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 physicians’ 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
          • Methodology
            • Abbreviations
            • Methodology: Primary Research Design
            • Methodology: Background of Payers and Payer-Advising KOLs
            • Methodology: Surveyed Physician Profile and Demographics
              • Methodology: Physician Demographics and Practice Setting—Endocrinologists and PCPs
              • Appendix
                • Key Current Therapies for Type 2 Diabetes
                  • Key Current Therapies Used in the Treatment of T2D
                  • Empagliflozin (Boehringer Ingelheim/Eli Lilly’s Jardiance)
                  • Glyxambi (Boehringer Ingelheim/Eli Lilly’s linagliptin/empagliflozin)
                  • Injectable Semaglutide (Novo Nordisk)
                  • Oral semaglutide (Novo Nordisk)
                  • ITCA-650 (Intarcia Therapeutics/Servier)
                  • LixiLan (Sanofi/Zealand Pharma’s insulin glargine/lixisenatide)
                • Physician Survey Data
                  • Current Prescribing of Key Drug Classes
                  • Physicians Expected 2019 Patient Shares in T2D - Italy
                  • Prescribing Related to HbA1c – DPP-IV Inhibitors
                  • Prescribing Related to HbA1c – SGLT-2 Inhibitors
                  • Prescribing Related to HbA1c – GLP-1 Receptor Agonists
                  • Prescribing Related to HbA1c – Long-Acting Insulin Analogues
                  • Prescribing Related to BMI – SGLT-2 Inhibitors
                  • Prescribing Related to BMI – 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 – France
                  • Drug Treatment Rates – Germany
                  • Drug Treatment Rates – Italy
                  • Drug Treatment Rates – Spain
                  • Drug Treatment Rates – 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 Lyxumia’s HTA Assessment in France
                  • Impact of Non-Inferior ELIXA CVOT Data for Lyxumia’s 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 – 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

            Author(s): Laurie J. Dimodica, MS

            Laurie DiModica has more than two decades of experience in healthcare and biopharmaceutical market research in the major and emerging markets. She currently works on DRG’s Access & Reimbursement series (formerly European Physician and Payer Forum) and its Global Market Access Solutions product. Ms. DiModica was previously a Medical Publications and Conference Director for the Institute for International Research, specializing in the U.S. managed care market. She has an M.S. from Simmons College in Boston. 


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