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Article

Economic Evaluation of Biosimilars for Reimbursement Purposes—What, When, How?

by
Evelien Moorkens
1,*,
Hannah Broux
1,
Isabelle Huys
1,
Arnold G. Vulto
1,2 and
Steven Simoens
1
1
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
2
Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, The Netherlands
*
Author to whom correspondence should be addressed.
J. Mark. Access Health Policy 2020, 8(1), 1739509; https://doi.org/10.1080/20016689.2020.1739509
Submission received: 11 November 2019 / Revised: 24 February 2020 / Accepted: 28 February 2020 / Published: 15 March 2020

Abstract

Background: Limited previous research and guidelines on the design of economic evaluation for biosimilars have led to unresolved methodological questions on how to assess biosimilars. Objectives: We want to raise awareness of and explore methodological issues for the economic evaluation of biosimilars. Methods: We relied on a literature review, exploratory interviews, and our experiences. Results and Conclusions: In the majority of cases in which reimbursement for a biosimilar is sought, it will not be necessary to conduct an economic evaluation, given that the reference product is already reimbursed and standard of care. If the latter is not the case, a full economic evaluation of the biosimilar versus standard of care is needed. This might also be needed in the case of differences in administration form or adherence (for example, due to a nocebo effect) and to take into account value-added services. The entry of biosimilars and of next-generation biological products should trigger a re-assessment of the entire product class. HTA bodies and reimbursement agencies should provide clear guidance on how to assess the value of a biosimilar in each of these circumstances.
Keywords: biosimilars; economic evaluation; reimbursement; cost-minimization; comparator; indication; off-patent biologicals biosimilars; economic evaluation; reimbursement; cost-minimization; comparator; indication; off-patent biologicals

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MDPI and ACS Style

Moorkens, E.; Broux, H.; Huys, I.; Vulto, A.G.; Simoens, S. Economic Evaluation of Biosimilars for Reimbursement Purposes—What, When, How? J. Mark. Access Health Policy 2020, 8, 1739509. https://doi.org/10.1080/20016689.2020.1739509

AMA Style

Moorkens E, Broux H, Huys I, Vulto AG, Simoens S. Economic Evaluation of Biosimilars for Reimbursement Purposes—What, When, How? Journal of Market Access & Health Policy. 2020; 8(1):1739509. https://doi.org/10.1080/20016689.2020.1739509

Chicago/Turabian Style

Moorkens, Evelien, Hannah Broux, Isabelle Huys, Arnold G. Vulto, and Steven Simoens. 2020. "Economic Evaluation of Biosimilars for Reimbursement Purposes—What, When, How?" Journal of Market Access & Health Policy 8, no. 1: 1739509. https://doi.org/10.1080/20016689.2020.1739509

APA Style

Moorkens, E., Broux, H., Huys, I., Vulto, A. G., & Simoens, S. (2020). Economic Evaluation of Biosimilars for Reimbursement Purposes—What, When, How? Journal of Market Access & Health Policy, 8(1), 1739509. https://doi.org/10.1080/20016689.2020.1739509

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