Expert Opinion Paper
Medical Advisory Board of the National Multiple Sclerosis Society
Treatment Recommendations for Physicians
The Executive Committee of the Medical Advisory Board of the National Multiple Sclerosis Society has adopted the following recommendations regarding use of the current MS disease-modifying agents:
immunomodulators:Betaseron® (beta interferon 1b)immunosuppressant:
Avonex® (beta interferon 1a—intramuscular)
Rebif ® (beta interferon 1a—subcutaneous)
Copaxone® (glatiramer acetate)Novantrone® (mitoxantrone)
The management of multiple sclerosis (MS) has been substantially advanced by the availability of the disease-modifying agents beta interferon 1a and 1b, and glatiramer acetate. A number of positive outcomes have been demonstrated in people with relapsing-remitting disease: reduction in the frequency and severity of relapses, reduction of brain lesion development, as evidenced by magnetic resonance imaging, (MRI) and the possibility of reduction of future disability. After several years of experience with the beta interferons and glatiramer acetate, it is the consensus of researchers and clinicians with expertise in MS that these agents reduce future disability and improve the quality of life for many individuals with relapsing-remitting multiple sclerosis. Data from several studies of beta interferons in secondary progressive disease also support a beneficial effect on relapses and MRI-defined disease activity in these patients. For those who are appropriate candidates for one of these drugs, treatment must be sustained for years. Cessation of treatment may result in a resumption of pre-treatment disease activity. Clinical trials are designed to evaluate the smallest number of people, over the shortest period of time, at the lowest cost. In order to accomplish this, inclusion criteria are necessarily narrow.
These restricted parameters of clinical trials are not intended to regulate subsequent clinical use of the agent. However, lacking clear direction, criteria for inclusion in the clinical trial often direct clinical use, unnecessarily limiting patient access to the new agent. With demonstrated benefit to people with MS from continued use of Betaseron®, Avonex®, Rebif ®, or Copaxone®, it is critical that these therapies be made available to appropriate candidates early in the disease process, and that Novantrone® be available for judicious use in aggressive relapsing disease and for those not responding to immunomodulators.
In August, 1994, the Quality Standards Subcommittee of the American Academy of Neurology published an advisory statement on the selection of patients with multiple sclerosis for treatment with Betaseron® (beta interferon 1b). Since then, four additional agents that modify the underlying disease process have been approved by the Food and Drug Administration (FDA): Avonex® (beta interferon 1a), Copaxone® (glatiramer acetate), Novantrone® (mitoxantrone) and Rebif ® (beta interferon 1a). The benefits of these agents include direct evidence of disease modification, with inferred advantage to function and quality of life. Clearly, an updated statement is needed to address use of all currently approved drugs. The National Multiple Sclerosis Society (NMSS) has determined that an updated consensus statement by its expert medical advisors meets this need in an expedited manner.
Significant obstacles to obtaining these agents exist for appropriate candidates with MS. One is the lack of adequate information reaching primary care providers and general neurologists, who each may have only a few patients with MS, but collectively care for a large percentage of the MS population. Another is misunderstanding by some policy makers and insurers of the benefits of disease management therapy, leading to inadequate coverage, both initially and long term. This NMSS Disease Management Consensus Statement addresses these barriers, while acknowledging that the field is in flux, and frequent review of recommendations is essential. Other obstacles, such as non-adherence to protocols and “drop out” by those already on drug are not addressed in this statement. The controversial area of neutralizing antibodies is mentioned only to state that sufficient data do not yet exist to base clinical decisions exclusively on the results of neutralizing antibody assays.
The NMSS Consensus Statement is an educational and advocacy tool. It is a component of the Society’s professional education programs, and is used to promote increased access to all five drugs through legislative, judicial and regulatory determinations. This Consensus Statement serves as a communication device for interactions with insurers, both nationally and locally.
The following points highlight the issues:
The Executive Committee of the Society’s Medical Advisory Board identified the need for the Society to develop and periodically update a formal position on the topic of disease management with the disease-modifying agents. A Medline search was conducted to document major studies in this area (see references). A task force was activated to develop the statement, and the NMSS Medical Advisory Board’s Executive Committee provided final review of the document.
Role of the National Multiple Sclerosis Society
The mission of the NMSS is to end the devastating effects of MS. Various strategies are employed, including professional education and advocacy. As a representative body and advocate for both people with MS and the medical/health professionals who provide their care, the Society is positioned to provide structure and support for a consensus statement to facilitate access to therapies for disease management. The NMSS has a nationwide network of chapters, each with a Clinical Advisory Committee composed of community health professionals with expertise in MS. Over 260,000 Society members have self-identified as having MS, and are part of a mailing list of almost 700,000 people interested in multiple sclerosisrelated issues. Regular communication is made with these various audiences through national and chapter publications. This extensive network and process for dissemination will ensure that the updated Consensus Statement is expeditiously communicated to care providers, insurers, and people with multiple sclerosis.
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This advisory statement was updated by the Executive Committee of
Medical Advisory Board of the National Multiple Sclerosis Society.
Aaron Miller, MD, Chair
Maimonides Medical Center
Jeffrey Cohen, MD
Cleveland Clinic Foundation
Benjamin Eidelman, MD
University of Pittsburgh
Barbara Giesser, MD
UCLA School of Medicine
David C. Good, MD
Wake Forest University
Andrew Goodman, MD
University of Rochester Medical Center
Barbara Green, MD
St. John’s Mercy Medical Center
Kenneth Johnson, MD
University of Maryland
Fred Lublin, MD
Mount Sinai Medical Center
Henry McFarland, MD
National Institutes of Health
John Noseworthy, MD
Mayo Clinic and Foundation
Kottil Rammohan, MD
Ohio State University
Richard Rudick, MD
Cleveland Clinic Foundation
Randall Schapiro, MD
Fairview MS Center
Stanley van den Noort, MD
University of California at Irvine
Jerry Wolinsky, MD
University of Texas Health Science Center
© 2002, The National Multiple Sclerosis Society