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Stakeholder Insight: Multiple Sclerosis - Disease-modifying efficacy and side effects guide treatment choicePublished by: Datamonitor Published: Dec. 21, 2006 - 175 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the multiple sclerosis market 4 CHAPTER 2 INTRODUCTION AND SCOPE 14 Coverage of the Stakeholder Insight Survey 14 Disease definition & epidemiology 14 Presentation and diagnosis 14 Treatment 14 Key prescribing influences 15 Unmet needs 15 CHAPTER 3 COUNTRY TREATMENT TREES 16 US 17 France 18 Germany 19 Italy 20 Spain 21 UK 22 CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION 23 Disease definition 23 There is no universal course for multiple sclerosis 23 Researchers have attempted to classify multiple sclerosis according to the clinical course of the disease 23 Epidemiology of multiple sclerosis 25 Young female adults are most at risk of developing multiple sclerosis 25 Other genetic and environmental factors appear to play a role in onset of MS 27 Prevalence of multiple sclerosis 28 Over 800,000 individuals across the US and 5EU are estimated to suffer from MS 28 US 30 5EU 30 The majority of patients suffer from relapse remitting multiple sclerosis 34 CHAPTER 5 PRESENTATION AND DIAGNOSIS 35 Presentation 35 Symptoms typically first emerge in relapsing-remitting course of multiple sclerosis 35 Fatigue and depression are most common symptoms 36 Less than half of new patients present to a physician at the time they suffer from first symptoms of MS 37 The majority of patients present to a primary care physician 41 Diagnosis 42 Diagnostic criteria 43 Only half of patients with multiple sclerosis symptoms receive an accurate diagnosis on initial presentation to a physician 45 CHAPTER 6 TREATMENT OPTIONS AND GUIDELINES 48 Treatment options 48 Symptomatic treatment 48 Disease-modifying drug treatments 49 Acute relapse treatment 52 Treatment guidelines 52 There are no official international guidelines for the chronic treatment of multiple sclerosis and use of disease-modifying therapies 52 Several treatment guidelines are in place for the management of acute relapses of multiple sclerosis 54 CHAPTER 7 PRESCRIBING TRENDS IN MULTIPLE SCLEROSIS 56 Treatment of multiple sclerosis with disease-modifying drug treatments 56 Across all stages of MS, 53% of total diagnosed patients receive disease modifying therapies 56 First-line therapy 60 Approximately one third of patients prescribed first-line therapy move to second-line therapy 64 Second-line therapy 67 Approximately one quarter of patients prescribed second-line therapy move to third-line therapy 70 Third-line therapy 72 Only one fifth of patients prescribed third-line therapy move to fourth-line therapy 74 Fourth-line therapy 77 Summary of treatment lines according to country 79 Novantrone (mitoxantrone) 80 Novantrone is the only treatment US Food and Drug Association-approved treatment for worsening MS 80 Approximately half of respondents prescribe mitoxantrone to their patients 81 The majority of current mitoxantrone prescriptions are reserved for last line therapy 82 In the future, mitoxantrone is unlikely to change from being reserved as a last line therapy 85 Tysabri (natalizumab) 87 Tysabri is the first humanized monoclonal antibody approved for the treatment of multiple sclerosis 87 Cases of progressive multifocal leukoencephalopathy led to withdrawal after only three months on the market 87 Tysabri has been relaunched albeit under tight controls 88 The majority of interviewed neurologists would consider prescribing Tysabri 89 Tysabri administered as an infusion presents a small barrier to use 90 A potential risk of progressive multifocal leukoencephalopathy with Tysabri would create a barrier to its use 92 Respondents expect to prescribe Tysabri predominantly to their patients with RRMS 94 There is no clear point for when Tysabri will be prescribed in the treatment algorithm 95 Treatment for acute relapse of multiple sclerosis 98 Steroids have historically been the mainstay of treatment 98 Interviewed neurologists consider intravenous methylprednisolone the number one treatment for acute relapses 98 Interviewed neurologists use numerous other therapies 100 Oral steroids are used by almost a quarter of patients but may increase risk of side effects 101 Intravenous dexamethasone offers a cheaper alternative to intravenous methylprednisolone 101 Aspirin and nonsteroidal anti-inflammatory drugs may help reduce side effects 102 Plasmapheresis should be considered for patients who fail to respond to intravenous methylprednisolone 102 Use of intramuscular adrenocortropic hormone is no longer the preferred treatment for treating acute relapse 103 Intrathecal steroids are not recommended for treating acute relapse 103 CHAPTER 8 INFLUENCING FACTORS ON PRESCRIBING TRENDS IN MULTIPLE SCLEROSIS 104 Current market overview 104 The disease-modifying drugs have continued to perform well in terms of revenues 104 Factors driving prescribing choice 106 Disease-modifying efficacy is the number one influential factor 106 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 107 Speed of onset of action is desirable 107 Ability to combine a drug with other therapies is heavily influenced by prescribing practices and trends 108 Drugs are used over a long period of time and must be considered safe for extended use 109 Dosing frequency and delivery methods may compromise patient compliance 111 In Europe cost typically has a greater influence on prescribing choice than formulary / reimbursement status 113 UK restricts use of disease-modifying drugs based on clinical versus cost-effectiveness 114 In the US formulary / reimbursement status is considered a greater influence on prescribing choice than cost 115 CHAPTER 9 IMPROVING TREATMENT OUTCOMES 117 Performance of prescribed drugs against attributes 117 Neurologists in the US and UK are most satisfied with current therapies 117 Avonex is perceived to perform slightly better across all attributes than the other disease-modifying therapies 118 Tysabri is perceived to perform best on disease modification efficacy 119 Higher dosed interferons are perceived to have a faster onset of action 121 None of the drugs are perceived to have a very good side-effect profile 123 Ability to combine with other therapies 126 A higher dosing frequency is perceived to more efficacious 127 Intravenous delivery methods are perceived less favorable 129 Interferons and Copaxone are considered safe for extended use 130 There is room to improve patient treatment compliance 131 Formulary / reimbursement status 132 Drugs with increased disease-modifying efficacy are considered to perform better on cost 133 Reasons for discontinuing therapy/switching to alternative drug therapy 135 Lack of efficacy and intolerable side effects are the key reasons for discontinuing or switching treatment 135 Occurrence of any side effect if poorly managed can lead to treatment discontinuation 137 Unmet needs 140 BIBLIOGRAPHY 143 References 143 Websites 149 APPENDIX A 152 Physician research methodology 152 Physician sample breakdown 152 US 152 France 153 Germany 153 Italy 154 Spain 154 UK 155 Contributing experts 155 APPENDIX B 156 The survey questionnaire 156 Physician details 156 Introduction 157 Section 1—Epidemiology and diagnosis of multiple sclerosis 157 Section 2—Treatment of multiple sclerosis 159 First-line therapy 160 Second-line therapy 162 Third-line therapy 164 Fourth-line therapy 166 Section 3—Key prescribing factors 170 Disclaimer 175 AbstractIntroductionThe 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 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 Get Full Details About This Report >> |
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