Suggested remit: To appraise the clinical and cost effectiveness of isatuxmab in combination within its marketing authorisation for treating multiple myeloma when a stem cell transplant is unsuitable.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 3981

Provisional Schedule

Committee meeting: 1 07 May 2025
Expected publication 16 July 2025

Project Team

Project lead Vonda Murray

Email enquiries

External Assessment Group Liverpool Reviews and Implementation Group, University of Liverpool

Stakeholders

Companies sponsors Sanofi
Others Department of Health and Social Care
  NHS England
Patient carer groups African Caribbean Leukaemia Trust
  Anthony Nolan
  Black Health Agency for Equality
  Blood Cancer UK
  Cancer Black Care
  Cancer Equality
  Cancer52
  DKMS
  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 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 guideline groups National Guideline Alliance
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies Accord Healthcare (bortezomib, lenalidomide)
  Advanz Pharma (dexamethasone, lenalidomide)
  Amarox (lenalidomide)
  Aspen (dexamethasone)
  Aspire Pharma (bortezomib, dexamethasone)
  Aurobindo Pharma (bortezomib)
  Baxter Healthcare (cyclophosphamide)
  Biocon Pharma (lenalidomide)
  Biotech Pharma (bortezomib)
  Bristol-Myers Squibb (lenalidomide)
  Dr Reddy’s Laboratories (bortezomib)
  Fresenius Kabi (bortezomib)
  Hameln Pharmaceuticals (dexamethasone)
  Glenmark Pharmaceuticals (dexamethasone)
  Hospira (dexamethasone)
  J&J Innovative Medicine (bortezomib, daratumumab)
  Kent Pharma (bortezomib)
  Krka UK (dexamethasone)
  Martindale Pharma (dexamethasone)
  Medac gmBH (bortezomib)
  MSN Laboratories Europe (bortezomib)
  Mylan (bortezomib, lenalidomide)
  Pfizer (bortezomib)
  Piramal Critical Care (lenalidomide)
  Rosemont Pharmaceuticals (dexamethasone)
  Sandoz (bortezomib, cyclophosphamide)
  Sun Pharmaceuticals (bortezomib, lenalidomide)
  Synchrony Pharma (dexamethasone)
  Teva UK (dexamethasone, lenalidomide)
  Thornton & Ross (bortezomib, lenalidomide)
  Tillomed Laboratories (bortezomib)
  Torrent Pharma (lenalidomide)
  Viatris UK Healthcare (bortezomib, lenalidomide)
  Zentiva (lenalidomide)
Evidence review group Liverpool Reviews and Implementation Group - University of Liverpool
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, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
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
29 August 2024 Invitation to participate
28 May 2024 - 25 June 2024 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 3981
28 May 2024 In progress. Scoping commenced.
01 December 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 late 2024 when we will write to you about how you can get involved.
30 November 2022 As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of Isatuximab in combination for untreated multiple myeloma when stem cell transplant is unsuitable. Please note that following on from advice received from the company the timelines for this appraisal are to be confirmed. The appraisal will be rescheduled to align with latest regulatory expectations and an update on the revised timelines will be provided when further information is available.
03 August 2022 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of Isatuximab in combination for untreated multiple myeloma when stem cell transplant is unsuitable. Please note that following on from advice received from the company the timelines for this appraisal have been revised. We now anticipate that the appraisal will begin during mid-April 2023.

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