Suggested remit: To appraise the clinical and cost effectiveness of elranatamab within its marketing authorisation for treating relapsed or refractory multiple myeloma after 3 therapies.
 
 
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 4026

Provisional Schedule

Draft guidance 12 July 2024 - 09 August 2024

Project Team

Project lead Vonda Murray

Email enquiries

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
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. We will update the website with the dates for consultation and second committee meeting soon.
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