Side-by-Side Comparison of Current and Proposed Text In the Compendium of Policies, Guidelines and Procedures

Schedule 11: Criteria for Commencing an Investigation

Table: Criteria for Commencing an Investigation

Board Staff will commence an investigation into the priceof a patented drug product when any of the following criteria are met:

1. The National Average Transaction Price or any Market-Specific Average Transaction Price of a new drug product exceeds the Maximum Average Potential Price during the introductory period by more than 5%.
2. The National Average Transaction Price of an existing drug product exceeds the National Non-Excessive Average Price by more than 5%.
3. Excess revenues for a new or existing drug product are $50,000 or more.
4. PMPRB receives a complaint.

Schedule 11: Criteria for Commencing an Investigation

Table: Criteria for Commencing an Investigation

Board Staff will commence an investigation into the price of a patented drug product when any of the following criteria are met:

1. The National Average Transaction Price or any Market-Specific Average Transaction Price of a new drug product exceeds the Maximum Average Potential Price during the introductory period by more than 5%.
2. The National Average Transaction Price of an existing drug product exceeds the National Non-Excessive Average Price by more than 5%
3. Excess revenues for a new or existing drug product are $50,000 or more.
4. PMPRB receives a complaint.

Schedule 13: Offset of Excess Revenues

Timeframes to offset excess revenues

1.3 Patentees are expected to offset excess revenues in a timely manner. The following parameters will generally be applied in the determination of repayment terms.

1.3.1* Excess revenue balances below the amount sufficient to trigger the investigation criteria that are carried for 3 years will be expected to be offset through a VCU. Failing this, Board Staff will refer the matter to the Chairperson. New investigations are based on the price and sales data for the January to June and July to December reporting periods covering the full calendar year. Offset of excess revenues will be calculated on the full calendar year.

As a result, and in order to be consistent with the annual review cycle, Board Staff will henceforth indicate only the calculated national ATP (N-ATP) and the national Non-Excessive Average Price (N-NEAP) for the existing patented drug products reported for that first six month period.

1.3.2 In the context of a VCU, and subject to the specific terms of the VCU, patentees will generally be allowed:

• 30 days following the Board´s acceptance of the VCU to make payment; or
• Until the end of the following reporting period to offset excess revenues through a price reduction. Any excess revenues remaining at the end of the specified period would be due in payment.

Schedule 13: Offset of Excess Revenues

Offset excess revenues

1.3 Patentees are expected to offset excess revenues in a timely manner:

1.3.1 In cases where the investigation criteria are not triggered, (in accordance with Part B-Policies, section B.5.2), the Board will ensure transparency with respect to the potential accumulation of excess revenues by reporting these drugs as “does not trigger”.

1.3.2 As new investigations are commenced based on regulatory filings covering a full calendar year, offset of excess revenues shall also be calculated on the full calendar year.

1.3.3 In the context of a VCU, and subject to the specific terms of the VCU, patentees will generally be allowed:

• 30 days following the Board´s acceptance of the VCU to make payment; or
• Until the end of the following reporting period to offset excess revenues through a price reduction. Any excess revenues remaining at the end of the specified period would be due in payment.