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.
The company have advised that they are no longer pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its work program. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes.
- Status:
- Suspended
- 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
If you have any queries please email tateam3@nice.org.uk
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 - 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 |
|---|---|
| 16 January 2025 | Suspended. The company have advised that they are no longer pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its work program. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes. |
| 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