The pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA) have agreed to a new three-year pricing initiative for generic drugs, effective October 1, 2023. This agreement, which includes an option to be extended by an additional two years, replaces the old five-year agreement set to expire in 2023. The new agreement adds Québec, implements changes to the Tiered Pricing Framework (TPF), removes two molecules from the pan-Canadian Select Molecules list, and adds "non-formulary benefits." The TPF applies to any generic product where the current or previously available brand reference product was eligible for reimbursement by any pCPA jurisdiction.
Changes to the TPF
The new agreement introduces changes for single-source generic products entering the TPF as of October 1, 2023 (Tier 1 of the TPF). Such drugs will be priced at:
- 85% of the brand reference price if a product listing agreement (PLA) or pricing agreement does not exist or never existed at any time in the past, and
- 75% of the brand reference price for the first three months and [new] 55% thereafter if a PLA or pricing agreement exists or existed.
There are no changes to Tier 2 (two generics, priced at 50% of the brand reference price), or Tier 3 (three or more generics, priced at 25% of the brand reference price for oral solid dosage forms, and at 35% for all other dosage forms.)
Addition of Non-Formulary Benefits
The TPF will apply to new generic products that are not formulary benefits but are "publicly funded through a defined and transparent public program." As of October 1, 2023, new generic drugs funded through the Ontario Exceptional Access Program will also be assessed through the TPF. Additional "defined drug programs" in other jurisdictions may be eligible for inclusion in the TPF in the future.
pCPA appoints Douglas Clark as its first CEO
The pCPA has appointed Douglas Clark as the pCPA's first CEO, effective September 11, 2023.
The former executive director of the Patented Medicine Prices Review Board (PMPRB) will be tasked with achieving goals of the pCPA's current strategic plan and creating a new strategic plan as the pCPA transitions to an independent organization.
Should you have any questions, please do not hesitate to contact a member of theLife Sciences Regulatory & ComplianceGroup.
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