Side-by-Side Comparison of Former and New Text in the Compendium of Policies, Guidelines and Procedures (July 2016)

List Price Relative to Maximum Average Potential Price (MAPP) Verification Amendment
Description: That an addition be made to the Compendium of Policies, Guidelines and Procedures (Guidelines) 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 MAPP
Former text New text
C.11 Review of Prices of New Patented Drug Products at Introduction

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

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 other elements of section C.11, the prices from sources identified in subsection C.11.13 for a new patented drug product shall not exceed the Maximum Average Potential Price (MAPP) established by the appropriate introductory price test(s). If a price from these sources is found to exceed the MAPP, it would trigger an investigation by Board Staff. The first step of this investigation would be to confirm with patentees whether any sales have taken place at this price. If it can be positively ascertained by Board Staff that such sales have taken place, an investigation will proceed as described elsewhere in the Guidelines.

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.

[The subsequent subsections of C.11 have been renumbered.

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