As of 2016, over 2 million people across the EU5 countries have a diagnosis of schizophrenia. Many of the oral atypical antipsychotic therapies used to treat the symptoms of schizophrenia are generically available. Newer depot formulations of atypical antipsychotics offer the possibility of better patient compliance and adherence to therapy. With a wide variety of atypical antipsychotic therapy options available throughout the EU5 markets, novel atypical antipsychotic therapies will be entering a crowded and highly genericized market. As such, new entrants will need to demonstrate superior efficacy and/or safety and tolerability compared with appropriate active comparators in order to be successful in achieving regulatory approval, attaining premium pricing, and securing favorable formulary placement.

Table of contents

  • Schizophrenia - Access & Reimbursement - Detailed, Expanded Analysis (EU5)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunity for New Schizophrenia Therapies in the EU5
    • Successes and Stumbles
      • Successes Among Schizophrenia Therapies in the EU5
      • Stumbles Among Schizophrenia 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, Dispensing, 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: 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 Schizophrenia
                  • Percentage of Drug-Treated Schizophrenia Patients Prescribed Different Drug Classes by Country
                  • Most Preferred vs. Most Prescribed Atypical Antipsychotic for Schizophrenia by Country
                  • Most Common Drug Classes Prescribed for Negative Symptoms of Schizophrenia by Country
                  • Most Common Drug Classes Prescribed for CIAS by Country
                • Impact of Payer Policy on Prescribing for Schizophrenia
                  • Impact of Access/Reimbursement Hurdles on Oral Atypical Antipsychotic Prescribing for Schizophrenia by Country
                  • Impact of Access/Reimbursement Hurdles on Depot Atypical Antipsychotic Prescribing for Schizophrenia by Country
                  • Reasons for Prescribing Abilify More Frequently Than Generic Aripiprazole to Schizophrenia Patients by Country
                  • Reasons for Prescribing Generic Aripiprazole More Frequently Than Abilify to Schizophrenia Patients by Country
                • Top Prescribing Drivers: Schizophrenia
                  • Most Important Factors Influencing Drug Choice for Schizophrenia by Country
                  • Most Common Reasons for Prescribing Depot Atypical Antipsychotics for Schizophrenia by Country
                  • Most Common Reasons for Prescribing Oral Atypical Antipsychotics for Schizophrenia by Country
              • Market Access Landscape for Emerging Therapies
                • Likely Impact of Emerging Therapies on Schizophrenia
                  • Likely Positioning of Emerging Therapies in the Schizophrenia Treatment Algorithm by Country
                  • Maximum Percentage of Schizophrenia Patients Likely to Receive Trevicta by Country
                  • Maximum Percentage of Schizophrenia Patients Likely to Receive Rexulti by Country
                  • Maximum Percentage of Schizophrenia Patients Likely to Receive Vraylar by Country
                • Market Access Challenges for Emerging Therapies for Schizophrenia
                  • Most Influential Factors on Prescribing of New Therapy for Schizophrenia by Country
                  • Impact of Regional Formulary Variation on Current and Anticipated Access to Schizophrenia Therapies by Country
                  • Likely Funding of Emerging Schizophrenia Therapies by Country
                  • Likely Funding Scenarios for Emerging Schizophrenia Therapies: United Kingdom
                • Payer Opinion on Emerging Therapies for Schizophrenia
                  • France: Payer Opinion on Emerging Therapies for Schizophrenia
                  • Germany: Payer Opinion on Emerging Therapies for Schizophrenia
                  • Italy: Payer Opinion on Emerging Therapies for Schizophrenia
                  • Spain: Payer Opinion on Emerging Therapies for Schizophrenia
                  • United Kingdom: Payer Opinion on Emerging Therapies for Schizophrenia
              • Methodology
                • Primary Research Design
                • Background of Payers and Payer-Advising KOLs
                • Physician Demographics and Practice Setting
                  • Distribution of Survey Respondents by Country
                  • Distribution of Years Practiced Post-Residency by Country
                  • Distribution of Schizophrenia Patients Under Management per Month by Country
                  • Survey Respondents' Primary Practice Setting by Country
                  • Drug Classes and Drugs Prescribed for Schizophrenia by Country
              • Appendix
                • Key Therapies for Schizophrenia
                  • Profiles of Key Therapies for Schizophrenia in the EU5
                  • Trevicta (Paliperidone Palmitate, Three Month)
                  • Janssen Pharmaceuticals' Trevicta (Paliperidone Palmitate, Three Month)
                  • Rexulti (Brexpiprazole)
                  • Otsuka Pharmaceutical/Lundbeck's Rexulti (Brexpiprazole)
                  • Vraylar (Cariprazine)
                  • Allergan/Gedeon Richter/Mitsubishi Tanabe Pharma's Vraylar (Cariprazine)
                • Physician Survey Data
                  • Drug-Treatment Rate for Schizophrenia by Country
                  • Reasons for Not Prescribing Drug Treatment to Schizophrenia Patients by Country
                  • Percentage of Drug-Treated Schizophrenia Patients Prescribed Different Drug Classes by Country
                  • Drug Treatment of Schizophrenia Symptoms by Country
                  • Reasons for Not Prescribing Oral Atypical Antipsychotics to Schizophrenia Patients by Country
                  • Reasons for Not Prescribing Depot Atypical Antipsychotics to Schizophrenia Patients by Country
                  • Treatment Resistance Among Drug-Treated Schizophrenia Patients by Country
                  • Residual Symptom Occurrence Among Treatment-Resistant Drug-Treated Schizophrenia Patients by Country
                  • Schizophrenia Patient Management and Referral Patterns by Country
                  • Most Important Factors Influencing Drug Choice for Schizophrenia by Country
                  • Branded vs. Generic Prescribing of Aripiprazole to Schizophrenia Patients by Country
                  • Reasons for Prescribing Abilify More Frequently Than Generic Aripiprazole to Schizophrenia Patients by Country
                  • Reasons for Prescribing Generic Aripiprazole More Frequently Than Abilify to Schizophrenia Patients by Country
                  • Most Preferred vs. Most Prescribed Atypical Antipsychotic for Schizophrenia by Country
                  • Most Common Reasons for Aripiprazole Being the Most Frequently Prescribed Atypical Antipsychotic for Schizophrenia: EU5 Total
                  • Most Common Reasons for Abilify Maintena Being the Most Frequently Prescribed Atypical Antipsychotic for Schizophrenia: EU5 Total
                  • Most Common Reasons for Olanzapine Being the Most Frequently Prescribed Atypical Antipsychotic for Schizophrenia: EU5 Total
                  • Most Common Reasons for Xeplion Being the Most Frequently Prescribed Atypical Antipsychotic for Schizophrenia: EU5 Total
                  • Most Common Reasons for Quetiapine XR Being the Most Frequently Prescribed Atypical Antipsychotic for Schizophrenia: EU5 Total
                  • Most Common Reasons for Risperidone Being the Most Frequently Prescribed Atypical Antipsychotic for Schizophrenia: EU5 Total
                  • Most Common Reasons for Risperdal Consta Being the Most Frequently Prescribed Atypical Antipsychotic for Schizophrenia: EU5 Total
                  • Most Common Reasons for Prescribing Oral Atypical Antipsychotics for Schizophrenia by Country
                  • Most Common Reasons for Prescribing Depot Atypical Antipsychotics for Schizophrenia by Country
                  • Impact of Access/Reimbursement Hurdles on Oral Atypical Antipsychotic Prescribing for Schizophrenia by Country
                  • Impact of Access/Reimbursement Hurdles on Depot Atypical Antipsychotic Prescribing for Schizophrenia by Country
                  • Ability to Secure Funding of Drugs Based on SMR Rating: France
                  • Reimbursement Status of Clozapine for Schizophrenia: France
                  • Impact of Reimbursement Rate for Zypadhera on Prescribing for Schizophrenia: France
                  • Impact of Richtgrößen on Access to Key Branded Schizophrenia Therapies: Germany
                  • Impact of Reimbursement Class and Restrictions on Prescribing of Atypical Antipsychotics for Schizophrenia: Italy
                  • Impact of REMS Program for Zypadhera on Prescribing for Schizophrenia: Italy
                  • Impact of Copay Requirements on Prescribing for Schizophrenia: Spain
                  • Impact of Regional CCG Policy on Prescribing of Drug Classes for Schizophrenia: United Kingdom
                  • Most Influential Factors on Prescribing of New Therapy for Schizophrenia by Country
                  • Second Most Influential Factors on Prescribing of New Therapy for Schizophrenia by Country
                  • Third Most Influential Factors on Prescribing of New Therapy for Schizophrenia by Country
                  • Drug-Treatment Rate for Negative Symptoms of Schizophrenia and CIAS by Country
                  • Most Common Drug Classes Prescribed for Negative Symptoms of Schizophrenia by Country
                  • Most Common Drug Classes Prescribed for CIAS by Country
                  • Most Common Drug Classes Prescribed for Negative Symptoms of Schizophrenia and CIAS: France
                  • Most Common Drug Classes Prescribed for Negative Symptoms of Schizophrenia and CIAS: Germany
                  • Most Common Drug Classes Prescribed for Negative Symptoms of Schizophrenia and CIAS: Italy
                  • Most Common Drug Classes Prescribed for Negative Symptoms of Schizophrenia and CIAS: Spain
                  • Most Common Drug Classes Prescribed for Negative Symptoms of Schizophrenia and CIAS: United Kingdom
                  • Most Common Drug Classes Prescribed for Negative Symptoms of Schizophrenia and CIAS: EU5 Total
                  • Reasons for Lack of Drug Treatment of Negative Symptoms of Schizophrenia and CIAS: EU5 Total
                  • Impact of IQWiG/G-BA Assessment of New Therapies on Prescribing: Germany
                  • Maximum Percentage of Schizophrenia Patients Likely to Receive Rexulti by Country
                  • Maximum Percentage of Schizophrenia Patients Likely to Receive Trevicta by Country
                  • Maximum Percentage of Schizophrenia Patients Likely to Receive Vraylar by Country
                  • Likely Positioning of Emerging Therapies in the Schizophrenia Treatment Algorithm by Country
                  • Likely Prescribing Scenarios for Rexulti in the Schizophrenia Treatment Algorithm by Country
                  • Likely Prescribing Scenarios for Trevicta in the Schizophrenia Treatment Algorithm by Country
                  • Current Antipsychotic Therapy Most Likely to Be Replaced by Trevicta for Schizophrenia by Country
                  • Likely Prescribing Scenarios for Vraylar in the Schizophrenia Treatment Algorithm by Country
                  • Current Antipsychotic Therapy Most Likely to Be Replaced by Rexulti for Schizophrenia by Country
                  • Current Antipsychotic Therapy Most Likely to Be Replaced by Vraylar for Schizophrenia by Country
                  • Impact of Regional Formulary Variation on Current and Anticipated Access to Schizophrenia Therapies by Country
                  • Likely Funding of Emerging Schizophrenia Therapies by Country
                  • Likelihood of Emerging Therapies Being Given an ATU for Schizophrenia: France
                  • Likelihood of the G-BA Granting Favorable Benefit Ratings to Emerging Therapies for Schizophrenia: Germany
                  • Likelihood of Emerging Schizophrenia Therapies Receiving Innovative Status: Italy
                  • Likelihood of Emerging Schizophrenia Therapies Being Included on Hospital Formulary or Available to Ambulatory Patients Through Retail Pharmacy: Spain
                  • Likely Funding Scenarios for Emerging Schizophrenia Therapies: United Kingdom
                  • Expected Future Impact of Cost-Containment Measures on Psychiatrists' Prescribing for Schizophrenia by Country
                  • Current vs. Anticipated Patient Shares for Drug Classes Among Drug-Treated Schizophrenia Patients by Country

            Author(s): Sarah Soucy

            Sarah Soucy, M.S., is a Business Insights Analyst with the central nervous system/ophthalmology disorders group at Decision Resources Group. She has authored primary research and insights for dry and wet age-related macular degeneration and multiple sclerosis.

            Prior to joining DRG, Ms. Soucy spent six years on the client side as a scientist at Pfizer in the inflammation and immunology research group with both in vitro and in vivo experience. She earned her B.S. in Animal Science with a Bioscience and Technology option and her M.S. in Nutritional Sciences from the University of New Hampshire, Durham, where she studied disordered metabolism


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