Guidance on Amendment to Section 3.1 of the Drug Price Regulation

(November 2016)

This page provides additional information to assist suppliers seeking consideration for an exclusive drug listing as part of the

Low Cost Alternative Program.

Effective April 1, 2017, PharmaCare will consider exclusive listing submissions.

To continue prioritizing submissions received at MALP, PharmaCare has introduced the opportunity to list only one generic drug that is submitted at or below the MALP in an LCA category for a period of up to 12 months.

Conditions for an exclusive listing include:

  • All generic drugs in the LCA category are provisionally listed (higher than MALP).
  • Supplier’s list price is at or below MALP for the category.
  • Supplier commits to ensure sufficient stock for the duration of exclusive coverage.
  • Supplier agrees to have 2 months’ stock in B.C. prior to the effective listing date.
  • Supplier agrees to have 2 months’ stock in B.C. at any time throughout the duration of the exclusive coverage.
  • Supplier indemnifies PharmaCare against any losses, costs, expenses, and liability incurred in the event that the province must list alternative products to cover a shortage.
  • Supplier agrees to notify PharmaCare if sufficient supply of the drug is at risk at any time during the period of exclusive coverage.

PharmaCare has sole discretion in determining whether any generic drug meets the eligibility criteria other than list price, and the eligibility criteria may be amended from time to time. PharmaCare has sole discretion to grant exclusive listings.

Submission Review

PharmaCare will review submissions for exclusive listings in the order they are received.

Upon receipt of an exclusive listing submission, an initial assessment may be performed. PharmaCare will carefully evaluate and assess the feasibility of the submission.

Additional steps may be taken including, but not limited to, the following:

  • a clinical assessment to ensure minimal risk or impact for patients
  • a review of recent and past performance for each supplier
  • overall value

The result of the initial assessment will be communicated to the supplier within 30 days of the receipt of the exclusive listing submission. Should the supplier choose to not proceed with the exclusive listing after being notified of a positive initial assessment, PharmaCare reserves the right not to consider the supplier for future opportunities for exclusivity.

Once exclusive coverage is granted, PharmaCare coverage of all other generic drugs in that category will be removed.

Approximately 2 months before the end of the exclusive coverage period, other suppliers will be given an opportunity to make regular submissions in that category.

Exclusive coverage of a generic drug may be terminated at any time at PharmaCare's sole discretion.