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Journal of Market Access & Health Policy (JMAHP) is published by MDPI from Volume 12 Issue 1 (2024). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Taylor & Francis.
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Article

Unlocking the Potential of Established Products: Toward New Incentives Rewarding Innovation in Europe

by
Gabrielle Nayroles
1,
Sandrine Frybourg
2,*,
Sylvie Gabriel
1,
Åsa Kornfeld
2,
Fernando Antoñanzas-Villar
3,
Jaime Espín
4,
Claudio Jommi
5,6,
Nello Martini
7,
Gérard de Pouvourville
8,
Keith Tolley
9,
Jürgen Wasem
10 and
Mondher Toumi
11
1
Global Market Access and Pricing, IPSEN Pharma, Boulogne-Billancourt, France
2
Pricing, Reimbursement and Market Access, Creativ-Ceutical, Paris, France
3
Department of Economy and Business, University of La Rioja, Logroño, Spain
4
Andalusian School of Public Health, Granada, Spain
5
Department of Pharmaceutical Sciences, University of Eastern Piedmont, Novara, Italy
6
Centre for Research on Health and Social Care Management (CERGAS), Bocconi University, Milan, Italy
7
Drugs & Health, Rome, Italy
8
Department of Economics, ESSEC Business School, Cergy-Pontoise, France
9
Tolley Health Economics Ltd., Buxton, UK
10
Department of Economics, University Duisburg-Essen, Essen, Germany
11
Department of Public Health, Aix-Marseille University, Marseille, France
 
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Author to whom correspondence should be addressed.
J. Mark. Access Health Policy 2017, 5(1), 1298190; https://doi.org/10.1080/20016689.2017.1298190
Submission received: 22 December 2016 / Revised: 1 January 2017 / Accepted: 10 February 2017 / Published: 12 March 2017

Abstract

Background: Many established products (EPs – marketed for eight years or more) are widely used off-label despite little evidence on benefit–risk ratio. This exposes patients to risks related to safety and lack of efficacy, and healthcare providers to liability. Introducing new indications for EPs may represent a high societal value; however, manufacturers rarely invest in R&D for EPs. The objective of this research was to describe incentives and disincentives for developing new indications for EPs in Europe and to investigate consequences of current policies. Methods: Targeted literature search and expert panel meetings. Results: Within the current European-level and national-level regulatory framework there are limited incentives for development of new indications with EPs. Extension of indication normally does not allow the price to be increased or maintained, the market protection period to be extended, or exclusion from a reference price system. New indication frequently triggers re-evaluation, resulting in price erosion, regardless of the level of added value with the new indication. In consequence, manufacturers are more prone to undertake R&D efforts at early to mid-stage of product life cycle rather than with EPs, or to invest in new chemical entities, even in therapeutic areas with broad off-label use. This represents a potentially missed opportunity as developing new indications for EPs offers an alternative to off-label use or lengthy and expensive R&D for new therapies, opens new opportunities for potentially cost-effective treatment alternatives, as well as greater equity in patients’ access to treatment options. Conclusion: There are potential benefits from the development of new indications for EPs that are currently not being realized due to a lack of regulatory and pricing incentives in Europe. Incentives for orphan or paediatric drugs have proven to be effective in promoting R&D. Similarly, incentives to promote R&D in EPs should be developed, for the benefit of patients and healthcare systems.
Keywords: established products; extension of indication; new indication; repurposing; repositioning; pricing; reimbursement; life cycle management established products; extension of indication; new indication; repurposing; repositioning; pricing; reimbursement; life cycle management

Share and Cite

MDPI and ACS Style

Nayroles, G.; Frybourg, S.; Gabriel, S.; Kornfeld, Å.; Antoñanzas-Villar, F.; Espín, J.; Jommi, C.; Martini, N.; de Pouvourville, G.; Tolley, K.; et al. Unlocking the Potential of Established Products: Toward New Incentives Rewarding Innovation in Europe. J. Mark. Access Health Policy 2017, 5, 1298190. https://doi.org/10.1080/20016689.2017.1298190

AMA Style

Nayroles G, Frybourg S, Gabriel S, Kornfeld Å, Antoñanzas-Villar F, Espín J, Jommi C, Martini N, de Pouvourville G, Tolley K, et al. Unlocking the Potential of Established Products: Toward New Incentives Rewarding Innovation in Europe. Journal of Market Access & Health Policy. 2017; 5(1):1298190. https://doi.org/10.1080/20016689.2017.1298190

Chicago/Turabian Style

Nayroles, Gabrielle, Sandrine Frybourg, Sylvie Gabriel, Åsa Kornfeld, Fernando Antoñanzas-Villar, Jaime Espín, Claudio Jommi, Nello Martini, Gérard de Pouvourville, Keith Tolley, and et al. 2017. "Unlocking the Potential of Established Products: Toward New Incentives Rewarding Innovation in Europe" Journal of Market Access & Health Policy 5, no. 1: 1298190. https://doi.org/10.1080/20016689.2017.1298190

APA Style

Nayroles, G., Frybourg, S., Gabriel, S., Kornfeld, Å., Antoñanzas-Villar, F., Espín, J., Jommi, C., Martini, N., de Pouvourville, G., Tolley, K., Wasem, J., & Toumi, M. (2017). Unlocking the Potential of Established Products: Toward New Incentives Rewarding Innovation in Europe. Journal of Market Access & Health Policy, 5(1), 1298190. https://doi.org/10.1080/20016689.2017.1298190

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