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ANAHEIM, Calif. -- Insurance coverage and out-of-pocket costs for GLP-1 receptor agonists pose serious barriers to patients prescribed these drugs for type 2 diabetes and other indications, two single-site studies showed.

In a cross-sectional study of patients on Medicare Part D at one primary care clinic, 40 of 118 orders for incretin mimetics, which include GLP-1 receptor agonists, for type 2 diabetes were associated with patients demonstrating financial need, reported David King, PharmD, MBA, of Baylor Scott & White Health in Texas, during the American Society of Health-System Pharmacists midyear meeting.

Though 34 of these patients were eligible for a patient assistance program, only three were already enrolled in one. A program led by pharmacists was able to intercept the prescriptions before they were filled, contact patients, and enroll an additional 32, reducing (or eliminating) their out-of-pocket costs.

King told 番茄社区 that the clinic's medical director had noticed that many of their patients were becoming non-adherent to these medications, and the researchers found that around half of diabetes patients stopped their GLP-1 receptor agonists at or after 147 days. This was when Medicare Part D's coverage gap phase began, which requires patients to pay 25% of the cost for certain medications until a "catastrophic" out-of-pocket cap of $7,400 is reached.

"It's showing the cost structure is driving medication adherence and outcomes," King said. "And those are the two things that we were able to utilize to then say, okay, now what can we do about it?"

In another study presented at the meeting, insurers approved 59.3% of prior authorizations for these drugs for type 2 diabetes or other indications (including obesity, prediabetes, and weight loss) and rejected 40.7% (P<0.0001), reported Addison Dumes, a PharmD candidate at UK HealthCare at the University of Kentucky in Lexington.

Commercial insurers, Medicare, and Medicaid approved 84.9%, 90.9%, and 82.2% of prior authorizations for type 2 diabetes, respectively, but only 27.4%, 14.2%, and 0% for other indications.

With these approval rates in mind, "our pharmacists can set those expectations with providers, so they know that if you're prescribing [GLP-1 receptor agonists] for anything other than type 2 diabetes, it may be harder for it to get approved," Dumes told 番茄社区. "Hopefully, maybe with more data coming out to support them and weight loss, we'll be able to see more of them get approved."

Treatment with newer GLP-1 receptor agonists like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) has resulted in positive outcomes for patients with diabetes, obesity, and cardiovascular disease. As their use has surged, patients and providers have noted problems with shortages, insurance coverage, and out-of-pocket costs.

Elizabeth Bernauer, PharmD, a pharmacy resident at Baptist Health Hardin in Louisville, Kentucky, who was not involved in either study, told 番茄社区, "I think in the future, it's good for not only providers and patients to know this information, but I kind of doubt that we'll see a shift at all in it, even though a lot of people are seeing those commercials like, 'use this for weight loss.'"

King was more optimistic about the GLP-1 affordability intervention for Medicare patients with diabetes. "We saved the system a ton of money, we saved patients a ton of money, and you kept the patient from getting sick."

For the affordability program study, pharmacy technicians intercepted 118 orders for incretin mimetics for Medicare Part D beneficiaries with type 2 diabetes at their clinic between March and June 2023, and conducted a financial review, followed by a call to the patient if deemed at risk for discontinuation of their medications because of cost. In the calls, pharmacy technicians assessed the patients' eligibility for patient assistance, and pharmacists or community healthcare workers enrolled them in the program or suggested lower-cost therapies.

For the retrospective study of prior authorization approvals for GLP-1 receptor agonists, Dumes and colleagues conducted a manual chart review in the electronic health record and prior authorization submission portal to identify patients and gather data about their conditions and medication history.

Patients referred to the specialty pharmacy needing prior authorization approval for a GLP-1 receptor agonist between June 2022 and June 2023 were included, for a total of 405 patients. Mean age was 49 years, 72% were women, and 77% were white. Patients having their medication continued, who were uninsured, or for whom not enough data were available were excluded.

The studies were limited by their single-site design. For the affordability program study, this was an unblinded quality improvement evaluation of a pilot program, and the findings cannot be generalized to other settings.