Introduction to Market Access for Pharmaceuticals

Cover
Half Title
Title Page
Copyright Page
Table of Contents
Foreword
Acknowledgments
Author
Common Abbreviations
Introduction
Chapter 1: Health as a Good
1.1 Welfare Economics and Health
1.2 Health Care: A Mixed and Collective Good
1.3 Equity, Health, and Health Care
1.4 Uncertainty Related to the Demand and Results
1.5 Physician’s Expected Behavior
1.6 Supply Condition
1.7 Discussion
References
Chapter 2: Decision-Making in Public Health
2.1 Public Health Definition
2.1.1 Example of the Influence of Air Pollution on Public Health
2.2 Decision-Making in Public Health
2.2.1 Organization of Public Health
2.2.2 Funding Health Care and Public Health
2.2.3 Criteria Used for Priority-Setting and Decision-Making
2.2.4 Health Inequalities
2.2.5 Monitoring and Evaluation of Public Health Policies
2.3 Decision-Making on the Reimbursement
2.3.1 Accountability for Reasonableness
2.3.2 Transparency
2.3.3 Participation
2.4 Methods of Incorporating Societal Preferences into Decision-Making
References
Suggested Reading
Chapter 3: Definitions and Concepts
3.1 Origin of the Market Access Term
3.1.1 Market Access for Goods
3.1.1.1 Tariff Measures
3.1.1.2 Nontariff Barriers/Measures
3.1.2 Application to Health Care
3.1.2.1 Tariff Barriers on Pharmaceuticals
3.1.2.2 Nontariff Barriers on Pharmaceuticals
3.1.2.3 Health Care Market Specificities
3.2 Market Access Key Concepts
3.2.1 What Is Value?
3.2.2 What Is Access?
3.3 Market Access Definition
3.3.1 Market Access and the Structure of Health Care System
3.3.1.1 Publicly Funded Health Care Systems
3.3.1.2 Mixed or Private Health Care Systems
3.3.1.3 Centralized and Regional Market Access
3.4 Cultural Specificities of Market Access
3.5 Market Access for Payers
3.5.1 Payers Employ Market Access Tools to Control Drug Expenditure
3.5.2 How to Identify Payers?
3.5.3 How Payers Assess Value?
3.5.4 How HTA Evaluation Is Translated into P&R Conditions?
3.6 Market Access for Industry
3.6.1 A New Paradigm
3.6.2 Organization in the Pharmaceutical Industry
3.6.3 Objective of Market Access Activities
Suggested Reading
Chapter 4: HTA Decision Analysis Framework
4.1 Introduction
4.2 History
4.3 HTA Processes and Decision Analysis Frameworks
4.3.1 National HTA Bodies and Main Assessment Outcomes
4.3.2 Decisions Impacted by the Assessed Outcomes
4.3.3 HTA Core Model® EUnetHTA
4.3.4 Evaluation Criteria and Processes for HTA and Pricing
4.3.4.1 HTA
4.3.4.2 Pricing
4.3.4.3 Market Access Agreements
4.3.5 Value Assessment Frameworks
4.4 France
4.4.1 SMR
4.4.2 ASMR
4.4.3 Efficiency Notice
4.5 England, Ireland, and Wales—Health Technology Appraisal
4.6 Scotland—New Product Assessment
4.7 Germany—Additional Benefit and Cost-Benefit
4.8 Sweden—Marginal Benefit and Cost-Effectiveness
4.9 Italy—Degree of Innovation and Cost-Effectiveness
4.10 Spain—Reimbursement and Pricing Recommendation
Suggested Reading
Chapter 5: Early HTA Advice
5.1 Overview of the Early HTA Advice Pathways
5.1.1 HTA-EMA Parallel Scientific Advice
5.1.2 MultiHTA Advice
5.1.3 EUnetHTA Pilot Assessment of Relative Effectiveness
5.1.4 Adaptive Pathway
5.1.5 Priority Medicines Scheme
5.2 National Early HTA Advice Programs
5.2.1 France
5.2.1.1 Questions to Focus on
5.2.1.2 Process
5.2.1.3 Content of the Dossier
5.2.2 The United Kingdom
5.2.2.1 Questions to Focus on
5.2.2.2 Process
5.2.2.3 Content of the Dossier
5.2.2.4 Light Scientific Advice
5.2.3 Germany
5.3 Strategic Considerations
5.3.1 Multidisciplinary Approach
5.3.2 Briefing Book Is the Cornerstone of Early HTA Advice
5.3.3 How to Choose the Right Option for Early HTA Advice
5.3.4 Types of Risk for the Company When Considering Early HTA Advice
5.3.4.1 Target Population Related Risk
5.3.4.2 Development Plan Related Risk
5.4 Conclusions
References
Chapter 6: Overview of Market Access Agreements
6.1 Background
6.2 Rationale behind MAAs
6.3 Different Definitions and Taxonomies of MAAs
6.3.1 Different Definitions
6.3.2 A Possible Definition
6.3.3 Different Taxonomies
6.3.4 Simplified Taxonomy
6.3.4.1 Commercial Agreement
6.3.4.2 Payment for Performance
6.3.4.3 Coverage with Evidence Development
6.4 Payers’ and Manufacturers’ Motivations to Implement MAAs
6.4.1 The Increasingly Cost-Sensitive Environment
6.4.2 The Uncertainty Related to Drug’s Performance
6.4.3 The “Trust Crisis”
6.5 International Comparison of MAA Health Policies
6.5.1 MAAs across Countries
6.5.2 Some Countries Are More Resistant Than Others
6.5.3 Regional MAAs Growth in Europe
6.5.3.1 Formularies in Italy Are Subject to Regional Influence
6.5.3.2 Regional MAA in Sweden
6.6 Best Practice of MAAs
6.6.1 The Rationale behind MAAs
6.6.1.1 When Should MAAs Be Considered?
6.6.2 The Implementation Process
6.6.2.1 Requirements for Implementing MAAs
6.6.2.2 Challenges in MAAs Implementation
6.6.3 Evaluation
6.7 Impact of MAAs on Product Uptake
6.7.1 Example of MS MAA in the United Kingdom: Impact on Sales
6.7.2 Example of Bevacizumab’s Uptake in Metastatic Colorectal Cancer across EU Countries
6.7.3 Etanercept MAA in Germany
6.8 Some Specific Case Studies
6.8.1 Example of CED in the United Kingdom: Use of ß-Interferons and Glatiramere for the Treatment of MS in the United Kingdom
6.8.1.1 Performance of MAAs
6.8.2 Examples of CEDs in France
6.8.2.1 Performance of MAAs
6.8.3 Examples of CEDs in Sweden
6.8.3.1 Performance of MAAs
6.8.4 Example of MAAs in Italy
6.8.4.1 Performance of MAAs
6.8.5 Financing of MAA Drugs
6.9 Overview of MAA Trends in Other Countries
6.9.1 MAA Is a Growing Phenomenon in Various Countries
6.9.2 MAAs in Australia
6.9.3 MAAs in Latin America
6.9.4 India: A Different MA Pathway
6.9.5 MA in South Korea
6.10 Perspectives
6.10.1 MAA Is a Growing Trend and Is Shifting toward Conditional Access
6.10.2 Challenges with MAAs
6.11 Conclusion: MAA, a Temporary Solution?
6.11.1 A Paradigm Shift in the Pharmaceutical Industry
6.11.2 From a Decision Point to a Decision Window
6.11.3 Which MAAs in the Future?
References
Chapter 7: External Reference Pricing
7.1 Definition of External Reference Pricing
7.2 ERP in Europe
7.2.1 National Legal Framework
7.2.2 Scope of ERP
7.2.3 Composition of the Country Basket
7.2.4 Price Calculation and Selection of Reference Products
7.3 ERP Processes in Non-European Countries
7.3.1 Australia
7.3.2 Canada
7.3.3 Japan
7.3.4 South Korea
7.3.5 Mexico
7.3.6 New Zealand
7.3.7 Turkey
7.4 Concerns Related to ERP
7.4.1 Potential Consequences of ERP
7.4.1.1 Patient Access to Medicine
7.4.1.2 Affordability
7.4.1.3 Industry Revenue and Sustainability
7.5 VBP and ERP
7.5.1 ERP as an Alternative to VBP
7.5.2 ERP and VBP Combination
References
Chapter 8: Gap between Payers and Regulators
8.1 Introduction
8.2 Uncertainty versus Risk
8.3 Payers versus Regulators
8.4 Sources of Uncertainty
8.4.1 Regulators
8.4.2 HTA Bodies/Payers
8.5 Risk Management of Drug Value Uncertainty—HTA/Payer Level
8.5.1 Population
8.5.2 Comparator
8.5.3 Design
8.5.4 Outcome
8.5.5 Indirect Comparison
8.6 Risk Management Tools
8.6.1 Regulators
8.6.2 HTA Bodies and Payers
8.7 Type of Studies Requested by HTA Bodies/Payers to Reduce the Uncertainty
8.8 Case Studies of Gaps between Regulatory and HTA/Payer Approval
8.8.1 Drugs General Characteristics and Approval History
8.8.2 Regulatory versus Payers’ Evaluations
8.8.3 Discussion of Case Studies
8.9 Conclusions
References
Chapter 9: Early Access Programs
9.1 Overview
9.2 Types of EAPs: Nominative and Cohort
9.3 Global EAP Trends
9.4 Key Success Factors and EAP Management
References
Chapter 10: Market Access of Orphan Drugs
10.1 Definitions of Orphan Drugs
10.1.1 US Definition
10.1.2 EU Definition
10.1.3 Japan
10.1.4 South Korea
10.2 The Legal Frameworks for Licensing and Assessment of Orphan Drugs and Development Incentives
10.2.1 The European Union
10.2.2 France
10.2.2.1 Compassionate Use
10.2.2.2 Development Incentives
10.2.3 Germany
10.2.3.1 Compassionate Use
10.2.3.2 Development Incentives
10.2.4 Spain
10.2.4.1 Compassionate Use
10.2.4.2 Development Incentives
10.2.5 Italy
10.2.5.1 Compassionate Use
10.2.5.2 Development Incentives
10.2.6 The United Kingdom
10.2.6.1 Scotland
10.2.6.2 England and Wales
10.2.7 Asia
10.2.7.1 Japan
10.2.7.2 South Korea
10.3 The Pricing Process of Orphan Drugs
10.3.1 France
10.3.2 Germany
10.3.3 Italy
10.3.4 Spain
10.3.5 The United Kingdom
10.3.6 Japan
10.3.7 South Korea
10.4 Comparison of Prices of Orphan Drugs
10.5 The HTA Framework for Orphan Drugs and Ultra-Orphan Drugs
10.6 The Concept of Ethics and Equity for Orphan Drugs
10.7 Potential Alternative Methods for HTA and Pricing of Orphan Drugs
10.8 The Issues with Prices of Orphan Drugs
10.9 Future Perspectives
10.10 Conclusion
References
Chapter 11: Market Access of Vaccines in Developed Countries
11.1 Introduction
11.1.1 Definition and Classifications
11.1.2 Preventive Vaccines
11.1.3 Therapeutic Vaccines
11.2 Vaccines’ Specifics
11.2.1 Development
11.2.2 Safety
11.2.3 Benefits and Cost-Effectiveness
11.2.3.1 Humanistic Benefits
11.2.3.2 Economic Benefit
11.2.3.3 Cost-Effectiveness
11.2.4 Market Typology
11.3 Overview of Vaccines’ Market Access in Developed Countries
11.3.1 Overview of NITAGs’ Processes
11.3.1.1 NITAGs’ Members
11.3.1.2 Operations
11.3.1.3 Decision Criteria
11.3.2 Implementation of NITAGs’ Recommendations
11.3.3 Time to Market
11.4 Overview of Vaccines’ Market Access in a Selection of European Countries and the United States
11.4.1 Austria
11.4.2 Denmark
11.4.3 France
11.4.4 Germany
11.4.5 Italy
11.4.6 The Netherlands
11.4.7 Spain
11.4.8 Sweden
11.4.9 The United Kingdom
11.4.10 The United States
References
Chapter 12: France
12.1 Stakeholders
12.1.1 Names of National Pricing and Reimbursement Decision Makers
12.1.2 Names of National Health Technology Assessment Agencies
12.1.3 Names of Other Key Stakeholders (Regional/Local Level)
12.2 Pricing and Reimbursement Policies
12.2.1 Overview of the System
12.2.2 Reimbursement Process
12.2.3 Pricing Process
12.3 Time to Market
12.4 Price Regulations
12.4.1 Pricing Policy Following the Marketing Authorization
12.4.2 External Reference Pricing
12.4.3 Internal Reference Pricing
12.4.4 Price Control at Ex-Factory Price Level
12.4.5 Price Control at Wholesale Level
12.4.6 Price Control at Pharmacy Retail Level
12.4.7 Mandatory Price Reduction on Brand Price after Generic/Biosimilar Entry
12.5 Reimbursement Specificities
12.6 Characteristics of Public Tendering
12.7 Expenditure Controls (Supply Side)
12.7.1 Discounts/Rebates
12.7.2 Clawback
12.7.3 Payback
12.7.4 Price-Volume Agreements
12.7.5 Other Market Access Agreements
12.7.6 Price Freezes and Cuts
12.8 Policies Targeted at Wholesalers, Pharmacists, Physicians, and Patients
12.8.1 Wholesaler and Pharmacy Mark-Up
12.8.2 Generic Substitution
12.8.3 INN Prescribing
12.8.4 Prescription Guidelines
12.8.5 Monitoring of Prescribing Behavior
12.8.6 Pharmaceutical Budgets Defined for Physicians
12.8.7 Prescription Quotas
12.8.8 Financial Incentives for Physicians
12.8.9 Financial Incentives for Pharmacists
12.8.10 Copayment for Patients
References
Further Reading
Chapter 13: Germany
13.1 Stakeholders
13.1.1 Names of National Pricing and Reimbursement Decision Makers
13.1.2 Names of National Health Technology Assessment Agencies
13.1.3 Names of Other Key Stakeholders (Regional/Local Level)
13.2 Pricing and Reimbursement Policies
13.2.1 Overview of the System
13.2.2 Reimbursement Process
13.2.3 Pricing Process
13.3 Time to Market
13.4 Price Regulations
13.4.1 Pricing Policy Following the Marketing Authorization
13.4.2 External Reference Pricing
13.4.3 Internal Reference Pricing
13.4.4 Price Control at Ex-Factory Price Level
13.4.5 Price Control at Wholesale Level
13.4.6 Price Control at Pharmacy Retail Level
13.4.7 Mandatory Price Reduction on Brand Price after Generic/Biosimilar Entry
13.5 Reimbursement Specifics
13.6 Characteristics of Public Tendering
13.6.1 Expenditure Controls Discounts/Rebates
13.6.2 Clawback
13.6.3 Payback
13.6.4 Price-Volume Agreements
13.6.5 Other Market Access Agreements
13.6.6 Price Freezes and Cuts
13.7 Policies Targeted at Wholesalers, Pharmacists, Physicians, and Patients
13.7.1 Wholesaler Mark-Up
13.7.2 Pharmacy Mark-Up
13.7.3 Generic Substitution
13.7.4 International Nonproprietary-Name Prescribing
13.7.5 Prescription Guidelines
13.7.6 Monitoring of Prescribing Behavior
13.7.7 Pharmaceutical Budgets Defined for Physicians
13.7.8 Prescription Quotas
13.7.9 Financial Incentives for Physicians
13.7.10 Financial Incentives for Pharmacists
13.7.11 Copayment for Patients
References
Chapter 14: Italy
14.1 Stakeholders
14.1.1 Names of National Pricing and Reimbursement Decision Makers
14.1.2 Names of National Health Technology Assessment Agencies
14.1.3 Other Key Stakeholders at National Level
14.1.4 Regional and Local Stakeholders
14.2 Pricing and Reimbursement of Pharmaceuticals in Italy
14.2.1 Overview of the System
14.2.2 The Process
14.2.3 Reimbursement Classes
14.3 Time to Market Access for Drugs
14.4 Price Regulation
14.4.1 Pricing Policy Following the Marketing Authorization
14.4.2 External Reference Pricing
14.4.3 Internal Reference Pricing
14.4.4 Price Control (at Ex-Factory, Wholesale, and Pharmacy Retail)
14.4.5 Mandatory Price Reduction on Brand Price after Generic/Biosimilar Entry
14.5 Cost-Containment Policies
14.5.1 Prescription Guidelines
14.5.2 Discounts/Rebates
14.5.3 Payback
14.5.4 Price-Volume Agreements
14.5.5 Other Market Access Agreements
14.5.6 Monitoring of Prescribing Behavior
14.5.7 Public Tenders
14.5.8 Generic Substitution
14.5.9 Copayment for Patients
14.6 Policies Targeted at Wholesalers, Pharmacists
14.6.1 Wholesaler Mark-Up
14.6.2 Pharmacy Mark-Up
References
Chapter 15: Spain
15.1 Stakeholders
15.1.1 Names of National Pricing and Reimbursement Decision Makers
15.1.2 Names of National Health Technology Assessment Agencies
15.1.3 Names of Other Key Stakeholders (Regional/Local Level)
15.2 Pricing and Reimbursement Policies
15.2.1 Overview of the System
15.2.2 Reimbursement Process
15.2.3 Pricing Process
15.3 Time to Market
15.4 Price Regulations
15.4.1 Pricing Policy Following the Marketing Authorization
15.4.2 External Reference Pricing
15.4.3 Internal Reference Pricing
15.4.4 Price Control at Ex-Factory Price Level
15.4.5 Price Control at Wholesale Level
15.4.6 Price Control at Pharmacy Retail Level
15.4.7 Mandatory Price Reduction on Brand Price after Generic/Biosimilar Entry
15.5 Reimbursement Specificities
15.6 Characteristics of Public Tendering
15.7 Expenditure Controls
15.7.1 Discounts/Rebates
15.7.2 Clawback
15.7.3 Payback
15.7.4 Price-Volume Agreements
15.7.5 Other Market Access Agreements
15.7.6 Price Freezes and Cuts
15.8 Policies Targeted at Wholesalers, Pharmacists, Physicians, and Patients
15.8.1 Wholesaler Mark-Up
15.8.2 Pharmacy Mark-Up
15.8.3 Generic Substitution
15.8.4 International Nonproprietary Name (INN) Prescribing
15.8.5 Prescription Guidelines
15.8.6 Monitoring of Prescribing Behavior
15.8.7 Pharmaceutical Budgets Defined for Physicians
15.8.8 Prescription Quotas
15.8.9 Financial Incentives for Physicians
15.8.10 Financial Incentives for Pharmacists
15.8.11 Copayment for Patients
References
Chapter 16: Sweden
16.1 Stakeholders
16.1.1 National Pricing and Reimbursement Decision Makers
16.1.2 National Health Technology Assessment Agencies
16.1.3 Other Key Stakeholders
16.2 Pricing and Reimbursement Policies
16.2.1 Overview of the System
16.2.2 Reimbursement Process
16.2.3 Pricing Process
16.2.4 Pharmaco-Economic Assessment
16.3 Time to Market
16.4 Price Regulations
16.4.1 Pricing Policy Following the Marketing Authorization
16.4.2 External Reference Pricing
16.4.3 Internal Reference Pricing
16.4.4 Price Control at Ex-Factory Price Level
16.4.5 Price Control at Wholesale Level
16.4.6 Price Control at Pharmacy Retail Level
16.4.7 Mandatory Price Reduction on Brand Price after Generic/Biosimilar Entry
16.5 Reimbursement Specificities
16.6 Characteristics of Public Tendering
16.7 Expenditure Controls
16.7.1 Discounts/Rebates
16.7.2 Clawback
16.7.3 Payback
16.7.4 Price-Volume Agreements
16.7.5 Other Market Access Agreements
16.7.6 Price Freezes and Cuts
16.8 Policies Targeted at Wholesalers, Pharmacists, Physicians, and Patients
16.8.1 Wholesaler Mark-Up
16.8.2 Pharmacy Mark-Up
16.8.3 Generic Substitution
16.8.4 International Nonproprietary Name (INN) Prescribing
16.8.5 Prescription Guidelines
16.8.6 Monitoring of Prescribing Behavior
16.8.7 Pharmaceutical Budgets Defined for Physicians
16.8.8 Prescription Quotas
16.8.9 Financial Incentives for Physicians
16.8.10 Financial Incentives for Pharmacists
16.8.11 Copayment for Patients
References
Chapter 17: United Kingdom
17.1 Stakeholders
17.1.1 National Pricing and Reimbursement Decision Makers
17.1.2 National Health Technology Assessment (HTA) Agencies
17.2 Pricing and Reimbursement Policies
17.2.1 Overview of the System
17.2.2 Reimbursement Process
17.2.3 Pricing Process
17.3 Time to Market
17.4 Price Regulations
17.4.1 Pricing Policy Following the Marketing Authorization
17.4.2 Reference Pricing
17.4.3 Price Control
17.4.4 Mandatory Price Reduction on Brand Price after Generic/Biosimilar Entry
17.5 Reimbursement Specifics
17.6 Characteristics of Public Tendering
17.6.1 Applied to Hospital Care
17.6.2 Applied to Ambulatory Care
17.7 Expenditure Controls (Supply Side)
17.7.1 Discounts/Rebates
17.7.2 Clawback
17.7.3 Payback
17.7.4 Price-Volume Agreements
17.7.5 Other Market Access Agreements
17.7.6 Price Freezes and Cuts
17.8 Policies Targeted at Wholesalers, Pharmacists, Physicians, and Patients
17.8.1 Wholesaler Mark-Up
17.8.2 Pharmacy Mark-Up
17.8.3 Generic Substitution
17.8.4 International Nonproprietary Name (INN) Prescribing
17.8.5 Prescription Guidelines
17.8.6 Monitoring of Prescribing Behavior
17.8.7 Pharmaceutical Budgets Defined for Physicians
17.8.8 Financial Incentives for Physicians
17.8.9 Copayment for Patients
References
Chapter 18: Belgium
18.1 Stakeholders
18.1.1 Names of National Pricing and Reimbursement Decision Makers
18.1.2 Names of National Health Technology Assessment Agencies
18.1.3 Names of Other Key Stakeholders (Regional/Local Level)
18.2 Pricing and Reimbursement Policies Overview
18.2.1 Overview of the System
18.2.2 Reimbursement Process
18.2.3 Pricing Process
18.3 Time to Market
18.4 Price Regulations
18.4.1 Pricing Policy Following the Marketing Authorization
18.4.2 External Reference Pricing
18.4.3 Internal Reference Pricing
18.4.4 Price Control at Ex-Factory Price Level
18.4.5 Price Control at Wholesale Level
18.4.6 Price Control at Pharmacy Retail Level
18.4.7 Mandatory Price Reduction on Brand Price after Generic/Biosimilar Entry
18.5 Reimbursement Specifics
18.5.1 Characteristics of Public Tendering
18.5.2 Expenditure Controls Discounts/Rebates
18.5.3 Clawback
18.5.4 Payback
18.5.5 Price-Volume Agreements
18.5.6 Other Market Access Agreements
18.5.7 Price Freezes and Cuts
18.6 Policies Targeted at Wholesalers, Pharmacists, Physicians, and Patients
18.6.1 Wholesaler Mark-Up
18.6.2 Pharmacy Mark-Up
18.6.3 Generic Substitution
18.6.4 International Nonproprietary Name Prescribing
18.6.5 Prescription Guidelines
18.6.6 Monitoring of Prescribing Behavior
18.6.7 Pharmaceutical Budgets Defined for Physicians
18.6.8 Prescription Quotas
18.6.9 Financial Incentives for Physicians
18.6.10 Financial Incentives for Pharmacists
18.6.11 Copayment for Patients
18.6.12 Special Funding Procedure for Individual Patients
References
Chapter 19: The United States
19.1 Stakeholders
19.1.1 Names of National Pricing and Reimbursement Decision Makers
19.1.2 Names of National Health Technology Assessment Agencies
19.1.3 Names of Other Key Stakeholders (Regional/Local Level)
19.2 Overview of Pricing and Reimbursement Policies
19.2.1 Overview of the System
19.2.2 Reimbursement Process
19.2.3 Pricing Process
19.3 Time to Market
19.4 Price Regulations
19.4.1 Pricing Policy Following the Marketing Authorization
19.4.2 External Reference Pricing
19.4.3 Internal Reference Pricing
19.4.4 Price Control at Ex-Factory Price Level
19.4.5 Price Control at Wholesale Level
19.4.6 Price Control at Pharmacy Retail Level
19.4.7 Mandatory Price Reduction on Brand Price after Generic/Biosimilar Entry
19.5 Reimbursement Specificities
19.6 Characteristics of Public Tendering
19.7 Expenditure Controls
19.7.1 Discounts/Rebates
19.7.2 Clawback
19.7.3 Payback
19.7.4 Price-Volume Agreements
19.7.5 Other Market Access Agreements
19.7.6 Price Freezes and Cuts
19.8 Policies Targeted at Wholesalers, Pharmacists, Physicians, and Patients
19.8.1 Wholesaler Mark-Up
19.8.2 Pharmacy Mark-Up
19.8.3 Generic Substitution
19.8.4 International Nonproprietary Name (INN) Prescribing
19.8.5 Prescription Guidelines
19.8.6 Monitoring of Prescribing Behavior
19.8.7 Pharmaceutical Budgets Defined for Physicians
19.8.8 Prescription Quotas
19.8.9 Financial Incentives for Physicians
19.8.10 Financial Incentives for Pharmacists
19.8.11 Copayment for Patients
References
Chapter 20: Japan
20.1 Stakeholders
20.1.1 National Pricing and Reimbursement Decision Makers
20.1.2 National Health Technology Assessment Agencies
20.1.3 Other Key Stakeholders (Regional/Local Level)
20.2 Overview of Pricing and Reimbursement Policies
20.2.1 Overview of the System
20.2.2 Reimbursement Process
20.2.3 Pricing Process
20.3 Time to Market
20.4 Price Regulations
20.4.1 Pricing Policy Following the Marketing Authorization
20.4.2 External Reference Pricing
20.4.3 Internal Reference Pricing
20.4.4 Price Control at Ex-Factory Price Level
20.4.5 Price Control at Wholesale Level
20.4.6 Price Control at Pharmacy Retail Level
20.4.7 Mandatory Price Reduction on Brand Price after Generic/Biosimilar Entry
20.5 Reimbursement Specifics
20.6 Characteristics of Public Tendering
20.7 Expenditure Controls
20.7.1 Discounts/Rebates
20.7.2 Clawback
20.7.3 Payback
20.7.4 Price-Volume Agreements
20.7.5 Other Market Access Agreements
20.7.6 Price Freezes and Cuts
20.8 Policies Targeted at Wholesalers, Pharmacists, Physicians, and Patients
20.8.1 Wholesaler and Pharmacy Mark-Up
20.8.2 Generic Substitution
20.8.3 International Nonproprietary Name (INN) Prescribing
20.8.4 Prescription Guidelines
20.8.5 Monitoring of Prescribing Behavior
20.8.6 Pharmaceutical Budgets Defined for Physicians
20.8.7 Prescription Quotas
20.8.8 Financial Incentives for Physicians
20.8.9 Financial Incentives for Pharmacists
20.8.10 Copayment for Patients
References
Chapter 21: China
21.1 Stakeholders
21.1.1 Names of National Pricing and Reimbursement Decision Makers
21.1.2 Names of National Health Technology Assessment Agencies
21.1.3 Names of Other Key Stakeholders (Regional/Local Level)
21.2 Pricing and Reimbursement Policies
21.2.1 Overview of the System
21.2.2 Reimbursement Process
21.2.3 Pricing Process
21.3 Time to Market
21.4 Price Regulations
21.4.1 Pricing Policy Following the Marketing Authorization
21.4.2 External Reference Pricing
21.4.3 Internal Reference Pricing
21.4.4 Price Control at Ex-Factory Price Level
21.4.5 Price Control at Wholesale Level
21.4.6 Price Control at Pharmacy Retail Level
21.4.7 Mandatory Price Reduction of Price of On-Patent Drugs after Generic/Biosimilar Entry
21.5 Reimbursement Specificities
21.6 Characteristics of Public Tendering
21.7 Expenditure Controls
21.7.1 Discounts/Rebates
21.7.2 Clawback
21.7.3 Payback
21.7.4 Price-Volume Agreements
21.7.5 Other Market Access Agreements
21.7.6 Price Freezes and Cuts
21.8 Policies Targeted at Wholesalers, Pharmacists, Physicians, and Patients
21.8.1 Wholesaler and Pharmacy Mark-Up
21.8.2 Generic Substitution
21.8.3 International Nonproprietary Name (INN) Prescribing
21.8.4 Prescription Guidelines
21.8.5 Monitoring of Prescribing Behavior
21.8.6 Pharmaceutical Budgets Defined for Physicians
21.8.7 Prescription Quotas
21.8.8 Financial Incentives for Physicians
21.8.9 Financial Incentives for Pharmacists
21.8.10 Copayment for Patients
21.8.11 Changes in the Pricing Mechanism
References
Epilogue
Index