Overview
The pCPA and the generic pharmaceutical industry have worked together over the past decade to lower the prices of generic drugs and to increase coverage and price consistency across public drug plans.
Initiatives such as the pan-Canadian Tiered Pricing Framework (TPF) and pan-Canadian Select Molecule pricing have resulted in substantial savings to Canadians (whether prescriptions are filled through public plans, private insurers, or individually by patients).
This process started in 2013 with the establishment of reduced pricing for six defined generic molecules and was updated and expanded annually from 2014 to 2017.
The pCPA and the Canadian Generic Pharmaceutical Association (CGPA) have agreed to a new three-year pricing initiative for generic drugs that will take effect on October 1, 2023 with the option to extend by an additional two years. Québec is included as a participant in the new agreement going forward.
A key component in the new agreement is that the price of new single-source generics entering the pan-Canadian Tiered Pricing Framework as of October 1, 2023, automatically drop to 55 per cent of brand reference price after three (3) months from the start of public funding in a participating jurisdiction. Notwithstanding, when additional generics enter the Canadian market, these generics are subject to dual-source or multi-source pricing prior to the elapsing of the three (3) month period. Please refer to the chart below for the updated information.
pan-Canadian Tiered Pricing Framework (TPF)
The pan-Canadian Generic Tiered Pricing Framework (TPF) initially began on April 1, 2014.
The TPF is comprised of three pricing tiers and applies to any generic product, where the current or previously available brand reference product was eligible for reimbursement by any pCPA jurisdiction.
The pCPA manages the TPF to evaluate and establish the price of generic products entering and exiting the Canadian market. The process takes into account various factors such as the number of competitors in the market and the price of the brand reference product. Effective October 1, 2023, submissions for market entry of newly launched single source generics are subject to an automatic price drop to 55 per cent of brand reference price after three months of public funding.
The pricing tiers are shown in the following table.
| TPF Tier Description | % of Brand Reference Pricing | Notes |
|---|---|---|
|
Tier 1: Established when the generic product is a single source (i.e. only one manufacturer of a generic product in the Canadian market) |
1a. Market Entry: 1b. Market Exit: 2a. Market Entry: 2b. Market Exit:
|
The Tiered Pricing Framework does not fetter the authority of any participating jurisdictions to make decisions with respect to coverage of drugs. |
|
Tier 2: Established when there are two generics in the Canadian market |
Priced at 50% of brand reference price | |
|
Tier 3: Established when there are three or more generic products on the Canadian market |
Priced at 25% of brand reference price for oral solids and at 35% for all dosage forms other than oral solids (e.g. liquids, patches, injectables, inhalers, etc.) |
pan-Canadian Select Molecules
In 2018, a five-year initiative was introduced that reduced the prices of 67 of the most commonly prescribed drugs (pan-Canadian Select Molecules) in Canada. These are not part of the Tiered Pricing Framework process but rather are set at fixed prices.
In 2022, pricing for some pan-Canadian Select Molecules were reduced from approximately 18% to 15% of relevant Brand Reference Prices: Alendronate, Atenolol, Bisoprolol, Carvedilol, Dutasteride, Finasteride, Risedronate & Risperidone.
Effective October 1, 2023, as a result of a new agreement, the following molecules will be removed from the pan-Canadian Select Molecule list: Famciclovir and Minocycline.
Non-Formulary Benefits
Effective October 1, 2023, newly launched generic molecules that are not formulary benefits, but are publicly funded through a defined and transparent public program will be assessed through the Tiered Pricing Framework (TPF). As of October 1, 2023, newly launched genericized molecules that are funded through the Ontario Exceptional Access Program (EAP) will be recognized for assessment through the TPF. Additional defined drug programs in participating jurisdictions may be eligible for inclusion in the TPF in the future.
For Generic Pharmaceutical Manufacturers
For a generic product to be listed on a public drug plan formulary, manufacturers are required to submit the TPF Form electronically to the pCPA for all generic products entering and exiting the Canadian market, including the pan-Canadian Select Molecules.
The pCPA will verify the Tiered Pricing Framework applies to the product, determine the appropriate price tier and advise the manufacturer and all participating jurisdictions of the assessment results.
The TPF Form does not replace the existing product listing requirements in participating jurisdictions.
TPF forms (request for pricing assessment):
For more information on the Tiered Pricing Framework please refer to the following:
- Pan-Canadian Price Tier Confirmation Process Flowchart (pdf)
- Pan-Canadian Price Tier Market Exit Eligibility Flowchart (pdf)
- Generic Framework FAQs (doc)
- Historical Products Policy (pdf)
Completed forms or inquiries regarding the TPF process may be sent to: [email protected].
Generic Categories Report
The pCPA Generic Categories Report provides the generic prices and tiers of products that have been assessed through the TPF. The TPF Categories are dynamic and the Category Report represents prices at a point in time. The report is made available as a reference tool to inform stakeholders, but may not be reflective of the TPF prices at the time of an assessment. As such, this document should be used as a guide and not relied upon for predicting TPF assessment prices. For Categories that are not listed in the report, manufacturers are encouraged to submit a pre-assessment request to the pCPA at [email protected].