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
- Expected publication:
- 10 September 2025
Project Team
- Project lead
- Thomas Feist
Email enquiries
If you have any queries please email [email protected]
- 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
- 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
- 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
- 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 |
|---|---|
| 02 July 2025 | Committee meeting: 2 |
| 02 July 2025 | Declaration of interests |
| 29 May 2025 - 19 June 2025 | Draft guidance |
| 07 May 2025 | Committee meeting: 1 |
| 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