Immune checkpoint inhibitors have entered multiple oncology indications but the high costs associated with these agents present significant challenges for payers. The potential for label expansions into additional indications and combinatorial approaches involving immune checkpoint inhibitors will put further pressure on MCO commercial plans. Developing a clear understanding of the reimbursement landscape and devising an effective market access strategy will be crucial for maximizing the commercial potential of immune checkpoint inhibitors. This content examines the current and future reimbursement dynamics for immune checkpoint inhibitors in the United States with a focus on key indications—NSCLC, malignant melanoma, renal cell carcinoma, and bladder cancer. We present an overview of the influence of payer reimbursement decisions on prescribing, and explore physician and payer opinions about emerging therapies in this drug class. In addition, we analyze future market access challenges and provide actionable recommendations for optimizing market access strategy.

Table of contents

  • Immune Checkpoint Inhibitors - Access & Reimbursement - Detailed, Expanded Analysis Bladder Cancer, Malignant Melanoma, Non-Small-Cell Lung Cancer And Renal Cell Carcinoma (US)
    • Actionable Recommendations to Optimize Market Access
      • Successes and Stumbles
        • Successes Among Immune Checkpoint Inhibitors in the United States
        • Stumbles Among Immune Checkpoint Inhibitors 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
              • Current Coverage Status of Immune Checkpoint Inhibitors by Commercial Plans
              • Expected Future Coverage of Immune Checkpoint Inhibitors by Commercial Plans
              • Factors Influencing Formulary Placement or Reimbursement of Immune Checkpoint Inhibitors
              • Impact of Biomarkers on Coverage Decisions for Immune Checkpoint Inhibitors
              • Key Findings
              • Restrictions Used in Commercial Plans
              • Key Restrictions
              • Prior Authorization Requirements for Immune Checkpoint Inhibitors Approved for Malignant Melanoma in Commercial Plans
              • Prior Authorization Requirements for Opdivo and Keytruda in NSCLC in Commercial Plans
              • Prior Authorization Requirements for Opdivo in Renal Cell Carcinoma in Commercial Plans
              • Prior Authorization Requirements for Tecentriq in Bladder Cancer in Commercial Plans
          • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
            • Patient Share in Commercially Insured Plans
              • Key Findings for Immune Checkpoint Inhibitors in Malignant Melanoma
              • Current and Anticipated Patient Share for High-Risk Stage III Resectable Malignant Melanoma
              • Patient Share for BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma in the First- and Second-Line Setting
              • Patient Share for BRAF-Wild-Type Unresectable or Metastatic Malignant Melanoma in the First- and Second-Line Setting
              • Key Findings for Immune Checkpoint Inhibitors in NSCLC
              • Patient Share of Opdivo for Previously Treated Metastatic NSCLC in the Second- and Third-Line Settings
              • Patient Share of Keytruda for Previously Treated Metastatic NSCLC by Line of Therapy and Histology
              • Use of Keytruda Prior to Its Approval for First-Line Metastatic NSCLC
              • Ease of Reimbursement of Keytruda in First-Line Metastatic NSCLC Prior to Its Approval for This Treatment Setting
              • Patient Share for Advanced/Metastatic Renal Cell Carcinoma in the First- and Second-Line Settings
              • Ease of Reimbursement of Opdivo in First-Line Advanced/Metastatic Renal Cell Carcinoma Prior to Approval for This Treatment Setting
              • Patient Share for Muscle-Invasive or Metastatic Bladder Cancer
              • Top Prescribing Drivers
              • Top Prescribing Drivers for Immune Checkpoint Inhibitors in Select Oncology Indications
              • Drivers of Higher Prescribing of Opdivo Than Keytruda for Previously Treated NSCLC
              • Drivers of Higher Prescribing of Keytruda Than Opdivo for Previously Treated Metastatic NSCLC
            • Prescriber Preference
              • Prescriber Preferences for Unresectable or Metastatic Malignant Melanoma
              • Prescriber Preferences for BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma in the First- and Second-Line Settings
              • Prescriber Preferences for BRAF-Wild-Type Unresectable or Metastatic Malignant Melanoma in the First- and Second-Line Settings
            • Impact of Payer Policy on Prescribing
              • Impact of Payer Policy on Prescribing of Immune Checkpoint Inhibitors for Select Oncology Indications
              • Impact of Payer Policy on Prescribing of Immune Checkpoint Inhibitors for Malignant Melanoma
              • Impact of Payer Policy on Prescribing of Opdivo and Keytruda for NSCLC
              • Impact of Payer Policy on Prescribing of Opdivo for Renal Cell Carcinoma
              • Impact of Payer Policy on Prescribing of Tecentriq for Bladder Cancer
              • Key Levers and Constraints: Role of Key Restrictions
          • Market Access Landscape for Emerging Therapies
            • Likely Impact of Emerging Therapy
              • Likely Impact of Emerging Immune Checkpoint Inhibitors for NSCLC
              • Impact of Tier Placement on Anticipated Prescribing of Tecentriq and Durvalumab for First-Line Metastatic NSCLC in 2020
              • Impact of Tier Placement on Anticipated Prescribing of Tecentriq, Durvalumab, and Avelumab for Second-Line Metastatic NSCLC in 2020
              • Likely Impact of Emerging Immune Checkpoint Inhibitors for Advanced Renal Cell Carcinoma
              • Impact of Tier Placement on Anticipated Prescribing of Keytruda, Tecentriq, and Avelumab for First-Line Advanced/Metastatic Renal Cell Carcinoma in 2020
              • Anticipated Sequential Treatment for Advanced/Metastatic Renal Cell Carcinoma in 2020
            • Potential Placement of Emerging Therapy at Various Prices
              • Potential Reimbursement of Emerging Immune Checkpoint Inhibitors for Select Oncology Indications
              • Expected Commercial MCO Coverage of Durvalumab for Metastatic NSCLC and Bladder Cancer
              • Expected Commercial MCO Coverage of Avelumab for Advanced or Metastatic NSCLC, Bladder Cancer, and Renal Cell Carcinoma
            • Prescriber and MCO Opinion on Remaining Unmet Need
              • Key Findings
              • Physician Advice on Pharma R&D Spending for Immune Checkpoint Inhibitors
          • Methodology
            • Abbreviations
            • Primary Market Research Methodology: Physicians
              • Practice Setting of Surveyed Oncologists
              • Postresidency Practice Experience
              • Average Number of Patients Treated per Month for Malignant Melanoma, NSCLC, Renal Cell Carcinoma, and Bladder Cancer
              • Agents Prescribed Outside of a Clinical Trial for Malignant Melanoma
              • Agents Prescribed Outside of a Clinical Trial for NSCLC
              • Agents Prescribed Outside of a Clinical Trial for Renal Cell Carcinoma
              • Agents Prescribed Outside of a Clinical Trial for Bladder Cancer
              • Distribution of Medical Practice by Region
              • Distribution of Medical Practice by State
              • Insurance Coverage of Malignant Melanoma, NSCLC, Renal Cell Carcinoma, and Bladder Cancer Patients
            • Primary Market Research Methodology: MCOs
              • Distribution of MCO Respondents by Job Title
              • Distribution of MCOs by Region
              • Distribution of MCOs by State
              • Operation 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 MCOs
          • Appendix
            • Physician Survey
              • Prescribing Drivers for Malignant Melanoma
              • Prescribing Drivers for NSCLC
              • Prescribing Drivers for Renal Cell Carcinoma
              • Prescribing Drivers for Bladder Cancer
              • Statement Agreement on Use of Opdivo Plus Yervoy for Malignant Melanoma
              • Reasons for Not Prescribing Opdivo Plus Yervoy for Malignant Melanoma
              • Statement Agreement on Immune Checkpoint Inhibitors for Malignant Melanoma
              • Statement Agreement on Use of Immune Checkpoint Inhibitors for NSCLC
              • Reasons for Not Prescribing Keytruda for NSCLC
              • Statement Agreement on Use of Immune Checkpoint Inhibitors for First-Line Metastatic NSCLC
              • Perception of Combinatorial Approaches Involving Immune Checkpoint Inhibitors for Metastatic NSCLC
              • Statement Agreement on Future Prescribing of Immune Checkpoint for Metastatic NSCLC
              • Willingness to Prescribe Immune Checkpoint Inhibitors for Unresectable Stage III NSCLC
              • Willingness to Prescribe Immune Checkpoint Inhibitors for Completely Resected Stage IB-IIA NSCLC
              • Statement Agreement on Use of Immune Checkpoint Inhibitors for Renal Cell Carcinoma
              • Statement Agreement on Use of Tecentriq for Advanced or Metastatic Bladder Cancer
              • Reasons for Not Yet Prescribing Tecentriq for Bladder Cancer
              • Percentage of Tecentriq Prescriptions Denied by Insurers for Bladder Cancer
              • Reasons for Denied Tecentriq Prescriptions for Bladder Cancer
              • Willingness to Prescribe Immune Checkpoint Inhibitors for Locally Advanced or Metastatic Bladder Cancer
              • Willingness to Re-Treat with an Immune Checkpoint Inhibitor Following Adjuvant Treatment
              • Off-Label Use of Yervoy Across Select Oncology Indications
              • Off-Label Use of Keytruda Across Select Oncology Indications
              • Off-Label Use of Opdivo Across Select Oncology Indications
              • Off-Label Use of Tecentriq Across Select Oncology Indications
              • Most Promising Treatment Strategies Involving Immune Checkpoint Inhibitors Across Select Oncology Indications
              • Aided Awareness of Novel Immune Checkpoint Targets
            • MCO Survey
              • Surveyed MCOs' Pharmacy and Therapeutics Committees
              • Formulary Type in Surveyed MCOs' Commercial Plans
              • Interim Coverage Status for New Immune Checkpoint Inhibitors
              • Planned Review of Immune Checkpoint Inhibitor Coverage by Commercial Plans
              • Review Time for Coverage of New Immune Checkpoint Inhibitors
              • Brand Deductible on Surveyed MCOs' Commercial Plans
              • Brand Deductible on Surveyed MCOs' Commercial Plans
              • Factors That Influence Re-evaluation of Immune Checkpoint Inhibitors on Commercial Plans
              • Reimbursement Status of Immune Checkpoint Inhibitors in Commercial Plans
              • Reasons for Moving Immune Checkpoint Inhibitors to a More-Favorable Coverage Status
              • Copayment for Current Immune Checkpoint Inhibitors on Commercial Plans
              • Coinsurance for Current Immune Checkpoint Inhibitors on Commercial Plans
              • Cost-Share for Current Immune Checkpoint Inhibitors Covered Under Medical Benefit
              • Copayment for Current Immune Checkpoint Inhibitors Covered Under Medical Benefit
              • Coinsurance for Current Immune Checkpoint Inhibitors Covered under Medical Benefit
              • Utilization Management Controls for Immune Checkpoint Inhibitors in Malignant Melanoma
              • Utilization Management Controls for Immune Checkpoint Inhibitors in NSCLC
              • Utilization Management Controls for Immune Checkpoint Inhibitors in Renal Cell Carcinoma
              • Utilization Management Controls for Immune Checkpoint Inhibitors in Bladder Cancer
              • Step Therapy Requirements for Opdivo and Keytruda in Squamous Metastatic NSCLC in Commercial Plans
              • Step Therapy Requirements for Opdivo and Keytruda in Non-Squamous Metastatic NSCLC in Commercial Plans
              • Step Therapy Requirements for Opdivo in Renal Cell Carcinoma in Commercial Plans
              • Step Therapy Requirements for Bladder Cancer in Commercial Plans
              • Perception of the Overall Clinical Profiles of Immune Checkpoint Inhibitors for Malignant Melanoma
              • Reimbursement of Opdivo and Yervoy When Used in Combination for Malignant Melanoma
              • Re-evaluation of Commercial MCO Coverage for Opdivo and Yervoy After Approval of Combination Therapy
              • Changes to Coverage of Opdivo and Yervoy After Approval of Combination Therapy
              • Restrictions on the Duration of Treatment with Yervoy as Adjuvant Therapy for Resectable Malignant Melanoma
              • Restrictions on the Duration of Treatment with Immune Checkpoint Inhibitors for First-Line Malignant Melanoma
              • Perception of the Overall Clinical Profiles of Opdivo and Keytruda for NSCLC
              • Expected Re-evaluation of Commercial MCO Coverage of Keytruda Upon Approval for First-Line Metastatic NSCLC
              • Expected Changes to Coverage of Keytruda After Approval for First-Line Metastatic NSCLC
              • Reimbursement of Companion Diagnostic for Keytruda in Metastatic NSCLC
              • Perception of the Overall Clinical Profile of Opdivo for Renal Cell Carcinoma
              • Perception of the Overall Clinical Profile of Tecentriq for Bladder Cancer
              • Preferred Comparator for an Emerging Therapy in Unresectable or Metastatic Malignant Melanoma
              • Preferred Comparator for an Emerging Therapy in Metastatic NSCLC
              • Preferred Comparator for an Emerging Therapy in Advanced/Metastatic Renal Cell Carcinoma
              • Preferred Comparator for an Emerging Therapy in Metastatic Bladder Cancer
              • Re-evaluation of Commercial MCO Coverage of Opdivo Following Successive Label Expansions
              • Changes to the Coverage of Opdivo on Commercial Plans Following Successive Label Expansions
              • Factors Most Influencing Reimbursement of Immune Checkpoint Inhibitors in Malignant Melanoma, NSCLC, Renal Cell Carcinoma, and Bladder Cancer
              • Expected Future Measures to Control the Cost of Cancer Immunotherapy
              • Most Compelling Pharmacoeconomic/Health Economic Outcomes Data for a New Immune Checkpoint Inhibitor
              • MCO Awareness of Companies’ Submission of Pharmacoeconomic/Health Economic Outcomes Data for Approved Immune Checkpoint Inhibitors in Malignant Melanoma
              • MCO Awareness of Companies’ Submission of Pharmacoeconomic/Health Economic Outcomes Data for Approved Immune Checkpoint Inhibitors in NSCLC
              • MCO Awareness of Companies’ Submission of Pharmacoeconomic/Health Economic Outcomes Data for Opdivo in Renal Cell Carcinoma
              • MCO Awareness of Companies’ Submission of Pharmacoeconomic/Health Economic Outcomes Data for Tecentriq in Bladder Cancer
              • Quality of the Pharmacoeconomic/Health Economic Outcomes Data Provided for Immune Checkpoint Inhibitors
              • Impact of Pharmacoeconomic/Health Economic Outcomes Data on the Coverage of Immune Checkpoint Inhibitors in Malignant Melanoma
              • Impact of Pharmacoeconomic/Health Economic Outcomes Data on the Coverage of Immune Checkpoint Inhibitors in NSCLC
              • Impact of Pharmacoeconomic/Health Economic Outcomes Data on the Coverage of Opdivo in Renal Cell Carcinoma
              • Impact of Pharmacoeconomic/Health Economic Outcomes Data on the Coverage of Tecentriq in Bladder Cancer

        Author(s): Evrim Gurpinar

        Evrim Gurpinar, Ph.D., is a Business Insights Analyst in the oncology team at Decision Resources Group.

        Prior to joining DRG, Evrim was a Postdoctoral Fellow at the Cancer Research UK Beatson Institute, where he studied the effects of p53 tumor suppressor mutations on cancer cell metabolism. He received his B.S. in Cell and Molecular Biology from Tulane University as a Fulbright Scholar and his Ph.D. from the University of Alabama at Birmingham School of Medicine. His PhD work entailed a preclinical drug development project to identify novel drug candidates for non-small cell lung cancer.


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