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Stakeholder Insight: Multiple Sclerosis

Disease-modifying efficacy and side effects guide treatment choice

Publication Date   December 2006
Publisher   Datamonitor
Product Type   Report
Pages   175
ISBN Number   not applicable
Product Code   DAT612
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Price £8,000.00

approximately: $11,881 | €9,414

Summary


Introduction

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

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

Content


  • Chapter 1 Executive Summary
    • Scope of the analysis
    • Datamonitor insight into the multiple sclerosis market
  • Chapter 2 Introduction And Scope
    • Coverage of the Stakeholder Insight Survey
    • Disease definition & epidemiology
    • Presentation and diagnosis
    • Treatment
    • Key prescribing influences
    • Unmet needs
  • Chapter 3 Country Treatment Trees
    • US
    • France
    • Germany
    • Italy
    • Spain
    • UK
  • Chapter 4 Epidemiology And Patient Segmentation
    • Disease definition
    • There is no universal course for multiple sclerosis
    • Researchers have attempted to classify multiple sclerosis according to the clinical course of the disease
    • Epidemiology of multiple sclerosis
    • Young female adults are most at risk of developing multiple sclerosis
    • Other genetic and environmental factors appear to play a role in onset of MS
    • Prevalence of multiple sclerosis
    • Over 800,000 individuals across the US and 5EU are estimated to suffer from MS
    • US
    • 5EU
    • The majority of patients suffer from relapse remitting multiple sclerosis
  • Chapter 5 Presentation And Diagnosis
    • Presentation
    • Symptoms typically first emerge in relapsing-remitting course of multiple sclerosis
    • Fatigue and depression are most common symptoms
    • Less than half of new patients present to a physician at the time they suffer from first symptoms of MS
    • The majority of patients present to a primary care physician
    • Diagnosis
    • Diagnostic criteria
    • Only half of patients with multiple sclerosis symptoms receive an accurate diagnosis on initial presentation to a physician
  • Chapter 6 Treatment Options And Guidelines
    • Treatment options
    • Symptomatic treatment
    • Disease-modifying drug treatments
    • Acute relapse treatment
    • Treatment guidelines
    • There are no official international guidelines for the chronic treatment of multiple sclerosis and use of disease-modifying therapies
    • Several treatment guidelines are in place for the management of acute relapses of multiple sclerosis
  • Chapter 7 Prescribing Trends In Multiple Sclerosis
    • Treatment of multiple sclerosis with disease-modifying drug treatments
    • Across all stages of MS, 53% of total diagnosed patients receive disease modifying therapies
    • First-line therapy
    • Approximately one third of patients prescribed first-line therapy move to second-line therapy
    • Second-line therapy
    • Approximately one quarter of patients prescribed second-line therapy move to third-line therapy
    • Third-line therapy
    • Only one fifth of patients prescribed third-line therapy move to fourth-line therapy
    • Fourth-line therapy
    • Summary of treatment lines according to country
    • Novantrone (mitoxantrone)
    • Novantrone is the only treatment US Food and Drug Association-approved treatment for worsening MS
    • Approximately half of respondents prescribe mitoxantrone to their patients
    • The majority of current mitoxantrone prescriptions are reserved for last line therapy
    • In the future, mitoxantrone is unlikely to change from being reserved as a last line therapy
    • Tysabri (natalizumab)
    • Tysabri is the first humanized monoclonal antibody approved for the treatment of multiple sclerosis
    • Cases of progressive multifocal leukoencephalopathy led to withdrawal after only three months on the market
    • Tysabri has been relaunched albeit under tight controls
    • The majority of interviewed neurologists would consider prescribing Tysabri
    • Tysabri administered as an infusion presents a small barrier to use
    • A potential risk of progressive multifocal leukoencephalopathy with Tysabri would create a barrier to its use
    • Respondents expect to prescribe Tysabri predominantly to their patients with RRMS
    • There is no clear point for when Tysabri will be prescribed in the treatment algorithm
    • Treatment for acute relapse of multiple sclerosis
    • Steroids have historically been the mainstay of treatment
    • Interviewed neurologists consider intravenous methylprednisolone the number one treatment for acute relapses
    • Interviewed neurologists use numerous other therapies
    • Oral steroids are used by almost a quarter of patients but may increase risk of side effects
    • Intravenous dexamethasone offers a cheaper alternative to intravenous methylprednisolone
    • Aspirin and nonsteroidal anti-inflammatory drugs may help reduce side effects
    • Plasmapheresis should be considered for patients who fail to respond to intravenous methylprednisolone
    • Use of intramuscular adrenocortropic hormone is no longer the preferred treatment for treating acute relapse
    • Intrathecal steroids are not recommended for treating acute relapse
  • Chapter 8 Influencing Factors On Prescribing Trends In Multiple Sclerosis
    • Current market overview
    • The disease-modifying drugs have continued to perform well in terms of revenues
    • Factors driving prescribing choice
    • Disease-modifying efficacy is the number one influential factor
    • 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
    • Speed of onset of action is desirable
    • Ability to combine a drug with other therapies is heavily influenced by prescribing practices and trends
    • Drugs are used over a long period of time and must be considered safe for extended use
    • Dosing frequency and delivery methods may compromise patient compliance
    • In Europe cost typically has a greater influence on prescribing choice than formulary / reimbursement status
    • UK restricts use of disease-modifying drugs based on clinical versus cost-effectiveness
    • In the US formulary / reimbursement status is considered a greater influence on prescribing choice than cost
  • Chapter 9 Improving Treatment Outcomes
    • Performance of prescribed drugs against attributes
    • Neurologists in the US and UK are most satisfied with current therapies
    • Avonex is perceived to perform slightly better across all attributes than the other disease-modifying therapies
    • Tysabri is perceived to perform best on disease modification efficacy
    • Higher dosed interferons are perceived to have a faster onset of action
    • None of the drugs are perceived to have a very good side-effect profile
    • Ability to combine with other therapies
    • A higher dosing frequency is perceived to more efficacious
    • Intravenous delivery methods are perceived less favorable
    • Interferons and Copaxone are considered safe for extended use
    • There is room to improve patient treatment compliance
    • Formulary / reimbursement status
    • Drugs with increased disease-modifying efficacy are considered to perform better on cost
    • Reasons for discontinuing therapy/switching to alternative drug therapy
    • Lack of efficacy and intolerable side effects are the key reasons for discontinuing or switching treatment
    • Occurrence of any side effect if poorly managed can lead to treatment discontinuation
    • Unmet needs
  • Bibliography
    • References
    • Websites
  • Appendix A
    • Physician research methodology
    • Physician sample breakdown
    • US
    • France
    • Germany
    • Italy
    • Spain
    • UK
    • Contributing experts
  • Appendix B
    • The survey questionnaire
    • Physician details
    • Introduction
    • Section 1—Epidemiology and diagnosis of multiple sclerosis
    • Section 2—Treatment of multiple sclerosis
    • First-line therapy
    • Second-line therapy
    • Third-line therapy
    • Fourth-line therapy
    • Section 3—Key prescribing factors
    • Disclaimer