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 Selected
Process STA Standard
ID number 3843

Provisional Schedule

Committee meeting: 1 03 December 2025
Expected publication 25 February 2026

Project Team

Project lead Vonda Murray

Email enquiries

Stakeholders

Companies sponsors Janssen (daratumumab)
Others Department of Health and Social Care
  NHS England
  Heath Technology Wales
Patient carer groups African Caribbean Leukaemia Trust
  Anthony Nolan
  Black Health Agency for Equality
  Blood Cancer UK
  Cancer Black Care
  Cancer52
  Helen Rollason Cancer Charity
  Independent Cancer Patients Voice
  Kevin Karawa Leukaemia Trust
  Leukaemia Cancer Society
  Leukaemia Care
  Leukaemia UK
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie
  Myeloma UK
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Tenovus Cancer Care
Professional groups Association of Cancer Physicians
  British Blood Transfusion Society
  British Committee for Standards in Haematology
  British Geriatrics Society
  British Institute of Radiology
  British Oncology Pharmacy Association
  British Psychosocial Oncology Society
  British Society for Haematology
  British Society of Interventional Radiology
  British Transplantation Society
  Cancer Research UK
  NHS Blood and Transplant
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society and College of Radiographers
  UK Clinical Pharmacy Association
  UK Myeloma Society
  UK Oncology Nursing Society
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies Advanz Pharma (lenalidomide)
  Amarox (lenalidomide)
  Aspire Pharma (bortezomib)
  Aurobindo Pharma (bortezomib)
  Biocon Pharma (lenalidomide)
  Biotech Pharma (bortezomib)
  Bristol Myers Squibb (lenalidomide)
  Dr Reddy’s Laboratories (bortezomib)
  Grindeks Kalceks (lenalidomide)
  Mylan (lenalidomide)
  MSN laboratories Europe (bortezomib)
  Pfizer (bortezomib)
  Piramal Critical Care (lenalidomide)
  Ranbaxy (bortezomib, lenalidomide)
  Sandoz (bortezomib, lenalidomide)
  Sanofi (isatuximab)
  Teva UK (lenalidomide)
  Thornton & Ross (bortezomib, lenalidomide)
  Tillomed Laboratories (bortezomib)
  Zentiva (bortezomib)
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
  Department of Health - Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Confederation
  NHS Wales Joint Commissioning Committee
  Scottish Medicines Consortium
  Welsh Government
Relevant research groups Cochrane Haematological Malignancies Group
  Genomics England
  Institute of Cancer Research
  Leukaemia Busters
  MRC Clinical Trials Unit
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
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