At a recent PMCQ meeting the topic was one of national debate… the proposed changes to the PMPRB’s price review process.
As a Canadian and prospective patient, the PMPRB’s mandate is an important one, to ensure prices of patented medicines are not excessive. However, drastic changes are being proposed that could have significant impact on drug innovation in Canada. One of the proposed changes is to remove the US and Switzerland from the OECD comparator list that sets international price medians and caps. Other notable revisions include:
Drugs will be classified as high, medium or low priority depending on market conditions
Filing requirements will require first-party discounts and third-party rebates to be made transparent
Areas of debate include an accurate evaluation of Canadian pharmaceutical industry investment in economic activity and the lack of industry consultation on guideline changes. The PMPRB is projecting the risk-based approach will result in a 10% reduction in net revenue over time and only $9,000 annually to be compliant. But this forecast is being challenged widely given there has been no transparency on how these calculations were made. Expectations are that the impact will be much greater, which could have a significant impact on new drugs coming to market and treatment options available to Canadians.
A revised guideline is expected to be available in January 2019. More speculation of the true impact is sure to arise, however with the industry locked out of discussions, only time will tell.