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
  Health Technology Wales (HTW)
  NHS England
Patient carer groups 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 None
Comparator companies J&J Innovative Medicine (bortezomib, daratumumab) (confidentiality agreement signed, participating)
  Accord Healthcare (bortezomib, lenalidomide) (confidentiality agreement not signed, not participating)
  Advanz Pharma (dexamethasone, lenalidomide) (confidentiality agreement not signed, not participating)
  Amarox (lenalidomide) (confidentiality agreement not signed, not participating)
  Aspen (dexamethasone) (confidentiality agreement not signed, not participating)
  Aspire Pharma (bortezomib, dexamethasone) (confidentiality agreement not signed, not participating)
  Aurobindo Pharma (bortezomib) (confidentiality agreement not signed, not participating)
  Baxter Healthcare (cyclophosphamide) (confidentiality agreement not signed, not participating)
  Biocon Pharma (lenalidomide) (confidentiality agreement not signed, not participating)
  Biotech Pharma (bortezomib) (confidentiality agreement not signed, not participating)
  Bristol-Myers Squibb (lenalidomide) (confidentiality agreement not signed, not participating)
  Dr Reddy’s Laboratories (bortezomib) (confidentiality agreement not signed, not participating)
  Fresenius Kabi (bortezomib) (confidentiality agreement not signed, not participating)
  Hameln Pharmaceuticals (dexamethasone) (confidentiality agreement not signed, not participating)
  Glenmark Pharmaceuticals (dexamethasone) (confidentiality agreement not signed, not participating)
  Hospira (dexamethasone) (confidentiality agreement not signed, not participating)
  Kent Pharma (bortezomib) (confidentiality agreement not signed, not participating)
  Krka UK (dexamethasone) (confidentiality agreement not signed, not participating)
  Martindale Pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  Medac gmBH (bortezomib) (confidentiality agreement not signed, not participating)
  MSN Laboratories Europe (bortezomib) (confidentiality agreement not signed, not participating)
  Mylan (bortezomib, lenalidomide) (confidentiality agreement not signed, not participating)
  Pfizer (bortezomib) (confidentiality agreement not signed, not participating)
  Piramal Critical Care (lenalidomide) (confidentiality agreement not signed, not participating)
  Rosemont Pharmaceuticals (dexamethasone) (confidentiality agreement not signed, not participating)
  Sandoz (bortezomib, cyclophosphamide) (confidentiality agreement not signed, not participating)
  Sun Pharmaceuticals (bortezomib, lenalidomide) (confidentiality agreement not signed, not participating)
  Synchrony Pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  Teva UK (dexamethasone, lenalidomide) (confidentiality agreement not signed, not participating)
  Thornton & Ross (bortezomib, lenalidomide) (confidentiality agreement not signed, not participating)
  Tillomed Laboratories (bortezomib) (confidentiality agreement not signed, not participating)
  Torrent Pharma (lenalidomide) (confidentiality agreement not signed, not participating)
  Viatris UK Healthcare (bortezomib, lenalidomide) (confidentiality agreement not signed, not participating)
  Zentiva (lenalidomide) (confidentiality agreement not signed, 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
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
27 November 2024 Unfortunately, due to unforeseen capacity constraints during the critique phase of this appraisal, the timelines for this topic have been adjusted. This means the committee meeting will be moving from April 2025 to May 2025.
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