Antibody drug conjugates (ADCs) are a class of drug therapies that combine the targeting abilities of monoclonal antibodies with the cancer-killing activities of cytotoxic agents. ADCs can potentially reduce the effect cytotoxic therapies have on healthy cells by delivering chemotherapy directly to cancer cells. Although their development has been tainted by product withdrawals (e.g., Pfizer’s Mylotarg [gemtuzumab ozogamicin] for the treatment of AML), the success of Genentech/Roche’s Kadcyla (trastuzumab emtansine; T-DM1) in HER2-positive breast cancer and the recent approval of Seattle Genetics’ Adcetris for relapsed Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma have rejuvenated the ADC drug class. The report captures the prescribers’ and payers’ opinion on market uptake of ADCs for breast cancer and hematological malignancies. While there is room for more efficacious and safer therapy options, devising a smart pricing strategy for novel ADCs will be crucial to ensure market access, secure reimbursement, maximize uptake, and realize commercial potential.

Table of contents

  • Antibody Drug Conjugates - Access & Reimbursement - Detailed, Expanded Analysis Breast Cancer, Hodgkin's Disease And Acute Lymphocytic Leukemia (US)
    • Actionable Recommendations to Optimize Market Access
      • Successes and Stumbles
        • Successes Among ADC Therapies in the United States
        • Stumbles Among ADC 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
              • Drivers of Reimbursement by MCOs of ADC Therapies for ALL
              • Drivers of Reimbursement by MCOs of ADC Therapies for Breast Cancer
              • Drivers
              • Key Findings
              • Restrictions Used for Hodgkin's Lymphoma and Breast Cancer in Commercial Plans
              • Cost-Control Measures for Key Therapies in Hodgkin's Lymphoma
              • Cost-Control Measures for Key Therapies in Breast Cancer
              • Key Restrictions
              • Impact of Prior Authorization on Hodgkin's Lymphoma and Breast Cancer Therapies
          • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
            • Patient Share of ADCs
              • Patient Share of Adcetris in Classical Hodgkin's Lymphoma
              • Patient Share of Key Classical Hodgkin's Therapies by Treatment Line
              • Physician Prescribing of Adcetris for Classical Hodgkin's Lymphoma by Treatment Setting
              • Proportion of Adcetris-Treated Classical Hodgkin's Lymphoma Patients by Treatment Setting
              • Patient Share of Kadcyla in HER2-Positive Metastatic Breast Cancer
              • Patient Share of Key Therapies for HER2-Positive Metastatic Breast Cancer by Line of Therapy
              • Reimbursement Status of Key HER2-Targeting Agents for Breast Cancer Therapy by Treatment Setting
            • Top Prescribing Drivers of ADCs
              • Top Prescribing Drivers of Adcetris for Classical Hodgkin's Lymphoma
              • Clinical Factors That Most Strongly Influence Prescribing of Adcetris for CHL Patients Experiencing Failure of Auto-HSCT
              • Clinical Factors That Most Strongly Influence Prescribing of Adcetris for CHL Patients' Post Auto-HSCT Consolidation
              • Clinical Factors Restricting Prescribing of Adcetris for CHL Patients Experiencing Failure of Auto-HSCT
              • Clinical Factors Restricting Prescribing of Adcetris for CHL Patients Post Auto-HSCT Consolidation
              • Top Prescribing Drivers of Kadcyla in HER2-Positive Metastatic Breast Cancer
              • Physician-Reported Factors Influencing Therapy Selection for Metastatic, HER2-Positive Breast Cancer Patients
              • Most Restrictive Non-Clinical Factors Impeding Oncologists' Ability to Prescribe Key HER2-Targeting Agents
            • Impact of Payer Policy on Prescribing of ADCs
              • Impact of Payer Policy on Prescribing of Adcetris for Classical Hodgkin's Lymphoma
              • Ease of Reimbursement of Adcetris by Treatment Setting
              • Percentage of Adcetris Prescriptions Denied by Treatment Setting
              • Reasons for Denial of Coverage for Adcetris Prescriptions by Insurers
              • Non-Clinical Factors Restricting Prescribing of Adcetris for Treatment of CHL Patients Experiencing Failure of Auto-HSCT
              • Non-Clinical Factors Restricting Prescribing of Adcetris for Treatment of CHL Patients Post Auto-HSCT Consolidation
              • Impact of Payer Policy on Prescribing of Kadcyla for Metastatic, HER2-Positive Breast Cancer
              • Ease of Reimbursement of Kadcyla by Treatment Setting
              • Kadcyla Prescriptions Denied by Insurers by Treatment Setting
              • Reasons for Denial of Coverage of Kadcyla Prescriptions by Insurers
              • Non-Clinical Factors Restricting Prescribing of Kadcyla
              • Key Levers and Constraints on Current Therapies: Role of Key Restrictions
          • Market Access Landscape for Emerging Therapies
            • Likely Impact of Emerging Therapy
              • Likely Impact of Tier Placement on Inotuzumab Ozogamicin's Patient Share for ALL
              • Oncologists' Opinion on Likely Uptake of Inotuzumab Ozogamicin for ALL
              • Likely Impact of Tier Placement on Glembatumumab Vedotin's and Sacituzumab Govitecan's Patient Share
              • Oncologists' Opinion on Likely Uptake of ADCs for Triple-Negative Breast Cancer
              • Impact of Availability of Companion Diagnostic Tests in Breast Cancer on Reimbursement for Glembatumumab Vedotin
            • Potential Placement of Emerging Therapy at Various Prices
              • Potential Reimbursement of Emerging ADC Therapies for ALL
              • Potential Placement of Inotuzumab Ozogamicin in ALL at Various Price Points
              • Potential Reimbursement of Emerging ADC Therapies for Breast Cancer
              • Potential Placement of Glembatumumab Vedotin in Triple-Negative Breast Cancer at Various Price Points
              • Potential Placement of Sacituzumab Govitecan in Triple-Negative Breast Cancer at Various Price Points
            • Prescriber and MCO Opinion on Remaining Unmet Need
              • Key Findings
              • Physicians' and MCOs' Advice on Pharma R&D Spending for New ADC Treatments in Oncology
          • Methodology
            • Primary Market Research Methodology: Physicians
              • Specialty of Surveyed Oncologists
              • Postresidency Practice Experience
              • Average Number of Patients with a Hematological Malignancy Treated per Month
              • Agents Prescribed Outside of a Clinical Trial for Classical Hodgkin's Lymphoma
              • Insurance Coverage of Classical Hodgkin's Lymphoma Patients
              • Average Number of Patients with Solid Tumors Treated per Month
              • Agents Prescribed Outside of a Clinical Trial for Breast Cancer
              • Insurance Coverage of Breast Cancer Patients
              • Practice Setting of Surveyed Oncologists
              • Practice Setting of Surveyed Oncologists: Hematologist Oncologists vs. Medical Oncologists
              • Distribution of Medical Practice by Region
              • Distribution of Medical Practice by Region: Hematologist Oncologists vs. Medical Oncologists
              • Distribution of Medical Practice by State
              • Distribution of Medical Practice by State: Hematologist Oncologists vs. Medical Oncologists
            • 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
              • Physicians' Level of Agreement with Statements Regarding ADCs
              • Level of Unmet Need for New Therapies: Hematologist Oncologists' Views
              • Level of Unmet Need for New Therapies: Medical Oncologists' Views
              • Reimbursement of Therapies for Classical Hodgkin's Lymphoma by Line of Therapy
              • Major Non-Clinical Factors Restricting Oncologists' Prescribing for Classical Hodgkin's Lymphoma
              • Proportion of Classical Hodgkin's Lymphoma Patients Treated by Subpopulation
              • Tumor Markers Included in Immunophenotyping Diagnostic Panels for Classical Hodgkin's Lymphoma Patients
              • Clinical Factors That Most Strongly Influence Oncologists' Prescribing for Classical Hodgkin's Lymphoma
              • Non-Clinical Factors That Most Strongly Influence Oncologists' Prescribing for Classical Hodgkin's Lymphoma
              • Performance of Therapies on Key Treatment Attributes for Relapsed or Refractory Classical Hodgkin's Lymphoma
              • Clinical Factors That Most Strongly Influence Prescribing of Adcetris for CHL Patients Requiring Pre-Transplant Induction Therapy
              • Clinical Factors Restricting Prescribing of Adcetris for CHL Patients Requiring Pre-Transplant Induction Therapy
              • Non-Clinical Factors Restricting Prescribing of Adcetris for CHL Patients Requiring Pre-Transplant Induction Therapy
              • Clinical Factors That Most Strongly Influence Prescribing of Adcetris for Systemic Anaplastic Large Cell Lymphoma
              • Clinical Factors Restricting Prescribing of Adcetris for Systemic Anaplastic Large Cell Lynphoma
              • Non-Clinical Factors Restricting Prescribing of Adcertis for Systemic Anaplastic Large Cell Lymphoma
              • Physicians' Level of Agreement with Statements Regarding Use of PD-1 Blocking Antibodies vs. Adcetris for CHL
              • Top Reasons Oncologists Do Not Expect to Prescribe Inotuzumab Ozogamicin for R/R Anaplastic Large Cell Lymphoma 12 Months After Launch
              • Major Non-Clinical Factors Restricting Oncologists' Prescribing for HER2-Positive Breast Cancer
              • HER2 Status-Testing Rates in Breast Cancer Patients by Treatment Setting
              • Performance of Therapies for HER2-Positive Metastatic Breast Cancer
              • Patient Characteristics Driving Prescribing of Kadcyla vs. Kadcyla + Perjeta
              • Clinical Factors Restricting Prescribing of Kadcyla vs. Kadcyla + Perjeta
              • Perceived Limitations Likely to Hinder Future ADC Prescribing for Triple-Negative Breast Cancer: Glembatumumab Vedotin vs. Sacituzumab Govitecan
              • Anticipated gpNMB Testing Rates After Glembatumumab Vedotin Launch
              • Physicians' Familiarity with ADCs in Development
              • Anticipated Performance of ADCs in Development: Physicians' Views
              • Ease of Reimbursement of Kadcyla and Kadcyla + Perjeta by Treatment Setting
              • Kadcyla and Kadcyla + Perjeta Prescriptions Denied by Insurers by Treatment Setting
              • Reasons for Denial of Coverage for Kadcyla and Kadcyla + Perjeta Prescriptions by Insurers
              • Non-Clinical Factors Restricting Prescribing of Kadcyla vs. Kadcyla + Perjeta
            • MCO Survey
              • Current Coverage Status of Key Therapies for CHL Included on Largest Commercial Risk-Based Plans
              • Expected Coverage of Key Therapies for Hodgkin's Lymphoma in 12 Months' Time
              • Current Coverage Status of Key Therapies for Breast Cancer Included on the Largest Commercial Risk-Based Plans
              • Number of Voting Members on MCOs' P&T Committee
              • Expected Coverage of Key Therapies for Breast Cancer in 12 Months' Time
              • Timing of Formulary Reviews for Cancer Therapies
              • Review Time for Coverage of New Cancer Therapies
              • Interim Coverage Status for New Cancer Therapies
              • P&T Committee Members with the Greatest Influence on Oncology Formulary Decisions
              • Items Needed for Formulary Review of Cancer Therapies
              • Formulary Type in Surveyed MCOs' Commercial Plans
              • Medical Benefit Coverage of Key Hodgkin's Lymphoma Therapies on Commercial Plans
              • Medical Benefit Coverage of Key Breast Cancer Therapies on Commercial Plans
              • Reasons to Move Key Hodgkin's Lymphoma Therapies to a More-Favorable Tier Status in Commercial Plans
              • Reasons to Move Key Breast Cancer Therapies to a More-Favorable Tier Status in Commercial Plans
              • Coverage Status of Key Hodgkin's Lymphoma Therapies Included on the Largest Medicare Advantage Plans
              • Coverage Status of Key Breast Cancer Therapies Included on the Largest Medicare Advantage Plans
              • Most Common Copay for Key Drugs for Hodgkin's Lymphoma and Breast Cancer Covered Under the Pharmacy Benefit
              • Most Common Coinsurance for Key Drugs for Hodgkin's Lymphoma and Breast Cancer Covered Under the Pharmacy Benefit
              • Percentage of MCOs with Drug Cost-Share Separate from Office Visit Copay
              • Most Common Copay Separate from Office Visit Coinsurance
              • Most Common Coinsurance Separate from Office Visit Coinsurance
              • Reasons for Excluding Key Therapies for Hodgkin's Lymphoma from Commercial Health Plans
              • Reasons for Excluding Key Therapies for Breast Cancer from Commercial Health Plans
              • Anticipated Future Requirement for Prior Authorization of Key Therapies for Hodgkin's Lymphoma and Breast Cancer in Next 12 Months
              • Prior Authorization Requirements for Key Therapies for Hodgkin's Lymphoma
              • Prior Authorization Requirements for Key Therapies for Breast Cancer
              • Number of Steps Required with Step Therapy for Key Therapies for Hodgkin's Lymphoma and Breast Cancer
              • Number of Weeks After Initial Hodgkin's Lymphoma and Breast Cancer Therapy Required for Seeking Reauthorization
              • Distribution Channels for Key Therapies for Hodgkin's Lymphoma and Breast Cancer in Commercial Plans
              • Use of Clinical Pathways for Classical Hodgkin's Lymphoma and Breast Cancer Now and in 12 Months' Time
              • Therapies for Hodgkin's Lymphoma Included in the Clinical Pathways Programs
              • Therapies for Breast Cancer Included in the Clinical Pathways Programs
              • MCOs' Anticipated Compliance Rate with Clinical Pathways in 12 Months' Time
              • Future Incentives for Oncologists to Encourage Compliance with Clinical Pathways
              • MCOs' Expectation of Leadership in Developing Clinical Pathways
              • Bundled Payments for ADC Therapies in Oncology
              • Compensation via Bundled Payments for ADC Therapies in Oncology in 12 and 24 Months’ Time
              • Current and Expected Reimbursement of Hodgkin's Lymphoma and Breast Cancer Therapies via Bundled Payment Program in Commercial Health Plans
              • Current and Expected Reimbursement of Hodgkin's Lymphoma and Breast Cancer Therapies via Bundled Payment Program in Medicare Plans
              • Current Inclusions for Bundled Payments for ADC Therapies in Oncology
              • Potential Placement of Inotuzumab Ozogamicin in ALL at Various Price Points
              • Potential Placement of Glembatumumab Vedotin in Triple-Negative Breast Cancer at Various Price Points
              • Potential Placement of Sacituzumab Govitecan in Triple-Negative Breast Cancer at Various Price Points
              • Most Compelling Pharmacoeconomic and Health Economic Outcomes Data for a New Oncology Agent
              • Expected Future Cost-Control Measures for ALL and Triple-Negative Breast Cancer ADC Therapies
              • Preferred Pharmacoeconomic Models for New Hodgkin's Lymphoma Therapies
              • Preferred Pharmacoeconomic Models for New Breast Cancer Therapies
              • Average Highest Acceptable ICER per QALY for a Drug in Hodgkin's Lymphoma
              • Minimum Number of Diagnosed Hodgkin's Lymphoma Plan Members Needed Before Requiring a Cost-Utility Model
              • Preferred Therapy for Proving Non-Inferiority and Lower Cost in Hodgkin's Lymphoma
              • Average Highest Acceptable ICER per QALY for a Drug in Breast Cancer
              • Minimum Number of Diagnosed Breast Cancer Plan Members Needed Before Requiring a Cost-Utility Model
              • Preferred Therapy for Proving Non-Inferiority and Lower Cost in Breast Cancer

        Author(s): Izabela Ammermann, PhD; Anamika Ghosh, Ph.D.

        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.

        Anamika Ghosh, Ph.D.,is a Senior Analyst for the oncology team at Decision Resources.

        Prior to joining DRG, Anamika was a Research Lead with Evalueserve Pvt. Ltd., a business solutions provider to pharmaceutical companies. At Evalueserve, she worked on various strategic insights solutions for a variety of indications, including oncology, cardiovascular, ophthalmology etc. Anamika holds a PhD on host-pathogen interactions in the context of M. tuberculosis from the International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, India, where she also worked as a Research Associate working on Dengue viral infection.


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