Biomarker-driven prescribing plays an increasingly prominent role in key oncology indications. The choice of therapy for breast cancer has long been informed by the presence of key biomarkers, and EGFR and ALK status are well-established markers for determining treatment in non-small-cell lung cancer (NSCLC). Treatment of ovarian cancer has only recently begun to benefit from this trend, but the role of biomarkers will continue to evolve in all three indications.

Table of contents

  • Biomarkers In Oncology - Access & Reimbursement - Detailed Expanded Analysis Biomarker In Oncology Breast Cancer, Non-Small-Cell Lung Cancer, Ovarian Cancer (US)
    • Actionable Recommendations to Optimize Market Access
      • Successes and Stumbles
        • Successes Among NSCLC Biomarker-Targeted Therapies in the United States
        • Successes Among Breast Cancer Biomarker-Targeted Therapies in the United States
        • Successes Among Ovarian Cancer Biomarker-Targeted Therapies in the United States
        • Stumbles Among NSCLC Biomarker-Targeted Therapies in the United States
        • Stumbles Among Breast Cancer Biomarker-Targeted Therapies in the United States
        • Stumbles Among Ovarian Cancer Biomarker-Targeted Therapies in the United States
        • United States: Reimbursement Successes and Stumbles
        • Key Stakeholders in the Road to Market Access
          • United States: Stakeholder Dynamics in the Road to Reimbursement
        • Key Market Access Roadblocks
          • Reimbursement Dynamics
            • United States: Commercial Managed Care Organizations
              • Lessons Learned and Key Takeaways
              • Influence of Companion Diagnostic Tests on Formulary Decisions
              • Influence of Companion Diagnostic Tests on Coverage Decisions for Biomarker-Targeted Therapies
              • Factors Associated with Biomarker-Targeted Therapies in Oncology
              • Key Findings
              • Restrictions Used for NSCLC Biomarker-Targeted Therapies in Commercial Plans
              • Restrictions Used for Breast Cancer and Ovarian Cancer Biomarker-Targeted Therapies in Commercial Plans
              • Cost-Control Measures for Biomarker-Targeted Therapies in NSCLC
              • Cost-Control Measures for Biomarker-Targeted Therapies in NSCLC (cont.)
              • Cost-Control Measures for Biomarker-Targeted Therapies in Breast and Ovarian Cancer
              • Key Restrictions
              • Impact of Prior Authorization on Biomarker-Targeted Therapies in NSCLC
              • Impact of Prior Authorization on Biomarker-Targeted Therapies in Breast Cancer and Ovarian Cancer
          • Pricing and Reimbursement, Policy, and Coverage - Impact on Prescribing
            • Patient Share in Commercially Insured Plans
              • Key Findings for Biomarker-Targeted Therapies in NSCLC
              • Patient Share of Treatments for First-Line Metastatic NSCLC, by Biomarker-Defined Populations
              • Patient Share of Tagrisso in Insured Previously Treated EGFR-T790M-Mutation-Positive Metastatic NSCLC
              • Key Findings for Biomarker-Targeted Therapies in Breast Cancer
              • Patient Share of Biomarker-Targeted Agents for HER2+ Metastatic Breast Cancer
              • Key Findings for Biomarker-Targeted Therapies in Ovarian Cancer
              • Patient Share of Treatments for Advanced Ovarian Cancer
              • Top Prescribing Drivers
              • Clinical Factors Influencing Prescribing of Tarceva for Newly Diagnosed EGFR-Mutation-Positive Metastatic NSCLC
              • Clinical Factors Influencing Prescribing of Gilotrif for Newly Diagnosed EGFR-Mutation-Positive Metastatic NSCLC
              • Clinical Factors Influencing Prescribing of Iressa for Newly Diagnosed EGFR-Mutation-Positive Metastatic NSCLC
              • Factors Restricting Prescribing of Tagrisso in EGFR-T790M-Mutated, EGFR TKI-Treated Metastatic NSCLC
              • Factors Influencing Selection of Zykadia or Alecensa
              • Factors Restricting Prescribing of Keytruda in PD-L1-Positive, EGFR-Wild Type/Unknown and ALK-Translocation-Negative Second-Line Metastatic NSCLC
              • Hospital-Based Physicians: Factors Restricting Prescribing of Herceptin + Perjeta + Chemotherapy in the Neoadjuvant and Metastatic Breast Cancer Settings
              • Office-Based Physician: Factors Restricting Prescribing of Herceptin + Perjeta + Chemotherapy in the Neoadjuvant and Metastatic Breast Cancer Settings
              • Factors Restricting Prescribing of Lynparza for Advanced Ovarian Cancer
            • Prescriber Preference
              • Prescriber Preferences for NSCLC and Breast Cancer
              • Most-Preferred Therapies for ALK-Translocation-Positive, Xalkori-Treated Metastatic NSCLC
              • Most-Preferred Therapies for HER2+ Metastatic Breast Cancer, by Line of Therapy
            • Impact of Payer Policy on Prescribing
              • Impact of Payer Policy on Prescribing for NSCLC
              • Physician-Reported Most Important Restrictions on Prescribing of Biomarker-Targeted Agents for Metastatic NSCLC
              • Physician-Reported Most Important Restrictions on Prescribing of Biomarker-Targeted Agents for Metastatic NSCLC (cont.)
              • Impact of Payer Policy on Prescribing for Breast Cancer and Ovarian Cancer
              • Physician-Reported Most Important Restrictions on Prescribing of Biomarker-Targeted Agents for Metastatic Breast Cancer and Advanced Ovarian Cancer
              • Key Levers and Constraints: Role of Key Restrictions
          • Market Access Landscape for Emerging Therapies
            • Likely Impact of Emerging Therapy
              • Likely Impact of Emerging Therapies for NSCLC
              • Likely Impact of Tier Placement on Selumetinib and Tafinlar plus Mekinist's Patient Share for KRAS and BRAF-V600E-Mutation-Positive NSCLC
              • Oncologists' Opinion of Likely Uptake of BRAF/MEK Inhibitors for Metastatic NSCLC
              • Likely Impact of Emerging Therapies for Breast Cancer
              • Likely Impact of Tier Placement on Niraparib and Lynparza's Patient Share for Germline BRCA1/2-Mutation-Positive HER2-Negative Breast Cancer
              • Oncologists' Opinion of Likely Uptake of PARP Inhibitors for Metastatic Breast Cancer
              • Likely Impact of Emerging Therapies for Ovarian Cancer
              • Likely Impact of Tier Placement on Niraparib's and Rucaparib's Patient Share for BRCA1/2-Mutation-Positive and BRCA-Like Advanced Ovarian Cancer
            • Potential Placement of Emerging Therapy at Various Prices
              • Potential Reimbursement of Emerging Therapies for NSCLC
              • Potential Placement of Selumetinib in KRAS-Mutation-Positive NSCLC at Various Price Points
              • Potential Reimbursement of Emerging Therapies for Breast Cancer
              • Potential Placement of Niraparib in HER2-Negative Germline BRCA-Mutation-Positive Breast Cancer at Various Price Points
              • Potential Reimbursement of Emerging Therapies for Ovarian Cancer
              • Potential Placement of Rucaparib in BRCA-Mutated and BRCA-Like Ovarian Cancer at Various Price Points
            • Prescriber and MCO Opinion on Remaining Unmet Need
              • Key Findings
              • Physician Advice on Pharma R&D Spending for New Biomarker-Targeted Treatments in Oncology
              • MCO Advice on Pharma R&D Spending for New Biomarker-Targeted Treatments in Oncology
          • Methodology
            • Abbreviations
            • Primary Market Research Methodology - Physicians
              • Specialty of Surveyed Oncologists
              • Postresidency Practice Experience
              • Average Number of Patients Treated per Month for NSCLC, Breast Cancer, and Ovarian Cancer
              • Agents Prescribed Outside of a Clinical Trial for NSCLC
              • Agents Prescribed Outside of a Clinical Trial for Breast Cancer and Ovarian Cancer
              • Practice Setting of Surveyed Oncologists
              • Distribution of Medical Practice by Region
              • Distribution of Medical Practice by State
              • Insurance Coverage of NSCLC, Breast Cancer, and Ovarian Cancer Patients
            • Primary Market Research Methodology - MCOs
              • Distribution of MCO Respondents by Job Title
              • Distribution of MCOs by Region
              • Distribution of MCOs by State
              • Operations of MCOs: National, Regional, or Single State
              • Types of Health Plans Offered by MCOs
              • Distribution of MCOs by Number of Covered Lives
              • Average Number of Lives Managed by Surveyed MCOs
          • Appendix
            • Physician Survey
              • Reimbursement of Biomarker-Targeted Agents in Metastatic NSCLC
              • Reimbursement of Biomarker-Targeted Agents in Metastatic Breast Cancer
              • Reimbursement of Lynparza for Advanced Ovarian Cancer
              • NSCLC, Breast Cancer, and Ovarian Cancer Therapies Reimbursed Under Bundled Payment Arrangements
              • Current Rate of Testing for Biomarkers in Patients with Newly Diagnosed Metastatic NSCLC
              • Current Rate of Testing for PD-L1 Expression in Patients with Previously Treated Metastatic NSCLC
              • PD-L1 Expression Testing in Patients with Previously Treated Metastatic NSCLC
              • Current Rate of Testing for EGFR T790M Mutation in EGFR-TKI-Pretreated Patients with Metastatic NSCLC
              • EGFR T790M Mutation Testing in EGFR-TKI-Pretreated Patients with Metastatic NSCLC
              • Retesting Rates for Molecular Characteristics Following Disease Progression in NSCLC
              • Reasons Why Some NSCLC Patients Are Not Retested
              • Current Rate of Blood-Based EGFR-Mutation and ALK-Translocation Testing in Metastatic NSCLC
              • Sources of Funding for Biomarker Testing in Metastatic NSCLC
              • Factors Restricting EGFR Mutation Testing in Metastatic NSCLC
              • Factors Restricting EGFR T790M Mutation Testing in Metastatic NSCLC
              • Factors Restricting ALK Translocation Testing in Metastatic NSCLC
              • Factors Restricting ROS1 Translocation Testing in Metastatic NSCLC
              • Factors Restricting PD-L1 Expression Testing in Metastatic NSCLC
              • Current Rate of Testing for BRCA1/2 Mutation in Patients with Metastatic Breast Cancer
              • Factors Influencing BRCA1/2 Mutation Testing in Metastatic Breast Cancer
              • Proportion of Herceptin/Perjeta/Chemotherapy Prescriptions Denied by Insurers in the Neoadjuvant and Metastatic Breast Cancer Settings
              • Reasons Why Herceptin/Perjeta/Chemotherapy Prescriptions Are Denied by Insurers
              • Ease of Reimbursement for Perjeta/Herceptin/Chemotherapy in the Neoadjuvant and Metastatic Breast Cancer Settings
              • Current and Anticipated 2018 BRCA1/2 Mutation Testing Rates in Metastatic Breast Cancer
              • Current Rate of Testing for BRCA1/2 Mutation in Patients with Advanced Ovarian Cancer
              • Germline BRCA1/2 Mutation Testing in Patients with Advanced Ovarian Cancer
              • Funding for BRCA1/2 Biomarker Testing in Advanced Ovarian Cancer
              • Factors Restricting BRCA1/2 Mutation Testing in Advanced Ovarian Cancer
              • Proportion of Lynparza Prescriptions Denied by Insurers in Advanced Ovarian Cancer
              • Reasons Why Lynparza Prescriptions Are Denied by Insurers
              • Ease of Reimbursement of Lynparza in Advanced Ovarian Cancer
              • Anticipated BRCA1/2 Mutation Testing Rates in Advanced Ovarian Cancer in 2018
            • MCO Survey
              • Number of Voting Members on MCO's P&T Committee
              • Timing of Formulary Reviews for Biomarker-Targeted Cancer Therapies
              • P&T Committee Members with the Greatest Influence on Oncology Formulary Decisions
              • Items Needed for Formulary Review of Biomarker-Targeted Therapies
              • Formulary Tier Structure of MCO's Largest Commercial and Medicare Advantage Plans
              • Coverage Status of Key Metastatic Breast Cancer and Advanced Ovarian Cancer Biomarker-Targeted Therapies Included on the Largest Commercial Risk-Based Plans
              • Coverage Status of Key Metastatic NSCLC Biomarker-Targeted Therapies Included on the Largest Commercial Risk-Based Plans
              • Medical Benefit Coverage of Key Biomarker-Targeted Agents on Commercial Plans
              • Formulary Tiering for Biomarker-Targeted Agents on Largest Risk-Based Commercial Plans
              • Reasons to Move Biomarker-Targeted Therapies for Metastatic Breast Cancer and Advanced Ovarian Cancer to More-Favorable Tier Status in Commercial Plans
              • Reasons to Move Biomarker-Targeted Therapies for Metastatic NSCLC to More-Favorable Tier Status in Commercial Plans
              • Reasons for Excluding Biomarker-Targeted Therapies for Metastatic Breast Cancer and Advanced Ovarian Cancer from Commercial Health Plans
              • Reasons for Excluding Biomarker-Targeted Therapies for Metastatic NSCLC from Commercial Health Plans
              • Expected Coverage of Biomarker-Targeted Therapies for NSCLC, Breast Cancer, and Ovarian Cancer in 12 Months' Time
              • Coverage Status of Biomarker-Targeted Therapies Included on the Largest Medicare Advantage Plans
              • Most Common Coinsurance for Biomarker-Targeted Drugs for NSCLC, Breast Cancer, and Ovarian Cancer Covered Under the Pharmacy Benefit
              • Most Common Copay for Biomarker-Targeted Drugs for NSCLC, Breast Cancer, and Ovarian Cancer Covered Under the Pharmacy Benefit
              • Percentage of MCOs with Drug Cost Share Separate from Office Visit Copay
              • Most Common Coinsurance Separate from Office Visit Coinsurance
              • Most Common Copay Separate from Office Visit Copay
              • Anticipated Future Requirement for Prior Authorization for Biomarker-Targeted Therapies in the Next 12 Months
              • Prior Authorization Requirements for Biomarker-Targeted Therapies for NSCLC
              • Prior Authorization Requirements for Biomarker-Targeted Therapies for Breast Cancer and Ovarian Cancer
              • Number of Steps Required with Step Therapy for Biomarker-Targeted Agents for NSCLC, Breast Cancer, and Ovarian Cancer
              • Distribution Channels for Biomarker-Targeted Therapies for NSCLC, Breast Cancer, and Ovarian Cancer in Commercial Plans
              • Importance of Specialty Pharmacy Services Used for Biomarker-Targeted Therapies for NSCLC, Breast Cancer, and Ovarian Cancer
              • Requests for Biomarker Testing Results for NSCLC, Breast Cancer, and Ovarian Cancer by MCO PDs/MDs
              • MCO Enforcement of Biomarker Testing
              • Likelihood of Funding for FDA-Approved Branded Biomarker Tests vs. Laboratory-Developed Biomarker Tests
              • Level of Reimbursement for Biomarker Tests
              • Level of Reimbursement for the PD-L1 IHC 28-8 PharmDx Test for Keytruda-Treated NSCLC Patients
              • Use of Clinical Pathways for NSCLC, Breast Cancer, and Ovarian Cancer Now and in 12 Months' Time
              • Inclusion of Biomarker Tests in Clinical Pathways Programs Now and in 12 Months' Time
              • MCOs' Anticipated Compliance Rate with Clinical Pathways in 12 Months' Time
              • Future Incentives for Oncologists to Encourage Compliance with Clinical Pathways
              • MCO Expectation of Leadership in Developing Clinical Pathways
              • Bundled Payments for Biomarker-Targeted Therapies in Oncology
              • Compensation via Bundled Payments for Biomarker-Targeted Therapies in Oncology in 12 and 24 Months’ Time
              • Current and Expected Reimbursement of Biomarker-Targeted Therapies via the Bundled Payment Program
              • Current Inclusions for Bundled Payments for Biomarker-Targeted Therapies in Oncology
              • Impact of the Availability of a Companion Diagnostic Test in NSCLC on the Reimbursement of MEK Inhibitors
              • Expected Future Cost-Control Measures for NSCLC, Breast Cancer, and Ovarian Cancer Biomarker Therapies

        Author(s): Izabela Ammermann, PhD; Laura Vinuesa, DVM, MSc

        Izabela Ammermann, Ph.D., M.Sc., is a business insights analyst in the oncology division at Decision Resources Group. She is a specialist in multiple myeloma and pancreatic cancer and has expertise in chronic lymphocytic leukemia. Dr. Ammermann holds a Ph.D. in molecular biology from the Technical University of Munich and a M.Sc. in biotechnology from the Polish Academy of Sciences. Prior to joining Decision Resources Group, Dr. Ammermann worked as a postdoctoral research associate (Marie Curie research fellow) at Imperial College London. Dr. Ammermann has published several peer-reviewed papers.

        Laura Vinuesa, DVM, M.Sc., is a Senior Business Insights Analyst in the Oncology Division at Decision Resources Group, with expertise in thyroid carcinoma and bladder cancer. Previously, Dr. Vinuesa was an EU Market Access Analyst in the Global Market Access Insights Team at Decision Resources Group. She has expertise in market access, pricing and reimbursement, health technology assessment, and health policy.

        Prior to joining Decision Resources, she worked as Market Access & Institutional Relations Analyst at Pfizer in Spain, providing support for the successful market launch of drugs for different areas: cardiovascular, oncology, mental disorder and rare disease. She is a Doctor of Veterinary Medicine from the Complutense University of Madrid, and holds a M.Sc. in Clinical Research and Pharmaceutical Medicine from EPHOS - School of PharmaStudies.

        lvinuesa@TeamDRG.com


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