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Re: Controlling Off-Label Medication Use
Submit responseOff-label prescriptions are sometimes necessary for individuals with rare disorders to be able to maintain some type of normal life. My wife has Takayasu's arteritis. Because of the rarity of this disorder, many treatments available will be considered off-label. She has been taking Provigil since November 2005, and now her insurance company has decided not to cover this medication because it has not been approved by the FDA for treating Takayasu's related fatigue. So far, Provigil is the only medication that she is being denied due to off-label use.
According to the package insert,"PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder." Although it has not been approved for other uses, research has shown that it is effective in treating fatigue associated with diseases such as multiple sclerosis, myotonic dystrophy, and Parkinson's disease. Provigil has been shown to have a low potential for abuse or addiction. Provigil may even be beneficial as far as improving her post-stroke cognitive functioning. Provigil also has a low risk of overdose, even with doses as high as 4500mg.
Fatigue is a common problem with Takayasu's patients. Since her stroke, the fatigue can be debilitating. Treatment is absolutely necessary for my wife to maintain her ability to work and have a somewhat normal level of functioning. Limiting off-label prescribing will have a major impact on the quality of life of many patients with rare disorders.
Conflict of Interest:
None declared
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A New Way To Ration Healthcare In The United States
Submit responseIt is a compelling argument that one would limit off- label uses of therapeutics based on a financial limit of $12,000 per year. As a rheumatologist I often have to decide on therapies for patients who have rare disorders. Whether it be a patient with catastrophic antiphospholipid syndrome, adult onset still's disease with hemophagocytosis, or amyloidosis secondary to familial mediterranean fever, there are often no available FDA approved therapeutics. Usually a cytokine directed therapy that is currently available for a different disorder is used in this context with much success. Such treatments would commonly exceed $12,000 a year. I am hoping that these decisions will not be based on financial llmitations but rather on risk/benefit analysis. This will lead to rationing of health care that will be biased against orphan and other disorders. It will elevate the FDA to the one's that will de facto be choosing whether patients will live or die.
Conflict of Interest:
None declared