Generic Drugs

Overview

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 current five-year agreement between pCPA and the Canadian Generic Pharmaceutical Association (CGPA) was established on April 1, 2018 and will expire in 2023.

As of March 24, 2022, the pCPA has formally entered into negotiations with the CGPA to renew discussions on these initiatives.

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 Office 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.

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)

Priced at 75% of brand reference price if product listing agreement (PLA) or pricing agreement for brand exists in any jurisdiction 

Priced at 85% of brand reference price if PLA or pricing agreement for brand product does not exist 

Products at this level will be reassessed after 2 years
 

Jurisdiction(s) have the option to retain PLA or pricing agreement with brand reference product if it provides a better value 

Tier 2:

Established when there are two generics on 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

Effective April 1, 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. 

As a result of the existing agreement with the CGPA, pricing for some pan-Canadian Select Molecules were reduced on April 29, 2022 from (approximately) 18% to 15% of relevant Brand Reference Prices: Alendronate, Atenlol, Bisoprolol, Carvedilol, Dutasteride, Finasteride, Risedronate & Risperidone.

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 Office for all generic products entering and exiting the Canadian market, including the pan-Canadian Select Molecules.

The pCPA Office 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:

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 Office at [email protected].

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