Suggested remit: To appraise the clinical and cost effectiveness of selinexor with bortezomib and low-dose dexamethasone within its marketing authorisation for treating relapsed refractory multiple myeloma.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 3797

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 Blood Cancer UK
  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 signed, participating)
  ADVANZ Pharma (dexamethasone, lenalidomide) (confidentiality agreement not signed, not participating)
  Amarox (lenalidomide) (confidentiality agreement not signed, not participating)
  Amgen (carfilzomib) (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)
  Bausch & Lomb U.K (dexamethasone) (confidentiality agreement not signed, not participating)
  Biocon Pharma UK (lenalidomide) (confidentiality agreement not signed, not participating)
  Bristol Myers Squibb Pharmaceuticals (lenalidomide) (confidentiality agreement not signed, not participating)
  Cipla EU (lenalidomide) (confidentiality agreement not signed, not participating)
  Dr. Reddy's Laboratories UK (bortezomib) (confidentiality agreement not signed, not participating)
  GlaxoSmithKline UK (belantamab mafodotin) (confidentiality agreement not signed, not participating)
  Glenmark Pharmaceuticals Europe (dexamethasone, lenalidomide) (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, daratumumab) (confidentiality agreement not signed, not participating)
  Krka UK (dexamethasone) (confidentiality agreement not signed, not participating)
  Martindale Pharma, an Ethypharm Group Company (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)
  Novartis Pharmaceuticals UK (dexamethasone) (confidentiality agreement signed, participating)
  Panpharma UK (dexamethasone) (confidentiality agreement not signed, not participating)
  ParaPharm Development (dexamethasone) (confidentiality agreement not signed, not participating)
  Pfizer (bortezomib) (confidentiality agreement not signed, not participating)
  Piramal Critical Care (lenalidomide) (confidentiality agreement not signed, not participating)
  Ranbaxy UK Limited a Sun Pharmaceutical Company (bortezomib, lenalidomide) (confidentiality agreement not signed, not participating)
  Rayner Pharmaceuticals (dexamethasone) (confidentiality agreement not signed, not participating)
  Rosemont Pharmaceuticals (dexamethasone) (confidentiality agreement not signed, not participating)
  Sandoz (bortezomib, lenalidomide) (confidentiality agreement not signed, not participating)
  Sanofi (dexamethasone, isatuximab) (confidentiality agreement not signed, not participating)
  Santen UK (dexamethasone) (confidentiality agreement not signed, not participating)
  Secura Bio (panobinostat) (confidentiality agreement not signed, not participating)
  Synchrony Pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  Takeda UK (ixazomib) (confidentiality agreement signed, participating)
  Teva UK (dexamethasone, lenalidomide) (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 & Ross (bortezomib, lenalidomide) (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, 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 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
07 March 2024 Committee meeting: 2
02 February 2024 - 23 February 2024 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 bortezomib and low-dose dexamethasone for treating relapsed refractory multiple myeloma 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.
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 bortezomib and low-dose dexamethasone for treating relapsed refractory multiple myeloma. 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.
17 August 2022 Assessment report sent for information
16 June 2021 Timelines for this appraisal are to be confirmed. Further information regarding the scheduling of this appraisal will be available in due course.
29 January 2021 The Department for Health and Social Care has asked NICE to conduct an appraisal of selinexor with bortezomib and low-dose dexamethasone for treating relapsed refractory multiple myeloma. Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in late September 2021 when we will write to you about how you can get involved. These timelines are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive submission.
25 August 2020 - 23 September 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
05 November 2019 In progress. DHSC referral received

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