Introduction

Oncology is increasingly moving toward a personalized treatment approach, enlisting predictive biomarkers to guide therapy choice. This trend is already being felt in indications as varied as non-small-cell lung cancer (NSCLC), breast cancer, and colorectal cancer (CRC), and it is affecting uptake of key brands. However, only some of these brands get partial reimbursement in selected provinces in China. Furthermore, how biomarker tests are paid for will in turn impact uptake of biomarker-driven therapies. Multiple emerging therapies in the oncology pipeline, such as Novartis’s Zykadia (ceritinib) and AstraZeneca’s Lynparza (olaparib), hope to benefit from biomarker-driven prescribing. To maximize opportunity in the Chinese market, developers of emerging therapies need to carefully balance preferred pricing with uptake potential, especially when taking into account the anticipated emergence of biosimilars and generics of key targeted therapies.

Questions Answered in This Report

Explore current and evolving prescribing trends: How do prescribing patterns differ between biomarker-driven therapies for NSCLC, breast cancer, and CRC? How does drug reimbursement status influence drug prescribing? What are the current drivers and barriers to biomarker-driven prescribing in oncology, and what are the main cost-related/clinical constraints to the uptake of agents with biomarkers? How do new government policies affect physicians’ prescribing of biomarker-driven therapies? What impact do biomarker tests have on the uptake of biomarker-driven therapies? How will differences in prescribers’ perceptions of major brands versus biosimilars impact prescribing? How will use of currently marketed agents evolve over the next three years?

Assess payer attitudes toward approved biomarker-driven drugs: Which agents are included on the National Reimbursement Drug List (NRDL) or Provincial Reimbursement Drug Lists (PRDLs)? What are the restrictions for the reimbursement of formulary-listed drugs? How might reimbursement of key biomarker-driven therapies change in the near future? What therapies do payers expect to be included in the new NRDL and/or PRDLs? How might the new government policies affect the pricing and reimbursement of biomarker-driven therapies? What is the reimbursement status of the biomarker tests? What are the current limitations to biomarker testing and the downstream impact on uptake of respective agents? How are the upcoming biosimilars and generics perceived by payers? Will the presence of biosimilars drive a price cut on the branded products and have impact on the reimbursement status of biomarker-driven oncology biologics?

Explore the outlook for emerging agents: What are the greatest unmet needs for the treatment of NSCLC, breast cancer, and CRC? How are the emerging drugs perceived? How do physicians expect to prescribe them? What are payers’ expectations for access to emerging therapies? How will payer policy impact their uptake? How will market access barriers evolve, and what challenges are companies likely to face in the future? How do oncologists expect to prescribe biosimilars, generics, and emerging agents?

Scope

This Emerging Markets Access & Reimbursement report on Biomarker-Driven Prescribing in Oncology in China: Breast Cancer, Colorectal Cancer, and Non-Small-Cell Lung Cancer, surveys 50 oncologists and interviews 3 payers in China. We explore the national and regional market access factors that will impact the biomarker-driven treatment for NSCLC, breast cancer, and CRC in China in the next two to three years.

Markets covered: China.

Primary research:

  • 50 oncologists completed an online quantitative survey designed by therapeutic and country experts.
  • 3 payers/payer-advising thought leaders who influence reimbursement of biomarker-driven therapies for NSCLC, breast cancer, and CRC at a national or regional level were interviewed: Member, Ministry of Human Resources and Social Security (MOHRSS) for updating of the PRDL, Shandong; Member, Ministry of Human Resources and Social Security (MOHRSS) for updating of the PRDL, Beijing; Member, China Food and Drug Administration (CFDA) for new drug application review, Guangdong.

Table of contents

  • Biomarkers In Oncology - Access & Reimbursement - Detailed, Expanded Analysis: Biomarker-Driven Prescribing In Oncology (China)
    • Actionable Recommendations to Optimize Market Access
      • Actionable Recommendations to Optimize Market Access for New Biomarker-Driven Oncology Therapies in China
    • Successes and Stumbles
      • Successes Among Biomarker-Driven Oncology Therapies in China
      • Stumbles Among Biomarker-Driven Oncology Therapies in China
    • Key Stakeholders in the Road to Market Access
      • China: Stakeholder Dynamics on the Road to Market Access
    • Key Market Access Roadblocks
      • Key Market Access Roadblocks for Biomarker-Driven Oncology Therapies in China
    • Reimbursement Dynamics
      • China: HTA Details and Implications in Drug Coverage
      • China: Drivers of Formulary Coverage for Biomarker-Driven Oncology Therapies
        • China: Drivers of Formulary Coverage
      • China: Reimbursement Detail and Successes or Stumbles
        • China: Lessons Learned and Key Takeaways
          • China: Reimbursement Background
            • China: Key Background Details of the Healthcare System
            • Prescribing Control and Monitoring
            • Access to Biomarker Tests
            • Chinese Payer Insight on Biomarker Tests
            • Catastrophic diseases coverage for oncology biomarker-driven therapies in example regions
        • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
          • Prescriber Preferences Among Current Therapies for EGFR Mutation-Positive NSCLC
            • Actual Patient Shares of First-Line Therapies for EGFR mutation-positive Advanced/Metastatic Non-Squamous NSCLC
            • Physicians’ First-line Choice in a Scenario of 100% Funding/Reimbursement
          • Prescriber Preferences Among Current Therapies for ALK Translocation-Positive NSCLC
            • Actual Patient Shares of First-Line Therapies for ALK translocation-positive Advanced/Metastatic Non-Squamous NSCLC
            • Physicians’ First-line Choice in a Scenario of 100% Funding/Reimbursement
          • Prescriber Preferences Among Current Therapies for HER2-Positive Breast Cancer
            • Actual Patient Shares of Treatments or Physicians’ Choice for HER2+ Advanced/Metastatic Breast Cancer
            • Physicians’ Choice in a Scenario of 100% Funding/Reimbursement
          • Prescriber Preferences Among Current Therapies for RAS Wild-Type mCRC
            • Actual Patient Shares of First-Line Therapies for RAS Wild-Type mCRC
            • Physicians’ First-line Choice in a Scenario of 100% Funding/Reimbursement
          • Impact of Payer Policy on Prescribing
            • Patient Access to Oncology Biomarker-Driven Therapies
          • Top Prescribing Drivers for Biomarker-Driven Oncology Therapies
            • Factors Driving Prescribing of Biomarker-Driven Therapies for NSCLC, Breast Cancer and CRC
          • Top Prescribing Drivers for Biomarker Tests
            • Factors Driving Prescribing of Biomarker-Driven Therapies for NSCLC, Breast Cancer and CRC
          • Key Levers and Constraints on Current Therapies
            • Payer Policy Uptake Constraints
            • Market Access Landscape for Emerging Therapies
              • Likely Impact of Emerging Therapies
                • Expected Patient Shares in the First-Line Setting One Year After the Launch of New Therapies
                • Treatment Most Likely to be Prescribed for HER2+ Breast Cancer One Year After the Launches of New Drugs
                • Expected Patient Share of Vectibix in RAS Wild-Type mCRC One Year After Its Launch
                • Average Expected Patient Shares of Branded Drugs and Biosimilar Versions By the End of 2019
                • Average Expected Patient Shares of Branded Drugs and Generic Versions By the End of 2019
              • Market Access Challenges for Emerging Therapies
                • Factors Limiting Prescribing of New Drugs for NSCLC One Year After Their Launches
                • Factors Limiting Prescribing of New Drugs for Breast Cancer One Year After Their Launches
              • Payer Opinion on Emerging Therapies
                • Chinese Payer Insight on Emerging Therapies for NSCLC
                • Chinese Payer Insight on Emerging Therapies for Breast Cancer
                • Chinese Payer Insight on Emerging Therapies for CRC
            • Methodology
              • Abbreviations in This Report
              • Primary Research Design
              • Background of Payers and Payer-Advising KOLs
              • Physician Demographics and Practice Setting
                • What is your specialty?
                • How many years have you practiced postresidency?
                • How many patients with the following tumor types do you treat per month?
                • In what city is your practice located?
                • What is your hospital type?
                • In which province is your practice located?
            • Appendix
              • Commercial Context
                • Diagnosed Incident Cases of NSCLC, Breast Cancer and CRC in China, 2015 and 2019
                • NSCLC
                • Breast Cancer
                • CRC
                • Treatment Algorithm of Advanced/Metastatic NSCLC in China
                • Treatment Algorithm of Breast Cancer in China
                • Treatment Algorithm of Metastatic CRC in China
                • Marketed Biomarker-Driven Therapies for NSCLC in China
                • Marketed Biomarker-Driven Therapies for Breast Cancer and CRC in China
                • Price per Cycle of Treatment for NSCLC, Breast Cancer and CRC in 2015
                • Approval of Biomarker-Driven Therapies for NSCLC, Breast Cancer and CRC in China
                • Near-Term Competitive Landscape for Emerging Biomarker-Driven Agents and Biosimilars/Generics
                • Afatinib (Gilotrif/Giotrif) (Boehringer Ingelheim)
                • Ceritinib (Zykadia; LDK-378) (Novartis)
                • Osimertinib (Tagrisso; AZD-9291) (AstraZeneca)
                • Neratinib (Puma Biotechnology)
                • Pertuzumab (Perjeta) (Roche)
                • Ado-trastuzumab emtansine (Kadcyla; T-DM1) (Roche)
                • Olaparib (Lynparza) (AstraZeneca)
                • Panitumumab (Vectibix) (Amgen)
              • Physician Survey Data
                • Commercial Insurance Coverage of Cancer Patients
                • Benefits of Commercial Insurance
                • Government Insurance Coverage for Biomarker-Driven Oncology Therapies
                • Possibility of PRDL Inclusion of Biomarker-Driven Oncology Therapies in Next Update
                • Oncologists’ Preference Regarding NRDL Inclusion of Biomarker-Driven Oncology Therapies
                • Reasons for Non Inclusion of Biomarker-Driven Oncology Therapies in the NRDL
                • Catastrophic Disease Coverage for Biomarker-Driven Oncology Therapies
                • Impact of Catastrophic Disease Coverage on Prescribing of Biomarker-Driven Oncology Therapies
                • Medicine Rate Targets
                • Impact of Medicine Rate Target on Prescribing of Biomarker-Driven Oncology Therapies
                • Impact of Zero Mark-Up Policy on Prescribing of Biomarker-Driven Oncology Therapies
                • Patients Not Treated with Biomarker-Driven Oncology Therapies for Cost/Budget/Reimbursement-Related Reasons
                • Reimbursement-Related Issues Limiting Prescribing of Biomarker-Driven Oncology Therapies
                • Coverage of Biomarker Tests’ Costs
                • Reimbursement Rate for Biomarker Tests Covered Under State Insurance
                • Factors Driving Prescribing of Biomarker-Driven Oncology Therapies
                • Patient Assistance Programs for Biomarker-Driven Oncology Therapies
                • Factors Limiting Patient Assistance Program Participation
                • Current Testing Rates for EGFR Mutation and ALK Translocation in NSCLC
                • Current Rate of Definitive Results for EGFR Mutation and ALK Translocation Tests
                • Reasons for Definitive Results Not Being Obtained for EGFR/ALK Testing in NSCLC
                • Average Waiting Time for EGFR Mutation and ALK Translocation Test Results
                • Timing of Testing for EGFR Mutation and ALK Translocation
                • Factors Restricting EGFR Mutation and ALK Translocation Tests in NSCLC
                • Drug Treatment Rates in Advanced/Metastatic NSCLC
                • Patient Shares of Treatments for First-Line NSCLC
                • Preferred First-Line Treatment for NSCLC Under a Scenario of 100% Reimbursement
                • Most Frequently Prescribed Sequential Treatment for EGFR Mutated and ALK Translocation-Positive NSCLC
                • Patient Shares of Branded Drugs vs. Generics by the End of 2019
                • Future Patient Shares for EGFR Inhibitors in EGFR Mutation-Positive NSCLC One Year After the Launch of Giotrif
                • Future Patient Shares for ALK Inhibitors in ALK Translocation-Positive NSCLC One Year After the Launch of Zykadia
                • Anticipated EGFR-T790M Mutation Testing Rate in NSCLC One Year After the Launch of Tagrisso
                • Expected Patient Share of Tagrisso in EGFR-T790M Mutation-Positive NSCLC One Year After Its Launch
                • Factors limiting Prescribing of Emerging Therapies for NSCLC
                • Current Testing Rate for HER2 Status in Breast Cancer
                • Timing of HER2 Test
                • Current Rate of Definitive Results for HER2 Test
                • Average Waiting Time for HER2 Test Results
                • Factors Restricting HER2 Test in Breast Cancer
                • Drug Treatment Rate in Advanced/Metastatic HER2+ Breast Cancer
                • Patient Shares of Treatments for Early Stage HER2+ Breast Cancer
                • Patient Shares of Treatments for Advanced/Metastatic HER2+ Breast Cancer in the First-Line of Therapy
                • Most Frequently Prescribed Sequential Treatment for Advanced/Metastatic HER2+ Breast Cancer
                • Preferred Treatment for Advanced/Metastatic HER2+ Breast Cancer Under a Scenario of 100% Reimbursement
                • Drug Treatment Rate in Early Stage HER2+ Breast Cancer
                • Anticipated Prescribing of Neratinib for HER2+ Breast Cancer One Year After Its Launch
                • Physician Perceptions of Perjeta in Combination of Herceptin for HER2+ Breast Cancer
                • Physician Perceptions of Kadcyla as Adjuvant Treatment for HER2+ Breast Cancer
                • Anticipated Prescribing for HER2+ Breast Cancer One Year After the Launches of Emerging Therapies
                • Current and Future BRCA1/2 Mutation Testing Rates in Breast Cancer
                • BRCA1/2 Screening Criteria in Breast Cancer If Lynparza is Approved
                • Anticipated Prescribing of Lynparza for BRCA1/2 Mutation-Positive Breast Cancer
                • Factors Limiting Prescribing of Emerging Therapies for Breast Cancer
                • Current Testing Rate for RAS Mutation in mCRC
                • Timing of RAS Mutation Test
                • Current Rate of Definitive Results for RAS Mutation Test
                • Average Waiting Time for RAS Mutation Test Results
                • Factors Restricting RAS Mutation Test in mCRC
                • Drug Treatment Rates in RAS Wild-Type mCRC
                • Patient Shares of Treatments for RAS Wild-Type mCRC
                • Preferred First-Line Treatment for RAS Wild-Type mCRC Under a Scenario of 100% Reimbursement
                • Anticipated Prescribing of Vectibix for RAS Wild-Type mCRC One Year After Its Launch
                • Factors Limiting Prescribing of Vectibix
                • Hospital Formulary Inclusions of Biosimilars by 2019
                • Hospital Policies Towards Prescribing of Biosimilars
                • Patient Shares of Branded Drugs vs. Biosimilars by the End of 2019

          Author(s): Michelle Qian Zhou, MBBS, PhD

          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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