BACKGROUND: In Canada, all public (provincial, territorial, and federal) and private drug payers require budget impact analyses (BIAs) to make funding decisions. Guidelines for conducting BIAs have been developed in Canada, as well as from international and national agencies. The alignment of Canadian guidelines with recommendations from other BIA guidelines is unknown.

OBJECTIVES: To review guidelines for BIAs and identify similarities and differences from the standpoint of Canadian payers.

METHODS: A literature review was performed to identify English-language guidelines for BIAs in Canada, and from international health economics societies and existing and proposed countries used for reference-based pricing of patented drugs in Canada. Specifically, guidelines from France, Germany, Italy, Sweden, Switzerland, the UK, and the US, as well as Australia, Belgium, Japan, the Netherlands, Norway, South Korea, and Spain were sought. Recommendations on key elements for conducting BIAs were extracted from the available guidelines and compared.

RESULTS: The literature review identified one national and three provincial guidelines (Alberta, Manitoba, and Ontario) from Canada, seven other national guidelines (Australia, Belgium, France, Germany, the Netherlands, UK, and US), and one recommendation for good practices from ISPOR. The Canadian guidelines were largely consistent with recommendations from other agencies for model structure, discounting, population, estimating market shares, drug costs, off-label use, presentation of results, uncertainty assessment, and model validation. Differences between the Canadian and other guidelines were observed in several key elements, including perspective, time horizon, comparators, and the inclusion of non-drug costs. Among the Canadian guidelines, there was variability in terms of guidance for province-specific population size, comparators, and drug costs.

CONCLUSIONS: Canada has unique requirements for BIAs compared with other countries. The specific requirement for multiple payer-specific BIAs is likely due to the unique Canadian drug reimbursement landscape where drugs are funded by siloed drug payers rather than a healthcare payer.