Type 2 Diabetes – Access & Reimbursement – Detailed, Expanded Analysis (EU5)

Type 2 diabetes (T2D) is a chronic metabolic disease affecting more than 28 million people in the five major European pharmaceutical markets (France, Germany, Italy, Spain, United Kingdom; EU5). At the core of T2D treatment is long-generic standard of care metformin (Merck KgaA’s Glucophage, generics) as first-line therapy. However, T2D patients typically require therapeutic intensification, with drugs from several other classes, including DPP-IV inhibitors, SGLT-2 inhibitors, GLP-1 receptor agonists, and insulin analogues competing with generic alternatives for position as second- and third-line therapy status. These branded agents are competing in an increasingly cost-sensitive environment, and marketers need to provide clear evidence of clinical improvements and/or cost benefits on well-defined clinical endpoints over well-entrenched, generically available standards-of-care to ensure favorable health technology assessment (HTA) and favorable pricing and reimbursement terms.

Table of contents

  • Type 2 Diabetes - Access & Reimbursement - Detailed, Expanded Analysis (EU5)
    • Actionable Recommendations to Optimize Market Access
      • Successes and Stumbles
        • Successes and Stumbles Among Antidiabetic Therapies
      • Key Stakeholders in the Road to Market Access
        • France: Stakeholder Dynamics in the Road to Market Access
        • Germany: Stakeholder Dynamics in the Road to Market Access
        • Italy: Stakeholder Dynamics in the Road to Market Access
        • Spain: Stakeholder Dynamics in the Road to Market Access
        • United Kingdom: Stakeholder Dynamics in the Road to Market Access
      • Key Market Access Roadblocks
        • Key Market Access Roadblocks for T2D Therapies in the EU5
      • Reimbursement Dynamics
        • France
          • France: Crucial HTA Criteria
          • France: P&R Drivers and Key HTA Considerations
          • France: HTA Review Details and Reimbursement Successes or Setbacks
          • France: Key Background Details of the Healthcare System
          • Prescribing Guidelines and Controls for T2D in France
          • Key Market Access Considerations
        • Germany
          • Germany: Crucial HTA Criteria
          • Germany: P&R Drivers and Key HTA Considerations
          • Germany: HTA and P&R Processes
          • Germany: Key Background Details of the Healthcare System
          • Germany: Reimbursement Details and Mechanisms
          • Germany: Prescribing Controls and Monitoring
        • Italy
          • Italy: Crucial HTA Criteria
          • Italy: P&R Drivers and Key HTA Considerations
          • Italy: Key Background Details of the Healthcare System
          • P&R decision criteria
          • Law 648/1996 on Off-Label Prescribing
          • Compassionate Use Programs
        • Spain
          • Spain: Crucial HTA Criteria
          • Spain: P&R Drivers and Key HTA Considerations
          • Spain: Key Background Details of the Healthcare System
          • Spain: HTA and P&R Processes
          • Spain: HTA Bodies
          • Spain: Autonomic Evaluation Committees (CAE)
          • Spain: Commissions for Pharmacy and Therapeutics (CFT)
        • United Kingdom
          • United Kingdom: Crucial HTA Criteria
          • United Kingdom: P&R Drivers and Key HTA Considerations
          • United Kingdom: Key Background Details of the Healthcare System
          • United Kingdom: HTA and P&R Processes
          • United Kingdom: Reimbursement Details and Budget Control
          • United Kingdom: Prescribing Controls and Monitoring
      • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
        • Patient Share: T2D in the EU5 for Major Drug(s)/Drug Classes
          • Patient Share for Major Drug(s)/Drug Classes in T2D
        • Prescriber Preferences in T2D Among Major Drug(s)/Drug Classes
          • Prescriber-Preferred Agents
        • Impact of Payer Policy on Prescribing T2D Treatments
          • Nonclinical factors restricting physiciansu2019 prescribing of key branded T2D therapies
        • Impact of Payer Policy on Prescribing T2D Therapies
          • Percentage of Eligible Patients That Fail to Receive Therapy due to Cost/Budget/Reimbursement Issues
        • The Impact of CV Outcomes Data on Prescribing Drivers in T2D
          • Top Prescribing Drivers for New Products in T2D
          • Market Access Landscape for Emerging Therapies
            • Likely Impact of Emerging Therapies on T2D
              • Surveyed Physicians' Maximum Potential Patient Share for Emerging Therapies
            • Payer Opinion on Emerging Therapies for T2D
              • French Payer Insight on Emerging T2D Therapies
              • German Payer Insight on Emerging T2D Therapies
              • Italian Payer Insight on Emerging T2D Therapies
              • United Kingdom Payer Insight on Emerging T2D Therapies
            • Prescriber Opinion on Remaining Unmet Need
              • Most Important Priorities for Novel Drug Development in T2D
          • Appendix
            • Key Current Therapies for Type 2 Diabetes
              • Key Current Therapies Used in the Treatment of T2D
              • Empagliflozin (Boehringer Ingelheim/Eli Lillyu2019s Jardiance)
              • Glyxambi (Boehringer Ingelheim/Eli Lillyu2019s linagliptin/empagliflozin)
              • Injectable Semaglutide (Novo Nordisk)
              • Oral semaglutide (Novo Nordisk)
              • ITCA-650 (Intarcia Therapeutics/Servier)
              • LixiLan (Sanofi/Zealand Pharmau2019s insulin glargine/lixisenatide)
            • Physician Survey Data
              • Current Prescribing of Key Drug Classes
              • Physicians Expected 2019 Patient Shares in T2D - Italy
              • Prescribing Related to HbA1c u2013 DPP-IV Inhibitors
              • Prescribing Related to HbA1c u2013 SGLT-2 Inhibitors
              • Prescribing Related to HbA1c u2013 GLP-1 Receptor Agonists
              • Prescribing Related to HbA1c u2013 Long-Acting Insulin Analogues
              • Prescribing Related to BMI u2013 SGLT-2 Inhibitors
              • Prescribing Related to BMI u2013 GLP-1 Receptor Agonists
              • T2D Patients Not Receiving Drug Therapy
              • Reasons for Not Treating T2D Patients
              • Management and Referral of T2D Patients
              • Key Drivers of DPP-IV Inhibitor Prescribing
              • Key Drivers of DPP-IV Inhibitor Prescribing
              • Key Drivers of DPP-IV Inhibitor Prescribing
              • Key Drivers of SGLT-2 Inhibitor Prescribing
              • Key Drivers of SGLT-2 Inhibitor Prescribing
              • Key Drivers of GLP-1 Receptor Agonist Prescribing
              • Key Drivers of GLP-1 Receptor Agonist Prescribing
              • Key Drivers of GLP-1 Receptor Agonist Prescribing
              • Key Drivers of Long-Acting Insulin Analogue Prescribing
              • Key Drivers of Long-Acting Insulin Analogue Prescribing
              • Key Drivers of Long-Acting Insulin Analogue Prescribing
              • Drug Treatment Rates u2013 France
              • Drug Treatment Rates u2013 Germany
              • Drug Treatment Rates u2013 Italy
              • Drug Treatment Rates u2013 Spain
              • Drug Treatment Rates u2013 United Kingdom
              • Breakdown of DPP-IV Inhibitor Prescribing
              • Drivers of Prescribing for Januvia
              • Drivers of Prescribing for Janumet
              • Drivers of Prescribing for Trajenta
              • Drivers of Prescribing for Eucreas
              • Breakdown of SGLT-2 Inhibitor Prescribing
              • Drivers of Prescribing for Invokana
              • Drivers of Prescribing for Forxiga
              • Drivers of Prescribing for Xigduo
              • Drivers of Prescribing for Jardiance
              • Estimated Target Patient Share for Jardiance
              • Ability to Prescribe Jardiance
              • Reimbursement Status of Jardiance
              • Impact of EMPA-REG OUTCOME Trial Results on Anticipated Prescribing of Jardiance
              • Physician Opinion of Jardiance
              • Factors Limiting Uptake of Jardiance
              • Breakdown of GLP-1 Receptor Agonist Prescribing
              • Drivers of Prescribing for Byetta
              • Drivers of Prescribing for Byetta
              • Drivers of Prescribing for Bydureon
              • Drivers of Prescribing for Victoza
              • Drivers of Prescribing for Victoza
              • Drivers of Prescribing for Lyxumia
              • Impact of Positive CVOT Data on Prescribing of GLP-1 Receptor Agonists
              • Impact of Non-Inferior ELIXA CVOT Data for Lyxumia on Prescribing
              • Impact of Non-Inferior ELIXA CVOT Data for Lyxumiau2019s HTA Assessment in France
              • Impact of Non-Inferior ELIXA CVOT Data for Lyxumiau2019s HTA Assessment in Germany
              • Breakdown of Long-Acting Insulin Analogue Prescribing
              • Drivers of Prescribing for Lantus
              • Drivers of Prescribing for Lantus
              • Drivers of Prescribing for Levemir
              • Drivers of Prescribing for Tresiba
              • Barriers to Prescribing of Xultophy
              • Drivers of Prescribing for Xultophy
              • Failure to Prescribe Individual Drug Classes Due to Cost/Reimbursement
              • Influence of Prescribing Labels on Use of DPP-IV Inhibitors
              • Influence of Prescribing Labels on Use of SGLT-2 Inhibitors
              • Influence of Prescribing Labels on Use of GLP-1 Receptor Agonists
              • Influence of Prescribing Labels on Use of Long-Acting Insulin Analogues
              • Reimbursement Challenges to the Prescribing of DPP-IV Inhibitors
              • Reimbursement Challenges to the Prescribing of DPP-IV Inhibitors
              • Reimbursement Challenges to the Prescribing of SGLT-2 Inhibitors
              • Reimbursement Challenges to the Prescribing of SGLT-2 Inhibitors
              • Reimbursement Challenges to the Prescribing of GLP-1 Receptor Agonists
              • Reimbursement Challenges to the Prescribing of GLP-1 Receptor Agonists
              • Reimbursement Challenges to the Prescribing of GLP-1 Receptor Agonists
              • Reimbursement Challenges to the Prescribing of Long-Acting Insulin Analogues
              • Reimbursement Challenges to the Prescribing of Long-Acting Insulin Analogues
              • Reimbursement Challenges to the Prescribing of Long-Acting Insulin Analogues
              • Cost-Containment Measures Employed in the Treatment of T2D
              • Impact of ALD status on T2D Patients
              • Access to Branded Therapies in France
              • The Impact of the ALD Status on Prescribing Costs
              • Access to Branded Therapies in Germany
              • The Impact of HTA Assessment on Choice of Therapy
              • The Potential Impact of the EMPA-REG CVOT on IQWiG Assessment of Jardiance
              • Impact of Prescribing Restrictions on Access to Branded Therapies in Italy
              • The Impact of the AIFA Registry on Prescribing in Italy
              • Impact of Visado de Inspeccion on Prescribing in Spain
              • The Impact of the Out-of-Pocket Costs on Prescribing in Spain
              • Impact of the Updated NICE Guidelines on Access to Branded Therapy in the United Kingdom
              • Estimated Target Patient Share for Abasaglar
              • Impact of Abasaglar on Prescribing Practices for Long-Acting Insulin Analogues
              • Physician Priorities for Novel Drug Development for T2D
              • Physician Priorities for Novel Drug Development for T2D
              • Physician Views of Payer Priorities for Novel Drug Development for T2D
              • Physician Views of Payer Priorities for Novel Drug Development for T2D
              • Factors Influencing Use of Novel Therapies
              • Factors Influencing Use of Novel Therapies
              • Factors Influencing Use of Novel Therapies
              • Likelihood of Prescribing a DPP-IV/SGLT-2 Inhibitor FDC
              • Estimated Target Patient Share for Glyxambi
              • Anticipated Usage of Glyxambi
              • Estimated Target Patient Share for SC Semaglutide
              • Estimated Target Patient Share for SC Semaglutide
              • Anticipated Usage of SC Semaglutide
              • Estimated Target Patient Share for Oral Semaglutide
              • Anticipated Usage of Oral Semaglutide
              • Estimated Target Patient Share for ITCA-650
              • Anticipated Usage of ITCA-650
              • Estimated Target Patient Share for SC Semaglutide
              • Anticipated Usage of SC Semaglutide
              • Anticipated Usage of LixiLan
              • Estimated Target Patient Share for LixiLan
              • Physicians Expected 2019 Patient Shares in T2D - France
              • Physicians Expected 2019 Patient Shares in T2D - Germany
              • Physicians Expected 2019 Patient Shares in T2D - Spain
              • Physicians Expected 2019 Patient Shares in T2D u2013 United Kingdom
              • Expectations for Delays in Availability of New Drugs Following EMA Approval
              • Potential Use of ATU for Emerging Therapies
              • Likelihood of Additional Benefit for Emerging Therapies
              • Likelihood of Innovative Status for Emerging Therapies
              • Likelihood of Formulary Inclusion for Emerging Therapies
              • Anticipated Reimbursement Status for Emerging Therapies
              • Impact of Regional Formulary Variation on Patient Access to New T2D Therapies