Obesity Drug's Promise Now Hinges On Insurance Coverage
When a promising new drug to treat obesity was approved by the Food and Drug Administration for sale in the U.S. last month, it was the first such treatment to gain approval since 2014.
In clinical trials, weekly injections of semaglutide — or Wegovy, as it's been branded — helped people drop an average of 15% of their body weight. That's an average of about 34 pounds over 16 months,before their weight plateaued — roughly triple what's achieved with other drugs on the market. At least as important, Wegovy raised none of the alarm bells with the FDA or obesity doctors that it might trigger serious side effects of the sort some people experienced by takingfen-phen or other previous medical treatments for obesity.
But with a price tag for Wegovy of $1,000 to $1,500 a month, a big question remains: Will insurers cover its significant cost for the millions such as Marleen Greenleaf who might benefit?
Greenleaf grew up on the island of Trinidad, where her family paid little heed to what they ate and paid a high medical price, she says: "My husband has diabetes, my sister has diabetes, my brother has diabetes."
Since then, she's tried — and failed — at numerous diets, says Greenleaf, now 58 and an administrator at a charter school in Washington, D.C. Then, in 2018, she signed up for the clinical trial of a new drug — a once-weekly shot that changes the way her brain signals hunger.
A drug that finally stops her cravings
She noticed the change soon after her first injection of Wegovy: "For me, there was something that triggered in my brain to tell me that I was not hungry," she says. No more fierce cravings for the chocolate chip cookies she adores. Without the cravings she was able to slow down and reconsider the foods she'd been reaching for.
"I also wanted to eat healthier," she says. "I was looking at options, reading labels, looking at the calories — not just the calories but also the sugar."
Over the 68-week research trial, Greenleaf dropped 40 pounds. Her blood pressure fell, which meant she qualified to donate her kidney to her husband, who was on dialysis.
"It was one of the best gifts of life that I could have ever given," she says.
But after that study ended, Greenleaf regained some of the weight. Wegovy is considered a long-term, possibly lifelong medication to treat chronic obesity. In the premarketing clinical studies, weight loss topped out at a total average of 15% to 18%, even as people continued to take the drug. And, as was the case with Greenleaf, once they stopped getting the weekly injections some of that weight came back.
Now Greenleaf wants to resume the Wegovy shots.
"My only challenge actually is getting the insurance company to approve it," she says.
Reimbursement for obesity drugs' cost is patchy
Insurance coverage, it turns out, is a giant question — not just with Wegovy but with obesity drugs in general. Some private insurers do include some prescription obesity drugs in the list of medicines they'll cover; it's too early to tell whether Wegovy will make those lists. Many doctors and patients are optimistic, because it is a higher dose of an existing diabetes medication called Ozempic, which insurers often cover.
A few select state Medicaid programs will cover medications that treat obesity in some circumstances. But, significantly, Medicare does not cover obesity drugs — and many private insurers typically follow Medicare's lead.
Yet the demand for a good treatment is there, says Dr. Fatima Cody Stanford, a leading obesity researcher at Harvard. She was not involved in conducting the Wegovy clinical trial but closely followed it. "I'm excited about it," she says, because of the dramatic weight loss.
The drug acts on the brain so people eat less and store less of what they eat. That helps address the excess weight as well as helping with related diseases of the liver or heart, for example.
Why the FDA has been slow to approve obesity treatments
There is a long history of drugs that have looked like promising treatments for obesity then failed. Decades ago, amphetamines were prescribed until their addictive properties became apparent. In the 1990s, the combination of fenfluramine and phentermine — administered as the diet drugfen-phen — was heavily marketed, only later to be pulled from the market for causing heart valve problems.
Those experiences and others have made physicians skeptical.
"In obesity medicine field, we've learned to be cautiously optimistic each time we have a new medication that looks promising," says Dr. Ihuoma Eneli, director of the Center for Healthy Weight and Nutrition at Nationwide Children's Hospital in Columbus, Ohio, who was not involved in the study of Wegovy.
So far, Eneli does not see any obvious concerns with the class of drugs that includes Wegovy, and she calls the results so far "very promising." Wegovy is similar to another drug made by Novo Nordisk — Saxenda — which has been on the market since 2014, and which Eneli occasionally prescribes to her pediatric patients who are struggling with obesity.
In clinical research studies, the primary side effects reported after taking Wegovy affected the digestive system: nausea, diarrhea, vomiting, constipation, abdominal pain or intestinal infections.
Eneli says such side effects and their frequency are milder than the problems that have arisen in the past. That good safety profile may mean the drug is "less likely to come up with unanticipated risks," she says.
But the new drug will be of little use, she and other doctors who treat obesity say, if it's not also affordable for patients.
"Before I even bring up that drug with my patients, I'm looking to see which insurance they are having on the left side of my screen — because that will determine whether I bring it up," says Stanford, the Harvard physician. "If it's out of reach, like I said, I won't bring it up."
Stanford says her patients on existing obesity medications do extraordinary things to keep their coverage so they can afford to stay on the drugs.
"Several nurses here at the hospital that are my patients stayed working — they were supposed to retire — so they could stay on their injectable medication," Stanford says, "because that's how beneficial it was to them."
Why some are willing to pay out of pocket
Some people, such as David Scheesley, 42, says he would consider paying for Wegovy, even if he had to pay the full sticker price. The Hanford, Calif., correctional officer has tried since 2019 to lose weight on various diets — low-fat, all-meat, all-vegetable — without success. His weight has led to other health concerns — with his blood fats and his heart — which makes Scheesley think of his 5-year-old son.
"I want to see him for a lot of years; I don't want to have a stroke," he says. "I don't want to have diabetes. I want to be there for him. So, for me personally, that [monetary cost] is not astronomical if it can give me some more time."
Novo Nordisk, the company that makes Wegovy, is in talks with insurers and acknowledges that ensuring health insurance coverage of its drug is critical. The challenge, says Douglas Langa, executive vice president of Novo Nordisk North America, is getting doctors, patients and politicians to recognize obesity as a disease — and that therefore insurance should cover the cost of medicine to treat it.
"There's a medical component to [obesity] that needs to be recognized; this is a disease state like we should be treating any other disease state," Langa says. He says about 40% of private insurers cover Saxenda, the similar weight-loss medication the company makes.
Langa tells insurance companies this, making the case for why prescriptions for Wegovy should be covered. His company also is heavily lobbying Congress to pass legislation to allow Medicare to cover obesity medications. It makes sense from a financial perspective, he argues, because obesity is the root disease underlying so many other diseases.
"We do believe insurers understand that [untreated obesity] is a gateway into 60 other health conditions," Langa says. The need is hard to ignore, he adds. More than 100 million people in the U.S. alone struggle with obesity.
Copyright 2021 NPR. To see more, visit https://www.npr.org.