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 |
MTA
|
ID number |
4038
|
Project Team
Project lead |
Louise Jafferally |
Email enquiries
External Assessment Group |
School of Health and Related Research (ScHARR), University of Sheffield |
Stakeholders
Companies sponsors |
Eli and Lilly (baricitinib) |
|
Gilead Sciences (remdesivir) |
|
GlaxoSmithKline (sotrovimab) |
|
Humanigen (lenzilumab) |
|
Merck Sharp & Dohme (molnupiravir) |
|
Pfizer (nirmatrelvir and ritonavir) |
|
Roche (casirivimab, imdevimab and tocilizumab) |
|
Swedish Orphan Biovitrum (anakinra) |
Others |
Department of Health and Social Care |
|
NHS England |
|
Welsh Government |
Patient carer groups |
Action for Pulmonary Fibrosis |
|
Anthony Nolan |
|
Blood Cancer UK |
|
covid:aid |
|
Diabetes UK |
|
Immunodeficiency UK |
|
Leukaemia Care |
|
Long Covid Kids |
|
Long COVID SOS |
|
Long Covid Support |
|
Lupus UK |
|
MS Society |
|
Multiple Sclerosis Trust |
|
Myeloma UK |
|
Sarcoidosis UK |
|
Thrombosis UK |
Professional groups |
Association of Cancer Physicians |
|
British Infection Association |
|
British Society for Allergy & Clinical Immunology |
|
British Society for Immunology |
|
British Thoracic Society |
|
British Transplant 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 |
None |
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 |
Date
|
Update
|
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