As GLP-1 Demand Goes Up, Access and Coverage Go Down

ORLANDO, Fla — Experts debating the pressing issue of how to prioritize patients in the increasingly common scenario of loss of access or insurance coverage for anti-obesity glucagon-like peptide 1 (GLP-1) receptor agonist drugs argued that comorbidities and obesity severity should strongly warrant continued coverage — while offering key strategies for getting and retaining approval from payers.

Paradoxically, “the demand for these drugs is growing just as the access and the coverage is going down,” emphasized Deborah Horn, DO, MPH, an associate professor and medical director at the University of Texas Health Science Center at Houston, who was among speakers in the lively session at the recent American Diabetes Association (ADA) 84th Scientific Sessions.

Underscoring the problem, Horn described a recent sobering notification to some patients in her system’s health plan, which announced that “once you achieve a body mass index (BMI) of 30, you will no longer be eligible to receive your GLP-1 medication for weight loss under your employee health plan.”

The critical problem with that kind of restriction is that consistent evidence shows that weight loss, as well as the array of additional cardio-metabolic benefits of the drugs, rapidly reverse upon discontinuation. Once patients reaching a BMI of 30 while on GLP-1s discontinue the medication, they typically regain some or not all the weight.

Similar caps and restrictive policies by health plans on GLP-1 coverage are being implemented around the United States, including at places like the Mayo Clinic — leaving clinicians and patients, scrambling for alternatives — a particularly frustrating yet remarkably unique situation, Horn added.

Arguing that patients who have succeeded on GLP-1 treatment should be prioritized for continued coverage, she noted that “we would not do this with other conditions like diabetes, for instance. We would not say ‘great job, your A1C is controlled, now you no longer get that medication that got you there.'”

With the added hurdle of GLP-1 drug shortages, “it should not be this hard for someone who’s succeeding on a medication to stay on their medication,” Horn said.

Focusing on Obesity Results in ‘Pushback’ — Focus on Cardiovascular Benefits Instead

Making the case for prioritizing patients with cardiovascular disease, Pam R. Taub, MD, a professor of medicine at the University of California San Diego School of Medicine, emphasized that the bottom line for insurers is ultimately to prevent the major cardiovascular events that add up to major costs.

“As a preventive cardiologist, I’m trying to prevent [events like] heart attack and stroke, and we need to understand that this is what payers are really concerned about,” Taub said.

Coverage should continue if those priorities are the focus, she asserted.

“By just focusing on obesity, we’re doing the field a disservice,” Taub said. “The argument we have to make is that it’s not about the weight loss — it’s about that sustained cardiovascular benefit of these drugs.”

She noted that in her practice, “I rarely write these drugs as a purely obesity indication — that’s when I get all the pushback from the payers.”

“I have a very high rate of approval because as a cardiologist, I’m writing for a type 2 diabetes indication,” Taub said.

Obesity and type 2 diabetes often encompass a range of cardiovascular comorbidities that should qualify many patients for approval of GLP-1 therapy, such as peripheral artery disease, which counts as atherosclerotic cardiovascular disease, she noted.

Likewise, elevated coronary calcium scores can be indicative of plaque and atherosclerotic cardiovascular disease, also leading to more likely payer approval for the patient, Taub said.

Ultimately, “we need to reframe our narrative,” she asserted. “Yes, obesity is important, and yes, we love it when our patients lose weight, but let’s focus on also just improving their overall cardio-metabolic health.”

But focusing on that, “payers will see that in the long run, these drugs are going to save them money, and they’re going to therefore give our patients access to these drugs.”

Prioritize Those With the Highest Risk Obesity

Arguing on the side of prioritizing patients with the highest risk obesity — class 3, with a BMI of 40 or higher — for GLP-1 treatment, Neda Rasouli, MD, professor at the University of Colorado School of Medicine, Aurora, Colorado, emphasized that those patients have a particularly high need for the therapy, with data on potential years of life lost with severe obesity compared with those of normal weight as much as 6-13 years, and even as much as a 17 years of life lost in men.

In context, the potential years of life lost among smokers vs nonsmokers are about 9, Rasouli said.

“So just think about all the resources and effort [put into] quitting smoking — that should be done with the same urgency for obesity,” she said.

Those with class 3 obesity also have been shown to be at a notably higher risk for disease including cancer, as well as often experiencing the psychologically damaging effects of being stigmatized and fat-shaming.

Of note, studies such as post hoc analyses of the pivotal trials for GLP-1s have shown that people with class 3 obesity appear to lose a higher percentage of weight with GLP-1 treatment, while also being more tolerant of the drugs and having lower rates of drug discontinuation, than those with less severe obesity.

Rasouli underscored that socioeconomic inequalities need to further be addressed to get the treatment for those patients with the highest need — as opposed to the current troubling situation in which the highly expensive drugs often only wind up going to those who can afford them, even without insurance coverage.

“Right now, it’s first come-first served, and it totally depends on who can afford it,” Rasouli said. Instead, “it should be based on maximizing the benefit and prior authorizations those people who do worse without this intervention.”

Why High Costs for GLP-1s When R&D Was Previously Conducted?

Further delving into the issue of the notoriously high costs of GLP-1s and concerns of inequities in access, William H. Herman, MD, MPH, underscored that “allowing wealthy individuals to purchase GLP-1 receptor agonists in short supply denies access to individuals more likely to benefit.”

He raised the important question of why GLP-1s need to be so costly in the first place, noting that while pharma companies typically attribute high costs to the heavy investment in research and development, for GLP-1 drugs already approved for type 2 diabetes, that work has already been done.

“It’s important to remember that these drugs carry a premium price for obesity, but they were developed for diabetes and so they’re basically freebies for obesity,” said Herman, who is the Stefan S. Fajans/GlaxoSmithKline Professor of diabetes and professor of internal medicine and epidemiology at the University of Michigan, in Ann Arbor, Michigan.

“There is no cost of research and development to develop these drugs — they were developed and already approved for diabetes.”

While the estimated minimum base price for semaglutide per year is about $480, the retail price for the drug per year is as much as $19,428, said Herman, citing data from GoodRx.

“There’s a big difference between $480 and about $19,000 a year, where the price could settle to make these drugs much more practical,” he said.

Alternatives to GLP-1s?

With access, insurance coverage, and cost issues of such pressing concern, the speakers grappled with the important consideration of alternatives to GLP-1s.

“If we can’t keep patients who succeeded on GLP-1 therapy at whatever their target was on medication, can we choose something else?” Horn pondered. “Among considerations is whether the weight-reduced state is different than the weight-active state, and what if we choose an additional target?”

Horn noted the growing trend of women who lose coverage or access to GLP-1 therapies increasingly turning to non-patented, compounded options.

“I can’t speak to safety or efficacy of those, and it’s a whole other conversation, but it’s something that [clinicians] have to be prepared for, and each provider may choose [a different approach].”

In terms of switching to other drugs, Horn added that the best option in the ‘next step down’ is phentermine-topiramate — “that gives you about 12% [weight loss] at the highest dose,” she said.

Of note, Herman’s pricing data showed the annual retail price of phentermine-topiramate of just $2832 compared with the $19k-plus price of semaglutide.

Taub mentioned that her patients sometimes turn to another alternative — oral semaglutide, which is in better supply. “A lot of my patients sometimes will go to Canada and get the oral semaglutide or use a Canadian pharmacy, and it is cheaper,” she said.

And there is also metformin, Taub added. “Let’s not forget that metformin can give you about a 5-pound weight loss, especially when used along with good concomitant lifestyle strategies,” she said.

Regarding oral semaglutide, Horn cautioned about differences in dosing.

“Just remember that the oral formulation you can get in the US is [in dosing of] 14 mg, while the trials on obesity used 50 mg,” she said.

“So, if you want the same response you get from semaglutide injectable, you’re going to have to get to 50 mg of the oral formulation, unless the patient is a super responder at early doses, which we haven’t studied adequately either.”

But in reiterating her debate argument — Horn underscored that the better solution is that “people who are on GLP-1 therapy and have succeeded deserve to continue.”

Horn’s disclosures included consulting and/or other relationships with Eli Lilly, KVK Tech, Novo Nordisk, and Weight Watchers. Taub’s disclosures included consulting and/or other relationships with Sanofi, Novo Nordisk, Novartis, Boehringer Ingelheim, Lilly Amgen, Bayer, Medtronic, Merck, Edwards, and Esperion, and she is a founder and shareholder of Epirium Bio. Rasouli’s disclosures included consulting and/or research support from Eli Lilly, Novo Nordisk, and Sanofi. Herman disclosed that he serves on the data safety monitoring boards for Merck and Rivus.