To appraise the clinical and cost effectiveness of tisagenlecleucel-T within its marketing authorisation for relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged 3 to 25 years
 
Status In progress
Process STA pre-2018
ID number 1167

Provisional Schedule

Expected publication 21 December 2018

Project Team

Project lead Stephanie Callaghan

Email enquiries

Consultees

Companies sponsors Novartis (tisagenlecleucel-T)
Others Department for Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Bloodwise
  Leukaemia CARE
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

Commentators

Comparator companies Accord Healthcare Ltd (cytarabine, filgrastim, fludarabine, idarubicin, imatinib) (Confidentiality agreement not signed, not participating)
  Actavis UK Ltd (fludarabine, imatinib) (Confidentiality agreement not signed, not participating)
  Amgen Ltd (blinatumomab, filgrastim)
  Aurobindo Pharma - Milpharm Ltd (imatinib) (Confidentiality agreement not signed, not participating)
  Bristol-Myers Squibb Pharmaceutical Limited (dasatinib) (Confidentiality agreement not signed, not participating)
  Chugai Pharma UK Ltd (lenograstim) (Confidentiality agreement not signed, not participating)
  Consilient Health Ltd (clofarabine) (Confidentiality agreement not signed, not participating)
  Dr. Reddy's Laboratories (UK) Ltd (imatinib) (Confidentiality agreement not signed, not participating)
  Generics UK T/A Mylan (imatinib) (Confidentiality agreement not signed, not participating)
  Hospira UK Ltd (cytarabine, filgrastim, fludarabine) (Confidentiality agreement not signed, not participating)
  Incyte BioSciences UK Ltd (ponatinib) (Confidentiality agreement not signed, not participating)
  Intrapharm Laboratories Limited (imatinib) (Confidentiality agreement not signed, not participating)
  Napp Pharmaceuticals Ltd (cytarabine) (Confidentiality agreement not signed, not participating)
  Novartis Pharmaceuticals Ltd (imatinib)
  Pfizer Ltd (cytarabine, idarubicin)
  Rivopharm UK Ltd (imatinib) (Confidentiality agreement not signed, not participating)
  Sandoz Ltd (filgrastim, fludarabine, imatinib) (Confidentiality agreement not signed, not participating)
  Sanofi (clofarabine, fludarabine) (Confidentiality agreement not signed, not participating)
  Teva Pharma B.V. (lipegfilgrastim) (Confidentiality agreement not signed, not participating)
  Wockhardt UK Ltd (imatinib) (Confidentiality agreement not signed, not participating)
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Cell and Gene Therapy Catapult
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
22 August 2018 Committee meeting: 1
15 March 2018 Invitation to participate
16 November 2017 - 14 December 2017 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
16 November 2017 In progress, In progress

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