Contents:

CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Summary 5 Key metrics 6 Study methodology and sample details 8 CHAPTER 2 OVERVIEW OF PATIENT COMPLIANCE IN PSYCHIATRY 18 Definition of patient compliance 18 Frequency of noncompliance across psychiatry indications 18 Epidemiology of schizophrenia 20 Overview 20 Prevalence 21 Diagnosis and treatment rates 21 Compliance rates 21 Epidemiology of bipolar disorder 24 Overview 24 Prevalence 25 Diagnosis and treatment rates 25 Compliance rates 25 Epidemiology of depression 27 Overview 27 Prevalence 27 Diagnosis and treatment rates 28 Compliance rates 29 Cost of noncompliance to pharmaceutical companies 31 Strategies shown to improve compliance 32 Treatment-related 32 Minimize drug side effects 32 Drug regimen 32 Reminder or compliance packaging by manufacturer 33 Number of doses per day 34 Unit dose convenience packs 34 Pill boxes 35 Drug delivery systems 35 Clinician-related 36 Patient counseling 36 Patient education and psychotherapy 36 Communication training 37 Patient education and compliance monitoring 38 Home visits 38 Patient related 39 Patient-skill building “Medication chart” 39 Reminders by telephone 39 Clinic and telephone visits with written correspondence 40 Electronic devices 40 Family support 40 Support group sessions 41 General considerations for patient compliance programs 41 Improving relationships with end-users makes good commercial sense 41 Interventions must be highly relevant to the individual 41 Information needs to be given throughout the treatment course 42 Specific European opportunities 44 Acceptance of depot formulations beyond schizophrenia 44 Patient education through Health professional led local meetings 44 Summary 45 CHAPTER 3 PATIENT COMPLIANCE IN SCHIZOPHRENIA 46 Market overview 46 First line treatment of schizophrenia 48 Reasons for noncompliance in chronic schizophrenia 49 General reasons 50 Lack of insight and drug side effects are key to noncompliance 50 Perceived treatment success suggest a need for education prior to and during drug treatment 54 Side effect-specific reasons 55 Weight gain is a big problem 58 BMS needs to emphasize in Abilify’s marketing messages that it causes minimal weight gain compared to rivals 59 Care managers do not normally warn patients about side effects 59 Patients are equally likely to be noncompliant due to a fear of a side effect as they are due to the actual occurrence of a side effect 60 Side effect management programs can improve patient retention 61 Case Study: Lilly’s ‘Solutions for Wellness’ program 62 Actions taken for noncompliant schizophrenia patients 63 Drug switching is a primary source of lost revenue 64 Approaches to improving compliance in schizophrenia 64 Drug approaches 66 There is a need for more atypical depots 66 Pain at site of injection is a problem for patients taking depots 68 Non drug approaches 70 A good therapeutic alliance is key 71 Directly observed therapy is good in theory but problematic in practice 72 Involving the family is challenging but effective 72 Influence of educational sources 74 The therapist is the best source of information on treatment compliance 76 Websites and DTC advertising are good sources of general information but are not so good for providing specific drug compliance education 76 Patient education should be given at different stages of treatment and tailored to the individual 77 Case study: Lilly’s ‘Meaningful Day’ educational program 77 Datamonitor conclusions and recommendations 79 CHAPTER 4 PATIENT COMPLIANCE IN BIPOLAR DISORDER 81 Market overview 81 First line treatment of bipolar disorder 82 Reasons for noncompliance in bipolar disorder 84 General reasons 84 Side effect-specific reasons 86 Actions taken for noncompliant bipolar disorder patients 88 Approaches to improving compliance in bipolar disorder 90 Drug approaches 90 Lessening the burden of oral pills is a good strategy 90 Combination pills offer few advantages 91 Non drug approaches 92 Leading players provide free compliance tools such as mood diaries 94 Influence of educational sources 96 Websites are not viewed as useful sources of information 97 The trend is to support health information sites 98 Public information is beneficial but key messages must be unrelated to product-specific marketing 99 Datamonitor conclusions and recommendations 100 CHAPTER 5 PATIENT COMPLIANCE IN DEPRESSION 103 Market overview 103 First line treatment of depression 104 Reasons for noncompliance in depression 105 General reasons 105 A multitude of reasons are responsible for noncompliance in depression 106 Patients will be noncompliant whether the drug does or does not work 106 Side effect-specific reasons 107 Sexual dysfunction is a leading cause of noncompliance in the US and EU 109 Case study: GSK’s Wellbutrin-XL successfully promoted as the only once-daily antidepressant without sexual side effects 110 Media coverage of the SSRI suicide risk story increased noncompliance 111 Actions taken for noncompliant depression patients 112 Approaches to improving compliance in depression 113 Drug approaches 113 Reformulation is not the way to go in the US depression market 114 Non drug approaches 115 A strong therapeutic-alliance and patient education are key means of improving compliance in depression 116 Collaborations with patient advocacy groups are recommended 118 Esteve launches innovative ‘PatientFeedback’ tool to improve communication between depression patients and their therapists 119 Influence of educational sources 120 DTC advertising is not practical as a compliance improving tool 122 Case study: Pfizer’s ‘Rhythms’ patient education campaign was an effective patient compliance strategy 125 Compliance aids are less accessible on depression information websites 126 Effective disorder information leaflets need to be clear, informative and stimulating 127 CME programs targeted to healthcare providers offer greater coverage of education 128 Datamonitor conclusions and recommendations 129 APPENDIX A 131 Bibliography 131 Websites 145 APPENDIX B 147 Sample details 147 First line treatment 147 General details 153 Physician research methodology 154 Study questionnaire 155 APPENDIX C 187 About Datamonitor 187 About Datamonitor Healthcare 187 About the CNS analysis team 188 Key therapy team members 189 Lynda Lynch, Director CNS 189 Disclaimer 190