Contact Information: Contact: Tufts Center for the Study of Drug Development Charlene Neu 617-636-2187 Business Communication Strategies Peter Lowy 617-734-9980
Three-Quarters of U.S. Health Plans Reimburse for Off-Label Uses of Prescription Drugs, According to Tufts Center for the Study of Drug Development
BOSTON, MA--(Marketwire - March 10, 2009) - Reflecting recent rapid growth of off-label
prescribing of prescription drugs, 75 percent of all health plans in the
United States now reimburse patients for such treatments, according to a
study recently completed by the Tufts Center for the Study of Drug
Development.
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.
The findings were based on a Tufts CSDD survey of 179 third-party payers in
the U.S. that administer Medicare and Medicaid pharmacy benefits.
"Since patients do not pay directly for most off-label uses, third-party
payers have become crucial for market access," said Joshua Cohen, a senior
research fellow at Tufts CSDD and lead investigator on the study. "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 practice of off-label use involves prescribing medicines for a purpose
outside the scope of a drug's intended purpose, as indicated on its label.
Once a drug is approved in the U.S., the Food and Drug Administration does
not regulate its use, and doctors may prescribe the drug for an off-label
use.
Cohen noted 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."
The Tufts CSDD study, reported in the March/April Tufts CSDD Impact Report,
released today, found that:
* Sixty percent of the health plans surveyed require that off-label uses
must be referenced in one or more pharmaceutical compendia to be
reimbursed.
* More than three-quarters of health plans ascribed a "very important" role
to peer-reviewed literature as a factor in determining off-label use
reimbursement decisions.
* Almost four-fifths of plans ascribed a role to cost-effectiveness in
off-label use reimbursement decisions; almost one-fifth said
cost-effectiveness data play a "very important" role.
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu)
at Tufts University provides strategic information to help drug developers,
regulators, and policy makers improve the quality and efficiency of
pharmaceutical development, review, and utilization. Tufts CSDD, based in
Boston, conducts a wide range of in-depth analyses on pharmaceutical issues
and hosts symposia, workshops, and public forums, and publishes the Tufts
CSDD Impact Report, a bi-monthly newsletter providing analysis and insight
into critical drug development issues.