Suggested remit: To appraise the clinical and cost effectiveness of pembrolizumab with enfortumab vedotin within its marketing authorisation for treating untreated locally advanced or metastatic urothelial cancer.
- Status:
- In progress
- Technology type:
- Medicine
- Decision:
- Selected
- Reason for decision:
- Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
- Process:
- STA Standard
- ID number:
- 6332
Provisional Schedule
- Expected publication:
- 21 August 2025
Project Team
- Project lead
- Leena Issa
Email enquiries
If you have any queries please email [email protected]
- External Assessment Group:
- Southampton Health Technology Assessment Centre (SHTAC), University of Southampton
Stakeholders
- Companies sponsors
- Astellas
- 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
- Cancer Research UK
- Royal College of Physicians
- Royal College of Radiologists
- Comparator companies
- Merck Sharp and Dohme (pembrolizumab) (confidentiality agreement signed, participating)
- Roche (atezolizumab) (confidentiality agreement signed, participating)
- Advanz Pharma (methotrexate) (confidentiality agreement not signed, not participating)
- Amgen (filgrastim, pegfilgrastim) (confidentiality agreement not signed, not participating)
- Baxter (doxorubicin) (confidentiality agreement not signed, not participating)
- Chugai Pharma (lenograstim) (confidentiality agreement not signed, not participating)
- Cipla (methotrexate) (confidentiality agreement not signed, not participating)
- Hospira UK (carboplatin, cisplatin, gemcitabine, methotrexate, vinblastine) (confidentiality agreement not signed, not participating)
- Medac GmbH (doxorubicin, methotrexate) (confidentiality agreement not signed, not participating)
- Morningside Healthcare (methotrexate) (confidentiality agreement not signed, not participating)
- Napp Pharmaceuticals (pegfilgrastim) (confidentiality agreement not signed, not participating)
- Pfizer (methotrexate, doxorubicin, filgrastim) (confidentiality agreement not signed, not participating)
- Rosemont Pharmaceuticals (methotrexate) (confidentiality agreement not signed, not participating)
- Sandoz (cisplatin, pegfilgrastim, filgrastim) (confidentiality agreement not signed, not participating)
- Seacross Pharmaceuticals (doxorubicin) (confidentiality agreement not signed, not participating)
- Sun Pharmaceutical (gemcitabine) (confidentiality agreement not signed, not participating)
- Synchrony Pharma (gemcitabine) (confidentiality agreement not signed, not participating)
- Therakind (methotrexate) (confidentiality agreement not signed, not participating)
- Teva Pharma (lipegfilgrastim) (confidentiality agreement not signed, not participating)
- General commentators
- All Wales Therapeutics and Toxicology Centre
- British National Formulary
- Department of Health - Northern Ireland
- Healthcare Improvement Scotland
- Medicines and Healthcare products Regulatory Agency
- NHS Wales Joint Commissioning Committee
- Scottish Medicines Consortium
- Welsh Government
- Relevant research groups
- Institute of Cancer Research
Timeline
Key events during the development of the guidance:
Date | Update |
---|---|
13 May 2025 | Committee meeting |
01 April 2025 - 29 April 2025 | Draft guidance |
11 March 2025 | Committee meeting |
11 March 2025 | Declaration of interests |
08 August 2024 | Invitation to participate |
27 February 2024 | Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in early August 2024. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission. |
12 January 2024 - 09 February 2024 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6332 |
12 January 2024 - 09 February 2024 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6332 |
12 January 2024 | In progress. Scoping commencing |
16 December 2022 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
16 December 2022 | Topic selection |
For further information on our processes and methods, please see our CHTE processes and methods manual