Budget impact analysis of medicines: estimated values versus real-world evidence and the implications

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.

KEYWORDS:

• Brazil
• budgetary impact analyses
• budgetary impact model
• economic evaluation
• Health Technology Assessment
• medicines

Acknowledgments

To users of the health system.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript.

Geolocation information

Brazil

Additional information – funding

Daniel Resende Faleiros received a scholarship from the Coordination for the Improvement of Higher Education Personnel (CAPES), Brazilian Ministry of Education, and this study is part of his thesis. The authors have no other relevant affiliations or financial involvement with any organizations or entities or conflicts of interest with the subject or objects discussed in this study.

Author contributions

Study design and governance: DRF; AAGJ. Write-up and ongoing critical review of the article: DRF; BBG; AAGJ. Materials/analysis tools: DRF; RGP; AAGJ. Ongoing study review and feedback regarding design, data collection, analysis and critical review of the manuscript: DRF; JAT; ENS; BBG; RGP; EIGA; FFA; AAGJ. All authors had full access to all of the data and take responsibility for the integrity of the data and the accuracy of the data analysis.

Compliance with ethics guidelines

RWE were analyzed using a unique numeric identifier, which hinders distinguishing patients. The methodology that allowed knowing the RWEs was approved by the Research Ethics Committee of the Federal University of Minas Gerais under ETIC 0069.0.203.000-11