Malignant Melanoma – Access & Reimbursement – Detailed, Expanded Analysis (US)

Combination therapies are transforming the malignant melanoma treatment landscape, raising the efficacy bar for emerging therapies. However, combination therapies have increased the cost of malignant melanoma treatment and drug manufacturers are under increasing pressure to justify the value of their therapy. In order to optimize market access, manufacturers need to understand the reimbursement dynamics in this market (e.g. the impact of payer-imposed restrictions, risk-sharing agreements, and patient assistance programs) and draw on insights from the successes and setbacks of current key malignant melanoma brands.

Table of contents

  • Malignant Melanoma - Access & Reimbursement - Detailed, Expanded Analysis (US)
    • Overview
      • Commercial MCO Reimbursement of Key Malignant Melanoma Drugs
        • Current Coverage of Malignant Melanoma Drugs by MCOs
        • Future Coverage of Malignant Melanoma Drugs by MCOs in 12 Monthsu2019 Time
      • Current and Expected Commercial MCO Reimbursement of Malignant Melanoma Combination Therapies
        • Current Reimbursement of Malignant Melanoma Combination Therapies
        • Anticipated Coverage of Combination Therapies in 12 Monthsu2019 Time If Different from Current Coverage
    • Actionable Recommendations to Optimize Market Access
      • Actionable Recommendations to Optimize Market Access for New Malignant Melanoma Therapies in the U.S.
    • Successes and Stumbles
      • Successes and Stumbles Among Malignant Melanoma Therapies in the United States
      • United States: Reimbursement Successes and Stumbles
        • Reimbursement Successes or Stumbles for Commercial Plans
    • Key Stakeholders in the Road to Market Access
      • Key Stakeholders in the Path to Formulary Access
      • Stakeholder Dynamics on the Road to Reimbursement
    • Key Market Access Roadblocks
      • Key Market Access Roadblocks for Malignant Melanoma Therapies in the U.S.
    • Reimbursement Dynamics
      • United States: Commercial Managed Care Organizations
        • Lessons Learned and Key Takeaways
        • Reimbursement Criteria and Background
        • Key P&R Drivers
        • Restrictions for Commercial Plans
        • Restrictions Used in Commercial Plans for Malignant Melanoma Brands
    • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
      • Patient Share
        • Most Influential Factors Driving Surveyed Oncologistsu2019 Prescribing of Unresectable or Metastatic Malignant Melanoma Therapies
        • Current and Anticipated Patient Share for Resected Stage III Malignant Melanoma
        • Ease of Reimbursement of Current Payer-Reimbursed Off-Label Use of Adjuvant Yervoy (3 mg/kg)
        • Patient Share of Therapies for BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma
        • Patient Share of Therapies for BRAF Wild-Type Unresectable or Metastatic Malignant Melanoma
      • Prescriber Preference
        • Patient Share of Current Therapies
        • Surveyed Oncologistsu2019 Most-Preferred Therapies
        • Patient Share of Current Therapies
        • Surveyed Oncologistsu2019 Most-Preferred Therapies
      • Impact of Payer Policy on Prescribing
        • Physician-Reported Nonclinical Prescribing Restrictions in Malignant Melanoma
    • Market Access Landscape for Emerging Therapies
      • Likely Impact of Emerging Therapy
        • Expected Patient Shares for Binimetinib for NRAS-Mutation-Positive Malignant Melanoma 12 Months After Launch
        • Expected Patient Shares for BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma in 2017
        • Expected Coverage of Binimetinib for Unresectable or Metastatic NRAS-Mutation-Positive Malignant Melanoma1
        • Expected Coverage of Encorafenib for Unresectable or Metastatic BRAF-Mutation-Positive Malignant Melanoma1
        • Expected Sequence of Therapies for BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma in 2020
        • Expected Sequence of Therapies for BRAF Wild-Type Unresectable or Metastatic Malignant Melanoma in 2020
    • Appendix
      • Physician Survey
        • Procurement of Key Therapies for Malignant Melanoma
        • Physicians: Malignant Melanoma Therapies Reimbursed Under Bundled Payment Arrangements
        • Physicians: Impact of Bundled Payments on Malignant Melanoma Therapy Prescribing
        • Physicians: Expected Procurement of Malignant Melanoma Therapies in Two Yearsu2019 Time
        • Physicians: Molecular Testing for Resectable and Unresectable Malignant Melanoma
        • Physicians: Reimbursement of Key Malignant Melanoma Therapies by Line of Therapy
        • Physicians: Nonclinical Factors Restricting Prescribing of Key Malignant Melanoma Therapies
        • Physicians: Patient Share of Key Adjuvant Therapies for Resected Stage III Malignant Melanoma
        • Physicians: Ease of Reimbursement for Off-Label Adjuvant Use of Yervoy at 3 mg/kg
        • Physicians: Anticipated Patient Share of Key Adjuvant Therapies for Resected Stage III Malignant Melanoma in 2020
        • Physicians: Decision to Re-Treat with Adjuvant Therapies in the Unresectable or Metastatic Setting Following Disease Recurrence
        • Physicians: Patient Characteristics Indicating Likely Clinical Deterioration Within 12 Weeks
        • Physicians: Patient Share of Key Therapies for BRAF-Mutation-Positive Unresectable or Metastatic Malignant Melanoma
        • Physicians: Evidence of Disease Stability to Secure First-Line Reimbursement for Opdivo or Keytruda
        • Physicians: Ease of Reimbursement for Off-Label Use of Opdivo for Previously Untreated BRAF Mutation-Positive Malignant Melanoma
        • Physicians: Ease of Reimbursement for Opdivo plus Yervoy for BRAF Mutation-Positive Malignant Melanoma by Line of Therapy
        • Physicians: Patient Share of Key Therapies for BRAF Wild-type Unresectable or Metastatic Malignant Melanoma
        • Physicians: Ease of Reimbursement for Keytruda for Previously Untreated Malignant Melanoma, by BRAF Mutational Status
        • Physicians: Preferred Therapy by Line of Treatment for BRAF-Mutation-Positive Malignant Melanoma
        • Physicians: Preferred Therapy by Line of Treatment for BRAF Wild-Type Malignant Melanoma
        • Physicians: Treatment Durations of Key Therapies for Unresectable or Metastatic Malignant Melanoma
        • Physicians: Reasons for Treating for a Fixed Duration of Treatment with Key Malignant Melanoma Therapies
        • Physicians: Influential Factors in Prescribing for Unresectable or Metastatic Malignant Melanoma
        • Physicians: Perceived Performance of Single-Agent Anti-PD-1 Therapies vs. Opdivo plus Yervoy on Clinical Attributes
        • Physicians: Perceived Performance of BRAF/MEK Inhibitor Combination Therapies on Clinical Attributes
        • Physicians: Perceived Performance of BRAF/MEK Inhibitor Combination Therapy vs. Opdivo plus Yervoy on Clinical Attributes
        • Physicians: Perceived Performance of Single-Agent BRAF Inhibitors vs. BRAF/MEK Inhibitor Combinations on Clinical Attributes
        • Physicians: Perceived Performance of Single-Agent Anti-PD-1 Therapies vs. Opdivo plus Yervoy on Nonclinical Attributes
        • Physicians: Perceived Performance of BRAF/MEK Inhibitor Combination Therapies on Nonclinical Attributes
        • Physicians: Perceived Performance of BRAF/MEK Inhibitor Combinations vs. Opdivo plus Yervoy on Nonclinical Attributes
        • Physicians: Perceived Performance of Single-Agent BRAF Inhibitors vs. BRAF/MEK Inhibitor Combinations on Nonclinical Attributes
        • Physicians: Opinion of Opdivo plus Yervoy for the Treatment of Unresectable or Metastatic Malignant Melanoma
        • Physicians: Proportion of Opdivo plus Yervoy Combination Prescriptions Denied by Insurers
        • Physicians: Reasons Why Opdivo plus Yervoy Combination Prescriptions Denied by Insurers
        • Physicians: Opinion of Imlygic
        • Physicians: Opinion of Imlygic in Combination with Keytruda
        • Physicians: Opinion of BRAF/MEK Inhibitor Combination Therapy
        • Physician: Anticipated Impact of Cotellic in Combination with Zelboraf on Prescribing of Other BRAF/MEK Therapies
        • Physicians: Reasons for Not Prescribing Zelboraf plus Cotellic Combination Therapy
        • Physicians: Intention to Prescribe Cotellic in Combination with Zelboraf Within the Next Six Months
        • Physicians: Minimal Acceptable Trial Primary End Point for FDA Approval and Reimbursement of a New First-Line Therapy
        • Physicians: Minimal Acceptable Trial Comparator for FDA Approval and Reimbursement of a New First-Line Therapy
        • Physicians: Minimal Acceptable Improvement over Comparator for FDA Approval and Reimbursement of a New First-Line Therapy
        • Physicians: Impact of Tier Placement on Anticipated Prescribing of Single-Agent Binimetinib
        • Physicians: Opinion of Binimetinib as a Single Agent
        • Hospital-Based Physicians: Impact of Binimetinib and Encorafenib Tier Placement on Anticipated Prescribing of Key Therapies
        • Office-Based Physicians: Impact of Binimetinib and Encorafenib Tier Placement on Anticipated Prescribing of Key Therapies
        • Physicians: Opinion of Binimetinib plus Encorafenib Combination Therapy
        • Physicians: Anticipated Sequential Treatment of BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma in 2020
        • Physicians: Anticipated Sequential Treatment for BRAF Wild-Type Unresectable or Metastatic Malignant Melanoma in 2020
        • Physicians: Prioritization of Major Pharmaceutical Company R&D Spending for Malignant Melanoma
      • MCO Survey
        • MCOs: Formulary Coverage and Tier Placement of Key Malignant Melanoma Drugs on Commercial Plans
        • MCOs: Medical Benefit Coverage of Key Malignant Melanoma Drugs on Commercial Plans
        • MCOs: Expected Future Coverage of Key Malignant Melanoma Drugs by Commercial Plans
        • MCOs: Reasons to Move Malignant Melanoma Drugs to a More Favorable Tier Status in Commercial Plans
        • MCOs: Reasons for Excluding Malignant Melanoma Drugs from Commercial Health Plans
        • MCOs: Coinsurance or Copayment for Current Malignant Melanoma Drugs on Commercial Plans
        • MCOs: Coinsurance Charge or Copayment Amount Levied for Current Malignant Melanoma Drugs on Commercial Plans
        • MCOs: Type of Copayments for Current Malignant Melanoma Drugs in Commercial Plans
        • MCOs: Current Reimbursement of Malignant Melanoma Combination Therapies
        • MCOs: Anticipated Changes to Reimbursement of Combination Therapies for Malignant Melanoma
        • MCOs: Anticipated Changes to Reimbursement of Combination Therapies for Malignant Melanoma
        • MCOs: Coinsurance Charge or Copayment Amount Levied for Current Malignant Melanoma Drugs on Commercial Plans
        • MCOs: Combined Coinsurance Charge or Copayment Amount Levied for Current Malignant Melanoma Combination Therapies
        • MCOs: Reevaluation of Tier Placement/Coverage of Opdivo and Yervoy upon Approval of the Combination Therapy
        • MCOs: Reevaluation of Tier Placement/Coverage of Yervoy upon Label Expansion of Yervoy as an Adjuvant Therapy
        • MCOs: Reevaluation of Tier Placement/Coverage of Zelboraf upon Approval of Zelboraf plus Cotellic Combination Therapy
        • MCOs: Expected Tier Placement of Key Malignant Melanoma Drugs in 12 Monthsu2019 Time
        • MCOs: Cost-Control Measures for Key Malignant Melanoma Therapies
        • MCOs: Prior Authorization Restrictions for Malignant Melanoma Therapies
        • MCOs: Distribution Channels for Malignant Melanoma Therapies
        • MCOs: Services Provided by Specialty Pharmacy for Malignant Melanoma Therapies
        • MCOs: Perception of the Overall Clinical Profiles of Approved Malignant Melanoma Therapies
        • MCOs: Current Reimbursement of Malignant Melanoma Therapies by Disease Setting and Line of Therapy
        • MCOs: Anticipated Reimbursement of Malignant Melanoma Therapies by Disease Setting and Line of Therapy
        • MCOs: Restrictions on Duration of Yervoy Treatment as an Adjuvant Therapy
        • MCOs: Restrictions on Treatment Duration of Key Therapies for First-Line Treatment of BRAF-Mutation-Positive Disease
        • MCOs: Attitude Toward Patient Payment Assistance Programs for Imlygic
        • MCOs: Impact of Patient Payment Assistance Programs for Imlygic on Formulary Decisions
        • MCOs: Use of Bundled Payments with Malignant Melanoma Drugs
        • MCOs: Use of Bundled Payments with Malignant Melanoma Drugs
        • MCOs: Current and Anticipated Inclusions for Bundled Payments
        • MCOs: Allowance of Physicians to Buy and Bill Malignant Melanoma Drugs
        • MCOs: Cost Shares for Oral vs. Injectable Therapies
        • MCOs: Preferred Comparator for an Emerging Therapy for Unresectable or Metastatic Malignant Melanoma
        • MCOs: Preferred Comparator for an Emerging Adjuvant Therapy for Resectable Malignant Melanoma
        • MCOs: Factors Most Likely to Influence Reimbursement Decisions for Malignant Melanoma Therapies
        • MCOs: Expected Tier Placement/Coverage of Single-Agent Binimetinib If Approved for Unresectable NRAS-Mutation-Positive Disease
        • MCOs: Expected Tier Placement/Coverage of Encorafenib If Approved for Unresectable BRAF-Mutated Disease
        • MCOs: Desired Achievements of a New Malignant Melanoma Treatment
        • MCOs: Anticipated Measures to Control the Cost of Malignant Melanoma Therapies
        • MCOs: Most Compelling Pharmacoeconomic/Health Economic Outcomes Data for a New Combination Therapy
        • MCOs: Awareness of Pharmaceutical Companiesu2019 Submission of Pharmacoeconomic/Health Economic Outcomes Data
      • Additional Information
        • Malignant Melanoma Diagnosed Incident Cases (U.S.)
        • Malignant Melanoma Drug-Treatable Opportunities (U.S.)
        • Commercial Context: Key Malignant Melanoma Therapies
        • Commercial Context: Timeline of FDA Approvals and Label Expansions for Current Key Therapies for Malignant Melanoma
        • Estimated Price/Cycle of Malignant Melanoma Therapies
        • How are the cycles of malignant melanoma therapies defined?
        • Commercial Context: Timeline of FDA Approvals and Label Expansions of Key Therapies for Malignant Melanoma
        • Commercial Context: Drug Profile of Binimetinib
        • Commercial Context: Drug Profile of Encorafenib in Combination with Binimetinib
        • Commercial Context: Timeline of Expected New Drug FDA Approvals and Current Therapy Label Expansions

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