Society recommendations on the new MS drugs.

An expert consensus

Last spring, under the leadership of chief medical officer Dr. Stanley van den Noort and vice president for Clinical Programs Dr. Nancy Holland, the Society created a task force to review data and seek a consensus among nationally recognized MS experts regarding the best use of the 3 new drugs that control MS. The resulting consensus statement is based on clinical experience of the task force members and their colleagues and their interpretation of trial data. It includes these points:

* Avonex, Betaseron, and Copaxone reduce future disability and improve the quality of life for many people with MS.

* Therapy should begin as soon as possible following a definite diagnosis of MS and determination of a relapsing course.

* Access to the therapy should not be limited by level of disability, age, or the frequency of relapses.

* Most concurrent medical conditions do not contraindicate the use of any of these 3 therapies.

* Therapy should be continued indefinitely, unless there is a clear lack of benefit, intolerable side effects, new data that reveal other reasons for stopping, or a better therapy becomes available. Therapy should not be discontinued during reevaluation for continuing treatment.

* All 3 agents should be included in formularies (lists of approved drugs) and covered by third-party payors. choice of drug should be made by the individual and her or his physician based on professional evaluation and individual preferences. Movement from one drug to another should be permitted.

Proven to slow down MS

These recommendations are made because trial data and clinical experience show that all 3 agents offer benefits in daily life for people with relapsing-remitting MS. Preliminary data from European studies of beta interferon 1b (Betaseron) support its use in secondary progressive MS. The argument for early therapy is further supported by many studies confirming that permanent damage to nerve fibers is coincident with the destruction of the myelin sheath. (Myelin layers normally protect nerve fibers in the brain and spinal cord. Myelin is attacked in MS.) This suggests that even early MS relapses that appear benign may have permanent consequences.

Obstacles to prescription

Insurers, including HMO managers, have had no standard guidelines on optimum treatment of MS, leaving them ill-equipped to make decisions about coverage. Some have imposed arbitrary eligibility requirements, such as the ability to walk, and some have insisted that an absence of MS attacks while on therapy justifies stopping the drug. In addition, a substantial number of doctors treating people with MS are not specialists and have only a few other MS patients. They are not always on the fast track for the latest information.

The Society is distributing the formal Disease Management Consensus Statement to insurers, health-care professionals, and advocates for health-care equity throughout the country. A printed copy can be obtained from Society chapters. Call 1800-FIGHT MS (1-800-344-4867) and choose Option #1. It may also be downloaded from the Society's web site: www.nmss.org