Suggested remit: To appraise the clinical and cost effectiveness of remdesivir, tocilizumab, casirivimab and imdevimab, baricitinib, sotrovimab, molnupiravir, anakinra, lenzilumab and nirmatrelvir and ritonavir within their proposed marketing authorisations for treating people with symptomatic coronavirus disease 2019 (COVID-19).
 
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 6261

Provisional Schedule

Committee meeting: 4 05 March 2024

Project Team

Project lead Louise Jafferally

Email enquiries

External Assessment Group School of Health and Related Research (ScHARR), University of Sheffield

Stakeholders

Companies sponsors AstraZeneca (tixagevimab and cilgavimab)
  Gilead Sciences (remdesivir)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Action for Pulmonary Fibrosis
  Anthony Nolan
  Blood Cancer UK
  Cardiothoracic Transplant Patient Group
  Clinically Vulnerable Families
  covid:aid
  Crohn’s & Colitis UK
  Diabetes UK
  Down's Syndrome Association
  Immunodeficiency UK
  Kidney Care UK
  Kidney Research UK
  Leukaemia Care
  Long Covid Kids
  Long COVID SOS
  Long Covid Support
  Lupus UK
  Lymphoma Action
  MS Society
  Multiple Sclerosis Trust
  Myeloma UK
  Sarcoidosis UK
  Thrombosis UK
Professional groups Association of Cancer Physicians
  British HIV Association
  British Infection Association
  British Paediatric Allergy Infection and Immunity Group
  British Society for Allergy & Clinical Immunology
  British Society for Immunology
  British Thoracic Society
  British Transplantation Society
  Cancer Research UK
  Faculty of Pharmaceutical Medicine
  Royal College of Physicians
  UK Clinical Pharmacy Association
  UK Kidney Association
  UK Renal Pharmacy Group
Associated public health groups Faculty of Public Health Medicine
  Public Health Wales
  Royal Society for Public Health
  UK Health Security Agency
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Long Covid Research Initiative

Timeline

Key events during the development of the guidance:

Date Update
18 January 2024 - 08 February 2024 Draft guidance: 2
12 December 2023 Committee meeting: 3
01 November 2023 Consultation documents published: Consultation on the in vitro data on neutralising monoclonal antibodies for COVID-19: methods framework
24 August 2023 Following the publication of the appeal decision for molnupiravir, remdesivir and tixagevimab plus cilgavimab for treating COVID-19, the next steps are: Molnupiravir: Following discussions with the company, it has been agreed that to address the upheld appeal points, a new single technology appraisal (STA) will be planned into the work programme. NICE will not publish final guidance on molnupiravir until the STA reaches a conclusion. Further details regarding timings will be available in due course. Remdesivir: Following discussions with the company, it has been agreed that the committee will consider additional evidence and modelling related to the upheld appeal points. The meeting is anticipated to take place towards the end of 2023. Tixagevimab plus cilgavimab: Discussions are continuing with the company. It is anticipated that final draft guidance on tixagevimab plus cilgavimab will be available at the same time as it is available for remdesivir.
05 July 2023 Appeal decision
20 March 2023 Appeal
21 February 2023 - 07 March 2023 Final draft guidance
24 January 2023 Committee meeting: 2
16 November 2022 - 07 December 2022 Draft guidance
18 October 2022 Committee meeting: 1
28 September 2022 Joint statement issued by NICE and the SMC/HIS, available in the Project documents.
01 August 2022 Invitation to participate
11 July 2022 Assessment report sent for information
19 April 2022 Invitation to participate
14 April 2022 Stakeholder Information Meeting
23 March 2022 In progress. Invitation to Stakeholder Information Meeting issued.
15 March 2022 Update and next steps following the scoping exercise for the proposed topic COVID-19 therapeutics ID4038. We carefully considered the comments from all stakeholders and were pleased that there was broad support for NICE to carry out an evaluation of the clinical and cost-effectiveness of these treatments. However, a common theme from the comments was that timing was crucial and that right now is perhaps not the right time to start a Multiple Technology Appraisal (MTA). We acknowledge the concerns around timing, but as some stakeholders highlighted, an MTA can take more than 11 months to reach recommendations. NICE would not be able to respond quickly using its standard MTA approach if it becomes clear that guidance is required. Taking this all into account, we will be resequencing the steps of an MTA in order to start the academic work to assess the clinical evidence and develop an economic model now, without formally starting an evaluation. Developing and validating an economic model first will enable us to be much more responsive and undertake the evaluation stage and produce recommendations in a much shorter time frame. We will not therefore be inviting stakeholder submissions at this stage. But we do intend for stakeholders to be involved in this phase of work. Firstly, we plan to hold a stakeholder information meeting in approximately 4-6 weeks time to give more information about what we are planning and for the academic group to present a protocol for how they will approach the work. Once the academic group has built the model and produced a report there will be a stakeholder consultation. The approach outlined is broadly supported by NHS England, the Department of Health and Social Care and the bodies responsible for HTA in other parts of the UK.
06 January 2022 - 03 February 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
25 January 2022 (10:00) Scoping workshop

For further information on our processes and methods, please see our CHTE processes and methods manual