On Wednesday, June 26^th, PMPRB initiated Phase 2 of the consultation process by publishing the Discussion Guide that will help shape future guidelines. They have indicated that changes to the Guidelines are necessary to address their new legislative and jurisprudential reality and are committed to modernizing and simplifying the administrative framework. PDCI has summarized the major elements in the Discussion Guide.

Key Themes in the Discussion Guide

Existing Medicines:

• PMPRB is proposing that under its new framework it will no longer differentiate between Existing Medicines (those with reviews prior to July 2022) and New Medicines. Existing Medicines will be given a transition time to adjust to the new framework.

Risk Based Approach:

• The price review framework will be centered around identifying products that are at risk of excessive pricing.
• All products will first face Initial Price Review based on an International Price Comparison (IPC) test. Products with prices that exceed this ‘Identification Criteria’ will face a subsequent ‘In-Depth Review’ (analogous to ‘Investigation Triggers’ under prior Guidelines).

Initial Price Review/Post-Initial Price Review

• The initial review of a products list price will be based on the IPC of the PMPRB11. The review will be repeated annually unless an In-Depth review is triggered.

In-Depth Price Review

• An In-Depth Review, if required, will consider all factors from Section 85(1) of the Patent Act. These include the IPC, CPI adjustments, and both the domestic and international Therapeutic Class Comparison (TCC).
• PMPRB Staff will conduct a Scientific Review followed by a Price Review. PMPRB will balance the various Section 85 factors based upon the ‘Level of Similarity’ between the product under review and its therapeutic comparators.
• Timelines for an In-Depth Review will range from 12-28 months. Rights Holders will have the option to submit a Voluntary Undertaking (VU) at any time following notice that an in-depth review will be conducted. The VU will be presented to the Chairperson with a recommendation from PMPRB Staff to either close the review or escalate to a Hearing.

Topics for Consultation

The PMPRB is seeking consultation on seven topics included in the Discussion Guide. These include:

1. Which International Price Comparison benchmark should be used in the Initial Price Review
2. Transition time for ‘Existing Medicines’
3. CPI-Price Increases
4. Who can lodge complaints with the PMPRB
5. How Biosimilars and Vaccines should be reviewed by the PMPRB
6. How to evaluate the ‘Level of Similarity’ for In-Depth Reviews
7. The role of HDAP in future Guidelines

The Discussion Guide outlines significant proposed changes to the price review framework. PDCI will be providing further communications through our TargetPharma, focusing on the major changes to the 2017 Guidelines. In the interim, our pricing team is available to discuss potential implications to both existing and new medicines.

Key Dates

• August 2024: PMPRB will hold a webinar intended to elaborate on the approach taken by the Board and addressed questions submitted in advance by stakeholders on the Discussion Guide.
• September 11, 2024: Written responses to the Discussion Guide are due. These responses are intended to give stakeholders the opportunity to provide feedback on the topics for consultation that are identified in the Discussion Guide.
• Prior to the end of 2024: Draft of new Guidelines will be published. Further consultation may be held at that time.
• 2025: Finalization and Implementation of the new Guidelines

For more information, please reach out to Dylan Lamb-Palmer, Associate Director, Pricing Data, at dylan.lambpalmer@pdci.ca, for more information.