Human Immunodeficiency Virus – Access & Reimbursement – Detailed, Expanded Analysis (EU5)

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 | EU5 content examines the market access factors that influence the success of HIV ARV therapies in the EU5 markets. The series is based on primary research with EU5 infectious disease specialists and internal medicine/general practitioner physicians, as well as country-specific payers.  This research explores how payers and physicians interact and how reimbursement decisions influence the prescribing and uptake of specific therapies at the brand level.

Table of contents

  • Human Immunodeficiency Virus - Access & Reimbursement - Detailed, Expanded Analysis (EU5)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for New HIV ARV Therapies/Regimens in the EU5
    • Successes and Stumbles
      • Successes Among HIV ARV Therapies/Regimens in the EU5
      • Stumbles Among HIV ARV Therapies/Regimens in the EU5
      • France: Reimbursement Successes and Stumbles
        • Germany: Reimbursement Successes and Stumbles
          • Italy: Reimbursement Successes and Stumbles
            • Spain: Reimbursement Successes and Stumbles
              • United Kingdom: Reimbursement Successes and Stumbles
              • Key Stakeholders in the Road to Market Access
                • France
                • Germany
                • Italy
                • Spain
                • United Kingdom
              • Key Market Access Roadblocks
                • France: Key Market Access Roadblocks
                • Germany: Key Market Access Roadblocks
                • Italy: Key Market Access Roadblocks
                • Spain: Key Market Access Roadblocks
                • United Kingdom: Key Market Access Roadblocks
              • Reimbursement Dynamics
                • France
                  • France: Crucial HTA Criteria
                  • France: P&R Drivers and Key HTA Considerations
                  • France: P&R Drivers and Key HTA Considerations
                  • France: HTA Review Details for HIV Therapies
                  • France: Lessons Learned and Key Takeaways
                  • France: Key Background Details of the Healthcare System
                  • France: P&R Process
                  • France: P&R Process
                  • France: Reimbursement Details and Mechanisms
                  • France: Prescribing Restrictions, Dispensations, and Monitoring
                • Germany
                  • Germany: Crucial HTA Criteria
                  • Germany: P&R Drivers and Key HTA Considerations
                  • Germany: P&R Drivers and Key HTA Considerations
                  • Germany: HTA Review Details for HIV Therapies
                  • Germany: Lessons Learned and Key Takeaways
                  • Germany: Key Background Details of the Healthcare System
                  • Germany: P&R Process
                  • Germany: P&R Process
                  • Germany: Reimbursement Details and Mechanisms
                  • Germany: Prescribing Controls and Monitoring
                • Italy
                  • Italy: Crucial HTA Criteria
                  • Italy: P&R Drivers and Key HTA Considerations
                  • Italy: P&R Drivers and Key HTA Considerations
                  • Italy: HTA Review Details for HIV Therapies
                  • Italy: Lessons Learned and Key Takeaways
                  • Italy: Key Background Details of the Healthcare System
                  • Italy: P&R Process
                  • Italy: P&R Process
                  • Italy: Reimbursement Details and Mechanisms
                  • Italy: Prescribing Restrictions, Dispensations, and Monitoring
                  • Italy: Additional Funding Mechanisms for Off-Label Use
                • Spain
                  • Spain: Crucial HTA Criteria
                  • Spain: P&R Drivers and Key HTA Considerations
                  • Spain: P&R Drivers and Key HTA Considerations
                  • Spain: HTA Review Details for HIV Therapies
                  • Spain: Lessons Learned and Key Takeaways
                  • Spain: Key Background Details of the Healthcare System
                  • Spain: P&R Process
                  • Spain: P&R Process
                  • Spain: HTA Bodies
                  • Spain: Prescribing Details and Budget Control
                • United Kingdom
                  • United Kingdom: Crucial HTA Criteria
                  • United Kingdom: P&R Drivers and Key HTA Considerations
                  • United Kingdom: P&R Drivers and Key HTA Considerations
                  • United Kingdom: BHIVA 2015 ARV Regimen Recommendations
                  • United Kingdom: Lessons Learned and Key Takeaways
                  • United Kingdom: Key Background Details of the Healthcare System
                  • United Kingdom: P&R Process
                  • United Kingdom: P&R Process
                  • United Kingdom: Reimbursement Details and Budget Controls
                  • United Kingdom: Prescribing Controls and Monitoring
              • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
                • Prescriber Preferences for HIV Patients
                  • HIV ARV Brand Patient Share by Country
                  • Regimen Patient Shares for Drug-Treated HIV Patients by Country
                  • Genvoya's Patient Share If Available Without Restriction, by Country
                  • Odefsey's Patient Share If Available Without Restriction, by Country
                • Impact of Payer Policy on Prescribing of HIV ARV Therapies/Regimens
                  • Proportion of Eligible Patients Not Receiving an ARV Therapy/Regimen Brand Due to Reimbursement Restrictions by Country
                • Top Prescribing Drivers of Key HIV ARV Therapies/Regimens
                  • Most Influential Factors in Physician Prescribing of HIV Treatments for Newly Diagnosed Patients by Country
                  • Most Influential Factors in Physician Prescribing of HIV Treatment Regimen by Country
              • Market Access Landscape for Emerging Therapies
                • Likely Impact of Emerging Therapies on HIV Treatment Practices
                  • Current and Anticipated Patient Share for HIV ARV Regimen Type by Country
                  • Anticipated Prescribing of Key HIV ARV Emerging Therapies by Country
                • Market Access Challenges for Emerging HIV ARV Therapies/Regimens
                  • Physicians' Perception of Cost-Containment Measures Currently Implemented and Expected in Two Years, by Country
                  • Factors Influencing Selection of New HIV ARV Therapy/Regimen: EU5
                  • Physicians' Opinion on Most Appropriate Comparator for Emerging HIV ARV Therapies/Regimens in HTA Evaluation by Country
                • Payer Opinion on Emerging Therapies for HIV
                  • France: Payer Opinion on Emerging Therapies for HIV
                  • Germany: Payer Opinion on Emerging Therapies for HIV
                  • Italy: Payer Opinion on Emerging Therapies for HIV
                  • Spain: Payer Opinion on Emerging Therapies for HIV
                  • United Kingdom: Payer Opinion on Emerging Therapies for HIV
              • Appendix
                • Key Current and Emerging HIV ARV Therapies/Regimens in the EU5
                  • Profiles of Key Current HIV ARV Therapies/Regimens in the EU5
                  • Profiles of Key Emerging HIV ARV Therapies/Regimens in the EU5
                  • Key Takeaways and Likely Impact of Emerging Therapies
                • Physician Survey Data
                  • HIV Patient Subpopulations by Country
                  • CD4+ Cell Count of Newly Diagnosed HIV Patients at the Time of Diagnosis by Country
                  • HIV Patient's CD4+ Cell Counts at Time of ARV Therapy/Regimen Initiation by Country
                  • EU5 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 by Country
                  • Percentage of Switch HIV Patients by Country
                  • Top Reasons Why Diagnosed Patients Do Not Receive Treatment by Country
                  • HIV Management and Referral Practices by Country
                  • Most Influential Drivers for Prescribing Atripla as the Top Prescribed STR by Country
                  • Most Influential Drivers for Prescribing Atripla But Not as the Top Prescribed STR by Country
                  • Most Influential Drivers for Prescribing Atripla by Country
                  • Most Influential Drivers for Prescribing Eviplera as the Top Prescribed STR by Country
                  • Most Influential Drivers for Prescribing Eviplera But Not as the Top Prescribed STR by Country
                  • Most Influential Drivers for Prescribing Eviplera by Country
                  • Most Influential Drivers for Prescribing Stribild as the Top Prescribed STR by Country
                  • Most Influential Drivers for Prescribing Stribild But Not as the Top Prescribed STR by Country
                  • Most Influential Drivers for Prescribing Stribild by Country
                  • Most Influential Drivers for Prescribing Triumeq as the Top Prescribed STR by Country
                  • Most Influential Drivers for Prescribing Triumeq But Not as the Top Prescribed STR by Country
                  • Most Influential Drivers for Prescribing Triumeq by Country
                  • EU5 Physicians' Perceptions of Dual NRTI Backbone Advantages and Disadvantages
                  • Most Influential Drivers for Prescribing Isentress by Country
                  • Most Influential Drivers for Prescribing Tivicay by Country
                  • Most Influential Drivers for Prescribing Vitekta by Country
                  • Physicians' Availability to Prescribe Genvoya by Country
                  • Funding Sources for Genvoya Prescribing by Country
                  • Physician Primary Treatment Use/Anticipated Use of Genvoya by Country
                  • Prescribing Physicians' Perceptions of Genvoya's Clinical and Nonclinical Benefits by Country
                  • Nonprescribing Physicians' Perceptions of Genvoya's Clinical and Nonclinical Benefits by Country
                  • Physicians' Perceptions of Approval of Truvada for HIV PrEP by Country
                  • Physicians' Opinion of Reimbursement Potential of Truvada for HIV PrEP If Approved by Country
                  • Physicians' Willingness to Prescribe Truvada for HIV PrEP If Approved by Country
                  • Reimbursement Restrictions Encountered by Physicians in Prescribing Atripla by Country
                  • Reimbursement Restrictions Encountered by Physicians in Prescribing Odefsey by Country
                  • Reimbursement Restrictions Encountered by Physicians in Prescribing Stribild by Country
                  • Reimbursement Restrictions Encountered by Physicians in Prescribing Genvoya by Country
                  • Reimbursement Restrictions Encountered by Physicians in Prescribing Triumeq by Country
                  • Reimbursement Restrictions Encountered by Physicians in Prescribing Descovy by Country
                  • Reimbursement Restrictions Encountered by Physicians in Prescribing Isentress by Country
                  • Reimbursement Restrictions Encountered by Physicians in Prescribing Vitekta by Country
                  • Reimbursement Restrictions Encountered by Physicians in Prescribing Tivicay by Country
                  • Physicians' Perception of Reimbursement Restrictions for Prescribing Atripla by Country
                  • Physicians' Perception of Reimbursement Restrictions for Prescribing Odefsey by Country
                  • Physicians' Perception of Reimbursement Restrictions for Prescribing Stribild by Country
                  • Physicians' Perception of Reimbursement Restrictions for Prescribing Genvoya by Country
                  • Physicians' Perception of Reimbursement Restrictions for Prescribing Triumeq by Country
                  • Physicians' Perception of Reimbursement Restrictions for Prescribing Descovy by Country
                  • Physicians' Perception of Reimbursement Restrictions for Prescribing Isentress by Country
                  • Physicians' Perception of Reimbursement Restrictions for Prescribing Vitekta by Country
                  • Physicians' Perception of Reimbursement Restrictions for Prescribing Tivicay by Country
                  • Changes to Budgeting for HIV ARV Therapies/Regimens, 2014-2016
                  • Relevance of ALD Status in France, by HIV ARV Therapy/ Regimen
                  • Impact of Richtgrosen on HIV ARV Therapy/Regimen Prescribing in Germany
                  • Relevance of Reimbursement/Budgetary Issues and RNRL Designation in Italy, by HIV ARV Therapy/Regimen
                  • Proportion of Eligible Patients Not Receiving an HIV ARV Therapy/Regimen Due to Constraints on Hospital Budget in Spain, by Brand
                  • Impact of BHIVA Treatment Guidelines for Key HIV ARV Therapy/Regimen on Prescribing in the United Kingdom
                  • Physician Willingness to Prescribe an HIV ARV Therapy/Regimen Based on ASMR Rating
                  • Impact of IQWiG Decisions on HIV ARV Therapy/Regimen Prescribing in Germany
                  • Impact of AIFA's Prescription Registry on HIV ARV Therapy/Regimen Prescribing in Italy
                  • Physicians' Perception on Impact of Pharmacy Level Generic Substitution on Patient Level Access to Branded Drugs, by Country
                  • Impact of Virtual Clinics on HIV ARV Therapy/Regimen Prescribing in the United Kingdom
                  • Relevance of ALD Status in France with Respect to Coverage of HIV-Related Medical Costs
                  • Impact of G-BA Decisions on Dolutegravir-Based Therapy Prescribing in Germany
                  • Factors Influencing Selection of New HIV ARV Therapy/Regimen: France
                  • Factors Influencing Selection of New HIV ARV Therapy/Regimen: Germany
                  • Factors Influencing Selection of New HIV ARV Therapy/Regimen: Italy
                  • Factors Influencing Selection of New HIV ARV Therapy/Regimen: Spain
                  • Factors Influencing Selection of New HIV ARV Therapy/Regimen: United Kingdom
                  • Physicians' Opinion of Darunavir/Cobicistat/FTC/TAF's Clinical and Nonclinical Benefits
                  • Newly Diagnosed Patient Subtypes to Whom Physicians Anticipate Prescribing Darunavir/Cobicistat/FTC/TAF by Country
                  • Physicians' Opinion of Doravirine's Clinical and Nonclinical Benefits by Country
                  • Newly Diagnosed Patient Subtypes to Whom Physicians Anticipate Prescribing Doravirine by Country
                  • Physicians' Opinion on Reasonable Pricing for Key Emerging HIV ARV Therapies Relative to Atripla by Country
                  • Primary Reason Why Physicians Do Not Anticipate Prescribing Key Emerging HIV ARV Therapies by Country
                  • Estimated Delay in Availability of HIV ARV Therapies After EMA Approval by Country
                  • French Physicians' Opinion of Whether Key HIV ARV Emerging Therapies Should Receive Temporary Authorization for Use (ATU)
                  • Anticipated IQWiG Ratings for Emerging HIV ARV Therapies/Regimens
                  • Italian Physicians' Opinion of Emerging HIV ARV Therapies' Potential to Receive Innovative Status
                  • Spanish Physicians' Opinion on Potential for Emerging HIV ARV Therapies to Be on Formulary Through Autonomic Evaluation Committees (CAEs)
                  • U.K. Physicians' Opinion of Anticipated Market Access Issues Facing Emerging HIV ARV Therapies
                  • Current and Anticipated Impact of Regional Formulary Variation on Patient Access to HIV Therapies
                  • EU5 Reimbursement for HIV Therapies
                  • HIV Drug Development Priorities Important to Physicians, by Country
                  • Most Influential Factors in Physician Prescribing of HIV Treatments for Newly Diagnosed Patients by Country
                  • Genvoya's Patient Share If Available Without Restriction, by Country
                  • Odefsey's Patient Share If Available Without Restriction, by Country
                  • Proportion of Eligible Patients Not Receiving an ARV Therapy/Regimen Brand Due to Reimbursement Restrictions by Country
                  • Regimen Patient Shares for Drug-Treated HIV Patients by Country
                  • Most Influential Factors in Physician Prescribing of HIV Treatment Regimen by Country
                  • HIV ARV Brand Patient Share by Country
                  • Physicians' Perception of Cost-Containment Measures Currently Implemented and Expected in Two Years, by Country
                  • Factors Influencing Selection of New HIV ARV Therapy/Regimen: EU5
                  • Current and Anticipated Patient Share for HIV ARV Regimen Type by Country
                  • Anticipated Prescribing of Key HIV ARV Emerging Therapies by Country
                  • Physicians' Opinion on Most Appropriate Comparator for Emerging HIV ARV Therapies/Regimens in HTA Evaluation by Country

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