The Food and Drug Administration approved two new weight-loss drugs last summer, but neither has achieved blockbuster status, and industry analysts don't expect them to anytime soon.

Qsymia, manufactured by Vivus, has been available since last September. It's a combination product with two active ingredients - one that works to decrease appetite and another that helps increase feelings of fullness.

Belviq, manufactured by Arena Pharmaceuticals, has FDA approval but is still being reviewed by the Drug Enforcement Agency and isn't yet on the market.

According to a report by pharmacy benefit manager Express Scripts, both drugs are approved for people who are obese (defined as having a body mass index greater than 30) or overweight (a BMI of at least 27) and who also have at least one other weight-related condition such as diabetes or high cholesterol.

"In clinical trials, 38% to 47% of patients who were taking Belviq lost at least 5% of their body weight, and between 62% and 69% of patients taking the recommended highest dose of Qsymia in clinical trials lost at least 5% of body weight," says Express Script's 2012 Q3 Drug Trend Quarterly.

Still, "these medications are not silver bullets - they come with serious side effects," says Anna Patrick, Pharm. D., a principal with Buck Consultants. "They still require patients to watch their diet and exercise. They're only effective with those two things combined."

Qsymia also has a DEA schedule attached to it, meaning it's tightly controlled from a prescribing and dispensing perspective. "My understanding is that it's limited to certain pharmacies [and] it comes with a risk evaluation and mitigation strategy," says Patrick. "I think any time physicians see medication being managed very strictly by the FDA, they're going to be really careful about prescribing it correctly."

Weight-loss medications don't exactly have a stellar reputation on the safety front, either. The infamous "fen-phen" combination was pulled from the market in 1997 after many patients developed heart valve problems. More recently, Meridia was voluntarily withdrawn because it increased the risk of heart attack and stroke for some patients.

"I think it's going to take physicians some time to get comfortable with them because the last ones got pulled from the market," says Hitesh Patel, vice president with Aon Hewitt.


Coverage decisions

Patel says many plans - about half - don't cover weight-loss medications, and he doesn't expect them to start. "There will be some [employers] that say, 'If these are really effective, [then] I need to help my employees lose weight.' But I think most of them won't," he says. "They're going to wait to see if they're effective and make a difference in people's lives before they make decisions [about whether to cover them.]"

Many of Patrick's self-insured employer-clients, meanwhile, do provide coverage for weight-loss medication. "But they don't just cover them without any controls," she explains. "They require a prior authorization process to make sure the patient meets the criteria of being obese."

For Qsymia, her clients "all decided to have the same types of utilization controls that they have for other weight-loss medications." So far, the drug hasn't taken off. "I'm not sure we're going to see the blockbuster utilization that perhaps everyone's concerned about when you hear 'weight-loss medications,'" she says.

While Patel hasn't seen too much utilization, he does say "at some point [these drugs] could be blockbusters and there could be cost implications."

Qsymia currently costs $4.80 per pill and is prescribed to be taken daily. That's about three times as much as over-the-counter weight-loss drug Alli, says Patrick, "so I think the manufacturers were definitely looking for a golden opportunity to have a prescription medication that's a little different. It's another reason employers want to make sure they're managing it and not just covering it with no limitations."

Michael Jacobs, vice president of national accounts with Truveris, believes these weight-loss medications are just an expensive way to address the real problem: behavior.

"The drugs don't help you change behavior," he says. "If you've tried to change behavior and you're serious about it and you need a little bit more of a push, then the drugs can help you a little bit in that area, but it's a very short-term fix."

For large self-funded employers, these drugs will have minimal impact, he believes.

"The U.S. pharmaceutical market is worth a little over $300 billion a year. Even if these drugs come out and they're worth $6 billion - which I doubt they will be - that's only 2% of the market," says Jacobs. "So although it's a lot of money, it's probably not going to make a lot of difference [to employers]."


Fat fighters in the pipeline

In addition to Qsymia and Bel-viq, several other new fat-fighting drugs are in the pipeline, according to the Express Scripts report. Contrave combines two existing medications - an opioid antagonist used in anti-addiciton therapy and an anti-depressant used for smoking cessation. In theory, Contrave could blunt the craving for food the way it dulls an addict's craving for heroin or alcohol. Contrave currently is undergoing additional FDA-required testing. Tesofensine, an appetite suppressant, and cetilistat, which blocks fat absorption, also are in late-stage clinical trials.

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