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