Affordability of oncology drugs: accuracy of budget impact estimations

Abstract

Background: In many countries, Budget Impact (BI) informs reimbursement decisions. Evidence has shown that decision-makers have restricted access based on high BI estimates but studies show that BI estimates are often inaccurate.Objective: To assess the accuracy of BI estimations used for informing access decisions on oncology drugs in the Netherlands.Study Design: Oncology products for which European Medicines Agency Marketing Authorisation was granted between 1-1-2000 and 1-10-2017 were selected. Observed BI data were provided by FarmInform. BI estimates were extracted from the reimbursement dossiers of the Dutch Healthcare Institute. Products without an estimated BI in the reimbursement dossier were excluded. Accuracy is defined as the ratio observed BI/estimated BI.Setting: General community, the Netherlands.Results: Ten products were included in the base case analysis. Mean accuracy was 0.64 and observed BI deviated by more than 40% and 100% from the estimated BI for 4 and 5 products, respectively. For all products together, €141 million BI was estimated and €82 million BI was observed, a €59 million difference.Conclusions: The findings indicate that BI estimates for oncology drugs in the Netherlands are inaccurate. The role and use of BI in reimbursement decisions for these potentially life-saving drugs should therefore be considered carefully, as well as BI estimation methodology.

Methodological Quality Assessment of Budget Impact Analyses for Orphan Drugs: A Systematic Review

“…However, this realization was preceded by debates on BIA value within HTA, making it a rather new analysis that is in continuous development (Niezen et al, 2009;Foroutan et al, 2020). Some studies point out the inaccuracy of BIA with often an overestimation of budget impacts (Geenen et al, 2020a;Geenen et al, 2020b). To aid in framing structural elements of BIA, several studies, as well as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in 2007 and 2014, released good practice guidelines on BIA (Trueman et al, 2001;Mauskopf et al, 2007;Garattini and van de Vooren, 2011;Sullivan et al, 2014;Silva et al, 2017).…”