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PMPRB Newsletter Summary
Discussion Paper Update:
- PMPRB has decided to review prices to ensure that prices are not excessive "in any market". The Newsletter also announces the hiring of 4 new statistical analysts - it is assumed these two events are connected. The methodology has yet to be worked out. This could have very serious implications for products that have different prices across provinces or trade levels.
- PMPRB has decided to develop new re-benchmarking criteria (costs, new science) moving forward. Science criteria will be done with scientific experts "as needed". Cost criteria will be developed pending the expert report & working group on this matter. The "interim" price based on number of countries and years criteria will be left as is.
- PMPRB will be looking further at the proposed amendments to the Regulations with respect to reporting free goods, in particular Option 2, exempting sales to third-party payers, and Option 6, permitting the Board to disallow benefits in limited circumstances.
- PMPRB will defer its decision on the changes to the Guidelines relating to CPI until the other aspects of the Guidelines Review are further advanced.
Other Updates
Dr. Adil Virani, Director of Pharmacy Services at Fraser Health Authority will replace James McCormack on the HDAP
Newsletter also reports on Category 2 price review for Replagal for enzyme therapy
Forecast CPI adjustment factors for 2009:
DINs 1st sold 2005 or before: 1.065 (higher than 2008 forecast)
DINs 1st sold in 2006: 1.042 (higher than 2008 forecast)
DINs 1st sold in 2007: 1.020 (same as 2008 forecast)
1 year cap 3% (same as 2008 forecast)
Hearings Update:
Adderall XR: Decision issued - May 10th deadline for submissions on final order. Referenced Concerta & Strattera...but Concerta decision still outstanding & Strattera proceeding yet to begin.
Apotex: Hearing called into status of Apotex as a patentee and filing data. Oct 6th.
Copaxone: Decision issued, submissions filed & final ruling on Order expected soon. Judicial review of decision has been applied for.
Nicoderm: Hearing called in 1999 - scheduled to commence July 3rd
Penlac: Scheduled for July 14, 15 and Aug 20th
Quadracel: Pentacel - to resume June 13th. FCC did not remove Board Counsel.
Thalomid: Celgene has applied for judicial review of Board decision on jurisdiction
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