Jan. 5, 2024 — Eli Lilly, maker of the anti-obesity drug Zepbound, announced this week the launch of LillyDirect, a direct-to-patient portal, allowing some patients to obtain its drug for as little as $25 a month.
The move is seen as a major shift in the way these popular medications can reach patients.
For many of the 42 million Americans with obesity, weight loss medications such as Wegovy, Saxenda, and the brand-new Zepbound can be a godsend, helping them lose the excess pounds they've struggled with for decades or a lifetime.
But getting these medications has been a struggle for many who are eligible. Shortages of the drugs have been one barrier, and costs of up to $1,300 monthly – the price tag without insurance coverage – are another hurdle.
But 2024 may be a much brighter year, thanks to Lilly's new portal as well as other developments:
- Insurance coverage on private health plans, while still spotty, may be improving. Federal legislators are fighting a 2003 law that forbids Medicare from paying for the medications when prescribed for obesity.
- New research found that semaglutide (Wegovy) can reduce the risk of recurrent strokes and heart attacks as well as deaths from cardiovascular events in those with obesity and preexisting cardiovascular disease (or diseases of the heart and blood vessels), a finding experts said should get the attention of health insurers.
The medications, also referred to as GLP-1 agonists, work by activating the receptors of hormones (called glucagon-like peptide 1 and others) that are naturally released after eating. That, in turn, makes you feel more full, leading to weight loss of up to 22% for some. The medications are approved for those with a body mass index (BMI) of 30 or a BMI of 27 with at least one other weight-related health condition such as high blood pressure or high cholesterol. The medicines, injected weekly or more often, are prescribed along with advice about a reduced-calorie diet and increased physical activity.
LillyDirect
Eli Lilly launched its direct-to-patient portal on Thursday, providing its obesity medicine (as well as diabetes and migraine drugs) direct to the consumer. Patients can access the obesity medicines through the telehealth platform FORM. Patients reach independent telehealth providers, according to Lilly, who can complement a patient's current doctor or be an alternative to in-patient care in some cases.
Eli Lilly officials did not respond to requests for comment.
Some obesity experts welcomed the new service. "Any program that improves availability and affordability of these ground-breaking medications is welcome news for our long-suffering patients," said Louis Aronne, MD, director of the Comprehensive Weight Control Center at Weill Cornell Medicine in New York City, a long-time obesity researcher.
"It's a great move for Lilly to do," agreed Caroline Apovian, MD, a professor of medicine at Harvard Medical School and co-director of the Center for Weight Management and Wellness at Brigham & Women's Hospital in Boston, who is also a veteran obesity specialist. "It is trying to help the accessibility issue and do it responsibly."
"The bottom line is, there is an overwhelming amount of consumer need and desire for these medications and not enough channels [to provide them]," said Zeev Neuwirth, MD, a former executive at Atrium Health who writes about health care trends. "Eli Lilly is responding to a market need that is out there and quite honestly continuing to grow."
There are still concerns and questions, Neuwirth said, "especially since this is to my knowledge the first of its kind in terms of a pharmaceutical manufacturer directly dispensing medication in this nontraditional way."
He called for transparency between telehealth providers and the pharmaceutical company to rule out any conflicts of interest.
The American College of Physicians, an organization of internal medicine doctors and others, issued a statement expressing concern. Omar T. Atiq, MD, group's president, said his organization is "concerned by the development of websites that enable patients to order prescription medications directly from the drugmakers. While information on in-person care is available, this direct-to-consumer approach is primarily oriented around the use of telehealth services to prescribe a drug maker's products."
The group urged that an established patient-doctor relationship be present, or that care should happen in consultation with a doctor who does have an established relationship (the latter an option offered by Lilly). "These direct-to-consumer services have the potential to leave patients confused and misinformed about medications."
Heart Attack, Stroke Reduction Benefits
Previous research has found that the GLP-1 medicines such as Ozempic (semaglutide), which the FDA approved to treat diabetes, also reduce the risk of cardiovascular issues such as strokes and heart attacks. Now, new research finds that semaglutide at the Wegovy dose (usually slightly higher than the Ozempic dose for diabetes) also has those benefits in those who don't have a diabetes diagnosis but do have obesity and cardiovascular disease.
In a clinical trial sponsored by Novo Nordisk, the maker of Wegovy, half of more than 17,000 people with obesity were given semaglutide (Wegovy); the other half got a placebo. Compared to those on the placebo, those who took the Wegovy had a 20% reduction in strokes, heart attacks, and deaths from cardiovascular causes over a 33-month period.
The study results are a "big deal," Aronne said. The results make it clear that those with obesity but not diabetes will get the cardiovascular benefits from the treatment as well. While more analysis is necessary, he said the important point is that the study showed that reducing body weight is linked to improvement in critical health outcomes.
As the research evolves, he said, it's going to be difficult for insurers to deny medications in the face of those findings, which promise reductions in long-term health care costs.
Insurance Coverage
In November, the American Medical Association voted to adopt a policy to urge insurance coverage for evidence-based treatment for obesity, including the new obesity medications.
"No single organization is going to be able to convince insurers and employers to cover this," Aronne said. "But I think a prominent organization like the AMA adding their voice to the rising chorus is going to help."
Coverage of GLP-1 medications could nearly double in 2024, according to a survey of 500 human resources decision-makers released in October by Accolade, a personalized health care advocacy and delivery company. While 25% of respondents said they currently offered coverage when the survey was done in August and September, 43% said they intend to offer coverage in 2024.
In an email, David Allen, a spokesperson for America's Health Insurance Plans, a health care industry association, said: "Every American deserves affordable coverage and high-quality care, and that includes coverage and care for evidence-based obesity treatments and therapies."
He said "clinical leaders and other experts at health insurance providers routinely review the evidence for all types of treatments, including treatments for obesity, and offer multiple options to patients – ranging from lifestyle changes and nutrition counseling, to surgical interventions, to prescription drugs."
Allen said the evidence that obesity drugs help with weight loss "is still evolving."
"And some patients are experiencing bad effects related to these drugs such as vomiting and nausea, for example, and the likelihood of gaining the weight back when discontinuing the drugs," he said.
Others are fighting for Medicare coverage, while some experts contend the costs of that coverage would be overwhelming. A bipartisan bill, the Treat and Reduce Obesity Act of 2023, would allow coverage under Medicare's prescription drug benefit for drugs used for the treatment of obesity or for weigh loss management for people who are overweight. Some say it's an uphill climb, citing a Vanderbilt University analysis that found giving just 10% of Medicare-eligible patients the drugs would cost $13.6 billion to more than $26 billion.
However, a white paper from the University of Southern California concluded that the value to society of covering the drugs for Medicare recipients would equal nearly $1 trillion over 10 years, citing savings in hospitalizations and other health care costs.
Comprehensive insurance coverage is needed, Apovian said. Private insurance plans, Medicare, and Medicaid must all realize the importance of covering what has been now shown to be life-saving drugs, she said.
Broader coverage might also reduce the number of patients getting obesity drugs from unreliable sources, in an effort to save money, and having adverse effects. The FDA warned against counterfeit semaglutide in December.
Long-Term Picture
Research suggests the obesity medications must be taken continuously, at least for most people, to maintain the weight loss. In a study of patients on Zepbound, Aronne and colleagues found that withdrawing the medication led people to regain weight, while continuing it led to maintaining and even increasing the initial weight loss. While some may be able to use the medications only from time to time, "the majority will have to take these on a chronic basis," Aronne said.
Obesity, like high blood pressure and other chronic conditions, needs continuous treatment, Apovian said. No one would suggest withdrawing blood pressure medications that stabilize blood pressure; the same should be true for the obesity drugs, she said.
Apovian consults for FORM, the telehealth platform Lilly uses for LillyDirect, and consults for Novo Nordisk, which makes Saxenda and Wegovy. Aronne is a consultant and investigator for Novo Nordisk, Eli Lilly, and other companies.
Sources:
CDC: "Adult Obesity Facts."
Louis Aronne, MD, director, Comprehensive Weight Control Center, Weill Cornell Medicine, New York City.
Caroline Apovian, MD, professor of medicine, Harvard Medical School; co-director, Center for Weight Management and Wellness, Brigham & Women's Hospital, Boston.
Zeev Neuwirth, MD, former executive, Atrium Health.
David Allen, spokesperson, America's Health Insurance Plans, Washington, DC.
Eli Lilly: "Lilly Launches End-to-End Digital Healthcare Experience through LillyDirect."
Statement, American College of Physicians.
Accolade: "GLP-1 Coverage in Employer Plans Could Nearly Double in 2024."
FDA: "FDA Approves New Medication for Chronic Weight Management."
American Medical Association: "AMA urges insurance coverage parity for emerging obesity treatment options."
Milliman: "Payer strategies for GLP-1 medications for weight loss."
Congress.Gov: "Treat and Reduce Obesity Act of 2023."
The New England Journal of Medicine: "Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT trial)," "Perspective: Medicare Part D Coverage of Antiobesity Medications – Challenges and Uncertainty Ahead."
The Journal of the American Medical Association: "Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults with Obesity: The SURMOUNT-4 Randomized Clinical Trial."
White paper, University of Southern California: "Benefits of Medicare Coverage for Weight Loss Drugs."
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