PMPRB NEWSletter - January 2009 Summary

• Rx&D / PMPRB Ad Hoc Committee has met twice
• March 27, 2009 (to be confirmed)- Final Notice & Comment on Guidelines published
• April 24, 2009 - deadline for submission on Revised Excessive Price Guidelines
• May/June – Revised Guidelines to be released.
• June 16-17, 2009 Judicial Review to be held
• July 1, 2009 - Revised Guidelines adopted
• January 1, 2010 - Likely date of implementation of mandatory reporting of benefits [Note this assumes outcome of JR]

Reminder:

The deadline for filing Form 3 information on revenues and R&D expenditures is March 2, 2009.

Hearing Updates:

• February 11-13: Hearing – Strattera, Eli Lilly Canada Inc.
• March 3: Federal Court hearing of the Judicial Review Application by Celgene Corporation of the Board’s decision in the matter of Thalomid
• March 5-6: Hearing – Penlac, sanofi-aventis Canada Inc.
• Closing Arguments have been heard in Quadracel/Pentacel

CPI Figures: (as previously reported by Brogan)

• Introduced in 2007: 1.024 (higher than forecast)
• Introduced in 2006: 1.045 (higher than forecast).
• Introduced in 2005: 1.066 (higher than forecast)

New Drug Reviews:

• Revlimid (lenalidomide) received a Category 2 designation by the HDAP. No comparators were identified. The monograph indication is "treatment of patients with transfusion-dependent anemia due to low or intermediate -1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. " The price is reported to be within Guidelines as it does not exceed the international median.