Suggested remit - To appraise the clinical and cost effectiveness of lisocabtagene maraleucel within its marketing authorisation for treating relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
Following on from information received from the company, NICE has decided to suspend this appraisal from its current work programme. The timelines for this appraisal are to be aligned with the latest regulatory and UK launch expectations and further information regarding the scheduling of this appraisal will be available in due course.
 
Status Suspended
Decision Selected
Process STA 2018
ID number 1444

Project Team

Project lead Louise Jafferally

Email enquiries

External Assessment Group Warwick Evidence, Warwick Medical School, University of Warwick

Stakeholders

Companies sponsors Celgene, a BMS company (Lisocabtagene maraleucel)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Blood Cancer UK
  Leukaemia Care
  Lymphoma Action
Professional groups Association of Cancer Physicians
  British Society for Haematology
  Cancer Research UK
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
Comparator companies Pfizer (cytarabine, epirubicin) (confidentiality agreement signed, participating)
  Servier Laboratories (pixantrone) (confidentiality agreement signed, participating)
  Accord Healthcare (carboplatin, cisplatin, cytarabine, epirubicin, etoposide, gemcitabine) (confidentiality agreement not signed, not participating)
  Advanz Pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  Aspen (dexamethasone) (confidentiality agreement not signed, not participating)
  Baxter Healthcare (ifosfamide) (confidentiality agreement not signed, not participating)
  Cheplapharm Arzneimittel GmbH (etoposide) (confidentiality agreement not signed, not participating)
  Consilient Health (carboplatin, 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)
  Hospira UK (carboplatin, cisplatin, cytarabine, dexamethasone, gemcitabine) (confidentiality agreement not signed, not participating)
  Jazz Pharmaceuticals UK (cytarabine) (confidentiality agreement not signed, not participating)
  Martindale Pharma (dexamethasone) (confidentiality agreement not signed, not participating)
  medac GmbH (epirubicin, etoposide) (confidentiality agreement not signed, not participating)
  Mylan (epirubicin) (confidentiality agreement not signed, not participating)
  Napp Pharmaceuticals (rituximab) (confidentiality agreement not signed, not participating)
  Panpharma UK (dexamethasone) (confidentiality agreement not signed, not participating)
  Sun Pharmaceutical (gemcitabine) (confidentiality agreement not signed, not participating)
  Roche Products (rituximab) (confidentiality agreement not signed, not participating)
  Rosemont Pharmaceuticals (dexamethasone) (confidentiality agreement not signed, not participating)
  Sandoz (cisplatin, rituximab) (confidentiality agreement not signed, not participating)
  Thame Laboratories (dexamethasone) (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
09 November 2021 Suspended. Following on from information received from the company, NICE has decided to suspend this appraisal from its current work programme. The timelines for this appraisal are to be aligned with the latest regulatory and UK launch expectations and further information regarding the scheduling of this appraisal will be available in due course.
27 July 2021 The appraisal was discussed by the technology appraisal committee on 13 July 2021. The Committee for Medicinal Products for Human Use (CHMP) has not yet given its opinion on lisocabtagene maraleucel for treating relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. We are therefore unable to release the committee’s recommendation.
13 July 2021 Committee meeting: 1
07 January 2021 The Department for Health and Social Care has asked NICE to conduct an appraisal of lisocabtagene maraleucel for treating relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. Please note that following a regulatory update from the company, the timelines for this appraisal have been revised and technical engagement is now anticipated to begin in late April 2021.
31 July 2020 Invitation to participate
12 June 2020 - 10 July 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
27 May 2020 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of lisocabtagene maraleucel for treating large B-cell lymphoma after at least 2 therapies. Please note that following on from communications with the company , the timelines for this appraisal have now been confirmed. The appraisal is anticipated to begin during late July 2020 when we will write to you about how you can get involved.
31 October 2019 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of lisocabtagene maraleucel for treating large B-cell lymphoma after at least 2 therapies. Please note that following on from advice received from the company further information regarding the timelines of this appraisal will be available in due course.
29 May 2019 - 26 June 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
10 May 2019 In progress. Referred 24 April 2017

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