OBJECTIVES: In the current cost-constrained environment and growing launch of innovative and expensive therapies, affordability is becoming increasingly critical for payers beyond cost-effectiveness analysis (CEA). The objective of this study was to assess how affordability was considered in pricing policies in France, Germany, Italy, Spain, the Netherlands, United Kingdom (UK), Australia and Canada.

METHODS: Review of pricing policies published on websites of health authorities in countries of scope.

RESULTS: All countries request budget impact analysis (BIA), but only Australia has an explicit consideration of affordability following CEA. In UK, BI pilot test introduced in 2017 requests that any new cost-effective medicines, but likely to be over the budget impact limit of £20 million in any one of their first three years of use, will trigger commercial discussions between the company and NHS England; the impact should be assessed in 2020. In Germany, BIA is requested in AMNOG dossier but not considered in early benefit assessment. In the Netherlands, economic data (CEA and BIA) are mandatory when drug budget impact is expected reach at least €2.5 million in any of the first three years following reimbursement.In France, BIA is formally requested under some conditions, i.e., an innovative drug with expected turnover superior to 50 million euros during the second full year of commercialization,but not formally considered for pricing; price-volume agreement is used for controlling BI. In Italy and Spain, BI is usually controlled through cap volume agreements and potential rebates; pay for performance is also important leverage for pricing negotiations in Italy. In Canada, CADTH focus on CEA even if BIA are part of submissions; BIA is mainly used at province level.

CONCLUSIONS: Despite becoming critical for decision making, very few countries have a formal process to integrate budget impact in their decision. This remains an empirical unclear deliberative process.