Patented Medicine Prices Review Board (PMPRB) published its initial thoughts on how to operationalize the Minister of Health’s proposed amendments to the Patented Medicines Regulations, (Published on December 2, 2017).

If approved, the PMBRB would review drugs following a stepped process. Initially, drugs would be subjected to a ‘price test’ that compares the proposed cost of the drug in Canada to its prices in 12 other countries. Next, the drug would be screened to determine if it is a high priority drug or a medium & low priority drug.

So instead of labelling a drug as an orphan drug or not, it will be categorized as high, medium, or low priority. Those with a high priority will undergo a review that will begin with an assessment the incremental cost per quality-adjusted life year (QALY) of the drug and compared to a cost effectiveness threshold. Details of this are currently vague but PMBRB states that drugs which prolong life or provide significant QALY gains could be subject to a more generous threshold.

PMBRB will make allowances to the threshold if the drug is for a very small market (ie, a rare disease).

In the coming weeks, both Heath Canada and PMBRB will be hosting webinars to obtain feedback from the public on the proposed changes.