Stakeholder Insight: Dyslipidemia - Statins Dominate Treatment Pathway - For Now

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

• About the cardiovascular pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

• Scope of the analysis
• Datamonitor insight into the dyslipidemia market
  • Statins are the number one choice for first-line therapy
  • Physicians predict that combination therapy will play anincreasingly important role over the next three years
  • New treatment options are required
  • Datamonitor conclusions

CHAPTER 2 INTRODUCTION AND SCOPE

• Coverage of the Stakeholder Insight Survey

CHAPTER 3 COUNTRY TREATMENT TREES

• Introduction to the treatment trees
• US
• Japan
• France
• Germany
• Italy
• Spain
• UK

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION

• Definition of dyslipidemia
  • What is dyslipidemia?
• Segmentation of dyslipidemia
  • Markers for dyslipidemia
  • Segmentation by type of dyslipidemia
    • Hypercholesterolemia
    • Mixed dyslipidemia
    • Hypertriglyceridemia
  • Familial hypertriglyceridemia
  • Low HDL cholesterol
  • Segmentation by disease severity
• Co-morbidities and risk factors
• Epidemiology of dyslipidemia

CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS

• Presentation and diagnosis
  • PCPs manage highest percentage of dyslipidemia patients
  • Greatest percentage of patients managed with both drugtherapy and lifestyle advice
• Influences on diagnosis and treatment rates
  • Treatment guidelines
    • NCEP treatment guidelines

CHAPTER 6 OVERALL PRESCRIBING TRENDS

• Overall prescribing trend dominated by statins
  • Statins
  • Ezetimibe
  • Caduet
    • ASCOT
    • AVALON
• Statin prescribing trends
  • Breakdown of statin prescribing by type of statin
    • Simvastatin most prescribed statin in six major markets
    • Pitavastatins rise to dominance in Japan
    • TNT study
    • CARDS study
  • Breakdown of statin prescribing by line of therapy
  • Breakdown of statin prescribing by daily dose
  • Increased generic prescribing within three years
    • Generic challenge to Lipitors patent
  • Limitations of statin therapy
    • Patients unable to tolerate statin therapy
    • Patients refusing to take statin therapy
    • Patients refractory to statin therapy

CHAPTER 7 ANALYSIS OF FIBRATE THERAPY

• Trends in fibrate therapy
  • Breakdown of fibrate prescribing by type of fibrate
    • Fenofibrate: leading fibrate in France and Germany
    • Bezafibrate: leading fibrate in Japan and the UK
    • Gemfibrozil: leading fibrate in the US, Italy and Spain
    • Clofibrate: low use in all major markets
  • Changes in fibrate usage over recent years

CHAPTER 8 FIRST- TO SECOND-LINE THERAPY

• First-line therapy
  • Breakdown of first-line therapy by drug class
• Second-line therapy
  • Patients progressing to second-line therapy
  • Breakdown of second-line therapy by drug class
  • Patients progressing to third-line therapy and beyond
• Changes in antidyslipidemic therapy
  • Patients having their drug therapy changed
  • Reasons for changes in therapy
  • Types of therapy changes

CHAPTER 9 ANALYSIS OF COMBINATION THERAPY

• Proportion of patients receiving combination therapy
• Future prescribing of combination therapy
• Breakdown of combination therapy
  • Statin + ezetimibe combination
  • Statin + fibrate combination
• Factors influencing future use of new adjunctivetherapies
  • Additional LDL cholesterol-reducing benefits
  • HDL cholesterol-raising benefits
  • Ability to prescribe lower-dose statins withoutcompromising efficacy
  • Triglyceride-lowering effects
  • Potential increase in side effects
  • Limited mortality data for combination therapy
  • Reduced compliance due to increase pill burden
  • Increase in cost

CHAPTER 10 IMPROVING TREATMENT OUTCOMES

• Treatment outcomes
  • Patients failing to achieve target cholesterol goals
    • Studies assessing treatment outcomes
  • Factors influencing the prescribing of antidyslipidemics
• The greatest unmet need in dyslipidemia according to keyopinion leaders, is for drugs with the ability to prevent or reverseatherosclerosis
  • Drugs need to prevent or even reverse the progression ofatherosclerosis
  • Drugs with novel mechanisms of action
  • Drugs with increased efficacy in lowering LDL andincreasing HDL
  • More long-term data is required to support primary andsecondary prevention of acute CVD event.
  • More combination therapies are needed
  • Additional statin safety studies not required

CHAPTER 11 NEW PRODUCT AWARENESS

• Ezetimibe
  • Physician awareness
  • Percentage of patients prescribed
  • Mean rating table
• Vytorin
  • Physician awareness
  • Percentage of patients prescribed
  • The cost and reimbursement of Vytorin
• Crestor
• Atorvastatin + torcetrapib
  • Physician awareness
  • Percentage of patients prescribed

• APPENDIX A BIBLIOGRAPHY
  • Clinical trial data
• Epidemiology methodology
  • Datamonitor forecast methodology
  • Methodology
  • US
  • Japan
  • France
  • Germany
  • Italy
  • Spain
  • UK
• APPENDIX B
  • Physician research methodology
    • Physician sample breakdown
    • US
    • Japan
    • France
    • Germany
    • Italy
    • Spain
    • UK
  • Stakeholder Insight Questionnaire
    • Diagnosis
    • Treatment overview
    • First line therapy
    • Therapy changes
    • Second line therapy
    • Combination therapy
    • Treatment outcomes
    • Future focus
    • Disclaimer

List of Tables

• Table 1: Key changes to lipid levels between the NCEPII and NCEP III
• Table 2: Estimated proportion of dyslipidemia patientswith co-morbid conditions and risk factors in the seven major markets,2005
• Table 3: Epidemiology overview of dyslipidemia,2005-15
• Table 4: Epidemiology figures by age for the sevenmajor markets, 2005
• Table 5: Estimated breakdown of the management ofdyslipidemia in the general population by physician type, 2005
• Table 6: Breakdown of dyslipidemia management acrossthe different populations in the seven major markets, 2005
• Table 7: Proportion of drug-treated patientsprescribed each type of therapy in the seven major markets, 2005
• Table 8: AVALON trial results
• Table 9: Generic price of simvastatin in the UK
• Table 10: TNT study results
• Table 11: CARDS study results
• Table 12: Breakdown of statin prescribing by line oftherapy in the seven major markets, 2005
• Table 13: Breakdown of statin prescribing by dailydose in the seven major markets, 2005
• Table 14: Availability of generic statins in the sevenmajor markets, 2005
• Table 15: Proportion of overall drug-treateddyslipidemia patients prescribed each antidyslipidemic drug class asfirst-line therapy in the seven major markets, 2005
• Table 16: Proportion of overall drug-treateddyslipidemia patients prescribed each antidyslipidemic drug class assecond-line therapy in the seven major markets, 2005
• Table 17: Average number of changes a patientundergoes over one year, 2005
• Table 18: Change in combination therapy over the nextthree years in the seven major markets, 2005
• Table 19: Breakdown of combination therapy bydyslipidemia sub-population in the seven major markets, 2005
• Table 20: Physician ratings of factors providingincentives/disincentives for the future prescribing of new therapies asadjuncts to statins in the seven major markets, 2005
• Table 21: Proportion of drug-treated dyslipidemiapatients in each sub-population failing to reach target cholesterolgoals in the seven major markets, 2005
• Table 22: Average rating of factors influencing theprescribing of antidyslipidemic therapy in the seven major markets, 2005
• Table 23: Mean ranking of preferred statin to use withezetimibe, 2005
• Table 24: Physician opinions of Vytorin, 2005
• Table 25: Price comparison of Vytorin, 2005
• Table 26: US physicians opinion of Crestor, 2005
• Table 27: US physician sample breakdown, 2005
• Table 28: Japan physician sample breakdown, 2005
• Table 29: France physician sample breakdown, 2005
• Table 30: Germany physician sample breakdown, 2005
• Table 31: Italy physician sample breakdown, 2005
• Table 32: Spain physician sample breakdown, 2005
• Table 33: UK physician sample breakdown, 2005

List of Figures

• Figure 1: Diagrammatic overview of the coverage of thedyslipidemia Stakeholder Insight survey, 2005
• Figure 2: Breakdown of the overall dyslipidemiapopulation in the US by diagnosis, type of dyslipidemia, diseaseseverity and prevalence of risk factors and co-morbidities, 2005
• Figure 3: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in the US, 2005
• Figure 4: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in the US,for the overall drug treated dyslipidemia population, 2005
• Figure 5: Breakdown of first- and second-line therapyby antidyslipidemic drug class in the US for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 6: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inthe US for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 7: Breakdown of combination therapy bydyslipidemia sub-population in the US for the overall diagnosed and drugtreated dyslipidemia population, 2005
• Figure 8: Breakdown of treatment outcomes bydyslipidemia sub-population in the US, 2005
• Figure 9: Breakdown of the overall dyslipidemiapopulation in Japan by diagnosis, type of dyslipidemia, disease severityand prevalence of risk factors and co-morbidities, 2005
• Figure 10: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in Japan, 2005
• Figure 11: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in Japan,for the overall drug treated dyslipidemia population, 2005
• Figure 12: Breakdown of first- and second-line therapyby antidyslipidemic drug class in Japan for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 13: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inJapan for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 14: Breakdown of combination therapy bydyslipidemia sub-population in Japan, 2005
• Figure 15: Breakdown of treatment outcomes bydyslipidemia sub-population in Japan, 2005
• Figure 16: Breakdown of the overall dyslipidemiapopulation in France by diagnosis, type of dyslipidemia, diseaseseverity and prevalence of risk factors and co-morbidities, 2005
• Figure 17: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in France, 2005
• Figure 18: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in France,for the overall drug treated dyslipidemia population, 2005
• Figure 19: Breakdown of first- and second-line therapyby antidyslipidemic drug class in France for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 20: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inFrance for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 21: Breakdown of combination therapy bydyslipidemia sub-population in France, 2005
• Figure 22: Breakdown of treatment outcomes bydyslipidemia sub-population in France, 2005
• Figure 23: Breakdown of the overall dyslipidemiapopulation in Germany by diagnosis, type of dyslipidemia, diseaseseverity and prevalence of risk factors and co-morbidities, 2005
• Figure 24: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in Germany, 2003
• Figure 25: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics inGermany, for the overall drug treated dyslipidemia population, 2005
• Figure 26: Breakdown of first- and second-line therapyby antidyslipidemic drug class in Germany for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 27: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inGermany for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 28: Breakdown of combination therapy bydyslipidemia sub-population in Germany, 2005
• Figure 29: Breakdown of treatment outcomes bydyslipidemia sub-population in Germany, 2005
• Figure 30: Breakdown of the overall dyslipidemiapopulation in Italy by diagnosis, type of dyslipidemia, disease severityand prevalence of risk factors and co-morbidities, 2005
• Figure 31: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in Italy, 2005
• Figure 32: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in Italy,for the overall drug treated dyslipidemia population, 2005
• Figure 33: Breakdown of first- and second-line therapyby antidyslipidemic drug class in Italy for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 34: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inItaly for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 35: Breakdown of combination therapy bydyslipidemia sub-population in Italy, 2005
• Figure 36: Breakdown of treatment outcomes bydyslipidemia sub-population in Italy, 2005
• Figure 37: Breakdown of the overall dyslipidemiapopulation in Spain by diagnosis, type of dyslipidemia, disease severityand prevalence of risk factors and co-morbidities, 2005
• Figure 38: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in Spain, 2005
• Figure 39: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in Spain,for the overall drug treated dyslipidemia population, 2005
• Figure 40: Breakdown of first- and second-line therapyby antidyslipidemic drug class in Spain for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 41: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inSpain for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 42: Breakdown of combination therapy bydyslipidemia sub-population in Spain, 2005
• Figure 43: Breakdown of treatment outcomes bydyslipidemia sub-population in Spain, 2005
• Figure 44: Breakdown of the overall dyslipidemiapopulation in the UK by diagnosis, type of dyslipidemia, diseaseseverity and prevalence of risk factors and co-morbidities, 2005
• Figure 45: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in the UK, 2005
• Figure 46: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in the UK,for the overall drug treated dyslipidemia population, 2005
• Figure 47: Breakdown of first- and second-line therapyby antidyslipidemic drug class in the UK for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 48: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inthe UK for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 49: Breakdown of combination therapy bydyslipidemia sub-population in the UK, 2005
• Figure 50: Breakdown of treatment outcomes bydyslipidemia sub-population in the UK, 2005
• Figure 51: Proportion of diagnosed dyslipidemiapatients with each type of dyslipidemia in the seven major markets, 2005
• Figure 52: Proportion of diagnosedhypercholesterolemia patients with familial hypercholesterolemia in theseven major markets, 2005
• Figure 53: Proportion of diagnosed dyslipidemiapatients with low HDL cholesterol in the seven major markets, 2005
• Figure 54: Breakdown of the diagnosed dyslipidemiapopulation by disease severity in the seven major markets, 2005
• Figure 55: Estimated proportion of dyslipidemiapatients in the general population diagnosed in the seven major markets,2005
• Figure 56: Overview of NCEP ATP III guidelines
• Figure 57: Breakdown of statin prescribing by type ofstatin in overall dyslipidemia patients in the seven major markets, 2005
• Figure 58: Brand versus generic prescribing ofstatins, currently and in three years, 2005
• Figure 59: Proportion of drug-treated dyslipidemiapatients unable to tolerate statin therapy in the seven major markets,2005
• Figure 60: Proportion of drug-treated dyslipidemiapatients refusing to take statin therapy in the seven major markets,2005
• Figure 61: Proportion of dyslipidemia patients onstatin therapy that are refractory to statins in the seven majormarkets, 2005
• Figure 62: Breakdown of fibrate prescribing bycompound in overall dyslipidemia patients in the seven major markets,2005
• Figure 63: Proportion of overall drug-treateddyslipidemia patients progressing to second-line therapy, 2005
• Figure 64: Comparison of antidyslipidemic drug classesat first- versus second-line in the combined seven markets, 2005
• Figure 65: Proportion of overall drug-treateddyslipidemia patients on second-line therapy progressing to third-linetherapy and beyond, 2005
• Figure 66: Proportion of overall drug-treateddyslipidemia patients having their therapy changed over a one-yearperiod, 2005
• Figure 67: Reasons for change in antidyslipidemictherapy in the seven major markets, 2005
• Figure 68: Type of changes in antidyslipidemic therapyin the seven major markets, 2005
• Figure 69: Proportion of overall drug-treateddyslipidemia patients receiving combination therapy in the seven majormarkets, 2005
• Figure 70: Proportion of hypercholesterolemiadrug-treated dyslipidemia patients receiving combination therapy in theseven major markets, 2005
• Figure 71: Proportion of drug-treated mixeddyslipidemia patients receiving combination therapy in the seven majormarkets, 2005
• Figure 72: Proportion of drug-treated diabeticdyslipidemia patients receiving combination therapy in the seven majormarkets, 2005
• Figure 73: Proportion of drug-treated dyslipidemiapatients in each sub-population receiving a statin + ezetimibecombination in the seven major markets, 2005
• Figure 74: Proportion of drug-treated dyslipidemiapatients in each sub-population receiving a statin + fibrate combinationin the seven major markets, 2003
• Figure 75: Unmet needs in the dyslipidemia market,2005
• Figure 76: Physician awareness of ezetimibe, 2005
• Figure 77: Proportion of patients expected to beprescribed ezetimibe, 2005
• Figure 78: Proportion of physicians aware of Vytorin,2005
• Figure 79: Proportion of patients estimated to receiveVytorin, 2005
• Figure 80: Physician awareness of atorvastatin +torcetrapib, 2005
• Figure 81: Proportion of patients expected to receiveatorvastatin + torcetrapib when launched, 2005