Market Report Source

Overview

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”

Table of Contents

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

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