Status Awaiting development
Technology type Medicine
Decision Selected
Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Process STA Standard
ID number 6193

Provisional Schedule

Expected publication 08 May 2024

Project Team

Project lead Leena Issa

Email enquiries

External Assessment Group BMJ Technology Assessment Group (BMJ-TAG), BMJ

Stakeholders

Companies sponsors Menarini Stemline (selinexor)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Myeloma UK
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  UK Myeloma Society
Comparator companies AbbVie (dexamethasone) (confidentiality agreement not signed, not participating)
  Advanz pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  AS Kalceks (dexamethasone) (confidentiality agreement not signed, not participating)
  Aspen (dexamethasone) (confidentiality agreement not signed, not participating)
  Aspire Pharma (bortezomib, dexamethasone) (confidentiality agreement not signed, not participating)
  Bristol Myers Squibb Pharmaceuticals (pomalidomide) (confidentiality agreement not signed, not participating)
  Celgene (pomalidomide) (confidentiality agreement not signed, not participating)
  Consilient Health (dexamethasone) (confidentiality agreement not signed, not participating)
  Dr Reddy’s Laboratories (bortezomib) (confidentiality agreement not signed, not participating)
  GlaxoSmithKline (belantamab mafodotin) (confidentiality agreement signed, participating)
  Glenmark Pharmaceuticals (dexamethasone) (confidentiality agreement not signed, not participating)
  Hameln Pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  Hospira UK (dexamethasone) (confidentiality agreement not signed, not participating)
  Janssen-Cilag (bortezomib) (confidentiality agreement signed, 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 (bortezomib) (confidentiality agreement not signed, not participating)
  Mylan (bortezomib) (confidentiality agreement not signed, not participating)
  Novartis Pharmaceuticals (panobinostat) (confidentiality agreement not signed, not participating)
  Panpharma UK (dexamethasone) (confidentiality agreement not signed, not participating)
  Pfizer (bortezomib) (confidentiality agreement not signed, not participating)
  Ranbaxy UK Limited a Sun Pharmaceutical Company (bortezomib) (confidentiality agreement not signed, not participating)
  Rosemont Pharmaceuticals (dexamethasone) (confidentiality agreement not signed, not participating)
  Sandoz (bortezomib) (confidentiality agreement not signed, not participating)
  Secura Bio (panobinostat) (confidentiality agreement not signed, not participating)
  Synchrony Pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  Thame Laboratories (dexamethasone) (confidentiality agreement not signed, not participating)
  Thea Pharmaceuticals (dexamethasone) (confidentiality agreement not signed, not participating)
  Thornton and Ross (bortezomib) (confidentiality agreement not signed, not participating)
  Tillomed Laboratories (bortezomib) (confidentiality agreement not signed, not participating)
  Wockhardt UK (dexamethasone) (confidentiality agreement not signed, not participating)
  Zentiva (bortezomib) (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 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
09 April 2024 - 23 April 2024 Final draft guidance
10 January 2024 Committee meeting
06 December 2023 Please note the update to the committee meeting date. The committee meeting is now scheduled to take place on Wednesday 10 January 2024. This change is to ensure there is enough time to discuss the topic in full during the meeting.
20 June 2023 Invitation to participate
06 April 2023 Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of Selinexor with dexamethasone for treating relapsed or refractory multiple myeloma after 4 or more treatments have been revised. It is anticipated that the appraisal will begin in mid-June 2023 when we will write to you about how you can get involved.
01 February 2023 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
12 December 2022 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of Selinexor with dexamethasone for treating relapsed or refractory multiple myeloma after 4 or more treatments. The appraisal is expected to start in late April 2023 with a consultation on the draft scope. It is then anticipated that the final scope will be released along with an invitation to participate in the appraisal during mid-June 2023. The deadline for submissions is expected in approximately mid-August 2023. For information, this was originally terminated guidance TA700.

For further information on our processes and methods, please see our CHTE processes and methods manual