Proposals for Updating the Canadian Patented Medicine Prices Review Board Pharmaceutical Budget Impact Analysis Guidelines for New Drug Submissions to Public and Private Payers

Abstract

Background: The main objective of this thesis was to provide a proposal for updating the Patented Medicine Prices Review Board (PMPRB) 2007 pharmaceutical budget impact analysis (BIA) guidelines in accordance with the best national and transnational practices in BIA methodology and Canadian stakeholder feedback.

Methods: National, transnational and Canadian federal, provincial and private BIA guidelines were reviewed and recommendations were abstracted. A mixed methods study, consisting of semi-structured interviews and a written survey, was designed for obtaining feedback from Canadian stakeholders on the list of BIA recommendations which were either not included or discussed differently in the PMPRB 2007 BIA guidelines.

Results: Sixteen BIA guidelines were reviewed and discordant recommendations between the PMPRB 2007 BIA guidelines and rest of the reviewed guidelines were identified. The stakeholder analysis included thirty-five participants and showed support for the inclusion of 56% of the proposed recommendations into the guidelines. These recommendations pertained to the use of expert opinions, data extrapolated from the payers’ database, scenario analysis, and dynamic population. Thirty percent of the recommendations, such as off-label indications in the base-case scenario, indirect costs, and cost transfers from other jurisdictions, were not supported by stakeholders. There was no consensus with respect to the inclusion of recommendations for cost offsets or patient adherence. The final proposal is 49% identical with the PMPRB 2007 BIA guidelines. Thirty-six percent of the proposed recommendations (n=26) are new and the remainder (15%; n=11) are modified.

Conclusions: This series of studies has provided sufficient insights to enable the creation of a penultimate version of revised PMPRB BIA guidelines. This penultimate version would be subject to a broader consultation process among stakeholders prior to the adoption of a final revision. Further Canadian stakeholder feedback is required for recommendations where consensus is lacking.