Disease Overview
Hepatitis C is a blood-borne liver disease caused by the hepatitis C virus (HCV). HCV belongs to the Flaviviridaevirus family, and is a communicable disease spread primarily through direct contact with the blood or the bodily fluids of an infected individual, including sexual and mother-to-child transmission. Hepatitis C infection normally does not produce signs or symptoms and, as such, most people who are infected do not know they have the disease.
Market Snapshot
Hepatitis C is a blood-borne liver disease caused by the hepatitis C virus (HCV). HCV belongs to the Flaviviridaevirus family, and is a communicable disease spread primarily through direct contact with the blood or the bodily fluids of an infected individual, including sexual and mother-to-child transmission. Hepatitis C infection normally does not produce signs or symptoms and, as such, most people who are infected do not know they have the disease.
Market Snapshot
- Falling disease prevalence and anticipated price decreases as competition intensifies will drive a net decline in market value.
- Harvoni remains the dominant option for GT-1/4 patients, but has ceded share to cheaper rivals as competition intensifies.
- Cases are expected to decline, driven by complexities in high-risk populations, demographics, and treatment developments.
- Mavyret’s approval at a substantial discount to Epclusa paves the way for a further decline in Gilead’s HCV revenues.
- Lack of unmet need and declining market value prompts Johnson & Johnson and Merck & Co to discontinue pipeline regimens.
- Pricing is the key differentiator for drugs in this market.
Table of Contents
FORECAST: HEPATITIS C (Published on 06 November 2017)EXECUTIVE SUMMARY
MARKET DYNAMICS
FORECAST AND FUTURE TRENDS
MARKET DEFINITION AND METHODOLOGY
PRIMARY RESEARCH METHODOLOGY
BIBLIOGRAPHY
PRODUCT PROFILE: DAKLINZA
PRODUCT PROFILE: EPCLUSA
PRODUCT PROFILE: HARVONI
PRODUCT PROFILE: MAVYRET
PRODUCT PROFILE: SOVALDI
PRODUCT PROFILE: VIEKIRA PAK FRANCHISE
PRODUCT PROFILE: VOSEVI
PRODUCT PROFILE: XIMENCY
PRODUCT PROFILE: ZEPATIER
TREATMENT: HEPATITIS C (Published on 10 January 2018)
EXECUTIVE SUMMARY
PRIMARY RESEARCH METHODOLOGY
DISEASE DEFINITION AND DIAGNOSIS
PATIENT SEGMENTATION
CURRENT TREATMENT OPTIONS
PRESCRIBING TRENDS
UNMET NEEDS IN HEPATITIS C
EPIDEMIOLOGY: HEPATITIS C IN THE US, JAPAN, AND 5EU (Published on 08 November 2017)
EXECUTIVE SUMMARY
DISEASE OVERVIEW
SOURCES AND METHODOLOGY
FORECAST
EPIDEMIOLOGIST INSIGHT
STRENGTHS AND LIMITATIONS
BIBLIOGRAPHY
MARKETED DRUGS: HEPATITIS C (Published on 06 November 2017)
EXECUTIVE SUMMARY
PRODUCT OVERVIEW
PRODUCT PROFILE: DAKLINZA
PRODUCT PROFILE: EPCLUSA
PRODUCT PROFILE: HARVONI
PRODUCT PROFILE: MAVYRET
PRODUCT PROFILE: SOVALDI
PRODUCT PROFILE: VIEKIRA PAK FRANCHISE
PRODUCT PROFILE: VOSEVI
PRODUCT PROFILE: XIMENCY
PRODUCT PROFILE: ZEPATIER
HEPATITIS C PRICING, REIMBURSEMENT, AND ACCESS (Published on 29 August 2017)
EXECUTIVE SUMMARY
REGULATORY LABELS
PAYER ARCHETYPES
ACCESS TO RECENTLY LAUNCHED AND PIPELINE PRODUCTS
EVIDENTIARY REQUIREMENTS AND FUTURE PIPELINE POTENTIAL
US PRICING
US REIMBURSEMENT
JAPAN
PRICING IN THE FIVE MAJOR EU MARKETS
FRANCE
GERMANY
ITALY
SPAIN
UK
METHODOLOGY
PIPELINE: HEPATITIS C (Published on 06 November 2017)
EXECUTIVE SUMMARY
PIPELINE TRENDS
List of Figures
Figure 1: Hepatitis C - current and future market dynamics analysis
Figure 2: Drug assessment summary of key marketed brands for hepatitis C
Figure 3: Total market sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 4: Hepatitis C market value in the US, 2017-26
Figure 5: Hepatitis C market value in Japan, 2017-26
Figure 6: Japanese sales for GT-2 hepatitis C, by brand, 2017-26
Figure 7: Hepatitis C sales in the five major EU markets, by country, 2017-26
Figure 8: Total treated patient numbers for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 9: Hepatitis C sales across the US, Japan, and five major EU markets, by company, 2017-26
Figure 10: Hepatitis C sales of key brands in the US, Japan, and five major EU markets, 2017-26
Figure 11: Patient-based forecast methodology for hepatitis C
Figure 12: Methodology for adjusting the hepatitis C prevalent population for drug cure rates
Figure 13: Price sources and calculations, by country
Figure 14: Daklinza for hepatitis C - SWOT analysis
Figure 15: Drug assessment summary of Daklinza for hepatitis C
Figure 16: Drug assessment summary of Daklinza for hepatitis C
Figure 17: Daklinza sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 18: Epclusa for hepatitis C - SWOT analysis
Figure 19: Drug assessment summary of Epclusa for hepatitis C
Figure 20: Drug assessment summary of Epclusa for hepatitis C
Figure 21: Epclusa sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 22: Harvoni for hepatitis C - SWOT analysis
Figure 23: Drug assessment summary of Harvoni for hepatitis C
Figure 24: Drug assessment summary of Harvoni for hepatitis C
Figure 25: Harvoni sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 26: Mavyret for hepatitis C - SWOT analysis
Figure 27: Drug assessment summary of Mavyret for hepatitis C
Figure 28: Drug assessment summary of Mavyret for hepatitis C
Figure 29: Mavyret sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 30: Sovaldi for hepatitis C - SWOT analysis
Figure 31: Drug assessment summary of Sovaldi for hepatitis C
Figure 32: Drug assessment summary of Sovaldi for hepatitis C
Figure 33: Sovaldi sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 34: Viekira Pak franchise for hepatitis C - SWOT analysis
Figure 35: Drug assessment summary of the Viekira Pak franchise for hepatitis C
Figure 36: Drug assessment summary of the Viekira Pak franchise for hepatitis C
Figure 37: Viekira Pak sales for hepatitis C across the US and five major EU markets, by country, 2017-26
Figure 38: Viekira XR sales for hepatitis C in the US, 2017-26
Figure 39: Technivie sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 40: Vosevi for hepatitis C - SWOT analysis
Figure 41: Drug assessment summary of Vosevi for hepatitis C
Figure 42: Drug assessment summary of Vosevi for hepatitis C
Figure 43: Vosevi sales for hepatitis C across the US and five major EU markets, by country, 2017-26
Figure 44: Ximency for hepatitis C - SWOT analysis
Figure 45: Drug assessment summary of Ximency for hepatitis C
Figure 46: Drug assessment summary of Ximency for hepatitis C
Figure 47: Ximency sales for hepatitis C in Japan, 2017-26
Figure 48: Zepatier for hepatitis C - SWOT analysis
Figure 49: Drug assessment summary of Zepatier for hepatitis C
Figure 50: Drug assessment summary of Zepatier for hepatitis C
Figure 51: Zepatier sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 52: Percentage of chronic hepatitis C prevalent population who are diagnosed in the US, Japan, and five major EU markets, by country
Figure 53: Percentage of the hepatitis C diagnosed population under physician care in the US, Japan, and five major EU markets, by country
Figure 54: Prevalence of hepatitis C genotypes across the US, Japan, and five major EU markets, by country
Figure 55: Treatment status of hepatitis C patients under specialist care in the US, Japan, and five major EU markets, by country (2017)
Figure 56: Treatment status of hepatitis C patients under specialist care in the US, Japan, and five major EU markets, by country (2015)
Figure 57: Breakdown of pharmacologically treated chronic hepatitis C patients in the US, Japan, and five major EU markets by line of therapy, by country
Figure 58: Top four brands of each analyzed market used for the treatment of GT-1 first-line hepatitis C patients, by country
Figure 59: Top five brands of each analyzed market used for the treatment of GT-1 second-line and beyond hepatitis C patients, by country
Figure 60: Top four brands of each analyzed market used for the treatment of GT-2 first-line hepatitis C patients, by country
Figure 61: Top four brands of each analyzed market used for the treatment of GT-2 second-line and beyond hepatitis C patients, by country
Figure 62: Top four regimens of each analyzed market used for the treatment of GT-3 first-line hepatitis C patients, by country
Figure 63: Top four brands of each analyzed market used for the treatment of GT-3 first-line hepatitis C patients, by country
Figure 64: Top five brands of each analyzed market used for the treatment of GT-4 first-line hepatitis C patients, by country
Figure 65: Methodology for adjusting hepatitis C prevalent population for drug cure rates
Figure 66: Trends in total hepatitis C prevalent cases in the US, Japan, and five major EU markets, by country, 2016-36
Figure 67: Absolute growth in total hepatitis C prevalent cases in the US, Japan, and five major EU markets, by country, 2016-36
Figure 68: Trends in chronic hepatitis C prevalent cases after adjusting for treatment and cure in the US, Japan, and five major EU markets, by country, 2016-36
Figure 69: Daklinza for hepatitis C - SWOT analysis
Figure 70: Drug assessment summary of Daklinza for hepatitis C
Figure 71: Drug assessment summary of Daklinza for hepatitis C
Figure 72: Daklinza sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 73: Epclusa for hepatitis C - SWOT analysis
Figure 74: Drug assessment summary of Epclusa for hepatitis C
Figure 75: Drug assessment summary of Epclusa for hepatitis C
Figure 76: Epclusa sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 77: Harvoni for hepatitis C - SWOT analysis
Figure 78: Drug assessment summary of Harvoni for hepatitis C
Figure 79: Drug assessment summary of Harvoni for hepatitis C
Figure 80: Harvoni sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 81: Mavyret for hepatitis C - SWOT analysis
Figure 82: Drug assessment summary of Mavyret for hepatitis C
Figure 83: Drug assessment summary of Mavyret for hepatitis C
Figure 84: Mavyret sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 85: Sovaldi for hepatitis C - SWOT analysis
Figure 86: Drug assessment summary of Sovaldi for hepatitis C
Figure 87: Drug assessment summary of Sovaldi for hepatitis C
Figure 88: Sovaldi sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 89: Viekira Pak franchise for hepatitis C - SWOT analysis
Figure 90: Drug assessment summary of the Viekira Pak franchise for hepatitis C
Figure 91: Drug assessment summary of the Viekira Pak franchise for hepatitis C
Figure 92: Viekira Pak sales for hepatitis C across the US and five major EU markets, by country, 2017-26
Figure 93: Viekira XR sales for hepatitis C in the US, 2017-26
Figure 94: Technivie sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 95: Vosevi for hepatitis C - SWOT analysis
Figure 96: Drug assessment summary of Vosevi for hepatitis C
Figure 97: Drug assessment summary of Vosevi for hepatitis C
Figure 98: Vosevi sales for hepatitis C across the US and five major EU markets, by country, 2017-26
Figure 99: Ximency for hepatitis C - SWOT analysis
Figure 100: Drug assessment summary of Ximency for hepatitis C
Figure 101: Drug assessment summary of Ximency for hepatitis C
Figure 102: Ximency sales for hepatitis C in Japan, 2017-26
Figure 103: Zepatier for hepatitis C - SWOT analysis
Figure 104: Drug assessment summary of Zepatier for hepatitis C
Figure 105: Drug assessment summary of Zepatier for hepatitis C
Figure 106: Zepatier sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Figure 107: Pricing of key marketed hepatitis C drugs in the five major EU markets, by country
Figure 108: Price sources and calculations, by country
List of Tables
Table 1: Total market sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 2: Hepatitis C market value in the US ($m), 2017-26
Table 3: Hepatitis C market value in Japan ($m), 2017-26
Table 4: Japanese sales for GT-2 hepatitis C, by brand ($m), 2017-26
Table 5: Hepatitis C sales in the five major EU markets, by country ($m), 2017-26
Table 6: Total treated patient numbers for hepatitis C across the US, Japan, and five major EU markets, by country, 2017-26
Table 7: Hepatitis C sales across the US, Japan, and five major EU markets, by company ($m), 2017-26
Table 8: Hepatitis C sales of key brands in the US, Japan, and five major EU markets ($m), 2017-26
Table 9: Summary of drug classes and molecules in the author’s chronic hepatitis C patient-based forecast
Table 10: Exchange rates used for calculating prices
Table 11: Gastroenterologists, hepatologists, and infectious disease specialists surveyed for the hepatitis C primary research study, 2017
Table 12: Daklinza drug profile
Table 13: Pivotal studies supporting approvals of Daklinza
Table 14: Daklinza sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 15: Epclusa drug profile
Table 16: Pivotal studies supporting approvals of Epclusa
Table 17: Epclusa late-phase trial data in hepatitis C
Table 18: Epclusa sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 19: Harvoni drug profile
Table 20: Pivotal studies supporting approvals of Harvoni
Table 21: Ongoing studies of Harvoni
Table 22: Harvoni sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 23: Mavyret drug profile
Table 24: Pivotal Phase III studies of Mavyret in hepatitis C
Table 25: Other Phase III studies of Mavyret in hepatitis C
Table 26: Mavyret ongoing Phase III trials in hepatitis C
Table 27: Mavyret sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 28: Sovaldi drug profile
Table 29: Pivotal studies supporting approvals of Sovaldi
Table 30: Sovaldi sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 31: Viekira Pak franchise drug profile
Table 32: Pivotal studies supporting approvals of the Viekira Pak franchise
Table 33: Viekira Pak sales for hepatitis C across the US and five major EU markets, by country ($m), 2017-26
Table 34: Viekira XR sales for hepatitis C in the US ($m), 2017-26
Table 35: Technivie sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 36: Vosevi drug profile
Table 37: Pivotal Phase III trials of Vosevi for chronic hepatitis C infection
Table 38: Vosevi sales for hepatitis C across the US and five major EU markets, by country ($m), 2017-26
Table 39: Ximency drug profile
Table 40: Key Phase III studies of Ximency in hepatitis C
Table 41: Ximency sales for hepatitis C in Japan ($m), 2017-26
Table 42: Zepatier drug profile
Table 43: Pivotal studies supporting approvals of Zepatier
Table 44: Zepatier late-phase trial data in hepatitis C
Table 45: Zepatier sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 46: Gastroenterologists, hepatologists, and infectious disease specialists surveyed for the hepatitis C primary research study, 2017
Table 47: Interpretation of results from hepatitis C screening assays
Table 48: Prevalence of hepatitis C genotypes across the US, Japan, and five major EU markets, by country
Table 49: METAVIR fibrosis scores of patients under specialist care in the US, Japan, and five major EU markets, by country
Table 50: Reasons for not receiving hepatitis C treatment in the US, Japan, and five major EU markets, by country
Table 51: Treatments available for hepatitis C across the US, Japan, and five major EU markets
Table 52: Summary of "recommended" treatment options for newly diagnosed patients in AASLD and EASL treatment guidelines
Table 53: Relative importance of unmet needs in hepatitis C treatment in the US, Japan, and five major EU markets, by country
Table 54: Sources used for hepatitis C analysis in the US, Japan, and five major EU markets
Table 55: Total prevalent cases of hepatitis C in the US, Japan, and five major EU markets, by country, 2016-36
Table 56: Age-specific total prevalent cases of hepatitis C in the US, Japan, and five major EU markets, by country, 2016
Table 57: Gender-specific total prevalent cases of hepatitis C in the US, Japan, and five major EU markets, by country, 2016
Table 58: Hepatitis C virus genotype distributions across the US, Japan, and five major EU markets, by country, 2016
Table 59: Total prevalent cases of hepatitis C, by genotype, across the US, Japan, and five major EU markets, by country, 2016
Table 60: Treatment- and cure-adjusted total prevalent cases of chronic hepatitis C in the US, Japan, and five major EU markets, by country, 2016-36
Table 61: Validation of total chronic hepatitis C forecast estimates against benchmark estimates, by country, 2016
Table 62: Profiled key marketed drugs for hepatitis c
Table 63: Daklinza drug profile
Table 64: Pivotal studies supporting approvals of Daklinza
Table 65: Daklinza sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 66: Epclusa drug profile
Table 67: Pivotal studies supporting approvals of Epclusa
Table 68: Epclusa late-phase trial data in hepatitis C
Table 69: Epclusa sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 70: Harvoni drug profile
Table 71: Pivotal studies supporting approvals of Harvoni
Table 72: Ongoing studies of Harvoni
Table 73: Harvoni sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 74: Mavyret drug profile
Table 75: Pivotal Phase III studies of Mavyret in hepatitis C
Table 76: Other Phase III studies of Mavyret in hepatitis C
Table 77: Mavyret ongoing Phase III trials in hepatitis C
Table 78: Mavyret sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 79: Sovaldi drug profile
Table 80: Pivotal studies supporting approvals of Sovaldi
Table 81: Sovaldi sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 82: Viekira Pak franchise drug profile
Table 83: Pivotal studies supporting approvals of the Viekira Pak franchise
Table 84: Viekira Pak sales for hepatitis C across the US and five major EU markets, by country ($m), 2017-26
Table 85: Viekira XR sales for hepatitis C in the US ($m), 2017-26
Table 86: Technivie sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 87: Vosevi drug profile
Table 88: Pivotal Phase III trials of Vosevi for chronic hepatitis C infection
Table 89: Vosevi sales for hepatitis C across the US and five major EU markets, by country ($m), 2017-26
Table 90: Ximency drug profile
Table 91: Key Phase III studies of Ximency in hepatitis C
Table 92: Ximency sales for hepatitis C in Japan ($m), 2017-26
Table 93: Zepatier drug profile
Table 94: Pivotal studies supporting approvals of Zepatier
Table 95: Zepatier late-phase trial data in hepatitis C
Table 96: Zepatier sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 97: Approved labels for marketed hepatitis C drugs in the US, Japan, and five major EU markets
Table 98: Initial cost-containment measures utilized to manage the budget impact of hepatitis C drugs in the US and five major EU markets
Table 99: Current cost-containment measures utilized to manage the budget impact of hepatitis C drugs in the US and five major EU markets
Table 100: Levers impacting access to hepatitis C drugs in the US and five major EU markets
Table 101: US pricing of key marketed drugs
Table 102: Prior authorization criteria for hepatitis C agents in six major health plans
Table 103: Formulary placement of hepatitis C agents in selected commercial formularies
Table 104: Formulary placement of hepatitis C agents in selected 2017 Medicare Part D formularies
Table 105: Formulary placement of hepatitis C medications in selected Medicaid state preferred drug lists
Table 106: Pricing of key marketed hepatitis C drugs in Japan
Table 107: Pricing of key hepatitis C drugs in Japan
Table 108: Transparency Committee’s ASMR ratings and pricing implications
Table 109: Transparency Committee's SMR ratings and pricing implications
Table 110: Transparency Committee’s assessment of hepatitis C treatments
Table 111: G-BA assessment of Sovaldi
Table 112: G-BA assessment of Olysio
Table 113: G-BA assessment of Daklinza
Table 114: G-BA assessment of Harvoni
Table 115: G-BA assessment of Viekirax ± Exviera
Table 116: G-BA assessment of Epclusa
Table 117: IQWiG assessment of Zepatier
Table 118: AIFA’s reimbursement decisions for hepatitis C agents in Italy
Table 119: Local formulary decisions for hepatitis C agents
Table 120: Therapeutic positioning reports for hepatitis C agents in Spain
Table 121: Spanish Society of Hospital Pharmacy ratings
Table 122: GENESIS-SEFH assessment of hepatitis C treatments
Table 123: NICE assessments for hepatitis C therapies
Table 124: SMC assessments for hepatitis C therapies
Table 125: Exchange rates used for calculating branded drug prices
