Medicare's recent announcement about obesity coverage policies sends a positive signal for the upcoming launch of Sanofi-Synthelabo's Acomplia , the company said during a July 21 conference call.

"American authorities recognized that obesity is a treatable and reimbursable disease, which of course we think is an extremely positive concept for the upcoming launch of the product at the beginning of 2006," Sanofi said.

Acomplia (rimonabant) is in Phase III for treatment of obesity and to aid smoking cessation; an NDA is expected to be filed by late 2004 or early 2005 (¹ Also see "Sanofi To Move Two NMEs Into Phase III In 2004, For Total Of Nine" - Pink Sheet, 23 February, 2004., p. 21).

The Centers for Medicare & Medicaid Services removed language in the Medicare Manual July 15 that stated that obesity is not an illness. The new language will allow obesity therapies to be reimbursed if they demonstrate meaningful health benefits.

The policy change will not directly affect coverage of oral medicines like Acomplia (or currently marketed agents like Roche's Xenical or Abbott's Meridia ).

The Medicare prescription drug law enacted in 2003 defines "covered outpatient drugs" for the new Part D benefit based on the Medicaid definition - which is written into statute and excludes obesity therapies (² Also see "AHRQ Obesity Report Recommends Behavior Therapy, Is Cautious On Drugs" - Pink Sheet, 8 December, 2003., p. 30).

The new Medicare policy does apply to physician administered drugs under Part B; some investigational biotechnology approaches to obesity could ultimately apply for coverage under that payment system.

Application of the new CMS standards for obesity to Part D would appear to require new legislation.

The policy change may nevertheless encourage more private plans to extend coverage to oral obesity agents. On the other hand, Roche is pursuing an OTC switch for Xenical that could further define the category as self-paid (see ³ Also see "Xenical OTC Switch Plans Underway; GSK Pays $100 Mil. For Rights" - Pink Sheet, 26 July, 2004.).

The Part D statute does specifically include smoking cessation agents as covered drugs, meaning that Acomplia will have an opportunity for formulary coverage under the new benefit.

Medicare Obesity Policy Change Will Help Acomplia Launch, Sanofi Says

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