Abstract
Off-label prescribing accounts for most uses of certain drugs and reportedly
is particularly common in oncology, neurology, and psychiatry. Although this
practice holds the potential for tremendous financial rewards for
pharmaceutical companies, the marketing of off-label prescribing is fraught
with legal peril as regulators place increasing restrictions on off-label
usage. This report examines the reimbursement barriers to off-label
prescribing in the world's six largest pharmaceutical markets: the United
States, France, Germany, Italy, the United Kingdom, and Japan. We analyze
off-label usage in the United States of four key drug classes: antineoplastic
drugs, antidepressants, antipsychotics, and anticonvulsants. We then review
the hazards that manufacturers may face when they engage in off-label
marketing and explore the reimbursement environment in the United States,
focusing on Medicare, Medicaid, and private insurance. Next, we consider the
reimbursement challenges in each of the other countries covered in this
report. We conclude with a brief assessment of the outlook and implications
for the pharmaceutical industry.
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