Drug Submission Requirements for Generic Drug Products

Introduction

Drug submission sponsors must apply to the Ministry of Health (the Ministry) to have their generic drug products considered as a PharmaCare benefit.

In 2010, PharmaCare began a phased decrease in reimbursement for generic drugs in the Low Cost Alternative (LCA) and Reference Drug programs. The three phases are described in the table below.

Phase MALP
Phase 1
(Oct 15, 2010 - Jul 3, 2011)		 Existing generics* - 50 percent of brand list price as of January 1, 2010

New generics* - 42 percent of brand list price as of January 1, 2010
Phase 2
(Jul 4, 2011 - Apr 1, 2012		 40 percent of brand list price as of January 1, 2010
Phase 3
(Apr 2, 2012 - Mar 31, 2013)		 35 percent of brand list price as of January 1, 2010

Maximum Accepted List Prices for each pricing period

During each phase, a Maximum Accepted List Price (MALP) has been established for every generic drug that is subject to the Low Cost Alternative (LCA) policy. In this latest phase, April 2, 2012 to March 31, 2013, the MALP that manufacturers can charge for generic LCA products has been reduced to 35% of the equivalent brand product’s list price.

Drug coverage decisions will be based on manufacturer list prices in effect thirty days before the start of each phase. This requirement is intended to provide pharmacies with a period for inventory adjustment before the new PharmaCare reimbursement comes into effect.

When drugs do not meet the MALP requirement

Unless an exception has been made for a specific generic drug, the generic manufacturer must confirm that its generic drug product will be priced at or below the established MALP for the applicable phase.

Where the Ministry does not receive confirmation from a manufacturer that a generic drug product will be priced at or below the established MALP in effect for the applicable phase, such drug will not be eligible for PharmaCare coverage for the duration of that phase. This condition applies even to those generic drugs that were previously eligible for PharmaCare reimbursement, as they will be removed from the Formulary for the duration of the applicable phase.

Generic drugs that have been deemed ineligible will not be considered for listing on the formulary until the next period, regardless of any change to its list price before then.

Benefit status of generic drugs

Generic drugs included in an LCA category have one of two benefit statuses: Full Benefit or Non-Benefit. PharmaCare does not cover generic drugs as Partial Benefits.

Pharmacy claims for Full Benefit products will generally be reimbursed up to a maximum of the manufacturer list price, plus a mark-up of eight percent, with the exception of drugs subject to the Reduced Mark-up for High Cost Drugs policy. Generic drugs subject to the Reference Drug Program will still be subject to limitations on maximum daily reimbursement costs.

When granting a generic drug an exception to the MALP requirement, the Ministry reserves the right to grant the exception on a provisional basis only. Because the exception and benefit status are granted provisionally, the Ministry reserves the right to rescind the exception, remove the Full Benefit status and delist the drug before the end of the applicable phase.

Drug submission procedures

Required documents

All prescription drugs submitted for inclusion as eligible benefits under the PharmaCare program must undergo a review.
Generic drug submissions must include the following three documents:

  1. a scanned copy of the completed and signed Generic Listing Submission Application in PDF format (PDF 39K),
  2. a completed Generic Listing Submission Workbook in Excel format (XLS 77K). This document constitutes "Exhibit A" to the Generic Listing Submission Application, and,
  3. a scanned copy of the Notice of Compliance (NOC) document issued by Health Canada in PDF format showing the applicable Drug Identification Numbers (DINs). This scanned document constitutes "Exhibit B" to the Generic Listing Submission Application.

The two PDFs and the Excel workbook must be attached to a single e-mail to be sent to the Province at generic.submissions@gov.bc.ca. The e-mail should bear the subject heading "Generic Submission."

Submissions that are not completed and delivered in the stipulated format and manner may not be reviewed. Please be aware that the Ministry reserves the right to request additional information as part of its review.

Sumissions for multiple strengths and formulations

Submissions for different strengths of the same chemical in the same formulation must be included together in the same email sent to the Province, using one common Generic Listing Submission Application and one common Generic Listing Submission Workbook, along with the applicable Notice of Compliance(s) listing all strengths submitted.

Submissions for different chemicals or different formulations of the same chemical must be forwarded to the Province using separate submission documents and must be individually submitted through their own respective separate email.

Determining the applicable MALP

For information about LCA categories, applicable MALPS, and products that are subject to the LCA policy, manufacturers should consult the LCA Master Spreadsheet and the LCA/RDP Updates Workbook at www.health.gov.bc.ca/pharmacare/lca/lcabooklets.html.

For an explanation of the LCA data in these spreadsheets, consult the PharmaCare Low Cost Alternative/Reference Drug Program Guide (PDF 240K) which contains

  • background information on the LCA and RDP programs
  • detailed explanations of the data fields in the LCA and the RDP master spreadsheets

Important: The LCA spreadsheets do not list the MALP; instead, they list the drug cost amount that PharmaCare will cover. This amount includes the maximum price for full benefit products and the LCA price for partial benefit products. The MALP would in most cases be equal to the LCA Price divided by 1.08 (so as to factor out the maximum allowable mark-up of 8%).

Manufacturers who remain unsure of the applicable MALP for their product may contact the Ministry at generic.submissions@gov.bc.ca for assistance.

Ministry notification of listing decisions

Manufacturers will be notified of the Ministry's listing decision by e-mail. Effective April 1, 2011, listing decisions on generic drug submissions are no longer announced in PharmaCare Newsletters. Instead, they are announced on the PharmaCare website at www.health.gov.bc.ca/pharmacare/lca/lcabooklets.html.

The Province will generally communicate listing decision on the first Thursday of every month, though this may also occur occasionally between such dates.

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