Working Group on Price Tests and CGPA Working Group Reports Published; Reminder: Publication of New Proposed Guidelines; Brogan Seminars

New PMPRB Working Group Reports Published

The reports by the Working Group on Price Tests and the CGPA Working Group are now posted on the PMPRB’s web site: http://www.pmprb-cepmb.gc.ca/english/view.asp?x=808


Highlights from Working Group on Price Tests:

• Moderate improvement: Includes convenience & compliance. MNE should be set based on the mid-point between the TCC and international median tests for “moderate improvement” drugs.



• TCC Test: Comparators should not be limited to the 4th level ATC class, and evidence required to select comparators outside the ATC class should not be limited to head-to-head clinical trials.


• MNE Definition: Highest non-excessive market-specific MNE price, to be applied nationally. Higher of introductory price test or highest previous non-excessive ATP.



• Publication of MNE: Introductory MNEs are already published by the PMPRB in Summary Reports. It is recommended that MNEs based on highest previous non-excessive ATP should also be published until the actual ATP surpasses this previous ATP. The PMPRB wishes this price to be used in the TCC test for new drugs using this medicine as a comparator. The WGPT suggests giving patentees the option to agree to the publication of these MNE prices in order to avoid contravening the confidentiality clause in the Patent Act.


• Note that using the highest previously published list price would achieve the same goal, while not compromising confidentiality of patentees, and moreover is consistent with the recent Board’s decision on Adderall XR on admissibility of evidence.


• De-linking: One-year increases should be permitted to exceed CPI where the price is lower than the previously allowable price. The restriction would be 33% of gap between MNE and ATP or 10-15% of ATP (not everyone agreed with the latter restriction, stating that the 33% was sufficient), depending on the specific circumstances. Where benefits reduced the price, no restriction on returning to previous levels would be in place. This proposal introduces two new definitions to the PMPRB lexicon: “gap” (difference between MNE and ATP in introductory period or for reasons other than “benefits”), and “dip” (caused by benefits).
  

       CPI-adjustment methodology should continue to apply to drug products whose ATP reaches the MNE. No clear recommendations were made as to how to modify the methodology, if at all.



• Any market review should take place only at introduction and on a case-by-case basis in the case of an investigation. No methodology was agreed upon as to method of calculating excess revenue.



• Re-setting the MNE: MNE should not be forced below the int’l median. Patentees should have one year or to the end of the calendar year to adjust their price without accumulating excess.


• Re-setting based on science should be based on changes in therapeutic improvement level or in the suitability of comparators selected. The onus should be on the requestor of re-setting to identify and submit relevant scientific evidence.


• Re-setting the international median based on few countries is unchanged.



• No changes to: Reasonable Relationship Test, and to the Exchange Rate Methodology, as well as to the test for combination products, with the exception that the sum of the MNE of both products should be used, according to the revised MNE definition.

• The Board recognizes the uniqueness of patented generic medicines relative to patented brand medicines.


• New guidelines would apply to cross-referenced generics with a bio-equivalent brand, and to cross-licensed generics only.


• Introductory price test should be the price of the bio-equivalent brand product.


• International price comparison should not be relied upon. The Regulations should be changed to exempt generics from filing international prices.


• No recommendations yet on year-over-year increases, however, the Regulations should be changed to exclude rebates, professional allowances and other like benefits from the calculation of the ATP.


• Regulations should be changed to allow generic patentees to file on a complaints basis.

• PMPRB Fundamentals Seminar is being held on September 18 in Montreal and September 19 in Toronto. This is a day-long introduction to the Patented Medicine Prices Review Board rules and policies including Scientific Review Procedures, Excessive Price Guidelines, Compliance and Enforcement Policy and Data Filing. Click_here_for_Fundamentals_Seminar_registration



• PMPRB Advanced Seminar is being held on October 28 in Montreal and October 29 in Toronto. This in-depth, day-long session provides a greater understanding of the PMPRB, especially in the areas of Voluntary Compliance Undertakings, Hearings, Category 2 Drugs, and Category 3 Drugs. Barb Ouellet, Executive Director of the PMPRB, and Ginette Tognet, Director of Compliance at the PMPRB, will join us for a brief presentation in the afternoon. Click_here_for_Advanced_Seminar_registration.