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.

In a Dec. 2 proposed national coverage determination, CMS did not "change existing coverage of nesiritide for acutely decompensated heart failure."

However, the agency found "insufficient evidence" to conclude that the off-label use of nesiritide for chronic heart failure is "reasonable and necessary for Medicare beneficiaries."

"Based on our analysis of the evidence to date, CMS proposes that Medicare coverage of nesiritide should be denied for the treatment of chronic heart failure," the proposed NCD states.

Natrecor is indicated for "the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity."

In June, CMS initiated an NCD review for nesiritide at the request of Trailblazer Health Enterprises. The Medicare contractor asked CMS to limit off-label coverage of nesiritide to when the drug is used in a clinical trial or registry. Coverage of Natrecor is currently determined by local Medicare contractors (¹ Also see "Medicare Outpatient Coverage Of Natrecor Could Be Limited To Clinical Trials" - Pink Sheet, 8 August, 2005., p. 17).

CMS' April draft guidance on "coverage with evidence development" outlined broad instances when formal data gathering could be a condition for covering a product under Medicare Part B, including when off-label uses have not been adequately addressed in literature (² Also see "CMS To Give More Specifics For Use Of Coverage With Evidence Development" - Pink Sheet, 25 July, 2005., p. 25).

According to CMS, the types of trials needed to define the safety and efficacy of Natrecor in chronic heart failure would not be the types of studies conducted under CED.

At a Food & Drug Law Institute conference Dec. 5, CMS Senior Advisor Peter Bach said evidence development would be applied only in situations where a product is likely to show benefit (see ³ Also see "CMS To Use Coverage With Evidence Development When Rx Benefit Is Likely" - Pink Sheet, 12 December, 2005.).

"CED will be used when we have a significant amount of evidence of benefit but not to the same level as we usually use in making our national coverage determinations," CMS said.

In its proposed NCD, CMS expresses concern about Natrecor's association with increased mortality rates and renal dysfunction.

The agency also found inconsistent data from its review of published medical literature, current evidence-based guidelines on nesiritide use and the recommendations of a Natrecor advisory panel convened by Scios.

"The results of some of the articles we reviewed suggest that nesiritide therapy for chronic heart failure may reduce days of hospitalization and improve symptoms. However, this is not a consistent finding across all studies," CMS said.

"The published articles supporting the off-label use of nesiritide for chronic heart failure are hampered by methodological shortcomings, including small sample size and the lack of long term outcome data."

CMS received 136 responses during the initial NCD public comment period, 98% of which supported coverage of nesiritide in the outpatient setting. While CMS recognized some patients may have benefited from outpatient nesiritide use, the agency said "individual anecdotal reports do not constitute sufficient evidence to disregard more methodologically rigorous data."

In its letter to CMS requesting an NCD review of Natrecor, Trailblazer suggested evidence-based coverage could be "directly linked to the ongoing FUSION II trial regarding nesiritide use in the outpatient setting."

In comments to the agency, Scios was supportive of linking Medicare coverage to formal data gathering; the company has had difficulty enrolling patients in its FUSION II study.

CMS is accepting public comments on its proposed determination until Jan. 2. After considering the public comments and any additional evidence, CMS will issue a final NCD.

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

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