As PDCI announced earlier today, the PMPRB has issued the second draft of the PMPRB Guidelines to support the implementation of Patented Medicines Regulations (Regulations) changes coming unto force on January 1, 2021. This draft is now available for a 30-day Notice and Comment Period. Written feedback is due to PMPRB by July 20, 2020.
As part of consultation on this draft, PMPRB will be hosting several webinars for various audiences over the coming weeks. You can register for these webinars online.
The factors and reporting requirements outlined in the amendment to the Regulations published in Canada Gazette II on August 21, 2019 have not changed, and this draft of the Guidelines addresses all those new factors and reporting requirements. That said, there are many important changes in this version since the initial version of the Draft Guidelines published by PMPRB in November 2019.
Highlights of Changes Include:
CATEGORY I PATENTED MEDICINES
- New thresholds for Category I designation:
- High cost treatments have an annual treatment cost of 1.5 times Canadian GDP/capita or ~$90,000 (instead of .5 times or ~$30,000)
- Market size adjustments apply to medicines with sales of ≥ $ 50 million (instead of ≥ $ 25 million) annually
- MRP=MLP for sales < $ 12 million, annually for high cost Category I medicines
- Introduction of four Therapeutic Criteria Levels (TCL) for Category I medicines associated with varying ICUR thresholds and limits on PEP-related MRP discounts
- Higher ICUR thresholds to set PEP ($150K/QALY, $ 200K/QALY for “breakthrough” medicines)
- Limits on MRP discounts due to market size with annual sales thresholds of $50 million and $100 million
GRANDFATHERED MEDICINES & LINE EXTENSIONS
- MLP = lower of HIP of PMPRB 11 and current NEAP
GAP MEDICINES (For DINs received after Aug 21, 2019 and first sold before December 31, 2020)
- Clarity on pricing for gap medicines: MLP = lower of MIP PMPRB 11 and current NEAP, no MRP ever
- Inclusion of NACI as a potential source for publicly conducted health technology assessment
- Limited use of dTCC and restoration of referencing the highest dTCC, where applicable
- Change in the RR test to allow for flat pricing among different strengths of a product
Issues and gaps remain in this draft of the Guidelines:
- Increased filing requirements vs. the existing framework
- Increased complexity vs. the existing framework
- No concrete guidance on how to file third party rebates (to be included in Help section)
- No concrete guidance about international price sources (to be included in Help section)
- Increased powers for Board Staff to deviate from the Guidelines in the context of Investigations
PDCI is hosting a free webinar for pharmaceutical industry members on the new Draft Guidelines on June 23rd from 10:30am to noon.
Please contact Kimberly Robinson, PDCI’s Director of Pricing and Market Access if you have questions