General Policy for Multiple Sclerosis
PURPOSE
To establish a basis for determining medical necessity of testing and treatment for individuals with multiple sclerosis.
DESCRIPTION
Multiple sclerosis (MS) is a demyelinating disease of the central nervous system and is considered an autoimmune disease with both a humoral and cellular component. Multiple sclerosis follows a variable course and the cause is unknown. Most individuals with multiple sclerosis are diagnosed at age 20 - 40 with a higher incidence of multiple sclerosis in women. There is no cure for multiple sclerosis and treatment depends on the clinical presentation of the disease, with the aim to slow progression and minimize attacks.
According to the National Multiple Sclerosis Society, multiple sclerosis is essentially divided into four disease courses, each of which may be mild, moderate, or severe:
Relapsing-remitting multiple sclerosis: This disease course is characterized by acute episodes of neurologic function with some amount of recovery and no progression in between. These episodes are called relapses, flare-ups, or exacerbations. Approximately 85% of people are initially diagnosed with relapsing-remitting multiple sclerosis.
Primary-progressive multiple sclerosis: This disease course is characterized by a continuing episode of the disease from the onset, with no distinct relapses or remissions. Approximately 10% of people are diagnosed with primary-progressive multiple sclerosis.
Secondary-progressive multiple sclerosis: This disease course is characterized by an initial period of relapsing-remitting disease, eventually developing a progressive form with a gradual loss of function.
Progressive-relapsing multiple sclerosis: This course is characterized by the progressive disease at the onset with acute relapses, with or without remissions. This disease course is relatively rare.
According to the February 2010 National Multiple Sclerosis Society Disease Management consensus statement, it has adopted the following recommendations regarding the use of the current multiple sclerosis disease-modifying agents; glatiramer acetate (Copaxone®), interferon beta-1a - intramuscular (Avonex®), interferon beta-1a - subcutaneous (Rebif®), interferon beta-1b (Betaseron®), mitoxantrone (Novantrone®) and natalizumab (Tysabri®).
Initiation of treatment with glatiramer acetate or a interferon beta drug should be considered as soon as possible following a definite diagnosis of multiple sclerosis and determination of a relapsing course
Treatment with mitoxantrone may be considered for selected relapsing individuals with acute relapses or with individuals with secondary-progressive multiple sclerosis who are acute, whether or not relapses are occurring
Natalizumab is generally recommended for individuals who have had an inadequate response to, or are unable to tolerate other multiple sclerosis therapies
The frequency of relapses, age or level of disability should not limit an individual's access to medication
Treatment is not to be stopped during evaluation for continuing treatment
Therapy is to be continued indefinitely, unless there is clear lack of benefit, intolerable side effects, new data, which reveals other reasons for cessation, or better therapy is available
No studies were found to address whether there is any evidence of benefit from concurrent use of two or more disease modifying agents at the same time
Steroids (given orally, intravenously, or by injection) have been used in treating acute exacerbations in multiple sclerosis individuals. Steroids reduce inflammation in the central nervous system. There is a generalized consensus among physicians regarding the use of steroids to treat acute exacerbations in multiple sclerosis. However, it is not unanimous among physicians as to the type, dose or therapeutic schedule for steroid administration. No clinical trials on the long-term effects or prophylactic use of steroid therapy are available. All indications are that treatment for multiple sclerosis with steroids must be individualized based on the individual's response. These medications may include the following:
ACTH
Betamethasone
Dexamethasone
Methylprednisolone
Prednisone
Depo-Medrol
Solu-Medrol
Mitoxantrone Hydrochloride (Novantrone®)
Novantrone® - a cytotoxic agent - according to the FDA is indicated for "reducing neurologic disability and/or the frequency of clinical relapses in individuals with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting MS". Cardiac function should be closely monitored with this medication due to dose related cardiac toxicity reported in cancer individuals. The Novantrone® package insert states: “Functional cardiac changes may occur in individuals with multiple sclerosis treated with Novantrone. Evaluation of LVEF (left ventricular ejection fraction) is recommended prior to administration of the initial dose of Novantrone”.
Azathioprine (Imuran®)
Imuran® - according to the National Multiple Sclerosis Society, "The use of azathioprine (Imuran®) as a treatment for MS remains controversial. A drug that suppresses the immune system, azathioprine is commonly used to treat autoimmune diseases such as rheumatoid arthritis, and as part of chemotherapy for some cancers. Over the past 20 years, azathioprine has been and continues to be, the subject of numerous clinical trials - both in the United States and abroad - to see if it is useful as a treatment for multiple sclerosis. The results - using different individual populations, different doses and different protocols - have been mixed. Some benefit, in the form of slowed progression or fewer relapses, was noted in 60% of the trials. There was no apparent benefit in the other trials. Some individuals have not been able to take azathioprine because of severe nausea. Other potential side effects of azathioprine include severe anemia or leukopenia (shortage of white blood cells), liver damage, and a long-term increased risk of developing cancers such as leukopenia (shortage of white blood cells), liver damage, and long-term increased risk of developing cancers such as leukemia or lymphoma. The decision to use azathioprine is a complicated one, and should be made by the physician and the patient together, after a discussion of the potential risks and benefits." Imuran® has been used for the treatment of relapsing-remitting and chronic-progressive multiple sclerosis.
Intravenous Immune Globulin (IVIG) Therapy
IVIG therapy is considered "medically appropriate" for the treatment of relapsing remitting MS according to BCBST policy. (See hyperlink to policy below.)
Plasma Exchange
Plasma Exchange is "investigational" for the treatment of MS according to BCBST policy. (See hyperlink to policy below.)
POLICY
BlueCross BlueShield of Tennessee recognizes the need for consistency in the determination of medical appropriateness for testing and treatment of multiple sclerosis.
Services will be considered medically appropriate only if they have met BlueCross BlueShield of Tennessee's technology evaluation criteria.
********* THE FOLLOWING POLICIES HAVE BEEN *********
REVIEWED. PLEASE REFER TO THE POLICY
********* TO DETERMINE MEDICAL APPROPRIATENESS. *********
DIAGNOSTICS:
THERAPEUTICS:
Deep Brain Stimulation for the Treatment of Movement Disorders
Mechanical Stretch Devices for the Treatment of Joint Stiffness
Sacral Nerve Neuromodulation / Stimulation for Pelvic Floor Dysfunction
ORIGINAL EFFECTIVE DATE: 12/14/2000
MOST RECENT REVIEW DATE: 2/2/2012
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.