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PMPRB January NEWSletter Executive Summary:
1. Update on Hearings: There are currently 7 hearing underway with the Board. They are:
A. Adderall XR (ADHD) - Resumes March 2, 2007. The Board also issued a decision regarding the patent period motion presented by Shire BioChem. The Board dismissed the motion. Shire filed an application for judicial review with this matter in Federal Court on January 16.
B. Airomir (Bronchial Asthma & Chronic Bronchitis) - is still postponed. 3M recently sold its pharmaceutical section to Graceway Pharmaceuticals. Hearing dates will be announced shortly.
C. Concerta (ADHD) - Resumes March 21.
D. Copaxone (Multiple Sclerosis) - Started in February and additional dates to be announced shortly.
E. Risperdal Consta (Schizophrenia) - Resumes February 28.
F. Strattera (ADHD) - Notice of Hearing was sent in December 2006. Eli Lilly has submitted a motion for adjournment pending the determinations in the Adderall XR and Concerta Hearings. The Board will hear submissions on this motion on February 22.
G. Dovobet (Plaque Psoriasis) - The Board established a MNE price and calculated the excess revenues for Dovobet. The Board's Order and reasons should be released in the next few weeks.
2. Board's Direction on Scheduling of Public Hearing Dates: Parties are required to make full use of scheduled hearing days by having witnesses ready to testify through out those days and standing-by where required in order to avoid delays or unutilized scheduled time.
3. Form 3 (R&D and Total Revenue) – Due March 1st
A. Clarification that licensee revenues must be reported and that R&D filed need not relate only to patented medicines. There is a new template on the Board’s website.
B. Licensees are also required to file Form 3
C. Data Filing Requirements
a. Companies are reminded that licensees are also considered to be patentees under the Board’s definitions – are required to comply with the data filing requirements.
b. A summary table of data filing requirements was provided on page 5 (see attached)
4. CPI Factors: As previously reported by Brogan Inc. – Actual 2006 3 year CPI adjustment factors for drugs introduced in 2004 or earlier were higher than forecast. The Actual 3 year factor for products introduced in 2005 and the 1 year cap were as published.
5. NPDUIS:
A. Pharmaceutical Trends report was published in June 2006
B. NPDUIS is expecting to release a report on current BIA practices as well as a template for conducting BIAs this spring.
C. New drug pipeline monitor (NDPM) listing drugs expected to be introduced in Canada in the next 2 – 5 years will be available on the Board’s website (under development)
6. HDAP Review: Deadlines for the 2007 HDAP meetings are as follows:
- March 4 monograph/ April 4 submission for June 4th meeting
- June 10 monograph / July 10 submission for September 10th meeting
- September 5 monograph / October 5 submission for December 5th meeting
Where submissions received exceed capacity for a particular meeting – the following criteria will be used for prioritization:
1. drug products that are patented and sold;
2. drug products that are patented and about to be sold;
3. drug products for which advisory assistance has been requested
- drug product is patented but is not sold;
- drug product is not patented but is sold;
- drug product is not patented and is not sold.
7. List of New Drugs - there were 35 new DINs (representing 24 medicines) added to the list for the period ending December 31, 2006. This amount is a high amount of new DINs for a single period.
8. Public Consultations: In May 2006, the Board released a Discussion Guide for the Consultations on the Board’s Excessive Price Guidelines and in November held public consultations with Stakeholders across Canada. The Board discussed the input from the public consultations at their most recent Board meeting as well as introductory price tests, which were not included in the discussions. This comment indicates that the consultations or deliberations will be expanded to include potential changes to the Guidelines.
9. Other items of note:
A. In November 2005 the Board received direction to monitor and report on non-patented prescription drugs as part of the National Pharmaceutical Strategy. The Board has released two quarterly reports and the third quarterly report on Generic Introduction of Recently Off Patent Drugs was expected in January but has been delayed.
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