Referencing in pharmaceutical compendia and peer-reviewed literature are a guide
Some 75% of health plans in the United States reimburse patients for off-label uses of prescription drugs, according to a study recently completed by the Tufts Center for the Study of Drug Development in Boston. Off-label uses are especially high among anti-convulsants, anti-psychotics, anti-neoplastics, and antibiotics. “We also see that off-label use is common among many biologics, particularly those targeting cancer,” says Joshua Cohen, senior research fellow and lead investigator.
Of health plans that reimburse for off-label uses, over half impose conditions, including step therapy, indication restrictions, prior authorization, and quantity limits, and nearly 90% rely on pharmaceutical compendia to inform their off-label use reimbursement decisions, the study found. Findings are based on a survey of 179 third-party payers in the U.S. that administer Medicare and Medicaid pharmacy benefits.
Cohen notes in an announcement that with off-label prescribing likely to increase, “health plans will need to balance the value of rapid patient access to the best pharmaceutical care possible, sometimes through the off-label use of a drug, with the need for comprehensive data on the benefits and risks of such care.” Off-label use accounts for approximately 21% of all prescriptions, according to industry statistics.
“Since patients do not pay directly for most off-label uses, third-party payers have become crucial for market access,” Cohen says. “While reimbursement decisions with respect to on-label indications are relatively well understood in terms of evidence requirements, off-label use reimbursement until now has been less transparent.”
The Tufts study, reported in the March/April Tufts CSDD Impact Report, found that:
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March 24th 2025Advances in the life sciences are driving a significant increase in the number of temperature-sensitive pharmaceuticals. The packaging industry is meeting the moment with advances of its own, including high-performance, environmentally-friendly materials that allow life science companies meet stringent thermal requirements and ambitious CO2e reduction goals. In this episode, TemperPack’s CEO Peter Wells shares insights from working with life sciences to move to certified biobased, home compostable, and curbside recyclable shipping solutions.