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New Notices of Hearing, Adderall XR on Admissibility of Evidence, and Brogan Fall Seminars
Notices of Hearing:
Two notices of Hearing were issued by the Board this week. Apo-salvent HFA was issued on July 16th, followed by Ratio-salbutamol HFA on July 23rd. Both products (salbutamol sulphate) are alleged to have taken a price increase exceeding the Guidelines. A few interesting notes:
- The statements of allegations for Apo-salvent and ratio-salbutamol HFA are essentially identical.
- The Staff are not alleging a “policy” of excessive pricing (which diminishes the threat of a double re-payment)
- The international price comparison was conducted against the equivalent brand version of the chemical.
- The Board is not scheduling the two hearings simultaneously, even though the issues and product in question are the same.
http://www.pmprb-cepmb.gc.ca/english/view.asp?x=254
Adderall XR on Prices of Comparable Medicines:
The PMPRB issued a decision on admissibility of evidence for selecting appropriate prices in order to calculate the allowable prices of Adderall XR following the Decision on merits issued on April 10, 2008. Following are a few interesting points that may guide future policy in price reviews and enforcement:
- Evidence filed following the hearing was accepted for consideration.
- Patented medicines identified as excessive should be excluded from the TCC of a competitor.
- Non-patented medicines should only be excluded where evidence demonstrates the absence of competition or presence of other market conditions warranting exclusion.
- Board has accepted Saskatchewan formulary price for Dexedrine in Adderall XR TCC (Saskatchewan formulary price includes markup).
Brogan Seminars
- 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.
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