| Status | In progress |
| Technology type | Medicine |
| Decision | Selected |
| Reason for decision | Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources |
| Further information | Scoping commencing |
| Process | STA Standard |
| ID number | 6282 |
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 (sipavibart) |
| Others | Department of Health and Social Care |
| NHS England | |
| Patient carer groups | Action for Pulmonary Fibrosis |
| African Caribbean Leukaemia Trust | |
| Anthony Nolan | |
| Aplastic Anaemia Trust | |
| Blood Cancer UK | |
| Cancer52 | |
| Cardiomyopathy UK | |
| Cardiothoracic Transplant Patient Group | |
| Chronic Lymphocytic Leukaemia Support Association | |
| Chronic Myeloid Leukaemia Support Group | |
| Clinically Vulnerable Families | |
| Crohn’s & Colitis UK | |
| Diabetes UK | |
| DKMS | |
| Down’s Syndrome Association | |
| Forgotten Lives UK | |
| Immunodeficiency UK | |
| Kidney Care UK | |
| Kidney Research UK | |
| Leukaemia Cancer Society | |
| Leukaemia Care | |
| Leukaemia UK | |
| Long Covid Kids | |
| Long Covid Physio | |
| Long COVID SOS | |
| Long Covid Support | |
| Lupus UK | |
| Lymphoma Action | |
| Macmillan Cancer Support | |
| MDS UK Patient Support Group | |
| Metabolic Support UK | |
| MS Society | |
| Multiple Sclerosis Trust | |
| Myeloma UK | |
| National Kidney Federation | |
| National Rheumatoid Arthritis Society | |
| Polycystic Kidney Disease Charity | |
| Sarcoidosis UK | |
| Scleroderma and Raynaud’s UK | |
| South Asian Health Foundation | |
| Specialised Healthcare Alliance | |
| Thrombosis UK | |
| Vasculitis UK | |
| Professional groups | Association for Clinical Biochemistry and Laboratory Medicine |
| Association of British Neurologists | |
| Association of Cancer Physicians | |
| British Geriatrics Society | |
| British HIV Association | |
| British Infection Association | |
| British Paediatric Allergy Infection and Immunity Group | |
| British Society for Allergy and Clinical Immunology | |
| British Society for Haematology | |
| British Society for Heart Failure | |
| British Society for Immunology | |
| British Society for Rheumatology | |
| British Society of Blood and Marrow Transplantation and Cellular Therapies | |
| British Thoracic Society | |
| British Transplant Society | |
| Cancer Research UK | |
| Faculty of Pharmaceutical Medicine | |
| Infection Prevention Society | |
| Microbiology Society | |
| NHS Blood and Transplant | |
| Royal College of General Practitioners | |
| Royal College of Nursing | |
| Royal College of Pathologists | |
| Royal College of Physicians | |
| Royal Pharmaceutical Society | |
| Royal Society of Medicine | |
| UK Clinical Pharmacy Association | |
| UK CLL Forum | |
| UK Kidney Association | |
| UK Renal Pharmacy Group | |
| Associated public health groups | Public Health Wales |
| UK Health Security Agency | |
| Comparator companies | None |
| General commentators | All Wales Therapeutics and Toxicology Centre |
| Allied Health Professionals Federation | |
| Board of Community Health Councils in Wales | |
| British National Formulary | |
| Care Quality Commission | |
| Chest, Heart and Stroke Scotland | |
| Department of Health, Social Services and Public Safety for Northern Ireland | |
| Diabetes UK Cymru | |
| Healthcare Improvement Scotland | |
| Hospital Information Services - Jehovah's Witnesses | |
| Long Covid Scotland | |
| Medicines and Healthcare products Regulatory Agency | |
| National Association of Primary Care | |
| National Pharmacy Association | |
| NHS Alliance | |
| NHS Confederation | |
| Northern Ireland Chest, Heart and Stroke Association | |
| Scottish Medicines Consortium | |
| Welsh Government | |
| Welsh Health Specialised Services Committee | |
| Relevant research groups | Cochrane Infections Diseases Group |
| Cochrane UK | |
| Genomics England | |
| Institute of Cancer Research | |
| Leukaemia Busters | |
| Long Covid Research Initiative | |
| MRC Clinical Trials Unit |
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 04 October 2024 | AstraZeneca has communicated to NICE that following a change to anticipated MHRA regulatory timelines AstraZeneca will be unable to submit to NICE as planned. AstraZeneca will continue to engage with the MHRA and will inform NICE when it can make its submission. NICE has therefore suspended the appraisal and will write to stakeholders with a new submission date when notified by AstraZeneca. |
| 06 August 2024 | Invitation to participate |
| 27 June 2024 | Please note that AstraZeneca has communicated to NICE that there has been a delay to the availability of the necessary analyses for its submission in July 2024 and has requested a delay. Following on from information received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin during early August 2024 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early October 2024. |
| 05 April 2024 | The company has now updated projections of when data will be available from the SUPERNOVA study, and NICE has therefore rescheduled the appraisal timelines to align with this. As a result, the first Committee meeting is now scheduled for Wednesday 4 December 2024. |
| 01 February 2024 | Invitation to participate |
| 27 November 2023 | Please note that NICE intends to formally start the appraisal in February 2024 and invite stakeholder submissions in April 2024. Timelines for both NICE guidance and licensing depend on data from the SUPERNOVA trial being available. However, the company will submit clinical data to NICE and the MHRA at the same time, with the aim of both organisations being able to reach decisions as close together as possible. |
| 08 August 2023 | Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early 2024 when we will write to you about how you can get involved. |
| 30 May 2023 - 19 June 2023 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6282 |
| 30 May 2023 | If you are representing an organisation that has not been sent the draft scope consultation directly, and want to be considered as a stakeholder, please contact scopingta@nice.org.uk. |
| 30 May 2023 | In progress |
For further information on our processes and methods, please see our CHTE processes and methods manual