Suggested remit: To appraise the clinical and cost effectiveness of KTE-X19 within its marketing authorisation for previously treated B-precursor acute lymphoblastic leukaemia.
 
Status In progress
Decision Selected
Process STA 2018
ID number 1494

Provisional Schedule

Committee meeting 04 October 2022
Expected publication 14 December 2022

Project Team

Project lead Gavin Kenny

Email enquiries

Stakeholders

Companies sponsors • Kite, a Gilead company (autologous auto-CD19-transduced CD3+ cells)
Others • Department of Health and Social Care
  • NHS Cumbria CCG
  • NHS England
  • NHS Mansfield & Ashfield CCG
  • Welsh Government
Patient carer groups • African Caribbean Leukaemia Trust
  • Anthony Nolan
  • Black Health Agency
  • Blood Cancer UK
  • Cancer Black Care
  • Cancer Equality
  • Cancer52
  • Chronic Lymphocytic Leukaemia Support Association
  • DKMS
  • Helen Rollason Cancer Charity
  • Independent Cancer Patients Voice
  • Leukaemia Cancer Society
  • Leukaemia Care
  • Leukaemia UK
  • Lymphoma Action
  • Macmillan Cancer Support
  • Maggie’s Centres
  • Marie Curie
  • South Asian Health Foundation
  • Specialised Healthcare Alliance
  • Tenovus Cancer Care
Professional groups • Association of Cancer Physicians
  • British Blood Transfusion Society
  • British Committee for Standards in Haematology
  • British Geriatrics Society
  • British Institute of Radiology
  • British Psychosocial Oncology Society
  • British Society for Haematology
  • Cancer Research UK
  • 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 Chronic Lymphocytic Leukaemia Forum
  • UK Clinical Pharmacy Association
  • UK Oncology Nursing Society
Associated guideline groups • Public Health England
  • Public Health Wales
Comparator companies • Accord Healthcare (cytarabine, filgrastim, fludarabine, idarubicin, imatinib)
  • Amgen (blinatumomab, filgrastim, pegfilgrastim)
  • Aurobindo Pharma (imatinib)
  • Bristol-Myers Squibb (dasatinib)
  • Chugai Pharma UK (lenograstim)
  • Cipla EU (imatinib)
  • Dr. Reddy’s Laboratories (imatinib)
  • Incyte Biosciences UK (ponatinib)
  • Intrapharm Laboratories (imatinib)
  • Novartis (imatinib)
  • Pfizer (cytarabine, filgrastim, idarubicin, inotuzumab ozogamicin)
  • Rivopharm UK (imatinib)
  • Rosemont Pharmaceuticals (imatinib)
  • Sandoz (filgrastim, imatinib)
  • Sanofi (fludarabine)
  • Teva Pharma (lipegfilgrastim)
  • Tillomed Laboratories (dasatinib)
  • Wockhardt UK (imatinib)
  • Zentiva (dasatinib, imatinib)
General commentators • All Wales Therapeutics and 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
  • Hospital Information Services – Jehovah’s Witnesses
  • Medicines and Healthcare products Regulatory Agency
  • National Association of Primary Care
  • National Pharmacy Association
  • NHS Alliance
  • NHS Blood and Transplant
  • NHS Confederation
  • Scottish Medicines Consortium
  • Welsh Health Specialised Services Committee
Relevant research groups • Cochrane Haematological Malignancies Group
  • Genomics England
  • Institute of Cancer Research
  • Leuka
  • Leukaemia Busters
  • MRC Clinical Trials Unit
  • National Cancer Research Institute
  • National Cancer Research Network
  • National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
22 September 2021 Invitation to participate
07 April 2021 - 06 May 2021 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
27 May 2020 Following on from advice received from the company the timelines for this appraisal are to be aligned with the latest regulatory expectations and further information regarding the scheduling of this appraisal will be available in due course.
13 February 2018 In progress. Topic referred

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