Aug 05, 2009
When a medication is "off label"
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Almost every medication used to treat a symptom of MS is prescribed off label. This means that the U.S. Food and Drug Administration ruled the drug safe and effective for another medical condition, but did not specifically approve it for use with MS. For instance, beta blockers are approved for treatment of high blood pressure and migraines, but they also help to reduce some tremors. Doctors often use these medicines “off label” to treat tremors in MS. Generic forms are available, so they are often covered by insurance companies.
In the case of medications that do not have generic forms (such as Provigil for fatigue), insurance providers may not cover their use. “It comes down to how expensive a medication is,” said Dr. George Garmany of Associated Neurologists of Boulder, Colo. “It’s usually not an issue when there is a generic equivalent for a drug.”
The expense factor
But why are so many medications that are effective for MS symptoms not approved for that use? “It costs a lot of money for drug companies to do the studies,” Dr. Garmany explained. “Once the drug is approved for its primary use, the company may not wish to cover the additional expense of trials to show that it is effective in MS.”
The right diagnosis
Some symptoms of MS, such as depression, may allow for on-label use. “Depression is depression,” Dr. Garmany said. “The fact that someone has MS only modifies the way the depression is expressed. And if a patient has a legitimate diagnosis that would allow for on-label use, the doctor is best off using that.”
Covering your costs
- Ask your health care provider if there is a generic equivalent.
- If there isn’t one, or your health care provider feels the off-label drug is best for you, file an appeal if insurance won’t cover it. “Every insurance plan must provide for an appeal of any ‘adverse determination’ made by the plan, including at least two levels of appeal,” said Kim Calder, director of Insurance Initiatives for the Society. The Society can help. Visit nationalMSsociety.org/insuranceappeals.
The National MS Society also has a toolkit of appeal letters for doctors that relate to commonly prescribed off-label treatments for MS. Visit www.nationalMSsociety.org/appealtoolkit or contact the society.