Stakeholder Insight: Diabetes

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Cardiovascular pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Key Findings
• CHAPTER 2 INTRODUCTION AND SCOPE
  • Scope of the analysis
  • Related reports
  • Common abbreviations used throughout this report:
• CHAPTER 3 COUNTRY TREATMENT ALGORITHMS
  • Introduction
    • US
    • Japan
    • France
    • Germany
    • Italy
    • Spain
    • UK
    • 5 European Markets Summary Algorithms
• CHAPTER 4 DISEASE DEFINITION AND OVERVIEW
  • Definition of diabetes
  • Segmentation of diabetes
    • Type 1 diabetes
    • Type 1.5 diabetes
    • Type 2 diabetes
  • Etiology and Risk factors
    • Mechanisms of development of diabetes
    • Genetic or acquired causes
  • Risk factors
    • Obesity
      • T2 diabetes epidemic hand-in-hand with obesity epidemic
    • Race
      • T2 diabetes more prevalent in Hispanics and African Americans than in Caucasians
    • Family history
      • T2 diabetes in first-degree relatives is a strong prognostic indicator
    • Advanced age
    • Gender and other factors
    • Gestational diabetes mellitus
• CHAPTER 5 EPIDEMIOLOGY OF DIABETES
  • Epidemiology of diabetes
    • Diabetes presents a worldwide public health problem
    • Current prevalence of type 1 and type 2 diabetes
    • Increasing prevalence of type 2 diabetes
    • Increase in prevalence to epidemic proportion
    • Datamonitor epidemiology forecast
      • Methodology
    • Epidemic rise in incidence of T2 diabetes
• CHAPTER 6 DIAGNOSIS AND PATIENT MANAGEMENT
  • Patient management
    • The majority of diabetics are diagnosed and managed by primary care practitioners
    • Referral to a specialist
  • Diagnosis rates in type 2 diabetes
  • Reasons for the poor diagnosis rate
    • Insidious nature of the disease
    • Lack of screening
    • Awareness of guidelines
    • Validity of diagnostic tests
    • Misdiagnosis of T2 and T1 diabetes
  • Strategies to increase diagnosis rates
    • The need for a targeted screening program
  • Late stage of diagnosis
  • Disease indicators at presentation
• CHAPTER 7 DIABETIC COMPLICATIONS
  • Complications of type 2 diabetes
    • Microvascular complications
      • Nephropathy
      • Retinopathy
      • Neuropathy
    • Macrovascular complications
      • Effect of macrovascular complications on type 2 diabetes treatment
    • End-stage disease considerations
  • Co-morbidities
    • Obesity
      • Effect of obesity on type 2 diabetes treatment
    • Hypertension
    • Dyslipidemia
• CHAPTER 8 TREATMENT OPTIONS FOR TYPE 2 DIABETES
  • Treatment guidelines for type 2 diabetes
    • Clinical practice guidelines from the ADA/EASD
    • The AACE clinical practice guidelines
  • Lifestyle management for type 2 diabetes
  • Pharmacological treatment for type 2 diabetes
  • Oral antidiabetic (OAD) agents
    • Biguanides (metformin)
    • Sulfonylureas
    • Prandial glucose regulators (PGRs)
    • Thiazolidinediones
    • Alpha-glucosidase inhibitors (AGIs)
    • Incretin Mimetics
    • Glucagon-like peptide-1 agonists (GLP-1s)
    • Dipeptidyl peptidase-4 inhibitors (DPP-4s)
  • Insulins
    • Lantus
    • Levemir
    • Humalog
    • Novolog
    • NovoLin
    • Humulin
    • Apidra
• CHAPTER 9 FIRST-LINE PHARMACOTHERAPY
  • Overview
    • First-line monotherapy
    • First-line combination therapy
• CHAPTER 10 SECOND-LINE PHARMACOTHERAPY
  • Overview
    • Second-line monotherapy
    • Second-line combination therapy
• CHAPTER 11 THIRD-LINE PHARMACOTHERAPY
  • Overview
    • Third-line monotherapy
    • Third-line combination therapy
• CHAPTER 12 TRANSITION TO INSULIN THERAPY
  • History of insulin therapy
  • Indications for insulin use in type 2 diabetes
  • Time of initiation of insulin therapy
  • Drivers for insulin uptake
    • Improved of glycemic control
    • Earlier initiation of insulin therapy
  • Restraints for uptake of insulin
    • Weight gain
    • Risk of hypoglycemia
    • Patient education and compliance with subcutaneous injections
    • Cost and reimbursement issues
  • Use of insulin
    • Overall usage of insulin
    • Changes to insulin prescribing habits
    • Past, present and future use
    • Usage of different types of insulin
  • Physician perception of different types of insulin
  • Brand map overview
    • Interpreting a brand map
      • Long-acting insulins: Lantus (Glargine) and Levemir (Detemir)
      • Short-acting insulins: Humalog (Lispro) and Apidra (Glulisine)
      • Failure of inhaled insulin
• CHAPTER 13 PRESCRIBING TRENDS IN THE TREATMENT OF TYPE 2 DIABETES
  • The evolution of the treatment regimen
    • Factors determining the alteration to a treatment regimen
    • Patient empowerment
    • Uptake of single-pill combination (SPC) therapies
  • The evolution of the treatment algorithm
    • Sulfonylureas and Metformin
    • Loss of confidence in TZDS
    • PGRs and AGIs
    • Insulin shifted down treatment algorithm by new classes of incretin mimetic
• CHAPTER 14 PRESCRIBING INFLUENCES IN THE TREATMENT OF TYPE 2 DIABETES
  • Factors influencing prescribing decisions in T2 diabetes
    • Efficacy is the major prescribing influence in type 2 diabetes
    • Safety is also an important prescribing influence
    • Cost issues possibly not as important as for other indications
    • Beta cell salvage and time to secondary failure
    • Mode of administration
    • Dosing frequency
  • Physician perception of existing therapies in type 2 diabetes
  • Brand map overview
    • Interpreting a brand map
    • Physician perception of established classes of antidiabetic drugs
    • Physician perception of novel classes of antidiabetic drugs
• CHAPTER 15 UNMET NEEDS IN TYPE 2 DIABETES
  • Overview
    • Each unmet need is ordered by relative importance, and discussed in more detail below:
    • Insulin response variability
    • Poor diagnosis
      • Routine screening programs to improve poor diagnosis rate
    • Guideline awareness
    • Non-invasive blood glucose measurement (BMG)
    • Tolerability
      • Incidence of hypoglycemic events
      • Delivery-related complications
      • Weight gain
    • Mode of administration (MoA)
      • Reluctance to self-inject
    • Patient compliance
    • Insulin secretion patterns
    • Patient awareness
    • Efficacy
• APPENDIX A
  • Bibliography
• APPENDIX B
  • Physician research methodology
    • Physician sample breakdown
      • US
      • Japan
      • France
      • Germany
      • Italy
      • Spain
      • UK
• APPENDIX C
  • The survey questionnaire
  • List of Tables
    • Table 1: Prevalence of diabetes mellitus is forecast to increase by the International Diabetes Foundation (IDF), 2003-2025
    • Table 2: Prevalence rate of type 1 and type 2 diabetes in the seven major markets (%), 2006-2015
    • Table 3: Estimated absolute prevalence of diabetes in the seven major markets (millions), 2007-2017
    • Table 4: Framingham Heart Study data on lipid levels in men and women with and without diabetes
    • Table 5: ADA evidence grading system for clinical practice guidelines
    • Table 6: Comparator Insulins by onset of action, 2006
    • Table 7: US physician sample breakdown, 2007
    • Table 8: Japan physician sample breakdown, 2007
    • Table 9: France physician sample breakdown, 2007
    • Table 10: Germany physician sample breakdown, 2007
    • Table 11: Italy physician sample breakdown, 2007
    • Table 12: Spain physician sample breakdown, 2007
    • Table 13: UK physician sample breakdown, 2007
  • List of Figures
    • Figure 1: Population demographic for diagnosed type 2 diabetic patients in the US, 2007
    • Figure 2: Population, treatment and treatment outcome data for type 2 diabetic patients in US, 2007
    • Figure 3: TypeFigTitleHere
    • Figure 4: Population, treatment and treatment outcome data for type 2 diabetic patients in Japan, 2007
    • Figure 5: Population demographic for diagnosed type 2 diabetic patients in France, 2007
    • Figure 6: Population, treatment and treatment outcome data for type 2 diabetic patients in France, 2007
    • Figure 7: Population demographic for diagnosed type 2 diabetic patients in Germany, 2007
    • Figure 8: Population, treatment and treatment outcome data for type 2 diabetic patients in Germany, 2007
    • Figure 9: Population demographic for diagnosed type 2 diabetic patients in Italy, 2007
    • Figure 10: Population, treatment and treatment outcome data for type 2 diabetic patients in Germany, 2007
    • Figure 11: Population demographic for diagnosed type 2 diabetic patients in Spain, 2007
    • Figure 12: Population, treatment and treatment outcome data for type 2 diabetic patients in Italy, 2007
    • Figure 13: Population demographic for diagnosed type 2 diabetic patients in the UK, 2007
    • Figure 14: Population, treatment and treatment outcome data for type 2 diabetic patients in the UK, 2007
    • Figure 15: Population, treatment and treatment outcome data for RCC in the 5EU, 2007 (continued)
    • Figure 16: Population, treatment and treatment outcome data for type 2 diabetic patients in the 5EU, 2007
    • Figure 17: Specialty of physician diagnosing and managing diabetic patients.
    • Figure 18: Estimated percentage of diagnosed type 2 diabetics in the seven major markets
    • Figure 19: Estimated percentage of diagnosed type 2 diabetics who are classified as either overweight or obese.
    • Figure 20: Estimated percentage of diagnosed type 2 diabetics who are classified as prehypertensive or hypertensive.
    • Figure 21: Estimated percentage of diagnosed type 2 diabetics with each degree of plasma cholesterol elevation
    • Figure 22: Proportion of type 2 diabetics in the seven major markets with complications
    • Figure 23: Proportion of type 2 diabetics with complications that suffer from microvascular and/or macrovascular complications in the seven major markets
    • Figure 24: Proportion of type 2 diabetics with different stages of nephropathy in the seven major markets
    • Figure 25: Average time from the diagnosis of diabetes required for the development of different stages of diabetic nephropathy in the seven major markets, 2007.
    • Figure 26: Proportion of type 2 diabetics with retinopathy in the seven major markets
    • Figure 27: Average time required for the development of diabetic retinopathy in the seven major markets
    • Figure 28: Proportion of type 2 diabetics with neuropathy in the seven major markets
    • Figure 29: Average time required for the development of diabetic neuropathy in the seven major markets
    • Figure 30: Proportion of type 2 diabetics with macrovascular complications in the seven major markets
    • Figure 31: Average time for the development of macrovascular complications in the seven major markets
    • Figure 32: Proportion of type 2 diabetics with serious complications (e.g. ESRD, acute MI, amputation)
    • Figure 33: Treatment algorithm for type 2 diabetes, recommended by the 2006 ADA/EASD clinical practice guidelines.
    • Figure 34: Percentage of diagnosed type 2 patients receiving drug therapy and/or lifestyle management in the seven major markets
    • Figure 35: Breakdown of patients by line of treatment in the seven major markets
    • Figure 36: Mechanism of action of sulfonylureas and prandial glucose regulators
    • Figure 37: Percentage of patients on monotherapy versus. combination therapy at first-line therapy, 2007.
    • Figure 38: Breakdown of overall drug class usage in patients on first-line therapy in the seven major markets
    • Figure 39: Breakdown of combination therapy at first-line in the seven major markets
    • Figure 40: Percentage of patients in monotherapy vs. combination therapy in second-line therapy
    • Figure 41: Breakdown of drug class use in patients on second-line monotherapy in the seven major markets
    • Figure 42: Breakdown of drug class use in patients on second-line monotherapy in the seven major markets
    • Figure 43: Percentage of patients on monotherapy versus combination therapy in third-line therapy, 2007.
    • Figure 44: Breakdown of drug class use in patients on third-line monotherapy in the seven major markets, 2007.
    • Figure 45: Breakdown of drug regimen use in patients on third-line combination therapy in the seven major markets
    • Figure 46: Common insulin regimens
    • Figure 47: When to start insulin therapy in type 2 diabetes?
    • Figure 48: Time to the inititation of insulin therapy
    • Figure 49: Specialists' rankings of the factors influencing insulin prescribing in the seven major markets (1 = most influencing, 5 = least influencing)
    • Figure 50: Uptake of insulin across the seven major markets, 2007.
    • Figure 51: Proportion of drug-treated type 2 diabetes patients prescribed insulin either alone or in combination therapy, by line of therapy, across the seven major markets, 2007
    • Figure 52: Comparison of current (2007) insulin prescription pattern with that in 2004, and 2010.
    • Figure 53: Brand map for the different types of insulin
    • Figure 54: Factors influencing therapy changes, 2007
    • Figure 55: Therapy changes across the seven major markets, 2007
    • Figure 56: Factors influencing the uptake of SPCs across the seven major markets, 2007
    • Figure 57: Uptake of SPCs across the seven major markets, 2007
    • Figure 58: Physicians' changing prescribing trends 2004-2010
    • Figure 59: Evolution of the treatment algorithm
    • Figure 60: Evolution of the treatment algorithm
    • Figure 61: Evolution of the treatment algorithm
    • Figure 62: Relative weighting given to each prescribing influence for type 2 diabetes drug therapy across the seven major markets, 2007
    • Figure 63: Brand map of established antidiabetic drugs in 7MM, 2007
    • Figure 64: Brand map of novel classes of antidiabetic drugs in 7MM, 2007
    • Figure 65: Unmet need for antidiabetic drugs in 7MM, 2007
    • Figure 66: Unmet need in blood glucose measurement (BMG)