Abstract
Objectives
Combinations of on-patent therapies (CTs) are increasingly common in oncology. They cause challenges for funding and affordability, and hence patient access, especially when constituent therapies are owned by different manufacturers. The aim of our study was to develop policy proposals for the assessment, pricing, and funding of CTs and identify which might be relevant in different European countries.
Methods
Following a review of available literature, seven hypothetical policy proposals were developed and subsequently assessed through 19 semi-structured interviews with health policy, pricing, technology assessment and legal experts in seven European countries to identify those most likely to gain traction.
Results
Experts saw a need for agreed approaches within a country to manage affordability and funding challenges for CTs. Changes to health technology assessment (HTA) and funding models were considered unlikely, but other policy proposals were seen as mostly useful, with country-specific adaptations. Bilateral discussions between manufacturers and payers were deemed important, and less challenging and protracted than arbitrated dialogue between manufacturers. Usage-specific pricing, possibly using weighted average prices, was considered a prerequisite for the financial management of CTs.
Conclusions
There is a growing need to ensure that CTs are affordable to health systems. It would appear that there is no one set of policies that is appropriate for all countries in Europe, so countries wishing to ensure that patients have (or continue to have) access to CTs of value to them must explore and implement the policies that are best suited to their general approach to funding health care and to the assessment and reimbursement of medicines.
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(Source: authors’ compilation, based on the EU Clinical Trials Register, https://www.clinicaltrialsregister.eu/. Analysis performed in January, 2022)
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Notes
The authors are consciously using the term 'usage-specific pricing' rather than 'indication-based pricing'. The main reason is that the baseline therapy may remain in use as monotherapy and/or become a baseline for other add-on therapies in exactly the same indication. The proposed way forward is therefore to make prices specific not to the indication, but rather to the specific usage (i.e., a specific combination or monotherapy).
Germany was not included in the scope of the analysis underlying this manuscript.
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Acknowledgements
Editorial assistance was provided by Julia Heagerty associated with Obsidian Healthcare Group.
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This paper builds on independent analysis funded by Novartis Pharma AG, Basel, Switzerland. All authors had complete freedom in conducting the study, compiled all data in the study themselves and take full responsibility for the content of the publication.
Conflict of interest
CH reports consulting fees, support to travel to meetings, and honoraria for conference presentations on HTA from various not-for-profit, consultancies, and companies including University of Warwick, ICER, Bellberry, OHE, CRA, Ideas and Solutions, Pfizer, Janssen, Abbott, Medtronic, Roche. DD reports a research grant from Amgen Switzerland GmbH, related to previous scientific publication on combination therapies, and consulting fees from MSD, Sanofi, Janssen, J&J for consulting projects in oncology. PI received honorarium from Swiss Health Quality Association for lectures and he is a member of the Steering Board of Swisstransplant. GP reports consulting fees from MSD, Janssen, Takeda, and Astra Zeneca for participation at scientific boards and honorarium from GSK for a press conference. LV reports honorarium and consulting fees from Novartis Pharma AG for participation at various oncology-related projects. NW reports payments from AstraZeneca, Bayer, Daiichi Sankyo, Incyte, Janssen, MSD, Novartis, Pierre Fabre and Oasmia for participation in advisory boards and educational activities outside the scope of the present manuscript; and fees from Roche/Genentech for participation in independent data monitoring committee. For the remaining authors, no conflicts of interest were declared in relation to the subject of this article.
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Search strategies used for the literature review are available in the supplementary file. The discussion guide used in the interviews is available from the corresponding author upon request.
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CH and DD conceived and designed the analysis, collected the data, and wrote the manuscript. All other authors participated in the expert discussion of the analysis, provided their inputs to the conclusions, and participated in the preparation, review and editing of the manuscript. All authors read and approved the final version of the manuscript.
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Henshall, C.H., Dankó, D., Barham, L. et al. Review and Assessment of Policy Options for Improving Access to Combination Therapies in Oncology in Europe. Appl Health Econ Health Policy 21, 537–546 (2023). https://doi.org/10.1007/s40258-023-00795-8
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DOI: https://doi.org/10.1007/s40258-023-00795-8