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Eli Lilly VCU / PMPRB New Drug Pipeline Monitor
PMPRB posts Eli Lilly VCU signed June 1, 2007
The PMPRB has accepted a voluntary compliance undertaking from Eli Lilly for its bone formation agent, Forteo, indicated for the treatment of severe osteoporosis in those postmenopausal woman at high risk of bone fracture or resistant to other therapies.
Forteo started selling in Canada on July 15, 2004 and is a category 3 new drug. Its maximum non-excessive price was established by the median of international prices. According to calculations based on the Board’s Excessive Price Guidelines, at the end of January 2006, cumulative excessive revenues totalled $333K. The 2006 ATP was within the Guidelines and partially offset the cumulative excessive revenues after 2005.
Lilly will maintain a 2007 ATP below the 2007 MNE to further offset remaining excess revenues. Any revenues not offset by December 31, 2007 will paid within 30 days of filing July – December 2007 price and sales data.
The VCU is available on the PMPRB website:
http://www.pmprb-cepmb.gc.ca/CMFiles/VCU_-_June_1_0738GLB-762007-7182.pdf
PMPRB releases its June 2007 New Drug Pipeline Monitor (NDPM)
The PMPRB has released the inaugural edition of a web-based pipeline monitor for those new drugs that could be on the Canadian market in 2 to 5 years and are expected to significantly impact F/P/T drug plan expenditures.
The NDPM uses the Biopharm Insight database screening for drugs currently in Phase III trials or under FDA (U.S.) or EMEA (Europe) review and additional Canadian sources. Drugs showing positive results in preliminary phase III are reviewed with particular regard to efficacy and safety outcomes.
Criteria used in selecting potential candidates for NDPM are: phase of development; indication and therapeutic area; drug description; clinical and other impacts.
In this edition, 10 new drugs are identified as potential “high impact drugs” and thus selected for the NDPM. Those drugs are detailed in the report on page 8.
For more detailed information please see the June 2007 report:
http://www.pmprb-cepmb.gc.ca/CMFiles/NewDrugPipeline-e38KML-742007-581.pdf
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