Canadian Market Access for Pharmaceuticals 2006 (C-MAP?)

Table of Contents

EXECUTIVE SUMMARY

• Table 1
• Summary of Drug Plan Descriptions
• Region
• Legislative Authority
• Administration
• Plan Name
• Beneficiaries
• Generic Drug Substitution
• Table 2
• Provincial Professional Fees and Maximum Days Supply
• Province
• Professional Fees, Regular Prescription Maximum
• Mark-ups
• Maximum Days Supply/Prescription
• Table 3
• Provincial Co-Payments and Deductibles
• Province
• Deductible
• Co-Payment
• Table 4
• Submission Items Required by the CDR and Quebec for Formulary Listing
• 31 Categories
• Table 5
• Listing Process Summary Table
• Region
• Formulary Name
• Review by Independent Committee
• Formulary Publishing Dates
• Submission Deadlines
• Table 6
• Time to Listing (from NOC) for Single Source Products Launched Between June 1, 2002 and May 31, 2004 (Full and Restricted Listings)
• Province
• No. of Listings
• Average TTL
• Range
• Table 7
• Population, Canada and the Provinces, 1992--2004
• Table 8
• Canada's Demographic Trends, 1999--2004

STATISTICAL TRENDS

• Figure 1 Total Health Expenditure in Canada, by Use of Funds, 2003
• Figure 2 Total Drug Expenditure in Canada and Prescribed Drugs by Payer, by Use of Funds, 2003
• Figure 3 Total Health and Drug Expenditures in Canada 1993--2002
• Figure 4 Total Health and Prescribed Drug Expenditures Per Capita, 1993--2003
• Figure 5 Public Expenditures on Health and Prescribed Drugs, 1993--2003
• Figure 6 Private Expenditures on Health and Prescribed Drugs, 1993--2003
• Figure 7 Drug (& Personal Health Supplies) Expenditure by Province and by Type, 2003
• Figure 8 Prescription Drug Expenditure in Canada, 1993--2003
• Figure 9 Provincial Prescription Drug Expenditure by Province, 2003
• Figure 10 Provincial Prescription Drug Expenditure Per Capita, 2003
• Figure 11 Prescription Drug Expenditure by Province and by Type, 2003
• Figure 12 Manufacturers' Sales of Patented and Non-Patented Drugs 1993--2003

COMMON DRUG REVIEW

• 1.0 Introduction
• 1.1 History
• 1.2 Common Drug Review
• 1.2.1 Objectives
• 1.2.2 Governance
• 1.2.3 The CDR Within the Drug Review Process
• 1.2.4 Manufacturers' Submission Process
• 1.2.5 Submission Requirements
• 1.2.6 Resubmissions
• 1.2.7 Specialty Drugs
• 1.2.8 Hospital Drugs
• 1.2.9 Priority Review
• 1.2.10 Deadlines
• 1.3 Transparency and Communications
• 1.4 Completed Submissions -- Time to Decision and Reasons for Recommendation
• 1.5 Next Steps
• 1.6 CDR Directorate Current Staff Members
• APPENDIX I
• Participating F/P/T Drug Plans
• APPENDIX II
• Participating F/P/T Drug Plans and their Submission Requirements
• APPENDIX III
• Final Recommendations and Reasons for Recommendations

BRITISH COLUMBIA

• 1.0 Introduction
• 1.0.1 Pharmacare/PharmaNet Policies and Procedures Manual
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.2.1 Seniors
• 1.2.2 Social Assistance
• 1.2.3 High-Cost to Income / Income-Based
• 1.2.4 Disease Specific
• 1.2.5 Others
• 1.3 Pricing
• 1.3.1 Low Cost Alternative Program
• 1.3.2 The Reference Drug Program
• 1.3.3 Policy on Price Increases
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Special Authorization Policy
• 1.4.2 Reimbursement of Non-Listed Drug Products
• 1.4.3 Exclusions
• 1.5 Submission and Drug Review Process
• 1.5.1 Priority Review Policy
• 1.5.2 Requirements for Manufacturers' Submissions
• 1.6 Formulary
• 1.7 Advisory Committees
• 1.8 Organizational Chart
• APPENDIX I
• Continuing Care Act

ALBERTA

• 1.0 Introduction
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.2.1 Seniors
• 1.2.2 Social Assistance
• 1.2.3 Disease Specific
• 1.2.4 Other
• 1.3 Pricing
• 1.3.1 Least Cost Alternative (LCA) Pricing
• 1.3.2 Maximum Allowable Cost (MAC) Pricing
• 1.3.3 Policy on Price Increases
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Special Authorization Policy
• 1.4.2 Restricted Benefits
• 1.4.3 Limited Restricted Benefits
• 1.4.4 Reimbursement of Non-Listed Drug Products
• 1.4.5 Exclusions
• 1.5 Submission and Drug Review Process
• 1.5.1 Criteria for Listing or Retaining Drug Products
• 1.5.2 Priority Review Policy
• 1.5.3 Requirements for Manufacturers' Submissions
• 1.6 Formulary
• 1.7 Advisory Committees
• 1.7.1 Members
• 1.8 Organizational Chart

SASKATCHEWAN

• 1.0 Introduction
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.2.1 Seniors
• 1.2.2 Social Assistance
• 1.2.3 High Cost to Income / Income-Based
• 1.2.4 Disease Specific
• 1.2.5 Other
• 1.3 Pricing
• 1.3.1 Maximum Allowable Cost (MAC) Pricing
• 1.3.2 Interchangeability and Pricing
• 1.3.3 Policy on Price Increases
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Exception Drug Status (EDS) Program
• 1.4.2 "No Substitution" Prescription Drug Coverage
• 1.4.3 Reimbursement of Non-Listed Drug Products
• 1.4.4 Exclusions
• 1.5 Submission and Drug Review Process
• 1.5.1 Criteria for Listing or Retaining Drug Products
• 1.5.2 Priority Review Policy
• 1.5.3 Requirements for Manufacturers' Submissions
• 1.6 Formulary
• 1.7 Advisory Committees
• 1.7.1 Members
• 1.8 Organizational Chart
• APPENDIX I
• Product Submission Process Flowchart
• APPENDIX II
• The Prescription Drugs Act

MANITOBA

• 1.0 Introduction
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.2.1 Seniors
• 1.2.2 Social Assistance
• 1.2.3 High Cost to Income / Income-Based
• 1.2.4 Disease Specific
• 1.2.5 Other
• 1.3 Pricing
• 1.3.1 Policy on Price Increases
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Exception Drug Status Coverage
• 1.5 Submission and Drug Review Process
• 1.5.1 Criteria for Listing or Retaining Drug Products
• 1.5.2 Policy for Formulary Deletion
• 1.5.3 Priority Review Policy
• 1.5.4 Requirements for Manufacturers' Submissions
• 1.6 Formulary
• 1.7 Advisory Committees
• 1.7.1 Members
• 1.8 Organizational Chart
• APPENDIX I
• Prescription Drugs Cost Assistance Act

ONTARIO

• 1.0 Introduction
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.2.1 Seniors
• 1.2.2 Social Assistance
• 1.2.3 High Cost to Income / Income-Based
• 1.2.4 Disease Specific
• 1.3 Pricing
• 1.3.1 Pricing of Interchangeable Drug Products
• 1.3.2 Policy on Price Increases
• 1.3.3 Cost to Operator Claims
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Limited Use Products
• 1.4.2 Medically Necessary "No Substitution" Claims
• 1.4.3 Reimbursement of Non-Listed Drug Products
• 1.4.4 Interchangeable Products
• 1.4.5 Extemporaneous Preparations
• 1.5 Submission and Drug Review Process
• 1.5.1 Formulary Listing Process
• 1.5.2 Requirements for Manufacturers' Submissions
• 1.5.3 Fast Tracking Mechanism
• 1.6 Formulary
• 1.7 Advisory Committees
• 1.7.1 Members
• 1.8 Organizational Chart
• APPENDIX I
• Ontario Drug Benefit Act
• APPENDIX II
• Drug Interchangeability and Dispensing Fee Act
• APPENDIX III
• Submission Consideration Process Flowchart

QUEBEC

• 1.0 Introduction
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.2.1 Seniors
• 1.2.2 Social Assistance
• 1.2.3 Other
• 1.3 Pricing
• 1.3.1 Guaranteed Selling Price
• 1.3.2 Interchangeability and Pricing
• 1.3.3 Policy on Price Increases
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Exception Drug Status
• 1.4.2 Reimbursement of Non-Listed Drug Products
• 1.4.3 Smoking Cessation Products
• 1.4.4 Extemporaneous Preparations
• 1.5 Submission and Drug Review Process
• 1.5.1 Criteria for Listing or Retaining Drug Products
• 1.5.2 Policy for Formulary Deletion
• 1.5.3 Priority Review Policy
• 1.5.4 Request for Review of Decision
• 1.5.5 Requirements for Manufacturers' Submissions
• 1.6 Formulary
• 1.7 Advisory Committees
• 1.7.1 Members
• 1.8 Organizational Chart
• APPENDIX I
• Loi sur l'Assurance Medicaments

NEW BRUNSWICK

• 1.0 Introduction
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.2.1 Seniors
• 1.2.2 Social Assistance
• 1.2.3 High-Cost to Income / Income-Based
• 1.2.4 Disease Specific
• 1.2.5 Others
• 1.3 Pricing
• 1.3.1 Policy on Price Increases
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Special Authorization Process
• 1.4.2 Reimbursement of Non-Listed Drug Products
• 1.4.3 Exclusions
• 1.4.4 Extemporaneous Preparations
• 1.5 Submission and Drug Review Process
• 1.5.1 Requirements for Manufacturers' Submissions
• 1.5.2 Priority Review Policy
• 1.5.3 Atlantic Common Drug Review
• 1.6 Formulary
• 1.7 Advisory Committees
• 1.7.1 Members
• 1.8 Organizational Chart
• APPENDIX I
• Prescription Drug Payment Act

NOVA SCOTIA

• 1.0 Introduction
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Provincial Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.2.1 Seniors
• 1.2.2 Social Assistance
• 1.2.3 Disease Specific
• 1.3 Pricing
• 1.3.1 Actual Acquisition Costs (AAC)
• 1.3.2 Maximum Allowable Cost (MAC)
• 1.3.3 Policy on Price Increases
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Special Authorization Process
• 1.4.2 Exception Status Drugs
• 1.4.3 Reimbursement of Non-Listed Drug Products
• 1.4.4 Benefit Exclusions
• 1.5 Submission and Drug Review Process
• 1.5.1 Criteria for Listing or Retaining Drug Products
• 1.5.2 Policy for Benefit List Deletion
• 1.5.3 Requirements for Manufacturers' Submissions
• 1.5.4 Priority Review
• 1.5.5 Atlantic Common Drug Review
• 1.6 Formulary
• 1.7 Advisory Committees
• 1.7.1 Members
• 1.8 Organizational Chart
• APPENDIX I
• Health Services and Insurance Act

PRINCE EDWARD ISLAND

• 1.0 Introduction
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.2.1 Seniors
• 1.2.2 Social Assistance
• 1.2.3 High Cost to Income
• 1.2.4 Disease Specific
• 1.2.5 Other
• 1.3 Pricing
• 1.3.1 Policy on Price Increases
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Exception Drug Status
• 1.4.2 "No Substitution" Prescriptions
• 1.4.3 Reimbursement of Non-Listed Drug Products
• 1.4.4 Interchangeable Products
• 1.4.5 Exclusions
• 1.4.6 Extemporaneous Preparations
• 1.5 Submission and Drug Review Process
• 1.5.1 Product Deletions
• 1.5.2 Priority Review Policy
• 1.5.3 Requirements for Manufacturers' Submissions
• 1.5.4 Atlantic Common Drug Review
• 1.6 Formulary
• 1.7 Advisory Committees
• 1.7.1 Members
• 1.8 Organizational Chart
• APPENDIX I
• Drug Cost Assistance Act

NEWFOUNDLAND

• 1.0 Introduction
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.2.1 Seniors
• 1.2.2 Social Assistance
• 1.2.3 High Cost to Income / Income-Based
• 1.2.4 Disease Specific
• 1.3 Pricing
• 1.3.1 Reasonable Based Pricing
• 1.3.2 Policy on Price Increases
• 1.3.3 Interchangeable Drug Products
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Therapeutic Class Reviews
• 1.4.2 Special Authorization Process
• 1.4.3 Reimbursement of Non-Listed Drug Products
• 1.4.4 Benefit Exclusions
• 1.5 Submission and Drug Review Process
• 1.5.1 Priority Review Policy
• 1.5.2 Requirements for Manufacturers' Submissions
• 1.5.3 Atlantic Common Drug Review
• 1.6 Formulary
• 1.7 Advisory Committees
• 1.7.1 Members
• 1.8 Organizational Chart

VETERANS AFFAIRS CANADA

• 1.0 Introduction
• 1.1 Drug Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.3 Pricing
• 1.3.1 Special Authorization Process
• 1.3.2 Exclusions
• 1.4 Submission and Drug Review Process
• 1.4.1 Requirements for Manufacturers' Submissions
• 1.5 Formulary
• 1.6 Advisory Committees
• 1.6.1 Members

NON-INSURED HEALTH BENEFITS

• 1.0 Introduction
• 1.1 Drug Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.3 Pricing
• 1.3.1 Policy on Price Increases
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Exception Status Drugs
• 1.4.2 Limited Use Benefits
• 1.4.3 Prior Approval Process
• 1.4.4 Medically Necessary "No Substitution" Claims
• 1.4.5 Reimbursement of Non-Listed Drug Products
• 1.4.6 Exclusions
• 1.4.7 Extemporaneous Mixtures
• 1.5 Submission and Drug Review Process
• 1.5.1 Criteria for Listing or Retaining Drug Products
• 1.5.2 Policy for Formulary Deletion
• 1.5.3 Requirements for Manufacturers' Submissions
• 1.5.4 Priority Review Policy
• 1.6 Formulary
• 1.6.1 Special Formulary for Chronic Renal Failure Patients
• 1.7 Advisory Committees
• 1.7.1 Members
• 1.8 Organizational Chart

DEPARTMENT OF NATIONAL DEFENCE

• 1.0 Introduction
• 1.1 Drug Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Patient Eligibility for Drug Plan Coverage
• 1.3 Pricing
• 1.4 Drugs Eligible for Reimbursement
• 1.4.1 Special Authorization Process
• 1.4.2 Over-the-Counter Drugs (OTC) and Personal Health Supplies
• 1.5 Submission and Drug Review Process
• 1.5.1 Types of Drug Benefit Listing
• 1.5.2 Exclusions
• 1.5.3 Requirements for Manufacturers' Submissions
• 1.6 Formulary
• 1.7 Advisory Committees
• 1.7.1 Members

CORRECTIONAL SERVICE CANADA

• 1.0 Introduction
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Plan Description
• 1.2.1 Patient Eligibility
• 1.2.2 Organization of CSC Health Services
• 1.2.3 CSC Drug Supply Process
• 1.2.4 Medication Distribution
• 1.2.5 Special Drugs Programs
• 1.3 Drugs Eligible for Reimbursement
• 1.3.1 Special Authorization Process
• 1.3.2 Restrictions
• 1.3.3 Therapeutic Interchange Policy -- Ontario Region
• 1.4 Submission and Drug Review Process
• 1.4.1 Criteria for Listing or Retaining Drug Products -- Ontario Region
• 1.4.2 Requirements for Manufacturers' Submissions
• 1.5 Formulary
• 1.5.1 The Ontario Regional Drug Formulary
• 1.6 Advisory Committees
• 1.6.1 Members

PRIVATE PAYERS

• 1.0 Introduction
• 1.1 Drug Plan Expenditures and Use Profile
• 1.1.1 Prescription Drug Plan Spending
• 1.1.2 Demographic Profile
• 1.2 Plan Description
• 1.2.1 Plan Designs
• 1.3 Reimbursement
• 1.4 Third Party Administrators/Pharmacy Benefit Managers
• 1.4.1 BCE Emergis eHealth Solutions Group
• 1.4.2 ESI Canada
• 1.4.3 Claimsecure
• 1.4.4 Blue Cross
• 1.4.5 Green Shield Canada
• 1.5 Approval/Listing Process
• 1.6 Requirements for Manufacturers' Submissions
• 1.6.1 Submissions to BCE Emergis eHealth Solutions Group National Formulary
• 1.6.2 Private Payers Submission Contacts
• 1.7 Formulary
• 1.7.1 The BCE National Formulary

CANADIAN COORDINATING OFFICE FOR HEALTH TECHNOLOGY ASSESSMENT (CCOHTA)

• 1.0 Introduction
• 1.1 Products and Publications
• 1.2 Research Programs
• 1.2.1 Health Technology Assessments
• 1.2.2 Current Pharmaceutical Projects by CCOHTA
• 1.2.3 Upcoming Pharmaceutical Projects by CCOHTA
• 1.3 Board of Directors
• 1.4 Advisory Committees
• 1.4.1 Devices and Systems Advisory Committee (DSAC)
• 1.4.2 Pharmaceutical Advisory Committee (PAC)
• 1.4.3 Scientific Advisory Panel (SAP)
• 1.5 CCOHTA Assessment Process
• 1.6 Canadian Optimal Medication Prescribing & Utilization Service (COMPUS)
• 1.6.1 Goals
• 1.6.2 Priority Areas
• 1.6.3 Committee Members
• 1.6.4 Observing Members
• 1.6.5 Voting Members

PATENTED MEDICINE PRICES REVIEW BOARD (PMPRB)

• 1.0 Overview
• 1.1 PMPRB Excessive Price Guidelines
• 1.1.1 Existing Medicines
• 1.1.2 PMPRB New Medicine Categories
• 1.1.3 PMPRB New Medicine Price Tests
• 1.2 PMPRB Enforcement
• 1.3 PMPRB Working Group on Price Review Issues
• 1.4 Research Agenda
• 1.5 Members of the Board and Senior Staff
• 1.6 Contact Information

FEDERAL/PROVINCIAL/TERRITORIAL INITIATIVES CATASTROPHIC DRUG COVERAGE

• 1.0 Introduction
• 1.1 Catastrophic Drug Coverage and Pharmaceutical Management
• 1.2 Progress to Date

NATIONAL PRESCRIPTION DRUG UTILIZATION INFORMATION SYSTEM (NPDUIS) 1.0 Introduction

• 1.1 Rationale
• 1.2 NPDUIS Project Phases
• 1.3 NPDUIS Steering Committee
• 1.3.1 NPDUIS Steering Committee Members

GLOSSARY