Disease Overview
Venous thromboembolism (VTE) consists of deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT refers to the formation of thrombi or blood clots in deep veins, which can block blood flow. A PE can form if the clot or a fragment travels to the lung, blocking oxygenated blood flow. VTE is estimated to be the third most common cardiovascular disease, and represents a significant financial burden for healthcare systems. PE is estimated to be the leading cause of in-hospital mortality, accounting for approximately 10% of deaths in this setting.
Market Snapshot
Venous thromboembolism (VTE) consists of deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT refers to the formation of thrombi or blood clots in deep veins, which can block blood flow. A PE can form if the clot or a fragment travels to the lung, blocking oxygenated blood flow. VTE is estimated to be the third most common cardiovascular disease, and represents a significant financial burden for healthcare systems. PE is estimated to be the leading cause of in-hospital mortality, accounting for approximately 10% of deaths in this setting.
Market Snapshot
- The VTE NOAC market will grow briefly, but begin to erode in 2024 with the introduction of generics.
- Survey of 222 specialists in the US, Japan, and five major EU markets sheds light on prescribing trends in VTE.
- Development of antidotes in the NOAC drug class will likely increase their adoption over traditional warfarin treatment.
- Improving NOACs pipeline agents will reduce risk of major bleeding and provide consistent anticoagulation.
- EU payers limit use due to high cost, while US payers support uptake.
Table of Contents
FORECAST: VENOUS THROMBOEMBOLISM (Published on 21 December 2017)OVERVIEW
EXECUTIVE SUMMARY
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: VENOUS THROMBOEMBOLISM (Published on 28 February 2018)
OVERVIEW
EXECUTIVE SUMMARY
PRIMARY RESEARCH METHODOLOGY
DISEASE DEFINITION AND DIAGNOSIS
CURRENT TREATMENT OPTIONS
PRESCRIBING TRENDS
EPIDEMIOLOGY: VENOUS THROMBOEMBOLISM (Published on 18 December 2017)
OVERVIEW
EXECUTIVE SUMMARY
DISEASE BACKGROUND
METHODOLOGY
FORECAST: DEEP VEIN THROMBOSIS
FORECAST: PULMONARY EMBOLISM
EPIDEMIOLOGIST INSIGHT
STRENGTHS AND LIMITATIONS
BIBLIOGRAPHY
APPENDIX: ADDITIONAL SOURCES
MARKETED DRUGS: VENOUS THROMBOEMBOLISM (Published on 21 December 2017)
OVERVIEW
EXECUTIVE SUMMARY
PRODUCT OVERVIEW
PRODUCT PROFILE: BEVYXXA
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: VENOUS THROMBOEMBOLISM (Published on 21 December 2017)
OVERVIEW
EXECUTIVE SUMMARY
PIPELINE TRENDS
List of Figures
Figure 1: VTE - Current and future market dynamics analysis
Figure 2: Drug assessment summary of brands for VTE
Figure 3: VTE drug sales across the US, Japan, and five major EU markets, by country, 2017-26
Figure 4: Sales of Eliquis across the US, Japan, and five major EU markets, by country, 2017-26
Figure 5: Sales of Eliquis and Xarelto in the US, Japan, and five major EU markets, 2017-26
Figure 6: VTE NOAC drug sales in the US, 2017-26
Figure 7: Patient-based forecast methodology for VTE
Figure 8: Price sources and calculations, by country
Figure 9: Eliquis for venous thromboembolism - SWOT analysis
Figure 10: Drug assessment summary of Eliquis for venous thromboembolism
Figure 11: Drug assessment summary of Eliquis for venous thromboembolism
Figure 12: Eliquis sales forecast for VTE in the US, Japan, and five major EU markets, by country, 2017-26
Figure 13: Pradaxa for venous thromboembolism - SWOT analysis
Figure 14: Drug assessment summary of Pradaxa for venous thromboembolism
Figure 15: Drug assessment summary of Pradaxa for venous thromboembolism
Figure 16: Pradaxa sales forecast for VTE in the US, Japan, and five major EU markets, by country, 2017-26
Figure 17: Savaysa for venous thromboembolism - SWOT analysis
Figure 18: Drug assessment summary of Savaysa for venous thromboembolism
Figure 19: Drug assessment summary Savaysa for venous thromboembolism
Figure 20: Savaysa sales forecast for VTE in the US, Japan, and five major EU markets, by country, 2017-26
Figure 21: Xarelto for venous thromboembolism - SWOT analysis
Figure 22: Drug assessment summary of Xarelto for venous thromboembolism
Figure 23: Drug assessment summary of Xarelto for venous thromboembolism
Figure 24: Xarelto sales forecast for VTE in the US, Japan, and five major EU markets, by country, 2017-26
Figure 25: Diagnosed venous thromboembolism patients with each comorbidity, all countries (%)
Figure 26: Deep vein thrombosis patients receiving each acute treatment option, by country (%)
Figure 27: Pulmonary embolism patients receiving each acute treatment option, by country (%)
Figure 28: Top five regimens used for the acute anticoagulation treatment of deep vein thrombosis patients, by country (%)
Figure 29: Top five regimens used for the acute anticoagulation treatment of pulmonary embolism patients, by country (%)
Figure 30: Deep vein thrombosis patients receiving each long-term treatment option, by country (%)
Figure 31: Pulmonary embolism patients receiving each long-term treatment option, by country (%)
Figure 32: Top five regimens used for the first-line long-term anticoagulation treatment of deep vein thrombosis patients, by country (%)
Figure 33: Top five regimens used for the first-line long-term anticoagulation treatment of pulmonary embolism patients, by country (%)
Figure 34: Top five regimens used for the second-line long-term anticoagulation treatment of deep vein thrombosis patients, by country (%)
Figure 35: Top five regimens used for the second-line long-term anticoagulation treatment of pulmonary embolism patients, by country (%)
Figure 36: Deep vein thrombosis patients receiving each extended treatment option, by country (%)
Figure 37: Pulmonary embolism patients receiving each extended treatment option, by country (%)
Figure 38: Top five regimens used for the first-line extended anticoagulation treatment of deep vein thrombosis patients, by country (%)
Figure 39: Top five regimens used for the first-line extended anticoagulation treatment of pulmonary embolism patients, by country (%)
Figure 40: Top five regimens used for the second-line extended anticoagulation treatment of deep vein thrombosis patients, by country (%)
Figure 41: Top five regimens used for the second-line extended anticoagulation treatment of pulmonary embolism patients, by country (%)
Figure 42: Trends in diagnosed incident cases of DVT in the US, Japan, and five major EU markets, 2016-36
Figure 43: Absolute change in diagnosed incident cases of DVT in the US, Japan, and five major EU markets, 2016-36
Figure 44: Trends in diagnosed incident cases of PE in the US, Japan, and five major EU markets, 2016-36
Figure 45: Absolute change in diagnosed incident cases of PE in the US, Japan, and five major EU markets, 2016-36
Figure 46: Bevyxxa for venous thromboembolism - SWOT analysis
Figure 47: Drug assessment summary of Bevyxxa for venous thromboembolism
Figure 48: Drug assessment summary of Bevyxxa for venous thromboembolism
Figure 49: Eliquis for venous thromboembolism - SWOT analysis
Figure 50: Drug assessment summary of Eliquis for venous thromboembolism
Figure 51: Drug assessment summary of Eliquis for venous thromboembolism
Figure 52: Eliquis sales forecast for VTE in the US, Japan, and five major EU markets, by country, 2017-26
Figure 53: Pradaxa for venous thromboembolism - SWOT analysis
Figure 54: Drug assessment summary of Pradaxa for venous thromboembolism
Figure 55: Drug assessment summary of Pradaxa for venous thromboembolism
Figure 56: Pradaxa sales forecast for VTE in the US, Japan, and five major EU markets, by country, 2017-26
Figure 57: Savaysa for venous thromboembolism - SWOT analysis
Figure 58: Drug assessment summary of Savaysa for venous thromboembolism
Figure 59: Drug assessment summary Savaysa for venous thromboembolism
Figure 60: Savaysa sales forecast for VTE in the US, Japan, and five major EU markets, by country, 2017-26
Figure 61: Xarelto for venous thromboembolism - SWOT analysis
Figure 62: Drug assessment summary of Xarelto for venous thromboembolism
Figure 63: Drug assessment summary of Xarelto for venous thromboembolism
Figure 64: Xarelto sales forecast for VTE in the US, Japan, and five major EU markets, by country, 2017-26
List of Tables
Table 1: VTE drug sales across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 2: Sales of Eliquis across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 3: VTE NOAC drug sales in the US ($m), 2017-26
Table 4: Summary of drug classes and molecules included in the author’s venous thromboembolism patientbased forecast
Table 5: Exchange rates used for calculating prices
Table 6: Cardiologists, hematologists, and vascular specialists/angiologists surveyed for the venous thromboembolism primary research study, 2017
Table 7: Eliquis drug profile
Table 8: Eliquis pivotal trial data in venous thromboembolism
Table 9: Eliquis late-phase trial data in venous thromboembolism
Table 10: Eliquis ongoing late-phase clinical trials in venous thromboembolism
Table 11: Eliquis sales for VTE in the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 12: Pradaxa drug profile
Table 13: Pradaxa pivotal trial data in venous thromboembolism
Table 14: Pradaxa late-phase trial data in venous thromboembolism
Table 15: Pradaxa ongoing late-phase clinical trials in venous thromboembolism
Table 16: Pradaxa sales for VTE in the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 17: Savaysa drug profile
Table 18: Savaysa pivotal trial data in venous thromboembolism
Table 19: Savaysa late-phase trial data in venous thromboembolism
Table 20: Savaysa ongoing late-phase clinical trial in venous thromboembolism
Table 21: Savaysa sales for VTE in the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 22: Xarelto drug profile
Table 23: Xarelto pivotal trial data in venous thromboembolism
Table 24: Xarelto late-phase trial data in venous thromboembolism
Table 25: Xarelto sales for VTE in the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 26: Cardiologists, hematologists, and vascular specialists/angiologists surveyed for the venous thromboembolism primary research study, 2017
Table 27: Diagnosed venous thromboembolism patients with each comorbidity, by country (%)
Table 28: Treatments available for venous thromboembolism across the US, Japan, and five major EU markets
Table 29: Sources used for the epidemiological analysis of VTE including DVT and PE in the US, Japan, and five major EU markets, by country
Table 30: Diagnosed incident cases of DVT in the US, Japan, and five major EU markets, by country, 2016-36
Table 31: Age-specific diagnosed incident cases of DVT in the US, Japan, and five major EU markets, by country, 2016
Table 32: Gender-specific diagnosed incident cases of DVT in the US, Japan, and five major EU markets, by country, 2016
Table 33: Diagnosed incident cases of PE in the US, Japan, and five major EU markets, by country, 2016-36
Table 34: Age-specific diagnosed incident cases of PE in the US, Japan, and five major EU markets, by country, 2016
Table 35: Gender-specific diagnosed incident cases of PE in the US, Japan, and five major EU markets, by country, 2016
Table 36: Key marketed drugs for venous thromboembolism
Table 37: Bevyxxa drug profile
Table 38: Bevyxxa pivotal trial data in venous thromboembolism
Table 39: Eliquis drug profile
Table 40: Eliquis pivotal trial data in venous thromboembolism
Table 41: Eliquis late-phase trial data in venous thromboembolism
Table 42: Eliquis ongoing late-phase clinical trials in venous thromboembolism
Table 43: Eliquis sales for VTE in the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 44: Pradaxa drug profile
Table 45: Pradaxa pivotal trial data in venous thromboembolism
Table 46: Pradaxa late-phase trial data in venous thromboembolism
Table 47: Pradaxa ongoing late-phase clinical trials in venous thromboembolism
Table 48: Pradaxa sales for VTE in the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 49: Savaysa drug profile
Table 50: Savaysa pivotal trial data in venous thromboembolism
Table 51: Savaysa late-phase trial data in venous thromboembolism
Table 52: Savaysa ongoing late-phase clinical trial in venous thromboembolism
Table 53: Savaysa sales for VTE in the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 54: Xarelto drug profile
Table 55: Xarelto pivotal trial data in venous thromboembolism
Table 56: Xarelto late-phase trial data in venous thromboembolism
Table 57: Xarelto sales for VTE in the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 58: Marketed NOAC products and approved indications in the US, Japan, and five major EU markets
Table 59: Levers impacting access to anticoagulants in the five major EU markets
Table 60: Levers impacting access to NOACs in the US and five major EU markets
Table 61: French and German HTA decisions
Table 62: US pricing of key marketed drugs
Table 63: Prior authorization criteria for NOACs in six major health plans
Table 64: Formulary placement of NOACs in selected 2016 commercial formularies
Table 65: Formulary placement of NOACs in top 10 2016 Medicare Part D formularies
Table 66: Formulary placement of NOACs in selected large Medicaid states’ preferred drug lists
Table 67: Pricing premiums given to medicines that can demonstrate benefit over comparators in Japan
Table 68: Pricing of NOACs in Japan
Table 69: Price calculation methodologies for NOACs in Japan
Table 70: Pricing of key NOACs in the five major EU markets
Table 71: Transparency Commission's ASMR ratings and pricing implications
Table 72: Transparency Committee's SMR ratings and pricing implications
Table 73: Transparency Commission's assessment of SPAF treatments in France
Table 74: Transparency Commission's assessment of VTE treatments in France
Table 75: Transparency Commission's assessment of Praxbind (reversal agent for Pradaxa) in France
Table 76: G-BA assessment of key SPAF therapies in Germany
Table 77: G-BA assessment of key VTE therapies in Germany
Table 78: AIFA’s reimbursement decisions for NOACs in Italy
Table 79: Reimbursement conditions for antidotes in Italy
Table 80: Local formulary decisions for NOACs in Italy
Table 81: Spain regional assessments of anticoagulants
Table 82: NICE assessments of key SPAF therapies in the UK
Table 83: NICE assessments of key VTE therapies in the UK
Table 84: Regional formulary decisions for SPAF therapies in the UK
Table 85: Regional formulary decisions for VTE therapies in the UK
Table 86: SMC decisions on key SPAF therapies
Table 87: SMC decisions on key VTE therapies
Table 88: SMC decisions on key antidotes
Table 89: Price sources and calculations, by country
Table 90: Exchange rates used for calculating prices
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