Influence of local policy measures and practices on biosimilar/originator market dynamics in Germany

In Europe, the individual Member States are responsible for designing policies that regulate the market entry and use of pharmaceuticals. This decentralized approach has been found to contribute to variations in biosimilar uptake across countries, and even within countries, as was investigated for tumour necrosis factor-alfa (TNF-α) inhibitor biosimilars in Sweden [1, 2]. In Germany, biosimilar market shares are also known to vary at the regional level. This was studied by Blankart et al. for erythropoiesis-stimulating substances, filgrastim and somatropin, and variations in biosimilar market shares were partly attributed to the presence of explicit regional cost-control measures, such as quota regulations [3]. Differences in the uptake of biosimilars have also been described in Germany for the class of TNF-α inhibitors, although reasons behind this variable uptake have not been examined in detail [4].

In a paper by Moorkens and Barcina Lacosta et al., the authors examine how several factors, especially regional-level differences in policy measures and practices, influence uptake of TNF-α inhibitor biosimilars in Germany [5]. Findings were based on a literature review, analysis of ambulatory dispensing data provided by the German Institute for Drug Use Evaluation (DAPI) and interviews investigating prescribers’ and insurers’ views in Germany.

Market shares of both biosimilar infliximab and etanercept varied widely between the 17 German Regional Associations of Statutory Health Insurance Accredited Physicians (PA regions), 33%‒87% and 33%‒77%, respectively in the last quarter of 2018. Quantitative analyses showed that biosimilar market shares for infliximab and etanercept were significantly lower in former East Germany when compared to former West Germany regions.

Through the qualitative analysis of interview data, the authors identified a set of incentives potentially driving biosimilar use. Relatively high price differences between the biosimilar and the originator product after discounts/rebates were regarded as a driver for increased biosimilar use. Price effects could not be evaluated in more detail, as information on discounted/rebated prices was not publicly available. Experts also highlighted the influence of prescription and budget control activities (organized at the regional and insurer level) on the variable uptake of infliximab and etanercept biosimilars across Germany. The use of biosimilars has been found to be primarily influenced by the regional-level implementation of biosimilar quotas, the presence of an effective monitoring and sanctioning system to regulate adherence to biosimilar quotas, the effectiveness of the communication between regional physician associations and individual prescribers, the different conditions for discount contracts established at the insurer-manufacturer level and the organization of initiatives for gainsharing.

Conflict of interest
The authors of the research paper [5] declared that there was no conflict of interest.

Abstracted by Teresa Barcina, PhD Researcher Market Dynamics and Sustainability of off-patent biologics and biosimilar medicines, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.

Editor’s comment
Readers interested to learn more about pricing and reimbursement policies for biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

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LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.

References
1. Moorkens E, Simoens S, Troein P, et al. Different policy measures and practices between Swedish counties influence market dynamics: Part 1-biosimilar and originator infliximab in the hospital setting. BioDrugs. 2019;33(3):285-97.
2. Moorkens E, Simoens S, Troein P, et al. Different policy measures and practices between Swedish counties influence market dynamics: Part 2-biosimilar and originator etanercept in the outpatient setting. BioDrugs. 2019;33(3):299-306.
3. Blankart KE, Arndt F. Physician-level cost control measures and regional variation of biosimilar utilization in Germany. Int J Environ Res Public Health. 2020;17(11):4113.
4. Schwabe U, Paffrath D, Ludwig WD, et al. Arzneiverordnungs-Report 2019; Springer Berlin Heidelberg: 2019.
5. Moorkens E, Barcina Lacosta T, Vulto AG, et al. Learnings from regional market dynamics of originator and biosimilar infliximab and etanercept in Germany. Pharmaceuticals (Basel) 2020;13(10):324.

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10 January 2021