Disease Overview
Atrial fibrillation is the most common chronic cardiac arrhythmia, and is usually associated with other cardiovascular diseases. Atrial fibrillation is characterized by an irregular heartbeat, where the atria may not contract properly. While the disease is not considered life-threatening in itself, atrial fibrillation is one of the leading causes of stroke, with the disease conferring a fivefold increased risk.
Market Snapshot
Atrial fibrillation is the most common chronic cardiac arrhythmia, and is usually associated with other cardiovascular diseases. Atrial fibrillation is characterized by an irregular heartbeat, where the atria may not contract properly. While the disease is not considered life-threatening in itself, atrial fibrillation is one of the leading causes of stroke, with the disease conferring a fivefold increased risk.
Market Snapshot
- Strong efficacy and safety data are expected to drive NOACs at the expense of warfarin over the forecast period.
- Survey of 213 cardiologists in the US, Japan, and five major EU markets sheds light on prescribing trends in SPAF.
- Diagnosed prevalent cases of atrial fibrillation are estimated to increase by more than 40% during the forecast period.
- The development of antidotes for the NOAC drug class is likely to substantially increase their uptake.
- Drug developers will need to identify reversal agents in order for pipeline medications to be able to compete with marketed drugs.
- EU payers limit use due to high cost, while US payers support uptake.
Table of Contents
FORECAST: STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF) (Published on 15 March 2018)OVERVIEW
RECENT FORECAST UPDATES
MARKET DYNAMICS
FORECAST AND FUTURE TRENDS
MARKET DEFINITION AND METHODOLOGY
PRIMARY RESEARCH METHODOLOGY
BIBLIOGRAPHY
PRODUCT PROFILE: ELIQUIS
PRODUCT PROFILE: PRADAXA
PRODUCT PROFILE: SAVAYSA
PRODUCT PROFILE: XARELTO
TREATMENT: STROKE PREVENTION IN ATRIAL FIBRILLATION (Published on 11 December 2017)
OVERVIEW
EXECUTIVE SUMMARY
PRIMARY RESEARCH METHODOLOGY
DISEASE DEFINITION AND DIAGNOSIS
CURRENT TREATMENT OPTIONS
PRESCRIBING TRENDS
EPIDEMIOLOGY: ATRIAL FIBRILLATION (Published on 08 December 2017)
OVERVIEW
EXECUTIVE SUMMARY
DISEASE BACKGROUND
METHODOLOGY
FORECAST
EPIDEMIOLOGIST INSIGHT
STRENGTHS AND LIMITATIONS
BIBLIOGRAPHY
APPENDIX: ADDITIONAL SOURCES
MARKETED DRUGS: STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF) (Published on 15 March 2018)
OVERVIEW
PRODUCT OVERVIEW
PRODUCT PROFILE: ELIQUIS
PRODUCT PROFILE: PRADAXA
PRODUCT PROFILE: SAVAYSA
PRODUCT PROFILE: XARELTO
NOACS PRICING, REIMBURSEMENT, AND ACCESS (Published on 10 May 2017)
OVERVIEW
EXECUTIVE SUMMARY
REGULATORY LABELS
GLOBAL PAYER AND KEY OPINION LEADER INSIGHTS
US PRICING
US REIMBURSEMENT
JAPAN
PRICING IN THE FIVE MAJOR EU MARKETS
FRANCE
GERMANY
ITALY
SPAIN
UK
METHODOLOGY
PIPELINE: STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF) (Published on 15 March 2018)
OVERVIEW
PIPELINE TRENDS
List of Figures
Figure 1: SPAF - Current and future market dynamics analysis
Figure 2: Assessment summary of key marketed drugs for SPAF
Figure 3: SPAF drug sales across the US, Japan, and five major EU markets, by country, 2017-26
Figure 4: Trajectories of Xarelto, Eliquis, and Pradaxa sales for SPAF across the US, Japan, and five major EU markets, 2017-26
Figure 5: Savaysa sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
Figure 6: Trajectories of Xarelto and Eliquis sales for SPAF across the US, Japan, and five major EU markets, 2017-26
Figure 7: Patient-based forecast methodology for SPAF
Figure 8: Price sources and calculations, by country
Figure 9: Eliquis for SPAF - SWOT analysis
Figure 10: Drug assessment summary of Eliquis for SPAF
Figure 11: Drug assessment summary of Eliquis for SPAF
Figure 12: Eliquis sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
Figure 13: Pradaxa for SPAF - SWOT analysis
Figure 14: Drug assessment summary of Pradaxa for SPAF
Figure 15: Drug assessment summary of Pradaxa for SPAF
Figure 16: Pradaxa sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
Figure 17: Savaysa for SPAF - SWOT analysis
Figure 18: Drug assessment summary of Savaysa for SPAF
Figure 19: Drug assessment summary of Savaysa for SPAF
Figure 20: Savaysa sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
Figure 21: Xarelto for SPAF - SWOT analysis
Figure 22: Drug assessment summary of Xarelto for SPAF
Figure 23: Drug assessment summary of Xarelto for SPAF
Figure 24: Xarelto sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
Figure 25: Mean percentage of atrial fibrillation patients diagnosed with each type of atrial fibrillation in the US, Japan, and five major EU markets, by country
Figure 26: Mean percentage of atrial fibrillation patients in each category of atrial fibrillation in the US, Japan, and five major EU markets, by country
Figure 27: Mean percentage of valvular atrial fibrillation patients receiving long-term stroke prevention treatment, by country
Figure 28: Mean percentage of valvular atrial fibrillation patients receiving each of the top five antiplatelet/anticoagulation therapies at first line, by country
Figure 29: Mean percentage of valvular atrial fibrillation patients receiving each of the top five antiplatelet/anticoagulation therapies at second line, by country
Figure 30: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 0 receiving long-term stroke prevention treatment, by country
Figure 31: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 0 receiving each of the top five therapies at first line, by country
Figure 32: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 0 receiving each of the top five therapies at second line, by country
Figure 33: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 1 receiving long-term stroke prevention treatment, by country
Figure 34: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 1 receiving each of the top five therapies at first line, by country
Figure 35: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 1 receiving each of the top five therapies at second line, by country
Figure 36: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores =2 receiving long-term stroke prevention treatment, by country
Figure 37: Risk of adverse events in patients with various CHADS-VASc scores, Swedish Atrial Fibrillation cohort study, 2005
Figure 38: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores =2 receiving each of the top five therapies at first line, by country
Figure 39: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores =2 receiving each of the top five therapies at second line, by country
Figure 40: Clinical implications of AF
Figure 41: Prevalence of co-morbidities in patients with AF, by organ system
Figure 42: Trend in diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016-36
Figure 43: Absolute change in diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016-36
Figure 44: Trend in age-specific diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016-36
Figure 45: Eliquis for SPAF - SWOT analysis
Figure 46: Drug assessment summary of Eliquis for SPAF
Figure 47: Drug assessment summary of Eliquis for SPAF
Figure 48: Eliquis sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
Figure 49: Pradaxa for SPAF - SWOT analysis
Figure 50: Drug assessment summary of Pradaxa for SPAF
Figure 51: Drug assessment summary of Pradaxa for SPAF
Figure 52: Pradaxa sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
Figure 53: Savaysa for SPAF - SWOT analysis
Figure 54: Drug assessment summary of Savaysa for SPAF
Figure 55: Drug assessment summary of Savaysa for SPAF
Figure 56: Savaysa sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
Figure 57: Xarelto for SPAF - SWOT analysis215 Figure 58: Drug assessment summary of Xarelto for SPAF
Figure 59: Drug assessment summary of Xarelto for SPAF
Figure 60: Xarelto sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
List of Tables
Table 1: SPAF drug sales across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 2: Proportion of SPAF total market sales according to patient subgroup (%), 2017-26
Table 3: SPAF total market sales according to patient subgroup ($m), 2017-26
Table 4: Average cost of treatment, CAGRs, and proportions of sales and patients across the US, Japan, and five major EU markets, by country, 2017-26
Table 5: Exchange rates used for calculating prices
Table 6: Cardiologists surveyed for the SPAF primary research study, 2017
Table 7: Eliquis drug profile
Table 8: Eliquis pivotal trial data in SPAF
Table 9: Eliquis late-phase trial data in SPAF
Table 10: Eliquis ongoing late-phase clinical trial in SPAF
Table 11: Eliquis sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 12: Pradaxa drug profile
Table 13: Pradaxa pivotal trial data in SPAF
Table 14: Pradaxa late-phase trial data in SPAF
Table 15: Pradaxa ongoing late-phase clinical trials in SPAF
Table 16: Pradaxa sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 17: Savaysa drug profile
Table 18: Savaysa pivotal trial data in SPAF
Table 19: Savaysa late-phase trial data in SPAF
Table 20: Savaysa ongoing late-phase clinical trials in SPAF
Table 21: Savaysa sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 22: Xarelto drug profile
Table 23: Xarelto pivotal trial data in SPAF
Table 24: Xarelto late-phase trial data in SPAF
Table 25: Xarelto ongoing late-phase clinical trial in SPAF
Table 26: Xarelto sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 27: Cardiologists surveyed for the stroke prevention in atrial fibrillation primary research study, 2017
Table 28: Overview of different atrial fibrillation classifications
Table 29: Overview of risk factors for atrial fibrillation
Table 30: Mean percentage of valvular atrial fibrillation patients who have co-morbidities in the US, Japan, and five major EU markets, by co-morbidity and country (%)
Table 31: Mean percentage of non-valvular atrial fibrillation patients who have co-morbidities in the US, Japan, and five major EU markets, by co-morbidity and country (%)
Table 32: Atrial fibrillation symptoms
Table 33: Overview of the CHA2DS2-VASc scoring system
Table 34: Treatments available for stroke prevention in atrial fibrillation across the US, Japan, and five major EU markets
Table 35: Sources used for the epidemiological analysis of diagnosed prevalence of AF in the US, Japan, and five major EU markets, by country
Table 36: Sources used for the epidemiological analysis of diagnosed incidence of AF in the US, Japan, and five major EU markets, by country
Table 37: Diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016-36
Table 38: Age-specific diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016
Table 39: Gender-specific diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016
Table 40: Diagnosed incident cases of AF in the US, Japan, and five major EU markets, by country, 2016-36
Table 41: Key marketed drugs for SPAF
Table 42: Eliquis drug profile
Table 43: Eliquis pivotal trial data in SPAF
Table 44: Eliquis late-phase trial data in SPAF
Table 45: Eliquis ongoing late-phase clinical trial in SPAF
Table 46: Eliquis sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 47: Pradaxa drug profile
Table 48: Pradaxa pivotal trial data in SPAF
Table 49: Pradaxa late-phase trial data in SPAF
Table 50: Pradaxa ongoing late-phase clinical trials in SPAF
Table 51: Pradaxa sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 52: Savaysa drug profile
Table 53: Savaysa pivotal trial data in SPAF
Table 54: Savaysa late-phase trial data in SPAF
Table 55: Savaysa ongoing late-phase clinical trials in SPAF
Table 56: Savaysa sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 57: Xarelto drug profile
Table 58: Xarelto pivotal trial data in SPAF
Table 59: Xarelto late-phase trial data in SPAF
Table 60: Xarelto ongoing late-phase clinical trial in SPAF
Table 61: Xarelto sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 62: Marketed NOAC products and approved indications in the US, Japan, and five major EU markets
Table 63: Levers impacting access to anticoagulants in the five major EU markets
Table 64: Levers impacting access to NOACs in the US and five major EU markets
Table 65: French and German HTA decisions
Table 66: US pricing of key marketed drugs
Table 67: Prior authorization criteria for NOACs in six major health plans
Table 68: Formulary placement of NOACs in selected 2016 commercial formularies
Table 69: Formulary placement of NOACs in top 10 2016 Medicare Part D formularies
Table 70: Formulary placement of NOACs in selected large Medicaid states’ preferred drug lists
Table 71: Pricing premiums given to medicines that can demonstrate benefit over comparators in Japan
Table 72: Pricing of NOACs in Japan
Table 73: Price calculation methodologies for NOACs in Japan
Table 74: Pricing of key NOACs in the five major EU markets
Table 75: Transparency Commission's ASMR ratings and pricing implications
Table 76: Transparency Committee's SMR ratings and pricing implications
Table 77: Transparency Commission's assessment of SPAF treatments in France
Table 78: Transparency Commission's assessment of VTE treatments in France
Table 79: Transparency Commission's assessment of Praxbind (reversal agent for Pradaxa) in France
Table 80: G-BA assessment of key SPAF therapies in Germany
Table 81: G-BA assessment of key VTE therapies in Germany
Table 82: AIFA’s reimbursement decisions for NOACs in Italy
Table 83: Reimbursement conditions for antidotes in Italy
Table 84: Local formulary decisions for NOACs in Italy
Table 85: Spain regional assessments of anticoagulants
Table 86: NICE assessments of key SPAF therapies in the UK
Table 87: NICE assessments of key VTE therapies in the UK
Table 88: Regional formulary decisions for SPAF therapies in the UK
Table 89: Regional formulary decisions for VTE therapies in the UK
Table 90: SMC decisions on key SPAF therapies
Table 91: SMC decisions on key VTE therapies
Table 92: SMC decisions on key antidotes
Table 93: Price sources and calculations, by country
Table 94: Exchange rates used for calculating prices
