WASHINGTON — The Centers for Medicare and Medicaid Services may issue a national coverage determination that would deny coverage of nesiritide (Natrecor) for the treatment of chronic heart failure in Medicare beneficiaries.
Nesiritide is indicated only for the intravenous treatment of acute decompensated heart failure (ADHF) in hospitalized patients with dyspnea at rest or with minimal activity, such as talking, eating, or bathing. The CMS proposal would change only one aspect of existing coverage of the drug, specifically its off-label use in patients with chronic heart failure.
“We're keeping it for the [Food and Drug Administration] approved [indication] and for all the other off-label uses. It's just this one thing that seems more risky than we thought,” said Don McLeod of the CMS press office. The agency will weigh public comments as well as other evidence before issuing a final determination.
According to Mark Wolfe, a spokesperson with Scios Inc.'s parent company, Johnson & Johnson, “The proposed national coverage determination is consistent with our own recommended use of Natrecor. Scios has ongoing studies involving Natrecor and will be keeping the [CMS] informed regarding this research.”
In an October letter sent to health care providers, Scios emphasized that nesiritide “is safe and effective” when used for its current indication. It rebutted recent reports that suggested nesiritide adversely affected renal function and short-term mortality more than other drugs for ADHF. “These reports have included inaccurate information and selective analysis of data previously included in the prescribing information,” stated the letter's author, Dr. Darlene Horton, senior vice president at Scios.
However, Dr. Jonathan Sackner-Bernstein, a prominent New York cardiologist and coauthor of several metaanalyses critical of nesiritide (N. Engl. J. Med. 2005;353:1525–7, JAMA 2005;293:1900–5) is unflinching in his contention that nesiritide “should be withdrawn from the market.”
“No analysis by anyone in any context can be used to support the statement that nesiritide is shown to be safe. Therefore, according to the law, it should not be legal to sell it,” Dr. Sackner-Bernstein said.
Many of his colleagues remain unconvinced that nesiritide should be withdrawn or that CMs' current action portends the drug's future withdrawal. “The FDA approval was for the treatment of decompensated heart failure in hospitalized patients, although the word 'hospitalized' wasn't used, that was implied … and it was indicated for symptomatic relief. I support its use for that indication,” said Dr. Wilson Colucci, chief of cardiovascular medicine at Boston Medical Center and Boston University. Further, he agreed with CMS that there is not a sufficient amount of data to support the use of nesiritide as a treatment for chronic heart failure.
However, Dr. Colucci disagreed with Dr. Sackner-Bernstein when it came to removing nesiritide from the market, “at least based on the current data.”
“With regard to renal function, there has been a lack of substantial benefit, but relatively very little effect one way or the other when one looks at the totality of the renal effect. That's not the indication, and that's not the reason to give the drug,” said Dr. Colucci.
He went on to say that Dr. Sackner-Bernstein's metaanalysis fell short of establishing any kind of risk with the drug.
Dr. Colucci disclosed that he was an investigator involved in the studies that led to nesiritide's FDA approval for treatment of ADHF.