1. Report Overview

1.1 How This Study Delivers

1.2 Method of Research and Analysis

1.3 Frequently Asked Questions (FAQs)

1.4 Associated Visiongain Reports

1.5 About Visiongain

2. Market Overview

2.1. A Brief History of Rheumatoid Arthritis and Treatments

2.2. Rheumatoid Arthritis: Treatment and Prevention

2.3 Marketed RA drugs in Major Countries

2.4 Pipeline Products

3. Global Pricing & Reimbursement of Therapeutic Drugs

3.1 Factors Affecting Pricing & Reimbursement Decision

3.2 Price Negotiations & Discounts

3.3 Pricing of a New Drug

3.4 Reimbursement Policies

4. Economic Evaluations

4.1 Role of HEOR and Economic Value Planning

4.2 Overview of Cost-Effectiveness Analysis

4.3 Drug Patent Expiry & Effects on Pricing

5. Health Technology Assessment (HTA) in Market Access

5.1 Key Benefits of HTA and its Process

5.2 Principle HTA Regulatory Agencies

5.3 Case Study: Brief About United Kingdom’s NICE

6. Global Pharmaceutical Market Dynamics

6.1. United States (U.S.)

6.1.1. U.S. Healthcare System

6.1.1.1 Healthcare Expenditure

6.1.1.2. Key Formularies

6.1.1.3. Role of Pharmacists in U.S. Healthcare System

6.1.1.4. Regulatory and Approval Process

6.1.2. Pricing & Reimbursement Process and HTA

6.1.3. Rheumatoid Arthritis Cost of Treatment in United States

6.1.4. United States’ Payer Insights

6.1.5. Features of RA in United States

6.2 Canada

6.2.1. Canada Healthcare System

6.2.1.1. Healthcare Expenditure:

6.2.1.2. Health Coverage:

6.2.1.3. Key Formularies:

6.2.1.4. Role of Pharmacists in Canada Healthcare System

6.2.2 Pricing of Pharmaceuticals in Canada

6.2.2.1 Drug Pricing Amendment in Canada

6.2.2.2 Reimbursement in Canada

6.2.3 Health Technology Assessment

6.2.4 Rheumatoid Arthritis Cost of Treatment

6.2.5 Canada Payer Insight

6.2.6 Features of Canadian Health care for Rheumatoid Arthritis

6.3 Europe (EU5)

6.3.1 United Kingdom

6.3.1.1 United Kingdom Healthcare System

6.3.1.1.1. Healthcare Expenditure:

6.3.1.1.2. Health Coverage:

6.3.1.1.3. Key Formularies:

6.3.1.1.4. Role of Pharmacists in U.K. Healthcare System

6.3.1.2. Pricing & Reimbursement

6.3.1.2.1. Pricing of Pharmaceuticals in the U.K.

6.3.1.2.2. Reimbursement of Pharmaceuticals in the U.K.

6.3.1.3. Health Technology Assessment

6.3.1.4. Rheumatoid Arthritis Cost of Treatment

6.3.1.5. U.K. Payer Insight

6.3.1.6. Features of Rheumatoid Arthritis in U.K.

6.3.2 Germany

6.3.2.1 Germany Healthcare System

6.3.2.1.1 Key Organizations in German Healthcare System

6.3.2.1.2 Healthcare Expenditure:

6.3.2.1.3 Health Coverage:

6.3.2.1.4. Key Formularies:

6.3.2.1.5. Role of Pharmacists in German Healthcare System

6.3.2.2. Pricing & Reimbursement

6.3.2.3. Health Technology Assessment

6.3.2.3.1 Regulatory & Approval Process

6.3.2.4. Rheumatoid Arthritis Cost of Treatment in Germany

6.3.2.5. Cost of Treatment

6.3.2.6. Germany’s Payer Insights

6.3.2.7. Features of RA in Germany

6.3.3 France

6.3.3.1. France Healthcare System

6.3.3.1.1. Healthcare Expenditure

6.3.3.1.2. Health Coverage

6.3.3.1.3. Key formularies

6.3.3.1.4. Role of Pharmacists in France Healthcare System

6.3.3.2. Pricing & Reimbursement:

6.3.3.2.1. Reimbursement Process

6.3.3.2.2. Pricing of Pharmaceuticals

6.3.3.3. Health Technology Assessment

6.3.3.4. Rheumatoid Arthritis Cost of Treatment in France

6.3.3.5. France Payer’s Insight

6.3.3.6. Features of RA in France

6.3.4. Italy

6.3.4.1. Italy Healthcare System

6.3.4.1.1. Healthcare Expenditure

6.3.4.1.2. Health Coverage

6.3.4.1.3. Key Formularies

6.3.4.1.4. Role of Pharmacists in Italy Healthcare System

6.3.4.2. Pricing & Reimbursement

6.3.4.2.1. Reimbursement Process

6.3.4.2.2. Pricing Approval Process

6.3.4.3. Health Technology Assessment

6.3.4.4. Rheumatoid Arthritis Cost of Treatment in Italy

6.3.4.5. Features of RA in Italy

6.3.5 Spain

6.3.5.1 Spain Healthcare System

6.3.5.1.1. Healthcare Expenditure:

6.3.5.1.2. Health Coverage:

6.3.5.1.3. Key Formularies:

6.3.5.1.4. Role of Pharmacists in Spain Healthcare System

6.3.5.2. Pricing & Reimbursement

6.3.5.2.1. Reimbursement of Pharmaceuticals in Spain

6.3.5.2.2. Pricing of Pharmaceuticals in Spain

6.3.5.3. Health Technology Assessment

6.3.5.4. Rheumatoid Arthritis Cost of Treatment in Spain

6.3.5.5 Cost of Treatment

6.3.5.6 Spain Payer Insight

6.3.5.7. Features of Spanish Health care for Rheumatoid Arthritis

6.4. Asia-Pacific

6.4.1 Japan

6.4.1.1. Japan Healthcare System

6.4.1.1.1 Key Formularies

6.4.1.2. Pricing & Reimbursement

6.4.1.3. Health Technology Assessment:

6.4.1.4. Rheumatoid Arthritis Cost of Treatment in Japan

6.4.1.5. Japan Payer’s Insight

6.4.1.6. Features of RA in Japan

6.4.2 Australia

6.4.2.1 Australia Healthcare System

6.4.2.1.1 Healthcare Expenditure:

6.4.2.1.2 Health Coverage:

6.4.2.1.3 Key Formularies:

6.4.2.1.4 Role of Pharmacists in Australian Healthcare System:

6.4.2.2. Pricing & Reimbursement

6.4.2.3. Health Technology Assessment

6.4.2.3.1. Regulatory and Approval Process

6.4.2.4. Rheumatoid Arthritis Cost of Treatment in Australia

6.4.2.5. Australia’s Payer’s Insight

6.4.2.6. Features of Australian Health care for Rheumatoid Arthritis

6.5. BRIC

6.5.1. Brazil

6.5.1.1. Brazilian Healthcare System

6.5.1.1.1. Role Pharmacists in Brazilian Healthcare System

6.5.1.2. Regulatory Process

6.5.1.2.1. ANVISA’s Regulatory framework for biological products

6.5.1.3. Brazil Pricing and Reimbursement

6.5.1.3.1. Pricing Process

6.5.1.3.2. Reimbursement Process

6.5.1.4. Health Technology Assessment

6.5.1.5. Cost of Rheumatoid arthritis in Brazil

6.5.1.6. Brazil Payer’s Insight

6.5.1.7. Features of RA in Brazil

6.5.2. Russia

6.5.2.1. Russia Healthcare System

6.5.2.1.1. Healthcare Expenditure

6.5.2.2. Pricing & Reimbursement

6.5.2.3. Health Technology Assessment:

6.5.2.4. Russia Payer’s Insight

6.5.2.5. Features of RA in Russia

6.5.3 India

6.5.3.1 India Healthcare System

6.5.3.2 Pricing & Reimbursement

6.5.3.2.1. Pricing of pharmaceuticals in India

6.5.3.2.2. Reimbursement of Pharmaceuticals in India

6.5.3.3 Cost of RA treatment in India

6.5.3.4 India Payer Insight

6.5.3.5 Features of RA in India

6.5.4 China

6.5.4.1 China Healthcare System

6.5.4.1.1. Healthcare Expenditure

6.5.4.1.2. Health Insurance & Coverage in China

6.5.4.2. Pricing & Reimbursement:

6.5.4.2.1. Pricing of Pharmaceuticals in China

6.5.4.2.2. Reimbursement of Pharmaceuticals in China

6.5.4.3. Health Technology Assessment (HTA):

6.5.4.4. Rheumatoid Arthritis Cost of Treatment in China

6.5.4.5. China Payer’s Insight

6.5.4.6. Features of RA in China

7. Parallel Import & Its Impact

7.1. Parallel Import in Europe

7.2. Parallel Import in the U.S.

7.3. Economic aspects in Parallel trade

7.4. Parallel trade and Rheumatoid Arthritis

Associated Visiongain Reports

Visiongain Report Sales Order Form

About Visiongain

Visiongain Report Evaluation Form

List of Tables

Table 2.1 Diagnosis of RA: ACR/EULAR 2012 Criteria

Table 2.2 Biologics used in RA

Table 2.3 Biologics used in RA

Table 2.4 Availability of Key RA Treatments in 13 Major Markets

Table 2.5 Pipeline Treatments for Rheumatoid Arthritis

Table 2.6 Pipeline Biosimilars for Rheumatoid Arthritis

Table 3.1 VBP Value Metrics

Table 5.1: Institutions and Advisory Bodies Responsible for HTA Activities In EU

Table 6.1: U.S.: Average ASP for Biologic DMARDs

Table 6.2: U.S.: Medicare Payment Rate Per Unit, Remicade Vs. Biosimilars, 2016-2017

Table 6.3: Cost of Treatment in the U.S. for Anti-TNF drugs (WAC Prices) (USD)

Table 6.4: U.S.: Rheumatoid Arthritis Drugs Price Trend & Forecast (WAC Price in USD), 2016-2028

Table 6.5: U.S.: Drug Categories for the 2015 ACR recommendations for treatment of Rheumatoid Arthritis

Table 6.6: Canada: Rheumatoid Arthritis Drugs Price Trend & Forecast (CAD$), 2014-2028

Table 6.7: Key Reimbursement Stakeholders’ in Canada

Table 6.8: Canada Competitor Pricing of Rheumatoid Arthritis Drugs – Unit Ex-factory Prices ($CAD) (2014-2017)

Table 6.9: Canada- Rheumatoid Arthritis Cost of Trearment ($CAD)

Table 6.10 Rheumatoid Arthritis: Tests, Diagnostic Value & Disease Activity Monitoring

Table 6.11: U.K.: Rheumatoid Arthritis Drugs Price Trend & Forecast (GBP), 2014-2028

Table 6.12: UK Competitor Pricing of Rheumatoid Arthritis Drugs – Unit Ex-Factory Prices (£) (2014-2017)

Table 6.13 Overall per annum economic burden of RA (UK)

Table 6.14: Rheumatoid Arthritis Cost of Treatment

Table 6.15: Germany: Rheumatoid Arthritis Drugs Price Trend & Forecast (Euro), 2016-2028

Table 6.16 Germany Competitor Pricing of Rheumatoid Arthritis Drugs – Unit Ex-Factory Prices (Euro) (2014-2017)

Table 6.17: Germany: Rheumatoid Arthritis Annual Treatment Cost, 2014-2017

Table 6.18 Reimbursement Rate

Table 6.19: France: Rheumatoid Arthritis Drugs Price Trend & Forecast (Euro) 2014-2028

Table 6.20: France Competitor Pricing of Rheumatoid Arthritis Drugs – Unit Ex-factory Prices (€) (2014-2017)

Table 6.21: France: Rheumatoid Arthritis Cost of Treatment

Table 6.22: Italy: Rheumatoid Arthritis Drugs Price Trend & Forecast (Euro), 2016-2028

Table 6.23: Italy Competitor Pricing of Rheumatoid Arthritis Drugs – Unit Ex-factory Prices (€) (2014-2017)

Table 6.24: Italy: Rheumatoid Arthritis Cost of Treatment

Table 6.25: Spain: Rheumatoid Arthritis Anti-TNF Drugs Price Trend & Forecast (Euro), 2016-2028

Table 6.26: Spain Competitor Pricing of Rheumatoid Arthritis Drugs – Unit Ex-factory Prices (Euro) 2014-2017

Table 6.27: Spain: Rheumatoid Arthritis Annual Treatment Cost, 2014-2017

Table 6.28: Japan: Rheumatoid Arthritis Drugs Price Trend & Forecast (¥), 2016-2028

Table 6.29: Japan: Competitor Pricing of Rheumatoid Arthritis Drugs – Unit Ex-factory Prices (¥) (2014-2017)

Table 6.30: Japan: Rheumatoid Arthritis Cost of Treatment

Table 6.31: Australia: Formulary Allocation for Rheumatoid Arthritis Drugs (F1/F2)

Table 6.32: Australia Competitor Pricing of Rheumatoid Arthritis Drugs – Unit Ex-factory Prices (AUD) (2014-2017)

Table 6.33: Australia: Arthritis Anti-TNF Drugs Price Trend & Forecast (AUD), 2016-2028

Table 6.34: Brazil: Rheumatoid Arthritis Drugs Price Trend & Forecast (BRL), 2016-2028

Table 6.35: Brazil Competitor Pricing of Rheumatoid Arthritis Drugs – Unit Ex-factory Prices (BRL) (2014-2017)

Table 6.36: Brazil: RA Medications available in the Brazilian Public Care System

Table 6.37: Russia: Rheumatoid Arthritis Drugs Price Trend & Forecast (Rubles), 2016-2028

Table 6.38: India: Rheumatoid Arthritis Drugs Price Trend & Forecast (INR), 2016-2028

Table 6.39: India: Cost and Dosage of available biologic DMARDs in India

Table 6.40: India Competitor Pricing of Rheumatoid Arthritis Drugs – Unit Ex-factory Prices (INR) (2014-2017)

Table 6.41 China Healthcare System: Stakeholders and Functions

Table 6.42 Healthcare Coverage and Insurance in China

Table 6.43 Number of Hospitals in China by Economic Classification and Hospital Level

Table 6.44: China Competitor Pricing of Rheumatoid Arthritis Drugs – Unit Ex-factory Prices (CNY) (2014-2017)

Table 6.45: China: Rheumatoid Arthritis Drugs Price Trend & Forecast (CNY), 2016-2028

List of Figures

Figure 5.1: Aspects of HTA for Different Technologies and Interventions

Figure 6.1: U.S.: Key Organizations in US Healthcare System

Figure 6.2: U.S. – Healthcare Expenditure (% of GDP Spending), 2014-2017

Figure 6.3: U.S. – National Expenditures (as of %GDP Spending), 2016

Figure 6.4: U.S.: Market Access Flow in United States

Figure 6.5 U.S.: Federally Funded Health Insurance Plans

Figure 6.6: U.S.: Top Anti-TNF Drugs Price Trend in U.S. (WAC Price in USD) (2014-2017)

Figure 6.7: U.S.: Rheumatoid Arthritis Drugs Price Trend & Forecast (WAC Price in USD), 2016-2028

Figure 6.8: Canada - Healthcare Structure

Figure 6.9: Canada – National Expenditures (as of %GDP Spending), 2016

Figure 6.10: Canada – Healthcare Expenditure (% of GDP Spending), 2014-2017

Figure 6.11: Pricing & Reimbursement in Canada

Figure 6.12: Canada: Rheumatoid Arthritis Drugs Price Trend & Forecast (CAD$), 2016-2028

Figure 6.13: Pathways to Reimbursement in Canada

Figure 6.14: Anti-TNF Drugs Price Trend in Canada

Figure 6.15 U.K. – Healthcare System Structure

Figure 6.16: U.K. – National Expenditures (as of %GDP Spending), 2013-2015

Figure 6.17: U.K. – Rheumatoid Arthritis Expenditure – 2015 ($ billion)

Figure 6.18: Pricing & Reimbursement in the U.K.

Figure 6.19: U.K.: Rheumatoid Arthritis Drugs Price Trend & Forecast (GBP), 2016-2028

Figure 6.20: Health Technology Assessment & Appraisal in the U.K.

Figure 6.21: Biosimilars Uptake: Infliximab & Etanercept

Figure 6.22: U.K.: Rheumatoid Arthritis Drugs Price Trend (GBP), 2014-2017

Figure 6.23: Germany – Healthcare System Structure

Figure 6.24 Key decision-makers in German Healthcare system

Figure 6.25: Germany – Healthcare Expenditure (% of GDP Spending), 2014-2017

Figure 6.26: Germany – Multi-player nature of German healthcare system

Figure 6.27: Pricing & Reimbursement in Germany

Figure 6.28: Germany: Rheumatoid Arthritis Drugs Price Trend & Forecast (Euro), 2016-2028

Figure 6.29: Germany Health Technology Assessment

Figure 6.30: Germany: Rheumatoid Arthritis - Top Anti-TNF Drugs Price Trend – Unit List Price

Figure 6.31: Germany: Rheumatoid Arthritis - Top Anti-TNF Drugs Price Trend – Unit Negotiated Price

Figure 6.32: France Healthcare System Structure

Figure 6.33: France – Healthcare Expenditure (% of GDP Spending), 2013-2016

Figure 6.34 France – National Expenditures (as of %GDP Spending), 2016

Figure 6.35: Pricing & Reimbursement in France

Figure 6.36: France: Rheumatoid Arthritis Drugs Price Trend & Forecast (Euro), 2016-2028

Figure 6.37: Health Technology Assessment in France

Figure 6.38: France: Drug review & Decision process:

Figure 6.39: Anti-TNF Drugs Price Trend

Figure 6.40: Italy Healthcare System Structure

Figure 6.41: Italy – Healthcare Expenditure (% of GDP Spending), 2014-2017

Figure 6.42: Italy – National Expenditures (as of %GDP Spending), 2016

Figure 6.43: Italy – Rheumatoid Arthritis Expenditure – 2017 ($ billion)

Figure 6.44: Pricing & Reimbursement in Italy

Figure 6.45: Italy: Rheumatoid Arthritis Drugs Price Trend & Forecast (Euro), 2016-2028

Figure 6.46: Anti-TNF Drugs Price Trend in Italy

Figure 6.47: Spain – Healthcare System Structure

Figure 6.48: Spain – Healthcare Expenditure (% of GDP Spending), 2014-2017

Figure 6.49: Spain – National Expenditures (% of GDP Spending), 2016

Figure 6.50: Pricing & Reimbursement in Spain

Figure 6.51: Reimbursement of pharmaceuticals in Spain

Figure 6.52: Spain: Rheumatoid Arthritis Drugs Price Trend & Forecast (Euro), 2016-2028

Figure 6.53: Health Technology Assessment in Spain

Figure 6.54: Spain: Rheumatoid Arthritis - Top Anti-TNF Drugs Price Trend

Figure 6.55: Japan – Healthcare Expenditure (% of GDP Spending), 2013-2016

Figure 6.56: Japan – National Expenditures (as of %GDP Spending), 2016

Figure 6.57: Japan Healthcare System Structure

Figure 6.58: Japan: Rheumatoid Arthritis Drugs Price Trend & Forecast (¥), 2016-2028

Figure 6.59: Health Technology Assessment in Japan

Figure 6.60: Anti-TNF Drugs Price Trend in Japan

Figure 6.61: Australia – Healthcare System Structure

Figure 6.62: Australia – Healthcare Expenditure (% of GDP Spending), 2014-2017

Figure 6.63: Health Technology Assessment & Regulatory and Approval Process in Australia

Figure 6.64: Australia: Rheumatoid Arthritis - Top Anti-TNF Drugs Price Trend

Figure 6.65: Australia: Rheumatoid Arthritis Drugs Price Trend & Forecast (Euro), 2016-2028

Figure 6.66: Brazil – Healthcare Expenditure (% of GDP Spending), 2013-2016

Figure 6.67: Key Decision-Makers in Brazilian Healthcare System

Figure 6.68: Brazil Regulatory Process

Figure 6.69: Brazil: ANVISA’s Regulatory approval pathway for biological products

Figure 6.70: Brazil: Rheumatoid Arthritis Drugs Price Trend & Forecast (BRL), 2016-2028

Figure 6.71: Brazil: Top Anti-TNF Drug Price Trend

Figure 6.72: Russia Healthcare System Structure

Figure 6.73: Russia – Healthcare Expenditure (% of GDP Spending), 2013-2016

Figure 6.74: Russia – National Expenditures (as of % GDP Spending), 2016

Figure 6.75: Russia: Rheumatoid Arthritis Drugs Price Trend & Forecast (Rubles), 2016-2028

Figure 6.76: India – Healthcare Expenditure (% of GDP Spending), 2014-2017

Figure 6.77: India Healthcare System Structure

Figure 6.78: Key Decision-Makers in Indian Healthcare System

Figure 6.79: India: Rheumatoid Arthritis Drugs Price Trend & Forecast (Euro), 2016-2028

Figure 6.80: Anti-TNF Drugs Price Trend in India (2014-2017)

Figure 6.81: China: Healthcare System Structure

Figure 6.82: China – Healthcare Expenditure (% of GDP Spending), 2013-2016

Figure 6.83: China – National Expenditures (as of %GDP Spending), 2016

Figure 6.84: Pricing & Reimbursement in China

Figure 6.85: China: Rheumatoid Arthritis Drugs Price Trend & Forecast (CNY), 2016-2028

Figure 6.86: China: Health Technology Assessment

Figure 6.87: Anti-TNF Drugs Price Trend in China