New York Times Examines Marketing, Off-Label Use of Natrecor
The New York Times on Tuesday examined how use of Natrecor has expanded beyond being administered in emergency departments to allow people with heart failure to breathe more easily to being "widely used by thousands of patients in outpatient clinics." According to the Times, the situation is "another example of the pharmaceutical industry's inexorable search for broader markets once a medicine has been approved for a narrower use" by FDA.
FDA in August 2001 approved the drug, made by Johnson & Johnson's Scios unit, for treating "acutely decompensated" heart failure, a condition that is treated in hospital settings. However, many physicians prescribe the drug off label to patients who receive it intravenously at clinics "sometimes weekly or more often, over several months," the Times reports. A four-hour infusion session can cost $600 or more, according to the Times. The Times reports that the drug generated $400 million in sales last year and has been forecast to have sales of $600 million this year. Much of the total cost is paid for by Medicare, as about 80% of those receiving the drug are ages 65 or older.
To help providers receive reimbursement for administering the drug in an outpatient setting, Johnson & Johnson runs a Natrecor Reimbursement Support hotline and has distributed information on how to submit claims to Medicare or other health plans. FDA reportedly has had informal discussions with Johnson & Johnson about the company's marketing of Natrecor. In addition, some physicians have raised concerns about the drug's safety -- it has been linked to kidney problems -- and that cheaper alternatives are available. A group representing a number of health plans participating in Medicare also intends to ask CMS to provide guidance on whether and in what circumstances Natrecor is reimbursable.
Johnson & Johnson officials said that the safety problems indicated in clinical trials are not statistically significant and that the company has formed a team of outside doctors to evaluate the drug. Mark Wolfe, a Johnson & Johnson spokesperson, denied that FDA has criticized the company's marketing, adding that the company and agency are in "ongoing discussions" (Saul, New York Times, 5/17).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.