Drug Submissions for Generic Drug Products
Updates to Generic Drug Pricing in the Drug Price Regulation
In February 2019, B.C. amended the Drug Price Regulation to enhance generic drug coverage. These changes are effective April 1, 2019 and include:
For more information on these new effects and their impacts, see 2019 Amendments to B.C. Drug Price Regulation.
On this page …
- Generic Drug Listings in B.C.
- Amendments to Drug Price Regulation
- Maximum Accepted List Price (MALP)
- When a Drug Does Not Meet the MALP
- Benefit Status of Generic Drugs
- Pan-Canadian Pharmaceutical Alliance Generic Initiatives Tiered Pricing Framework
- Generic Drug Submission Procedures
As set forth in the Pharmaceutical Services Act and the Drug Price Regulation, manufacturers must apply to BC PharmaCare to have their generic drug products considered for PharmaCare benefit status. PharmaCare assesses the benefit status of generic drugs based on the factors listed below.
This section outlines amendments made to the Drug Price Regulation (the Regulation) to improve the generic drug listing process in B.C.
In November 2016, the Regulation was amended so that effective April 1, 2017, PharmaCare no longer has an annual confirmation of generic drug pricing. Manufacturers are not required to participate in an annual price confirmation process to ensure continued listing of their products.
Any drugs on the PharmaCare formulary as of April 1, 2017, will remain on the formulary at their current reimbursement level until price changes are processed or until coverage of the drug is removed.
In February 2019, B.C. amended the Regulation again to enhance generic drug coverage, effective April 1, 2019. The changes include the removal of exclusivity, an increase to the Maximum Accepted List Price (MALP), and the adoption of brand reference prices from other jurisdictions.
Exclusivity will be removed so manufacturers can no longer submit exclusive generic drug listings. Removing exclusivity will increase patient choice by opening the market to multiple generic drug listings within the same LCA category.
The MALP increases from 20 percent to 25 percent of the brand-name drug for oral solids and remains at 35 percent for all other generic drugs. An MALP increase allows B.C. to better align with other participating jurisdictions in using the Tiered Pricing Framework.
B.C. will have the opportunity to adopt brand-name reference prices from Ontario or other jurisdictions, when appropriate. Using brand reference prices from other jurisdictions may increase the number of PharmaCare-covered generic drugs.
(For more information, see 2019 Amendments to B.C. Drug Price Regulation.)
PharmaCare continues to review submissions for new generic drugs and to update the generic formulary each month.
The Regulation establishes a Maximum Accepted List Price (MALP) for every generic drug in the Low Cost Alternative (LCA) Program. Only generic drugs priced at or below the MALP are considered for PharmaCare coverage, unless an exception is made for a specific generic drug on a provisional basis.
On January 29, 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA) announced a new five-year initiative that will reduce prices of most common generic drugs. For more information, please see PharmaCare Newsletter 18-004.
The maximum price that manufacturers can charge for generic LCA products is:
Effective April 1, 2018, most of the following generic drugs that are subject to pan-Canadian Pharmaceutical Alliance (pCPA) Generic Initiative pricing will be reimbursed at approximately 18% of the equivalent brand name product, plus an 8% markup. Items marked with an asterisk (*) are non-benefits and will not be reimbursed by PharmaCare.
|amiodarone||candesartan HCTZ||eletriptan*||lamotrigine||pravastatin||telmisartan HCTZ|
- Effective April 1, 2018, most of the following generic drugs that are subject to pan-Canadian Pharmaceutical Alliance (pCPA) Generic Initiative pricing will be reimbursed at approximately 10% of the equivalent brand name product, plus an 8% markup. Items marked with an asterisk (*) are non-benefits and will not be reimbursed by PharmaCare.
|atorvastatin||ezetimibe*||olanzapine ODT||rabeprazole EC||simvastatin|
- 25% of the equivalent brand product list price for all other oral solids
- 35% of the equivalent brand product list price for all other drugs
For more complete pricing details, please refer to the list of molecules subject to pan-Canadian generic pricing, with their established price points.
Note: the prices set for these molecules, in individual jurisdictions, are contingent upon the drug being covered by the public drug plan in the respective jurisdiction. Drugs marked with an asterisk in the table above are included on the list of molecules, but are not PharmaCare benefits, and therefore not subject to the negotiated prices in British Columbia.
For information about LCA categories, applicable MALPs, and current listing and reimbursement information for products subject to the LCA Program, consult the LCA/RDP Data Files.
Manufacturers with questions about the applicable MALP for their product may contact PharmaCare at firstname.lastname@example.org.
When a Drug Does Not Meet the MALP
When granting an exception to the MALP for a generic drug, PharmaCare grants the exception on a provisional basis only. Provisional grants occur in the event of an insufficient drug supply within an LCA category, when the listing of a provisional drug can help counteract the shortage, and it is in the public interest to do so. PharmaCare reserves the right to rescind the exception, remove the full benefit status, and delist the drug.
Unless an exception is made for a specific generic drug, a manufacturer must confirm that its generic drug product will be priced at or below the MALP.
If PharmaCare does not receive confirmation of this from a manufacturer, the drug is not be eligible for PharmaCare coverage. This applies even to generic drugs that have been eligible for PharmaCare reimbursement previously, as they may be removed from the PharmaCare formulary.
Note: Effective April 1, 2019, MALP increases to 25 percent of the reference brand-name drug price for oral solids. MALP remains at 35 percent for all other generic drugs.
Generic drugs in an LCA category are listed as full benefits. PharmaCare does not cover generic drugs as partial benefits.
Full benefit products are generally reimbursed to a maximum of the supplier list price, plus a mark-up of 8%. Drugs subject to the High Cost Drugs policy are reimbursed to a maximum of the manufacturer list price, plus a mark-up of 5% or less.
If a drug is subject to both the LCA Program and the Reference Drug Program, the lowest maximum reimbursement amount applies.
Pan-Canadian Pharmaceutical Alliance (pCPA) Generic Initiatives
Tiered Pricing Framework
In 2014, the Canadian Generic Pharmaceutical Association (CGPA) and the pan-Canadian Pharmaceutical Alliance (pCPA), of which B.C. is a member, reached an agreement on a Tiered Pricing Framework (TPF) for generic drugs. BC PharmaCare implements the TPF in its generic drug pricing process where possible. Tiered pricing does not supersede existing PharmaCare regulation and policies, such as the MALP.
Tiered pricing is applied to certain LCA categories based on the number of competitors in that LCA category.
# of Competitors in the Market
75% of the brand reference price if a product listing agreement for the brand reference product exists in any jurisdiction
Products at this level may be reassessed after 2 years following their initial assessment.
PharmaCare may retain a PLA or pricing agreement with a brand product if it provides better value.
50% of the brand reference price
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, etc.)
Manufacturers are expected to submit prices in accordance with the Tiered Pricing Framework. If there is any change in the number of competitors that causes a lower tier base price, the supplier(s) must reduce their list price to the appropriate tier base price if they want their drugs to be considered for coverage in that category.
Note: Effective April 1, 2019, the TPF is used to determine when it is appropriate for B.C. to adopt a brand reference price from another participating jurisdiction for an LCA category.
All prescription drugs submitted for inclusion as benefits under the PharmaCare program must undergo a review subject to the LCA or RDP programs and TPF assessment.
Effective April 1, 2017, PharmaCare accepts submissions at any time throughout the year. Submissions are accepted only if the manufacturer can confirm supply availability and enters submissions in the appropriate workbook, in the required format.
Before making submissions to PharmaCare, manufacturers seeking coverage for new generic drugs must submit a Tiered Pricing Confirmation Form to the pan-Canadian Pharmaceutical Alliance Centralized Price Confirmation Process. For further details, refer to the Centralized Price Confirmation Process section of the pan-Canadian Generics page.
Required Documents for Submission
Regular submissions must include the following documents:
- Scanned copy of the signed British Columbia Generic Drug Listing Terms and Conditions (PDF)
- Generic Listing Submission Workbook (XLS)
- Scanned copy of the Notice of Compliance (NOC) document issued by Health Canada showing the applicable Drug Identification Numbers (DINs)
These documents must be attached in a single email to email@example.com. The email subject line must read "Generic Listing Submission for [chemical name of drug] from [manufacturer name]."
Submitting 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:
- One signed British Columbia Generic Drug Listing Terms and Conditions (PDF)
- The applicable NOCs of all strengths submitted
Submitting Price Changes
To request a price change (increase or decrease), follow the associated procedures.
Notification of Listing Decisions
PharmaCare notifies manufacturers of listing decisions by email. Listing decisions are also published online in the LCA/RDP Data Files.
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 changes in pricing 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 reduce their drug price.
- PharmaCare Policy Manual, LCA/RDP policies, Sections 5.11 and 5.12 (PDF)
- Current listing and reimbursement data files for LCA/RDP,
- LCA/RDP data file interpretation documents, including
- 2019 Amendments to B.C. Drug Price Regulation (PDF)
- British Columbia Generic Drug Listing Terms and Conditions (PDF)
- Generic Listing Submission Workbook (XLS)
- Drug Submission Procedures for Patented Drug Products and Biosimilars
- Submitting Price Changes for Generic Drugs
- Submitting Price Changes for Brand Name and Single-Source Generic Drugs
- Pan-Canadian Tiered Pricing Framework