Life Science News

If Extensive Off-Label Usage Stimulates Sales Far in Excess of ...

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. In this report, Decision Resources Inc examine 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. Decision Resources Inc analyze off-label usage in the United States of four key drug classes: antineoplastic drugs, antidepressants, antipsychotics, and anticonvulsants. Decision Resources Inc 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. The report is concluded with a brief assessment of the outlook and implications for the pharmaceutical industry.