As a result of the change to the schedule of international comparator countries, as of July 1, 2020 all existing comparisons and test performed by the PMPRB will be done against the PMPRB11, not the PMPRB7. It is true that the number of multinational clinical trials is in decline overall, a trend observed in both Canada, the U.S. and other PMPRB comparator countries. 2. A report of the experts’ deliberations and recommendations will be submitted this month to the PMPRB’s committee, followed by a new … PMPRB will consider the opportunity cost of a medicine in the health system when evaluation if a price is excessive. The Proposed Regulations essentially mirror the provisions of the PMPRB consultation paper published earlier in 2017 by introducing new factors the PMPRB may consider in determining the value of a medicine, removing the United States as a comparator country for pricing reference, and modifying reporting requirements so rebates and discounts to any third parties (e.g. PMPRB has indicated it will focus its activities on addressing affordability and value for money. An updated schedule of comparator countries (the new “PMPRB11”) The amendments revise the schedule of comparator countries to be more consistent with the PMPRB’s mandate to protect consumers from excessive prices for patented medicines and better reflect current Government of Canada policy priorities. Today, the prices of patented medicines in Canada remain below the median of the prices in the PMPRB comparator countries (France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the USA). Schedule of comparator countries: South Korea was removed from the schedule Difference between the proposed and final amended regulations 9. 3. South Korea was initially proposed in the list of new countries, however it was removed from the final schedule of international comparator countries. PMPRB Draft Guidelines Released Nov 21, 2019 .
Changes in reporting requirements Price of product cannot rise to become the highest among the comparator countries, under Guidelines’ Highest International Price Comparison test. The PMPRB’s basket of comparator countries would increase to twelve from the current seven.
Seven new countries would be added, while the U.S. and Switzerland, described as “outliers,” would be removed as they do not have national pricing containment measures … The PMPRB is currently leading another consultation, assisted by a group of experts to help implement the proposed amendments.
PMPRB HEARING WITH ALEXION CANADA PMPRB GUIDELINES The price of a “breakthrough” product is measured against the publicly-available prices of the same product in 7 comparator countries.