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nani · Sun Oct 16, 2005 6:05 am The National MS Society's

The National MS Society's
Disease Management Consensus Statement
Summary

From The MS Information Sourcebook, produced by the National MS Society.

Introduction
The Consensus Statement is an education and advocacy tool that is used to promote increased access to the approved disease-modifying therapies. It serves as a communication device for interactions with insurers at the local and national level. The goal of the Consensus Statement is to help ensure that all those who are appropriate candidates for these medications have access to them as early in the disease process as possible. Available in PDF format

Download the Consensus Statement summary

To share with your healthcare provider...

Download the complete Disease Management Consensus Statement

Disease-Modifying Medications

Immunomodulators (medications designed to modify the immune system in order to alter the course of MS):

beta interferon 1a-intramuscular (Avonex®)

beta interferon 1a-subcutaneous (Rebif®)

beta interferon 1b (Betaseron®)

glatiramer acetate (Copaxone®)

Immunosuppressant (medication designed to shut down the immune system temporarily in order to alter the course of MS):

mitoxantrone (Novantrone®)

Rationale
The disease-modifying therapies have demonstrated the following positive outcomes in people with relapsing forms of MS:

Reduction in the frequency and severity of relapses (also known as attacks or exacerbations)

Reduction in the numbers of brain lesions as shown on MRI

Possible reduction in future disability

Treatment early in the disease course is important because:

Numerous studies have demonstrated that irreversible damage to nerve axons can occur during early relapses.

Studies have also shown that lesions can develop and brain atrophy can occur even in those individuals who are not experiencing any symptoms or relapses.

Recommendations
Based on these findings, it is the consensus of researchers and clinicians with expertise in MS that these agents can reduce future disease activity and improve quality of life for many individuals with relapsing forms of MS, including those with secondary progressive disease who continue to have relapses. Therefore, the Executive Committee of the Medical Advisory Board of the National Multiple Sclerosis Society has adopted the following recommendations:

Treatment should be considered as soon as possible following a definite diagnosis of MS with active disease (i.e., recent relapses and/or new lesions on MRI), and may also be considered for some patients with a first attack who are at high risk of developing MS (known as clinically isolated syndrome).

Insurers should not limit a person's access to medication because of low relapse rate, age, or level of disability.

Insurers should not require a person to stop a medication while they are determining the person's eligibility for continued coverage of the medication.

Treatment should be continued unless the person is not benefiting from it, the side effects are intolerable, or a better treatment becomes available.

All of these FDA-approved medications should be covered by each insurer so that a physician and patient can determine the most appropriate treatment for that individual.

Changing from one immunomodulatory therapy to another should occur only for medically-appropriate reasons.

Immunosuppressant therapy with mitoxantrone (Novantrone®) may be considered for some individuals with worsening relapsing MS or with secondary-progressive MS.

Most individuals with other medical conditions in addition to their MS can safely take these medications.

None of these medications have been approved by the FDA for use by women who are trying to become pregnant, are pregnant, or are nursing mothers.

Glossary

Axon
The extension of a nerve cell that conducts impulses to other nerve cells or muscles.

Brain atrophy
Shrinkage of the brain that seems to be due, at least in part, to the destruction of myelin and axons. This destruction, and related atrophy, can occur even early in the disease course.

Clinically isolated syndrome (CIS)
A first neurological event (e.g., an episode of optic neuritis) that suggests demyelination in the central nervous system, and is accompanied by several "silent" or asymptomatic lesions on MRI that are typical of MS. Individuals with CIS are at high risk for developing clinically definite MS.

Relapse (also known as attack, flare-up, or exacerbation)
The appearance of new symptoms or the aggravation of old ones, lasting at least twenty-four hours; usually associated with inflammation and demyelination in the brain or spinal cord.

Relapsing forms of MS

Relapsing-remitting MS—A clinical course of MS that is
characterized by clearly-defined, acute attacks (relapses), usually with full or partial recovery, and no disease progression between attacks.

Secondary-progressive MS—A clinical course of MS that initially is relapsing-remitting and then becomes continuously progressive at a variable rate, with or without occasional relapses along the way. The disease-modifying medications are thought to provide benefit for those who continue to have relapses.

Progressive-relapsing MS—A clinical course of MS that shows disease progression from the beginning, but with clear, acute relapses along the way.