Introduction

Rheumatoid arthritis (RA) represents a lucrative market, particularly because of the entrenched positioning of biologics in the treatment algorithm. A number of RA biologics have been marketed in China and South Korea, which results in a high barrier of access for novel agents entering the market. The competition will become increasingly fierce given the dominance of current tumor necrosis factor (TNF)-α inhibitors and anticipated market entries of additional lower cost biosimilars. In this Access & Reimbursement module, we assesses the dynamics that affect uptake of biologics for RA and examine the market access challenges that novel JAK inhibitors, biologics and biosimilars will face in the next two to three years.

Questions Answered in This Report:

  • Healthcare coverage available in China and South Korea for key RA therapies, and how it varies between countries.
  • Prescribing patterns of RA biologics in China and South Korea. The influence of reimbursement status on drug prescribing.
  • The current drivers and barriers to prescribing RA biologics in each country, and the main cost-related/clinical constraints to the uptake of these costly agents.
  • The impact of government P&R policies in China and South Korea on the uptake and reimbursement of RA biologics.
  • The impact of launches of biosimilar versions of key biologics on prescribing and reimbursement.
  • Payer expectations for emerging RA agents. The opportunities and challenges emerging therapies are likely to face in the future.
  • How rheumatologists expect to prescribe biosimilars and emerging agents and their likely impact on current brands over the next three years.
  • The role head-to-head and pharmacoeconomic outcomes will play in differentiating the coverage and uptake of emerging RA therapies versus currently available options.

Scope:

Decision Resources Group’s Access & Reimbursement module in Rheumatoid Arthritis in China and South Korea explores the prescribing patterns of current RA therapies, the potential impact of the anticipated arrival of novel biologics and biosimilars, and key national and regional market access factors that will shape the use of biologics in both China and South Korea over the next two to three years.

Markets covered: China and South Korea.

Primary research:

  • 101 rheumatologists.
  • 6 payers.
  • China:
    • Expert for new drug evaluation at CFDA, Beijing.
    • Panel member for PRDL update, Shanghai.
    • Panel member for PRDL update, Jiangsu.
  • South Korea:
    • Advisor to HIRA.
    • Director, HIRA.
    • Manager, HIRA.

Table of contents

  • Rheumatoid Arthritis - Access & Reimbursement - Detailed, Expanded Analysis (China/South Korea)
    • Actionable Recommendations to Optimize Market Access to RA Treatments in China and South Korea
      • Optimizing Market Access Opportunity for New RA Therapies in China and South Korea
    • Successes and Stumbles
      • Successes Among RA Therapies in China and South Korea
      • Stumbles Among RA Therapies in China and South Korea
      • China: Reimbursement Successes & Stumbles
        • China: Reimbursement Successes and Stumbles Among RA Biologics
      • South Korea: Reimbursement Successes & Stumbles
        • South Korea: Reimbursement Successes and Stumbles Among RA Biologics
    • Key Stakeholders in the Road to Market Access
      • China
      • South Korea
    • Key Market Access Roadblocks
      • Key Market Access Roadblocks for RA Therapies in China and South Korea
      • China: Key Market Access Roadblocks
      • South Korea: Key Market Access Roadblocks
    • Reimbursement Dynamics
      • China: Reimbursement/Coverage Dynamics for RA Therapies
        • China: Drivers of Formulary Coverage
        • China: Key Background Details of the Healthcare System
        • China: P&R Process
        • China: Impact of Public Hospital Reform on Access to Patent Drugs
        • China: Prescribing Controls and Monitoring
        • China: Patient Assistance Programs for RA Biologics
        • China: Off-Label Use of MabThera for RA
      • South Korea: Reimbursement Dynamics for RA Therapies
        • South Korea: Drivers of Formulary Coverage for RA Drugs
        • South Korea: Reimbursement & HTA Details for RA Drugs
        • South Korea: Key Background Details of the Healthcare System
        • South Korea: P&R Process
    • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
      • China: Prescriber Preferences Among Current Biologics for RA
        • Most-Prescribed Agents: Physicians’ Current Choice of Biologic for RA After Failure with Conventional DMARDs
        • Most-Preferred Agents: Physicians’ Choice of Biologic for RA in a Scenario of 100% Funding/Reimbursement
      • South Korea: Prescriber Preferences Among Current Biologics for RA
        • Most-Prescribed Agents: Physicians’ Current Choice of Biologic for RA After Failure with Conventional DMARDs
        • Most-Preferred Agents: Physicians’ Choice of Biologic for RA in a Scenario of 100% Funding/Reimbursement
        • Patient Shares for SC Formulations and IV Formulations of Actemra and Orencia in South Korea
      • Impact of Payer Policy on Prescribing for RA Biologics
        • Patients Not Receiving Biologics or Xeljanz Due to Lack of Reimbursement and/or Budget Restrictions
        • Patients Discontinuing Therapy Due to Non-Clinical Reasons
      • Top Prescribing Drivers for Preferred TNF-α Inhibitors as First-Line Biologics
        • Reasons Contributing to Prescribing of Select TNF-α Inhibitors as First-Line Biologics for RA
      • Payer Policy Uptake Constraints
        • Impact of Budget/Funding/Reimbursement-Related Reasons on the Prescribing of Key RA Drugs
      • Key Levers and Constraints on Current Therapies
      • Market Access Landscape for Emerging Therapies
        • Likely Impact of Emerging Therapies for RA
          • Key Biologics for RA Most Likely to Be Replaced by Emerging Therapies in China
          • Key Biologics for RA Most Likely to Be Replaced by Emerging Therapies in South Korea
          • Target Populations for Emerging JAK Inhibitors in China and South Korea
        • Likely Impact of Biosimilars
          • Impact of Emergence of Biosimilars on Prescribing of Branded Biologics
          • Average Expected Patient Shares of Biosimilars by the End of 2019
        • Market Access Challenges for Emerging Therapies for RA
          • Market Access Challenges for Emerging Therapies for RA in South Korea
          • Factors Limiting Prescribing of Emerging Therapies for RA in South Korea
          • Anticipated Treatment Preferences for DMARD-Refractory RA in South Korea by Year-End 2019, by Line of Therapy
        • Payer Opinion on Emerging Therapies for RA
          • China: Payer Opinions on Biosimilars for RA
          • China: Payer Opinions on Biosimilars for RA
          • China: Payer Opinions on Biosimilars for RA
          • China: Payer Opinions on Emerging Therapies for RA
          • China: Payer Opinions on Emerging Therapies for RA
          • South Korea: Payer Opinions on Emerging Therapies for RA
          • South Korea: Payer Opinion on Emerging Therapies for RA
      • Methodology
        • Primary Research Design
        • Background of Payers and Payer-Advising KOLs
        • Physician Demographics and Practice Setting
          • In what country is your practice located?
          • What is your specialty?
          • How many years have you practiced post-residency?
          • How many patients with RA do you treat per month?
          • In what city is your practice located (China)?
          • In what city is your practice located (South Korea)?
          • In what province is your practice located (China)?
          • What is your hospital type (China)?
          • Where is your practice based primarily (South Korea)?
          • How would you best describe the setting in which you practice (South Korea)?
          • Which biologics do you prescribe for RA?
      • Appendix
        • Commercial Context
          • Total Prevalent Cases of RA in 2015 and 2019
          • Treatment Algorithm for RA
          • Profiles of TNF-α Inhibitors for RA
          • Profiles of Non-TNF-α Inhibitors for RA
          • Daily Cost of Select RA Drugs
          • Timeline of Launch/Approvals of Key Biologics for RA
          • Timeline of Approvals of Key Current Biologics for RA
          • Near-Term Competitive Landscape for Emerging Agents and Biosimilars for RA
          • Clinical Profile of Emerging Therapies—Simponi (China)
          • Golimumab (Simponi) (Janssen)
          • Clinical Profile of Emerging Therapies-Cimzia (China)
          • Certolizumab pegol (Cimzia) (UCB)
          • Clinical Profile of Emerging Therapies—Xeljanz (China)
          • Tofacitinib (Xeljanz) (Pfizer)
          • Clinical Profile of Emerging Therapies—Baricitinib (China and South Korea)
          • Baricitinib (Eli Lilly)
          • Clinical Profile of Emerging Therapies—Sarilumab (South Korea)
          • Sarilumab (Sanofi)
          • Clinical Profile of Emerging Therapies—Sirukumab (South Korea)
          • Sirukumab (Janssen)
        • Physician Survey Data
          • Commercial Insurance Coverage of RA Patients
          • Benefits of Commercial Insurance
          • Drug Treatment Rates for RA Patients
          • Patient Shares of Treatments for RA Patients
          • Administration Places for SC Biologics
          • Patient Shares for SC Formulations and IV Formulations of Actemra and Orencia in South Korea
          • Reasons Not Receiving SC Versions but IV Versions in South Korea
          • Patient Shares of TNF-α Inhibitors for RA Patients
          • Most Frequently Prescribed Biologics for RA Patients After Conventional DMARDs in China
          • Most Frequently Prescribed Biologics for RA Patients After Conventional DMARDs in South Korea
          • Reasons Driving Prescribing of One TNF-α Inhibitor Over the Others in the First Line in China (Overall)
          • Reasons Driving Prescribing of Select TNF-α Inhibitor Over the Others in the First Line in China
          • Reasons Driving Prescribing of a Second-Line Agent in China (Overall)
          • Reasons Driving Prescribing of Select Second-Line Agents in China
          • Reasons Driving Prescribing of One TNF-α Inhibitor Over the Others in the First Line in South Korea (Overall)
          • Reasons Driving Prescribing of Select TNF-α Inhibitor Over the Others in the First Line in South Korea
          • Reasons Driving Prescribing of a Second-Line Agent in South Korea (Overall)
          • Reasons Driving Prescribing of Select Second-Line Agents in South Korea
          • Reasons Driving Prescribing of Select Second-Line Agents in South Korea (cont.)
          • Patients Discontinuing Therapy for Non-Clinical Reasons
          • Biologics Candidates Not Receiving Therapy Because of Reimbursement/Funding/Budget Restrictions
          • Reimbursement/Budget/Funding Factors Limiting Prescribing of Biologics for RA in China
          • Reimbursement/Budget/Funding Factors Limiting Prescribing of Biologics or Xeljanz for RA in South Korea
          • Preferred Treatment for RA After Conventional DMARDs Under a Scenario of 100% Reimbursement in China
          • Preferred Treatment for RA After Conventional DMARDs Under a Scenario of 100% Reimbursement in South Korea
          • PRDL Coverage for RA Biologics in China
          • Reimbursement Rates of PRDL-Covered RA Biologics in China
          • Copayment Restrictions on Prescribing of RA Biologics in China
          • Restriction of MabThera's Off-Label Status on Its Reimbursement for RA in China
          • Restriction of MabThera's Off-Label Status on Its Use for RA in China
          • Patient Access Routes of RA Biologics Not Covered by Government Insurance in China
          • Payment Methods for RA Biologics Copays in South Korea
          • Possibility of PRDL Inclusion of RA Biologics in Next Update in China
          • Rheumatologists’ Preference Regarding NRDL Inclusion of Biologics for RA in China
          • Reasons for Non-Inclusion of RA Biologics in the NRDL in China
          • Medicine Rate Targets in China
          • Impact of Medicine Rate Target on Prescribing of RA Biologics in China
          • Impact of Zero Mark-Up Policy on Prescribing of RA Biologics in China
          • Patient Enrollment in Patient Assistance Programs for RA Biologics in China
          • Factors Limiting Patient Assistance Program Participation in China
          • Eligible RA Patients for the Medical Expense Support System by NHI in South Korea
          • Impact of Government-Sponsored Medical Expense Support System on Prescribing of RA Biologics in South Korea
          • Copayment Rates for RA Patients Not Eligible for the Medical Expense Support System in South Korea
          • Restriction of Copayment on Prescribing of RA Biologics in South Korea
          • Cost-Containment Measures for RA Drug Cost Management in South Korea, Now and in Three Years
          • Anticipated Reimbursement of Simponi in 2018 in South Korea
          • Reasons for Delaying Diagnosis of RA in South Korea
          • Impact of Emergence of Biosimilars on Prescribing of Branded Biologics in China
          • Impact of Emergence of Biosimilars on Prescribing of Branded Biologics in South Korea
          • Anticipated Launch Price for Biosimilars
          • Physician Expectations for Prescribing of Biosimilars Upon Two Years of Availability in China
          • Physician Expectations for Prescribing of Biosimilars Upon Two Years of Availability in South Korea
          • Percentage of RA Patients Naive to Biologics Likely to Receive Biosimilars
          • Percentage of RA Patients Likely to Be Switched from Brands to Biosimilars
          • Likelihood of Physician Switching to Respective Brand After Patient Failure of Biosimilars in China
          • Likelihood of Physician Switching to Respective Brand After Patient Failure of Biosimilars in South Korea
          • Patient Shares for Brand vs. Biosimilar of Select Biologics for RA by 2019
          • Reasons for Not Prescribing Biosimilars in China
          • Reasons for Not Prescribing Biosimilars in South Korea
          • Key Drivers for Prescribing of an Emerging Biologic Therapy in the First Line
          • Advantages of Simponi and Cimzia Over the Other TNF-α Inhibitors
          • Target Patient Populations for Xeljanz in China
          • Target Patient Populations for Baricitinib in China
          • Target Patient Populations for Baricitinib in South Korea
          • Advantages of Xeljanz and Baricitinib Over TNF-α Inhibitors Viewed by Chinese Physicians
          • Advantages of Baricitinib Over TNF-α Inhibitors Viewed by South Korean Physicians
          • Reasons for Not Prescribing Xeljanz or Baricitinib Within Two Years of Their Launches in China
          • Reasons for Not Prescribing Baricitinib Within Two Years of Its Launch in South Korea
          • Target Patient Populations for Sarilumab in South Korea
          • Target Patient Populations for Sirukumab in South Korea
          • Advantages of Sarilumab and Sirukumab Over TNF-α Inhibitors Viewed by South Korean Physicians
          • Reasons for Not Prescribing Sarilumab or Sirukumab in South Korea
          • Most Likely Replacement of Current Biologics with Emerging Agents in China
          • Most Likely Replacement of Current Biologics with Emerging Agents in South Korea
          • Expected Patient Shares of Key RA Treatments by Year-End 2019
          • Expected Patient Shares of TNF-α Inhibitors by Year-End 2019
          • Expected Patient Shares of JAK Inhibitors in South Korea by Year-End 2019
          • Expected Patient Shares of IL-6 Inhibitors in South Korea by Year-End 2019
          • Anticipated Treatment Preferences for DMARD-Refractory RA in China by Year-End 2019, by Line of Therapy
          • Factors Limiting Prescribing of Emerging Therapies for RA in China
          • Anticipated Treatment Preferences for DMARD-Refractory RA in South Korea by Year-End 2019, by Line of Therapy
          • Factors Limiting Prescribing of Emerging Therapies for RA in South Korea

    Author(s): Michael Yeung, MSc; Michelle Qian Zhou, MBBS, PhD

    Based in DRG’s Hong Kong office, Michael analyses the evolving market access landscape in the Asia-Pacific region, including Australia, China, Japan, South Korea, The Philippines, and Taiwan. Michael is also responsible for market research and sales forecast in China among key therapeutic areas including diabetes.

    Michael previously worked as a health economics and outcome research consultant in Tokyo. Michael completed his Master degree in International Health Policy at London School of Economics and has a degree in Biochemistry from Imperial College London.

    Michelle Zhou is a senior analyst at Decision Resources Group Hong Kong office. She is specialized in China research across multiple disease areas, working on multiple products, including Access & Reimbursement, and ChinaRx.

    Prior to joining DRG, Dr. Zhou worked as a Scientist at New A Innovation Limited in Hong Kong where she managed preclinical studies in both mainland China and Hong Kong investigating new treatments for cancer and hemorrhagic shock. Dr. Zhou has a medical degree from Zhejiang University in China and a Ph.D. in clinical oncology from the Chinese University of Hong Kong, where she was involved in the investigation of novel therapeutics on signaling pathways in hepatocellular carcinoma.


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