Stakeholder Insight: Major Depressive Disorder - Duloxetine - Fulfilling An Unmet Need?

Published by: Datamonitor

Published: Mar. 30, 2006 - 224 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the CNS pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the Major Depressive Disorder (MDD) market

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.

The safety concerns surrounding antidepressants have been over-hyped and are not generally shared by physicians.

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.

CHAPTER 2 INTRODUCTION AND SCOPE

Coverage of the Stakeholder Insight survey - MDD

Epidemiology

Presentation and diagnosis

Treatment of Major Depressive Disorder

CHAPTER 3 COUNTRY TREATMENT TREES

Country treatment trees

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION OF MDD

Major Depressive Disorder: definitions and classification

Diagnostic criteria of MDD

DSM-IV

ICD-10

Severity

Dysthymic disorder is a milder form of depression

Etiology of Major Depressive Disorder

Epidemiology of MDD

Prevalence of MDD

Segmentation of MDD

Prevalence of MDD subtypes

Comorbidities

Anxiety

Cancer and other serious illnesses can be accompanied by depression

Heart disease

Diabetes

Neurodegenerative diseases

CHAPTER 5 PRESENTATION & REFERRAL

Presentation rates for milder forms of MDD are low suggesting a significant untreated patient population may exist

The PCP is the first contact for the majority of MDD patients

PCPs opt to refer the patients as MDD severity increases

Greater patient awareness may result in greater numbers seeking help

Further use of internet-based screeners could increase presentation rates.

CHAPTER 6 DIAGNOSIS OF MDD

A number of diagnostic tools are available to ensure correct diagnosis on presentation

WHO-Five Well-being Index provides a useful screener for the suspected depression

The Major Depression Inventory is recommended for use in diagnosing MDD

Clinical trials or epidemiological studies require more advanced diagnostic tools

The Hamilton Rating Scale for Depression (HAM-D) is the gold standard used in clinical trials.

The CIDI is favored for epidemiologic studies

Diagnosis of MDD can be confused with bipolar disorder

Diagnosis rate of MDD

Interviewed physicians ask about the key symptoms when making a diagnosis of MDD.

Painful physical symptoms are often associated with depression

CHAPTER 7 TREATMENT GUIDELINES

Treatment guidelines aim to improve treatment outcomes but are underused outside of the US.

Updates to the APA guideline cover recent issues.

The NICE guideline includes cost-benefit assessment.

CHAPTER 8 TREATMENTS AVAILABLE

Choice of treatment modality is key to the treatment outcome

Treatments already tried depend on the severity of depression

Treatments chosen by interviewed physicians

Drug class overview

MAOIs and TCAs-effective but potentially unsafe.

SSRIs avoid the problems of earlier antidepressants.

Prozac (fluoxetine)

Zoloft (sertraline)

Celexa (citalopram)

Lexapro (escitalopram)

Luvox (fluvoxamine)

Paxil (paroxetine)

SNRIs have added a new layer of available treatment options

Effexor (venlafaxine)

Cymbalta (duloxetine)

Other drugs have proven effective in treating MDD

Wellbutrin (bupropion)

Remeron (mirtazapine)

Ixel (milnacipran)

Edronax (reboxetine)

Serzone (nefazodone)

St.John's Wort (Hypericum perforatum)

Non-pharmacological treatment overview

Psychotherapy

Cognitive behavioral therapy

Electroconvulsive therapy (ECT)

CHAPTER 9 PRESCRIBING TRENDS

Choice of prescribed drug class

TCAs and SSRIs are prescribed to the majority of patients

Choice of prescribed drugs

Drug choices by US physicians

Key prescribing trends in the US

Drug choices by physicians in Japan

Key prescribing trends in Japan

Drug choices by physicians in France

Key prescribing trends in France

Drug choices by physicians in Germany

Key prescribing trends in Germany

Drug choices by physicians in Italy

Key prescribing trends in Italy

Drug choices by physicians in Spain

Key prescribing trends in Spain

Drug choices by UK physicians

Key prescribing trends in the UK

First-line to second-line progression

Second to third line progression

Reasons for switching treatment

CHAPTER 10 FACTORS INFLUENCING PRESCRIBING TRENDS

Choice of therapy - drug attributes

Efficacy

Side effects

Sexual dysfunction

Weight gain

Sleep problems

GI effects

Safety profile

Risk of suicide

Cardiovascular (CV) risks

Warnings given to patients

Comorbid anxiety

Ability to treat painful physical symptoms of depression

Other factors

Branded versus generic

CHAPTER 11 IMPROVING TREATMENT OUTCOMES

Optimum duration of therapy

Remission and relapse

Proportion of patients achieving remission

Time to achieve remission

Proportion of patients who relapse during remission

Unmet needs

APPENDIX A

Bibliography

Websites

APPENDIX B

Physician research methodology

Physician sample breakdown

US

Japan

France

Germany

Spain

Italy

UK

Physician questionnaire

Section One Epidemiology and presentation

Epidemiology

Presentation and diagnosis

Section Two Referral patterns

Section Three Treatment

Guidelines

All treatments

Pharmacological treatment

Treatment of Mild Major Depressive Disorder

Treatment of Moderate Major Depressive Disorder

Treatment of Severe Major Depressive Disorder

General

Section Four Drug profiles

APPENDIX C

About Datamonitor

About Datamonitor Healthcare

About the CNS analysis team

Disclaimer

List of Tables

Table 1: Total adult population in the seven major markets, (millions)

Table 2: Adult MDD population estimates using 12-month prevalence, (millions)

Table 3: The number of individuals suffering from each MDD severity, (millions)

Table 4: Antidepressants approved for anxiety disorders in the US, EU and Japan

Table 5: Search engine hits for "Depression".

Table 6: Average time taken for MDD patients to achieve remission

Table 7: Average time taken for MDD patients to relapse

Table 8: US physician sample breakdown, 2005

Table 9: Japan physician sample breakdown, 2005

Table 10: France physician sample breakdown, 2005

Table 11: Germany physician sample breakdown, 2005

Table 12: Spain physician sample breakdown, 2005

Table 13: Italy physician sample breakdown, 2005

Table 14: UK physician sample breakdown, 2005

List of Figures

Figure 1: The presentation, diagnosis and treatment of MDD in the US

Figure 2: The presentation, diagnosis and treatment of MDD in Japan

Figure 3: The presentation, diagnosis and treatment of MDD in France

Figure 4: The presentation, diagnosis and treatment of MDD in Germany

Figure 5: The presentation, diagnosis and treatment of MDD in Italy

Figure 6: The presentation, diagnosis and treatment of MDD in Spain

Figure 7: The presentation, diagnosis and treatment of MDD in the UK

Figure 8: Interviewed physicians' estimate of MDD prevalence

Figure 9: Physicians' perception of the severity of patients suffering from MDD across the seven major markets

Figure 10: Proportion of patients with mild, moderate and severe MDD that present to a physician.

Figure 11: Percentage of MDD patients who consult PCPs directly across the seven major markets

Figure 12: Percentage of patients who consult psychiatrists directly across the seven major markets

Figure 13: Healthcare professional types referring to psychiatrists across the seven major markets.

Figure 14: Percentage of interviewed physician's patients referred to another healthcare professional.

Figure 15: Referral of mild MDD patients to other healthcare professionals.

Figure 16: Referral of moderate MDD patients to other healthcare professionals.

Figure 17: Referral of severe MDD patients to other healthcare professionals.

Figure 18: Proportion of patients with mild, moderate and severe MDD that receive an accurate diagnosis at first presentation

Figure 19: Symptoms asked about by physicians prior to making a diagnosis of MDD

Figure 20: Patients reporting painful physical symptoms associated with their depression

Figure 21: Patients reporting painful physical symptoms associated with their depression to interviewed PCPs and psychiatrists

Figure 22: Use of recognized practice guidelines according to interviewed physicians across the seven major markets

Figure 23: Relative use of guidelines for the treatment of MDD by interviewed physicians in the US

Figure 24: Treatment already tried when patients first present to psychiatrists

Figure 25: Treatment already tried when mild MDD patients first present to psychiatrists

Figure 26: Treatment already tried when moderate MDD patients first present to psychiatrists

Figure 27: Treatment already tried when severe MDD patients first present to psychiatrists

Figure 28: Types of treatment chosen for MDD patients by physicians

Figure 29: APA guideline - Choice of treatment modalities for MDD

Figure 30: Types of treatment chosen for mild MDD patients

Figure 31: Types of treatment chosen for moderate MDD patients

Figure 32: Types of treatment chosen for severe MDD patients

Figure 33: Drug classes prescribed to MDD patients as monotherapy

Figure 34: Drug classes prescribed to mild MDD patients

Figure 35: Drug classes prescribed to moderate MDD patients

Figure 36: Drug classes prescribed to severe MDD patients

Figure 37: Drugs chosen for MDD by physicians in the US

Figure 38: Drugs chosen for MDD by physicians in Japan

Figure 39: Drugs chosen for MDD by physicians in France

Figure 40: Drugs chosen for MDD by physicians in Germany

Figure 41: Drugs chosen for MDD by physicians in Italy

Figure 42: Drugs chosen for MDD by physicians in Spain

Figure 43: Drugs chosen for MDD by physicians in the UK

Figure 44: The proportion of MDD patients that progress from first to second-line therapy

Figure 45: Time taken before physicians decide to progress MDD patients from first to second-line therapy

Figure 46: The proportion of MDD patients that progress from second to third-line therapy

Figure 47: Time taken before physicians decide to progress MDD patients from second to third-line therapy

Figure 48: The reasons for switching patients from first-line treatment

Figure 49: Influence on physicians' choice of therapy

Figure 50: Overall efficacy rating according to interviewed physicians.

Figure 51: Physicians' rating of overall side effect profile

Figure 52: Influence of side effects on physicians' choice of therapy

Figure 53: Physicians' concern about the occurrence of sexual dysfunction

Figure 54: Physicians' concern about the occurrence of weight gain

Figure 55: Physicians' concern about the occurrence of insomnia

Figure 56: Physicians' concern about the occurrence of GI effects

Figure 57: Rating of good safety profile according to interviewed physicians

Figure 58: Physicians' concern about risk of suicidal ideation

Figure 59: The black box warning added to all antidepressants in the US

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

Figure 61: The warnings given by physicians to patients when initiating treatment with an antidepressant

Figure 62: Ability to treat comorbid anxiety disorders according to interviewed physicians

Figure 63: Ability to treat painful physical symptoms of depression according to interviewed physicians

Figure 64: Lilly's Cymbalta website-www.depressionhurts.com

Figure 65: The proportion of prescriptions for which physicians specify use of a generic product when branded version is also available

Figure 66: Optimum time period for MDD patients on pharmacological therapy (weighted score)

Figure 67: Optimum time period for mild MDD patients on pharmacological therapy

Figure 68: Optimum time period for moderate MDD patients on pharmacological therapy

Figure 69: Optimum time period for severe MDD patients on pharmacological therapy

Figure 70: Patients achieving remission after one treatment cycle

Figure 71: Weighted scores for the average time taken for MDD patients to achieve remission

Figure 72: Patients who relapse during remission

Figure 73: Unmet needs rated by interviewed physicians as the most important

Abstract

• 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

• Identify which healthcare professional is responsible for treating patients with differing severities of MDD, allowing for efficient product marketing
• Ascertain the preferred and most frequently prescribed drugs for first and second-line therapy, gaining key insight into the competitive landscape
• Identify unmet needs to enhance development and market penetration strategies of MDD drugs

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