Major Depressive Disorder - Duloxetine - Fulfilling An Unmet Need?

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Publication Date: 2006-03-30

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Major Depressive Disorder (MDD) is estimated to affect over 34 million individuals yearly across the seven major markets. Only a fraction of this patient population is treated adequately, resulting in lost productivity, unnecessary patient suffering and unfulfilled revenue potential for manufacturers.

Scope

Analysis of a survey of 180 prescribing physicians in the seven major markets as well as in-depth interviews with Key Opinion Leaders

Detailed treatment trees showing the prevalence, diagnosis and treatment rates of Major Depressive Disorder across the seven major markets

Discussion of the influence of treatment guidelines on physicians

Insight into diagnostic and therapeutic unmet needs, and recommendations to aid market penetration and maximize prescription rates

Report Highlights
Individuals with milder forms of MDD are unlikely to present to physicians. Across the seven major markets, only around a half of individuals are then accurately diagnosed at first presentation.

Despite safety concerns surrounding some of the newer antidepressants, the prescribing habits of physicians have changed little, suggesting that the concerns may have been over-hyped.

Cymbalta (duloxetine) is at risk of being seen as a 'me-too' SNRI. Datamonitor's primary research suggests that by focusing on the treatment of painful physical symptoms of depression, Lilly might be missing the drug's more significant advantages.

Reasons to Purchase

Identify unmet treatment and market needs to enhance development and market penetration strategies for MDD drugs

Ascertain the preferred and most frequently prescribed drugs for first and second-line therapy, gaining key insight into the competitive landscape

Identify which healthcare professional is responsible for treating patients with differing severities of MDD, allowing for efficient product marketing

ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS pharmaceutical analysis team - page 2
CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the Major Depressive Disorder (MDD) market - page 5
- Individuals with milder forms of Major Depressive Disorder are unlikely to present to physicians. Across the seven major markets, only around a half of individuals are then accurately diagnosed at first presentation. - page 6
- The safety concerns surrounding antidepressants have been over-hyped and are not generally shared by physicians. - page 6
- Cymbalta (duloxetine) is at risk of being seen as a 'me-too' SNRI. Datamonitor's primary research suggests that by focusing on the treatment of painful physical symptoms of depression, Lilly might be missing the drug's more significant advantages. - page 7
CHAPTER 2 INTRODUCTION AND SCOPE - page 15
- Coverage of the Stakeholder Insight survey - MDD - page 15
  - Epidemiology - page 15
  - Presentation and diagnosis - page 15
  - Treatment of Major Depressive Disorder - page 15
CHAPTER 3 COUNTRY TREATMENT TREES - page 17
- Country treatment trees - page 17
CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION OF MDD - page 25
- Major Depressive Disorder: definitions and classification - page 25
  - Diagnostic criteria of MDD - page 25
    - DSM-IV - page 25
    - ICD-10 - page 26
    - Severity - page 27
    - Dysthymic disorder is a milder form of depression - page 27
- Etiology of Major Depressive Disorder - page 28
- Epidemiology of MDD - page 29
  - Prevalence of MDD - page 29
- Segmentation of MDD - page 32
  - Prevalence of MDD subtypes - page 32
  - Comorbidities - page 33
    - Anxiety - page 33
    - Cancer and other serious illnesses can be accompanied by depression - page 34
    - Heart disease - page 35
    - Diabetes - page 35
    - Neurodegenerative diseases - page 35
CHAPTER 5 PRESENTATION & REFERRAL - page 37
- Presentation rates for milder forms of MDD are low suggesting a significant untreated patient population may exist - page 37
- The PCP is the first contact for the majority of MDD patients - page 39
- PCPs opt to refer the patients as MDD severity increases - page 42
- Greater patient awareness may result in greater numbers seeking help - page 48
  - Further use of internet-based screeners could increase presentation rates. - page 49
CHAPTER 6 DIAGNOSIS OF MDD - page 51
- A number of diagnostic tools are available to ensure correct diagnosis on presentation - page 51
  - WHO-Five Well-being Index provides a useful screener for the suspected depression - page 51
  - The Major Depression Inventory is recommended for use in diagnosing MDD - page 52
  - Clinical trials or epidemiological studies require more advanced diagnostic tools - page 52
    - The Hamilton Rating Scale for Depression (HAM-D) is the gold standard used in clinical trials. - page 52
    - The CIDI is favored for epidemiologic studies - page 53
  - Diagnosis of MDD can be confused with bipolar disorder - page 53
- Diagnosis rate of MDD - page 54
  - Interviewed physicians ask about the key symptoms when making a diagnosis of MDD. - page 55
  - Painful physical symptoms are often associated with depression - page 58
CHAPTER 7 TREATMENT GUIDELINES - page 60
- Treatment guidelines aim to improve treatment outcomes but are underused outside of the US. - page 60
  - Updates to the APA guideline cover recent issues. - page 63
  - The NICE guideline includes cost-benefit assessment. - page 65
CHAPTER 8 TREATMENTS AVAILABLE - page 67
- Choice of treatment modality is key to the treatment outcome - page 67
  - Treatments already tried depend on the severity of depression - page 67
  - Treatments chosen by interviewed physicians - page 72
- Drug class overview - page 77
  - MAOIs and TCAs-effective but potentially unsafe. - page 77
  - SSRIs avoid the problems of earlier antidepressants. - page 79
    - Prozac (fluoxetine) - page 79
    - Zoloft (sertraline) - page 80
    - Celexa (citalopram) - page 80
    - Lexapro (escitalopram) - page 81
    - Luvox (fluvoxamine) - page 83
    - Paxil (paroxetine) - page 83
  - SNRIs have added a new layer of available treatment options - page 85
    - Effexor (venlafaxine) - page 85
    - Cymbalta (duloxetine) - page 86
  - Other drugs have proven effective in treating MDD - page 90
    - Wellbutrin (bupropion) - page 90
    - Remeron (mirtazapine) - page 91
    - Ixel (milnacipran) - page 92
    - Edronax (reboxetine) - page 92
    - Serzone (nefazodone) - page 93
    - St.John's Wort (Hypericum perforatum) - page 93
- Non-pharmacological treatment overview - page 95
  - Psychotherapy - page 95
    - Cognitive behavioral therapy - page 95
  - Electroconvulsive therapy (ECT) - page 98
CHAPTER 9 PRESCRIBING TRENDS - page 100
- Choice of prescribed drug class - page 100
  - TCAs and SSRIs are prescribed to the majority of patients - page 100
- Choice of prescribed drugs - page 105
  - Drug choices by US physicians - page 106
    - Key prescribing trends in the US - page 107
  - Drug choices by physicians in Japan - page 108
    - Key prescribing trends in Japan - page 109
  - Drug choices by physicians in France - page 110
    - Key prescribing trends in France - page 111
  - Drug choices by physicians in Germany - page 112
    - Key prescribing trends in Germany - page 113
  - Drug choices by physicians in Italy - page 114
    - Key prescribing trends in Italy - page 115
  - Drug choices by physicians in Spain - page 116
    - Key prescribing trends in Spain - page 117
  - Drug choices by UK physicians - page 118
    - Key prescribing trends in the UK - page 119
- First-line to second-line progression - page 121
- Second to third line progression - page 124
- Reasons for switching treatment - page 126
CHAPTER 10 FACTORS INFLUENCING PRESCRIBING TRENDS - page 127
- Choice of therapy - drug attributes - page 127
  - Efficacy - page 128
  - Side effects - page 130
    - Sexual dysfunction - page 132
    - Weight gain - page 135
    - Sleep problems - page 137
    - GI effects - page 139
  - Safety profile - page 141
    - Risk of suicide - page 142
    - Cardiovascular (CV) risks - page 148
    - Warnings given to patients - page 149
  - Comorbid anxiety - page 150
  - Ability to treat painful physical symptoms of depression - page 151
- Other factors - page 153
  - Branded versus generic - page 154
CHAPTER 11 IMPROVING TREATMENT OUTCOMES - page 156
- Optimum duration of therapy - page 156
- Remission and relapse - page 161
  - Proportion of patients achieving remission - page 161
  - Time to achieve remission - page 163
  - Proportion of patients who relapse during remission - page 165
- Unmet needs - page 168
APPENDIX A - page 171
- Bibliography - page 171
- Websites - page 181
APPENDIX B - page 183
- Physician research methodology - page 183
- Physician sample breakdown - page 183
  - US - page 183
  - Japan - page 184
  - France - page 184
  - Germany - page 185
  - Spain - page 185
  - Italy - page 186
  - UK - page 186
- Physician questionnaire - page 187
  - Section One Epidemiology and presentation - page 188
    - Epidemiology - page 188
    - Presentation and diagnosis - page 188
  - Section Two Referral patterns - page 191
  - Section Three Treatment - page 193
    - Guidelines - page 193
    - All treatments - page 193
    - Pharmacological treatment - page 195
    - Treatment of Mild Major Depressive Disorder - page 197
    - Treatment of Moderate Major Depressive Disorder - page 201
    - Treatment of Severe Major Depressive Disorder - page 204
    - General - page 208
  - Section Four Drug profiles - page 213
APPENDIX C - page 221
- About Datamonitor - page 221
  - About Datamonitor Healthcare - page 221
  - About the CNS analysis team - page 222
- Disclaimer - page 224

List of Tables
Table 1: Total adult population in the seven major markets, (millions) - page 30
Table 2: Adult MDD population estimates using 12-month prevalence, (millions) - page 31
Table 3: The number of individuals suffering from each MDD severity, (millions) - page 33
Table 4: Antidepressants approved for anxiety disorders in the US, EU and Japan - page 34
Table 5: Search engine hits for "Depression". - page 50
Table 6: Average time taken for MDD patients to achieve remission - page 163
Table 7: Average time taken for MDD patients to relapse - page 167
Table 8: US physician sample breakdown, 2005 - page 183
Table 9: Japan physician sample breakdown, 2005 - page 184
Table 10: France physician sample breakdown, 2005 - page 184
Table 11: Germany physician sample breakdown, 2005 - page 185
Table 12: Spain physician sample breakdown, 2005 - page 185
Table 13: Italy physician sample breakdown, 2005 - page 186
Table 14: UK physician sample breakdown, 2005 - page 186

List of Figures
Figure 1: The presentation, diagnosis and treatment of MDD in the US - page 18
Figure 2: The presentation, diagnosis and treatment of MDD in Japan - page 19
Figure 3: The presentation, diagnosis and treatment of MDD in France - page 20
Figure 4: The presentation, diagnosis and treatment of MDD in Germany - page 21
Figure 5: The presentation, diagnosis and treatment of MDD in Italy - page 22
Figure 6: The presentation, diagnosis and treatment of MDD in Spain - page 23
Figure 7: The presentation, diagnosis and treatment of MDD in the UK - page 24
Figure 8: Interviewed physicians' estimate of MDD prevalence - page 29
Figure 9: Physicians' perception of the severity of patients suffering from MDD across the seven major markets - page 32
Figure 10: Proportion of patients with mild, moderate and severe MDD that present to a physician. - page 37
Figure 11: Percentage of MDD patients who consult PCPs directly across the seven major markets - page 39
Figure 12: Percentage of patients who consult psychiatrists directly across the seven major markets - page 40
Figure 13: Healthcare professional types referring to psychiatrists across the seven major markets. - page 41
Figure 14: Percentage of interviewed physician's patients referred to another healthcare professional. - page 43
Figure 15: Referral of mild MDD patients to other healthcare professionals. - page 44
Figure 16: Referral of moderate MDD patients to other healthcare professionals. - page 45
Figure 17: Referral of severe MDD patients to other healthcare professionals. - page 46
Figure 18: Proportion of patients with mild, moderate and severe MDD that receive an accurate diagnosis at first presentation - page 54
Figure 19: Symptoms asked about by physicians prior to making a diagnosis of MDD - page 56
Figure 20: Patients reporting painful physical symptoms associated with their depression - page 58
Figure 21: Patients reporting painful physical symptoms associated with their depression to interviewed PCPs and psychiatrists - page 59
Figure 22: Use of recognized practice guidelines according to interviewed physicians across the seven major markets - page 61
Figure 23: Relative use of guidelines for the treatment of MDD by interviewed physicians in the US - page 62
Figure 24: Treatment already tried when patients first present to psychiatrists - page 68
Figure 25: Treatment already tried when mild MDD patients first present to psychiatrists - page 69
Figure 26: Treatment already tried when moderate MDD patients first present to psychiatrists - page 70
Figure 27: Treatment already tried when severe MDD patients first present to psychiatrists - page 71
Figure 28: Types of treatment chosen for MDD patients by physicians - page 72
Figure 29: APA guideline - Choice of treatment modalities for MDD - page 73
Figure 30: Types of treatment chosen for mild MDD patients - page 74
Figure 31: Types of treatment chosen for moderate MDD patients - page 75
Figure 32: Types of treatment chosen for severe MDD patients - page 76
Figure 33: Drug classes prescribed to MDD patients as monotherapy - page 100
Figure 34: Drug classes prescribed to mild MDD patients - page 101
Figure 35: Drug classes prescribed to moderate MDD patients - page 103
Figure 36: Drug classes prescribed to severe MDD patients - page 104
Figure 37: Drugs chosen for MDD by physicians in the US - page 106
Figure 38: Drugs chosen for MDD by physicians in Japan - page 108
Figure 39: Drugs chosen for MDD by physicians in France - page 110
Figure 40: Drugs chosen for MDD by physicians in Germany - page 112
Figure 41: Drugs chosen for MDD by physicians in Italy - page 114
Figure 42: Drugs chosen for MDD by physicians in Spain - page 116
Figure 43: Drugs chosen for MDD by physicians in the UK - page 118
Figure 44: The proportion of MDD patients that progress from first to second-line therapy - page 121
Figure 45: Time taken before physicians decide to progress MDD patients from first to second-line therapy - page 122
Figure 46: The proportion of MDD patients that progress from second to third-line therapy - page 124
Figure 47: Time taken before physicians decide to progress MDD patients from second to third-line therapy - page 125
Figure 48: The reasons for switching patients from first-line treatment - page 126
Figure 49: Influence on physicians' choice of therapy - page 127
Figure 50: Overall efficacy rating according to interviewed physicians. - page 128
Figure 51: Physicians' rating of overall side effect profile - page 130
Figure 52: Influence of side effects on physicians' choice of therapy - page 131
Figure 53: Physicians' concern about the occurrence of sexual dysfunction - page 132
Figure 54: Physicians' concern about the occurrence of weight gain - page 135
Figure 55: Physicians' concern about the occurrence of insomnia - page 137
Figure 56: Physicians' concern about the occurrence of GI effects - page 139
Figure 57: Rating of good safety profile according to interviewed physicians - page 141
Figure 58: Physicians' concern about risk of suicidal ideation - page 142
Figure 59: The black box warning added to all antidepressants in the US - page 143
Figure 60: Physicians that have changed their prescribing habits as a result of reports suggesting a link between antidepressant use and increased risk of suicidality - page 145
Figure 61: The warnings given by physicians to patients when initiating treatment with an antidepressant - page 149
Figure 62: Ability to treat comorbid anxiety disorders according to interviewed physicians - page 150
Figure 63: Ability to treat painful physical symptoms of depression according to interviewed physicians - page 151
Figure 64: Lilly's Cymbalta website-www.depressionhurts.com - page 152
Figure 65: The proportion of prescriptions for which physicians specify use of a generic product when branded version is also available - page 154
Figure 66: Optimum time period for MDD patients on pharmacological therapy (weighted score) - page 156
Figure 67: Optimum time period for mild MDD patients on pharmacological therapy - page 157
Figure 68: Optimum time period for moderate MDD patients on pharmacological therapy - page 158
Figure 69: Optimum time period for severe MDD patients on pharmacological therapy - page 159
Figure 70: Patients achieving remission after one treatment cycle - page 161
Figure 71: Weighted scores for the average time taken for MDD patients to achieve remission - page 164
Figure 72: Patients who relapse during remission - page 165
Figure 73: Unmet needs rated by interviewed physicians as the most important - page 168

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Major Depressive Disorder - Duloxetine - Fulfilling An Unmet Need?

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