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Canadian Market Access for Pharmaceuticals 2006 (C-MAP?)
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Abstract
Ninety per cent of Canadians have some form of drug plan coverage. However,
staying up-to-date with the policies and requirements of the various
reimbursement schemes is a challenging but necessary requirement for gaining
access to the multi-billion dollar Canadian market. This comprehensive
reference guide is an essential tool for developing and maintaining a clear
understanding of Canadas public and private sector drug plans.
The Canadian Market Access for Pharmaceuticals (C-MAP™ Canadian Drug Benefit
Plans Reference Guide 2006 Edition provides detailed information on the
policies and procedures of the ten provincial prescription drug programs and
includes separate chapters on four federal drug programs. There are also
detailed overviews of the Provincial Cancer Programs, the Patented Medicine
Prices Review Board (PMPRB), the Canadian Coordinating Office for Health
Technology Assessment (CCOHTA), Federal/ Provincial/ Territorial Initiatives
and the private drug plans in Canada. An extensive section on the Common Drug
Review provides a comprehensive description of the CDR process including CDR
rationale for CEDAC decisions, time to decision tracking of submissions and
CDR submission forms and templates available online. The executive summary
provides essential facts on each of the drug plans in convenient tabular
format.
This publication includes, but is not restricted to:
- Identification of each provincial plan or selected federal program
- Detailed description of each plan
- Identification of the governing acts and regulations
- Drug plan expenditures and use profile
- Formulary descriptions
- Summaries of processes and procedures for listing and approval
- Special authorization processes
- Reimbursement regulations and procedures
- Requirements for manufacturers submissions to the Common Drug Review and
directly to the provincial drug plans including generic products
- A description of the Special Drug Programs for each province
- Reporting structure within each province
- PDCI online version of C-MAP™Canadian Drug Benefit Plans Reference Guide
- A glossary of terms
The new features of the 2006 Edition are:
- A Comprehensive Section on Provincial Cancer Programs
- A Listing Process Summary Table for Interchangeables including generic
submission deadline dates (where applicable)
- An improved and more comprehensible section on submission requirements for
CDR and non-CDR submissions
- An enhanced Private Payers Section
- A free trial of PDCIs Canadian Drug Claims Database
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
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