Pangaea Express: PMPRB publishes a Discussion Guide

The PMPRB has published a Discussion Guide, the next stage towards their updated Guidelines. The Board is implementing a 3 phase Guidelines consultation process to develop updated Guidelines that will support the amendments to the Patented Medicines Regulations that came into effect July 1, 2022. The first phase included the Scoping Paper with 6 themes from which written and in-person feedback was obtained and summarized in the What We Learned Report January 2024. The second phase is the publication of this Discussion Guide that outlines the proposed framework as well as the Board’s perspective of specific issues, some of which were identified in the What We Learned Report. Feedback on this phase is due Sept 11, 2024. The 3rd phase will be the draft guidelines that are planned to be released by the end of 2024.

The Discussion Guide outlines the structure of the PMPRB review process that is divided into four main sections: Section A: Initial Price Review; Section B: Post-Initial Price Review; Section C: Special Provisions; and Section D: In-Depth Review. The graphic presented in the Guide helps to visualize the process.

Section A: The Initial Price Review will look at the identification criteria based on the International Price Comparison (IPC). This will occur during the medicine’s initial filing period.

Section B: The Post-initial Price Review is the annual post-initial review of prices for all patented medicines under its jurisdiction, with the identification criteria based on the IPC and changes in the Consumer Price Index (CPI). All medicines – new and existing will be subject to the same identification criteria (Existing medicines will be given a period of time to adapt to the Guidelines)

Section C: Special Provisions involves the complaints process and can lead to an in-depth review. Special provisions for certain therapeutic markets are also being considered

Section D: In-Depth Reviews will assess the domestic Therapeutic Comparison (dTCC), the IPC, the International Therapeutic Class Comparison (iTCC) and changes in the CPI. The in-depth review may result in a recommendation to the Chairperson that it be closed (with or without an undertaking) or proceed to a Notice of Hearing

Note: the dTCC and iTCC are not carried out as part of the Initial Price Review or the Post-Initial Price Review, but only as part of an in-depth review. The PMPRB reasons, unlike the IPC, the TCC does not enable a direct price comparison with the same medicine. Consequently, the Board’s position is that Staff should consider the TCC in combination with other factors.

The PMPRB is open to comments regarding any aspect of the Discussion Guide (the process outlining the 4 sections); however, the Board is specifically seeking input from stakeholders on 7 specific topics for which they are assessing various options. The Discussion Guide outlines its reasoning for the various options within each topic and is opening the door for input on each.

Topic 1: Price level within the PMPRB11 to be used in the initial and post-initial price review:

• Option 1: Median International Price (MIP)
• Option 2: Highest International Price (HIP), or
• Option 3: midpoint between the MIP and HIP

Topic 2: The length of time Staff should wait, following the implementation of the Guidelines, to determine whether the IPC identification criterion for an Existing medicine is met:

• Option 1: one year
• Option 2: two years
• Option 3: three years

Topic 3: In-depth review based on CPI increase criteria:

• Option 1: if the list price increase is above one-year CPI
• Option 2: if the cumulative increase in list price over the last two years is above the combined CPI for the past two years and the increase only took place within the last year (i.e. no increase in price in the first of the two years, followed by an increase on the second year)

Topic 4: The individuals/groups permitted to submit a complaint:

• Option 1: limit complaints to the Federal Minister of Health or any of his/her Provincial or Territorial counterparts
• Option 2A: limit complaints to option 1 above plus public payors only; or
• Option 2B: limit complaints to option 1 above plus private and public payors
• Option 3: limit complaints to everyone except for Rights Holders.
• Option 4: no limits/restrictions.

Topic 5: Expanding the list of products that would only be subject to an in-depth review following a complaint to include biosimilars and/or vaccines.

• Option 1: The PMPRB will treat patented biosimilars and/or vaccines the same as other medicines.
• Option 2: The PMPRB will only open an in-depth review for biosimilars and/or vaccines when a complaint is received.

Topic 6: Use of clinical evidence to contextualize the degree of similarity of comparators identified for the TCC.

• Option 1: one level of similarity is identified for the comparators as a whole.
• Option 2: each comparator will be assigned a level of similarity.

Topic 7: Future role of Human Drug Advisory Panel (HDAP)

• Option 1: HDAP will be used only on an ad hoc basis when deemed necessary by Staff.
• Option 2: No HDAP – the scientific process will be conducted by Staff. *HDAP independent health professionals who are contracted by the PMPRB to assist with scientific evaluations in view of their broad general knowledge of drug therapy, drug evaluation, drug utilization and clinical research methodology. The HDAP historically provides impartial advice to PMRPB Staff as part of the scientific review process.

Feedback from phase 1, the Scoping Paper, brought forth a number of issues and concerns raised by stakeholders. The PMPRB has identified those that will not be addressed in the Guidelines as they fall outside of the PMPRB’s statutory authority. These include: rewarding innovation; supply chain considerations (downstream impact of list price reductions); distribution of excess revenues (dispersion of payments from voluntary undertakings to include private payers); access to medicines and patient perspectives; as well pharmacoeconomics and cost-effectiveness will not be considered by the Board.

This summary provides a very basic outline of the process identified in the Guide. Please refer to the publication for a more details.

The PMPRB listened to stakeholders’ views at the roundtable sessions last year and are now seeking your opinion on the topics and options put forth. Be sure to provide your feedback by Sept 11, to ensure your voice is heard.

For more information, please contact Suzanne Solman at ssolman@pangaea-consultants.com or Marla Weingarten at mweingarten@pangaea-consultants.com.