January 2008 NEWSletter Released

January 2008 NEWSletter Update:
Enforcement Update, Discussion Paper, Form-3 Reporting, NPDUIS Update, Actual vs. Forecast CPI, and Spriafil a New Category 2 Medicine

1. Board Decisions & Enforcement Update

• Board Decision: Thalomid, Celgene Corporation. The Board determined that it does have jurisdiction on Thalomid, and more generally on patented medicines sold under Special Access Programs.
• Ongoing Hearings:
° Quadracel/Pentacel, sanofi pasteur Limited., held Nov 28, 2007. Proceeding adjourned due to respondent filing a motion for a Federal Court Order to dismiss Blake Cassels & Graydon as counsel to the Hearing Panel. Next date TBD.
° Penlac, sanofi-aventis Canada Inc., held Jan 16-18. Two additional sessions are being scheduled.
° Strattera, Eli Lilly Canada Inc. Hearing date TBD.

• Pending Hearing Decisions:
° Adderall XR, Shire BioChem Inc.
° Concerta, Janssen-Ortho Inc.
° Copaxone, Teva Neuroscience G.P.-S.E.N.C.

• VCU: Dovobet, Leo Pharma Inc., January 19, 2008. Payment of $4,606,824.39 to the Government of Canada pursuant to Board order.

• The effective filing deadline for submitting Revenues and R&D expenditures is March 3rd, same as the deadline for responses to the Discussion Paper.
• All patentees, whether patent holders, licensees or others, must report total gross revenues from all sales (patented and non-patented) in Canada, total revenues received from all licensees/others including royalties, as well as a summary of all expenditures towards the cost of R&D for patented and non-patented (human and veterinary) medicines carried out in Canada by or on behalf of the patentee.

• NPDUIS team now has access to claims-level data.
• The Steering Committee met on January 31 and February 1 to identify major research priorities for 2008-2009.
• The next edition of the Pharmaceutical Trends Overview Report and the New Drug Pipeline Monitoring Report are underway and will be released end of March, and the Forecasting Drug Plan Expenditures project is expected to be completed by the summer.

• The actual cap for price increases in 2007 was revised from the forecast 2.9% to 3.2%.
• The 3 year CPI adjustment factor for drugs introduced in 2004 or earlier was revised from the forecast 1.066 to 1.065.

• Spriafil is a new Category 2 antifungal medicine that provides a substantial improvement in the prevention of invasive fungal infections in immuno-compromised patients.
• The HDAP recommended no comparators and the price of Spriafil was within guidelines based on the international median price of $9.5175. Note that the US price of $4.8401was the lowest price of all comparator countries, compared to the maximum price of $10.0192 in the UK.