Suggested remit: to appraise the clinical and cost effectiveness of erdafitinib within its marketing authorisation for treating metastatic or unresectable fibroblast growth factor receptor (FGFR)-positive urothelial cancer.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 1333

Provisional Schedule

Committee meeting 05 December 2024
Expected publication 26 February 2025

Project Team

Project lead Celia Mayers

Email enquiries

Stakeholders

Companies sponsors Johnson and Johnson Innovative Medicine
Others Department of Health and Social Care
  NHS England
Patient carer groups Action Bladder Cancer UK
  Fight Bladder Cancer
Professional groups Association of Cancer Physicians
  British Uro-Oncology Group
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists
Comparator companies Bristol Myers Squibb Pharmaceuticals limited (nivolumab) – confidentiality agreement not signed, not participating
  Celgene (paclitaxel) – confidentiality agreement not signed, not participating
  Hospira UK Ltd (docetaxel, paclitaxel) – confidentiality agreement not signed, not participating
  Merck, Sharp & Dohme (pembrolizumab) – confidentiality agreement not signed, not participating
  Roche (atezolizumab)
  Seacross Pharmaceuticals (docetaxel,
  paclitaxel) – confidentiality agreement not signed, not participating
  Teva UK Limited (paclitaxel) – 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 Government
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
09 September 2024 Due to scheduling reasons, the first committee meeting for this topic will now be held on Thursday 5 December 2024.
22 April 2024 Invitation to participate
16 January 2024 - 13 February 2024 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: ID1333
16 January 2024 In progress. Scoping commenced.
23 October 2023 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 mid-April 2024 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid-June 2024.
13 December 2018 Following notification from the company, the timelines for this appraisal will be confirmed once regulatory approval timelines have been established. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties as and when the situation changes.
03 September 2018 This appraisal will be rescheduled to allow the company to include important data to be presented in their submission. This delay means that this appraisal will be removed from the NICE’s reporting targets for timeliness. In addition, through this request for delay the company accepts that this drug will not be eligible to receive interim CDF funding from the date of marketing authorisation.
06 June 2018 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of erdafitinib for treating metastatic or unresectable FGFR-positive urothelial cancer. Following on from an update from the company, the timelines for this appraisal remain to be confirmed. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties as and when the situation changes.
28 September 2017 In progress. In progress

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