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Off-Label Drug Coverage Bill Advances

A measure requiring certain health insurance carriers to cover the off-label use of certain drugs has been approved by the Assembly Appropriations Committee. Off-label use refers to when a drug is prescribed for uses, periods of time, or at dosages that are not FDA-approved. Off-label drug use is legal when prescribed in a medically appropriate way.

(Flickr Photo: Charles Williams)

The bill is sponsored by Assembly members Herb Conaway M.D., Valerie Vainieri Huttle and Ruben  Ramos.

“The purpose of this bill is to extend the medical benefits that may derive from the use of off-label drugs to individuals who may not be able to access these medications,” explains Conaway, “In particular those individuals who are suffering from a terminal or chronically debilitating illness, because their insurance carriers won’t cover these drugs.”

The legislation requires health benefits plans offered in the individual and small employer markets in New Jersey, which cover drugs that are approved by the federal Food and Drug Administration (FDA), the State Health Benefits Program (SHBP) and the School Employees’ Health Benefits Program (SEHBP), to provide coverage for certain off-label uses of those drugs.

“Medications can be quite expensive, especially when they must be taken routinely to treat a debilitating disease,” says Vainieri Huttle. “If these drugs have proven effective in the treatment of a particular illness and deemed safe by a medical professional, then I don’t see why they should not be covered by these insurance companies. The health of the patient should come first.”

The bill requires health insurance carriers that participate in the Individual Health Coverage Program, the Small Employer Health Benefits Program, the SHBP and the SEHBP to cover the off-label use of a drug, if the drug is recognized as being medically appropriate for the specific treatment for which it has been prescribed, in one of the two established reference compendia (the American Hospital Formulary Service Drug Information or the United States Pharmacopeia Drug Information), or is recommended by a clinical study or review article in a major peer-reviewed professional journal.

“Staying healthy in this country is costly,” says Ramos. “A person who is battling a serious illness should not have to worry about how they will afford a particular drug when they are paying for health insurance. If the medication has been prescribed by a licensed physician and has proven beneficial to the patient, then the insurance company has a responsibility to cover it.”

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