https://orcid.org/0000-0003-2576-5360
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ABSTRACT
Objectives
While there are good Budget Impact Analysis (BIA) guidelines, studies still register potential bias. To do this, we compared the results between theoretical and real-world evidence (RWE) expenditures for medicines for Hepatitis C: boceprevir (BOC) and telaprevir (TVR). While both are not currently recommended in treatment guidelines following recent developments, this is an emblematic case because for 4 years these medicines consumed considerable resources.
Methods
Theoretical results and RWE expenditures were compared regarding the incorporation of BOC and TVR in 2013–2014 into the Brazilian Public Health System. Theoretical values were extracted from Commission for Technology Incorporation Report and RWE expenditures were extracted from the administrative data records using deterministic-probabilistic linkage.
Results
The estimated number of patients treated (BOC+TVR) was 13,012 versus 7,641 (real). The estimated purchase price for BOC was US$6.20 versus US$11.07 (real) and for TVR was US$42.21 versus US$84.09 (average/real). The estimated budget impact was US$285.16 million versus US$128.58 million (real).
Conclusion
This study demonstrates appreciable divergence (US$156.58 million) between the theoretical budget impact and RWE expenditures due to underestimated purchase prices and overestimated populations. The greater the degree of accuracy the more reliable and usable BIAs become for decision-making.
Article highlights
Budget Impact Analysis (BIA) seeks to estimate the economic consequences of technologies to health authority decision makers to help with future budget allocation and investment decisions. However, there are concerns with the quality of current BIAs.
To point out weaknesses and promote a higher degree of accuracy in BIA, this study compared the results from estimated and real-world evidence (RWE) expenditures for new medicines in the treatment of Hepatitis C.
The estimated population was 1.7 times higher than reality (7.641 patients). The total cost of drug treatment was 2.2 times higher in the estimates than the real-world situation (US$128.58 million), and the budget impact was overestimated by US$156.58 million.
For BIA to become more accurate, population calculations should estimate a transition from current standardized treatments to the new treatment and the purchase price forecast must be more accurate where possible.
The greater the degree of proximity between theory and RWE expenditures, the more reliable and usable BIAs become.
Acknowledgments
To users of the health system. Geolocation information Brazil
Author contributions
Study design and governance: D Faleiros; A Guerra Junior; E Silva; A Santos. Write-up and ongoing critical review of the article: D Faleiros; B Godman; A Guerra Junior. Materials/analysis tools: D Faleiros; R Pereira; A Guerra Junior. Ongoing study review and feedback regarding design, data collection, analysis and critical review of the manuscript: D Faleiros; E Silva; B Godman; R Pereira; A Santos; A Guerra Junior. 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. The authors agree for the final version of the manuscript to be published.
Compliance with ethics guidelines
The real-life data were analyzed by means of a unique numerical identifier, which makes it impossible to distinguish between patients. The methodology, which followed the concepts of research ethics, was approved by the Research Ethics Committee of the Federal University of Minas Gerais – Brazil Under ETIC 0069.0.203.000-11.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.