Suggested remit: To appraise the clinical and cost effectiveness of durvalumab with gemcitabine and cisplatin within its marketing authorisation for treating untreated unresectable or advanced biliary tract cancer.
 
Status In progress
Technology type Medicine
Decision Selected
Process TA
ID number 4031

Project Team

Project lead Louise Jafferally

Email enquiries

External Assessment Group Liverpool Reviews and Implementation Group, University of Liverpool

Stakeholders

Companies sponsors AstraZeneca (durvalumab)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups AMMF – The Cholangiocarcinoma Charity
Professional groups Association of Cancer Physicians
  British Association for the Study of the Liver
  Cancer Research UK
  Cholangiocarcinoma-UK
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
Associated public health groups None
Comparator companies Accord Healthcare (capecitabine, cisplatin, fluorouracil, gemcitabine, oxaliplatin) (confidentiality agreement not signed, not participating)
  Dr. Reddy's Laboratories (capecitabine) (confidentiality agreement not signed, not participating)
  Glenmark Pharmaceuticals (capecitabine) (confidentiality agreement not signed, not participating)
  Medac Pharma (fluorouracil, oxaliplatin) (confidentiality agreement not signed, not participating)
  Morningside Healthcare (capecitabine) (confidentiality agreement not signed, not participating)
  Pfizer (cisplatin, fluorouracil, gemcitabine, oxaliplatin) (confidentiality agreement not signed, not participating)
  Sandoz (cisplatin) (confidentiality agreement not signed, not participating)
  Seacross Pharmaceuticals (oxaliplatin) (confidentiality agreement not signed, not participating)
  Sun Pharma (gemcitabine, oxaliplatin) (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 Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
08 August 2023 Committee meeting
28 November 2022 Invitation to participate
14 October 2022 - 11 November 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
14 October 2022 In progress. Scoping commencing

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