On October 6, 2022, the Patented Medicine Prices Review Board (PMPRB) published its highly anticipated draft price regulatory Guidelines and has invited stakeholders to comment on its approach by December 5, 2022.

While some aspects of these guidelines were anticipated, there are a number of new concerns and uncertainties to be addressed throughout the consultation period. Join PDCI Experts on October 17, 2022 to discuss implications of these changes and how to optimize your opportunity to provide a consultation submission.

PDCI is analyzing the differences between the previous Guidelines (last updated in 2017) and the Draft ones proposed yesterday by PMPRB. Impact analyses are ongoing, but here’s what we know so far.

EXISTING MEDICINES

• All products with NOC prior to July 1, 2022, will be classified as “existing” medicines and have a price ceiling applied at the Highest International Price (HIP) of PMPRB11 basket.
• This is mostly good news for what had been a growing number of “gap” medicines with NOCs since August of 2019 as before yesterday, it was unclear whether these products would be classified as New or Existing Medicines.
• Manufacturers will have two reporting periods to come into compliance.
• Note: Despite HIP generally governing investigation criteria for Existing Meds, IF they should fall under investigation they may be subject to other price tests.  

NEW MEDICINES
PMPRB suggests these guidelines move away from “prescriptive price ceilings” in favour of more “pragmatic” criteria that may trigger an investigation. PMPRB would then take into account the “totality of circumstances to determine if a price is excessive”, leaving much unsaid and uncertain about how PMPRB intends to apply this approach.

• New Medicines will be regulated
  • At the lower of
    • The top of their Domestic Therapeutic Class Comparison (dTCC), or
    • Median International Price (MIP) of PMPRB11
  • And with a floor that is at least 50% of Lowest International Price (LIP) of PMPRB11
• Unlike previous Guidelines (last updated in 2017), there’s NO Level or Therapeutic Improvement classification which would allow price premiums for products offering improvements versus an existing standard of care product. This may result in harsher prices tests for highly innovative drugs offering substantial benefit but for indications in which there are existing treatments.  
• New scientific review is possible upon new indication
• This guidance leaves considerable uncertainty on the following points:
  • How comparators will be identified for the dTCC (beyond 4^th ATC)
  • How a New Medicine will be regulated after its introduction
    •  how frequent reassessments could occur
    • whether a medicine with NOC after July 1, 2022, will ever be regulated as an Existing Medicine
  • When and how HDAP would be consulted for scientific review purposes.

PDCI Webinar – Impact and Implications of Recent Draft PMPRB GuidelinesMonday, October 17,202212 p.m. to 1:15 p.m. EST CLICK HERE to register! 
This webinar is intended for pharmaceutical manufacturers, industry associations, patient stakeholders and other PDCI clients and partners. Registration requires a valid e-mail address. 

For additional information, please contact Dylan Lamb-Palmer at dylan.lambpalmer@pdci.ca