Hepatitis C Virus – Access & Reimbursement – Detailed, Expanded Analysis (China & South Korea)

Introduction

Hepatitis C virus (HCV) is the leading cause of end-stage liver disease and hepatocellular carcinoma in China and South Korea. The prevalence of this chronic disease remains high owing to the presence of a large existing undiagnosed population and a population of nonresponders (i.e., patients who failed previous interferon (IFN)-based therapy or relapsed following prior therapy). Recent launches of direct-acting antivirals (DAAs), notably Sovaldi and Harvoni, in South Korea has been a watershed in the treatment of HCV in Asia, and patients now finally have access to these efficacious antiviral therapies. However, owing to the backlog of regulatory approvals, no DAA is available in China yet. As a result, many patients do not receive further treatment beyond (IFN)-based therapy. However, some patients are willing to travel from China tocountries such as India to receive DAA treatment with generics that are available at one-tenth of the price compared with mature markets.

Scope:

Clarivate’s Access & Reimbursement module in Hepatitis C Virus in China and South Korea explores the prescribing patterns of current HCV therapies (include interferons and DAAs), the ongoing (South Korea) and potential (China) impact of the anticipated arrival of novel DAAs, and key national and regional market access factors that will shape pricing and reimbursement and the use of HCV therapies in both China and South Korea over the next two to three years.

Markets covered: China and South Korea.

Primary research:

  • 98 hepatologists and gastroenterologists surveyed.
  • 6 payers interviewed.
    • China:
      • Panel member for NRDL and PRDL update, Beijing.
      • Panel member for PRDL update, Shanghai.
      • Panel member for PRDL update, Sichuan.
    • South Korea:
      • Manager at HIRA, Regulation Reform Department (review & assessment).
      • Manager at HIRA, Regulation Reform Department (review & assessment).
      • Gastroenterologist KOL, Financial officer and Member of the reimbursement committee at the Korean Association for the study of the liver.

Table of contents

  • Hepatitis C Virus - Access & Reimbursement - Detailed, Expanded Analysis (China & South Korea)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for New HCV Therapies in China and South Korea
    • Successes and Stumbles
      • Successes for HCV Chronic Infection Therapies in China and South Korea
      • Stumbles for HCV Chronic Infection Therapies in China and South Korea
      • China: Reimbursement Successes and Stumbles for HCV
        • China: Reimbursement Successes and Stumbles for HCV Drugs
      • South Korea: Reimbursement Successes and Stumbles for HCV
      • Key Stakeholders in the Road to Market Access
        • China
        • South Korea
      • Key Market Access Roadblocks
        • Key Market Access Roadblocks for Emerging HCV Therapies in China and South Korea
        • China: Key Market Access Roadblocks
        • South Korea: Key Market Access Roadblocks
      • Reimbursement Dynamics
        • China: Reimbursement Dynamics for HCV
          • China: Drivers of Formulary Coverage for HCV Treatments
          • China: Reimbursement Details for Key HCV Drugs
          • China: Key Background Details of the Healthcare System
          • China: P&R Process
          • China: P&R Process
          • China: Impact of Hospital Reform on Access to Patent Drugs
          • China: Impact of Public Hospital Reform on Access to Patent Drugs
        • South Korea: Reimbursement Dynamics for HCV
          • South Korea: Drivers of Formulary Coverage for HCV Drugs
          • South Korea: Reimbursement Details for HCV Drugs
          • South Korea: Key Background Details of the Healthcare System
          • South Korea: P&R Process
          • South Korea: P&R Process
      • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
        • China: Prescriber Preferences for HCV Treatment
          • China: Patient Share for HCV Treatments
          • China: Changes in Prescribing of HCV Treatments in the Past Year
        • South Korea: Prescriber Preferences for HCV Treatment
          • South Korea: Patient Share for HCV Treatments
          • South Korea: Physiciansu2019 Choice of HCV Treatment in a Scenario of 100% Funding/Reimbursement
        • Impact of Payer Policy on Prescribing for HCV Treatment
          • Percentage of Public Patients Not Receiving Select HCV Treatments Due to Reimbursement/Budget/Access Restrictions
          • Reimbursement/Budgetary/Access Reasons That Restrict Patients from Receiving Select HCV Treatments
        • Top Prescribing Drivers for HCV Therapies
          • Top Prescribing Drivers for HCV Therapies for Genotype-1 Patients
        • Key Levers and Constraints on Current Therapies
        • Market Access Landscape for Emerging Therapies
          • Likely Impact of Emerging Therapies on HCV Treatment in China
            • Physicians' Perceived Changes in Patient Share of HCV Genotype-1 Drug Therapies in China by 2019
            • Physicians' Perceived Changes in Patient Share of HCV Genotype-2 and Genotype-3 Drug Therapies in China by 2019
            • Physicians' Expected Patient Shares of HCV Drug Therapies in China: 2016-2019 (% change)
          • Likely Impact of Emerging Therapies on HCV Treatment in South Korea
            • Physicians' Perceived Changes in Patient Share of HCV Genotype-1 Drug Therapies in South Korea by 2017 and 2019
          • Market Access Challenges for Emerging Therapies for HCV Chronic Infections
            • Top Factors Influencing Prescribing of Emerging HCV Therapies in China
            • Top Factors Influencing Prescribing of Emerging HCV Therapies in South Korea
          • Payer Opinion on Emerging Therapies for HCV
            • China: Interviewed Payer Preferences for DAAs by Patient Type
            • China: Payer Opinion on Emerging Therapies for HCV
            • South Korea: Payer Opinion on Emerging Therapies for HCV
        • Appendix
          • Commercial Context
            • Patient Populations: HCV Total Prevalent Cases in China and South Korea
            • HCV Genotype Distribution Among Patients in China and South Korea
            • Currently Marketed Therapies for HCV in South Korea and China
            • Profiles of Current Drug Therapies for HCV
            • Treatment Algorithms in China and South Korea
            • Contraindications for Treatment with Peg-IFN and RBV
            • Treatment Algorithm for HCV Genotype-1 Patients (China)
            • Treatment Algorithm for HCV Genotype-2 and Genotype-3 Patients (China)
            • Treatment Algorithm for HCV Genotype-1 Patients (South Korea)
            • Treatment Algorithm for HCV Genotype-2 Patients (South Korea)
            • Treatment Algorithm for HCV Genotype-3 Patients (South Korea)
            • Treatment Algorithm for HCV Genotypes-4, -5, and -6 Patients (South Korea)
            • Treatment of Patients with Decompensated Cirrhosis (South Korea)
            • HCV Drug Treatment Cost
            • Daily Cost per Treated Day of Select HCV Drugs
            • Approvals of HCV Drug Therapies in China and South Korea
            • Timeline of Approvals of Key Current and Emerging HCV Treatments
            • Emerging HCV Drugs on the Expedited Approval List of CFDA (April 2016)
            • Emerging Therapy: ASC08 (danoprevir) - China
            • ASC08 (danoprevir)
            • Emerging Therapy: Sovaldi (sofosbuvir) - China
            • Sovaldi (sofosbuvir)
            • Emerging Therapy: Daklinza (daclatasvir) - China
            • Daklinza (daclatasvir)
            • Emerging Therapy: Harvoni (sofosbuvir/ledipasvir FDC) - China
            • Harvoni (sofosbuvir/ledipasvir FDC)
            • Emerging Therapy: Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) - China and South Korea
            • Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir)
            • Emerging Therapy: Olysio (simeprevir) - China and South Korea
            • Olysio (simprevir)
            • Emerging Therapy: Zepatier (MK-5172/MK-8742) (grazoprevir/elbasvir) - South Korea
            • Zepatier (MK-5172/MK-8742)(grazoprevir/elbasvir)
            • China: Access to DAAs for HCV Treatment Overseas
            • Details of Chinese Companies Currently Providing Overseas DAA Treatment Services to HCV Patients in China
          • Physician Survey Data
            • Percentage of HCV Patients with Commercial Medical Insurance to Supplement State Basic Medical Insurance in China
            • Perceived Benefits of Commercial Insurance in Patients' Access to HCV Drug Treatments in China and South Korea
            • Common Diagnostic Tests Used for HCV Patients
            • Average Number of Days Required for Diagnostic Test Results
            • Physicians' Perception of the Effectiveness of HCV Public Awareness Campaign
            • HCV Drugs on the Hospital Formulary
            • Factors Restricting Formulary Inclusion in China
            • Factors Restricting Formulary Inclusion in South Korea
            • Ranking of the Influence of Different Guidelines on HCV Chronic Infection Treatment in China and South Korea
            • Influence of Guidelines on Prescribing Practices
            • HCV Prescriptions Modified Due to Guideline Changes
            • Patients by Genotype and Treatment Experience in China
            • Patients by Genotype and Treatment Experience in South Korea
            • Patient Share of Different HCV Drug Therapies for HCV-1 Chronic Infections in China and South Korea
            • Patient Share of Different HCV Drug Therapies for HCV-2/3 Chronic Infections in China and South Korea
            • Patient Share of Different HCV Drug Therapies by Genotype in China
            • Patient Share of Different HCV Drug Therapies by Genotype in South Korea
            • Patient Access to HCV Drugs Not on Hospital Formulary in China
            • Patient Access to HCV Drugs Not on Hospital Formulary in South Korea
            • Rationale for the Choice of Drug Regimens Among HCV-1 Patients in China
            • Factors Driving Drug Regimen Prescription Among HCV-1 Patients in China
            • Rationale for the Choice of Drug Regimens Among HCV-1 Patients in South Korea
            • Rationale for the Choice of Drug Regimens Among HCV-1 Patients in South Korea (continued)
            • Factors Driving Drug Regimen Prescriptions Among HCV-1 Patients in South Korea
            • Frequency of Patient Inquiries for HCV Therapies
            • Changes in Prescription of HCV Treatments in the Past Year for Public Patients
            • Changes in Prescription of HCV Treatments in the Past Year for Private Patients
            • Percentage of HCV Patients Not Receiving Eligible Treatments in China Due to Cost, Reimbursement, and Access Issues
            • Percentage of HCV Patients Not Receiving Eligible Treatments in South Korea Due to Cost, Reimbursement, and Access Issues
            • Reimbursement or Availability Reasons That HCV Patients Do Not Receive Treatment in China
            • Reimbursement or Availability Reasons That HCV Patients Do Not Receive Treatment in South Korea
            • Barriers to Treatment by Patient Type
            • Cost and Coverage/Reimbursement Reasons that Affect Patient Access to Treatment
            • Physicians' Perception of Cost-Effectiveness Justification for Prescribing DAAs
            • Impact of Higher Cure Rate of Dual Therapy on Prescribing of DAAs for Genotype-2 Patients
            • Availability of Reimbursement for Interferons in China
            • Percentage of Reimbursement for Interferons in China
            • Impact of Patient Copayment on Prescription of HCV Treatments in China
            • Availability of Catastrophic Disease Coverage for HCV Therapies in China
            • Copayment Rate of HCV Treatments in South Korea
            • Impact of Reimbursability of Daklinza and Sunvepra on Prescribing in South Korea
            • Physician Prescribing Preferences for MFDS Approved HCV Treatments in the Absence of Access Barriers in South Korea
            • Influence of Clinical Factors on Prescribing Choices for HCV Treatment if All Approved Drugs are Reimbursed
            • Clinical Reasons for Chronically Infected HCV Patients Not Receiving Antiviral Treatment
            • Percentage of Genotype-1 Patients Warehousing
            • Percentage of Genotype-2/3 Patients Warehousing
            • Patient Compliance Rate for HCV Therapies
            • Physicians' Expectations for Pricing of DAAs in China
            • Physicians' Preferences in Prescribing DAAs in China Without Reimbursement Constraints
            • Factors Affecting Physicians' Selection of DAA in China
            • Impact of Emerging Therapies on the Treatment of Treatment-Naive HCV Genotype-1 Patients in China
            • Impact of Emerging Therapies on the Treatment of Treatment-Experienced HCV Genotype-1 Patients in China
            • Impact of Emerging Therapies on the Treatment of Treatment-Naive HCV Genotype-2 and Genotype-3 Patients in China
            • Impact of Emerging Therapies on the Treatment of Treatment-Experienced HCV Genotype-2 and HCV Genotype-3 Patients in China
            • Impact of Emerging Therapies on the Treatment of Treatment-Naive HCV Genotype-1 Patients in South Korea
            • Impact of Emerging Therapies on the Treatment of Treatment-Experienced HCV Genotype-1 Patients in South Korea
            • Physicians' Preferences in Prescribing DAAs Without Reimbursement Constraints in South Korea
            • South Korea's Physicians' Intention to Prescribe Emerging Therapies Instead of Sovaldi and Daklinza in 2019 (assume all emerging therapies are reimbursable and available)
            • Proritization of Patients for Treatment with Emerging Therapies in South Korea
            • Factors Affecting Physicians' Selection of DAAs in South Korea
            • Physicians' Expectations for Pricing of Novel DAAs in South Korea
            • Impact of Emerging Therapies on the Treatment of Treatment-Naive HCV Genotype-1 Patients in South Korea by 2019
            • Impact of Emerging Therapies on the Treatment of Treatment-Experienced HCV Genotype-1 Patients in South Korea by 2019
            • Physicians' Recommendations on Coverage/Reimbursement of Novel DAAs in China
            • Physicians' Recommendations on Coverage/Reimbursement of Novel DAAs in South Korea

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