Unipolar Depression – Access & Reimbursement – Detailed, Expanded Analysis (EU5)

Nearly 23 million people across the EU5 suffer from major depressive disorder. Generic availability of a growing number of therapies has improved patient access to antidepressants and loosened restrictions on off-label adjunctive use of atypical antipsychotics. New branded therapies will face increasing market access challenges as they compete for positioning in this crowded market. Clear demonstration of improved efficacy over standard-of-care comparators is necessary, though in some markets, safety or quality of life improvements are acceptable when accompanied by noninferior efficacy, and successfully targeting subpopulations or unmet treatment needs are additional keys to therapies securing favorable formulary placement and reimbursement terms.

Table of contents

  • Unipolar Depression - Access & Reimbursement - Detailed, Expanded Analysis (EU5)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for New MDD Therapies in the EU5
    • Successes and Stumbles
      • Successes Among MDD Therapies in the EU5
      • Stumbles Among MDD Therapies 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
                  • France: HTA Review Details
                  • 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, Dispensation, 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
                  • Germany: HTA Review Details
                  • 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
                  • Italy: HTA Review Details
                  • 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
                • 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
                  • Spain: HTA Review Details
                  • Spain: Lessons Learned and Key Takeaways
                  • Spain: Key Background Details of the Healthcare System
                  • Spain: P&R Process
                  • Spain: P&R Process
                  • Spain: Reimbursement Details and Mechanisms
                • 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: HTA Review Details
                  • United Kingdom: HTA Review Details
                  • 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 Control
                  • United Kingdom: Prescribing Controls and Monitoring
              • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
                • Prescriber Preferences for MDD
                  • MDD Drug Class Patient Share by Country
                  • Treatment Steps Following First-Line Therapy Failure
                • Impact of Payer Policy on Prescribing for MDD
                  • How A&R Hurdles Affect Prescribing of MDD Therapies
                  • Reasons for Prescribing Branded Cipralex/Seroplex vs. Generic Escitalopram
                  • Reasons for Prescribing Branded Cymbalta/Xeristar vs. Generic Duloxetine
                  • Reasons for Prescribing Branded Abilify vs. Generic Aripiprazole
                  • A&R Considerations Impacting Prescribing of Branded MDD Therapies in Europe
                • Top Prescribing Drivers: MDD
                  • Top Influential Factors in the Prescribing of MDD Therapies
                  • Influence of Copay Requirements on Prescribing of MDD Therapies in Spain
                  • Influence of NICE Guidelines on Prescribing of Branded Antidepressants in the United Kingdom
              • Market Access Landscape for Emerging Therapies
                • Likely Impact of Emerging Therapies on MDD
                  • Most Influential Factor When Prescribing a New MDD Therapy
                  • Likely Patient Share and Use of Rexulti for MDD
                  • Likely Patient Share and Use of ALKS-5461 for MDD
                  • Current MDD Therapy Most Likely to Be Replaced by Rexulti or ALKS-5461
                • Market Access Challenges for Emerging Therapies for MDD
                  • Likelihood of Positive HTA or Formulary Placement of Emerging MDD Therapies
                  • Influence of NICE Assessments on Access to Emerging MDD Therapies in the United Kingdom
                  • Impact of Cost-Containment Measures on Prescribing of MDD Therapies in the Next Three Years
                • Payer Opinion on Emerging Therapies for MDD
                  • France: Payer Opinion on Emerging Therapies for MDD
                  • Germany: Payer Opinion on Emerging Therapies for MDD
                  • Italy: Payer Opinion on Emerging Therapies for MDD
                  • Spain: Payer Opinion on Emerging Therapies for MDD
                  • United Kingdom: Payer Opinion on Emerging Therapies for MDD
              • Appendix
                • Key Therapies for Major Depressive Disorder
                  • Profiles of Key Drugs for Major Depressive Disorder in the EU5
                  • Rexulti (Brexpiprazole)
                  • Otsuka Pharmaceutical/Lundbeck's Rexulti (Brexpiprazole)
                  • ALKS-5461
                  • Alkermes' ALKS-5461
                • Physician Survey Data
                  • Drug-Treatment Rates for MDD Across the EU5 by Country
                  • Reasons for Not Prescribing Prescription Drug Treatment to MDD Patients
                  • Percentage of Drug-Treated MDD Patients Considered to Be Treatment-Resistant
                  • Treatment Steps Following First-Line Therapy Failure: France
                  • Treatment Steps Following First-Line Therapy Failure: Germany
                  • Treatment Steps Following First-Line Therapy Failure: Italy
                  • Treatment Steps Following First-Line Therapy Failure: Spain
                  • Treatment Steps Following First-Line Therapy Failure: United Kingdom
                  • MDD Drug Class Patient Share by Country
                  • MDD Patient Management and Referral Patterns
                  • Top Influential Factors in the Prescribing of MDD Therapies
                  • Percentage of Escitalopram-Treated MDD Patients Receiving Branded Cipralex/Seroplex vs. Generic Escitalopram
                  • Primary Reasons for Prescribing Branded Cipralex/Seroplex Over Generic Escitalopram
                  • Primary Reasons for Prescribing Generic Escitalopram Over Branded Cipralex/Seroplex
                  • Percentage of Duloxetine-Treated MDD Patients Receiving Branded Cymbalta vs. Generic Duloxetine
                  • Primary Reasons for Prescribing Branded Cymbalta/Xeristar Over Generic Duloxetine
                  • Primary Reasons for Prescribing Generic Duloxetine Over Branded Cymbalta/Xeristar
                  • Percentage of Aripiprazole-Treated MDD Patients Receiving Branded Abilify vs. Generic Aripiprazole
                  • Primary Reasons for Prescribing Branded Abilify Over Generic Aripiprazole
                  • Primary Reasons for Prescribing Generic Aripiprazole Over Branded Abilify
                  • How A&R Hurdles Affect Prescribing of MDD Therapies
                  • Use of Abilify in MDD
                  • Use of Latuda in MDD
                  • A&R Considerations Impacting Prescribing of Branded MDD Therapies in France
                  • A&R Considerations Impacting Prescribing of Branded MDD Therapies in Germany
                  • A&R Considerations Impacting Prescribing of Branded MDD Therapies in Italy
                  • A&R Considerations Impacting Prescribing of Branded MDD Therapies in Spain
                  • A&R Considerations Impacting Prescribing of Branded MDD Therapies in the United Kingdom
                  • A&R Considerations Impacting Prescribing of Branded MDD Therapies in Europe
                  • Ability to Secure Funding of Drugs Based on SMR Rating: France
                  • Impact of G-BA Determination on Ability to Prescribe Brintellix: Germany
                  • Impact of Richtgru00f6u00dfen on Access to Key Branded Therapies for MDD: Germany
                  • Influence of AIFA's HTA Assessment on Prescribing of New MDD Therapies in Italy
                  • Impact of Reimbursement Class and Restrictions on Prescribing of Select Drugs for MDD: Italy
                  • Impact of Reimbursement Class on Prescribing of Valdoxan for MDD: Italy
                  • Reimbursement Status for Latuda: Italy
                  • Influence of Copay Requirements on Prescribing of MDD Therapies in Spain
                  • Influence of NICE Guidelines on Prescribing of Branded Antidepressants in the United Kingdom
                  • Influence of CCG Policy on Prescribing of Drug Classes for MDD: United Kingdom
                  • Most Influential Factor When Prescribing a New MDD Therapy
                  • Second-Most Influential Factor When Prescribing a New MDD Therapy
                  • Third-Most Influential Factor When Prescribing a New MDD Therapy
                  • Influence of IQWiG/G-BA Assessment on Prescribing of New MDD Therapies in Germany
                  • Percentage of MDD Patients Likely to Receive Rexulti by Country
                  • Percentage of MDD Patients Likely to Receive ALKS-5461 by Country
                  • Most Likely Use of Emerging Therapies for MDD
                  • Likely Positioning of Rexulti in the MDD Treatment Algorithm
                  • Likely Positioning of ALKS-5461 in the MDD Treatment Algorithm
                  • Current MDD Therapy Most Likely to Be Replaced by Rexulti or ALKS-5461
                  • Reasons for Not Prescribing Emerging Therapies for MDD
                  • Current and Projected Future Impact of Regional Formulary Variation on Patient Access to MDD Therapies
                  • Likelihood of Positive HTA or Formulary Placement of Emerging MDD Therapies
                  • Influence of NICE Assessments on Access to Emerging MDD Therapies in the United Kingdom
                  • Impact of Cost-Containment Measures on Prescribing of MDD Therapies in the Next Three Years
                  • Current and Projected Future Patient Share of MDD Therapies by Drug Class

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