Suggested remit: To appraise the clinical and cost effectiveness of daratumumab with bortezomib, lenalidomide and dexamethasone within its marketing authorisation for untreated multiple myeloma when stem cell transplant is unsuitable.

Status:
In progress
Technology type:
Medicine
Decision:
Prioritised
Process:
STA Standard
ID number:
3843

Provisional Schedule

Draft guidance:
09 January 2026 - 30 January 2026
Committee meeting: 2:
12 March 2026
Expected publication:
13 May 2026

Project Team

Project lead
Jeremy Powell

Email enquiries

If you have any queries please email TACommB@nice.org.uk

Stakeholders

Companies sponsors
Janssen (daratumumab)
Others
Department of Health and Social Care
 
NHS England
 
Heath Technology Wales
Patient carer groups
Blood Cancer UK
 
Myeloma UK
Professional groups
Association of Cancer Physicians
 
Cancer Research UK
 
Royal College of Physicians
 
Royal College of Radiologists
 
UK Myeloma Society
Associated public health groups
Public Health Wales
 
UK Health Security Agency
Comparator companies
Advanz Pharma (lenalidomide)- No CAU- Not Participating
 
Amarox (lenalidomide) - No CAU- Not Participating
 
Aspire Pharma (bortezomib) - No CAU- Not Participating
 
Aurobindo Pharma (bortezomib) - No CAU- Not Participating
 
Biocon Pharma (lenalidomide) - No CAU- Not Participating
 
Biotech Pharma (bortezomib) - No CAU- Not Participating
 
Bristol Myers Squibb (lenalidomide)- CAU received- participating
 
Dr Reddy’s Laboratories (bortezomib)- No CAU- Not Participating
 
Grindeks Kalceks (lenalidomide)- No CAU- Not Participating
 
Mylan (lenalidomide) - No CAU- Not Participating
 
MSN laboratories Europe (bortezomib) - No CAU- Not Participating
 
Pfizer (bortezomib) - No CAU- Not Participating
 
Piramal Critical Care (lenalidomide) - No CAU- Not Participating
 
Ranbaxy (bortezomib, lenalidomide) - No CAU- Not Participating
 
Sandoz (bortezomib, lenalidomide) - No CAU- Not Participating
 
Sanofi (isatuximab) No CAU- Not Participating
 
Teva UK (lenalidomide)- No CAU- Not Participating
 
Thornton & Ross (bortezomib, lenalidomide) - No CAU- Not Participating
 
Tillomed Laboratories (bortezomib) - No CAU- Not Participating
 
Zentiva (bortezomib)- No CAU- Not Participating
General commentators
All Wales Therapeutics and Toxicology Centre
 
British National Formulary
 
Department of Health - Northern Ireland
 
Healthcare Improvement Scotland
 
Medicines and Healthcare products Regulatory Agency
 
NHS Wales Joint Commissioning Committee
 
Scottish Medicines Consortium
 
Welsh Government
Relevant research groups
Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
03 December 2025 Committee meeting: 1
13 May 2025 Invitation to participate
17 March 2025 - 14 April 2025 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 3843
17 March 2025 In progress. Scoping commencing
04 November 2024 Please note that following on from a request received from the company, the appraisal has been scheduled back into the work programme and it is now anticipated to begin in early mid-May 2025 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid-July 2025.
19 July 2023 Suspended. Please note that following on from information received from the company, NICE has decided to suspend this appraisal from its current work programme. The timelines for this appraisal are to be aligned with the latest regulatory and UK launch expectations and further information regarding the scheduling of this appraisal will be available in due course. NICE will continue to monitor any development and will update interested parties as and when the situation changes.
16 June 2021 Timelines for this appraisal are to be confirmed. Further information regarding the scheduling of this appraisal will be available in due course.

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

Consultation in progress

Consultation documents