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Update on the Consultation Process and other information from the PMPRB Newsletter
New Guidelines & Policy Events
- Publication in June (date to be confirmed), Implementation on July 1st
- June 16-17: Federal Court Hearing on the Board’s August 18, 2008 Communiqué on mandatory reporting of benefits
- June 17-18: Regulatory Affairs and Outreach Branch information sessions with patentees on the new Guidelines, Toronto and Montreal
Comments to PMPRB Notice & Comment Deadline
30 submissions posted to date:
- 3 Associations (Biotech, Brand & Generic)
- 18 brand companies
- 2 biotechnology companies
- 2 Consumer Groups (Cumming Jewish Centre for Seniors, Canadian Life and Health Insurance Association Inc)
- 2 Government Bodies (British Columbia, Federal Health Care Partnership)
- 3 Others (Joel Lexchin, MD, McKesson Canada, Brogan Inc.)
PMPRB NEWSLetter
Forecast CPI adjustment factors for 2010:
- DINs 1st sold 2007 or before: 1.050
- DINs 1st sold in 2008: 1.026
- DINs 1st sold in 2007: 1.019
- 1 year cap 2.9% (1.029)
[Note: inflation for 2009 is running behind forecast, which could have an impact on 2010 forecast prices - please call if you would like to discuss the risks for 2010.]
Hearings:
- Notice of Hearing issued for Neulasta, from Amgen.
- June 3: Neulasta Pre-Hearing conference
- July 6-10: ratio-Salbutamol Hearing
Recent VCU's
Board has accepted a VCU in the Concerta (ADHD drug sold by Janssen-Ortho) hearing. http://www.pmprb-cepmb.gc.ca/cmfiles/VCU_ConcertaApr109.pdf. The Board had not rendered a decision on this case, although arguments had been completed. The decision in the Adderall XR case, however, included the Board's position regarding the price of Concerta being set by the price of Adderall XR. Repayment of $1.5million - taking into account amount offset in 2nd half 2008.
Board has also accepted two VCUs from Sanofi-Aventis:
- Suprax: an antibiotic, exceeded CPI increase in 2006,2007 and 2008. Total excess $98k to June 2008
http://www.pmprb-cepmb.gc.ca/CMFiles/VCU_Suprax.pdf
- Eligard: for advanced prostate cancer, International maximum price dropped to cause excess. VCU mentioned MNEs for each province/territory and differential MNE calculation depending on circumstances. Total excess $13m to Dec 2008.
http://www.pmprb-cepmb.gc.ca/cmfiles/VCU_Eligard.pdf
As reported in a previous email, a VCU in the Strattera case has been accepted with a repayment of $15.3million for the period from 2005 to 2008.
New Drug Review
Relistor (methylnaltrexone bromide) received Category 2, no comparators. It is indicated for the treatment of opioid-induced constipation in patients with advanced illness, receiving palliative care. Median was set based on US price alone.
Upcoming Brogan Seminar:
Brogan’s PMPRB Fundamentals Seminar is being held in Montreal on May 21st and Toronto on May 22nd. New this year is Béatrice Mullington and Catherine Lombardo from the PMPRB Staff will be presenting on scientific and process issues adding to our introduction to the PMPRB, it’s rules and regulations . To register: http://www.broganinc.com/english/seminars/pmprbF-form.php
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