Launch of Sanofi's Acomplia Will Likely Affect MCO Coverage of Anti-Obesity Drugs

Reprinted from the Sept. 17, 2004 issue of DRUG COST MANAGEMENT REPORT, a hard-hitting biweekly report with timely news, data and analysis on steps being taken to control soaring pharmaceutical costs.

Following recent news of successful first-year clinical trial results for unique weight-loss drug Acomplia (rimonabant) and FDA's plans to revise guidance on clinical trials of anti-obesity drugs, payers may start keeping a closer watch on a number of emerging treatments that could be safer and more efficient in the long term than have been previous options for managing obesity.

"Today's [obesity] treatments are amphetamine-derived for the most part or they block fat absorption, aren't very effective, have a lot of side effects and haven't been proven to work for a long time," Aetna, Inc. Chief Pharmacy Officer Marc Rubino tells AIS. "Certainly if [Acomplia] pans out the way it looks, it is going to be a real addition to our quiver to treat this disease population."

Acomplia is the first agent in a new therapeutic class known as selective cannabinoid type 1 (CB1) blockers.

Rubino says many of Aetna's plan sponsors choose not to cover appetite suppressants or anti-obesity drugs because of the questionable efficacy and effectiveness and short-term effect of these drugs. The insurer takes a more comprehensive approach to weight management, with medications playing only a small role. Meridia (sibutramine) and Xenical (orlistat) are two anti-obesity drugs for which Aetna and many other payers have specific coverage guidelines.

But given the low risk of side effects seen so far with Acomplia, Rubino says Aetna would probably recommend coverage to its sponsors and would not treat the drug as an appetite suppressant. "It's probably, of the drugs we've seen in the pipeline, one of the most exciting ones," says Rubino. "It's not a 'me, too' drug, and those are the kind we want to pay for. And this drug is truly a unique chemical with a unique mode of action."

Research firm Decision Resources, Inc. says it predicts Acomplia will have a huge impact on the obesity drug market, which could reach $2.3 billion in 2013.

There are 18 compounds in late-stage clinical development (Phase II or later) worldwide for treating obesity, and 10 of those products could be launched by 2008, according to a market report from Navigant Consulting, an independent consulting firm headquartered in Chicago. While drug therapies for obesity are typically used in combination with other obesity management techniques such as behavioral modification and bariatric surgery, the firm says it predicts that insurers will be more likely to cover weight-loss drugs in the future. The one therapy that is likely to have the earliest and biggest impact on the obesity drug market is Acomplia, which drug maker Sanofi-Aventis says it plans to file for U.S. regulatory approval early next year and hopes to market by 2006.

Acomplia is expected to be such a big blockbuster that there has been speculation that it was the leading cause of a recent merger between Sanofi-Synthelabo and Aventis, which created the world's third-largest drug company. With Aventis' large U.S. sales team, European drug maker Sanofi will be able to make Acomplia widely available to a nation in which 20% of the people are overweight and the percentage is growing.

Rubino adds that he wouldn't be surprised if Acomplia was given priority review status by FDA, which is now revising draft guidance, "Clinical Evaluation of Weight-Control Drugs," issued in 1996 that gave recommendations for the design and conduct of Phase I through III clinical studies aimed at demonstrating the efficacy and safety of weight-loss drugs. The committee met on Sept. 8 to discuss public comments it requested earlier this year. FDA did not respond to inquiries from AIS regarding the meeting or the possible review status of Acomplia.

Acomplia works by blocking the CB1 receptor, which is associated with food intake and tobacco dependency, and it has had brief, yet successful clinical trials in both Europe and the U.S. First-year results from a two-year clinical trial in Europe showed that overweight or obese people taking daily 20 mg doses of Acomplia experienced significant reductions in their body weight and waist circumference and improvements in their lipid and glycemic profiles, according to University Hospital Antwerp. There are not, however, any completed two-year trials to show the long-term effects of the drug in treating obesity.