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

Initiative #1: Reasonable Relationship Test (Schedule 4) Amendment
Proposal: When applying the Reasonable Relationship Test, if the new drug product and the comparable drug product(s) are both patented and owned by the same patentee, that Board Staff would use the non-excessive National Average Transaction Price of the comparable drug product(s) when establishing the Maximum Average Potential Price for the new strength of the patented drug product. If the new drug and the comparable drug product(s) are owned by different patentees, then Board Staff would apply the current practice of using the lowest of the six publicly available sources to establish the Maximum Average Potential Price. This would be effective for all drugs introduced in Canada after January 1, 2016.
Current Guidelines Text Proposed New Text
Schedule 4 – Reasonable Relationship Test
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Board Staff will use public sources for prices for the drug products used for comparison purposes. The sources of prices which Board Staff will consult are (in alphabetical order): the Association québécoise des pharmaciens propriétaires (AQPP); IMS Health; McKesson Canada; Ontario Drug Benefit (ODB) Programs; PPS Pharma; and the Régie de l’assurance maladie du Québec (RAMQ). Board Staff will select the lowest public price from these sources for each of the drug products identified for comparison purposes. If no price is available for a comparator from these sources, Board Staff will explore additional sources until a public price is found.
…		 Schedule 4 – Reasonable Relationship Test
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If both the new drug product and comparable drug product(s) are owned by the same patentee, then the National Average Transaction Price of the comparable drug product(s) will be used for comparison purposes.

If the new drug product and comparable drug product(s) are owned by different patentees, Board Staff will select the lowest public price from the following sources for each of the drug products identified for comparison purposes (in alphabetical order): the Association québécoise des pharmaciens propriétaires (AQPP); IMS Health; McKesson Canada; Ontario Drug Benefit (ODB) Programs; PPS Pharma; and the Régie de l’assurance maladie du Québec (RAMQ). If no price is available for a comparable drug product from these sources, Board Staff will explore additional sources until a public price is found.

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Initiative #2: List Price Relative to Maximum Average Potential Price (MAPP) Verification Amendment
Proposal: That an addition be made to section C.11 “Review of Prices of New Patented Drug Products at Introduction” requiring patentees to ensure that domestic list prices for new drugs are below the Maximum Average Potential Price.
Current Guidelines Text Proposed New Text
C.11 Review of Prices of New Patented Drug Products at Introduction
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Procedures:

C.11.13 Board Staff will use public sources for the prices of the drug products used for comparison purposes. The sources of prices which Board Staff will consult are (in alphabetical order): the Association québécoise des pharmaciens propriétaires (AQPP); IMS Health; McKesson Canada; Ontario Drug Benefit (ODB) Programs; PPS Pharma; and the Régie de l’assurance maladie du Québec (RAMQ). Board Staff will select the lowest public price from these sources for each of the drug products identified for comparison purposes. If no price is available for a comparator from these sources, Board Staff will explore additional sources until a public price is found.

C.11.14 Based on the application of the appropriate introductory price test(s) to the first day of sale price and sales data, Board Staff will provide interim advice to the patentee as to whether or not the price would appear to be excessive.

 C.11 Review of Prices of New Patented Drug Products at Introduction
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Procedures:

C.11.13 Board Staff will use public sources for the prices of the drug products used for comparison purposes. The sources of prices which Board Staff will consult are (in alphabetical order): the Association québécoise des pharmaciens propriétaires (AQPP); IMS Health; McKesson Canada; Ontario Drug Benefit (ODB) Programs; PPS Pharma; and the Régie de l’assurance maladie du Québec (RAMQ). Board Staff will select the lowest public price from these sources for each of the drug products identified for comparison purposes. If no price is available for a comparator from these sources, Board Staff will explore additional sources until a public price is found.

C.11.14 Notwithstanding sections C.11.3 to C.11.13, the prices found in the public sources listed in C.11.13 for a new patented drug product shall not exceed the Maximum Average Potential Price established by the appropriate introductory price test(s).

C.11.15 Based on the application of the appropriate introductory price test(s) to the first day of sale price and sales data, Board Staff will provide interim advice to the patentee as to whether or not the price would appear to be excessive.

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[The subsequent subsections of C.11 would then be renumbered.]
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