精神医学における患者のコンプライアンス

Introduction

• Generic saturation coupled with a poor R&D pipeline is forcing pharmaceutical companies to seek alternative ways of maintaining revenue growth in the ever-competitive psychiatry sector. Surprisingly, despite being long recognized as a costly problem, interest in patient compliance is only just gaining momentum and effective patient compliance programs have yet to become standard practice.

Scope of this report

• Analysis of the prevalence of noncompliance in schizophrenia, bipolar disorder and depression with an overview of compliance improving strategies
• For these three disorders: discussion of general and side-effect specific reasons for noncompliance
• Insight into the actions taken by care managers of noncompliant patients
• In-depth analysis of the perceived usefulness of approaches to tackle noncompliance and the influence of education sources

Research and analysis highlights

• Players in the schizophrenia, bipolar disorder, and depression markets lose millions of dollars in drug sales annually due to noncompliance. Capturing this lost revenue is becoming ever important as the return on investment of traditional lifecycle management strategies is dwindling.
• Pfizer and Eli Lilly have both implemented large compliance programs in psychiatry, which have been well received by the medical community. The popularity of these programs can be attributed to a patient-focused design, which, among other benefits, has served the companies profile among end-users.
• Ultimately, education to patients is a free service provided by companies. If shown to improve treatment outcomes in controlled studies, companies would be in a stronger position to convince payers and regulatory bodies to advocate their brands over generics.

Key reasons to read this report

• Understand the key reasons causing noncompliance in schizophrenia, bipolar disorder, and depression and the actions taken by therapists
• Benchmark your own patient compliance programs to those that have already been conducted by other companies
• Optimize the communication of your compliance messages by recognizing the most influential sources of information for these patient groups

ABOUT DATAMONITOR HEALTHCARE

• About the CNS pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

• Scope of the analysis
• Summary
• Key metrics
• Study methodology and sample details

CHAPTER 2 OVERVIEW OF PATIENT COMPLIANCE IN PSYCHIATRY

• Definition of patient compliance
• Frequency of noncompliance across psychiatry indications
• Epidemiology of schizophrenia
  • Overview
  • Prevalence
  • Diagnosis and treatment rates
  • Compliance rates
• Epidemiology of bipolar disorder
  • Overview
  • Prevalence
  • Diagnosis and treatment rates
  • Compliance rates
• Epidemiology of depression
  • Overview
  • Prevalence
  • Diagnosis and treatment rates
  • Compliance rates
• Cost of noncompliance to pharmaceutical companies
• Strategies shown to improve compliance
  • Treatment-related
    • Minimize drug side effects
    • Drug regimen
    • Reminder or compliance packaging by manufacturer
    • Number of doses per day
    • Unit dose convenience packs
    • Pill boxes
    • Drug delivery systems
  • Clinician-related
    • Patient counseling
    • Patient education and psychotherapy
    • Communication training
    • Patient education and compliance monitoring
    • Home visits
  • Patient related
    • Patient-skill building "Medication chart"
    • Reminders by telephone
    • Clinic and telephone visits with written correspondence
    • Electronic devices
  • Family support
  • Support group sessions
• General considerations for patient compliance programs
  • Improving relationships with end-users makes good commercial sense
  • Interventions must be highly relevant to the individual
  • Information needs to be given throughout the treatment course
  • Specific European opportunities
    • Acceptance of depot formulations beyond schizophrenia
    • Patient education through Health professional led local meetings
  • Summary

CHAPTER 3 PATIENT COMPLIANCE IN SCHIZOPHRENIA

• Market overview
• First line treatment of schizophrenia
• Reasons for noncompliance in chronic schizophrenia
  • General reasons
    • Lack of insight and drug side effects are key to noncompliance
    • Perceived treatment success suggest a need for education prior to and during drug treatment
  • Side effect-specific reasons
    • Weight gain is a big problem
    • BMS needs to emphasize in Abilifys marketing messages that it causes minimal weight gain compared to rivals
    • Care managers do not normally warn patients about side effects
    • 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
    • Side effect management programs can improve patient retention
    • Case Study: Lillys Solutions for Wellness program
• Actions taken for noncompliant schizophrenia patients
  • Drug switching is a primary source of lost revenue
• Approaches to improving compliance in schizophrenia
  • Drug approaches
    • There is a need for more atypical depots
    • Pain at site of injection is a problem for patients taking depots
  • Non drug approaches
    • A good therapeutic alliance is key
    • Directly observed therapy is good in theory but problematic in practice
    • Involving the family is challenging but effective
  • Influence of educational sources
    • The therapist is the best source of information on treatment compliance
    • Websites and DTC advertising are good sources of general information but are not so good for providing specific drug compliance education
    • Patient education should be given at different stages of treatment and tailored to the individual
    • Case study: Lillys Meaningful Day educational program
• Datamonitor conclusions and recommendations

CHAPTER 4 PATIENT COMPLIANCE IN BIPOLAR DISORDER

• Market overview
• First line treatment of bipolar disorder
• Reasons for noncompliance in bipolar disorder
  • General reasons
  • Side effect-specific reasons
• Actions taken for noncompliant bipolar disorder patients
• Approaches to improving compliance in bipolar disorder
  • Drug approaches
    • Lessening the burden of oral pills is a good strategy
    • Combination pills offer few advantages
  • Non drug approaches
    • Leading players provide free compliance tools such as mood diaries
  • Influence of educational sources
    • Websites are not viewed as useful sources of information
    • The trend is to support health information sites
    • Public information is beneficial but key messages must be unrelated to product-specific marketing
• Datamonitor conclusions and recommendations

CHAPTER 5 PATIENT COMPLIANCE IN DEPRESSION

• Market overview
• First line treatment of depression
• Reasons for noncompliance in depression
  • General reasons
    • A multitude of reasons are responsible for noncompliance in depression
    • Patients will be noncompliant whether the drug does or does not work
  • Side effect-specific reasons
    • Sexual dysfunction is a leading cause of noncompliance in the US and EU
    • Case study: GSKs Wellbutrin-XL successfully promoted as the only once-daily antidepressant without sexual side effects
    • Media coverage of the SSRI suicide risk story increased noncompliance
• Actions taken for noncompliant depression patients
• Approaches to improving compliance in depression
  • Drug approaches
    • Reformulation is not the way to go in the US depression market
  • Non drug approaches
    • A strong therapeutic-alliance and patient education are key means of improving compliance in depression
    • Collaborations with patient advocacy groups are recommended
    • Esteve launches innovative PatientFeedback tool to improve communication between depression patients and their therapists
  • Influence of educational sources
    • DTC advertising is not practical as a compliance improving tool
    • Case study: Pfizers Rhythms patient education campaign was an effective patient compliance strategy
    • Compliance aids are less accessible on depression information websites
    • Effective disorder information leaflets need to be clear, informative and stimulating
    • CME programs targeted to healthcare providers offer greater coverage of education
• Datamonitor conclusions and recommendations

APPENDIX A

• Bibliography
• Websites

APPENDIX B

• Sample details
  • First line treatment
  • General details
• Physician research methodology
• Study questionnaire

APPENDIX C

• About Datamonitor
  • About Datamonitor Healthcare
  • About the CNS analysis team
  • Key therapy team members
    • Lynda Lynch, Director CNS
  • Disclaimer
• List of Tables
  • Table 1: Key schizophrenia epidemiology, 2004
  • Table 2: Key bipolar disorder epidemiology, 2004
  • Table 3: Key depression epidemiology, 2004
  • Table 4: Sample details for the Stakeholder Insight: Patient Compliance in Psychiatry Survey, 2004
  • Table 5: Key schizophrenia epidemiology, 2004
  • Table 6: Key bipolar disorder epidemiology, 2004
  • Table 7: Key depression epidemiology, 2004
  • Table 8: Percentage patient compliance versus number of doses per day
  • Table 9: Side effect profile comparison of key antipsychotics
  • Table 10: Sample details of the Patient Compliance in Psychiatry Survey, 2004
• List of Figures
  • Figure 1: Noncompliance rates across psychiatric disorders, 2004
  • Figure 2: Lamictals fold-out compliance packaging
  • Figure 3: First line monotherapy for schizophrenia, 2004
  • Figure 4: Reasons why schizophrenia patients are noncompliant, 2004
  • Figure 5: Medication adherence rates at 12-month follow-up for outpatients filling prescriptions for typical and atypical medications in a veteran affairs health care system
  • Figure 6: Noncompliance due to the fear versus actual occurrence of a side effect in schizophrenia in the US, 2004
  • Figure 7: Noncompliance due to the fear versus actual occurrence of a side effect in schizophrenia in Japan, 2004
  • Figure 8: Noncompliance due to the fear versus actual occurrence of a side effect in schizophrenia in the EU, 2004
  • Figure 9: Actions taken for noncompliant schizophrenia patients, 2004
  • Figure 10: How well drug formulations improve compliance in schizophrenia, 2004
  • Figure 11: Quarterly sales of Risperdal Consta in the EU and US, 2002-2004
  • Figure 12: How well non drug approaches improve compliance in schizophrenia, 2004
  • Figure 13: The effect of patient education sources on treatment compliance in schizophrenia, 2004
  • Figure 14: First line monotherapy for bipolar disorder, 2004
  • Figure 15: First line 2-drug combination therapy for bipolar disorder, 2004
  • Figure 16: Reasons why bipolar disorder patients are noncompliant, 2004
  • Figure 17: Noncompliance due to the fear versus actual occurrence of a side effect in bipolar disorder in the US, 2004
  • Figure 18: Noncompliance due to the fear versus actual occurrence of a side effect in bipolar disorder in Japan, 2004
  • Figure 19: Noncompliance due to the fear versus actual occurrence of a side effect in bipolar disorder in the EU, 2004
  • Figure 20: Actions taken for noncompliant bipolar disorder patients, 2004
  • Figure 21: How well drug formulations improve compliance in bipolar disorder, 2004
  • Figure 22: Quarterly sales of Symbyax in the US, 2004
  • Figure 23: How well non drug approaches improve compliance in bipolar disorder, 2004
  • Figure 24: Eli Lillys downloadable Mood Diary program for the PC
  • Figure 25: The effect of patient education sources on treatment compliance in bipolar disorder, 2004
  • Figure 26: A bipolar disorder information website sponsored by GSK
  • Figure 27: First line monotherapy for depression, 2004
  • Figure 28: Reasons why depression patients are noncompliant, 2004
  • Figure 29: Noncompliance due to the fear versus actual occurrence of a side effect in depression in the US, 2004
  • Figure 30: Noncompliance due to the fear versus actual occurrence of a side effect in depression in Japan, 2004
  • Figure 31: Noncompliance due to the fear versus actual occurrence of a side effect in depression in the EU, 2004
  • Figure 32: Actions taken for noncompliant depression patients, 2004
  • Figure 33: How well drug formulations improve compliance in depression, 2004
  • Figure 34: How well non drug approaches improve compliance in depression, 2004
  • Figure 35: The effect of patient education sources on treatment compliance in depression, 2004
  • Figure 36: Zoloft US product website promoting the "Knowing More" program to new patients
  • Figure 37: Excerpt from Strattera support brochure "Parents: What Should I Expect with Strattera?"
  • Figure 38: Prescription growth and DTC spend for selected US antidepressants, 2001-03
  • Figure 39: Drug versus non drug first line therapy, 2004
  • Figure 40: Monotherapy versus combination first line therapy, 2004
  • Figure 41: First line monotherapy for schizophrenia, 2004
  • Figure 42: First line monotherapy for bipolar disorder, 2004
  • Figure 43: First line 2-drug combination therapy for bipolar disorder, 2004
  • Figure 44: First line monotherapy for depression, 2004