An Eli Lilly drug if approved for weightloss could become the best-selling drug of all time, but concerns are growing over who will actually be able to afford it.
Experts are confident that the drug, called tirzepatide, will be approved by the Food and Drug Administration sometime next year. If so, it would join two other popular and expensive weight loss drugs recently approved on the market, Wegovy and Saxenda, both from drugmaker Novo Nordisk.
Annual sales of tirzepatide could reach a record $48 billion, according to an estimate by Bank of America analyst Geoff Meacham. Another Wall Street analyst, Colin Bristow of UBS, estimated that the drug would reach $25 billion in annual sales – a figure that would still surpass the record of $20.7 billion set by the rheumatoid arthritis drug. ‘AbbVie Humira in 2021.
Kelly Smith, spokeswoman for Eli Lilly, declined to comment on the price of tirzepatide. Outside experts said it’s possible the drugmaker could price it similar to Wegovy, which offers a list price of around $1,500 for a month’s supply, and Saxenda, which costs about $1,350 for a month’s supply.
If the FDA confirms the drug’s effectiveness, a “fair” price for tirzepatide could be around $13,000 per year, or about $1,100 per month, said Dr. David Rind, chief medical officer of the Institute for Clinical and Economic Review, a research group that helps determine fair prices for drugs.
Clinical trials have shown the drugs to be very effective in losing weight. The three drugs – which are given by injection – work in the same way: they are a class of drugs called GLP-1 agonists, which mimic a hormone that helps reduce food intake and appetite.
However, Eli Lilly’s tirzepatide also mimics a second hormone, called GIP, which, in addition to reducing appetite, may also improve the way the body breaks down sugar and fat.
A phase 3 clinical trial found that a high dose of tirzepatide helped patients lose an average of 22.5% of their body weight, or about 52 pounds, better than any drug currently on the market. More trial patients had a body mass index, or BMI, of 30 or more. In trials, Wegovy and Saxenda reduced body weight by about 15% and about 5%respectively.
Are weight loss medications covered by insurance?
At lower doses, all three drugs are already approved to treat diabetes.
- Tirzepatide is sold as Mounjaro for diabetes.
- Semaglutide, when marketed for weight loss, is sold in a higher dose and called Wegovy; at a lower dose it is marketed for diabetes and sold as Ozempic.
- Similarly, a higher dose of the drug liraglutide is sold as Saxenda for weight loss, and at a lower dose it is sold as Victoza, for diabetes.
With the exception of Mounjaro, which was approved earlier this year, versions of the drugs used to treat diabetes are covered by most insurance.
This is not always the case when prescribed for obesity.
Obesity carries a unique stigma, said Dr. W. Scott Butsch, director of obesity medicine at the Cleveland Clinic’s Bariatric and Metabolic Institute. Many doctors, he said, still see it as a behavioral issue rather than a medical issue.
This belief — along with the fact that older anti-obesity drugs aren’t very effective — has made insurers reluctant to cover many of the newer therapies, he said.
“You have a bias,” Butsch said, adding that insurance companies ask for more evidence of the benefits of anti-obesity drugs than they normally would for other types of drugs.
Some insurers can select one of the weight-loss drugs and offer coverage, he said, but they often restrict access only to patients who meet a certain threshold, such as a BMI over 30.
Also, Butsch said, not everyone reacts the same way to a given weight-loss drug. If the insurance-covered drug isn’t effective for that patient, there are usually no other drug options left, he said.
Dr. Holly Lofton, director of the weight management program at NYU Langone Health, regularly prescribes the new drugs to her patients, but many, she says, are denied coverage by their insurance. “Patients tell me that it feels like insurance companies want to wait until they get so sick they need more medication,” she said.
Lofton said some of his patients will end up spending thousands of dollars out of pocket on medication for a few months as they negotiate with their insurer for coverage. Patients are generally not reimbursed by their insurance plan for the money they have already spent on drugs, she added.
Dr. Fatima Stanford, an obesity medicine specialist and director of equity for the endocrine division of Massachusetts General Hospital in Boston, said private insurance coverage for anti-obesity drugs is patchy, with treatments often being limited to the most expensive plans.
Medicare does not cover them. Anti-obesity drugs are not a mandatory Medicaid benefit, although some states have chosen to include them, she said.
Obesity is considered a chronic disease, and like any other chronic disease, most patients have to take the drugs for life — a heavy financial burden if they have to pay out of pocket, Stanford said.
The only people who are likely to be able to afford a drug like tirzepatide themselves, she said, will be the “very rich.”
Despite access barriers, the UBS Bristow analyst said he still expects tirzepatide to be a blockbuster obesity drug, noting that the United States is already experiencing supply shortages for medicine like a diabetes injection.
“It’s pretty clear how strong the demand is,” he said.
What must change?
Lofton, of NYU Langone Health, said insurance coverage for obesity drugs may not improve until more people in the medical field change their view of obesity. It’s not something that diet, exercise or sheer willpower can fix — it’s more of a dysregulation of fat cells in the body, she said.
Prejudices and stigma related to obesity are rampant throughout the medical community.
It’s “evident in all healthcare professionals, including doctors, nurses, dietitians and others,” said Lisa Howley, an educational psychologist and the Association’s senior director of strategic initiatives and partnerships. of American Medical Colleges.
A review published last year in the research journal Obesity found that healthcare professionals have implicit and/or explicit weight-related attitudes towards obese people.
But changing the opinion of the medical community – and with it, insurance companies – is extremely difficult. Requiring that anti-obesity drugs be covered by insurance may require legislative action, Stanford said.
In 2021, House of Representatives lawmakers introduced The Obesity Treatment and Reduction Act, which would have allowed the federal government to expand Medicare Part D coverage to include anti-obesity drugs. The legislation had 154 bipartisan co-sponsors, according to Congress.govbut did not receive a vote in the House before the end of the term.
America’s Health Insurance Plans, or AHIP, a trade group that represents insurance companies, declined to say whether it would support coverage of tirzepatide if the drug gains FDA approval next year or other drugs anti-obesity.
“Health insurance providers regularly review the evidence for drugs and surgical treatments for obesity, and they offer many options to patients – ranging from lifestyle changes and nutritional counseling to surgical procedures and medications. prescription,” said AHIP spokesman David Allen.
Butsch of the Cleveland Clinic said he hopes insurance companies will cover tirzepatide.
“We’re really seeing very effective anti-obesity drugs for the first time,” he said. “The benefit is real.”