Submitting Generic Drug Products

Under the Pharmaceutical Services Act and the Drug Price Regulation, manufacturers must apply to PharmaCare to have generic drugs considered for benefit status.

PharmaCare reviews submissions and updates the generic formulary each month. Drugs remain on the PharmaCare formulary at their current reimbursement level until price changes are made or the drug’s coverage is ended.

PharmaCare reimburses generic drugs in categories that fall under the Low Cost Alternative (LCA) Program based on the Maximum Accepted List Price (MALP) and a tiered pricing framework. PharmaCare’s generic drug reimbursement policies are consistent with agreements developed between the pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA).

The Drug Price Regulation establishes a Maximum Accepted List Price (MALP) for every generic drug in the Low Cost Alternative (LCA) Program. The MALP for each LCA category is based on a brand name drug for that category. The MALP for oral solids is 25 percent of the brand reference drug price for categories either established on or after April 1, 2019, or which had a drug added or removed on or after April 1, 2019; it is 20 percent of the brand reference price otherwise.

The MALP for all other drugs (i.e., those that are not oral solids) is 35 percent of the brand reference drug price.

The Canadian Generic Pharmaceutical Association (CGPA) and the pan-Canadian Pharmaceutical Alliance (pCPA) have agreed on a Tiered Pricing Framework (TPF) for generic drugs. PharmaCare implements the TPF in its generic drug pricing where possible. Tiered pricing does not supersede existing PharmaCare regulation and policies, such as the MALP.

Tiered pricing applies to certain LCA categories based on the number of competitors in that LCA category.

 
Tier Number of Competitors Maximum Reimbursement Notes
Tier 1 One

75% of the brand reference price if a product listing agreement (PLA) for the brand reference product exists, in any jurisdiction
                                     OR
85% of the brand price if no product listing agreement exists in any jurisdiction

Products at this level may be reassessed anytime after two years since their initial assessment
PharmaCare may retain a PLA or pricing agreement with a brand product if it provides better value
Tier 2 Two 50% of the brand reference price
Tier 3 Three or more

25% of the brand reference price (oral solids)

35% of the brand reference price for all other dosage forms (e.g., liquids, patches, inhalers, injectables)

Drug manufacturers are expected to submit prices in accordance with the TPF. If there is a change in the number of competitors causing a lower tier base price, the manufacturer must reduce their list price to the appropriate tier if they want their drugs to be considered for coverage.

PharmaCare can adopt brand-name reference pricing from other jurisdictions for existing or new LCA categories in cases where specific criteria are met.

All generic drugs submitted by manufacturers priced at or below the MALP are considered for PharmaCare coverage. Exceptions are made on a provisional basis, usually because of a drug shortage within an LCA category or if listing the drug is in the public interest. PharmaCare reserves the right to rescind the exception, remove the full benefit status, and delist the drug.

For complete pricing details, see the list of drugs subject to pan-Canadian generic pricing (monitored by Saskatchewan Drug Plan).

Note: the prices set for these molecules are contingent on their being covered by the public drug plan in the respective jurisdiction. Some listed drugs may not be PharmaCare benefits, and therefore not subject to the negotiated prices.

LCA categories and current listing and reimbursement information for LCA program products can be found in the LCA/RDP Data Files.

Manufacturers with questions about the MALP for their product may contact PharmaCare at generic.submissions@gov.bc.ca.

Generic drugs in an LCA category are listed only as full benefits.

PharmaCare reimburses pharmacies for full-benefit products to a maximum of the supplier list price plus a markup of 8%. Drugs subject to the High Cost Drugs policy are reimbursed to a maximum of the supplier list price plus a mark-up of 5% or less. 

If a drug is subject to either or both the LCA program and the RDP, the lowest maximum reimbursement amount applies.

All prescription drugs submitted to PharmaCare are reviewed and subject to the LCA or RDP programs and TPF assessment. Submissions are accepted any time throughout the year.

Before submission, manufacturers must submit a Tiered Pricing Confirmation Form to the pCPA. For further details, see the Centralized Price Confirmation Process section of the pan-Canadian Generics web page.

As part of the submission, manufacturers must confirm supply and complete the appropriate workbook, in the required format.

Regular submissions must include a

These documents must be attached in a single email to generic.submissions@gov.bc.ca with the subject line: "Generic listing submission for [chemical name of drug] from [manufacturer name]."

Submissions that are not complete and delivered this way will not be reviewed. PharmaCare reserves the right to request additional information.

Multiple Strengths and Formulations

Regular submissions for different strengths of the same chemical in the same formulation must be included in a single submission email, using one common Generic Listing Submission Workbook. The submission must include

When submitting different chemicals or different formulations of the same chemical, each must be submitted as a single email with all supporting documents attached.

Submitting Price Changes

To request a price change (increase or decrease), see Submitting Price Changes.

Notification of Listing Decisions

PharmaCare publishes listing decisions online in the LCA/RDP Data Files, which are generally updated on the first Thursday of the month. Drug manufacturers who made the submission are also emailed with the listing decision.

Notification of Price Changes Resulting from Tiered Pricing Framework

To help pharmacies manage their inventory and to lessen the impact of price adjustments, pharmacies are given 14 days advance notice of price changes resulting from the tiered pricing model through an update to the LCA/RDP Data Files. During the 14-day notification period, suppliers are not obligated to change their drug price.

2019: B.C. amended the Drug Price Regulation to enhance generic drug coverage. This includes the removal of exclusive drug listings, an increase to the Maximum Accepted List Price (MALP) in a Low Cost Alternative (LCA) category, and the ability of B.C. to adopt brand reference prices from other jurisdictions.

2018: The pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA) announced a five-year initiative to reduce prices of most common generic drugs. For information and a drug list, see PharmaCare Newsletter 18-004.

2016: The Drug Price Regulation is amended. PharmaCare no longer has an annual confirmation of generic drug pricing.

2014: The Canadian Generic Pharmaceutical Association (CGPA) and the pan-Canadian Pharmaceutical Alliance (pCPA) agreed on a Tiered Pricing Framework (TPF) for generic drugs.