“There’s no way patients can afford it.” Why aren’t new drugs that can help you lose weight more widely used?
A decades-old law prevents 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.
A pair of new drugs offer something many Americans desperately want: a way to lose weight.
In clinical trials, Wegovy by Novo Nordisk helped adults lose approximately 15% of their body weight. The drug, which received US Food and Drug Administration approval last year, had such a successful launch that it is now sold out. Eli Lilly’s tirzepatide (LLY), meanwhile, is still in clinical trials, but data from a phase 3 trial showed people taking the drug lost up to 22% of their weight. bodily.
For the approximately 42% of obese Americans, these results are nothing short of a miracle.
Wall Street is elated, predicting a global market for drugs reaching $54 billion by 2030. And doctors believe they finally have a new treatment option for their patients. “I was prescribing Wegovy almost as fast as I could,” said Elizabeth Fryoux, a physician who practices obesity medicine at the University of Mississippi Medical Center.
And there’s more research to come: Lilly and Novo are also conducting studies to see if the same drugs can reduce the risk of death or improve outcomes for conditions like high blood pressure and stroke that often range from paired with obesity.
But there are barriers to getting these therapies to patients who need them. Late last year, Wegovy ran into supply problems caused by a combination of high demand and production issues involving the syringes used in the pens that inject the drug. The problems should be resolved before the end of the year. The stigma surrounding obesity, meanwhile, can discourage insurers and policymakers from covering these drugs.
Drugs developed by Novo and Lilly to treat obesity have both been approved, in different formulations, to treat type 2 diabetes. in May – are covered by Medicare, the federal health insurance program for the elderly and disabled. Medicare does not cover Wegovy or other FDA-approved weight management therapies, including Vivus’ Qsymia.
“If we have a drug which is Wegovy which is for weight loss, and it’s not covered, but we have a drug which is Ozempic, and it’s for diabetes, the exact same drug is covered,” said Holly Lofton, a physician who works in obesity medicine at NYU Langone Health in New York. “There is no drug problem. There is a ‘we don’t want to treat this patient’ problem. It comes from stigma or discrimination or lack of knowledge about obesity as a condition. ”
A decades-old law prohibits Medicare from covering prescription drugs to treat weight gain or loss. That means the roughly 49 million people in the United States who get their prescription drug coverage from Medicare would have to spend more than $1,300 a month on a Wegovy prescription, putting access out of reach for many. Even for people with private health insurance, these drugs may not be covered. Less than 10% of people have commercial health insurance that covers weight management therapies like Wegovy.
But an aggressive lobbying push in Washington and quiet support in different parts of the Biden administration indicate the longstanding rule is being reconsidered. In June, the House Appropriations Committee described Medicare coverage for obesity drugs as a “health equity issue.” The Office of Personnel Management, the federal government’s human resources department, reiterated this year that obesity drugs cannot be excluded from insurance plans for federal workers. “The bottom line is that we are following the science, and in this case the science is telling us that we should be recommending the use of anti-obesity drugs more strongly than we have been doing before,” a spokesperson for the agency said. ‘OPM at MarketWatch.
This line of thinking suggests that “additional federal coverage may not be far behind,” said UBS analyst Colin Bristow.
Ted Kyle runs ConscienHealth, an obesity advocacy organization. “That momentum comes from people having a better understanding of what we’re dealing with,” he said. “Ten years ago, policy makers would come out and say, ‘Fat people need to eat less and move more.'”
A vanity drug or an outdated policy?
Until recently, the medical community often attributed obesity to a lack of willpower or a mismatch between calories consumed and calories burned. The American Medical Association now considers obesity a disease, and doctors describe patients as overweight or obese, not overweight and obese, and refer to weight management, not loss weight.
But this shift in mindset is still relatively new — the American Board of Obesity Medicine, which certifies doctors who work in this field, was established in 2011 — and challenges remain. An article published last spring in The New York Times reported that a health insurer had refused to cover Wegovy for a patient on the grounds that it was a “vanity drug”.
“It’s so stigmatizing,” said Diana Thiara, medical director of the weight management program at the University of California, San Francisco.
Medicare’s ban on coverage for weight-loss drugs, which was part of the implementation of the Medicare Part D program in 2003, likely stems from this same stigma. This also followed the fenfluramine phentermine (“fen-phen”) crisis of the late 1990s, in which the stimulants fenfluramine and dexfenfluramine, prescribed for short-term use for weight loss, were withdrawn from the market when it was discovered that they could cause heart problems. -damage to the valves which, in some cases, has resulted in death.
Newer weight management drugs — as well as therapies like Currax Pharmaceuticals’ Contrave, which was approved about a decade ago — aren’t stimulants. (However, Qsymia, approved in 2012, includes the stimulant phentermine.) Wegovy, which is the first new weight management drug to be approved since 2014, is a glucagon-like peptide-1 (GLP-) agonist. 1), while Tirzepatide is a GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 receptor agonist. Combined with physical activity and calorie reduction, they help slow digestion and increase insulin release so patients end up feeling full faster and for longer.
“These are now very physiological,” Lofton said. “Most of them [are] hormones that we give people to adjust their 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 fixes to drug prohibition have been proposed, including the Obesity Treatment and Reduction Act, which has been introduced several times over the past decade, the most recent in March 2021. Both Lilly and Novo are pushing to change Medicare. language, and doctors, including NYU’s Lofton, have also called on lawmakers to do so.
So far, these efforts have not been successful.
“Medicare is behind the times and is hampered by its own outdated policies,” said Dorothea Vafiadis, director of the National Council on Aging’s Center for Healthy Aging. “If you look at CMS’s stated commitment, they are designed to close gaps in health care access, quality and outcomes for underserved populations. And it really goes against that. commitment.”
The National Council on Aging, as well as obesity advocacy organizations such as the Obesity Action Coalition, receive funding from pharmaceutical companies that market or develop weight management therapies. Just like Kyle and Lofton, among other doctors and advocates. These financial relationships, while common in American medicine and public policy, also underscore the billions of dollars in sales that could be at stake for Lilly and Novo.
A $54 billion market
Companies are racing not only to develop the most effective weight management drug, but also to bring to market the one that can best improve outcomes for obese patients beyond weight loss.
Novo expects to have the first batch of data from its Phase 3 clinical trial – which will show whether Wegovy can reduce the risk of heart disease and stroke – by mid-2023, according to a spokesperson. . (The company also makes Saxenda, an ancient weight management drug that has been shown to reduce body weight by around 5%). -the management therapy for obese adults and overweight adults with comorbidities, also plans to launch a phase 3 trial later this year to assess whether its drug can reduce morbidity and mortality.
If either study shows positive results, it could change the conversation with insurers and employers, as the value of an individual patient taking one of these drugs will then double. Not only will patients lose weight, but their comorbidities could improve, possibly avoiding expensive medical care.
Morgan Stanley predicts an obesity drug market to reach $54 billion by 2030. UBS predicts $25 billion in peak sales for tirzepatide, which would make it “one of the best-selling drugs in the world.” history,” according to analysts at the bank. SVB Securities places the maximum sales expectations for tirzepatide, taking into account its potential use for both diabetes and obesity, a little lower, at around $21 billion. For context, Humira, AbbVie’s rheumatoid arthritis drug, is the world’s top-selling drug, generating $20.7 billion in annual sales in 2021.
“Historically, [insurance] payers viewed obesity drugs as they did Botox for wrinkles. They viewed it as something that was a cosmetic drug that shouldn’t be covered by insurance,” said David Risinger, an analyst at SVB. “You need to rethink coverage when there are drugs that provide transformational health benefits for a disease, even if it’s common.”
If so, think of these drugs less like Botox and more like a new knee.
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