Pricing & Reimbursment Title Canadian Market Access for Pharmaceuticals 2006 (C-MAP™) Sub title Canadian Drug Benefit Plans Reference Guide Author Palmer D'Angelo Publication date January 2006 ISBN Pages Information currently unavailable Price pdf n/a   |   print £2195 Summary 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 Canada's 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 PDCI's Canadian Drug Claims Database Subscribers to C-MAP™ Canadian Drug Benefit Plans Reference Guide 2006 Edition are provided with ongoing email updates to ensure the content is always current. Subscribers also receive unlimited password protected access to the online version of Canadian Drug Benefit Plans Reference Guide 2006 Edition including manufacturers' submission forms and templates. The online version of this publication can be accessed by anyone within the subscribing organization. TABLE OF CONTENTS OUTLINE Canadian Drug Benefit Plans Reference Guide – 2005 Edition 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 Médicaments 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 Pricing & Reimbursment

No additional author information available for this product