Suggested remit: To appraise the clinical and cost effectiveness of tucatinib with trastuzumab within its anticipated marketing authorisation for treating previously treated HER2-positive colorectal 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 6227

Project Team

Project lead Vonda Murray

Email enquiries

Stakeholders

Companies sponsors Pfizer (tucatinib)
Others Department of Health and Social Care
  Health Technology Wales
Patient carer groups Bowel Cancer UK
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists
Assessment group Liverpool Reviews and Implementation Group (LRIG)
Associated public health groups None
Comparator companies Bayer (regorafenib) (confidentiality agreement signed, participating)
  Merck Serono (cetuximab) (confidentiality agreement signed, participating)
  Pfizer (folinic acid, fluorouracil, irinotecan, oxaliplatin, raltitrexed, trastuzumab) (confidentiality agreement signed, participating)
  Roche (trastuzumab) (confidentiality agreement signed, participating)
  Servier (trifluridine with tipiracil) (confidentiality agreement signed, participating)
  A H pharmaceuticas (folinic acid, fluorouracil) (confidentiality agreement not signed, not participating)
  Accord (fluorouracil, irinotecan, oxaliplatin, trastuzumab) (confidentiality agreement not signed, not participating)
  Alliance (folinic acid) (confidentiality agreement not signed, not participating)
  Amgen (trastuzumab) (confidentiality agreement not signed, not participating)
  Celtrion (trastuzumab) (confidentiality agreement not signed, not participating)
  Consilient Health (folinic acid, irinotecan, oxaliplatin) (confidentiality agreement not signed, not participating)
  Fresenius Kabi (folinic acid, oxaliplatin) (confidentiality agreement not signed, not participating)
  Medac (folinic acid, fluorouracil, irinotecan, oxaliplatin) (confidentiality agreement not signed, not participating)
  Medihealth (folinic acid) (confidentiality agreement not signed, not participating)
  Organon (trastuzumab) (confidentiality agreement not signed, not participating)
  Pierre Fabre (encorafenib) (confidentiality agreement not signed, not participating)
  Seacross (irinotecan, oxaliplatin) (confidentiality agreement not signed, not participating)
  Sigma pharmaceuticals (folinic acid) (confidentiality agreement not signed, not participating)
  Sun pharmaceuticals (oxaliplatin) (confidentiality agreement not signed, not participating)
  Teva (folinic acid) (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
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
17 July 2024 Marketing authorisation has not yet been provided for Tucatinib with trastuzumab for previously treated HER2-positive colorectal cancer. We are therefore unable to publish the guideline until this is received.
11 July 2024 Committee meeting: 1
04 October 2023 Invitation to participate
25 August 2023 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 during early October 2023 when we will write to you about how you can get involved.
09 June 2023 - 07 July 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
09 June 2023 In progress. Scoping commenced
16 December 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

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