Suggested Remit: To appraise the clinical and cost effectiveness of axicabtagene ciloleucel within its marketing authorisation for treating relapsed or refractory diffuse large B-cell lymphoma
 
Status In progress
Decision Selected
Process STA 2018
ID number 1684

Provisional Schedule

Committee meeting: 1 06 September 2022
Expected publication 16 November 2022

Project Team

Project lead Louise Jafferally

Email enquiries

Stakeholders

Companies sponsors Kite, a Gilead company (axicabtagene ciloleucel)
  Association of Cancer Physicians
  British Committee for Standards in Haematology
  British Geriatrics Society
  British Institute of Radiology
  British Psychosocial Oncology Society
  British Society for Haematology
  British Society of Interventional Radiology
  Cancer Research UK
  Health Lumen
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society and College of Radiographers
  UK Clinical Pharmacy Association
  UK Cutaneous Lymphoma Group
  UK Oncology Nursing Society
Others Department of Health and Social Care
  NHS England
  NHS Lewisham CCG
  NHS North East London CCG
  Welsh Government
Patient carer groups African Caribbean Leukaemia Trust
  Anthony Nolan
  Black Health Agency for Equality
  Blood Cancer UK
  Cancer Black Care
  Cancer Equality
  Cancer52
  DKMS
  Helen Rollason Cancer Charity
  Independent Cancer Patients Voice
  Leukaemia Cancer Society
  Leukaemia Care
  Lymphoma Action
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Tenovus Cancer Care
  WMUK
Assessment group Cochrane Haematological Malignancies Group
  Cochrane UK
  Genomics England
  Institute of Cancer Research
  Leukaemia Busters
  Leukaemia UK
  Lymphoma Research Trust
  MRC Clinical Trials Unit
  National Cancer Research Network
  National Institute for Health Research
  Public Health Wales
  UK Health Security Agency
Comparator companies Accord Healthcare (bendamustine, carboplatin, cisplatin, cytarabine, epirubicin, etoposide, gemcitabine, oxaliplatin)
  Baxter Healthcare (cyclophosphamide, ifosfamide)
  Bristol-Myers Squibb Pharmaceuticals (lenalidomide)
  Dr Reddy’s Laboratories (bendamustine)
  Hospira UK (carboplatin, cisplatin, cytarabine, gemcitabine, oxaliplatin)
  Incyte (tafasitamab)
  Jazz Pharmaceuticals UK (cytarabine)
  Medac UK (epirubicin, etoposide, oxaliplatin
  Napp Pharmaceuticals (rituximab)
  Neon Healthcare (etoposide)
  Pfizer (cytarabine, epirubicin, methylprednisolone, rituximab)
  Roche Products (polatuzumab vedotin, rituximab)
  Sandoz Ltd (cisplatin, cyclophosphamide, rituximab)
  Seacross Pharmaceuticals (bendamustine, oxaliplatin)
  Sun Pharmaceutical Company (gemcitabine, oxaliplatin)
General commentators All Wales Therapeutics & Toxicology Centre
  Allied Health Professionals Federation
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
06 January 2022 Invitation to participate
29 October 2021 - 26 November 2021 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
18 June 2021 Timelines for this appraisal are to be confirmed. Further information regarding the scheduling of this appraisal will be available in due course.
21 May 2021 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 during early January 2022 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid-March 2022.
28 May 2020 The National Institute for Health and Care Excellence (NICE) has been asked to conduct an appraisal of axicabtagene ciloleucel for treating relapsed or refractory diffuse large B-cell lymphoma after 1 systemic therapy ID1684. We have recently invited stakeholders to respond to a written consultation on the draft scope. On receiving updated regulatory timing information from the company that is developing axicabtagene ciloleucel, NICE has agreed that holding a scoping exercise at this time would not be appropriate. Consequently, the consultation on the draft scope will be closed. The scoping exercise will be rescheduled to take place in line with anticipated regulatory approval timings. We apologise for any inconvenience this may cause. If you have any comments or concerns please contact the project manager for this proposed appraisal Emily Richards on (44 (0)161 413 4070 or via email on emily.richards@nice.org.uk)
24 January 2020 In progress. Topic is in progress

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