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PMPRB

DIP Methodology – Follow-up Recommendations Released

The DIP Methodology Technical Working Group (DIP WG) has released its Follow-up Recommendations on the Implementation of the DIP Methodology. After examining the pilot period of the DIP Methodology since the Board adopted it in March 2011, the DIP WG concluded that the pilot has been a positive experience, though there is opportunity to fine-tune application-related issues. The report summarizes the DIP WG´s assessment of the pilot experience, application-related issues identified during the pilot, proposed options to address these issues, and the DIP-WG´s recommendation to the Board to adopt the DIP Methodology on a permanent basis.
The PMPRB Regulatory Affairs and Outreach branch will host a webinar for patentees to discuss these recommendations on May 31, 2012.

PMPRB April 2012 NEWSletter Released

Included in this edition are:

  • CPI-Adjustment Factors for 2013: This edition of the NEWSletter presents the CPI adjustment factors and cap to be used in the calculation of the non-excessive average prices (NEAP) for patented drug prices in 2013.

FORECAST 2013 PRICE-ADJUSTMENT FACTORS FOR PATENTED DRUG PRODUCTS

Benchmark Year

2010

2011

2012

Price -Adjustment Factor

1.072

1.041

1.020

Note: The cap for 2013 is 3.0% (i.e., 2.0% X 1.5)

  • VoluntaryCompliance Undertakings (VCUs) – see NEWSletter for details:
    • Hospira Healthcare Corporation (Canada) / Precedex

  • Other PMPRB NEWSletter topics covered include:
    • Updates to the Patentee’s Guide to Reporting
    • Proposed Changes to the Compendium
    • Clarification on the Guideline on “Any Market” Price Reviews
    • New Patented Medicines Reported to the PMPRB
    • Hearings – Update
    • Summary of February 16 Board Meeting
    • Upcoming Events

Click here to read PMPRB’s April 2012 NEWSletter

The Board is seeking comments on proposed changes to the Compendium of Policies, Guidelines and Procedures. The two proposed changes for which the Board is seeking stakeholder comments are:

  1. For existing drug products, eliminate the 5% investigation trigger at the national level.
  2. Replace 3-year period to offset de minimus excess revenues through a Voluntary Compliance Undertaking (VCU) with requirement to offset in a timely manner.

Written feedback on the proposed changes should be sent on or before May 14, 2012.

Click here for more information on these changes or for information on how to provide comments.

NEW - Patentee’s Guide to Reporting – Updated

  • The PMPRB has updated its Patentee’s Guide to Reporting, a reference document to assist patentees in completing their filing requirements. This new version of the guide, updated in February 2012, provides information on each element of information to be reported to the Board as well as timing for the filings. This publication replaces the version issued in March 2008. A copy of the updated Patentee’s Guide to Reporting is available on the PMPRB’s website.

Voluntary Compliance Undertaking (VCU)

  • On March 19, 2012, the Chairperson of the Board accepted a VCU in the matter of Hospira Healthcare Corporation (Canada) and its drug, Precedex, indicated for intensive care unit sedation and for conscious sedation.

PMPRB January 2012 NEWSletter Released

Included in this edition are:

  • NEW – Web-Application for New Patented Medicines Reported to the PMPRB: On January 31, 2012, the PMPRB launched its user-friendly Web application for New Patented Medicines Reported to the PMPRB.  This new application includes a complete list of medicines reported to the PMPRB since 1998 and is searchable by the year reported and by the status of the price review (for 2001 onward).  The application is now available on the PMPRB’s website under Regulating Prices.
  • 2011 CPI- Based Price-Adjustment Factors: The PMPRB has published the actual CPI adjustment factors that will be used in its calculation of the 2011 NEAPs. While the PMPRB had used a 2.2% inflation forecast in its determination of forecast CPI adjustment factors for 2011, the actual change in CPI for 2011 over 2010 was 2.9%. As a result, the actual CPI adjustment factors for 2011 are higher than the forecast (e.g., 3-yr adjustment of 1.051 vs 1.043, respectively) and the actual one-year increase cap has come in at 4.4% as opposed to the 3.3% previously forecast.
  • Guidelines Monitoring and Evaluation Plan – Initial Results: The PMPRB published its “Monitoring and Evaluation Plan for the Major Changes in the Guidelines (GMEP)” on its website in June 2011.
  • Voluntary Compliance Undertakings (VCUs) – see NEWSletter for details:
    • Paladin Laboratories Inc. /  Trinipatch.
    • Celgene Corporation / Thalomid
    • LEO Pharma Inc. /  Dovobet,
  • Other PMPRB NEWSletter topics covered include:
    • NPDUIS – Release of Analytical Report
    • New Patented Medicines Reported to the PMPRB
    • Core Control Audit of the PMPRB
    • Complaints Process on Prices of Patented Medicines Sold in Canada
    • Hearings – Update
    • Board Meeting Activities
    • Upcoming Events

October 2011 Edition of the NEWSletter Released

Included in this edition are:

  • NEW - Drug Products Not Normally Reviewed by the Human Drug Advisory Panel (HDAP): In the past year, there have been many occasions when a patentee has indicated in writing when it files the product monograph (or information similar to that contained in a product monograph), for drug products listed in section C.3.2 of the Guidelines, that it intended to claim a therapeutic advantage in the submission to HDAP but ended up not claiming improvement in the actual submission.  Consequently, a patentee wishing to make a submission with respect to the level of therapeutic improvement, the selection of drug products and dosage regimens to be used for comparison purposes for the drug products listed in section C.3.2 (i.e., those that would not otherwise be reviewed by the HDAP) must make its submission at the same time as it files its product monograph (or information similar to that contained in a product monograph).  The October 2011 NEWSletter provides the submission deadlines and revised requirements for the HDAP meetings in 2012.
  • Other news include:
    • NEWSletter - Online access only beginning in January 2012
    • NPDUIS – Release of Analytical Reports
    • New Patented Medicines Reported to the PMPRB
    • Summary Report on Patented Drugs
    • Updates to the PMPRB Website
    • Voluntary Compliance Undertakings:
          • Sinemet CR, Bristol-Myers Squibb Canada Co.
          • Effient, Eli Lilly Canada Inc.
          • Nasonex, Merck Canada Inc.
          • Orgalutran, Merck Canada Inc.
    • Hearings – Update
    • Summary of October Board Meeting
    • Upcoming Events

PMPRB Guidelines – Updated

  • On June 30, 2011, the PMPRB released its annual updated version of the Compendium of Policies, Guidelines and Procedures for 2011 which includes the latest revisions and clarifications made to the Compendium since it came into effect on January 1, 2010.  Any further clarifications will be reflected in future updated versions of the Guidelines, which will be released annually each June.

The Board also released its Monitoring and Evaluation Plan for the Major Changes in the Guidelines which presents information on how the impact of the 2010 will be measured.  This document will also be updated annually.

For more information, please consult the PMPRB’s website.

PMPRB Update – 2010 PMPRB Annual Report Released

The 2010 PMPRB Annual Report was tabled before Parliament on June 16, 2011 and subsequently published by the PMPRB. The report provides detailed information on sales and price trends of medicines in Canada, including:

  • The R&D-to-sales ratio for all patentees decreased in 2010 to 6.9% from 7.5% in 2009 while the R&D-to-sales ratio for Rx&D member companies remained the same as in 2009, at 8.2% in 2010.
  • Canadian prices of patented medicines during 2010 were 0.4% below 2009 levels, while the CPI rose by 1.8% during the same period.
  • Canadian prices in 2010 were approximately 6% below the international median price, on average (Canadian prices were approximately 4% below the international median in 2009).

The full document can be accessed on PMPRB’s website. 

PMPRB Deadline Reminder
September 2011 HDAP Meeting – Filing Deadlines (May 25, June 27)

Patentees intending to file submissions for consideration at the September 2011 HDAP meeting must file a product monograph (along with level of therapeutic improvement that will be sought) by Wednesday, May 25, 2011 in order to have the medicine included on the September 2011 meeting agenda.  The actual submissions must be filed by June 27, 2011.  Additional details on new medicine submission requirements can be accessed on the Board’s website.

PDCI Market Access has extensive experience in the preparation and filing of new medicine submissions.  We will be pleased to assist you with your upcoming new medicine submissions.  For more information, please contact Nancy Paul-Roc at 613-742-8225 x32 or atnancy.paul-roc@pdci.ca.

April 2011 Edition of the NEWSletter Released

Included in this edition are:

  • CPI-Adjustment Factors for 2012: This edition of the NEWSletter presents the CPI adjustment factors and cap to be used in the calculation of the non-excessive average prices (NEAP) for patented drug prices in 2012. 

CPI-ADJUSTMENT FACTORS FOR 2012

Benchmark Year

2009

2010

2011

Price -Adjustment Factor

1.064

1.046

1.021

Note:  The cap for 2012 is 3.2% (i.e., 2.1% X 1.5)

 

 

 

  • Consultation on the Board’s Rules for Hearings: The PMPRB is amending its current Rules of Practice and Procedures for Hearings and is seeking comments from interested parties. The proposed amendments to the current set of Rules relate mainly to the areas of procedure and evidence, filing, preservation of electronic evidence, expert witnesses, service, confidentiality as well as document and case management.  The proposed Rules will be available for comments on the PMPRB’s website under Consultations/Notice and Comments on May 16, 2011.  Interested parties will have until June 30, 2011 to submit their comments by email to the Director of the Board Secretariat at sylvie.dupont@pmprb-cepmb.gc.ca.
  • Additional NEWSletter Topics
    • Appointment of New Board Members: Mary Catherine Lindberg as Chairperson of the Board and Dr. Mitchell Levine as Vice-Chairperson.
    • The Guidelines – Observations to Date (DIP Methodology)
    • Completed and Ongoing Hearings
    • Voluntary Compliance Undertakings (''VCUs'')
    • Olmetec and Olmetec Plus – 2008 New Medicine Reviews (Category 3)
    • New Drugs Introduced Reported to the PMPRB in 2011
    • Upcoming Events

PMPRB FILING REMINDER

PMPRB Form 2 relating to the prices and sales of patented medicines during the period January through June 2011 must be completed and filed with the PMPRB by Monday August 1, 2011.  The Patented Medicines Regulations require the filing of Canadian sales data (Block 4) for all patented medicines as well as the medicines’ corresponding foreign ex-factory prices (Block 5) in the seven countries referenced by the PMPRB (i.e. France, Germany, Italy, Sweden, Switzerland, the UK and the US). 

PDCI Market Access offers extensive expertise and experience assisting clients with price regulation strategies and submissions.  PDCI also maintains an extensive international price database and will be pleased to assist you with your upcoming PMPRB Form 2 filing. 

For more information on our PMPRB Form 2 Filing Services please contact Emmanuel Lazaridis at 613-742-8225 (ext 36) or at Emmanuel.Lazaridis@pdci.ca.

PMPRB suspends implementation of DIP, “any market” reviews and to establish technical working group

The PMPRB issued a message to patentees on December 24, 2010 that “the measures in the Guidelines regarding the review of prices of existing patented drug products related to the review of prices in any market and the DIP Methodology are not being implemented at this time.  Board Staff will be assessing the application and impact of these elements of the Guidelines and will propose adjustments to the Board for consideration. ”  A technical working group will be established in January 2011.  The complete message to patentees can be found here.

Board Order – Penlac Nail Lacquer

The PMPRB Hearing Panel issued a Board Order with respect to Penlac Nail Lacquer marketed by sanofi-aventis Canada Inc.   In its Decision on the merits of the case, the Panel agreed with the PMPRB staff’s application of the Guidelines in that there are no comparators that are clinically equivalent to Penlac and as a result, the median international price should determine the introductory maximum non-excessive price for Penlac. Sanofi-aventis had offered evidence (including expert witnesses) that Sporanox and Lamisil should be considered clinically equivalent to Penlac for purposes of a therapeutic class comparison test.    According to the Board Order issued on January 31, 2011, sanofi-aventis is to offset the cumulative excess revenues accruing from the sales of Penlac by making a payment in the amount of $9,409,074.36.  This Order concludes the hearing proceedings that were initiated in March 2007. 

PMPRB Outreach Sessions

The PMPRB will hold two outreach sessions in March with patentees: in Montreal on March 2 and in Toronto on March 3.

PMPRB suspends implementation of DIP, “any market” reviews and to establish technical working group

The PMPRB issued a message to patentees on December 24, 2010 that “the measures in the Guidelines regarding the review of prices of existing patented drug products related to the review of prices in any market and the DIP Methodology are not being implemented at this time.  Board Staff will be assessing the application and impact of these elements of the Guidelines and will propose adjustments to the Board for consideration. ”  A technical working group will be established in January 2011.  The complete message to patentees can be found here.

Voluntary Compliance Undertakings (“VCUs”)

On November 15, 2010, the Vice-Chairperson of the Board accepted two VCUs submitted by Novartis Pharmaceuticals Canada Inc.:

  • A VCU in relation to the medicine Miochol-E (acetylcholine chloride—electrolytes), indicated to obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid miosis may be required.  Novartis has undertaken, on a without prejudice basis, to reduce the price of Miochol-E so that it does not exceed the 2010 N-NEAP price of $16.4883.  Novartis has also undertaken to offset cumulative excess revenues received from July 1, 2000 to June 30, 2010 by making a payment in the amount of $323,870.70.
  • A VCU in relation to the medicine Tasigna (nilotinib), indicated for the treatment of accelerated phase Philadelphia chromosome positive chronic myeloid leukemia in adult patients resistant to or intolerant of at least one prior therapy including imatinib.  The Human Drug Advisory Panel recommended that Tasigna be classified as a Category 3 new medicine and further recommended Sprycel (dasatinib) as the only comparator.  According to the VCU, it is Novartis’ position that another comparator and different dosing should have been considered in the price review. Novartis has undertaken, on a without prejudice basis, to reduce the price of Tasigna so that it does not exceed the 2010 N-NEAP price of $38.7147 for the remainder of 2010.  Novartis has also undertaken to offset the cumulative excess revenues received from September 30, 2008 to December 31, 2009 by making a payment in the amount of $196,069.26.

October 2010 Edition of the NEWSletter Released

Included in this edition is an important update to the PMPRB’s Guidelines:

  • The Board’s Guidelines currently state that Board Staff may exclude from the new medicine price test any drug product (patented and non-patented) if the application of the Board’s Guidelines results in the conclusion that the comparator is excessively priced.  In light of the Board’s decision in the Nicoderm case, the Board has now directed Board Staff to include the price of a relevant non-patented drug product unless the Staff is of the view that the price of the medicine is excessive as a result of the absence of competition or other market conditions.

Other news/updates:

  • Board Staff has been made aware of a potential point of confusion in its Guidelines as a result of Schedule 13 – Offset of Excess Revenues.  The NEWSletter provides confirmation that the PMPRB continues to identify/initiate investigations on the basis of total year sales and that excess revenues are calculated on an annual basis.  Schedule 13’s reference to “six consecutive six month reporting periods” may have incorrectly given the impression that PMPRB was conducting price reviews every six months and calculating excess revenues/offsets generated during each six month reporting period.
  • On October 27, 2010, the Vice-Chairperson of the Board approved a Voluntary Compliance Undertaking (“VCU”) submitted by AstraZeneca Canada Inc. in relation to the medicine Faslodex (fulvestrant).  The result of the therapeutic class comparison (TCC) test indicated that the introductory price appeared excessive while the Canadian price was lower than the corresponding prices in all seven PMPRB reference countries in the international price comparison (IPC).  A Notice and Comment was issued on June 18, 2010 and provides the rationale for the VCU and background information surrounding the applications of the ratio approach and international therapeutic class comparison (ITCC).  Under the terms of the VCU, the patentee undertook to reduce the price of Faslodex so that it does not exceed the 2010 maximum non-excessive price of $558.7899, and will offset cumulative excess revenues by making a payment to the Crown in the amount of $405,030.29.
  • Other PMPRB NEWSletter topics include:
    • Other VCUs – Andriol (Schering-Plough), Vancocin (Iroko)
    • New patented medicines reported to the PMPRB – 41 new DINs in 2010
    • September 16 Board Meeting (welcomed Michelle Boudreau as the new PMPRB Executive Director)
    • Torisel – 2008 New Medicine Review (Category 3)

Re-determination of the Copaxone Matter

In May 2006, PMPRB issued a Notice of Hearing in the matter of Teva Neuroscience G.P. – S.E.N.C. and its medicine Copaxone, used in the treatment of multiple sclerosis.  The Hearing Panel issued its decision in early 2008 concluding that the price of Copaxone was excessive.   Teva appealed the Board’s decision to the Federal Court which set aside the Board’s decision as unreasonable (i.e., the Board failed to give reasonable consideration to all the excessive price factors in the Patent Act) and returned the matter to the Board for re-determination, ideally by a new hearing panel. The Board will proceed with the re-determination hearing on October 4-5, 2010.

More information is available on the Board’s website.

July 2010 NEWSletter Released

The July 2010 edition of the quarterly PMPRB NEWSletter has been released.  Included in this edition are:

  • 2011 HDAP Meeting Schedule (earlier deadlines, new requirement): The Human Drug Advisory Panel (HDAP) is composed of six members and meets four times a year.  The dates of the 2011 meetings are: February 7, May 16, September 8 and November 7.  In this NEWSletter, the PMPRB updated its filing requirements as follows:
    • The deadline for filing the product monograph has been advanced by two weeks to permit sufficient time to process.
    • The patentee submissions must be filed no later than 10 weeks prior to the particular HDAP meeting.
    • New: Patentees are required to indicate the level of therapeutic improvement to be addressed in the submission at the same time as the product monograph filing

More details on submission deadlines are provided in the NEWSletter.

  • Completed and Ongoing Hearings:
    • Re-determination of the Copaxone matter
    • Supplementary Order in the matter of Shire Canada Inc. and the medicine Adderall XR
    • Thalomid – Matter before the Supreme Court  

  • Other PMPRB NEWSletter topics covered include:
    • Michelle Boudreau - the new PMPRB Executive Director effective August 30, 2010
    • New Patented Medicines Reported to the PMPRB
    • Pristiq – 2009 New Medicine Review (Category 3 under the pre-2010 Guidelines)
    • Upcoming Events

Voluntary Compliance Undertakings (“VCUs”)

  • On July 28, 2010, the Vice-Chairperson of the Board approved two VCUs:
    • An amendement to the original VCU submitted by Schering-Plough Canada Inc. in relation to Andriol (testosterone undecanoate), a medicine indicated for the replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.  The purpose of amendment is to revise the terms of the VCU because Schering-Plough has discontinued its discounted pricing for Andriol and as a result a lump sum payment is required to offset the remaining $2.3 million in excess revenues.
    • Iroko International LP submitted a VCU in relation to Vancocin (vancomycin hydrochloride), an antibiotic used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis cause by Clostridium difficile.  The prices of both strengths of Vancocin exceeded the Guidelines in 2008 and 2009.  Iroko will offset excess revenues by making a payment of $173,003.30.
  • On June 15, 2010, the Vice-Chairperson of the Board approved a VCU from Otsuka America Pharmaceutical Inc. in relation to Busulfex (busulfan), which is for use in combination with other chemotherapeutic agents and/or radiotherapy as a conditioning regimen prior to hematopoietic progenitor cell transplantation.  Otsuka began selling Busulfex following acquisition of the product in 2008. Otsuka will offset excess revenues by making a payment of $22,092.48.
  • On May 13, 2010, the Chairman of the Board approved a VCU from Solvay Pharma Inc. for Dicetel (pinaverium), a gastrointestinal calcium antagonist indicated for several indications including the treatment and relief of symptoms associated with irritable bowel syndrome (IBS).  Under the terms of the VCU, Solvay Pharma offset excess revenues by making a payment of $31,287.32 plus an additional payment by August 30, 2010 for any excess revenues received since January 1, 2010.
  • On May 8, 2010, the Chairman of the Board approved two VCUs:
    • Novo Nordisk Canada Inc. submitted a VCU in relation to Levemir (insulin detemir), an antidiabetic agent for the treatment of adult patients with type 1 or type 2 diabetes mellitus. In order to comply with the Guidelines, Novo Nordisk has lowered the price of Levemir effective April 1, 2010 and offset excess revenues by making payments totalling $6,468,240.33.
    • Astellas Pharma Canada Inc. submitted a VCU in relation to Adenoscan (adenosine injection), indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.  The patent pertaining to Adenoscan expired on August 4, 2009.  Under the terms of the VCU, Astellas offset excess revenues by making a payment of $34,545.32. 

Voluntary Compliance Undertaking (“VCU”)

The Board is seeking comments on a VCU it is proposing to approve from AstraZeneca Canada Inc. with respect to the price of Faslodex (fulvestrant), a patented medicine indicated for the hormonal treatment of locally advanced or metastatic breast cancer in post-menopausal women, regardless of age, who have disease progression following prior endocrine therapy. A Notice and Comment was issued on June 18, 2010.

PMPRB Update – 2009 PMPRB Annual Report Released

The 2009 PMPRB Annual Report was tabled before Parliament on June 16, 2010 and subsequently published by the PMPRB. The report provides detailed information on sales and price trends of medicines in Canada, including:
  • The R&D-to-sales ratio for all patentees decreased in 2009 to 7.5% from 8.1% in 2008 while the R&D-to-sales ratio for Rx&D member companies declined in 2009 to 8.2% from 8.9% in 2008.
  • Canadian prices of patented medicines during 2009 were 0.3% above 2008 levels, while the CPI also rose by 0.3% during the same period.
  • Prices in five [Germany, Italy, Sweden, UK, US] of the seven PMPRB reference countries recorded overall price increases in 2009 over 2008. Canadian prices were approximately 2% above international median prices, on average, but lower than their highest international price.
The full document can be accessed on PMPRB’s website.

Michelle Boudreau – The New PMPRB Executive Director

Mary Catherine Lindberg, the Vice-Chairperson of the Patented Medicine Prices Review Board (PMPRB) has announced Michelle Boudreau as the new Executive Director replacing Barbara Ouellet. Michelle Boudreau comes to the PMPRB from Health Canada where she was Director General of the Natural Health Products Directorate (NHPD) since September 2008. She has degrees in both pharmacy and law. Please consult the PMPRB’s website for more details.

PMPRB Form 2 relating to the prices and sales of patented medicines during the period January through June 2010 must be completed and filed with the PMPRB by Friday July 30, 2010. The Patented Medicines Regulations require the filing of Canadian sales data (Block 4) for all patented medicines as well as the medicines’ corresponding foreign ex-factory prices (Block 5) in the seven countries referenced by the PMPRB (i.e. France, Germany, Italy, Sweden, Switzerland, the UK and the US).

PDCI Market Access maintains an extensive international price database and will be pleased to assist you with your upcoming PMPRB Form 2 filing. For more information on our PMPRB Form 2 Filing Services please contact Dana Mills at 613-742-8225 (ext 26) or at dana.mills@pdci.ca.

Revision to CPI Adjustment Factors for 2011

The April 2010 edition of the quarterly PMPRB NEWSletter included notification of the CPI adjustment factors and cap to be used in the calculation of the non-excessive average prices (NEAP) for patented drug prices in 2011.  The PMPRB has now confirmed that these published adjustment factors are incorrect. The PMPRB has indicated that it will be issuing the following revised factors via e-mail to patentees shortly. 

REVISED CPI ADJUSTMENT FACTORS FOR 2011
Benchmark Year

2008

2009

2010
Adjustment Factor

1.043

1.039

1.022
Note:  The cap for 2011 is 3.3% (i.e. 2.2% X 1.5)

The revised figures will be included in the web version of the PMPRB’s April 2010 NEWSletter.

Voluntary Compliance Undertakings ("VCUs")

On March 31, 2010, the Chairman of the Board approved two VCUs:

  • Baxter Corporation submitted a VCU in relation to the vaccine FSME-IMMUN (tick-borne encephalitis vaccine - inactivated), which is indicated for immunization against the TBE virus in individuals 16 years and older who are at risk of contact with ticks that carry TBE virus. Sales in Canada through Health Canada´s Special Access Programme (SAP) began on April 27, 1999 while NOC was granted on February 3, 2005. FSME-IMMUN was classified as a category 2 new medicine. According to the VCU, the price of FSME-IMMUN exceeded the Guidelines in 2002, based on the highest international price test. Baxter undertakes to offset the cumulative excess revenues received from January 1, 2002 to December 31, 2009 by making a payment to Her Majesty in the amount of $53,578.62.
  • GlaxoSmithKline Inc. submitted a VCU in relation to the medicine Paxil CR (paroxetine hydrochloride), a selective serotonin reuptake inhibitor indicated for the symptomatic treatment of depression and panic disorder. Launched in 2004, Paxil CR is a new dosage form (controlled release tablets) of an existing medicine. A follow-up to a VCU accepted by the Board in March 2005, this latest VCU addresses additional excess revenues resulting from a data re-filing by GSK for Paxil CR for the period covered by the original VCU. GSK undertakes to offset the additional excess revenues received in the January to December 2004 and January to December 2005 reporting periods by making a payment to the Crown in the amount of $53,177.88.

Board Order - Quadracel and Pentacel

The PMPRB Hearing Panel issued a Board Order on March 16, 2010 in the matter of sanofi pasteur Limited and the vaccines Quadracel and Pentacel. In its Decision on the merits of the case, the Panel agreed with the PMPRB staff's application of the Guidelines but instructed the PMPRB staff and sanofi pasteur to determine the ATPs and MNEs of Quadracel and Pentacel as if discounts to Ontario had not occurred. They were further instructed to provide the Panel with a draft proposed Order reflecting this decision. According to the Board Order issued on March 16, sanofi pasteur will offset the excess revenues pertaining to Pentacel and Quadracel by making a payment to her Majesty in the amount of $2,512,877.74, representing excess revenues of $1,878,583.20 for Pentacel and $634,294.54 for Quadracel.

This Order concludes the proceedings initiated on March 27, 2007.


Notice of Hearing

The PMPRB issued a Notice of Hearing dated March 8, 2010 the purpose of which is to hear arguments from Board Staff and from Sandoz Canada Inc (Sandoz) relating to an application by Board Staff for the issuance of a Board Order compelling Sandoz to file information required pursuant to the Patent Act and the Regulations. It is the Board Staff's position that Sandoz is a patentee in the context of the Patent Act and as such the PMPRB has jurisdiction over the prices of various medicines being sold or that have been sold in Canada by Sandoz, including but not limited to Sandoz Cyclosporine, Sandoz Ondansetron, Sandoz Azithromycin, Sandoz Famciclovir, Sandoz Estradiol Derm and Sandoz Terbinafine. Sandoz refutes the claim that it is a patentee.

Those wishing to intervene in the proceedings must apply to the PMPRB by April 6, 2010. Documents relating to the hearing notice, including the Schedule of Events, can be viewed on the PMPRB's website.


Voluntary Compliance Undertaking ("VCU")

On January 26, 2010, the Chairman of the Board approved a VCU from Bayer Inc. in relation to the medicine Xarelto (rivaroxaban), which is indicated for the prevention of venous thromboembolic events in patients who have undergone elective hip or total knee replacement surgery. According to the VCU, Xarelto's price exceeded the PMPRB's international price guideline at introduction and in 2009. Bayer has undertaken to offset cumulative excess revenues accrued from September 18, 2008 to June 30, 2009 by making a payment to the Crown in the amount of $49,978.33. Bayer also undertakes to make further payment to Her Majesty for any additional excess revenues received after June 30, 2009.


January 2010 NEWSletter Released

The January 2010 edition of the quarterly PMPRB NEWSletter has been released. Included in this edition are:

  • 2009 CPI adjustment factors: The PMPRB has published the actual CPI adjustment factors that will be used in its calculation of the 2009 MNEs. While the PMPRB had used a 2.0% inflation forecast in its determination of forecast CPI adjustment factors for 2009, the actual change in CPI for 2009 over 2008 was only 0.3%. As a result, the actual CPI adjustment factors for 2009 are significantly lower than the forecast (e.g., 3-yr adjustment of 1.049 vs 1.065, respectively) and the actual one-year increase cap has come in at 0.5% as opposed to the 3.0% previously forecast.
  • Changes / additions to the PMPRB's personnel and additions to the Human Drug Advisory Panel membership, the latter of which is to accommodate increased workload of the HDAP as a result of the new Guidelines. The "Comings and Goings"' and "Human Drug Advisory Panel" sections of the January 2010 PMPRB NEWSletter presents an overview of those changes.
  • Other PMPRB NEWSletter topics covered include:

    • Completed and Ongoing Hearings
    • New Patented Medicines Reported to PMPRB (period October to December 1, 2009)
    • Voluntary Compliance Undertakings ("VCUs")
    • Sprycel - 2009 New Medicine Review (Category 2)
    • Board Meeting Activities
    • Upcoming Event

Voluntary Compliance Undertakings (VCUs)

On February 1, 2010, the PMPRB announced the Chairman's acceptance of the following two VCUs:

  • A VCU from Schering-Plough Canada Inc. in relation to the medicine Claritin Allergy and Sinus Extra Strength (10 mg loratadine / 240 mg pseudoephedrine sulphate), which is indicated for the relief of symptoms associated with allergic rhinitis. According to the VCU, the introductory price of Claritin Allergy & Sinus ES in Canada was above the maximum non-excessive price established by the PMPRB; the product was classified as a category 1 new medicine. Schering-Plough undertakes to offset the cumulative excess revenues received during the period January 1, 2005 through June 30, 2009 by making a payment to Her Majesty in the amount of $69,950.43. Schering-Plough also undertakes to ensure that the price of Claritin Allergy & Sinus ES remains within the Guidelines in all future periods during which the product is under the PMPRB's jurisdiction.
  • A VCU from Fresenius Kabi Canada in relation to the medicine Voluven (hydroxyethyl starch), a product indicated for the treatment of hypovolemia. The Human Drug Advisory Panel recommended that Voluven be classified as a Category 1 new medicine and identified Hextend and Pentaspan as the most appropriate comparable medicines. However, the PMPRB staff concluded that the Reasonable Relationship (RR) test methodology was not appropriate in this instance because of differences in molecular structure and pharmacokinetic/ pharmacodynamic properties versus other hetastarch preparations. Thus, a Therapeutic Class Comparison (TCC) and an International Price Comparison (IPC) test were conducted, resulting in the introductory price of Voluven appearing to exceed the Guidelines. Fresenius Kabi undertakes to offset cumulative excess revenues received during the period March 3, 2007 through August 7, 2008 (the patent expiry date) by making a payment to Her Majesty in the amount of $1,448,002.25.

Board's Decision on Pentacel and Quadracel

The PMPRB Hearing Panel has published its Decision on the merits regarding the prices of Quadracel and Pentacel (sanofi pasteur Limited). The original Notice of Hearing was issued in March 2007. Quadracel and Pentacel have been sold in Canada since June 1997 and are combination or multi-component vaccines that protect against four and five different diseases, respectively. In the Board Staff's Statement of Allegations, it is alleged that sanofi pasteur sold Quadracel (from 2002-2006) and Pentacel (2002-2007) at excessive prices. Sanofi pasteur argued that the Board Staff applied the Guidelines (and in particular the CPI Guidelines) incorrectly. In its decision, the Hearing Panel concluded that the prices of Quadracel and Pentacel were excessive and that patentees cannot "contract out" the CPI guideline (a reference to sanofi's reliance on the CPI price increase provisions in the contracts with the Canadian government). The Panel directed sanofi pasteur to reduce the prices at which it sells the vaccines during the term of the current contract with the Government of Canada to levels that offset the excessive revenues (as yet to be calculated) that have accrued to date. The Panel also instructed the PMPRB staff and sanofi pasteur to determine the ATPs and MNEs of Quadracel and Pentacel as if discounts to Ontario had not occurred.

Please consult the PMPRB's website for more details.


Federal Court Quashes PMPRB Copaxone Decision

In a November 12 2009 decision, Justice Hughes of the Federal Court of Canada ruIed that the PMPRB's finding of excessive pricing in the Teva Neuroscience / Copaxone matter was "unreasonable" and the calculation of excess revenues "unintelligible". The Judge concluded that the Board, in reaching its decision, had relied solely on the CPI guideline to the exclusion of the other excessive price factors listed in section 85 of the Patent Act (e.g., prices of other drugs in the therapeutic class, international prices.). The matter has been referred back to the Board for a new hearing (by a different hearing panel if possible). The Attorney General of Canada has 30 days to appeal the decision. The implications of the decision may be far reaching.The PMPRB's compliance and enforcement policies are built on price tests that reflect the excessive price factors in s. 85 but are premised on a presumption of excessive pricing if the price of a patented medicine contravenes just one of the price tests. The Federal Court decision requires the Board to consider and give some weight to all of the factors. Moreover, the tenor of the decision would suggest that this consideration should occur well in advance of the formal hearing process. For example, Board Staff could be required to give some weight to all the s. 85 factors when conducting an investigation into the price of a patented medicine that failed any one particular price test. How this would be accomplished remains to be seen. However, with the 2010 implementation of the revised guidelines, this decision offers patentees yet more uncertainty to uncertain times.

For more information, or a copy of the Federal Court decision, please contact Neil Palmer or Janice D'Angelo.


October 2009 NEWSletter Released

The October 2009 edition of the quarterly PMPRB NEWSletter has been released. This edition provides updates on some ongoing PMPRB activities, including:

  • The new Excessive Price Guidelines which will come into force on January 1, 2010. The Board Staff will be monitoring and evaluating the application and impact of the changes to the Guidelines on an ongoing basis once in effect. On September 17, 2009, the Board met and discussed the monitoring and the evaluation of the Board's new Excessive Price Guidelines. Dr. Benoit states in the October 2009 NEWSletter that "the revised Guidelines will provide greater transparency and predictability in the price review process". Outreach sessions were held in late October, in Montreal and Toronto, on the upcoming application of the Guidelines.
  • The Federal Court of Canada heard the Application for Judicial Review on the Board's decision in the matter of Teva Neuroscience and the medicine Copaxone. The PMPRB issued a Board Order and Reasons on May 12, 2008 in relation to this matter. This was in accordance with the Decision of the Board issued on February 25, 2008, finding that the medicine was sold at an excessive price in 2004 and 2005. The Federal Court decision is pending.
  • Other NEWSletter topics:

    • Completed and Ongoing Hearings
    • New Drugs Introduced since July 2009 NEWSletter
    • Pradax - 2008 New Medicine Review (Category 3)
    • Board Meeting Activities
    • Upcoming Events

Voluntary Compliance Undertakings ("VCUs")

On October 21, 2009, the Board approved a VCU from Amgen in relation to the medicine Neulasta (pegfilgrastim), which is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. For the purpose of resolving the matter relating to the Notice of Hearing issued in March 2009, Board Staff and Amgen agree that Neulasta is properly classified as a Category 3 new medicine and that the application of a domestic therapeutic class comparison pricing test with Amgen's Neupogen (filgratim) as the comparator is appropriate. Amgen undertakes to make a payment to the Crown in the amount of $6,730,120.32 to offset any revenues above the maximum prices set out in the VCU.

On October 16, 2009, the Board accepted a VCU from Schering-Plough Canada Inc. regarding the price of Andriol (testosterone undecanoate), a medicine indicated for the replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Schering-Plough will provide a discount of 21.25% against the 2009 MNE price to all customers through to end-December 2010 and will offset excess revenues deemed to have accrued over the period November 1 through December 31, 2004 by making a payment to Her Majesty in the amount of $348,605.86.

On October 5, 2009, the Board approved a VCU from Baxter Corporation in relation to the medicine Brevibloc (esmolol hydrochloride), a product indicated for the perioperative management of tachycardia and hypertension. In addition to a price reduction put in place by Baxter in June 2009, the company will offset cumulative excess revenues by making payments totaling $212,440.76 to customers that previously purchased Brevibloc.


The 2008 PMPRB Annual Report was tabled before Parliament on July 22, 2009 and subsequently published by the PMPRB.

The report provides detailed information on sales and price trends of medicines in Canada, including:

  • The R&D-to-sales ratio for all patentees decreased in 2008 to 8.1% from 8.3% recorded in 2007. The R&D-to-sales ratio for Rx&D member companies remained at 8.9%.
  • Canadian prices of patented medicines during 2008 were 0.1% above 2007 levels. The CPI rose by 2.3% during the same period.
  • Prices in only three [Germany, UK, US] of the seven PMPRB reference countries recorded overall price increases in 2008 over 2007. Canadian prices were approximately 4% above international median prices, on average, but lower than their highest international price. The full document can be accessed on PMPRB's website.

PMPRB Update - January 2009 NEWSletter Released

The January 2009 edition of the quarterly PMPRB NEWSletter has been released. This edition provides updates on some ongoing PMPRB activities, including:

  • Update on the Proposed Changes to the Excessive Price Guidelines.

    The Board is finalizing its review of the feedback received in response to the August 20, 2008 package, which included extensive changes to PMPRB's Excessive Price Guidelines. The PMPRB is still considering some areas where stakeholders' comments were more significant. The PMPRB plans to release a new version of the draft revised Guidelines in March 2009, which will be the subject of a final Notice and Comment period, followed by release of the final text of the Guidelines around the end of May. Implementation of the new Guidelines is anticipated for July 1, 2009.

    On November 25, 2008, the PMPRB issued a Communiqué temporarily suspending patentees' mandatory reporting of benefits for the January 1 to June 30, 2009 reporting period. The judicial reviews on this matter, resulting from applications filed by Pfizer Canada and Rx&D et al., are scheduled for June 16-17. The PMPRB, anticipating that a Federal Court decision is not likely prior to July 1, 2009, has suspended mandatory reporting of benefits until January 1, 2010.
  • 2008 CPI adjustment factors: The PMPRB has published the actual CPI adjustment factors that will be used in the calculation of 2008 MNEs. While the PMPRB had used a 2.0% inflation forecast in its determination of forecast CPI adjustment factors for 2008, the actual change in CPI for 2008 over 2007 was 2.4%. As a result, the actual CPI adjustment factors for 2008 are higher than forecast (e.g. 3-yr adjustment of 1.066 vs 1.057, respectively) as is the cap on one year increases in 2008 (3.6% vs 3.0%, respectively). These will result in higher than expected MNEs for 2008.
  • REMINDER: The deadline for filing PMPRB Form 3 - Revenues and Research and Development Expenditures is March 2, 2009.
  • Other NEWSletter topics:

    • Completed and Ongoing Hearings
    • New Drugs Introduced since October 2008 NEWSletter
    • Revlimid - 2008 New Medicine Review (Category 2)
    • Board Meeting Activities
    • Upcoming Events

The Board has postponed the hearing in the matter of Eli Lilly Canada and its medicine Strattera to February 11, 2009. The hearing was originally scheduled from January 27 to 29, 2009.

Board Communiqué on Mandatory Reporting

The PMPRB issued a Communiqué on November 25, 2008 temporarily suspending patentees' mandatory reporting of benefits for the January 1 to June 30, 2009 period as a result of Rx&D et al. and Pfizer Canada's applications for Judicial Review stemming from the Board's August 18, 2008 Communiqué.

The Board is continuing its assessments of the issues relating to its Draft Revised Excessive Price Guidelines and will be communicating next steps through its website and NEWSletters.


The October edition of the quarterly PMPRB NEWSletter has been released.

This edition provides updates on several PMPRB activities, including:

  • Update on the Proposed Changes to the Excessive Price Guidelines On August 20, 2008, the Board released a PMPRB Notice and Comment package which included extensive changes to PMPRB's Excessive Price Guidelines. Interested parties were asked to provide comments on the proposed changes. The comments received since then have been posted on the PMPRB's website. The Board met on October 22 to review stakeholders' comments and is continuing its assessment of the issues. Updates on its progress will be communicated on the PMPRB's website and through its NEWSletters. According to the original August 18, 2008 PMPRB Communiqué, the amended Compendium of Policies, Guidelines and Procedures as well as transition and implementation plans are to be released on November 17, 2008.
  • Additional NEWSletter topics:

    • Completed and Ongoing Hearings
    • 2009 HDAP Meeting Schedule
    • Lucentis - 2007 New Medicine Review (Category 2)
    • New Drugs Introduced since July 2008 NEWSletter
    • Upcoming Events

PMPRB Updates

Apo-Salvent Hearing

The PMPRB has postponed the pre-hearing conference in the matter of Apotex and its medicine Apo-Salvent, originally scheduled on September 29, 2008. Apo-Salvent is a new DIN of an existing dosage form of an existing bronchodilator (salbutamol sulfate). The drug is indicated for the relief of chest tightness and wheezing caused by spasms or narrowing in the small air passages of the lungs. The Board will be announcing a new date shortly. Please consult the PMPRB's website for more information.

Proposed Changes to the Excessive Price Guidelines

REMINDER: Interested parties have until Monday, October 6, 2008, to submit their comments on the PMPRB's Notice and Comment August 20, 2008 package, which includes extensive changes to the PMPRB's Excessive Price Guidelines. Responses to the proposed changes should be sent to the Secretary of the Board by e-mail at sdupont@pmprb-cepmb.gc.ca , or by mail at:

Sylvie Dupont
Secretary of the Board
Patented Medicine Prices Review Board
Box L40
Standard Life Centre
333 Laurier Avenue West
Suite 1400
Ottawa, Ontario
K1P 1C1

More information on the topic and comments received to date are provided on the Board's website.


HDAP Meeting Schedule

    The PMPRB has released the Human Drug Advisory Panel (HDAP) meeting schedule for 2009:

  • February 19, 2009
  • May 15, 2009
  • September 17, 2009
  • November 19, 2009.

Details on submission deadlines are provided on the Board's website.

 

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