NCPA - National Center for Policy Analysis


May 23, 2005

Through Medicare, taxpayers foot most of the bill for Natrecor, an expensive and controversial drug approved for treating emergency heart failure, says the New York Times. Since its debut in 2001, the drug has become widely used in outpatient settings as a once-a-week maintenance therapy, and observers express concern over cost and safety.

Some doctors say Natrecor's expansion into maintenance therapy is another example of the pharmaceutical industry's inexorable search for broader markets once a medicine is approved for a narrower use by the Food and Drug Administration. Furthermore, much cheaper alternatives, like nitroglycerin, are just as effective as emergency treatments for heart failure.

Regardless of Natrecor?s purpose or effectiveness, the soaring costs for taxpayers are beyond dispute, says the Times:

  • The four-hour outpatient infusion sessions cost $600 or more, not including doctor examination fees; last year, Natrecor generated sales of $400 million and sales this year could top $600 million.
  • About 80 percent of patients who receive Natrecor are 65 or over, and therefore eligible for Medicare -- which fully covers infusion therapies in most states.
  • An estimated 125,000 patients are candidates for Natrecor on an outpatient basis; the company projects they sell 24 vials of the drug for each serial outpatient case, compared to 2.7 vials for a hospitalized patient.

While Johnson & Johnson, the makers of Natrecor, do not promote the (legal, but federally unapproved) off-label use of the drug, they simultaneously operate a Natrecor Reimbursement Support telephone line. The company also provides sample sheets of instructions for submitting claims to Medicare for outpatient reimbursement.

As for safety concerns, two recently published studies linked Natrecor to worsened kidney function and hastened death. Researchers say the frequent use of Natrecor requires additional study and in the meantime, it should be used only when other treatment options have failed.

Source: Stephanie Saul, "The Marketing Of a Tuneup For the Heart: Issues Arise as Drug's Use Goes Beyond Emergencies," New York Times, May 17, 2005.

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