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Conaway, Vainieri Huttle, Sumter & Lampitt Bill Requiring Insurers to Cover Off-Label Rx Drug Treatments Advances

Legislation sponsored by Assembly Democrats Herb Conaway Jr., Valerie Vainieri Huttle, Shavonda Sumter and Pamela Lampitt that would require certain health insurance carriers to cover off-label uses of prescription drugs was approved by an Assembly panel Thursday.

The bill (A-1807) would require certain health insurance plans – the State Health Benefits Program, the School Employees’ Health Benefits Program and health benefits plans offered in the individual and small employer markets that cover Food and Drug Administration-approved drugs – to provide coverage for off-label uses, or medically-appropriate uses that deviate from the original intent designated by the FDA.

“This bill will help extend the medical benefits of prescription drugs to individuals – in particular those suffering from a terminal or chronically debilitating illness – who may not otherwise be able to access these medications because their insurance won’t cover it,” said Conaway (D-Burlington).

“Medications can be quite expensive, especially when they must be taken routinely to treat a debilitating disease,” said Vainieri Huttle (D-Bergen). “If these drugs are proven to be effective in the treatment of a particular illness and deemed safe by a medical professional, then I don’t see why they shouldn’t be covered by insurance.”

When prescribed by a medical professional, off-label use of an FDA-approved drug is legal, provided the specific treatment for which it has been prescribed has been universally acknowledged by professionals within the pharmaceutical community or recommended by three clinical studies or a review article in a peer-reviewed professional journal.

“This legislation removes a barrier to wellness and will enable medical professionals to do what is best for their patients,” said Sumter (D-Bergen/Passaic). “The health of our residents should always come first.”

“Physicians have a unique understanding of their patient’s needs, the way they respond to certain medications and the latest industry recommendations for off-label treatments,” said Lampitt (D-Camden/Burlington). “This bill will enable them to treat more patients in a personalized manner that is best suited for their individual condition.”

The FDA is responsible for ensuring that a treatment is safe and effective for its designated use but does not regulate the practice of medicine. As such, provided a drug is FDA-approved, a licensed physician can prescribe it to a patient for any purpose he or she considers medically appropriate.

For example, doctors may prescribe the drug citalopram, an FDA-approved anti-depressant, to treat Alzheimer’s disease, a use that deviates from the original intent of the drug. Under current law, however, insurance companies are not required to cover such use.

The bill was approved by the Health and Senior Services Committee chaired by Conaway.