Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the central nervous system pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the Parkinson' s disease market
- Contributing experts
- Related reports
- CHAPTER 2 INTRODUCTION AND SCOPE
- Coverage of the Stakeholder Insight Survey
- Disease definition and epidemiology
- Presentation, diagnosis and comorbidities
- Pharmacological treatment trends
- Key prescribing influences
- Treatment outcomes and surgery
- Future trends
- CHAPTER 3 COUNTRY TREATMENT TREES
- Introduction to treatment trees
- First-line treatment trees
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Second-line treatment trees
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION
- Disease definition
- The etiology of PD is not yet clear
- Parkinson' s disease is typically classified by the Hoehn and Yahr scale
- Patient population is generally well spread across the three disease
severities
- Epidemiology of Parkinson' s disease
- Parkinson' s disease rarely affects adults younger than 50 years of age
- Prevalence of Parkinson' s disease
- Over 1.4 million individuals across the US, Japan and 5EU are
estimated to suffer from PD
- European and Japanese epidemiology studies
- CHAPTER 5 PRESENTATION, DIAGNOSIS AND COMORBIDITIES
- Presentation
- Time to presentation
- Early symptoms are generally very subtle and often go unnoticed
- Improving presentation rates
- Internet and patient advocacy groups are essential awareness drivers
- Improved education of the public and primary care physicians is
needed
- The four common presentations of PD
- Tremor
- Rigidity
- Akinesia and bradykinesia
- Postural instability
- Diagnosis
- An accurate diagnosis of PD comes from combined neurological,
laboratory and imaging evaluations
- Neurological evaluation of PD
- Laboratory evaluation of PD
- Imaging studies for PD
- Delays in the diagnosis of PD
- Misdiagnosis is as high as 20-30% in the early stages
- It takes on average 13 weeks from presentation to a physician to an
accurate diagnosis of PD
- Differential diagnosis to rule out other possible neurological
conditions
- More than half of prevalent early-stage PD patients remain undiagnosed
- Over 80% of patients are characterized as having either early- or
mid-stage PD at diagnosis
- Comorbidities (non-motor symptoms) of PD
- Depression is the most common comorbidity at each stage of the disease
- Depression
- Dementia
- Psychosis
- Sleep disturbances
- CHAPTER 6 TREATMENT OPTIONS AND GUIDELINES
- Treatment options
- Non-pharmacological treatment
- Non-pharmacological only approaches are largely shelved once
mid-stage PD is reached
- Pharmacological treatment
- Dopaminergics
- Dopamine agonists
- Catechol-O-methyltransferase inhibitors
- Monoamine oxidase inhibitors
- Other treatments
- Surgical treatment
- Surgery becomes an option when PD symptoms cannot be adequately
controlled with medication
- Deep brain stimulation is now the current standard surgical practice
for PD
- Duodopa pump provides continuous dopaminergic stimulation
- Treatment guidelines
- The treatment of PD is a highly individualized process
- US-guidelines based on AAN recommendations
- New guidelines issued by the AAN in 2006 are more proscriptive than
prescriptive
- UK-National Institute for Health and Clinical Excellence guidelines
- Recommended pharmacological therapy in early PD
- Recommended pharmacotherapy in later PD
- Guidance on surgery for PD
- Other guidelines by region
- CHAPTER 7 PRESCRIBING TRENDS IN PARKINSON' S DISEASE
- Pharmacological prescribing trends
- Caveats-prescribing trends
- Seven major market overview of prescribing trends
- A greater proportion of patients progress to second-line therapy as
the disease severity advances
- Physician type responsible for initial prescription of PD therapy
- Neurologists make the majority of initial treatment decisions for PD
in the 7MMs
- Role of pharmacological treatment in the management of PD
- UK neurologists report waiting the longest period of time before
initiating pharmacological therapy once early-stage PD has been diagnosed
- Pharmacological therapy is not deemed essential in patients
characterized as having early-stage PD
- Pharmacological and non-pharmacological therapy is combined in more
than half of all advanced-stage PD patients in Germany and the UK
- Prescribing trends in early-stage PD
- The proposed neuroprotective properties of the MAO-B inhibitors and
dopamine agonists are still to be proven
- Age and symptom severity dictates first-line therapy decisions
- Boehringer Ingelheim' s pramipexole (Mirapex) leads the way in
first-line early-stage PD management
- Initiation of pharmacological therapy with levodopa remains high
- First-line selegiline monotherapy is rarely seen
- Monotherapy largely dominates early-stage PD management
- Some 40% of early-stage patients progress to second-line therapy
within 20 months
- 60% of early-stage PD patients who progress to second-line therapy
have a drug added-on to their first-line regimen
- Levodopa-carbidopa or levodopa monotherapy are the most commonly
added-on products at second-line for early-stage PD
- Pramipexole and ropinirole are the most common second-line regimens
switched to at early-stage
- Prescribing trends in mid-stage PD
- Fixed-dose combinations containing levodopa and dopamine agonist
therapy make up first-line therapy for mid-stage PD
- Levodopa-carbidopa therapy is prescribed first-line to a fifth of
all mid-stage PD patients in the US
- Over half of all mid-stage PD patients receive combination therapy
- 50% of mid-stage patients progress to second-line therapy within 2
years
- Adding-on accounts for the greater proportion of second-line
dynamics for mid-stage PD
- Entacapone is the most commonly added-on therapy at second-line in
mid-stage PD
- Second-line mid-stage PD sees like-for-like dopamine agonist
switching and movement towards more complex fixed-dose combination
products
- Prescribing trends in advanced-stage PD
- Levodopa-carbidopa fixed-dose combination products dominate
first-line therapy for advanced PD
- Monotherapy is rare in advanced-stage PD
- Over 70% of UK patients progress to second-line therapy for
advanced-stage PD
- Neurologists continue to add-on therapy in the majority of advanced
PD cases
- Amantadine and rasagiline are highly popular add-ons in second-line
for advanced PD
- Apomorphine adding-on is highest in France and Spain
- Levodopa-benserazide viewed as a second-line alternative to
levodopa-carbidopa
- CHAPTER 8 PRESCRIBING INFLUENCES AND BRAND ASSESSMENT
- Factors influencing physician decision making
- Side-effect profile is the number one influential factor
- Mid- and advanced-stage pharmacotherapy is governed by managing the
side effects of levodopa
- Dopamine agonist side effects are mostly cognitive in nature
- A drugs ability to reduce OFF periods has a high influence on
prescribing decisions
- The goals of therapy are to reduce OFF periods as much as possible
- Ability to minimize dyskinesias was rated the most influential
attribute in Japan
- Ability to use as either monotherapy or adjunctive therapy becomes
more influential as the disease progresses
- Ability to delay the use of levodopa therapy influences only initial
treatment decisions
- Ability to enhance the benefit of levodopa therapy has led to the
development of a number of products
- Physician perception of key brands
- Neurologists in Japan are most satisfied with current therapies
- Interpreting a brand map
- Brand comparison shows levodopa remains the "gold standard"
symptomatic PD treatment
- Sinemet (carbidopa-levodopa)
- Parcopa (carbidopa-levodopa)
- Madopar (levodopa-benserazide)
- Stalevo (carbidopa-levodopa-entacapone)
- The dopamine agonists and now Azilect continue to battle it out for
market position
- Requip (ropinirole)
- Mirapex (pramipexole)
- Neupro (rotigotine)
- Apokyn (apomorphine)
- Azilect (rasagiline)
- Comtan (entacapone)
- CHAPTER 9 TREATMENTS OUTCOMES AND SURGERY
- Treatment outcomes
- Only 36% of advanced-stage patients are adequately controlled by
pharmacological therapy
- Intolerable side effects are the key reason for discontinuing or
switching treatment
- Although pill burden affects patient quality of life, it has a low
influence on discontinuing or switching therapies
- Surgical treatment of Parkinson' s disease
- Progression to surgery
- More than half of the 9% of PD patients who require surgery go on to
receive it
- The invasive nature of surgical techniques limits their use
- Surgical techniques used
- Deep Brain Stimulation is by far the most common surgical technique
used across the seven major markets
- Outcome of surgery
- Over 50% of patients will experience both a reduction in PD symptoms
and a reduction in the dose of pharmacological medication with each
surgical technique
- BIBLIOGRAPHY
- APPENDIX A
- Physician research methodology
- Physician sample breakdown
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Contributing experts
- APPENDIX B
- The survey questionnaire
- Physician' s details
- Screening questions
- INTRODUCTION
- Section 1-Patient segmentation and diagnosis of Parkinson' s disease
- Section 2-Treatment of Parkinson' s disease
- Early-stage pharmacological treatment
- Mid-stage pharmacological treatment
- Advanced-stage pharmacological treatment
- Section 3-Key prescribing factors
- Section 4-Treatment outcomes and Surgery
- Demographics
- Disclaimer
- List of Tables
- Table 1: The five stages of PD according to the Hoehn and Yahr scale
- Table 2: Prevalence of PD across the seven major markets, 2007
- Table 3: Unified Parkinson' s Disease Rating Scale-cognition, behavior
and mood
- Table 4: Proportion of prevalent PD population diagnosed at each
disease stage across the seven major markets, 2007
- Table 5: Options for initial pharmacotherapy in early PD as proposed
in NICE guidelines, 2006
- Table 6: Options for adjuvant pharmacotherapy in later PD as proposed
in NICE guidelines, 2006
- Table 7: Percentage of interviewed neurologists selecting each regimen
as a first-line therapy for early-stage PD, 2007
- Table 8: Early-stage PD second-line therapy patient progression
details, 2007
- Table 9: Percentage of drugs added-on at second-line to the dopamine
agonists selected for first-line early-stage PD therapy across the seven
major markets, 2007
- Table 10: Most common selected second-line regimens after switching
from first-line dopamine agonist monotherapy for early-stage PD across the
seven major markets, 2007
- Table 11: Percentage of interviewed neurologists selecting each
regimen as a first-line therapy for mid-stage PD, 2007
- Table 12: Percentage of patients receiving each drug regimen as
first-line for mid-stage PD, 2007
- Table 13: Mid-stage PD second-line therapy patient progression
details, 2007
- Table 14: Advanced-stage PD second-line therapy patient progression
details, 2007
- Table 15: Factors that influence drug choice for the management of PD,
2007
- Table 16: Number and percentage of neurologists able to rate each brand
- Table 17: Overall performance of each Parkinson' s disease drug against
six attributes according to interviewed neurologists in the seven major
markets, 2007
- Table 18: The overall performance of each drug against all attributes,
and with attribute weightings applied
- Table 19: Sinemet' s attribute scores, by country
- Table 20: Comparison of Parcopa' s and Sinemet' s US attribute scores
- Table 21: Madopar' s attribute scores, by country
- Table 22: Stalevo' s attribute scores, by country
- Table 23: Requip' s attribute scores, by country
- Table 24: Mirapex' s attribute scores, by country
- Table 25: Neupro' s attribute scores, by country
- Table 26: Apokyn' s attribute scores, by country
- Table 27: Treatment-emergent adverse events (incidence ≥10%) and
associated rate of discontinuation during open-label long-term use of
Apokyn (n=550)
- Table 28: Azilect' s attribute scores, by country
- Table 29: Comtan' s attribute scores, by country
- Table 30: Reasons for patients discontinuing a therapy/switching to an
alternative drug therapy on a scale of 1 to 10, where 1=factor of low
influence and 10=factor of high influence, 2006
- Table 31: US-physician sample breakdown, 2007
- Table 32: Japan-physician sample breakdown, 2007
- Table 33: France-physician sample breakdown, 2007
- Table 34: Germany-physician sample breakdown, 2007
- Table 35: Italy-physician sample breakdown, 2007
- Table 36: Spain-physician sample breakdown, 2007
- Table 37: UK-physician sample breakdown, 2007
- List of Figures
- Figure 1: Diagrammatic overview of the coverage of the Stakeholder
Insight: Parkinson' s Disease survey, 2007
- Figure 2: Parkinson' s disease treatment tree split by disease severity
in the US, 2007
- Figure 3: Parkinson' s disease treatment tree split by disease severity
in Japan, 2007
- Figure 4: Parkinson' s disease treatment tree split by disease severity
in France, 2007
- Figure 5: Parkinson' s disease treatment tree split by disease severity
in Germany, 2007
- Figure 6: Parkinson' s disease treatment tree split by disease severity
in Italy, 2007
- Figure 7: Parkinson' s disease treatment tree split by disease severity
in Spain, 2007
- Figure 8: Parkinson' s disease treatment tree split by disease severity
in the UK, 2007
- Figure 9: Second-line early-stage Parkinson' s disease treatment
dynamics in the US, 2007
- Figure 10: Second-line mid-stage Parkinson' s disease treatment
dynamics in the US, 2007
- Figure 11: Second-line advanced-stage Parkinson' s disease treatment
dynamics in the US, 2007
- Figure 12: Second-line early-stage Parkinson' s disease treatment
dynamics in Japan, 2007
- Figure 13: Second-line mid-stage Parkinson' s disease treatment
dynamics in Japan, 2007
- Figure 14: Second-line advanced-stage Parkinson' s disease treatment
dynamics in Japan, 2007
- Figure 15: Second-line early-stage Parkinson' s disease treatment
dynamics in France, 2007
- Figure 16: Second-line mid-stage Parkinson' s disease treatment
dynamics in France, 2007
- Figure 17: Second-line advanced-stage Parkinson' s disease treatment
dynamics in France, 2007
- Figure 18: Second-line early-stage Parkinson' s disease treatment
dynamics in Germany, 2007
- Figure 19: Second-line mid-stage Parkinson' s disease treatment
dynamics in Germany, 2007
- Figure 20: Second-line advanced-stage Parkinson' s disease treatment
dynamics in Germany, 2007
- Figure 21: Second-line early-stage Parkinson' s disease treatment
dynamics in Italy, 2007
- Figure 22: Second-line mid-stage Parkinson' s disease treatment
dynamics in Italy, 2007
- Figure 23: Second-line advanced-stage Parkinson' s disease treatment
dynamics in Italy, 2007
- Figure 24: Second-line early-stage Parkinson' s disease treatment
dynamics in Spain, 2007
- Figure 25: Second-line mid-stage Parkinson' s disease treatment
dynamics in Spain, 2007
- Figure 26: Second-line advanced-stage Parkinson' s disease treatment
dynamics in Spain, 2007
- Figure 27: Second-line early-stage Parkinson' s disease treatment
dynamics in the UK, 2007
- Figure 28: Second-line mid-stage Parkinson' s disease treatment
dynamics in the UK, 2007
- Figure 29: Second-line advanced-stage Parkinson' s disease treatment
dynamics in the UK, 2007
- Figure 30: Proportion of diagnosed PD patients suffering from each
disease severity, 2007
- Figure 31: PD progression timeline from onset of early-stage disease
to death as indicated by interviewed neurologists, 2007
- Figure 32: Age at diagnosis for each stage of PD, 2007
- Figure 33: Average time in months from the onset of symptoms of PD to
initial presentation to a physician, 2007
- Figure 34: Percentage of neurologists using each diagnostic imaging
technique to make a diagnosis of PD, 2007
- Figure 35: The number of weeks between presentation to a physician and
an accurate diagnosis of PD, 2007
- Figure 36: Percentage of prevalent PD population diagnosed vs
undiagnosed for each disease stage, 2007
- Figure 37: Proportion of interviewed neurologists' PD patients
characterized as having each stage of the disease, 2007
- Figure 38: Proportion of interviewed neurologists' PD patients with
each severity of the disease at initial diagnosis, 2007
- Figure 39: Proportion of PD patients suffering with each comorbidity
at the three stages of the disease, 2007
- Figure 40: Mean percentage of pharmacological and non-pharmacological
PD therapy across the seven major markets, 2007
- Figure 41: Mechanism of action of levodopa therapy
- Figure 42: Mechanism of action of AADC inhibitors (DDIs)
- Figure 43: Mechanism of action of COMT inhibitor (entacapone)
- Figure 44: Mechanism of action of MAO-B inhibitors
- Figure 45: Pharmacological treatment algorithm for PD
- Figure 46: The dynamics of pharmacological treatment in PD management,
2007
- Figure 47: Physician type breakdown of the initial treatment decision
of PD in the seven major markets, 2007
- Figure 48: Weeks between diagnosis of PD and the initiation of
pharmacological therapy by disease stage, 2007
- Figure 49: Percentage of patients receiving pharmacological therapy
for PD across the seven major markets by stage, 2007
- Figure 50: Percentage of patients receiving pharmacological and
non-pharmacological therapy for PD across the seven major markets by
stage, 2007
- Figure 51: Early-stage second-line management strategies for
pramipexole across the seven major markets, 2007
- Figure 52: First-line treatment regimens for early-stage PD in the
seven major markets, 2007
- Figure 53: Monotherapy vs combination therapy split for early-stage PD
management, 2007
- Figure 54: Patients who progress to second-line early-stage PD therapy
and receive add-on or are switched, 2007
- Figure 55: Second-line drug add-ons for early-stage PD in the seven
major markets, 2007
- Figure 56: Most common drug regimens switched to at second-line for
early-stage PD across the seven major markets, 2007
- Figure 57: Mid-stage second-line management strategies for
levodopa-carbidopa (Sinemet, Parcopa) across the seven major markets, 2007
- Figure 58: First-line treatment regimens for mid-stage PD in the seven
major markets, 2007
- Figure 59: Monotherapy and combination therapy split for mid-stage PD
management, 2007
- Figure 60: Patients who progress to second-line mid-stage PD therapy
and receive add-on or switch, 2007
- Figure 61: Second-line drug add-ons for mid-stage PD in the seven
major markets, 2007
- Figure 62: Most common drug regimens switched to at second-line for
mid-stage PD across the seven major markets, 2007
- Figure 63: Advanced-stage second-line management strategies for
levodopa-carbidopa (Sinemet, Parcopa) across the seven major markets, 2007
- Figure 64: First-line treatment regimens for advanced-stage PD in the
seven major markets, 2007
- Figure 65: Monotherapy and combination therapy split for
advanced-stage PD management, 2007
- Figure 66: Patients who progress to second-line advanced-stage PD
therapy and receive add-on or switch, 2007
- Figure 67: Second-line drug add-ons for advanced-stage PD in the seven
major markets, 2007
- Figure 68: Number of times neurologists added on Apokyn in second-line
for advanced-stage PD across the seven major markets, 2007
- Figure 69: Most common drug regimens switched to at second-line for
advanced-stage PD across the seven major markets, 2007
- Figure 70: Average rating of factors which influence drug choice for
the management of PD, 2007
- Figure 71: Neurologist' s scores of side-effect profile, by brand
- Figure 72: Importance of a drug' s ability to minimize dyskinesias on
prescribing decisions by country, 2007
- Figure 73: Overview brand map of attributes versus brand perception
- Figure 74: Physician perception of levodopa-based combination products
- Figure 75: Levodopa-based combination brand map of attributes versus
brand perception
- Figure 76: PD-specific Sinemet sales, 2003-06
- Figure 77: Sinemet map, country preference to prescribing attributes
- Figure 78: PD-specific Madopar sales, 2003-06
- Figure 79: Madopar' s attribute scores, by country
- Figure 80: PD-specific Stalevo sales, 2003-06
- Figure 81: Stalevo' s attribute scores, by country
- Figure 82: Proportion of patients receiving Stalevo at first-line for
each stage of PD, 2007
- Figure 83: Physician perception of the dopamine agonists, Azilect and
Comtan
- Figure 84: Non-levodopa containing product brand map of attributes
versus brand perception
- Figure 85: PD-specific Requip sales, 2003-06
- Figure 86: Requip' s overall attribute scores
- Figure 87: PD-specific Mirapex sales, 2003-06
- Figure 88: Mirapex and Requip overall attribute scores
- Figure 89: Diagrammatic representation of Neupro' s mode of action
- Figure 90: PD-specific quarterly Neupro sales in Germany, Spain and
the UK, Q3-2006-Q2-2007
- Figure 91: Country rating of Neupro, Requip and Mirapex on the ability
to use as either monotherapy or adjunctive therapy
- Figure 92: Proportion of patients receiving Neupro at first-line for
each stage of PD, 2007
- Figure 93: Apokyn' s overall attribute scores
- Figure 94: PD- specific quarterly US Apokyn sales, Q1 2006-Q2 2007
- Figure 95: PD- specific Azilect sales, H2 2005-H1 2007
- Figure 96: Percentage of patients adequately controlled by
pharmacological therapy at each stage of the disease as indicated by
interviewed neurologists across the seven major markets, 2007
- Figure 97: Percentage of PD patients requiring and receiving surgery
across the seven major markets, 2007
- Figure 98: Ratings of the reasons why patients do not receive surgery
in the seven major markets, 2007
- Figure 99: Percentage of neurologists with patients who receive
surgery utilizing each PD surgical technique, 2007
- Figure 100: Percentage of patients who undergo surgery and receive
each surgical technique, 2007
- Figure 101: Mean percentage of patients for whom each surgical
technique results in a reduction in Parkinson' s disease symptoms and a
reduction in the dose of pharmacological medication across the seven major
markets, 2007
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