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Background <p>To carry out external validation of the analysis of the budget impact of the drug fingolimod after its incorporation into the Brazilian Unified Health System, comparing the real parameters arising from its incorporation in the treatment of relapsing-remitting multiple sclerosis with the estimates presented in the incorporation report in 2017. This topic is highly pertinent and makes a valuable contribution to the sparse literature on real-world BIA validation, especially in low- and middle-income countries like Brazil, yielding crucial insights for enhancing health policy optimization.</p> Methods <p>Survey of the target population validated by demand measured through the dispensing of drugs, in the Brazilian Unified Health System of patients with multiple sclerosis; validation of the unit costs of drugs through purchases made by the Logistics Department of the Ministry of Health; determination of market share within the time horizon defined based on drugs purchases; estimation of direct administration costs; and monitoring of drugs to compare estimated values with the real value.</p> Results <p>Divergences were identified between real-life data collected in relation to the study’s defined population and the market share of the drug fingolimod over the studied time horizon. There was a significant increase in the fingolimod market share, with the bigger market shares being in 2019 and 2020. The budget impact presented in the incorporation report was US$ 277,431,260.28, and the validated impact was US$ 194,955,442.76.</p> Conclusions <p>The validation process of the budget impact analysis of the incorporation of the drug fingolimod in 2017 resulted in savings of around US$ 82,4&#xa0;million in relation to the value proposed for incorporation.</p>

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External validation of the budget impact analysis of the drug fingolimode in the treatment of multiple sclerosis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月2日

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  • Cesar Ricardo Simioni Campello,
  • Márcia Gisele Santos da Costa,
  • Márcia Pinto

摘要

Background

To carry out external validation of the analysis of the budget impact of the drug fingolimod after its incorporation into the Brazilian Unified Health System, comparing the real parameters arising from its incorporation in the treatment of relapsing-remitting multiple sclerosis with the estimates presented in the incorporation report in 2017. This topic is highly pertinent and makes a valuable contribution to the sparse literature on real-world BIA validation, especially in low- and middle-income countries like Brazil, yielding crucial insights for enhancing health policy optimization.

Methods

Survey of the target population validated by demand measured through the dispensing of drugs, in the Brazilian Unified Health System of patients with multiple sclerosis; validation of the unit costs of drugs through purchases made by the Logistics Department of the Ministry of Health; determination of market share within the time horizon defined based on drugs purchases; estimation of direct administration costs; and monitoring of drugs to compare estimated values with the real value.

Results

Divergences were identified between real-life data collected in relation to the study’s defined population and the market share of the drug fingolimod over the studied time horizon. There was a significant increase in the fingolimod market share, with the bigger market shares being in 2019 and 2020. The budget impact presented in the incorporation report was US$ 277,431,260.28, and the validated impact was US$ 194,955,442.76.

Conclusions

The validation process of the budget impact analysis of the incorporation of the drug fingolimod in 2017 resulted in savings of around US$ 82,4 million in relation to the value proposed for incorporation.