The PMPRB has issued the final version of the PMPRB Guidelines to support the implementation of Patented Medicines Regulations (Regulations) changes coming into force on January 1st, 2021.
Highlights of Changes Include:
Impact of Judicial Review
In response to the Federal Court decision made earlier this year, the Final Guidelines have limited the impact of the Pharmacoeconomic and Market Size price tests. Only excessive List Prices will trigger investigations for both Category I and II products. However, Maximum Rebated Prices will still be calculated and may have a role during an investigation. PMPRB, in their October NewsLetter published today, stated that this limited role may be reassessed once the Federal Appeal process has concluded.
The Pharmacoeconomic Value Threshold for Category I drugs receiving a Level IV Therapeutic Criteria Level (slight or no therapeutic improvement) has been reduced from $150K/QALY to $100K/QALY.
Remaining Issues
Grandfathered medicines will have their Maximum List Price (MLP) set to the lower of the HIP of the PMPRB 11 and their ceiling under the current Guidelines (Non-Excessive Average Price (NEAP)). Gap medicines will be set to the lower of the median of the PMPRB 11 and their ceiling under the current Guidelines (NEAP or Maximum Average Potential Price (MAPP)). Products currently offering and reporting benefits to customers will have PMPRB requiring List Price reductions to account for these benefits. PMPRB has indicated that a process will exist for patentees to appeal this reduction, similar to the current DIP methodology. Grandfathered and Gap medicines will be required to reduce List Prices before January 1st, 2022.
No changes have been made to the Guidelines regarding the conduct of the Domestic Therapeutic Class Comparison (dTCC) test. The PMPRB intends to use the lowest price for each of the medicines identified for comparison purposes, which would include prices of generic medicines. This is contrast to how the TCC is conducted under the Current Guidelines, where the highest price of each comparator is used.
The New Guidelines greatly expand the powers of board staff to deviate from the Guidelines in the context of investigations. Additionally, Board Staff may impose price controls based on Pharmacoeconomic and Market Size price tests to drugs under investigation. Affected products would not be able to rely on 3rd – party rebates to achieve compliance.
Information necessary for accurate reporting and compliance methodology, including International Price sources, is still not available. A release date for PMPRB’s Online Filing Tool has not been provided.
PDCI is hosting a free webinar for pharmaceutical industry members on the final Guidelines on October 29th , 2020 from 1:00 – 2:30pm.
Register here for the free session.
Please contact Jennifer Mathews, Pricing Data Associate at PDCI Market Access,
if you have any questions.