New weight-loss drugs out of reach for millions in the US

New medications to treat obesity show promising results in helping some people lose pounds, but they will remain out of reach for millions of older Americans because Medicare is prohibited from covering such drugs.

Drug companies and a broad and growing bipartisan coalition of lawmakers are preparing to push for that to change this year.

As obesity rates rise among older adults, some lawmakers say USA can’t afford to maintain a decades-old law that prohibits Medicare from paying for new weight-loss drugs, including Wegovy and Zepbound. But research shows that the initial price of covering those drugs is so high that it could wipe out Medicare’s already shaky bank account.

Here’s a look at the debate over whether—and how—Medicare should cover drugs to treat overweight and obesity:

The U.S. Food and Drug Administration (FDA) has approved a new class of weekly injectables in recent years—Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound—to treat obesity.

People can lose between 15% and 25% of their body weight with these medications, which mimic hormones that regulate appetite by communicating satiety between the gut and the brain when people eat.

The cost of drugs, beloved by celebrities, has largely limited them to the wealthy. A monthly supply of Wegovy costs $1,300, and Zepbound costs $1,000. Drug shortages have also limited supply. Private insurers often do not cover medications or place strict restrictions on who can access them.

Last month, a large, international study found a 20% reduction in the risk of serious heart problems, such as heart attacks, in patients taking Wegovy. WHY DOES MEDICARE NOT COVER MEDICATIONS?

Long before Oprah Winfrey and TikTok influencers gushed about the benefits of these weight-loss drugs, Congress made a rule: Medicare Part D—the health insurance plan for older Americans to get drugs that require a prescription—could not cover medications used to help gain or lose weight. Medicare covers obesity screening and behavioral treatment if a person has a body mass index (BMI) greater than 30. People with a BMI greater than 30 are considered obese.

The rule was passed by Congress in 2003 as part of a package of initiatives that overhauled Medicare prescription drug benefits.

Lawmakers opposed paying high costs for drugs to treat a condition that was historically considered cosmetic. The safety issues that arose in the 1990s with the obesity treatment known as fen-phen, which had to be withdrawn from the market, were also a near memory.

Medicaid, the state-federal program for low-income people, covers medications in some areas, but access is fragmented.

THE CONVERSATION IS CHANGING

New studies show that medications do more than help patients lose weight.

Republican Rep. Brad Wenstrup of Ohio introduced a bill this year with Democratic Rep. Raúl Ruiz of California that would allow Medicare to cover obesity medications, therapies, nutritionists and dieticians that it currently cannot.

“For years there was a stigma against these people, then there was a stigma about talking about obesity,” Wenstrup said in an interview with The Associated Press. “We are now at a point where we say this is a health problem and we have to address it.”

Wenstrup believes the intervention could alleviate all sorts of ills associated with obesity that cost the system money.

“The problem is very prevalent,” he added. “People are starting to realize that you have to take into account the savings that come with better health.”

Last year, about 40% of the nearly 66 million people enrolled in Medicare were obese. That’s basically the same proportion as in the general U.S. population, where 42% of adults are obese, according to the Centers for Disease Control and Prevention.

Notably, Medicare covers certain surgical procedures to treat the medical complications of obesity in people with a BMI of 35 and at least one related disease. Congress approved the exception in 2006, said Mark McClellan, former director of the Centers for Medicare and Medicaid Services and the FDA.

The law, which dates back 17 years, can provide a model for expanding coverage to new drugs — the results of which are similar to those of bariatric surgery in some cases — McClellan said. Evidence showed that surgery reduced the risks of death and serious illness from obesity-related conditions.

“And that’s been the basis of the coverage this whole time,” McClellan added.

THE COST IS NOW THE PROBLEM

Still, the initial price tag for changing the norm is still a challenge.

Some research shows that offering weight-loss drugs would ensure the imminent bankruptcy of Medicare. A Vanderbilt University analysis from March 2023 estimated an annual price tag of about $26 billion for anti-obesity drugs for Medicare if they were prescribed to 10% of the system’s enrollees.

However, other research shows that it could also save the government billions—and even trillions—over many years by reducing some of the chronic diseases and problems that result from obesity.

An early 2023 analysis by the University of Southern California’s Schaeffer Center estimated the government could save up to $245 billion over a decade, with most of the savings coming from reducing hospitalizations and other medical services.

“What we did was look at the long-term health consequences of treating obesity in the Medicare population,” said study co-author Darius Lakdawalla, research director at the center. The Schaeffer Center receives funding from pharmaceutical companies, including Eli Lilly.

Lakdawalla said it’s almost impossible to put a cost on drug coverage because no one knows how many people will end up taking them or what the price of the drugs will be.

The Congressional Budget Office (or CBO), charged with evaluating legislative proposals, acknowledged this difficulty in a blog in October, and the director called for further investigation into the issue.

Overall, the agency “expects the net cost of drugs to the Medicare program to be significant over the next 10 years.”

Cost is the biggest obstacle to gaining support for the bill, Ruiz said.

“When we talk about the initial cost, I often have to inform members that the CBO does not take savings into account in its cost-benefit analysis,” Ruiz told the AP. “Taking that number in isolation, you don’t get the full picture of the total economics of reducing obesity and all its comorbidities in our patients.”

WHO WANTS MEDICARE TO COVER THEIR MEDICATIONS?

Doctors say weight-loss drugs are only part of the most effective strategies for treating an obese patient.

When Dr. Andrew Kraftson develops a plan with his patients in the Weight Navigator program at the University of Michigan, it involves a “perfect mix” of behavioral intervention, health and diet education, and possibly anti-inflammatory drugs. obesity.

But with Medicare patients, you are limited in what you can prescribe.

“A blanket ban on the use of anti-obesity medications is an outdated way of thinking and fails to recognize obesity as a disease, and is perpetuating health disparities,” Kraftson said. “I’m not so ignorant as to think that Medicare should just start covering expensive treatments for everyone. But there is something between everything and nothing.”

Over the past decade, lawmakers have made some changes to the law that would allow Medicare to cover weight-loss drugs. But this year’s bill has drawn the interest of more than 60 lawmakers, from Arizona Republican Rep. David Schweikert, a self-proclaimed budget hardliner, to progressive Rep. Judy Chu of California.

Passage is a priority for two lawmakers, Wenstrup and Sen. Tom Carper of Delaware, before they retire next year.

Pharmaceutical companies are also bracing for intense lobbying this year as the drugs win FDA approval for use in weight loss.

“Americans should have access to the medications their doctors think they should take,” Stephen Ubl, president of the pharmaceutical research and manufacturers of America lobbying group, said in a call with reporters last month. past. “We ask that Medicare cover these medications.”

Novo Nordisk has already employed eight different companies and spent nearly $20 million lobbying the federal government on various issues, including the Treat and Reduce Obesity Act, since 2020, briefing documents show. Eli Lilly has spent approximately $2.4 million on lobbying since 2021.

Advocates from groups like The Obesity Society, dedicated to the study and treatment of obesity, have pushed for years to have Medicare cover the drugs. But momentum may be shifting thanks to growing evidence that drugs to treat obesity can prevent strokes, heart attacks and even death, said Ted Kyle, a policy adviser.

“The conversation has shifted from debating whether obesity treatment is worth it to figuring out how to make it work economically,” he added. “This is why I now believe that change is inevitable.”

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Associated Press writers JoNel Aleccia in Temecula, California, and Brian Slodysko contributed to this report.