ABSTRACT

Objectives

Budget Impact Analyses (BIA) of medicines helps managers in promoting health systems’ sustainability when assessing the role and value of new medicines. However, it is not clear whether BIAs typically underestimate or overestimate the impact on real-world budgets. This retroactive analysis seeks to compare estimated values obtained by a BIA and Real-World Evidence (RWE) to guide discussions.

Methods

The estimated values were obtained through a BIA concerning the incorporation of adalimumab for the treatment of Rheumatoid Arthritis into the Brazilian Unified Health System (SUS) carried out retroactively and per international guidelines. RWE data was extracted from SUS computerized systems. We subsequently compared the number of treatments, costs, and Incremental Budget Impact (IBI).

Results

– The total number of treatments was underestimated by 10% (6,243) and the total expenditure was overestimated by 463% (US$ 4.7 billion). In five years, the total difference between the estimated values and real IBI reached US$ 1.1 billion. A current expenditure of US$ 1.0 was observed for every US$ 5.60 of estimated expenditure.

Conclusion

– The higher estimates from the BIA might cause decision makers to be more cautious with the introduction of a new medicine to reduce the opportunity costs for other interventions.

中文翻译：

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药物预算影响分析：估计值与现实世界证据及其影响

摘要

目标

在评估新药的作用和价值时，药物的预算影响分析 (BIA) 可帮助管理人员促进卫生系统的可持续性。然而，目前尚不清楚 BIA 通常是低估还是高估了对现实世界预算的影响。该追溯分析旨在比较 BIA 和真实世界证据 (RWE) 获得的估计值以指导讨论。

方法

估计值是通过 BIA 获得的，该 BIA 涉及将阿达木单抗用于治疗类风湿性关节炎纳入巴西统一卫生系统 (SUS)，该系统具有追溯性并按照国际指南进行。RWE 数据是从 SUS 计算机系统中提取的。我们随后比较了治疗次数、成本和增量预算影响 (IBI)。

结果

– 治疗总数被低估了 10%（6,243 次），总支出被高估了 463%（47 亿美元）。五年内，估计值与实际 IBI 之间的总差异达到 11 亿美元。对于每 5.60 美元的估计支出，观察到的当前支出为 1.0 美元。

结论

– BIA 更高的估计值可能会导致决策者在引入新药以降低其他干预措施的机会成本时更加谨慎。