| Status | In progress |
| Technology type | Medicine |
| Decision | Selected |
| Process | STA Standard |
| ID number | 6261 |
Provisional Schedule
| Expected publication | 08 May 2024 |
Project Team
| Project lead | Louise Jafferally |
Email enquiries
- If you have any queries please email TATeam4@nice.org.uk
| 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 |
|---|---|
| 09 April 2024 - 23 April 2024 | Final draft guidance: 2 |
| 05 March 2024 | Committee meeting: 4 |
| 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