Topic update: this appraisal has not been defined as therapeutically critical. The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide an update when this information is available.
 
Status Schedule affected by COVID-19
Process CDF Review
ID number 1536

Project Team

Project lead Kate Moore

Email enquiries

Evidence Review Group / Assessment Group Warwick Evidence, Warwick Medical School, University of Warwick

Consultees

Companies sponsors Merck Sharp & Dohme (pembrolizumab)
Others Department of Health
  NHS England
  Welsh Government
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

Commentators

Comparator companies None
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
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
23 June 2020 Appeal
23 June 2020 Appeal
05 May 2020 Schedule affected by COVID-19. Topic update: this appraisal has not been defined as therapeutically critical. The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide an update when this information is available.
30 April 2020 NICE received three appeals against the Final Appraisal Document on the above technology from the following organisations: Action Bladder Cancer UK, Fight Bladder Cancer and Merck Sharp Dohme Ltd (MSD). During initial scrutiny, it was agreed that MSD’s appeal will proceed to an oral appeal hearing. As the other appeals did not fall within one or more of the two strictly limited grounds for appeal, these were rejected at scrutiny and will not proceed to the hearing. The appeal panel will convene on Tuesday 23 June 2020 at 10am to hear oral representations from the appellant, MSD. Due to the current COVID-19 pandemic, this will be a virtual appeal hearing via Zoom.
12 March 2020 - 26 March 2020 Final appraisal document
06 February 2020 Committee meeting: 2
15 November 2019 - 05 December 2019 Appraisal consultation
03 December 2019 The company, Merck Sharp & Dohme, have asked to submit additional analyses with their response to the appraisal consultation, and this request has been accepted. To allow a review of the evidence, the second appraisal committee meeting has been moved to 6 February 2020.
15 November 2019 This appraisal (ID1536) is a review of pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy (TA519) following data collection via a managed access agreement. Patient access according to the terms of TA519 is unaffected by the draft recommendations of ID1536 while the review is ongoing.
22 October 2019 Committee meeting
26 June 2019 Invitation to participate
10 May 2019 In progress. Referred 22 July 2016

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