Suggested remit: To appraise the clinical and cost effectiveness of trastuzumab deruxtecan within its marketing authorisation for treating HER2-low metastatic or unresectable breast cancer after chemotherapy.
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 3935

Project Team

Project lead Thomas Feist

Email enquiries

External Assessment Group School of Health and Related Research (ScHARR), University of Sheffield


Companies sponsors Daiichi Sankyo
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Breast Cancer Now
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists
  UK Breast Cancer Group (UKBCG)
Comparator companies Eisai
  Gilead Sciences
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary (BNF)
  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


Key events during the development of the guidance:

Date Update
15 May 2024 We are issuing a short exceptional pause to the publication of our final guidance on this topic. The aim is to allow all parties to reach a rapid commercial solution that enables patient access to this treatment.
05 March 2024 - 19 March 2024 Final draft guidance
05 March 2024 Commercial discussions have concluded and the appraisal has resumed. Final Draft Guidance has been issued.
17 January 2024 Declaration of interests
06 December 2023 This topic has been paused following the second committee meeting to allow the company and NHSE to engage in commercial discussions. This pause is analogous to that described in section 5.8.34 to 5.8.41 of NICE health technology evaluations: the manual, except that there is no opportunity for further consultation.
07 November 2023 Committee meeting: 2
26 September 2023 - 17 October 2023 Draft guidance
05 September 2023 Committee meeting: 1
06 January 2023 Invitation to participate
20 October 2022 - 17 November 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
20 October 2022 In progress. Scoping commenced.

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