Stakeholders' feedback on the proposed recommendations for updating the patented medicine prices review board (pmprb) budget impact analysis guidelines.

Introduction: The present study aimed to obtain Canadian stakeholders' feedback on a list of proposed recommendations for updating the Patented Medicine Prices Review Board (PMPRB)'s 2007 budget impact analysis (BIA) guidelines.

Methods: A mixed-methods study was designed to obtain feedback from two stakeholder perspectives-(public and private) payers and manufacturers-on the proposed BIA recommendations. We obtained policymakers' opinion through one-on-one interviews and collected feedback from manufacturers and their consultants using a survey. The interview guide and the survey were developed based on the list of recommendations related to BIA key elements, which were either not discussed or addressed differently in the PMPRB 2007 BIA guidelines. The list was derived from 16 Canadian or other national and transnational BIA guidelines. A thematic analysis was applied for analysis of the qualitative (interview) data.

Results: Thirty-five policymakers and manufacturers participated in the study. Stakeholders supported the inclusion of 56% of the proposed recommendations into the guidelines pertaining to the use of expert opinions, data extrapolated from the payers' database, scenario analysis, and dynamic population. Inclusion of indirect costs, and cost transfers from other jurisdictions, were not approved. There was no consensus regarding the inclusion of patients' adherence/compliance and cost offsets.

Conclusions: The present study has provided sufficient insights to enable the creation of a penultimate version for updating the PMPRB BIA guidelines. This penultimate version will be subject to a broader consultation among stakeholders prior to a final revision and approval. Further Canadian stakeholder feedback is required for reaching consensus on inconclusive recommendations.