Multiple Sclerosis - Disease-modifying efficacy and side effects guide treatment

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Publication Date: 2006-12-21

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The disease-modifying drugs are considered by physicians to represent a significant advance for the management of MS. However, none is fully effective and there are problems with regards to side effects, dosing regimens and cost. Tysabri, a novel once-monthly drug is expected to be an improvement in terms of efficacy; however, there remains a concern over side effects and long-term safety.

Scope

Overview of epidemiology, presentation, referral and diagnostic assessment in MS

Breakdown of first-line to fourth-line treatment regimens and treatment choice according to disease category

Influences on treatment choice and perception of current drug therapies

Evaluation of unmet needs and future outlook

Report Highlights
Multiple sclerosis affects less than 1% of the population in the US and Europe. Despite the high level of general awareness of the disease, neurologists estimate less than half of individuals present at the time they suffer from first symptoms and it can take more than one year to receive an accurate diagnosis.

Numerous strategies, including switching to an alternative interferon beta, are adopted as second-line therapy. Although not favored by opinion leaders or US neurologists, combining two disease-modifying drugs is popular in the 5EU markets. Given the willingness of neurologists to try this strategy, further trials are required.

Tysabri is perceived by neurologists as offering a clear improvement in terms of disease-modifying efficacy. However, a lack of long-term safety data will ensure for the moment it remains positioned as a last-line therapy for relapse-remitting patients who have failed first- and second-line treatment with interferon beta or glatiramer acetate.

Reasons to Purchase

Target prescribers more effectively, through an understanding of prescribing behavior and its influences

Validate new product forecasting based on diagnosis and treatment rates, and the likely rate of uptake for new products

Benchmark brand awareness and perceptions surrounding product positioning in order to formulate competitive lifecycle management strategies

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 multiple sclerosis market - page 4
CHAPTER 2 INTRODUCTION AND SCOPE - page 14
- Coverage of the Stakeholder Insight Survey - page 14
  - Disease definition & epidemiology - page 14
  - Presentation and diagnosis - page 14
  - Treatment - page 14
  - Key prescribing influences - page 15
  - Unmet needs - page 15
CHAPTER 3 COUNTRY TREATMENT TREES - page 16
- US - page 17
- Japan - page 18
- France - page 19
- Germany - page 20
- Italy - page 21
- Spain - page 22
- UK - page 23
CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION - page 24
- Disease definition - page 24
  - There is no universal course for multiple sclerosis - page 24
  - Researchers have attempted to classify multiple sclerosis according to the clinical course of the disease - page 24
- Epidemiology of multiple sclerosis - page 26
  - Young female adults are most at risk of developing multiple sclerosis - page 26
  - Other genetic and environmental factors appear to play a role in onset of MS - page 28
  - Prevalence of multiple sclerosis - page 29
    - Over 800,000 individuals in the US, Japan and 5EU markets are estimated to suffer from MS - page 29
    - US - page 31
    - Japan - page 31
    - 5EU - page 32
  - The majority of patients suffer from relapse remitting multiple sclerosis - page 36
CHAPTER 5 PRESENTATION AND DIAGNOSIS - page 37
- Presentation - page 37
  - Symptoms typically first emerge in relapsing-remitting course of multiple sclerosis - page 37
  - Fatigue and depression are most common symptoms - page 38
  - Less than half of new patients present to a physician at the time they suffer from first symptoms of MS - page 39
  - The majority of patients present to a primary care physician - page 43
- Diagnosis - page 44
  - Diagnostic criteria - page 45
  - Only half of patients with multiple sclerosis symptoms receive an accurate diagnosis on initial presentation to a physician - page 47
CHAPTER 6 TREATMENT OPTIONS AND GUIDELINES - page 51
- Treatment options - page 51
  - Symptomatic treatment - page 51
  - Disease-modifying drug treatments - page 52
  - Acute relapse treatment - page 55
- Treatment guidelines - page 55
  - There are no official international guidelines for the chronic treatment of multiple sclerosis and use of disease-modifying therapies - page 55
  - Several treatment guidelines are in place for the management of acute relapses of multiple sclerosis - page 57
CHAPTER 7 PRESCRIBING TRENDS IN MULTIPLE SCLEROSIS - page 59
- Treatment of multiple sclerosis with disease-modifying drug treatments - page 59
  - Across all stages of MS, 55% of total diagnosed patients receive disease modifying therapies - page 59
  - First-line therapy - page 63
    - Approximately one third of patients prescribed first-line therapy move to second-line therapy - page 67
  - Second-line therapy - page 70
    - Approximately one quarter of patients prescribed second-line therapy move to third-line therapy - page 73
  - Third-line therapy - page 76
    - Only one fifth of patients prescribed third-line therapy move to fourth-line therapy - page 78
  - Fourth-line therapy - page 81
  - Summary of treatment lines according to country - page 83
  - Novantrone (mitoxantrone) - page 84
    - Novantrone is the only treatment US Food and Drug Association-approved treatment for worsening MS - page 84
    - Approximately half of respondents prescribe mitoxantrone to their patients - page 85
    - The majority of current mitoxantrone prescriptions are reserved for last line therapy - page 86
    - In the future, mitoxantrone is unlikely to change from being reserved as a last line therapy - page 90
  - Tysabri (natalizumab) - page 92
    - Tysabri is the first humanized monoclonal antibody approved for the treatment of multiple sclerosis - page 92
    - Cases of progressive multifocal leukoencephalopathy led to withdrawal after only three months on the market - page 92
    - Tysabri has been relaunched albeit under tight controls - page 93
    - The majority of interviewed neurologists would consider prescribing Tysabri - page 94
    - Tysabri administered as an infusion presents a small barrier to use - page 96
    - A potential risk of progressive multifocal leukoencephalopathy with Tysabri would create a barrier to its use - page 97
    - Respondents expect to prescribe Tysabri predominantly to their patients with RRMS - page 100
    - There is no clear point for when Tysabri will be prescribed in the treatment algorithm - page 101
- Treatment for acute relapse of multiple sclerosis - page 104
  - Steroids have historically been the mainstay of treatment - page 104
  - Interviewed neurologists consider intravenous methylprednisolone the number one treatment for acute relapses - page 104
  - Interviewed neurologists use numerous other therapies - page 106
    - Oral steroids are used by almost a quarter of patients but may increase risk of side effects - page 107
    - Intravenous dexamethasone offers a cheaper alternative to intravenous methylprednisolone - page 107
    - Aspirin and nonsteroidal anti-inflammatory drugs may help reduce side effects - page 108
    - Plasmapheresis should be considered for patients who fail to respond to intravenous methylprednisolone - page 108
    - Use of intramuscular adrenocortropic hormone is no longer the preferred treatment for treating acute relapse - page 109
    - Intrathecal steroids are not recommended for treating acute relapse - page 109
CHAPTER 8 INFLUENCING FACTORS ON PRESCRIBING TRENDS IN MULTIPLE SCLEROSIS - page 110
- Current market overview - page 110
  - The disease-modifying drugs have continued to perform well in terms of revenues - page 110
- Factors driving prescribing choice - page 112
  - Disease-modifying efficacy is the number one influential factor - page 112
  - Side effects are accepted as an inherent outcome of taking any disease-modifying drug but the nature and severity of the side effects are key influencers - page 113
  - Speed of onset of action is desirable - page 113
  - Ability to combine a drug with other therapies is heavily influenced by prescribing practices and trends - page 114
  - Drugs are used over a long period of time and must be considered safe for extended use - page 116
  - Dosing frequency and delivery methods may compromise patient compliance - page 117
  - In Europe cost typically has a greater influence on prescribing choice than formulary / reimbursement status - page 119
    - UK restricts use of disease-modifying drugs based on clinical versus cost-effectiveness - page 120
  - In the US formulary / reimbursement status is considered a greater influence on prescribing choice than cost - page 121
CHAPTER 9 IMPROVING TREATMENT OUTCOMES - page 123
- Performance of prescribed drugs against attributes - page 123
  - Neurologists in the US and UK are most satisfied with current therapies - page 123
  - Avonex is perceived to perform slightly better across all attributes than the other disease-modifying therapies - page 124
  - Tysabri is perceived to perform best on disease modification efficacy - page 125
  - Higher dosed interferons are perceived to have a faster onset of action - page 127
  - None of the drugs are perceived to have a very good side-effect profile - page 129
  - Ability to combine with other therapies - page 132
  - A higher dosing frequency is perceived to be more efficacious - page 133
  - Intravenous delivery methods are perceived less favorable - page 135
  - Interferons and Copaxone are considered safe for extended use - page 136
  - There is room to improve patient treatment compliance - page 138
  - Formulary / reimbursement status - page 138
  - Drugs with increased disease-modifying efficacy are considered to perform better on cost - page 140
- Reasons for discontinuing therapy/switching to alternative drug therapy - page 141
  - Lack of efficacy and intolerable side effects are the key reasons for discontinuing or switching treatment - page 142
  - Occurrence of any side effect if poorly managed can lead to treatment discontinuation - page 143
- Unmet needs - page 146
BIBLIOGRAPHY - page 151
- References - page 151
- Websites - page 157
APPENDIX A - page 160
- Physician research methodology - page 160
  - Physician sample breakdown - page 160
  - US - page 160
  - Japan - page 161
  - France - page 161
  - Germany - page 162
  - Italy - page 162
  - Spain - page 163
  - UK - page 163
- Contributing experts - page 164
APPENDIX B - page 165
- The survey questionnaire - page 165
  - Physician details - page 165
  - Introduction - page 166
  - Section 1-Epidemiology and diagnosis of multiple sclerosis - page 166
  - Section 2-Treatment of multiple sclerosis - page 168
    - First-line therapy - page 169
    - Second-line therapy - page 171
    - Third-line therapy - page 173
    - Fourth-line therapy - page 175
  - Section 3-Key prescribing factors - page 179
  - Disclaimer - page 184

List of Tables
Table 1: Prevalence of MS in the US, Japan and 5EU markets, 2006 - page 29
Table 2: Most common signs and symptoms of RRMS, 2006 - page 39
Table 3: Poser criteria for the diagnosis of clinically definite MS and laboratory supported MS - page 46
Table 4: Key facts for marketed disease-modifying drug for MS - page 54
Table 5: Key recommendations for treatment of multiple sclerosis relapses: EFNS task force: - page 58
Table 6: Percentage of patients diagnosed with each stage of MS who receive disease-modifying drug therapy, 2006 - page 59
Table 7: Percentage of all interviewed neurologists who prescribe each disease-modifying drug/ combination for first-line treatment of MS, 2006 - page 63
Table 8: Percentage of all interviewed neurologist's patients who are prescribed disease modifying drugs / combinations for first-line treatment of MS, 2006 - page 64
Table 9: Proportion of patients prescribed disease modifying treatments as monotherapy versus combination therapy at first-line, 2006 - page 65
Table 10: Percentage of all interviewed neurologists who prescribe each disease-modifying drug/ combination for second-line treatment of MS, 2006 - page 70
Table 11: Percentage of all interviewed neurologist's patients who are prescribed disease modifying drugs /combinations for second-line treatment of MS, 2006 - page 71
Table 12: Proportion of patients prescribed disease-modifying treatments as monotherapy versus combination therapy at second-line, 2006 - page 72
Table 13: Percentage of all interviewed neurologists who prescribe each disease-modifying drug / combination for third-line treatment of MS, 2006 - page 76
Table 14: Percentage of all interviewed neurologist's patients who are prescribed disease modifying drugs /combinations for third-line treatment of MS, 2006 - page 77
Table 15: Proportion of patients prescribed disease modifying treatments as monotherapy versus combination therapy at third-line, 2006 - page 78
Table 16: Percentage of all interviewed neurologists who prescribe each disease-modifying drug / combination for fourth-line treatment of MS, 2006 - page 81
Table 17: Percentage of all interviewed neurologist's patients who are prescribed disease modifying drugs /combinations for fourth-line treatment of MS, 2006 - page 82
Table 18: Proportion of patients prescribed disease modifying treatments as monotherapy versus combination therapy at fourth-line, 2006 - page 83
Table 19: Percentage of total mitoxantrone prescriptions that fall under each treatment strategy, 2006 - page 87
Table 20: Percentage of total mitoxantrone prescriptions that interviewed neurologists in the US, Japan and 5EU markets would ideally like to see fall under each treatment strategy in the future treatment of MS, 2006 - page 91
Table 21: Percentage of neurologists in each country who provided each rating, 2006 - page 96
Table 22: Percentage of neurologists in each country who provided each rating, 2006 - page 98
Table 23: Likely use of how Tysabri will be prescribed where 1= strongly disagree and 5= strongly agree, 2006 - page 102
Table 24: Total of mean scores for likely use of how Tysabri will be prescribed- before, with or after other disease modifying therapies (DMT), 2006 - page 103
Table 25: Percentage of treated patients receiving therapy specifically for the treatment of a relapse of MS, 2006 - page 105
Table 26: Sales of disease-modifying drugs across the seven major markets, 2005 - page 110
Table 27: Factors which influence drug choice for the management of multiple sclerosis, 2006 - page 112
Table 28: Overall performance of each disease-modifying drug against 10 attributes according to interviewed neurologists in the US, Japan and 5EU markets, 2006 - page 124
Table 29: Performance of disease-modifying drugs on disease modification efficacy (where 1= very poor performance; 10 = very good performance) , 2006 - page 126
Table 30: Performance of disease-modifying drugs on onset of action (where 1= very poor performance; 10 = very good performance), 2006 - page 128
Table 31: Performance of disease-modifying drugs on side-effect profile (where 1= very poor performance; 10 = very good performance), 2006 - page 129
Table 32: Performance of disease-modifying drugs on ability to combine with other therapies (where 1= very poor performance; 10 = very good performance) , 2006 - page 132
Table 33: Dosing frequency of disease modifying drugs - page 133
Table 34: Performance of disease-modifying drugs on dosing frequency (where 1= very poor performance; 10 = very good performance), 2006 - page 134
Table 35: Performance of disease-modifying drugs on delivery method (where 1= very poor performance; 10 = very good performance), 2006 - page 135
Table 36: Performance of disease-modifying drugs on safe for extended use (where 1= very poor performance; 10 = very good performance), 2006 - page 136
Table 37: Performance of disease-modifying drugs on patient compliance (where 1= very poor performance; 10 = very good performance), 2006 - page 138
Table 38: Performance of disease-modifying drugs on formulary / reimbursement status (where 1= very poor performance; 10 = very good performance), 2006 - page 139
Table 39: Cost analysis of disease-modifying therapies (based on patient receiving treatment for one year) in US dollars - page 140
Table 40: Performance of disease-modifying drugs on cost (where 1= very poor performance; 10 = very good performance), 2006 - page 141
Table 41: 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 - page 142
Table 42: Influence of side effects on discontinuing a therapy / switching to an alternative drug therapy, where 1 = factor of low influence and 10= factor of high influence, 2006 - page 145
Table 43: Priority assigned by interviewed neurologists to unmet needs or improvements which need to be made in the diagnosis, pharmacological treatment, management or awareness of MS, by country, 2006 - page 148
Table 44: US physician sample breakdown, 2006 - page 160
Table 45: Japan physician sample breakdown, 2006 - page 161
Table 46: France physician sample breakdown, 2006 - page 161
Table 47: Germany physician sample breakdown, 2006 - page 162
Table 48: Italy physician sample breakdown, 2006 - page 162
Table 49: Spain physician sample breakdown, 2006 - page 163
Table 50: UK physician sample breakdown, 2006 - page 163

List of Figures
Figure 1: US MS patient population split by physician estimated diagnoses by subtype, disease-modifying therapy treated population and first- and second-line disease-modifying drug usage, 2006 - page 17
Figure 2: Japan MS patient population split by physician estimated diagnoses by subtype, disease-modifying therapy treated population and first- and second-line disease-modifying drug usage, 2006 - page 18
Figure 3: France MS patient population split by physician estimated diagnoses by subtype, disease-modifying therapy treated population and first- and second-line disease-modifying drug usage, 2006 - page 19
Figure 4: Germany MS patient population split by physician estimated diagnoses by subtype, disease-modifying therapy treated population and first- and second-line disease-modifying drug usage, 2006 - page 20
Figure 5: Italy MS patient population split by physician estimated diagnoses by subtype, disease-modifying therapy treated population and first- and second-line disease-modifying drug usage, 2006 - page 21
Figure 6: Spain MS patient population split by physician estimated diagnoses by subtype, disease-modifying therapy treated population and first- and second-line disease-modifying drug usage, 2006 - page 22
Figure 7: UK MS patient population split by physician estimated diagnoses by subtype, disease-modifying therapy treated population and first- and second-line disease-modifying drug usage, 2006 - page 23
Figure 8: Age that MS patients experience their first episode of MS, 2006 - page 26
Figure 9: Percentage of patients who experience their first episode of MS within each specific age range, 2006 - page 27
Figure 10: Prevalence rate of multiple sclerosis in the general population in each of the US, Japan and 5EU markets, 2006 - page 30
Figure 11: Percentage of diagnosed MS patients who suffer from each type of MS, 2006 - page 36
Figure 12: Emergence of symptoms with disease progression - page 37
Figure 13: Percentage of new patients who suffer from their first symptoms of multiple sclerosis that present to a physician, 2006 - page 40
Figure 14: Average time from the onset of symptoms of multiple sclerosis to initial presentation to a physician, 2006 - page 41
Figure 15: Stages in the diagnosis of MS leading to a confirmed diagnosis - page 45
Figure 16: Percentage of patients presenting to a physician with multiple sclerosis symptoms that receive an accurate diagnosis, 2006 - page 48
Figure 17: The average time from presentation to a physician to receiving an accurate diagnosis of multiple sclerosis, 2006 - page 49
Figure 18: Timeline: launch dates of disease modifying therapies for treatment of MS, 1993-2006 - page 53
Figure 19: Percentage of patients diagnosed with each stage of MS who receive disease-modifying drug therapy, 2006 - page 60
Figure 20: Percentage of patients receiving first-line disease-modifying therapy that move to second-line therapy, 2006 - page 68
Figure 21: Average number of months patient continues on first-line therapy before moving to second-line therapy, 2006 - page 69
Figure 22: Percentage of patients receiving second-line disease-modifying therapy that move to third-line therapy, 2006 - page 74
Figure 23: Average number of months patient continues on second-line therapy before moving to third-line therapy, 2006 - page 75
Figure 24: Percentage of patients receiving third-line disease-modifying therapy that move to fourth-line therapy, 2006 - page 79
Figure 25: Average number of months patient continues on third-line therapy before moving to fourth-line therapy, 2006 - page 80
Figure 26: Interviewed neurologists who prescribe mitoxantrone to their MS patients, 2006 - page 85
Figure 27: Physicians who would consider prescribing Tysabri for the treatment of multiple sclerosis when it is launched / relaunched, 2006 - page 94
Figure 28: Mean score indicating the extent to which Tysabri administered as an infusion would be a barrier to use, 2006 - page 97
Figure 29: Mean score indicating the extent to which PML with Tysabri would be a barrier to use, where 1= a significant barrier and 5 = no barrier at all, 2006 - page 99
Figure 30: Patient group that interviewed neurologists are likely to prescribe Tysabri for, 2006 - page 101
Figure 31: Percentage of treated patients in the US, Japan and 5EU markets receiving therapy specifically for the treatment of a relapse of MS, 2006 - page 105
Figure 32: Overview brand map of attributes versus brand perception, 2006 - page 125
Figure 33: Priority of clinical unmet needs in MS according to interviewed neurologists, where 1 = unmet need of low priority and 10 = high priority, 2006 - page 147

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Multiple Sclerosis - Disease-modifying efficacy and side effects guide treatment

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