Why Aren't Rx Weight-Loss Drugs More in Demand?
By Rita Rubin
Reviewed by Michael W. Smith, MD
Aug. 27, 2014 -- Obesity costs the U.S. health-care system close to $150 billion a year -- not terribly surprising when you consider that more than a third of American adults are obese.
That number, from 2009, is the latest reported by the CDC. Other estimates are even higher, and those costs are expected to rise.
And yet, less than 1% of that $150 billion goes toward prescription medications approved to treat obesity. Although the highly anticipated approval of two newer anti-obesity drugs, Belviq and Qsymia, has bumped up sales, neither is anywhere close to a blockbuster.
In 2013, U.S. sales of anti-obesity drugs totaled about $114 million, according to IMS Health, an international information, services, and technology company. By comparison, U.S. sales of drugs to treat diabetes, one type of which is linked to obesity, totaled about $22 billion.
Obesity experts blame lackluster sales of the drugs on several things: doctors' lack of training in how to treat obesity, concerns about the medications' safety, and a lack of insurance coverage.
"We still as a society believe that the things that work for preventing obesity are going to work for treatment," says Steven Smith, MD, president of The Obesity Society, a scientific organization. "We have this inherent belief that willpower's going to help with these kinds of issues." But, Smith says, diet and exercise alone "by and large are ineffective for treating obesity."
Most obese people need the help of anti-obesity medication, yet few are getting prescriptions for them, Smith says. Doctors are more likely to advise obese patients to eat less and move more or, at the other end of the spectrum, refer them for weight-loss surgery than prescribe medication, he says. Smith is the founding scientific director of the Translational Research Institute for Metabolism and Diabetes at Florida Hospital in Orlando.
"The gap in the middle is clear," says Smith, who was involved in all phases of clinical trials of Belviq, the newest anti-obesity medication on the U.S. market. He spoke on behalf of its manufacturer, Arena Pharmaceuticals, at an FDA advisory committee meeting on the drug. "We are not educating physicians about how to manage obesity in a busy clinical practice."
Sales of anti-obesity drugs, while relatively small, did nearly double from 2011 to 2013, according to IMS Health. During that time, Qsymia, the first new weight-loss drug in 13 years, entered the market in September 2012. Belviq became available in June 2013.
The drugs are approved to treat obese people, those with a body mass index (BMI) of 30 or higher, and overweight people with at least one weight-related condition, such as type 2 diabetes or high blood pressure, whose BMI is 27 or higher. (The FDA was expected to approve another weight-loss drug, Contrave, in June, but the agency delayed a decision by 3 months. It wants to further discuss how to track the drug's heart effects once it comes on the market.)
In the two clinical trials that led to Qsymia's FDA approval, people treated with the recommended starting dose lost 6.7% more weight in a year than those given a placebo pill. People treated with the highest dose lost 8.9% more weight in a year than those on a placebo.
In the three clinical trials that led to Belviq's FDA approval, people who took the drug for up to 1 year on average lost 3% to 3.7% more compared to placebo. Both medications are supposed to be used along with lifestyle changes, namely eating less and exercising more.
Even if doctors prescribe the pills, patients are likely to find their health insurance won't pay for them, Smith says. "Coverage is key," he says, noting that fewer than half of health insurance companies cover weight-loss drugs. "We have 50, 60 diseases that are caused by obesity. We're happy to replace your knees, but we're not addressing the root problem."
Obesity specialist Caroline Apovian, MD, a professor of medicine at the Boston University School of Medicine, says lack of insurance coverage for anti-obesity medications is the reason phentermine, a generic drug, is the most-prescribed weight-loss drug in the U.S.
Years ago, phentermine was combined with fenfluramine, in a drug known as fen-phen. The drug was widely prescribed for weight loss until the FDA banned fenfluramine in 1997 after it was linked to heart valve problems.
Phentermine was not taken off the market. It is also one of the two ingredients in Qsymia, along with topiramate, a medication also used to control seizures and prevent migraines.
While phentermine, a stimulant similar to an amphetamine, is more likely to cause insomnia, palpitations, and anxiety than Qsymia and Belviq, Apovian says, it costs only $11 a month. "That explains everything," she says.
The companies that market Qsymia and Belviq offer 2 weeks of their drugs for free, and then $75 off the retail price for each of 12 30-day filled prescriptions. But patients still end up paying as much as $200 a month out-of-pocket, Apovian says. "Believe me, they tell me about how much it costs them."
If people are willing to pay for Qsymia or Belviq, Apovian says, she considers their medical history, family history, and other medications they're taking in trying to decide which drug to prescribe. "Sometimes you try one, and then you try the other," she says.
"The drugs seem to be just as effective as in the trials," she says of her experience with her patients. But, she adds, it's "hard to keep people on them as long as 1 year due to price."
Loss of Appetite, Pounds
One of Apovian's patients, 29-year-old Versey Bell, took Qsymia for a month but had to stop because her insurance didn't cover it, and she couldn't afford to pay out of pocket. But several months later, Bell's financial situation improved, and she started taking the drug again.
After 3 months back on Qsymia, the 5-foot-5-inch Bell says she had dropped nearly 20 pounds from her starting weight of 214. (This may not represent typical weight loss on the drug.)
"It suppresses your appetite," she says. "Stuff that I normally eat, I no longer have the desire to eat." Or, she says, she'll eat a much smaller portion. On top of that, she's taken up running again, a pastime she had given up after moving from California to Boston 2 years ago.
Despite her initial success, she quit taking Qsymia in June.
"It was making me very irritable and angry," says Bell, who works as a nurse's aide and is enrolled in nursing school. "I'm not really an arguing type of person. It really did change my mood." And she wasn't sleeping as well as she used to, she says. "If I went to sleep, I couldn't stay asleep. I couldn't fall back asleep right away."
She recently switched to phentermine. "It gives me a lot of energy, and it suppresses my appetite." The main side effect, she says, is "cotton mouth," but she deals with that by drinking a lot of water.
Vicki March, MD, an internist and obesity specialist at the University of Pittsburgh Medical Center, says, "I'm pretty cautious and mindful about whom I start on these medications."
Insurance is a factor, she says, and people also worry the drugs won't work or are concerned about side effects.
According to the FDA, Qsymia's most common side effects are tingling of the hands and feet, dizziness, altered taste, insomnia, constipation, and dry mouth. The most common side effects of Belviq in people who don't have diabetes are headache, dizziness, fatigue, nausea, dry mouth, and constipation, according to the FDA. Also, people with heart failure need to be cautious taking this drug. Other side effects may include heart valve problems and a dangerous but rare condition called serotonin syndrome, in which high levels of the chemical serotonin build up in the body, causing symptoms including fever and seizures.
In people with diabetes, the most common side effects are low blood sugar, headache, back pain, cough, and fatigue.
Neither drug is supposed to be taken by pregnant women because of the risk of birth defects. Qsymia carries a risk of cleft palate or cleft lip; the drug's safety information says women should have a pregnancy test to confirm they're not pregnant before beginning Qsymia and every month while taking it. The FDA has asked the makers of both drugs to do more studies to see whether they raise the risk of major problems such as heart attack and stroke.
March says she's prescribed all three drugs with "great" results. For many obese people, she says, the potential side effects are worth the boost they give to weight-loss efforts. Still, losing weight isn't as simple as popping a pill, she says. Anti-obesity medication "is not going to work by itself. It really isn't."
SOURCES: Steven Smith, MD, professor at the Sanford-Burnham Institute for Medical Research, Lake Nona, Fla. Caroline Apovian, MD, professor of medicine, Boston University School of MedicineVersey Bell, nurse's aide. Vicki March, MD, internist and obesity specialist, University of Pittsburgh Medical Center. IMS Health. FDA: "FDA approves weight management drug Qysmia." FDA: "FDA approves Belviq to treat some overweight or obese adults." CDC: "Prevalence of Obesity in the United States, 2009-2010." CDC: "Adult Obesity Facts." IMS Health: "Top 5 Products in the Obesity Market."