
- This work continues with the addition of new topics, and the transfer of existing guidance from the NHS England portfolio. This represents a significant body of work for which NICE will retain ongoing responsibility for keeping up to date as new evidence is released.
- Based on its experience of developing rapid guidelines, NICE has produced interim process and methods for guidelines developed in response to health and social care emergencies when guidance is urgently needed. The interim process and methods only apply to developing guidelines in response to health and social care emergencies during and immediately after (recovery phase) the crisis. The process and methods conform to the principles that guide the development of NICE guidance and standards.
Potential new drugs for COVID-19
- NICE has a vital role in coordinating activities within the Research to Access Pathway for Investigational Drugs – COVID-19 (RAPID-C19) to identify the most promising medicines. These medicines are then considered by the Oversight Group, which comprises senior representatives of the 4 collaborating agencies; the Medicines Healthcare Regulatory Agency (MHRA), the National Institute for Health Research (NIHR) and NHS England and NHS Improvement (NHSE and NHSI).
- The RAPID-C19 pathway ensures a full understanding of trial timetables and when substantive outcomes are likely to emerge, allowing advanced preparation for downstream evaluation and patient access activities (for example use of the early access to medicines scheme). The model actively pulls medicines in clinical development into clinical practice with activities aligned across the collaborating organisations. This model is potentially applicable beyond COVID-19 treatments leading to rapid, safe, and financially sustainable adoption of important medicines.
- NICE is also providing important scientific advice work to support life science companies to develop products relating to COVID-19. Joint scientific advice with the MHRA can also be provided.
- The Department of Health and Social Care (DHSC), NHSE and NHSI requested support from NICE to do exploratory economic modelling of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral detection point-of-care tests and serology tests to identify the parameters that are most influential on cost-effectiveness modelling results.
- This assessment should help inform DHSC’s, NHSE’s and NHSI’s COVID-19 diagnostic strategy, and the need for further research or audit commissioning on key data that are missing or found to be highly uncertain. The assessment will provide a framework to enable accelerated evaluation of such tests for guidance development.
NICE’s collaborative work for communication of scientific evidence internationally
- With the COVID-19 pandemic, there are substantial efforts worldwide to develop rapid evidence-based reviews and guidance to help inform decision making across clinicians, policy makers and the public. We will continue to support, contribute to, and learn from international efforts, such as the Evidence Collaborative for COVID-19 established by the World Health Organization. This ensures our rapid guidelines are drawing on, and contributing to, international evidence to inform the best approach to the COVID-19 pandemic.
- Since April, NICE staff have been actively engaged in collaborative opportunities being coordinated by the World Health Organization (the Evidence Collaborative for COVID-19 [ECC-19]), the Cochrane Collaboration, Guidelines International Network and the International Network of Agencies for Health Technology Assessment (INAHTA).
- The COVID-19 Evidence Network (COVID-END) hosted by McMaster University has come together to support decision-making to find and use the best evidence and to help reduce duplication in and better coordinate the evidence syntheses, technology assessment and guidelines being produced. In May, staff from the Centre for Guidelines joined the COVID-END partners coordination group.
- The European Network for Heath Technology Assessment (EUnetHTA) is initiating a programme of collaborative work between its partners. Partners have agreed to carry out two projects so far, which are in the planning phase: 1. A series of evidence summaries of treatments for COVID-19. These will include monitoring the developing evidence on treatments and assessment of clinical evidence; 2. Rapid relative effectiveness assessment of antibody tests. It is expected that further work will be announced to include other collaborative assessments of non-pharmaceutical technologies, scientific advice and evidence generation projects of COVID 19 treatments.
- NICE’s Science, Policy and Research (SP&R) team are partners in the IMI EHDEN project (European Health Data and Evidence Network and Innovative Medicines Initiative) and the IMI Value Dx project, both of which now have a COVID-19 focus. The EHDEN project is developing a federated European data network, and SP&R staff have participated in projects involving the safety of hydroxychloroquine with azithromycin and a characterisation of patients admitted to hospital with COVID-19. The IMI Value Dx project was focused on advancing diagnostics and reducing antimicrobial resistance. The COVID-19 focus for this project now includes a multi-national prevalence survey that has been extended to capture presentation and management of patients with acute respiratory tract infection during the COVID-19 pandemic.
- The NICE rapid COVID-19 guidelines are being used to inform the development of WHO guidelines. For example, the WHO Antimicrobial Stewardship (AMS) team is working on providing AMS recommendations in the HQ Clinical management of COVID 19 patients guidance document and have requested sight of the evidence tables informing the rapid Covid-19 guideline NG173: antibiotics for pneumonia in adults in hospital.
- NICE is continuing to share our COVID-19 activities with INAHTA. Members of the Centre for Guidelines Methods and Economics team are members of the GRADE Rapid Guidelines project group that are working to develop a GRADE concept paper considering approaches to developing robust recommendations in response to public health emergencies.
International initiatives led by NICE
- The Accelerated Access Collaborative Secretariat, hosted at NICE, is collaborating with colleagues from the Scottish Medicines Consortium (SMC) on the development of medicine briefing documents for the RAPID C-19 Oversight Group to aid prioritisation of promising medicines in the NHS.
- NICE International is coordinating a new collaboration between NICE, the Canadian Agency for Drugs and Technologies in Health (CADTH), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) and SMC to share experiences of our COVID-19 responses and explore sharing resources in relation to rapid HTAs. CADTH, PBAC, and the SMC have all agreed to collaborate with NICE.
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