On June 20, 2023, PMPRB published proposed amendments to the Interim Guidance relating to New Medicines. PMPRB has invited stakeholders to comment on the approach before August 21, 2023 (60-day consultation). After stakeholder consultation, a new set of guidelines is anticipated to be finalized in 2024.
Key considerations are:
- Medicines without a MAPP (Maximum Average Potential Price) or NEAP (Non-Excessive Average Price) as of July 1, 2022, are considered reviewed if their list price is below the median international price (MIP) for the PMPRB11 countries.
- New Medicines that do not meet the above criteria (below MIP) will continue to be “under review” until new guidelines are in place.
- No potential excess revenues will be calculated by staff retrospectively for any New Medicines for sales made during the interim period.
- According to the notice and comment, PMPRB is proposing that List Price increases taken in 2023 will continue to trigger investigations, consistent with the August 18, 2022 Interim Guidance.
For patented medicines with a MAPP or projected NEAP as of July 1, 2022, the interim guidance remains unchanged from the August 18, 2022 interim guidance.
For more information, please consult PMPRB’s Notice and Comment or contact Dylan Lamb-Palmer, PDCI’s Associate Director, Pricing and Data Analytics at email@example.com for any questions about future directions of PMPRB.