Multicriteria Decision Modeling for the Inclusion of Generic Medicines and Biosimilars in Reimbursement Systems

Reimbursement systems face steady pressure to control pharmaceutical spending while protecting patient access, and off patent competition from generic medicines and biosimilars is a practical lever for this balance. In the United States, generic and biosimilar medicines produced 467 billion dollars in savings during 2024, yet the criteria that govern their inclusion in formularies remain uneven, and price often dominates. This article examines how multicriteria decision analysis can structure inclusion decisions for generics and biosimilars in reimbursement systems. Using comparative analysis, a structured review of peer reviewed methodological and applied literature, and content analysis of policy and regulatory documentation, the study organizes the relevant value dimensions into a coherent decision model. The results present an adapted workflow, a criterion set with indicative weights, and a worked application that separates the generic decision from the biosimilar decision. The work concludes that a transparent, weighted model improves consistency and supply resilience. Payers, health technology assessment analysts, and formulary committees will find the framework directly applicable.

multicriteria decision analysis, generic medicines, biosimilars, reimbursement, health technology assessment, Pharmacoeconomics, formulary decision making, value assessment, budget impact, real-world evidence.

Association for Accessible Medicines, & IQVIA Institute. (2025). 2025 U.S. generic and biosimilar medicines savings report. Association for Accessible Medicines. Retrieved from: https://accessiblemeds.org/resources/reports/2025-savings-report/ (date accessed: March 24, 2026).

Association for Accessible Medicines, & IQVIA Institute. (2024). 2024 U.S. generic and biosimilar medicines savings report. Association for Accessible Medicines. Retrieved from: https://accessiblemeds.org/resources/reports/2024-savings-report/ (date accessed: April 4, 2026).

Samy, P. J., Mouslim, M. C., Bennett, C. L., & Trujillo, A. J. (2026). Regulatory requirements for interchangeable biosimilar designation. Therapeutic Innovation & Regulatory Science, 60, 346–348. https://doi.org/10.1007/s43441-025-00897-6

Gongora-Salazar, P., Rocks, S., Fahr, P., Rivero-Arias, O., & Tsiachristas, A. (2023). The use of multicriteria decision analysis to support decision making in healthcare: An updated systematic literature review. Value in Health, 26(5), 780–790. https://doi.org/10.1016/j.jval.2022.11.007

Su, P., Zhi, K., Xu, H., Xiao, J., Liu, J., Wang, Z., Liu, Q., Yu, Y., & Dang, H. (2024). The application of multi-criteria decision analysis in evaluating the value of drug-oriented intervention: A literature review. Frontiers in Pharmacology, 15, 1245825. https://doi.org/10.3389/fphar.2024.1245825

Barcina Lacosta, T., Inotai, A., Pereira, C. L., Barbier, L., & Simoens, S. (2024). Mapping health technology assessment agency approaches for biosimilar value assessment: An ISPOR Special Interest Group Report. Value in Health, 27(5), 543–551. https://doi.org/10.1016/j.jval.2024.01.018

Jakab, I., Németh, B., Elezbawy, B., Karadayi, M. A., Tozan, H., Aydin, S., Shen, J., & Kaló, Z. (2020). Potential criteria for frameworks to support the evaluation of innovative medicines in upper middle-income countries: A systematic literature review on value frameworks and multi-criteria decision analyses. Frontiers in Pharmacology, 11, 1203. https://doi.org/10.3389/fphar.2020.01203

Zelei, T., Mendola, N. D., Elezbawy, B., Németh, B., & Campbell, J. D. (2021). Criteria and scoring functions used in multi-criteria decision analysis and value frameworks for the assessment of rare disease therapies: A systematic literature review. PharmacoEconomics - Open, 5(4), 605–612. https://doi.org/10.1007/s41669-021-00271-w

Alruthia, Y., Alhajri, H., Almohammed, O. A., Balkhi, B., Alsaqa’aby, M. F., Almuqbil, M. A., Al-Abdulkarim, H. A., & Almutairi, A. R. (2026). Creating a multi-criteria decision analysis tool to enhance value-based purchasing of generic and biosimilar medications in Saudi Arabia: A pilot study. ClinicoEconomics and Outcomes Research, 18, 1–11. https://doi.org/10.2147/CEOR.S568722

Farghaly, M. N., Al Dallal, S. A. M., Fasseeh, A. N., Monsef, N. A., Suliman, E. A. M. A., Tahoun, M. A., Abaza, S., & Kaló, Z. (2021). Recommendation for a pilot MCDA tool to support the value-based purchasing of generic medicines in the UAE. Frontiers in Pharmacology, 12, 680737. https://doi.org/10.3389/fphar.2021.680737

Elezbawy, B., Fasseeh, A. N., Sedrak, A., Eldessouki, R., Gamal, M., Eldebeiky, M., Amer, H., Akeel, S., Morsy, A., Amin, A., Shafik, A., Abaza, S., & Kaló, Z. (2022). A multi-criteria decision analysis (MCDA) tool for purchasing off-patent oncology medicines in Egypt. Journal of Pharmaceutical Policy and Practice, 15, 10. https://doi.org/10.1186/s40545-022-00414-2

Otte, M., Kaló, Z., Al-Omar, H. A., Boysen, M., Chen, Y., Etges, A. P. B. D. S., Kockaya, G., Gutierrez-Ibarluzea, I., Seyam, A. M., Mullen, D., & Dauben, H.-P. (2025). Contextual factors in value-based decision support to enhance health technologies adoption: The case of biosimilars. Frontiers in Pharmacology, 16, 1599013. https://doi.org/10.3389/fphar.2025.1599013

Otte, M., Dauben, H.-P., Ahn, J., Gutierrez Ibarluzea, I., Drummond, M., Simoens, S., Kaló, Z., & Suh, D. C. (2024). Value based healthcare and health technology assessment for emerging market countries: Joint efforts to overcome barriers. Expert Review of Pharmacoeconomics & Outcomes Research, 24(9), 1061–1066. https://doi.org/10.1080/14737167.2024.2398482

Alnaqbi, K. A., Al-jedai, A., Farghaly, M., Omair, M. A., Hamad, A., Abutiban, F. M. A., Al Shirawi, A., Al Rayes, H., Aldallal, S., Fahmy, S., & Simoens, S. (2025). Expert consensus recommendations on a biosimilars value framework for the Gulf Cooperation Council countries. Therapeutic Innovation & Regulatory Science, 59(1), 153–163. https://doi.org/10.1007/s43441-024-00716-4

Mulcahy, A., Buttorff, C., Finegold, K., El-Kilani, Z., Oliver, J. F., Murphy, S., & Jessup, A. (2022). Projected US savings from biosimilars, 2021–2025. The American Journal of Managed Care, 28(7), 329–335. https://doi.org/10.37765/ajmc.2022.88809

Institute for Clinical and Economic Review. (2023). 2023 value assessment framework. Institute for Clinical and Economic Review. Retrieved from: https://icer.org/our-approach/methods-process/value-assessment-framework/ (date accessed: April 18, 2026).

Yang, J., Blinzler, K., Lankin, J., Vijayakumar, S., Maculaitis, M. C., & Shelbaya, A. (2022). Evolving perceptions, utilization, and real-world implementation experiences of oncology monoclonal antibody biosimilars in the USA: Perspectives from both payers and physicians. BioDrugs, 36(1), 71–83. https://doi.org/10.1007/s40259-021-00509-3

IQVIA Institute for Human Data Science. (2026). Biosimilar sustainability scorecards for Europe 2026. IQVIA Institute for Human Data Science. Retrieved from: https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilar-sustainability-scorecards-for-europe-2026 (date accessed: June 14, 2026).

Metelkin, I. A., Yagudina, R. I., & Kulikov, A. Yu. (2012). Methodology of cost-effectiveness analysis in pharmacoeconomic research. Pharmacoeconomics: Modern Pharmacoeconomics and Epidemiology, (4), 3-8.

Metelkin, I. A., Yagudina, R. I., Kulikov, A. Yu., & Serpik, V. G. (2013). Pharmacoeconomic analysis of nutritional support in hospitalized patients. In Parenteral and enteral nutrition: National guidelines (pp. 77-92). Moscow.