Human Immunodeficiency Virus – Access & Reimbursement – Detailed, Expanded Analysis (US)

The HIV therapy market is growing as a result of the uptake of new premium-priced antiretroviral (ARV) agents, particularly the latest single-tablet regimens (STRs), which offer improved safety and tolerability. Human Immunodeficiency Virus | Access & Reimbursement | U.S. content examines the market access factors that influence the success of HIV ARV therapies in the U.S. market. The series is based on primary research with U.S. infectious disease specialists and internal medicine/primary care physicians, as well as with MCO medical directors and pharmacy directors. It explores how payers and physicians interact and how reimbursement decisions influence the prescribing and uptake of specific HIV therapies at the brand level.

Table of contents

  • Human Immunodeficiency Virus - Access & Reimbursement - Detailed, Expanded Analysis (US)
    • Actionable Recommendations to Optimize Market Access
      • Successes and Stumbles
        • Successes Among HIV ARV Therapies in the United States
        • Stumbles Among HIV Therapies in the United States
        • United States: Reimbursement Successes and Stumbles
          • United States Reimbursement Successes and Stumbles
      • Key Market Access Roadblocks
        • Reimbursement Dynamics
          • United States: Commercial Managed Care Organizations
            • Lessons Learned and Key Takeaways
            • Factors Driving Formulary Inclusion
            • Drivers of HIV Therapy Reimbursement by MCOs
            • Drivers
            • Key Findings
            • Prescribing Restrictions for Key ARV Brands in Commercial Plans
            • Prescribing Restrictions for Key ARV Brands in Medicaid MCO Plans
            • Prescribing Restrictions with Key ARV Brands That Physicians Encounter
            • Step-Therapy Requirements
            • Step-Therapy Requirements for Key HIV ARVs in Commercial Plans
            • Step-Therapy Requirements for Key HIV ARVs in Medicaid MCO Plans
        • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
          • Patient Share in Key Payer Channel
            • Key Findings
            • HIV ARVs' Patient Share Among Commercially Insured Patients
            • Top Prescribing Drivers
            • Most Influential Factors in Physician Prescribing of HIV Therapies/Regimens
            • Most Influential Factors in Physician Prescribing of HIV Treatments, by Type of Regimen
          • Prescriber Preference
            • Prescriber Preferences for HIV Therapies/Regimens
            • Preferred HIV ARV Brand by Physician Type
            • Genvoya's Patient Share If Available Without Restriction, by Patient Subtype
            • Odefsey's Patient Share If Available Without Restriction, by Patient Subtype
          • Impact of Payer Policy on Prescribing
            • Key Findings
            • Role of Key Restrictions
            • Proportion of Eligible Patients Not Receiving an ARV Therapy/Regimen Brand due to Reimbursement Restrictions
        • Key Stakeholders in the Road to Market Access
          • United States: Stakeholder Dynamics on the Road to Reimbursement
        • Market Access Landscape for Emerging Therapies
          • Likely Impact of Emerging Therapy
            • Likely Impact of Emerging Therapies in HIV
            • Patient Share by Type of Regimen If Emerging Agents Are on Preferred vs. Nonpreferred Tier
            • Newly Diagnosed Patient Share of Therapies If Emerging Agents Are on Preferred vs. Nonpreferred Tier
            • Previously Diagnosed Patient Share of Therapies If Emerging Agents Are on Preferred vs. Nonpreferred Tier
          • Potential Placement of Emerging Therapy at Various Prices
            • Potential Reimbursement of Emerging HIV Therapies
            • Potential Reimbursement for Darunavir/Cobicistat/FTC/TAF
            • Potential Formulary Placement of Darunavir/Cobicistat/FTC/TAF at Various Price Points: Commercial Plans
            • Potential Formulary Placement of Darunavir/Cobicistat/FTC/TAF at Various Price Points: Medicaid MCO Plans
            • Anticipated Prescribing Restrictions for Darunavir/Cobicistat/FTC/TAF
            • Potential Reimbursement for Doravirine
            • Potential Formulary Placement of Doravirine at Various Price Points: Medicaid MCO Plans
            • Anticipated Reimbursement Restrictions for Doravirine
          • Prescriber and MCO Opinion on Remaining Unmet Need
            • Key Findings
            • Physician Advice on Pharma R&D Spending
            • Payer Advice on Pharma R&D Spending
        • Appendix
          • Physician Survey
            • Practice Setting of Surveyed ID Specialists and IM Physicians/PCPS
            • HIV Patient Subpopulations by Physician Specialty
            • CD4 Cell Count of Newly Diagnosed HIV Patients at Time of Diagnosis
            • HIV Patients' CD4 Cell Counts at Time of ARV Therapy/Regimen Initiation
            • Importance of Patient CD4 Cell Counts in Physician Decision to Prescribe ARV Therapies/Regimens
            • Primary Reason Why Patients Diagnosed with HIV Do Not Receive Treatment
            • Factors That Influence Physicians' Decision to Prescribe Atripla
            • Factors That Influence Physicians' Decision to Prescribe Complera
            • Factors That Influence Physicians' Decision to Prescribe Stribild
            • Factors That Influence Physicians' Decision to Prescribe Triumeq
            • Factors That Influence Physicians' Prescribing of Fixed-Dose Nucleoside Reverse Transcriptase Inhibitors
            • Factors That Influence Physicians' Prescribing of Preferred Integrase Strand Transfer Inhibitors in Newly Diagnosed Patients
            • Factors That Influence Physicians' Prescribing of Preferred Integrase Strand Transfer Inhibitors in Previously Diagnosed Patients
            • Physician Primary Treatment Use/Anticipated Use of Genvoya
            • Physician Perceptions of Genvoya's Clinical Benefits
            • Prevalence of Truvada Prescribing for PrEP by Physician Specialty
            • Average Number of Individuals Prescribed Truvada for PrEP by Physician Specialty
            • Characteristics of Patients Prescribed Truvada for PrEP
            • Changes in Physician Prescribing of Truvada for PrEP in the Past 12 Months
            • Reimbursement Status of Truvada for PrEP
            • Restrictions Associated with Prescribing of Truvada for PrEP
            • Grant Funding for Prescribing of Truvada for PrEP
            • Factors That Influence Physicians' Decision to Not Prescribe Truvada for PrEP
            • Frequency of HIV Screening for Individuals Who Use Truvada for PrEP
            • Physician Opinion of STR Brands' Clinical Benefits
            • Changes in Insurance Coverage of HIV Patients
            • Reimbursement Restrictions Encountered by Internal Medicine/Primary Care Physicians
            • Reimbursement Restrictions Encountered by ID Specialists
            • Physician Opinion of STR Brands' Reimbursement Attributes
            • Anticipated Impact of the Availability of Generic Efavirenz on Physician Prescribing of HIV ARVs
            • Physician Familiarity with AIDS Drug Assistance Programs
            • Funding of Patient HIV ARV Therapies by AIDS Drugs Assistance Programs
            • Impact of Patients' Dependence on AIDS Drug Assistance Programs on Physician Prescribing
            • Physician Opinion of HIV ARV Development Priorities
            • Physician Opinion of Darunavir/Cobicistat/FTC/TAF's Clinical Benefits
            • Newly Diagnosed Patient Subtypes to Whom Physicians Anticipate Prescribing Darunavir/Cobicistat/FTC/TAF
            • Physician Opinion of Doravirine's Clinical Benefits
            • Primary Reason Why Physicians Do Not Anticipate Prescribing Doravirine
            • Average Delay in Physician Access Following FDA Approval by Type of Patient Insurance Coverage
          • MCO Survey
            • Factors Influencing Payers' Decision to Exclude TAF-Containing FDCs
            • Tier Status of Key HIV Drugs in Commercial Plans
            • Average Coinsurance by HIV ARV Brand: Commercial Plans
            • Average Copayment by HIV ARV Brand: Commercial Plans
            • Formulary Status of Key HIV Drugs in Medicaid MCO Plans
            • Restriction by Prior Treatment History of Key HIV Therapies: Commercial Plans
            • Restrictions to Treatment-Experienced Patient Subgroups of Key HIV Therapies: Commercial Plans
            • Restriction by Prior Treatment History of Key HIV Therapies: Medicaid MCO Plans
            • Restrictions to Treatment-Experienced Patient Subgroups of Key HIV Therapies: Medicaid MCO Plans
            • Importance of Cost Savings Associated with Long-Term Safety in Formulary Placement
            • Time-Scale Considerations When Assessing Long-Term Cost Savings with Novel HIV ARVs
            • Manufacturing Contract Agreements for Key HIV Drugs
            • Payer Policy on Use of Generic HIV ARVs
            • Anticipated Impact of Generic Efavirenz on Atripla/STR Formulary Status: Commercial Plans
            • Average Time for P&T Committee Utilization Management Decisions
            • Payer Default Policy on New FDA-Approved HIV Drugs
            • Factors Influencing Payer Decision to Exclude Darunavir/Cobicistat/FTC/TAF from Formulary
            • Preferred Comparator for Darunavir/Cobicistat/FTC/TAF in P&T Committee Review
            • Factors Influencing Payer Decision to Exclude Doravirine from Formulary
            • Preferred Comparator for Doravirine in P&T Committee Review
            • Payer Familiarity with Truvada's Expanded Label for PrEP
            • Truvada's Reimbursement Status for Pre-Exposure Prophylaxis
            • Prescribing Restrictions on Truvada for Pre-Exposure Prophylaxis
            • Patients with Access to Truvada for HIV Pre-Exposure Prophylaxis
            • Factors Influencing Payer Decision to Not Reimburse Truvada for HIV Pre-Exposure Prophylaxis
            • Anticipated Future Reimbursement of Truvada for HIV Pre-Exposure Prophylaxis
            • Average HIV Antiretroviral Budget Allocation
            • Changes in HIV ARV Expenditure in the Past Five Years
            • Anticipated Changes to HIV ARV Budgets over the Next Two Years
            • Frequency of P&T Committee Meetings
            • Most Influential Members in P&T Committees
            • P&T Committees' Requirements for HIV Drug Reviews
            • Compelling Outcomes Data for a New HIV Therapy
            • Pharmacoeconomic Data Supporting Value of HIV Therapies
            • Impact of Pharmacoeconomic Data on Formulary Inclusion/Placement

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