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The Patented Medicine Prices Review Board Procurity Conference

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Pharmaceutical industry. Rx&D Canada's Research Based Pharmaceutical Companies. BIOTECanada. CGPA Canadian Generic Pharmaceutical Association. Health associations ... – PowerPoint PPT presentation

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Title: The Patented Medicine Prices Review Board Procurity Conference


1
The Patented Medicine Prices Review
BoardProcurity Conference
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  • Barbara Ouellet, Executive Director
  • PMPRB
  • November 26, 2008
  • Scottsdale, Arizona

2
Overview
  • The PMPRB
  • Mandate
  • Stakeholders
  • Regulatory Mandate and the Excessive Price
    Guidelines
  • Reporting Mandate

3
The PMPRB
  • Arms-length agency in the Federal Health
    Portfolio
  • No involvement in Federal policy-making
  • Created in 1987 as consumer protection pillar
    of drug patent law reform
  • Quasi-judicial tribunal
  • Remedial orders provided for in the Patent Act
    carry the force of the Federal Court
  • Structure and Budget
  • 5 part-time Board members
  • Governor-in-Council Appointees
  • Selected based on area of expertise, regional
    representation, official language proficiency
  • 62 employees
  • Budget 11.5 million

4
Mandate of the PMPRB
  • Regulatory To ensure that prices charged by
    manufacturers for patented medicines are not
    excessive, thereby protecting consumers and
    contribute to Canadian health care
  • Reporting To report on pharmaceutical trends
    and on the RD spending by pharmaceutical
    patentees, thereby contributing to informed
    decisions and policy making

5
Stakeholders
  • Provincial and Territorial Ministers of Health
  • Consumers
  • Consumers Association of Canada
  • Seniors groups
  • Pharmaceutical industry
  • RxD Canadas Research Based Pharmaceutical
    Companies
  • BIOTECanada
  • CGPA Canadian Generic Pharmaceutical
    Association
  • Health associations
  • Canadian Pharmacists Association
  • Canadian Society of Hospital Pharmacists
  • Canadian Health Coalition
  • Canadian Healthcare Association
  • Disease groups patient advocacy groups

6
  • Regulatory Mandate

7
Parameters
  • The PMPRB ensures introductory prices, and price
    increases, for patented drugs sold in Canada not
    excessive
  • Does not set prices for patented drug products
  • FPT drug plans negotiate actual formulary listing
    prices
  • Price does not need PMPRB approval before
    patented drug is sold in Canada
  • But, patentee encouraged to seek advisory
    assistance on price compliance with Excessive
    Price Guidelines (Guidelines) prior to first
    sale, and prior to any price increase

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  • Excessive Price Guidelines

10
Conducting the Scientific Review
  • Purpose To determine
  • the primary indication/use of the new medicine,
    and dosage regime
  • the category into which it fits
  • whether there are any therapeutically comparable
    medicines, and their respective comparable dosage
    regimes

11
Categorization
  • Category 1
  • Line extension comparable dosage form of an
    existing medicine
  • Category 2
  • First drug product available in Canada that
    treats effectively a particular illness or
    addresses effectively a particular indication
    (breakthrough) OR
  • Substantial improvement in therapeutic effect
    (such as increased efficiency or major reductions
    in dangerous adverse reactions) or significant
    savings to the Canadian health care system
  • Category 3
  • Non-comparable dosage form of an existing
    medicine or new chemical entity - Moderate,
    little or no therapeutic advantage over existing
    medicines

12
Different Introductory Price Tests for each
Category
  • Category 1 Drug Products
  • Reasonable Relationship Test (RR) compares
    price of new drug to prices of existing drugs
    with comparable dosage forms
  • Category 2 Drug Products - Higher of
  • Therapeutic Class Comparison (TCC) test up to
    highest price of therapeutic comparators or
  • International Price Comparison (IPC) test up to
    median of prices of the new drug in the seven
    comparator countries (France, Germany, Italy,
    Sweden, Switzerland, U.K., U.S.)
  • Category 3 Drug products
  • Therapeutic Class Comparison (TCC)
  • A drug may be excluded if its price considered
    excessive
  • For all products Canadian price cannot be the
    highest in the world

13
Existing Drugs (not new to the market)
  • Consumer Price Increase (CPI) adjustment
    methodology
  • Lower of
  • Price three years ago adjusted for cumulative
    change in the CPI or
  • One year cap equal to 1.5 times the forecast
    change in the annual CPI
  • Again, Canadian price can never be the highest
    among comparator countries
  • Even if allowed by CPI methodology
  • In periods of high inflation (over 10), limit
    is 5 more than the forecast change in CPI

14
Possible Outcomes of Investigations
  • Price not excessive and investigation closed
  • Price excessive under the Guidelines
  • Patentee given opportunity to provide a Voluntary
    Compliance Undertaken (VCU) (i.e., to comply with
    the MNE and agree to repay excess revenues)
  • Requires approval of Board Chairperson
  • OR
  • Board Staff refers the matter to the Chairperson
  • Decides whether it is in the public interest to
    issue a Notice of Hearing
  • Note Even if hearing called, Board Staff still
    available to negotiate VCU on a parallel track
    with the Hearing process

15
Review of the Boards Excessive Price Guidelines
  • Consultations with stakeholders over the last 3
    years
  • Key changes in draft revised Guidelines issued on
    August 20, 2008
  • 4 new categories of therapeutic improvement
    (breakthrough substantial improvement moderate
    improvement slight or no improvement)
  • Revised price tests to correspond to 4 v 3
    categories
  • ¬†Any market¬† reviews
  • Deviation from CPI limit if price increase is due
    to end of a benefit

16
Enforcement Activities
  • 10 Voluntary Compliance Undertakings since 2006
  • Airomir AndroGel Denavir Dovobet (following
    the September 2007 Board Order) Forteo Lantus
    OctreoScan Risperdal Consta) Vaniqa Zemplar
  • Combination of price reductions and reimbursement
    of excessive revenues totalling over 10M
  • Since 1993, 49 VCUs have been approved
  • Price reduction price reduction of other
    patented medicines payments of excess revenues
    totalling 37M
  • VCU concluded proceedings initiated in 2006

17
Hearings
  • 15 Notices of Hearing issued since 2006
  • 7 completed Adderall XR Airomir Copaxone
    Dovobet Risperdal Consta Thalomid Zemplar
  • 9 hearings ongoing Apotex (failure to file)
    Apo-Salvent Concerta (decision pending)
    Nicoderm (initiated in 1999) Penlac (resumes
    December 8) Quadracel-Pentacel (resumes November
    25) ratiopharm Inc. (failure to file)
    ratio-Salbutamol Strattera (resumes January 27,
    2009)
  • Hearings terminated as a result of a voluntary
    compliance undertaking (VCU)

18
  • Reporting Mandate

19
Highlights 2007
  • Sales of patented drugs up 3 to 12.3 billion
  • 64 new drugs (or DINs)
  • 20 NASs (34 DINs)
  • 9 VCUs approved 3 Notices of Hearing issued (2
    in 2007
  • 1, to date, in 2008)
  • PMPI decreased by 0.1 mainly attributable to
    hospitals
  • Canadian prices at 1.01 of the MIP
  • RD-to-sales ratio up to 8.3 (all patentees) and
    8.9
  • (RxD members)

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27
Utilization of Patented Drugs
  • Utilization of patented drugs grew by 3.5, the
    smallest rate of growth since 1994
  • The primary drivers of the overall utilization
    growth include drugs related to
  • Antineoplastics and immunomodulating agents
  • Respiratory system
  • They accounted for 2/3rd of the overall
    utilization growth in the PMQI

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RD Expenditure in 2007
  • Patentees reported total RD expenditures of
    1.32 B in 2007, an increase of 9.5 from 2006
  • The RD-to-sales ratio increased
  • All patentees 8.3 - up from 8.1 in 2006
  • RxD members 8.9 from 8.5

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33
National Prescription Drug Utilization
Information System (NPDUIS)
  • Pursuant to section 90 of the Patent Act
  • In partnership with the Canadian Institute for
    Health Information (data custodian and some
    analyses)
  • Responsive to priorities of F/P/T drug plans
    (Steering Committee)
  • Recent publications to-date
  • Guidelines for conducting pharmaceutical budget
    impact analyses
  • New Drug Pipeline
  • Pharmaceutical Trends Overview

34
  • pmprb_at_pmprb-cepmb.gc.ca
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