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Medicare Proposes To Cover J&J’s Natrecor For Labeled Indication Only

Executive Summary

The Centers for Medicare & Medicaid Services is proposing to restrict Medicare coverage of Johnson & Johnson/Scios' Natrecor to its labeled indication for acutely decompensated heart failure, rather than provide wider coverage for the drug under a "coverage with evidence development" program

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CMS Natrecor NCD

Medicare contractors may opt to cover J&J/Scios' Natrecor for some off-label uses despite a March 2 CMS national coverage decision against using nesiritide for chronic heart failure. The decision "does not change contractor discretion to cover other off-label uses of nesiritide" or affect coverage for the labeled indication of acutely decompensated heart failure, CMS said. The agency had expressed concern about the drug's potential for increased mortality rates and renal dysfunction. The NCD review found inconsistent data on use of Natrecor for chronic heart failure (1"The Pink Sheet" Dec. 12, 2005, p. 12)...

CMS Natrecor NCD

Medicare contractors may opt to cover J&J/Scios' Natrecor for some off-label uses despite a March 2 CMS national coverage decision against using nesiritide for chronic heart failure. The decision "does not change contractor discretion to cover other off-label uses of nesiritide" or affect coverage for the labeled indication of acutely decompensated heart failure, CMS said. The agency had expressed concern about the drug's potential for increased mortality rates and renal dysfunction. The NCD review found inconsistent data on use of Natrecor for chronic heart failure (1"The Pink Sheet" Dec. 12, 2005, p. 12)...

CMS To Use Coverage With Evidence Development When Rx Benefit Is Likely

The Centers for Medicare & Medicaid Services will use coverage with evidence development only when an agent is highly likely to show benefit in a broader patient population than its labeled indication, CMS Senior Advisor Peter Bach said Dec. 5

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