Drug Submissions for Generic Drug Products

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Generic Drug Listings in B.C.

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.

In November 2016, the Drug Price Regulation was amended to improve the generic drug listing process in B.C.

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.

PharmaCare continues to review submissions for new generic drugs and to update  the generic formulary each month.

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.

Maximum Accepted List Price

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.

The maximum price that manufacturers can charge for generic LCA products is:

amlodipine besylate | atorvastatin | citalopram hydrobromide | clopidogrel bisulfate | donepezil | gabapentin | metformin | olanzapine | pantoprazole sodium | quetiapine | ramipril | omeprazole 20mg | rabeprazole sodium | rosuvastatin calcium | simvastatin | venlafaxine HCl | zopiclone

  • 20% of the equivalent brand product list price for all other oral solids
  • 35% of the equivalent brand product list price for all other drugs

When granting an exception to the MALP for a generic drug, PharmaCare grants the exception on a provisional basis only. PharmaCare reserves the right to rescind the exception, remove the full benefit status, and delist the drug.

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 generic.submissions@gov.bc.ca.

When a Drug Does Not Meet the MALP

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 previosuly, as they may be removed from the PharmaCare formulary.

If a drug is removed from the PharmaCare formulary as a result of an exclusive listing agreement, a manufacturer may resubmit the drug for consideration once the exclusive listing period has ended.

Benefit Status of 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

The Canadian Generic Pharmaceutical Association, British Columbia, and other participating provinces and territories reached an agreement on a Tiered Pricing Framework for generic drugs. BC PharmaCare implements this framework in its generic drug pricing process where possible. Tiered pricing does not supersede existing PharmaCare regulation and policies, such as the LCA Program MALP.

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

Tier

# of Competitors in the Market

Maximum Reimbursement

Tier 1

One

75% of the brand reference price
OR
85% of the brand price if no product listing agreement exists in any jurisdiction

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 (Non-oral Solids)

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 must reduce their list price to the appropriate tier base price if they want their drugs to be considered for coverage in that category.

Generic Drug Submission Procedures

All prescription drugs submitted for inclusion as benefits under the PharmaCare program must undergo a review.

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 (other than exclusive listing 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 Submission

Regular submissions must include the following documents:

  1. Scanned copy of the signed British Columbia Generic Drug Listing Terms and Conditions (PDF)
  2. Generic Listing Submission Workbook (XLS)
  3. 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 generic.submissions@gov.bc.ca. The email subject line must read "Generic Listing Submission for [chemical name of drug] from [manufacturer name]."

Submissions that are not completed and delivered in this format and manner will not be reviewed. PharmaCare reserves the right to request additional information as part of its review.

Guidance on the Amendment to Section 3.1 of the Drug Price Regulation (November 2016)—Exclusive Listing Submissions

PharmaCare prioritizes submissions received at or below the MALP. If a manufacturer makes an exclusive listing submission for an LCA category that contains only provisionally listed generic drugs, PharmaCare reviews their submission under a separate process. If accepted, that drug will be the sole generic drug listed in that LCA category for a period of up to 12 months.

For more information, see Guidance on the Amendment to Section 3.1 of the Drug Price Regulation.

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:

When submitting different chemicals, or different formulations of the same chemical, send separate submission documents attached to an individual email for each chemical and formulation.

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.

PharmaCare usually posts new listing information in the LCA/RDP Data Files on the first Thursday of every month, but may occasionally post updates at other times.

Notification of Price Changes Resulting from Tiered Pricing Framework

To help pharmacies manage their inventory and to lessen the impact of price reductions, 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.

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