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. Please note that the Tiered Pricing Framework does not fetter the authority of any participating jurisdictions to make decisions with respect to coverage of drugs.
- Tier 1: Single source
Established when the generic product is a single source (i.e. only one manufacturer of a generic product in the Canadian market)
Brand Reference Pricing:
- 1a. Market Entry: Priced at 85% of brand reference price if PLA or pricing agreement for brand product does not exist or never existed at any time in the past.
- 1b. Market Exit: A single source generic for which no PLA or pricing agreement exists currently or in the past, will be limited to a maximum of 85% of brand reference price.
- 2a. Market Entry: Priced at 75% of brand reference price if PLA or pricing agreement exists or existed at any time in the past. Automatically reduces to 55% of brand reference price after three months of funding. The three-month period is specific to each jurisdiction.
- 2b. Market Exit: A single source generic if PLA or pricing agreement exists or existed at any time in the past, will be limited to a maximum of 55% of brand reference price.
- Tier 2: Dual source
Established when there are two generics in the Canadian market.
Brand Reference Pricing: Priced at 50% of brand reference price.
- Tier 3: Multi source
Established when there are three or more generic products on the Canadian market.
Brand Reference Pricing: 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.).
For more information on the Tiered Pricing Framework please refer to the following:
Generic Tiered Pricing Framework FAQs
pan-Canadian Price Tier Confirmation Process Flowchart
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.
Commonly prescribed drug pricing
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):
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].
Current Generic Categories Report August 2024
Archive:
Centralized price change process
The pCPA has introduced an easier and faster way to submit price change requests.
Manufacturers will now use the price change request form to submit directly to the pCPA instead of to individual drug plans.
The pCPA will evaluate the price change to ensure eligibility for respective jurisdictional price change mechanisms. Final decisions on price changes will remain at the discretion of participating drug plans, subject to jurisdictional policy, regulatory and legislative requirements.