Suggested remit - To appraise the clinical and cost effectiveness of KTE-X19 within its marketing authorisation for treating relapsed or refractory mantle cell lymphoma
 
Status In progress
Process STA 2018
ID number 1313

Provisional Schedule

Committee meeting: 1 13 October 2020
Expected publication 06 January 2021

Project Team

Project lead Thomas Feist

Email enquiries

Evidence Review Group / Assessment Group Centre for Reviews and Dissemination and Centre for Health Economics, University of York

Consultees

Companies sponsors Kite, a Gilead company
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Royal College of Physicians
  Royal College of Radiologists
Professional groups Leukaemia CARE
  Lymphoma Action

Commentators

General commentators All Wales Therapeutics & Toxicology Centre
  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

Timeline

Key events during the development of the guidance:

Date Update
13 February 2020 Invitation to participate
18 October 2019 - 15 November 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
07 May 2019 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of KTE-X19 for treating relapsed or refractory mantle cell lymphoma. Please note that following on from advice received from the company the timelines for this appraisal have been revised. We now anticipate that the appraisal will begin during late January 2020 when we will write to you about how you can get involved.
14 February 2019 The National Institute for Health and Clinical Excellence (NICE) has been invited to carry out an appraisal of lymphoma (mantle cell, relapsed, refractory) – KTE-X19 (Axicabtagene ciloleucel in the consultation invitation). We have recently invited stakeholders to respond to a written consultation on the draft scope and to attend a scoping workshop for this appraisal. On receiving updated regulatory timing information from the company developing KTE-X19, NICE has agreed that a consultation on the draft scope and holding a scoping workshop at this time would not be appropriate. In light of this information, NICE will not be progressing with the scoping exercise at this time. Consequently the consultation on the draft scope will be closed and the scoping workshop arranged for Monday 11 March 2019 at 10:00 will be cancelled. 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 do not hesitate to contact me as the project manager for this appraisal on (0161 870 3148 or via email on michelle.adhemar@nice.org.uk or scopingta@nice.org.uk)
24 April 2018 In progress, Topic referred

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