Demand for GLP-1s and other weight loss drugs has yet to subside, and a new study aims to establish an ethical framework that can be used to ensure the patients who need these therapies can access them amid shortages.
Several countries, including Belgium and Great Britain, have taken steps to ban or discourage the use of these products for weight loss and instead prioritize their distribution to patients with diabetes. Neither the federal government in the U.S. nor individual states have made similar moves, though individual health plans and Medicare have restricted use of these products.
One of the goals of the study, which was published in The New England Journal of Medicine in mid-April, is to establish a clear path that stakeholders can follow around these drugs, said Ezekiel Emanuel, M.D., Ph.D., one of the study's authors and a world-renowned health policy expert who is now a professor at the University of Pennsylvania.
The researchers also found that focusing solely on patients who have diabetes may not be the most ethical or effective way to distribute these drugs.
"Our policy should follow the ethics in this case, and they're not consistent with them," he told Fierce Healthcare.
The study is built on four "fundamental ethical values" that inform the model: preventing or reducing harm; offering equal moral concern; prioritizing disadvantaged groups; and rewarding social contributions.
With those principles as the foundation, the researchers established four tiers based on need for a fair allocation of these products. In the first tier, or the top priority group, are people with class three obesity, or a body mass index of at least 40, as well as people with severe Type 2 diabetes that has not responded to other treatments.
By prioritizing this population first, clinical teams can reach the patients at the highest risk for premature death or other severe complications.
In the second tier are obese patients with a BMI of between 35 and 39.9 as well as patients with Type 2 diabetes that is more controlled than in the top priority population. Reaching this population can address key medical complications they may imminently face, such as cardiovascular events.
In the third tier are patients with class one obesity, or a BMI between 30 and 34.9 as well as people with less severe Type 2 diabetes that has not responded to other treatments. Similar to tier two, the priority here is to prevent potential complications that could arise in the future.
In the lowest tier is patients who are overweight, with a BMI between 25 and 29.9, and diabetic patients who don't qualify in the other groups. They'll see the benefits of accessing these drugs by improvements in quality of life and social and emotional health, according to the study.
Within each tier, the study recommends giving priority to younger patients, as it focuses on avoiding unnecessary loss of life or years of life.
Emanuel said the study team initially expected to prioritize diabetes care, as many public and private insurers in the U.S. have. However, as they gathered the data, it became clear that obesity is the source of many health problems that aren't limited to diabetes, so reaching severely obese patients is crucial.
He said that obesity is often viewed as a personal failing, which can lead to stigma against people who are struggling with their weight.
"We're more prejudiced, I think, against patients who are obese than patients who have diabetes," Emanuel said. "And I think that's clearly wrong."
Policymakers in a number of countries are looking at different solutions to the access question around GLP-1s and other weight loss drugs, but, given the fragmentation in U.S. healthcare, a broad policy will prove difficult to settle on. Physicians in the U.S. can adopt the principles of fair allocation even absent a national framework, the researchers said.
"This framework could guide physicians and professional societies aspiring to ethical prescribing of GLP-1 receptor agonists and dual GLP-1–GIP receptor agonists," they wrote.