Disease Overview
Rheumatoid arthritis (RA) is a chronic inflammatory disease that leads to progressive joint deformity, disability, and occasionally premature death. RA may affect many tissues and organs, but it principally attacks the joints, producing an inflammatory synovitis that often progresses to destruction of the articular cartilage and ankylosis of the joints. While the etiology of RA is still unknown, human autoimmunity and some genetic and environmental factors have been suggested to play a major role in the occurrence and progression of the disease.
Market Snapshot
Rheumatoid arthritis (RA) is a chronic inflammatory disease that leads to progressive joint deformity, disability, and occasionally premature death. RA may affect many tissues and organs, but it principally attacks the joints, producing an inflammatory synovitis that often progresses to destruction of the articular cartilage and ankylosis of the joints. While the etiology of RA is still unknown, human autoimmunity and some genetic and environmental factors have been suggested to play a major role in the occurrence and progression of the disease.
Market Snapshot
- US price increases and rising disease prevalence will lead to net growth of the market, despite biosimilar erosion.
- Enbrel and Humira remain the preferred first-line biologics for the majority of insurance carriers in the US.
- Prevalent cases of RA will increase slightly in the US, Japan, and five major EU markets over the next 20 years.
- Increasing availability of biosimilars poses significant pressure for well-established brands and pipeline agents.
- The success of JAK inhibitors will depend on their cost rather than physician preference based on clinical performance.
- Access conditions for JAK inhibitors hinge on pricing strategy.
Table of Contents
FORECAST: RHEUMATOID ARTHRITIS (Published on 19 December 2017)
Overview
Executive Summary
Market Overview And Trends
Market Definition And Methodology
Actemra (Tocilizumab)
Cimzia (Certolizumab Pegol)
Enbrel (Etanercept)
Filgotinib
Humira (Adalimumab)
Kevzara (Sarilumab)
Olumiant (Baricitinib)
Orencia (Abatacept)
Remicade (Infliximab)
Rituxan (Rituximab)
Simponi (Golimumab)
Upadacitinib
Xeljanz (Tofacitinib)
Primary Research Methodology
Executive Summary
Market Overview And Trends
Market Definition And Methodology
Actemra (Tocilizumab)
Cimzia (Certolizumab Pegol)
Enbrel (Etanercept)
Filgotinib
Humira (Adalimumab)
Kevzara (Sarilumab)
Olumiant (Baricitinib)
Orencia (Abatacept)
Remicade (Infliximab)
Rituxan (Rituximab)
Simponi (Golimumab)
Upadacitinib
Xeljanz (Tofacitinib)
Primary Research Methodology
TREATMENT: RHEUMATOID ARTHRITIS (Published on 24 February 2017)
Overview
Executive Summary
Primary Research Methodology
Disease Definition And Diagnosis
Patient Segmentation
Current Treatment Options
Treatment Guidelines
Prescribing Trends
Compliance
Unmet Needs In Rheumatoid Arthritis
Impact Of Pipeline Agents
Impact Of Biosimilars
Overview
Disease Background
Methodology
Forecast
Bibliography
Executive Summary
Primary Research Methodology
Disease Definition And Diagnosis
Patient Segmentation
Current Treatment Options
Treatment Guidelines
Prescribing Trends
Compliance
Unmet Needs In Rheumatoid Arthritis
Impact Of Pipeline Agents
Impact Of Biosimilars
Overview
Disease Background
Methodology
Forecast
Bibliography
MARKETED DRUGS: RHEUMATOID ARTHRITIS (Published on 19 December 2017)
Overview
Executive Summary
Product Overview
Appendix
Product Profile: Actemra
Product Profile: Cimzia
Product Profile: Enbrel
Product Profile: Humira
Product Profile: Kevzara
Product Profile: Olumiant
Product Profile: Orencia
Product Profile: Remicade
Product Profile: Rituxan
Product Profile: Simponi
Product Profile: Xeljanz
Executive Summary
Product Overview
Appendix
Product Profile: Actemra
Product Profile: Cimzia
Product Profile: Enbrel
Product Profile: Humira
Product Profile: Kevzara
Product Profile: Olumiant
Product Profile: Orencia
Product Profile: Remicade
Product Profile: Rituxan
Product Profile: Simponi
Product Profile: Xeljanz
RHEUMATOID ARTHRITIS PRICING, REIMBURSEMENT, AND ACCESS (Published on 04 April 2017)
Overview
Executive Summary
Regulatory Labels
Global Access Levers
Evidence And Value
Access To Recently Approved And Pipeline Products
Pricing
US
Biosimilar Tnf-Alpha Inhibitors In The Five Major Eu Markets
France
Germany
Italy
Spain
UK
Methodology
Executive Summary
Regulatory Labels
Global Access Levers
Evidence And Value
Access To Recently Approved And Pipeline Products
Pricing
US
Biosimilar Tnf-Alpha Inhibitors In The Five Major Eu Markets
France
Germany
Italy
Spain
UK
Methodology
PIPELINE: RHEUMATOID ARTHRITIS (Published on 19 December 2017)
Overview
Executive Summary
Clinical Pipeline Overview
Appendix
Additional Pharma Intelligence Pipeline Resources
Product Profile (Late Stage): Filgotinib
Product Profile (Late Stage): Upadacitinib
Executive Summary
Clinical Pipeline Overview
Appendix
Additional Pharma Intelligence Pipeline Resources
Product Profile (Late Stage): Filgotinib
Product Profile (Late Stage): Upadacitinib
LIST OF FIGURES
Figure 1: Rheumatoid arthritis sales across the US, Japan, and five major EU markets, by country, 2016–25
Figure 2: Rheumatoid arthritis sales across the US, Japan, and five major EU markets, by class, 2016–25
Figure 3: Sales of Humira, Enbrel, and their biosimilar versions in the US, Japan, and five major EU markets, 2016–25
Figure 4: Sales of Janus kinase inhibitors in the US, Japan, and five major EU markets, by drug, 2016–25
Figure 5: Forecast sales of Kevzara compared to Actemra in the US, Japan, and five major EU markets, 2016–25
Figure 6: The authors rheumatoid arthritis forecast methodology
Figure 7: Price sources and calculations, by country
Figure 8: Actemra sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 9: Cimzia sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 10: Enbrel sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 11: Filgotinib sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 12: Humira sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 13: Kevzara sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 14: Olumiant sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 15: Orencia sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 16: Remicade sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 17: Rituxan sales in rheumatoid arthritis across the US and five major EU markets, by country, 2016–25
Figure 18: Simponi and Simponi Aria sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 19: Upadacitinib sales in rheumatoid arthritis across the US and five major EU markets, by country, 2016–25
Figure 20: Xeljanz sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 21: Summaries of the 1987 ACR and 2010 ACR/EULAR classification criteria for RA
Figure 22: Estimated percentage of diagnosed versus undiagnosed RA patients in the US, Japan, and five major EU markets, by country
Figure 23: Severity of prevalent RA cases across the US, Japan, and five major EU markets, by country
Figure 24: Treatment algorithm for early RA based on 2015 ACR guidelines
Figure 25: Treatment algorithm for established RA based on 2015 ACR guidelines
Figure 26: Treatment algorithm for RA based on 2016 EULAR guidelines
Figure 27: Diagnosed RA patients managed by each type of healthcare professional, by country
Figure 28: Diagnosed RA patients who receive pharmacological (with or without non-pharmacological therapy), nonpharmacological, or no therapy, by country
Figure 29: Compliance rates of RA patients in the US, Japan, and five major EU markets, by formulation type
Figure 30: Top three treatment challenges in RA
Figure 31: Summary of future usage of biosimilars at one year and three years post-launch
Figure 32: Physician confidence in prescribing biosimilars for RA approved on the basis of indication extrapolation, by country
Figure 33: Trends in diagnosed prevalent cases of RA in the US, Japan, and five major EU markets, by country, 2017–37
Figure 34: The authors drug assessment summary for rheumatoid arthritis
Figure 35: Actemra for rheumatoid arthritis – SWOT analysis
Figure 36: The authors drug assessment summary of Actemra in rheumatoid arthritis
Figure 37: The authors drug assessment summary of Actemra in rheumatoid arthritis
Figure 38: Cimzia for rheumatoid arthritis – SWOT analysis
Figure 39: The authors drug assessment summary of Cimzia in rheumatoid arthritis
Figure 40: The authors drug assessment summary of Cimzia in rheumatoid arthritis
Figure 41: Enbrel for rheumatoid arthritis – SWOT analysis
Figure 42: The authors drug assessment summary of Enbrel in rheumatoid arthritis
Figure 43: The authors drug assessment summary of Enbrel in rheumatoid arthritis
Figure 44: Humira for rheumatoid arthritis – SWOT analysis
Figure 45: The authors drug assessment summary of Humira in rheumatoid arthritis
Figure 46: The authors drug assessment summary of Humira in rheumatoid arthritis
Figure 47: Kevzara for rheumatoid arthritis – SWOT analysis
Figure 48: The authors drug assessment summary of Kevzara in rheumatoid arthritis
Figure 49: The authors drug assessment summary of Kevzara in rheumatoid arthritis
Figure 50: Olumiant for rheumatoid arthritis – SWOT analysis
Figure 51: The authors drug assessment summary of Olumiant in rheumatoid arthritis
Figure 52: The authors drug assessment summary of Olumiant in rheumatoid arthritis
Figure 53: Orencia for rheumatoid arthritis – SWOT analysis
Figure 54: The authors drug assessment summary of Orencia in rheumatoid arthritis
Figure 55: The authors drug assessment summary of Orencia in rheumatoid arthritis
Figure 56: Remicade for rheumatoid arthritis – SWOT analysis
Figure 57: The authors drug assessment summary of Remicade in rheumatoid arthritis
Figure 58: The authors drug assessment summary of Remicade in rheumatoid arthritis
Figure 59: Rituxan for rheumatoid arthritis – SWOT analysis
Figure 60: The authors drug assessment summary of Rituxan in rheumatoid arthritis
Figure 61: The authors drug assessment summary of Rituxan in rheumatoid arthritis
Figure 62: Simponi for rheumatoid arthritis – SWOT analysis
Figure 63: The authors drug assessment summary of Simponi in rheumatoid arthritis
Figure 64: The authors drug assessment summary of Simponi in rheumatoid arthritis
Figure 65: Xeljanz for rheumatoid arthritis – SWOT analysis
Figure 66: The authors drug assessment summary of Xeljanz in rheumatoid arthritis
Figure 67: The authors drug assessment summary of Xeljanz in rheumatoid arthritis
Figure 68: Filgotinib for rheumatoid arthritis – SWOT analysis
Figure 69: The authors drug assessment summary of filgotinib in rheumatoid arthritis
Figure 70: The authors drug assessment summary of filgotinib in rheumatoid arthritis
Figure 71: Upadacitinib for rheumatoid arthritis – SWOT analysis
Figure 72: The authors drug assessment summary of upadacitinib in rheumatoid arthritis
Figure 73: The authors drug assessment summary of upadacitinib in rheumatoid arthritis
Figure 2: Rheumatoid arthritis sales across the US, Japan, and five major EU markets, by class, 2016–25
Figure 3: Sales of Humira, Enbrel, and their biosimilar versions in the US, Japan, and five major EU markets, 2016–25
Figure 4: Sales of Janus kinase inhibitors in the US, Japan, and five major EU markets, by drug, 2016–25
Figure 5: Forecast sales of Kevzara compared to Actemra in the US, Japan, and five major EU markets, 2016–25
Figure 6: The authors rheumatoid arthritis forecast methodology
Figure 7: Price sources and calculations, by country
Figure 8: Actemra sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 9: Cimzia sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 10: Enbrel sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 11: Filgotinib sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 12: Humira sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 13: Kevzara sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 14: Olumiant sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 15: Orencia sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 16: Remicade sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 17: Rituxan sales in rheumatoid arthritis across the US and five major EU markets, by country, 2016–25
Figure 18: Simponi and Simponi Aria sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 19: Upadacitinib sales in rheumatoid arthritis across the US and five major EU markets, by country, 2016–25
Figure 20: Xeljanz sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country, 2016–25
Figure 21: Summaries of the 1987 ACR and 2010 ACR/EULAR classification criteria for RA
Figure 22: Estimated percentage of diagnosed versus undiagnosed RA patients in the US, Japan, and five major EU markets, by country
Figure 23: Severity of prevalent RA cases across the US, Japan, and five major EU markets, by country
Figure 24: Treatment algorithm for early RA based on 2015 ACR guidelines
Figure 25: Treatment algorithm for established RA based on 2015 ACR guidelines
Figure 26: Treatment algorithm for RA based on 2016 EULAR guidelines
Figure 27: Diagnosed RA patients managed by each type of healthcare professional, by country
Figure 28: Diagnosed RA patients who receive pharmacological (with or without non-pharmacological therapy), nonpharmacological, or no therapy, by country
Figure 29: Compliance rates of RA patients in the US, Japan, and five major EU markets, by formulation type
Figure 30: Top three treatment challenges in RA
Figure 31: Summary of future usage of biosimilars at one year and three years post-launch
Figure 32: Physician confidence in prescribing biosimilars for RA approved on the basis of indication extrapolation, by country
Figure 33: Trends in diagnosed prevalent cases of RA in the US, Japan, and five major EU markets, by country, 2017–37
Figure 34: The authors drug assessment summary for rheumatoid arthritis
Figure 35: Actemra for rheumatoid arthritis – SWOT analysis
Figure 36: The authors drug assessment summary of Actemra in rheumatoid arthritis
Figure 37: The authors drug assessment summary of Actemra in rheumatoid arthritis
Figure 38: Cimzia for rheumatoid arthritis – SWOT analysis
Figure 39: The authors drug assessment summary of Cimzia in rheumatoid arthritis
Figure 40: The authors drug assessment summary of Cimzia in rheumatoid arthritis
Figure 41: Enbrel for rheumatoid arthritis – SWOT analysis
Figure 42: The authors drug assessment summary of Enbrel in rheumatoid arthritis
Figure 43: The authors drug assessment summary of Enbrel in rheumatoid arthritis
Figure 44: Humira for rheumatoid arthritis – SWOT analysis
Figure 45: The authors drug assessment summary of Humira in rheumatoid arthritis
Figure 46: The authors drug assessment summary of Humira in rheumatoid arthritis
Figure 47: Kevzara for rheumatoid arthritis – SWOT analysis
Figure 48: The authors drug assessment summary of Kevzara in rheumatoid arthritis
Figure 49: The authors drug assessment summary of Kevzara in rheumatoid arthritis
Figure 50: Olumiant for rheumatoid arthritis – SWOT analysis
Figure 51: The authors drug assessment summary of Olumiant in rheumatoid arthritis
Figure 52: The authors drug assessment summary of Olumiant in rheumatoid arthritis
Figure 53: Orencia for rheumatoid arthritis – SWOT analysis
Figure 54: The authors drug assessment summary of Orencia in rheumatoid arthritis
Figure 55: The authors drug assessment summary of Orencia in rheumatoid arthritis
Figure 56: Remicade for rheumatoid arthritis – SWOT analysis
Figure 57: The authors drug assessment summary of Remicade in rheumatoid arthritis
Figure 58: The authors drug assessment summary of Remicade in rheumatoid arthritis
Figure 59: Rituxan for rheumatoid arthritis – SWOT analysis
Figure 60: The authors drug assessment summary of Rituxan in rheumatoid arthritis
Figure 61: The authors drug assessment summary of Rituxan in rheumatoid arthritis
Figure 62: Simponi for rheumatoid arthritis – SWOT analysis
Figure 63: The authors drug assessment summary of Simponi in rheumatoid arthritis
Figure 64: The authors drug assessment summary of Simponi in rheumatoid arthritis
Figure 65: Xeljanz for rheumatoid arthritis – SWOT analysis
Figure 66: The authors drug assessment summary of Xeljanz in rheumatoid arthritis
Figure 67: The authors drug assessment summary of Xeljanz in rheumatoid arthritis
Figure 68: Filgotinib for rheumatoid arthritis – SWOT analysis
Figure 69: The authors drug assessment summary of filgotinib in rheumatoid arthritis
Figure 70: The authors drug assessment summary of filgotinib in rheumatoid arthritis
Figure 71: Upadacitinib for rheumatoid arthritis – SWOT analysis
Figure 72: The authors drug assessment summary of upadacitinib in rheumatoid arthritis
Figure 73: The authors drug assessment summary of upadacitinib in rheumatoid arthritis
LIST OF TABLES
Table 1: Summary of brands and molecules included in The authors rheumatoid arthritis patient-based forecast
Table 2: Exchange rates used for calculating prices
Table 3: The authors price assumptions for intravenous Actemra
Table 4: The authors price assumptions for subcutaneous Actemra
Table 5: Actemra sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by formulation and country ($m), 2016–25
Table 6: The authors price assumptions for Cimzia
Table 7: Cimzia sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 8: The authors price assumptions for Enbrel
Table 9: Enbrel sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 10: Filgotinib sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 11: The authors price assumptions for Humira
Table 12: Humira sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 13: The authors price assumptions for Kevzara
Table 14: Kevzara sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 15: The authors price assumptions for Olumiant
Table 16: Olumiant sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 17: The authors price assumptions for intravenous Orencia
Table 18: The authors price assumptions for subcutaneous Orencia
Table 19: Orencia sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by formulation and country ($m), 2016–25
Table 20: The authors price assumptions for Remicade
Table 21: Remicade sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 22: The authors price assumptions for Rituxan
Table 23: Rituxan sales in rheumatoid arthritis across the US and five major EU markets, by country ($m), 2016–25
Table 24: The authors price assumptions for Simponi
Table 25: The authors price assumptions for Simponi Aria
Table 26: Simponi and Simponi Aria sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 27: Upadacitinib sales in rheumatoid arthritis across the US and five major EU markets, by country ($m), 2016–25
Table 28: The authors price assumptions for Xeljanz
Table 29: Xeljanz sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 30: Rheumatologists surveyed for the rheumatoid arthritis primary research study, 2016
Table 31: Rheumatologists surveyed for the RA primary research study, 2016
Table 32: Treatments available for RA across the US, Japan, and five major EU markets
Table 33: 2015 ACR recommendations for patients with symptomatic early RA
Table 34: 2015 ACR recommendations for patients with established RA
Table 35: 2016 EULAR recommendations for the management of RA
Table 36: Diagnosed RA patients who receive pharmacological (with/without non-pharmacological therapy), nonpharmacological, or no therapy, by country
Table 37: Compliance rates of RA patients in the US, Japan, and five major EU markets, by formulation type (%)
Table 38: Relative importance of treatment challenges in RA, by country
Table 39: Expected share of diagnosed, DMARD-treated RA patients for currently approved and pipeline agents five years after launch, by country (%)
Table 40: Initial usage of biosimilar infliximab, according to respondents using biosimilar infliximab at the time of the survey, by country (%)
Table 41: Expected usage of biosimilar infliximab, according to respondents who did not prescribe biosimilar infliximab at the time of the survey, by country (%)
Table 42: Sources used for the epidemiological analysis of diagnosed RA prevalence and incidence in the US, Japan, and five major EU markets, by country
Table 43: Total prevalent cases of RA in the US, Japan, and five major EU markets, by country, 2017–37
Table 44: Diagnosed prevalent cases of RA in the US, Japan, and five major EU markets, by country, 2017–37
Table 45: Key marketed products for rheumatoid arthritis
Table 46: The authors drug assessment parameters for rheumatoid arthritis
Table 47: Actemra drug profile
Table 48: Actemra IV pivotal trial data in rheumatoid arthritis
Table 49: Actemra SC pivotal trial data in rheumatoid arthritis
Table 50: Actemra late-phase trial data in rheumatoid arthritis
Table 51: Six-year retention rates of IV Actemra, Humira, and Enbrel as second-line biologics (%)
Table 52: Cimzia drug profile
Table 53: Cimzia pivotal trial data in rheumatoid arthritis
Table 54: Cimzia late-phase trial data in rheumatoid arthritis
Table 55: Enbrel drug profile
Table 56: Enbrel pivotal trial data in rheumatoid arthritis
Table 57: Enbrel late-phase trial data in rheumatoid arthritis
Table 58: Enbrel ongoing late-phase clinical trials in rheumatoid arthritis
Table 59: Humira drug profile
Table 60: Humira pivotal trial data in rheumatoid arthritis
Table 61: Humira late-phase trial data in rheumatoid arthritis
Table 62: Kevzara drug profile
Table 63: Pivotal trial data for Kevzara in rheumatoid arthritis
Table 64: Kevzara Phase III trials in rheumatoid arthritis
Table 65: Olumiant drug profile
Table 66: Olumiant Phase III data in rheumatoid arthritis
Table 67: Orencia drug profile
Table 68: IV Orencia pivotal trial data in rheumatoid arthritis
Table 69: SC Orencia pivotal trial data in rheumatoid arthritis
Table 70: IV and SC Orencia late-phase trial data in rheumatoid arthritis
Table 71: Remicade drug profile
Table 72: Remicade pivotal trial data in rheumatoid arthritis
Table 73: Remicade late-phase trial data in rheumatoid arthritis
Table 74: Rituxan drug profile
Table 75: Rituxan pivotal trial data in rheumatoid arthritis
Table 76: Rituxan late-phase trial data in rheumatoid arthritis
Table 77: Simponi drug profile
Table 78: Simponi pivotal trial data in rheumatoid arthritis
Table 79: Simponi Aria pivotal trial data in rheumatoid arthritis
Table 80: Overview of the five-year efficacy and safety data for Simponi pivotal Phase III trials
Table 81: Xeljanz drug profile
Table 82: Xeljanz pivotal trial data in rheumatoid arthritis
Table 83: Xeljanz late-phase trial data in rheumatoid arthritis
Table 84: Summary of Xeljanz safety data (all tofacitinib; n=4,867)
Table 85: Adverse events of particular interest with Xeljanz (safety population) (all tofacitinib; n=4,867)
Table 86: Response rates for all tofacitinib-treated patients (%)
Table 87: Discontinuation rates for all tofacitinib-treated patients
Table 88: Marketed products and approved indications for rheumatoid arthritis in the US, Japan, and five major EU markets
Table 89: Levers impacting access to rheumatoid arthritis drugs in the US and five major EU markets, by country
Table 90: Annual treatment cost of rheumatoid arthritis drugs in the US and five major EU markets, by country ($)
Table 91: Top anti-inflammatory drug prescriptions filled by Medicare beneficiaries participating in Part B and D programs, 2015
Table 92: Specialty drug spend by Express Scripts commercial members (inflammatory diseases market), 2016
Table 93: CVS Caremark’s and Express Scripts’ formulary exclusions for rheumatoid arthritis drugs
Table 94: Formulary placement of rheumatoid arthritis medications in selected commercial formularies
Table 95: Formulary placement of rheumatoid arthritis medications in selected Medicare formularies
Table 96: Selected formulary practices of top 10 Medicare Part D and Medicare Advantage rheumatoid arthritis drugs
Table 97: Formulary placement of rheumatoid arthritis drugs in selected Medicaid programs
Table 98: Prior authorization criteria for rheumatoid arthritis drugs in major health insurers and pharmacy benefit managers
Table 99: Market access tools used to promote biosimilar TNF-alpha inhibitor uptake in the five major EU markets, by country
Table 100: Transparency Committee’s ASMR ratings and pricing implications
Table 101: Transparency Committee's SMR ratings and pricing implications
Table 102: Transparency Committee’s assessment of rheumatoid arthritis treatments
Table 103: Reimbursement conditions for rheumatoid arthritis treatments in Italy
Table 104: Italian regional formulary decisions for rheumatoid arthritis drugs
Table 105: Spanish Society of Hospital Pharmacy ratings
Table 106: Regional MADRE assessments for rheumatoid arthritis drugs
Table 107: NICE assessments of key rheumatoid arthritis therapies
Table 108: UK regional formulary decisions for rheumatoid arthritis drugs
Table 109: SMC decisions on key rheumatoid arthritis therapies
Table 110: Price sources and calculations for the US
Table 111: Price sources and calculations for the EU
Table 112: Exchange rates used for calculating branded drug prices
Table 113: Phase III pipeline candidates under development for rheumatoid arthritis
Table 114: The authors drug assessment parameters for rheumatoid arthritis
Table 115: Filgotinib drug profile
Table 116: Filgotinib Phase III trials in rheumatoid arthritis
Table 117: Primary endpoint for filgotinib at week 12 in the Phase IIb DARWIN 2 trial
Table 118: Efficacy responses with filgotinib after 12 and 24 weeks of treatment in the DARWIN 1 trial (%)
Table 119: Upadacitinib drug profile
Table 120: Upadacitinib pivotal Phase III trials in rheumatoid arthritis
Table 121: Primary and key secondary endpoints for upadacitinib at week 12 in the BALANCE-II trial
Table 2: Exchange rates used for calculating prices
Table 3: The authors price assumptions for intravenous Actemra
Table 4: The authors price assumptions for subcutaneous Actemra
Table 5: Actemra sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by formulation and country ($m), 2016–25
Table 6: The authors price assumptions for Cimzia
Table 7: Cimzia sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 8: The authors price assumptions for Enbrel
Table 9: Enbrel sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 10: Filgotinib sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 11: The authors price assumptions for Humira
Table 12: Humira sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 13: The authors price assumptions for Kevzara
Table 14: Kevzara sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 15: The authors price assumptions for Olumiant
Table 16: Olumiant sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 17: The authors price assumptions for intravenous Orencia
Table 18: The authors price assumptions for subcutaneous Orencia
Table 19: Orencia sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by formulation and country ($m), 2016–25
Table 20: The authors price assumptions for Remicade
Table 21: Remicade sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 22: The authors price assumptions for Rituxan
Table 23: Rituxan sales in rheumatoid arthritis across the US and five major EU markets, by country ($m), 2016–25
Table 24: The authors price assumptions for Simponi
Table 25: The authors price assumptions for Simponi Aria
Table 26: Simponi and Simponi Aria sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 27: Upadacitinib sales in rheumatoid arthritis across the US and five major EU markets, by country ($m), 2016–25
Table 28: The authors price assumptions for Xeljanz
Table 29: Xeljanz sales in rheumatoid arthritis across the US, Japan, and five major EU markets, by country ($m), 2016–25
Table 30: Rheumatologists surveyed for the rheumatoid arthritis primary research study, 2016
Table 31: Rheumatologists surveyed for the RA primary research study, 2016
Table 32: Treatments available for RA across the US, Japan, and five major EU markets
Table 33: 2015 ACR recommendations for patients with symptomatic early RA
Table 34: 2015 ACR recommendations for patients with established RA
Table 35: 2016 EULAR recommendations for the management of RA
Table 36: Diagnosed RA patients who receive pharmacological (with/without non-pharmacological therapy), nonpharmacological, or no therapy, by country
Table 37: Compliance rates of RA patients in the US, Japan, and five major EU markets, by formulation type (%)
Table 38: Relative importance of treatment challenges in RA, by country
Table 39: Expected share of diagnosed, DMARD-treated RA patients for currently approved and pipeline agents five years after launch, by country (%)
Table 40: Initial usage of biosimilar infliximab, according to respondents using biosimilar infliximab at the time of the survey, by country (%)
Table 41: Expected usage of biosimilar infliximab, according to respondents who did not prescribe biosimilar infliximab at the time of the survey, by country (%)
Table 42: Sources used for the epidemiological analysis of diagnosed RA prevalence and incidence in the US, Japan, and five major EU markets, by country
Table 43: Total prevalent cases of RA in the US, Japan, and five major EU markets, by country, 2017–37
Table 44: Diagnosed prevalent cases of RA in the US, Japan, and five major EU markets, by country, 2017–37
Table 45: Key marketed products for rheumatoid arthritis
Table 46: The authors drug assessment parameters for rheumatoid arthritis
Table 47: Actemra drug profile
Table 48: Actemra IV pivotal trial data in rheumatoid arthritis
Table 49: Actemra SC pivotal trial data in rheumatoid arthritis
Table 50: Actemra late-phase trial data in rheumatoid arthritis
Table 51: Six-year retention rates of IV Actemra, Humira, and Enbrel as second-line biologics (%)
Table 52: Cimzia drug profile
Table 53: Cimzia pivotal trial data in rheumatoid arthritis
Table 54: Cimzia late-phase trial data in rheumatoid arthritis
Table 55: Enbrel drug profile
Table 56: Enbrel pivotal trial data in rheumatoid arthritis
Table 57: Enbrel late-phase trial data in rheumatoid arthritis
Table 58: Enbrel ongoing late-phase clinical trials in rheumatoid arthritis
Table 59: Humira drug profile
Table 60: Humira pivotal trial data in rheumatoid arthritis
Table 61: Humira late-phase trial data in rheumatoid arthritis
Table 62: Kevzara drug profile
Table 63: Pivotal trial data for Kevzara in rheumatoid arthritis
Table 64: Kevzara Phase III trials in rheumatoid arthritis
Table 65: Olumiant drug profile
Table 66: Olumiant Phase III data in rheumatoid arthritis
Table 67: Orencia drug profile
Table 68: IV Orencia pivotal trial data in rheumatoid arthritis
Table 69: SC Orencia pivotal trial data in rheumatoid arthritis
Table 70: IV and SC Orencia late-phase trial data in rheumatoid arthritis
Table 71: Remicade drug profile
Table 72: Remicade pivotal trial data in rheumatoid arthritis
Table 73: Remicade late-phase trial data in rheumatoid arthritis
Table 74: Rituxan drug profile
Table 75: Rituxan pivotal trial data in rheumatoid arthritis
Table 76: Rituxan late-phase trial data in rheumatoid arthritis
Table 77: Simponi drug profile
Table 78: Simponi pivotal trial data in rheumatoid arthritis
Table 79: Simponi Aria pivotal trial data in rheumatoid arthritis
Table 80: Overview of the five-year efficacy and safety data for Simponi pivotal Phase III trials
Table 81: Xeljanz drug profile
Table 82: Xeljanz pivotal trial data in rheumatoid arthritis
Table 83: Xeljanz late-phase trial data in rheumatoid arthritis
Table 84: Summary of Xeljanz safety data (all tofacitinib; n=4,867)
Table 85: Adverse events of particular interest with Xeljanz (safety population) (all tofacitinib; n=4,867)
Table 86: Response rates for all tofacitinib-treated patients (%)
Table 87: Discontinuation rates for all tofacitinib-treated patients
Table 88: Marketed products and approved indications for rheumatoid arthritis in the US, Japan, and five major EU markets
Table 89: Levers impacting access to rheumatoid arthritis drugs in the US and five major EU markets, by country
Table 90: Annual treatment cost of rheumatoid arthritis drugs in the US and five major EU markets, by country ($)
Table 91: Top anti-inflammatory drug prescriptions filled by Medicare beneficiaries participating in Part B and D programs, 2015
Table 92: Specialty drug spend by Express Scripts commercial members (inflammatory diseases market), 2016
Table 93: CVS Caremark’s and Express Scripts’ formulary exclusions for rheumatoid arthritis drugs
Table 94: Formulary placement of rheumatoid arthritis medications in selected commercial formularies
Table 95: Formulary placement of rheumatoid arthritis medications in selected Medicare formularies
Table 96: Selected formulary practices of top 10 Medicare Part D and Medicare Advantage rheumatoid arthritis drugs
Table 97: Formulary placement of rheumatoid arthritis drugs in selected Medicaid programs
Table 98: Prior authorization criteria for rheumatoid arthritis drugs in major health insurers and pharmacy benefit managers
Table 99: Market access tools used to promote biosimilar TNF-alpha inhibitor uptake in the five major EU markets, by country
Table 100: Transparency Committee’s ASMR ratings and pricing implications
Table 101: Transparency Committee's SMR ratings and pricing implications
Table 102: Transparency Committee’s assessment of rheumatoid arthritis treatments
Table 103: Reimbursement conditions for rheumatoid arthritis treatments in Italy
Table 104: Italian regional formulary decisions for rheumatoid arthritis drugs
Table 105: Spanish Society of Hospital Pharmacy ratings
Table 106: Regional MADRE assessments for rheumatoid arthritis drugs
Table 107: NICE assessments of key rheumatoid arthritis therapies
Table 108: UK regional formulary decisions for rheumatoid arthritis drugs
Table 109: SMC decisions on key rheumatoid arthritis therapies
Table 110: Price sources and calculations for the US
Table 111: Price sources and calculations for the EU
Table 112: Exchange rates used for calculating branded drug prices
Table 113: Phase III pipeline candidates under development for rheumatoid arthritis
Table 114: The authors drug assessment parameters for rheumatoid arthritis
Table 115: Filgotinib drug profile
Table 116: Filgotinib Phase III trials in rheumatoid arthritis
Table 117: Primary endpoint for filgotinib at week 12 in the Phase IIb DARWIN 2 trial
Table 118: Efficacy responses with filgotinib after 12 and 24 weeks of treatment in the DARWIN 1 trial (%)
Table 119: Upadacitinib drug profile
Table 120: Upadacitinib pivotal Phase III trials in rheumatoid arthritis
Table 121: Primary and key secondary endpoints for upadacitinib at week 12 in the BALANCE-II trial
