Biomarker-targeted therapies are distinguished from other oncology drugs in that they are accompanied by a diagnostic test that can identify a specific patient type most likely to benefit from therapy. This form of personalized medicine is well entrenched in the treatment of non-small-cell lung cancer and malignant melanoma, and is playing an increasingly important role in the management of patients with BRCA-mutant ovarian cancer. While biomarker-targeted therapies offer the advantage of selecting the patients most likely to respond to treatment, these therapies are premium priced and are often subject to payer restrictions. DRG explores the drivers and barriers associated with use of these agents and reports on how reimbursement impacts drug selection and prescribing. We also evaluate surveyed physicians’ and surveyed payers’ perceptions of emerging biomarker-targeted-therapies.

QUESTIONS ANSWERED

  • What factors most greatly influence payers’ reimbursement decisions for biomarker-driven therapies in NSCLC, malignant melanoma, and ovarian cancer? What restrictions do they impose?
  • Do access and reimbursement challenges differ by indication and/or how well established the biomarker is in each indication?
  • What roles do reimbursement, cost, and clinical factors play in oncologists’ decisions to prescribe biomarker-driven therapies?
  • What are payer opinions of emerging agents, and how will oncologists’ prescribing patterns change with the launch of new therapies?
  • What factors influence reimbursement and access of companion biomarker tests?

PRODUCT DESCRIPTION

Access & Reimbursement:

Provides in-depth insight regarding the impact of payer policy on physician prescribing behavior so you can build your market access strategy and optimize your brand positioning.

Table of contents

  • Biomarkers In Oncology - Access & Reimbursement - Detailed, Expanded Analysis (US)
    • Market Access Overview
      • Actionable Recommendations to Optimize Market Access
        • Successes and Stumbles
          • Overview of Successes and Stumbles for Select Biomarker-Targeted Therapies
          • Successes Among Select Biomarker-Targeted Therapies in the United States: Physicians
          • Stumbles Among Select Biomarker-Targeted Therapies in the United States: Physicians
          • Oncologists' Reported Best-Performing NSCLC Agents Based on Nonclinical Factors
          • Oncologists' Reported Best-Performing PARP Inhibitors in Ovarian Cancer Based on Clinical and Nonclinical Factors
          • Successes Among Select Biomarker-Targeted Therapies in the United States: MCOs
          • Stumbles Among Select Biomarker-Targeted Therapies in the United States - MCOs
        • Key Stakeholders in the Road to Market Access
          • Stakeholder Influence on Physician Prescribing
          • United States: Stakeholder Dynamics in the Road to Reimbursement
          • Healthcare Coverage in the United States
          • Healthcare Coverage in the United States
          • Major Commercial Insurers in the United States
        • Key Market Access Roadblocks
          • Reimbursement Dynamics
            • United States: Commercial Managed Care Organizations
              • Lessons Learned and Key Takeaways
              • Current Reimbursement of Select Therapies Treating NSCLC
              • Current Reimbursement of Select Therapies Treating Malignant Melanoma and Ovarian Cancer
              • Reimbursement of Select Therapies Treating NSCLC in 12 Months' Time
              • Reimbursement of Select Therapies Treating Malignant Melanoma and Ovarian Cancer in 12 Months' Time
              • Pricing and Reimbursement Drivers
              • Key Findings - P&R
              • Factors Influencing Formulary Placement of Anticancer Therapies
              • Factors Most Associated with Biomarker-Targeted Therapies in Oncology
              • Degree of Influence of Companion Diagnostic Tests on Formulary Decisions
              • Impact of Companion Diagnostic Tests on Coverage
              • Value Assessment and Pharmacoeconomics
              • Contracting Agreement for Biomarker-Targeted Therapies for NSCLC, Malignant Melanoma, and Ovarian Cancer
              • Cost Sharing for Key Biomarker-Targeted Therapies
              • Cost-Sharing Incentives to Use Preferred Drugs
              • Restrictions Affecting Treatment of NSCLC, Malignant Melanoma, and Ovarian Cancer
              • Restrictions Used in Commercial Plans: NSCLC
              • Restrictions Used in Commercial Plans: Malignant Melanoma
              • Restrictions Used in Commercial Plans: Ovarian Cancer
              • Impact of Prior Authorization on Biomarker-Targeted Therapies in NSCLC
              • Impact of Prior Authorization on Biomarker-Targeted Therapies in Malignant Melanoma
              • Impact of Prior Authorization on Biomarker-Targeted Therapies in Ovarian Cancer
          • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
            • Patient Share in Key Payer Channel
              • Key Findings for Biomarker-Targeted Therapies in NSCLC
              • Patient Share of Keytruda, PD-L1 Targeting First-Line Therapy for Advanced NSCLC Patients, 2017 and 2018
              • Patient Share of Treatments for First-Line Metastatic NSCLC, by EGFR-Mutation-Positive Biomarker-Defined Population
              • Key Findings for Biomarker-Targeted Therapies in Malignant Melanoma
              • Patient Share of Treatments for First-Line Malignant Melanoma
              • Key Findings for Biomarker-Targeted Therapies in Ovarian Cancer
              • Patient Share of Treatments in Previously Treated BRCA-Mutated Recurrent Ovarian Cancer
              • Top Prescribing Drivers
              • Clinical Factors Influencing Prescribing of a Biomarker-Driven Drug for NSCLC
              • Factors Strongly Influencing Prescribing of BRAF/MEK Combination Therapy as First-Line Treatment for Melanoma Patients
              • Factors Influencing Prescribing of Lynparza as Second-Line Treatment for Ovarian Cancer Patients
            • Prescriber Preference
              • Prescriber Preferences for NSCLC, Malignant Melanoma, and Ovarian Cancer
              • Top Therapies for First-Line Malignant Melanoma Patients in the Absence of Market Access Hurdles
            • Impact of Restrictions on Prescribing
              • Impact of Payer Policy on Prescribing for NSCLC, Malignant Melanoma, and Ovarian Cancer
              • Factors Limiting Prescription of Therapies to Commercial Malignant Melanoma Patients
              • Factors Limiting Prescription of Therapies to Commercial NSCLC Patients
              • Factors Limiting Prescription of Therapies to Commercial Ovarian Cancer Patients
          • Market Access Landscape for Emerging Therapies
            • Impact of Emerging Therapies on Prescribing
              • Likely Impact of Tier Placement on Lorlatinib Patient Share for First-Line, ALK-Translocation-Positive NSCLC
              • Current and Anticipated 2019 Patient Share of Agents Treating BRAF-Mutation-Positive Malignant Melanoma Patients Depending on Emerging Therapy Tier Status
              • Statement Agreement on the Future Use of Encorafenib Plus Binimetinib for Unresectable or Metastatic Malignant Melanoma
              • Oncologists' Opinion of Likely Uptake of Mirvetuximab Soravtansine in Ovarian Cancer
            • Potential Placement of Emerging Therapy at Various Prices
              • Potential Reimbursement of Emerging Therapies for NSCLC, Malignant Melanoma, and Ovarian Cancer
              • Potential Placement of Lorlatinib in ALK-Translocation-Positive NSCLC at Various Price Points
              • Potential Commercial Plan Expense Management Approaches for Encorafenib Plus Binimetinib
              • Potential Commercial Plan Utilization Management Approaches for Encorafenib Plus Binimetinib
              • Potential Placement of Mirvetuximab Soravtansine in Ovarian Cancer at Various Price Points
            • Prescriber and MCO Priorities for Emerging Therapy Evaluation
              • Key Findings
              • Key Attributes for Development of Emerging Biomarker-Driven Therapies in Oncology: Physicians
              • Key Attributes for Development of Emerging Biomarker-Driven Therapies in Oncology: MCOs
          • Methodology
            • Primary Market Research Methodology: Physicians
              • Specialty of Surveyed Oncologists
              • Postresidency Practice Experience
              • Practice Setting of Surveyed Oncologists
              • Average Number of Patients Treated per Month for NSCLC, Malignant Melanoma, and Ovarian Cancer
              • Distribution of Medical Practice by Region
              • Distribution of Medical Practice by State
              • Insurance Coverage of NSCLC, Malignant Melanoma, 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
              • Percentage of Advanced or Metastatic NSCLC Patients Tested for Various Biomarkers
              • Percentage of Advanced or Metastatic NSCLC Patients Tested for PD-L1 Biomarker, 2017 and 2018, by Line of Treatment
              • Percentage of EGFR-TKI-Pretreated Metastatic NSCLC Patients Tested for EGFR T790M Mutation
              • Percentage of Advanced or Metastatic NSCLC Patients Tested for BRAF Biomarker, 2017 and 2018, by Line of Treatment
              • Percentage of NSCLC Patients Tested for EGFR, ALK, and/or BRAF Biomarkers Using Only Blood-Based Test
              • Top Three Reasons Restricting Prescribing of Keytruda to First-Line NSCLC Patients
              • Patient Share of Treatments in Insured Previously Treated EGFR-T790M-Mutation-Positive Metastatic NSCLC
              • Patient Share of Treatments for First-Line Metastatic NSCLC, by ALK-Translocation-Positive Biomarker-Defined Population
              • Patient Share of Treatments in Xalkori-Treated, ALK-Translocation-Positive, Second-Line Metastatic NSCLC Patients
              • Top Reasons for Not Prescribing Alunbrig in ALK-Translocation-Positive, Xalkori-Treated, Second-Line Metastatic NSCLC Patients
              • Patient Share of Treatments for First-Line Metastatic NSCLC, by V600E-Mutation-Positive Biomarker-Defined Population
              • Top Reasons for Not Prescribing Tafinlar and Mekinist to All BRAF-Mutation-Positive, Metastatic NSCLC Patients
              • Nonclinical Factors Influencing Prescribing of a Biomarker-Driven Drug for NSCLC
              • Oncologists' Reported Best-Performing NSCLC Based on Clinical Factors
              • Percentage of Melanoma Patients Tested for BRAF Biomarker, by Disease Stage
              • Top Three Reasons for Not Testing Melanoma Patients for BRAF Mutation
              • Factors Restricting Use of Combination Therapy for First-Line BRAF-Mutation-Positive Melanoma Patients
              • Oncologists' Opinion of Clinical Development and Future Adjuvant Use of BRAF/MEK Inhibitors in Malignant Melanoma
              • Reasons Limiting Future Prescribing of Encorafenib Plus Binimetinib
              • Reasons Limiting Future Prescribing of Encorafenib Plus Binimetinib by Prescribers and Nonprescribers
              • Ovarian Cancer Patients Tested for Biomarker BRCA1/2
              • Percentage of Advanced Ovarian Cancer Patients Tested for Germline BRCA1/2 Mutation Using Different Tests Available in the Market
              • Oncologists' Opinion on Prescribing of Zejula as a Maintenance Treatment for Platinum-Sensitive Recurrent Ovarian Cancer
              • Oncologists' Opinion on Future Prescribing of Lynparza for Ovarian Cancer
              • Anticipated 2018 Prescribing of Lynparza in Ovarian Cancer Patients
              • Sources of Funding for Biomarker Testing in Metastatic NSCLC
              • Sources of Funding for Biomarker Testing in Malignant Melanoma
              • Sources of Funding for Biomarker Testing in Ovarian Cancer
              • Ease of Reimbursement for Biomarker Tests in NSCLC
              • Ease of Reimbursement for BRAF Mutation Biomarker Tests in Malignant Melanoma
              • Ease of Reimbursement for BRCA Mutation Biomarker Tests in Ovarian Cancer
              • Factors Restricting Biomarker Testing in NSCLC
              • Factors Restricting Biomarker Testing in Malignant Melanoma
              • Factors Restricting Biomarker Testing in Ovarian Cancer
              • Prescribing of Malignant Melanoma Therapies in the Absence of Cost or Utilization Constraints
              • Prescribing of NSCLC Therapies in the Absence of Cost or Utilization Constraints
              • Prescribing of Ovarian Cancer Therapies in the Absence of Cost or Utilization Constraints
              • Prior Authorization Requirements Limiting Prescription of Biomarker-Driven Therapies to Commercial Malignant Melanoma Patients
              • Prior Authorization Requirements Limiting Prescription of Biomarker-Driven Therapies to Commercial NSCLC Patients
              • Prior Authorization Requirements Limiting Prescription of Biomarker-Driven Therapies to Commercial Ovarian Cancer Patients
              • Agents Prescribed Outside of a Clinical Trial for NSCLC
              • Agents Prescribed Outside of a Clinical Trial for Malignant Melanoma
              • Agents Prescribed Outside of a Clinical Trial for Ovarian Cancer
            • MCO Survey
              • Internal vs. External Management of Formulary Development and Pharmaceutical Contracting
              • MCO Use of a Standard vs. Custom PBM Formulary
              • Degree of Customization with Custom Formulary
              • Most Influential Members of the P&T Committee
              • Items Needed for P&T Committee Review of Biomarker-Driven Cancer Drugs
              • Time to P&T Committee Review of a New Biomarker-Driven Cancer Drug
              • Use of Separate Tiers for Branded Drugs and Specialty Drugs
              • Switch to Separate Tiering in 12 Months
              • Medical Benefit Coverage of Key Biomarker-Targeted NSCLC Drugs on Commercial Plans
              • Medical Benefit Coverage of Key Biomarker-Targeted Drugs on Commercial Plans
              • Copay Differential Between Preferred and Nonpreferred Biomarker-Targeted Branded Drugs on Nonspecialty Tier
              • Coinsurance for Preferred and Nonpreferred Biomarker-Driven Branded Drugs on Nonspecialty Tier
              • Copay for Preferred and Nonpreferred Biomarker-Driven Branded Drugs on Nonspecialty Tier
              • Average Copays for Biomarker-Targeted Therapies on a Specialty Tier
              • Average Coinsurance for Biomarker-Targeted Therapies on a Specialty Tier
              • Restrictions Used for NSCLC Biomarker-Targeted Therapies in Commercial Plans
              • Restrictions Used for Malignant Melanoma Biomarker-Targeted Therapies in Commercial Plans
              • Restrictions Used for Ovarian Cancer Biomarker-Targeted Therapies in Commercial Plans
              • MCO Requests for Biomarker Testing Results for NSCLC
              • MCO Requests for Biomarker Testing Results for NSCLC, Malignant Melanoma, and Ovarian Cancer
              • MCO Biomarker Test Result Requirements
              • Likelihood of Funding for FDA-Approved Branded Biomarker Tests vs. Laboratory-Developed Biomarker Tests
              • Level of Reimbursement of Biomarker Tests
              • Use of Clinical Pathways for NSCLC, Malignant Melanoma, 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 for Oncologists Using Clinical Pathways in 12 Months' Time
              • Future Incentives for Oncologists to Encourage Compliance with Clinical Pathways
              • MCOs' Preferred Pharmacoeconomic Models

        Author(s): Niamh Buckley; Evrim Gurpinar

        Niamh Buckley Ph.D. is a senior director in the oncology team at Decision Resources Group where she manages a team of analysts in producing syndicated and custom primary and secondary market research on a wide range of oncology indications. She also provides sales and client support for all oncology products.

        Dr. Buckley has extensive experience in market access and forecasting across oncology and hematology-oncology drug markets She also has considerable experience in conducting primary research with physicians and payers throughout the major pharmaceutical markets. Prior to joining Decision Resources, Dr. Buckley worked as a postdoctoral scientist focusing on translational breast cancer research. She has a B.Sc. in biotechnology and obtained her Ph.D. in molecular oncology from Trinity College in Ireland.

        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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