Status | In progress |
Decision | Selected |
Process | TA |
ID number | 3748 |
Provisional Schedule
Expected publication | 27 March 2024 |
Project Team
Project lead | Jeremy Powell |
Email enquiries
- If you have any queries please email TATeam2@nice.org.uk
External Assessment Group | Centre for Reviews and Dissemination and Centre for Health Economics, University of York |
Stakeholders
Companies sponsors | Janssen (daratumumab) |
Others | Department of Health and Social Care |
NHS England | |
Welsh Government | |
Patient carer groups | Cardiomyopathy UK |
Myeloma UK | |
Professional groups | British Cardiovascular Society |
British Society for Heart Failure | |
Renal Association | |
Royal College of Pathologists | |
Royal College of Physicians | |
Associated public health groups | Public Health England |
Public Health Wales | |
Comparator companies | ADVANZ Pharma (dexamethasone) - not participating |
Aspen (dexamethasone, melphalan) - not participating | |
Aspire Pharma (bortezomib) - not participating | |
Baxter Healthcare (cyclophosphamide) - not participating | |
Consilient Health (dexamethasone)- not participating | |
Dr Reddy’s Laboratories (bortezomib) - not participating | |
Glenmark Pharmaceuticals Europe (dexamethasone) - not participating | |
Hameln pharmaceuticals (dexamethasone) - not participating | |
Hospira UK (dexamethasone) - not participating | |
Martindale Pharma (dexamethasone) - not participating | |
Novartis Pharmaceuticals (dexamethasone) - not participating | |
Janssen-Cilag (bortezomib) | |
Panpharma UK (dexamethasone) - not participating | |
Rosemont Pharmaceuticals (dexamethasone) - not participating | |
Sandoz (cyclophosphamide) - not participating | |
Sun Pharmaceutical (melphalan) - not participating | |
Thame Laboratories (dexamethasone) - not participating | |
Thea Pharmaceuticals (dexamethasone) - not participating | |
Thornton & Ross (bortezomib) - not participating | |
Tillomed Laboratories (melphalan) - not participating | |
Wockhardt UK (dexamethasone) - not participating | |
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 | |
Welsh Health Specialised Services Committee | |
Relevant research groups | None |
Timeline
Key events during the development of the guidance:
Date | Update |
---|---|
28 February 2024 - 13 March 2024 | Final draft guidance |
08 November 2023 | Committee meeting: 3 |
25 August 2023 | Following the decision by the NICE Appeal panel the Appraisal Committee will consider this at their meeting on 8 November 2023. |
28 June 2023 | Appeal decision |
04 January 2023 | Appeal |
09 March 2022 | The company has requested a delay to the second committee meeting to allow them time collect more information to address concerns highlighted in the appraisal consultation document. We have accepted this request and are looking to reschedule the committee meeting for the summer 2022. We will provide a further update when a meeting date has been set. |
02 December 2022 - 16 February 2022 | Final draft guidance |
20 January 2022 - 10 February 2022 | Draft guidance: 1 |
08 December 2021 | Committee meeting |
20 April 2021 | Invitation to participate |
20 November 2020 | The Department for Health and Social Care has asked NICE to conduct an appraisal of daratumumab (in combination) for untreated systemic amyloid light-chain amyloidosis. Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid-Apr 2021 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately late June 2021. These timelines are based on a request from the company for a three month delay to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive submission. |
20 November 2020 | In progress. Topic is in progress |
14 September 2020 (10:00) | Scoping workshop |
15 July 2020 - 12 August 2020 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
For further information on our processes and methods, please see our CHTE processes and methods manual