In the health technology assessment (HTA) process, cost- effectiveness analysis gets more attention, however over last decade, the budget impact analysis (BIA) has certainly become more important to the subsequent steps, including the adoption decision. The first Canadian BIA Guidelines was published by Patented Medicine Prices Review Board (PMPRB) in 2007. According to the results of a recent survey with regards to validate the practicality of the guidelines for policy makers, an update was recommended in order to reflect the changes that have occurred in the pharmaceutical industry. The objectives of the present study is to update the current Canadian BIA guidelines based on the most recent international methodological improvements, Canadian stakeholders` opinions and pharmaceutical regulatory changes since 2008 to 2018.
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