Suggested remit: To appraise the clinical and cost effectiveness of belantamab mafodotin within its marketing authorisation for treating relapsed or refractory multiple myeloma after 4 or more therapies.
Status
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In progress
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Technology type
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Medicine
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Decision
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Selected
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Process |
TA
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ID number |
2701
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Project Team
Email enquiries
External Assessment Group |
Peninsula Technology Assessment Group (PenTAG), University of Exeter |
Stakeholders
Companies sponsors |
GlaxoSmithKline (belantamab mafodotin) |
Others |
Department of Health and Social Care |
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NHS England |
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Welsh Government |
Patient carer groups |
Blood Cancer UK |
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Myeloma UK |
Professional groups |
Association of Cancer Physicians |
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Cancer Research UK |
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Royal College of Physicians |
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Royal College of Radiologists |
Comparator companies |
Bristol Myers Squibb (pomalidomide and thalidomide) |
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Janssen-Cilag (bortezomib) |
General commentators |
All Wales Therapeutics and Toxicology Centre |
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British National Formulary |
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Department of Health, Social Services and Public Safety for Northern Ireland |
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Healthcare Improvement Scotland |
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Medicines and Healthcare products Regulatory Agency |
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Scottish Medicines Consortium |
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Welsh Health Specialised Services Committee |
Relevant research groups |
Institute of Cancer Research |
Date
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Update
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19 October 2023
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On 14 September 2023, a non-favourable opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) was issued for the belantamab mafodotin annual renewal procedure (EMEA/H/C/004935/R/0017). The non favourable opinion means that the European Medicines Agency’s CHMP has recommended not renewing the conditional marketing authorisation for belantamab mafodotin. On 21 September 2023 and in accordance with Article 9(2) of Regulation (EC) No. 726/2004, GSK requested the re-examination of the CHMP opinion for belantamab mafodotin’s annual renewal.
Following the company’s re-examination request, the Medicines and Healthcare products Regulatory Agency (MHRA), the regulator of medicines in the UK, is currently assessing the annual renewal of the GB marketing authorisation for belantamab mafodotin, as per the national procedure, and will make the decision on whether the licence is renewed in this country. NICE is therefore withdrawing the Final Draft Guidance and the appraisal will be paused until NICE has received the MHRA’s decision. This means that the appeal hearing will not proceed on 2 November but will be rescheduled in due course (if required).
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07 September 2023
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Appeal |
14 June 2023
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Committee meeting: 2 |
09 May 2023 - 31 May 2023
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Draft guidance |
13 April 2023
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Committee meeting |
02 August 2022
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Invitation to participate |
01 June 2022 - 01 July 2022
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Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
01 June 2022
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Scoping commenced |
24 January 2020
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In progress. Topic is in progress |
For further information on our processes and methods, please see our CHTE processes and methods manual