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PMPRB News - Regulations
This page will be regularly updated with the latest PMPRB News in 2010. For the previous PMPRB news please check our archives.
Release of the July 30, 2010 PMPRB NEWSletter
New PMPRB Executive Director Announced
PMPRB NEWSletter - April 2010
PMPRB NEWSletter - January 2010
Release of the July 30, 2010 PMPRB NEWSletter
1. PMPRB Member & Staff Changes
- The departure of Dr. Brien Benoit – Chair. During the vacancy, the Vice-Chair, Mary Catherine Lindberg is the acting Chairperson.
- The new Executive Director, Michelle Boudreau will officially begin on Aug 30, 2010. Mrs. Boudreau comes from Health Canada where she was Director General of the Natural Health Products Directorate.
- The Board met on May 13th to approve the 2009 Annual Report, tabled in Parliament Jun 16.
2. Four VCUs were accepted in the last quarter, repayment totals $6.6M, bringing the 2010 VCU total to $8.4M
- Busulfex (Otsuka) – offsetting 2008-2009 excess by payment in the amount of $22,092.
- Dicetel (Solvay) – offsetting 2008-2009 excess by payment in the amount of $31,287, further payment for any excess in 2010.
- Levemir (Novo Nordisk) – offsetting 2006-2009 excess by payment of $6,035,903, and an additional payment of $432,336 for 2010. Price was reduced on April 1, 2010.
- Adenoscan (Astellas) – payment of $34,545 for the 1996-2009 period. Patent expired on Aug 4, 2009.
3. Hearings
- Board Hearing: Oct 4-5, 2010, Copaxone (Teva) – Board’s decision from 2008 was set aside by the Federal Court and the matter was returned to the Board for redetermination. Teva submitted a VCU which was declined by the Vice-Chairperson.
- Board Order: Adderall XR (Shire) – Supplementary Order for adjustment on payment for the Jan-Sept 2008 period and further calculations of excess pricing. The total amount for repayment of the Supplementary Order is $544,931.
- Supreme Court of Canada: Nov 10, 2010, Thalomid (Celgene) – Federal Court of Appeal upheld the Board’s decision. Celgene was granted leave to appeal to the Supreme Court.
4. The PMPRB issued a Notice and Comment on the price of the medicine Faslodex (http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1333) and is seeking comments from stakeholders by September 17, 2010.
- Faslodex is indicated for the hormonal treatment of locally advanced or metastatic breast cancer in post-menopausal women, who have disease progression following endocrine therapy.
- The lowest international price of Faslodex is over 70% higher than the price as determined by the TCC test (maximum price of comparators in Canada).
- The patentee, AstraZeneca Canada Inc., and the Board Staff are proposing that the price of Faslodex be determined based on the international therapeutic class comparison test (ITCC), to reflect the premium of Faslodex in other countries compared to the price of its comparator Arimidex in other countries. This would result in a price of $521, compared to a price of $161 using the TCC test. Faslodex is currently being sold for $600.
- The ITCC test was not available under the old Guidelines, even though it was used in 2 cases (Viread and Humalog). Faslodex was introduced under the old Guidelines. The new Guidelines allow the ITCC test to be used in the context of an investigation (such as this case) for information purposes.
5. HDAP meeting schedule for 2011:
- The new HDAP is composed of 6 panel members (up from 3 previously).
- Note that submission deadlines have been advanced by 2 weeks compared to previously.
- NEW: Patentees must now indicate at the same time as submitting the product monograph whether a price rationale submission will be made and the proposed level of therapeutic improvement.
| HDAP Meeting Date |
Product Monograph Deadline
(14 weeks prior to meeting) |
Price Rationale Submission Deadline
(10 weeks prior to meeting) |
| February 7, 2011 |
October 25, 2010 |
November 25, 2010 |
| May 16, 2011 |
February 2, 2011 |
March 2, 2011 |
| September 8, 2011 |
May 25, 2011 |
June 27, 2011 |
| November 7, 2011 |
July 25, 2011 |
August 25, 2011 |
6. New Summary Report (using the old Guidelines): Pristiq (Wyeth Pharmaceuticals)
- Pristiq (desvenlafaxine succinate) was introduced in March 2009 and is indicated for the symptomatic relief of major depressive disorder.
- Pristiq was classified a category 3 drug product and was compared to other products in the same 4th level ATC class that shared the same indication: Effexor XR (venlafaxine), Desyrel (trazodone), Remeron RD (mirtazapine), Wellbutrin (buproprion), and Cymbalta (duloxetine). Pristiq was sold only in the US.
- The price of both strengths of Pristiq (same price) did not exceed the price of its comparators or its US price.
7. New Patented DINs in 2010: 28 new DINs (22 new products) were first reported to the PMPRB between January and June 2010.
Announcement of New PMPRB Executive Director
Michelle Boudreau was announced today, as the new Executive Director of the PMPRB. “Ms. Boudreau moves into this role effective August 30, 2010, from Health Canada where she was Director General of the Natural Health Products Directorate (NHPD) since September 2008” (Board Staff Communiqué). Ms. Boudreau replaces current Executive Director, Barbara Ouellette, who will be retiring from the Public Service on June 18th. Ms. Ouellette has served as the PMPRB Executive Director for the last five years. The Board Communiqué is located here.
Recent VCU’s
- Adenoscan VCU (Apr 27): Astellas Pharma Canada has agreed to pay $34,545.32 to offset excess revenues accumulated from 1996 to Aug, 2009. This product was Within Guidelines at time of launch. No price adjustment is required as the patent has expired. The VCU can be found here.
- Levemir VCU (Apr 30): Novo Nordisk Canada to pay $6,035,903.54 in excess revenues generated from Jan 2006 to the end of 2009, and provide notice to customers that April 1, 2010 price reduction was to ensure adherence to the Guidelines. The VCU can be found here.
Data Filing Reminder
As the middle of 2010 approaches, we are forwarding this reminder of the July 30th Patented Medicine Prices Review Board (PMPRB) data filing deadline for patented medicines under the Board's jurisdiction. You are required to file a Form 2 submission to the PMPRB by that date for your sales of patented medicines from January to June 2009.
PMPRB NEWSletter - April 2010
The PMPRB April 2010 NEWSLetter was released. The NEWSLetter is located here.
Membership Changes at the PMPRB:
- Chairman Brien Benoit will leave the Board at the end of his term on May 16, 2010
- Anthony Boardman’s 2nd and final term ended March 11, 2010.
- Barbara Ouellet, Executive Director of the Board Staff, will be retiring in June 2010.
CPI-Adjustment Factors for 2011 (these match the factors forecast by Brogan earlier this month)
- Intro in 2008 or before: 1.041; Intro in 2009: 1.038; Intro in 2010: 1.020.
- 1-year cap = 1.030
Hearing Updates
NEW
- Sandoz Canada Inc (failure to file) – Notice of Hearing Issued March 8, 2010
- Thalomid (Celgene Corp) – Celgene Corp. was granted leave to appeal to the Supreme Court of Canada regarding Thalomid. No date has been set.
PENDING/ONGOING
- Apo-Salvent CFC Free & Apotex Inc (failure to file): ongoing
- ratiopharm Inc (failure to file) – Board Decision pending
- ratio-Salbutamol HFA – Final written arguments due May 14, 2010 (last hearing date was April 16, 2010)
- Penlac – Board Decision pending (last hearing date was March 5, 2009)
- Copaxone – Redetermination ordered by FCC decision Nov 12, 2009. Dates TBD.
DECISION ISSUED
- Nicoderm – Board Decision issued April 9, 2010
- Pentacel/Quadracel – Board Decision (Dec 21, 2009 & amended March 1, 2010 - which removed the requirement for a price reduction) and Board Order (March 16, 2010) issued
Voluntary Compliance Undertakings
- FSME-IMMUN (Baxter Corporation) agreed to reduce price and pay $53,578.62 to the Crown for excess generated from 2002-2009.
- Paxil CR (GlaxoSmithKline Inc.) paid $53,177.88 to offset excess generated in 2004-2005.
Report on New Drug Nevanac (2008 first sale)
- Nevanac (Alcon), indicated for pain and inflammation associated with cataract surgery was compared to AQPP prices of Voltaren Ophtha, Acular & Acular LS (all in the same ATC). Differences in days of therapy were recognized.
Correction to the Compendium of Guidelines, Policies and Procedures (June 2009) regarding the ITCC test:
- New language clarifying the ratio approach to calculating the ITCC to be applied to the price of the pivotal comparator in the domestic TCC, which is then compared to the national ATP of the drug product under review (Schedule 7, Sub-Section 3.1, page 33).
- A new version of the Compendium will be posted on the website.
PMPRB NEWSletter - January 2010
The PMPRB January Newsletter was released (http://www.pmprb-cepmb.gc.ca/cmfiles/NEWSletter-January2010.pdf). Key elements are summarized below:
It appears that net growth of 10 people to Board Staff has occurred in the last quarter.
HDAP
The HDAP has increased from 3 to 6 members. The new members are:
- Dr. Fred Y. Aoki, Professor of Medicine, Medical Microbiology and Pharmacology and Therapeutics at the University of Manitoba
- Dr. Jacques LeLorier, Professor in the Departments of Medicine and Pharmacology at the Université de Montréal and Adjunct Professor in the Department of Epidemiology and Biostatistics at McGill University
- Dr. Muhammad Mamdani who is the Director of the Applied Health Research Centre, Li Ka Shing Knowledge Institute at St. Michael’s Hospital, Toronto and Associate Professor in the Department of Health Policy, Management and Evaluation at the University of Toronto
CPI Factors
The actual factors for 2009 are (original published forecast factors in brackets):
- Introduced in 2006 or earlier: 1.049 (1.065)
- Introduced in 2007: 1.027 (1.042)
- Introduced in 2008: 1.003 (1.020)
- 1 year cap: 1.005 (1.030)
Hearings:
Ongoing Hearings:
- Apotex Inc. Failure to File (jurisdiction) – no dates scheduled
- Apo-Salvent CFC-Free (Apotex Inc.) – no dates scheduled
- ratio-Salbutamol HFA (ratiopharm Inc.) – Jan 25-26, Mar 4-5, April 12-16
Pending Decisions:
- ratiopharm Inc. – Failure to file (jurisdiction)
- Nicoderm (sanofi-aventis) – last arguments heard on October 7, 2009
- Penlac (sanofi-aventis) – last arguments heard on March 5, 2009
Recent Decisions:
VCUs
- Andriol (Schering-Plough) – payment of $348,605 and a 21.25% discount to their customers until December 2010.
- Claritin Allergy & Sinus Extra Strength (Schering-Plough) – payment of $69,950.
- Trinipatch (Novartis) – payment of $47,099. Novartis is no longer selling Trinipatch in Canada.
- Voluven (Fresenius Kabi) – payment of $1,448,002. No longer under PMPRB jurisdiction since August 2008.
- Xarelto (Bayer Inc.) – payment of $49,978. Further payment to be made for any remaining excess received after July 1, 2009 to the date of the implementation of the price reduction.
Report on New Drugs
Sprycel (BMS) received category 2. Primary indication (greatest therapeutic advantage) is chronic myeloid leukemia (CML). The price test in 2007 was the interim international median and no pricing adjustments were required once prices were available in 6 countries in 2008.
Reminder
Form 3 (Revenues and Research and Development Expenditures) is due to the PMPRB by March 1. The Form 3 can be found on this website: (http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1188). Please send to compliance@pmprb-cepmb.gc.ca and to lokanadha.cheruvu@pmprb-cepmb.gc.ca.
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