January 10, 2019
The PMPRB released its reference notes from the last Steering Committee meeting December 13, 2018. In this face-to-face meeting, six different case studies involving Category 1 drugs were analyzed and reviewed to identify how the proposed Guidelines would be applied, as well as a comparison in ceiling price of the current Guidelines vs. the proposed Guidelines. The six cases covered a variety of market conditions and types of populations with the following cases explored:
Both the Maximum List Price (MLP) and the Maximum Rebated Price (MRP) factor into the price ceilings for Category 1 drugs. The MRP is determined by applying pharmacoeconomic (PE) value and market size factors. There would be a decrease in the PE value price for a drug with a large market size, but an increase in the maximum PE value price for a small market size that applies to drugs of rare disease. For instance, if the market size is above a certain threshold, (i.e. $40 million was used in these case studies), the PMPRB is proposing a progressive discount to the total annual drug cost (revenue) - 10% for each $10M-increment above $40M up to a maximum of 50%. Conversely for drugs of rare disease, the market size could increase the ceiling price so that the MRP may be adjusted upwards by as much as two to three times the pharmacoeconomic value threshold price.
The next steps were summarized as the following:
So we will not see any further draft Guidelines until after the Canada Gazette 2 (the Patented Medicines Regulations) has been published. Timing is speculative but as we predicted before, it is unlikely we will see any implementation of new Guidelines before the end of 2019. As well, given the election, timing of these Guidelines is even more precarious. These proposed measures for the MRP may help render the price of drugs for rare disease to be somewhat more acceptable for manufacturers, but these calculations could increase the analytical effort and time taken by companies to properly establish a price.
For further information, please contact Marla Weingarten, Consultant, The Pangaea Group.