Decades-old laws keep older people in the United States from trying new weight-management therapies like Wegovy, and drug companies are paying millions of dollars to try to change it.
Two new drugs offer what many Americans desperately want: a way to lose weight.
In clinical trials, Novo Nordisk’s WeGobee helped adults lose about 15% of their body weight. The drug, which received approval from the U.S. Food and Drug Administration last year, is now in short supply after its successful launch. Meanwhile, Eli Lilly’s (LLY’s) tirzepatide, which is still in clinical trials, showed that people taking the drug lost up to 22% of their weight, according to Phase 3 data.
For the approximately 42% of Americans who are obese, these results are nothing short of miraculous.
Wall Street is thrilled to predict that the drug’s global market will reach $54 billion by 2030. And doctors feel they finally have a new treatment option for their patients. “I was prescribing Wegovy as soon as I could,” said Elizabeth Frykes, a physician who practices obesity medicine at the University of Mississippi Medical Center.
Lilly and Novo are also working to find out if the same drug can reduce the risk of death or improve outcomes for conditions often associated with obesity, such as high blood pressure and stroke. .
But there are obstacles to getting these treatments to patients in need. Late last year, Wegovy faced supply problems due to a combination of high demand and production problems with the syringes used in its drug-injecting pens. This issue is expected to be resolved by the end of the year. Meanwhile, the stigma surrounding obesity may discourage insurance companies and policy makers from covering these drugs.
Drugs developed by Novo and Lilly to treat obesity are approved in different formulations for type 2 diabetes. Novo’s Ozempic and Lilly’s Mounjaro, which received FDA approval in May, are covered by Medicare, a federal health insurance program for the elderly and disabled. Medicare does not cover Wegovy or other FDA-approved weight management therapies, including Vivus’ Qsymia.
“There’s a drug called Wegovy for weight loss, and it’s not covered, but there’s a drug called Ozempic, and if it’s for diabetes, the exact same drug is covered,” says working doctor Holly. Lofton said he holds a doctorate in obesity medicine from NYU Langone Health in New York City. “There is no drug problem. There is the ‘I don’t want to treat this patient’ problem. It comes from stigma or discrimination or a lack of knowledge about obesity as a condition.”
A decades-old law prohibits Medicare from covering prescription drugs to treat weight gain or weight loss. will have to spend $1,300 or more per month on, making access much more difficult for many. These drugs may not be covered, even for people with private health insurance. Less than 10% of people have private health insurance that covers weight management therapies like Wegovy.
But aggressive lobbying in Washington and quiet support in various parts of the Biden administration indicate that longstanding rules are being reconsidered. described Medicare coverage as a “health equity issue.” The Federal Office of Human Resources, the Office of Human Resources, reiterated earlier this year that obesity drugs cannot be excluded from insurance plans for federal workers. I’m here.
UBS analyst Colin Bristow suggests such thinking “may not be far behind additional federal coverage.”
Ted Kyle runs the obesity advocacy group ConscienHealth. “That momentum comes from people having a better understanding of what we’re dealing with,” he said. I need to lose weight and exercise more.'”
Vanity drugs or outdated policies?
Until recently, the medical community often attributed obesity to a lack of willpower and a discrepancy in the amount of calories burned. The American Medical Association now considers obesity to be a disease, with doctors describing patients as overweight or obese rather than overweight and referring to weight management rather than weight loss.
But this shift in thinking is still relatively new, and the American College of Obesity Medicine, which certifies physicians working in the field, was established in 2011, and challenges remain. According to an article in the New York Times last spring, a health insurance company denied her Wegovy coverage to a patient because it was a “shower drug.”
“It feels very stigmatized,” said Diana Tiara, medical director of the weight management program at the University of California, San Francisco.
The Medicare ban on weight loss drug coverage that was part of the Medicare Part D program in 2003 probably stemmed from the same stigma. It also followed the fenfluramine phentermine (“phenphen”) crisis in the late 1990s, when the stimulants fenfluramine and dexfenfluramine were prescribed for short-term use for weight loss. , was withdrawn from the market when it was discovered that it could cause heart disease.
Much like treatments like Qsymia and Currax Pharmaceuticals’ Contrave, which were approved nearly a decade ago, modern weight control drugs are not stimulants. The first new weight management drugs approved since 2014, Tirzepatide and Wegovy, are known as glucagon-like peptide-1 (GLP-1) agonists. When combined with physical activity and calorie reduction, it slows digestion and increases insulin release, allowing patients to feel full faster and for longer.
“These are actually very physiological,” said Lofton. [are] The hormones we give people regulate gut and brain pathways to send different messages about hunger, satiety and the desire to eat.
Medicare pays for bariatric surgery and behavioral weight loss therapy. Over the years, legislative amendments to the drug ban have been proposed several times over the past decade, most recently the Obesity Treatment and Alleviation Act, which was introduced in March 2021. Language, and doctors, including her NYU Lofton, have also asked lawmakers to do so.
So far, these efforts have been unsuccessful.
“Medicare is outdated and hampered by its own outdated policies,” says Dorothea Bafiadis, director of the Center for Healthy Aging at the National Council on Aging. “If you look at the commitment CMS has expressed, it is designed to bridge the gaps in healthcare access, quality, and outcomes for underserved people. It’s a fly.”
The National Council on Aging, along with obesity advocacy groups such as the Obesity Action Coalition, are funded by pharmaceutical companies that market or develop weight management therapies. So do Kyle and Lofton, as well as other doctors and advocates. While these financial ties are commonplace in US healthcare and public policy, they also highlight that billions of dollars in sales could be at stake for Lilly and Novo.
$54 billion market
Companies are racing not only to develop the most effective weight management drugs, but to market the drugs that can best improve outcomes for obese patients beyond weight loss.
A spokesperson said Novo plans to have the first data from a Phase 3 clinical trial showing whether Wegovy can reduce the risk of heart disease and stroke by mid-2023. (The company also makes Saxenda, an older weight control drug that has been shown to reduce body weight by about 5%.) Lilly, which will soon file for FDA approval of tirzepatide as a weight control therapy, also has are planning A Phase 3 trial will be conducted later this year to evaluate whether the drug can reduce morbidity and mortality.
If any of the studies show positive results, it could change the conversation with insurance companies and employers. Because of these drugs he doubles the value of an individual patient taking one. Patients not only lose weight, but their comorbidities may improve, potentially avoiding high medical costs in the future.
Morgan Stanley projects the obesity drug market to reach $54 billion by 2030. UBS forecasts that peak sales of tirzepatide will hit $25 billion, making it “one of the best-selling drugs in history,” according to bank analysts. SVB Securities has slightly lower its peak sales projections for tirzepatide, at about $21 billion, given its potential use in both diabetes and obesity. For context, AbbVie’s rheumatoid arthritis drug Humira is the world’s best-selling drug, with annual sales of his $20.7 billion in 2021.
“Historically, [insurance] Payers saw obesity drugs as they did Botox for wrinkles. SVB analyst David Risinger said: If normal. ”
In that case, think of these drugs as your new knee, not Botox.
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