| Status | In progress |
| Technology type | Medicine |
| Decision | Selected |
| Process | STA Standard |
| ID number | 1333 |
Provisional Schedule
| Expected publication | 26 February 2025 |
Project Team
| Project lead | Leena Issa |
Email enquiries
- If you have any queries please email TATeam6@nice.org.uk
| External Assessment Group | Kleijnen Systematic Reviews Ltd |
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 | |
| Associated public health groups | None |
| 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) - confidentiality agreement signed, participating | |
| 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 |
|---|---|
| 04 December 2024 | Committee meeting |
| 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