Skip to main content
SpringerLink
Log in

Disease Severity Modifier in the NICE Single Technology Appraisal of Trastuzumab Deruxtecan: External Assessment Group Perspective

  • Commentary
  • Published:
PharmacoEconomics Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. National Institute for Health and Care Excellence (NICE). Guide to the methods of technology appraisal. 2022. https://www.nice.org.uk/process/pmg36/. Accessed 11 Aug 2023.

  2. National Institute for Health and Care Excellence (NICE).TA862: Trastuzumab deruxtecan for treating HER2-positive unresectable or metastatic breast cancer after 1 or more anti-HER2 treatments. 2023. https://www.nice.org.uk/guidance/ta862. Accessed 11 Aug 2023.

  3. Collins B. Access to new Medicines in the English NHS. 2020. https://www.kingsfund.org.uk/publications/access-new-medicines-english-nhs. Accessed 7 Aug 2023.

  4. Mott D. Value Based Assessment: The Case of Proportional Shortfall. 2014. https://blogs.ncl.ac.uk/healtheconomicsgroup/2014/10/17/value-based-assessment-the-case-of-proportional-shortfall/. Accessed 11 Aug 2023.

  5. National Institute for Health and Care Excellence (NICE).Modifiers task and finish group report. 2020. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/chte-methods-consultation. Accessed 9 Aug 2023.

  6. Skedgel C, Henderson N, Towse A, Mott D, Green C. Considering severity in health technology assessment: can we do better? Value Health. 2022;25(8):1399–403.

    Article  PubMed  Google Scholar 

  7. Stolk EA, van Donselaar G, Brouwer WB, Busschbach JJ. Reconciliation of economic concerns and health policy: illustration of an equity adjustment procedure using proportional shortfall. Pharmacoeconomics. 2004;22(17):1097–107.

    Article  PubMed  Google Scholar 

  8. Sinha AH, Howard D, Thurgar E. The NICE Disease Severity Modifier: a retrospective analysis on its potential impact on previous reimbursement decisions in England [abstract]. Value Health. 2022;2(12 Suppl):S303.

    Article  Google Scholar 

  9. National Institute for Health and Care Excellence (NICE). Position statement on the use of the EQ-5D-5L value set for England (updated October 2019). 2019. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/technology-appraisal-guidance/eq-5d-5l. Accessed 8 Aug 2023.

  10. Hernández Alava M, Pudney S, Wailoo A. Estimating the relationship between EQ-5D-5L and EQ-5D-3L: results from an English Population Study. Policy Research Unit in Economic Evaluation of Health and Care Interventions, Universities of Sheffield and York Report 063; 2020.

  11. Hernández-Alava M, Pudney S. Econometric modelling of multiple self-reports of health states: the switch from EQ-5D-3L to EQ-5D-5L in evaluating drug therapies for rheumatoid arthritis. J Health Econ. 2017;55:139–52.

    Article  PubMed  PubMed Central  Google Scholar 

  12. National Institute for Health and Care Excellence (NICE). Review of methods, processes and topic selection for health technology evaluation programmes: conclusions and final update. Appendix: Further discussion and rationale for conclusions—methods. 2022. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/changes-to-health-technology-evaluation. Accessed 8 Aug 2023.

  13. Cortés J, Kim S-B, Chung W-P, Im S-A, Park YH, Hegg R, et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386(12):1143–54. https://doi.org/10.1056/NEJMoa2115022.

    Article  PubMed  Google Scholar 

  14. Schneider P, McNamara S, Love-Koh J, Doran T, Gutacker N. QALY shortfall calculator. 2021. https://shiny.york.ac.uk/shortfall/. Accessed 11 Aug 2023.

  15. National Institute for Health and Care Excellence (NICE). Review of methods for health technology evaluation programmes: proposals for change (Consulation 2). 2021. https://www.nice.org.uk/Media/Default/About/what-we-do/our-programmes/nice-guidance/chte-methods-and-processes-consultation/methods-proposal-paperdocx. Accessed 7 Aug 2023.

  16. van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012;15(5):708–15.

    Article  PubMed  Google Scholar 

  17. Diéras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, et al. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(6):732–42.

    Article  PubMed  PubMed Central  Google Scholar 

  18. National Institute for Health and Care Excellence (NICE). TA458: Trastuzumab emtansine for treating HER2-positive advanced breast cancer after trastuzumab and a taxane. 2017. https://www.nice.org.uk/guidance/ta458. Accessed 11 Aug 2023.

Download references

Author information

Authors and Affiliations

  1. Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, NE2 4AX, UK

    Diarmuid Coughlan, Ge Yu, Ashleigh Kernohan & Stephen Rice

  2. Evidence Synthesis Group, Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, NE2 4AX, UK

    Oluwatomi Arisa, Katie Thomson, Fiona Pearson, Sonia Garcia Gonzalez-Moral & Sheila Wallace

Authors
  1. Diarmuid Coughlan
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Oluwatomi Arisa
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Katie Thomson
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Ge Yu
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Fiona Pearson
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Ashleigh Kernohan
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Sonia Garcia Gonzalez-Moral
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Sheila Wallace
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Stephen Rice
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Diarmuid Coughlan.

Ethics declarations

Authors’ Contributions

The draft of this manuscript was written by DC, SR and OA. All authors had the chance to comment on previous versions of the manuscript. All authors contributed to the study conception and design and were involved in the work of the EAG. SR acted as project lead, health economist and systematic reviewer on this assessment, critiqued the clinical-effectiveness and cost-effectiveness methods and evidence, and contributed to the writing of the report. GY acted as health economic project lead, critiqued the company’s economic evaluation, and contributed to the writing of the EAG report. DC and AK acted as health economists on this assessment, critiqued the company’s economic evaluation and contributed to the writing of the EAG report. KT, OA and FP acted as systematic reviewers, critiqued the clinical effectiveness methods and evidence, and contributed to the writing of the EAG report. SGG-M and SW acted as information retrieval reviewers, critiqued the search methods in the submission and contributed to the writing of the EAG report.

Funding

This project was commissioned by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (Grant number: NIHR132004). See the HTA programme website for further project information (https://www.nihr.ac.uk/explore-nihr/funding-programmes/health-technology-assessment.htm). This summary of the EAG report was compiled after NICE issued recommendations for the Cancer Drug Fund (CDF). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the NICE, NIHR or Department of Health and Social Care.

Conflicts of Interest

Diarmuid Coughlan, Oluwatomi Arisa, Katie Thomson, Ge Yu, Fiona Pearson, Ashleigh Kernohan, Sonia Garcia Gonzalez-Moral, Sheila Wallace and Stephen Rice have no conflicts of interest to declare.

Ethics Approval

Not applicable.

Informed Consent

Not applicable.

Data Availability

Not applicable.

Consent to Participate

Not applicable.

Consent for Publication

Not applicable.

Code Availability

Not applicable.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Coughlan, D., Arisa, O., Thomson, K. et al. Disease Severity Modifier in the NICE Single Technology Appraisal of Trastuzumab Deruxtecan: External Assessment Group Perspective. PharmacoEconomics 42, 5–9 (2024). https://doi.org/10.1007/s40273-023-01317-z

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40273-023-01317-z

Search

Navigation