| Status | In progress |
| Technology type | Medicine |
| Decision | Selected |
| Process | STA Standard |
| ID number | 4026 |
Provisional Schedule
| Expected publication | 11 December 2024 |
Project Team
| Project lead | Vonda Murray |
Email enquiries
- If you have any queries please email tateam3@nice.org.uk
| External Assessment Group | Health Economics Research Unit and Health Services Research Unit, University of Aberdeen |
Stakeholders
| Companies sponsors | Pfizer (elranatamab) |
| Others | Department of Health and Social Care |
| NHS England | |
| Patient carer groups | Myeloma UK |
| Professional groups | Association of Cancer Physicians |
| Cancer Research UK | |
| Royal College of Radiologists | |
| Royal College of Physicians | |
| UK Myeloma Society | |
| Assessment group | Aberdeen HTA Group |
| Associated public health groups | Public Health Wales |
| UK Health Security Agency | |
| Comparator companies | Bristol Myers Squibb Pharmaceuticals (lenalidomide, pomalidomide) (confidentiality agreement signed, participating) |
| GlaxoSmithKline (belantamab mafodotin) (confidentiality agreement signed, participating) | |
| Janssen-Cilag (bortezomib, daratumumab) (confidentiality agreement signed, participating) | |
| Takeda (ixazomib) (confidentiality agreement signed, participating) | |
| Accord Healthcare (bortezomib, lenalidomide) (confidentiality agreement not signed, not participating) | |
| Aspire Pharma (bortezomib) (confidentiality agreement not signed, not participating) | |
| Cipla EU (lenalidomide) (confidentiality agreement not signed, not participating) | |
| Dr Reddy's Laboratories (bortezomib) (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 (lenalidomide) (confidentiality agreement not signed, not participating) | |
| Piramal Critical Care (lenalidomide) | |
| Ranbaxy (bortezomib) (confidentiality agreement not signed, not participating) | |
| Sandoz (bortezomib, cyclophosphamide) (confidentiality agreement not signed, not participating) | |
| Secura Bio (panobinostat) (confidentiality agreement not signed, not participating) | |
| Teva UK (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) | |
| Zentiva (bortezomib, lenalidomide) (confidentiality agreement not signed, not participating) | |
| General commentators | All Wales Therapeutics and Toxicology Centre |
| British National Formulary | |
| Department of Health, Social Services and Public Safety for 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 |
| National Institute for Health Research |
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 29 October 2024 - 18 November 2024 | Final draft guidance |
| 09 October 2024 | Committee meeting: 2 |
| 09 October 2024 | Declaration of interests |
| 12 July 2024 - 09 August 2024 | Draft guidance |
| 11 July 2024 | NICE has decided to withdraw the final draft guidance for elranatamab for treating relapsed and refractory multiple myeloma after 3 or more treatments [ID4026] and instead will be issuing draft guidance to consult on the optimised recommendation. NICE will hold a 28-day consultation in which stakeholders invited to comment on the draft guidance document. NICE will then hold a committee meeting to consider the consultation responses. As there will continue to be a positive draft recommendation for managed access in the relevant population, interim funding will remain available for patients eligible for elranatamab under this recommendation. |
| 14 March 2024 | Committee meeting: 1 |
| 14 March 2024 | Declaration of interests |
| 14 August 2023 | Invitation to participate |
| 16 May 2023 | Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of Elranatamab for treating refractory multiple myeloma after 3 standard therapies have been revised. It is anticipated that the appraisal will begin in early-August 2023 when we will write to you about how you can get involved. |
| 16 November 2022 - 14 December 2022 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
| 02 December 2022 | As you will be aware, the Department for Health & Social Care has asked NICE to conduct an appraisal of Elranatamab for treating refractory multiple myeloma after 3 standard therapies. 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 in mid-April 2023 when we will write to you about how you can get involved. |
| 28 January 2022 | In progress. DHSC referral received |
For further information on our processes and methods, please see our CHTE processes and methods manual