Suggested remit: To appraise the clinical and cost effectiveness of idecabtagene vicleucel within its marketing authorisation for treating relapsed and refractory multiple myeloma in people who have received at least 3 prior therapies.
 
Status In progress
Process STA 2018
ID number 1442

Project Team

Project lead Louise Jafferally

Email enquiries

Evidence Review Group / Assessment Group BMJ Technology Assessment Group (BMJ-TAG), BMJ

Consultees

Companies sponsors Celgene, a Bristol Myers Squibb (BMS) company (Idecabtagene vicleucel)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Blood Cancer UK
  Leukaemia Care
  Myeloma UK
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists
  UK Myeloma Forum

Commentators

Comparator companies Celgene, a BMS company (pomalidomide) (confidentiality agreement signed, participating)
  Janssen-Cilag (bortezomib) (confidentiality agreement signed, participating)
  Novartis Pharmaceuticals (panobinostat) (confidentiality agreement signed, participating)
  Pfizer (dexamethasone) (confidentiality agreement signed, participating)
  Advanz Pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  Aspen Pharma Trading (dexamethasone) (confidentiality agreement not signed, not participating)
  Aspire Pharma Ltd (bortezomib, dexamethasone) (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)
  Ethypharm (dexamethasone) (confidentiality agreement not signed, not participating)
  Glenmark Pharmaceuticals (dexamethasone) (confidentiality agreement not signed, not participating)
  Hameln Pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  Martindale Pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  Panpharma UK (dexamethasone) (confidentiality agreement not signed, not participating)
  Rosemont Pharmaceuticals (dexamethasone) (confidentiality agreement not signed, not participating)
  Synchrony Pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  Thame Laboratories (dexamethasone) (confidentiality agreement not signed, not participating)
  Thornton & Ross (bortezomib) (confidentiality agreement not signed, not participating)
  Wockhardt UK (dexamethasone) (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

Timeline

Key events during the development of the guidance:

Date Update
07 January 2021 The Department for Health and Social Care has asked NICE to conduct an appraisal of idecabtagene vicleucel for treating relapsed and refractory multiple myeloma in people who have received at least 3 prior therapies. Please note that following on from advice received from the company the timelines for this appraisal are to be confirmed. As this appraisal has been referred, NICE will continue to monitor any developments and will provide an update as and when the situation changes.
06 October 2020 Invitation to participate
17 July 2020 - 14 August 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
08 June 2020 In progress. Topic is in progress
08 June 2020 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of Idecabtagene vicleucel for treating relapsed and refractory multiple myeloma. This appraisal has been rescheduled to allow the company to include important data to be presented in their submission. This delay means that this appraisal will be removed from NICE’s reporting targets for timeliness. In addition, as the delay will mean a NICE recommendation will not be available at the point of marketing authorisation, the company accepts that funding will only be available after the NICE recommendation, and not during the interim period between marketing authorisation and NICE recommendation. For information, this appraisal is now anticipated to begin during early October 2020 when we will write to you about how you can get involved.

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance