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GLP-1 weight-loss drugs had the highest denial rate

By Mark Huffman of ConsumerAffairs

• Insurance denials for first-time prescriptions of brand-name drugs with no generic alternative jumped 67% between 2018 and 2024, according to a new study published in JAMA.

• Nearly half of patients whose prescriptions were initially denied never filled either the prescribed medication or a similar drug within 90 days, raising concerns about delayed or foregone treatment.

• Researchers say growing use of prior authorization, step therapy and formulary exclusions is the primary driver of the increase, reflecting insurers' efforts to control soaring prescription drug costs.

Americans prescribed brand-name medications without generic alternatives are increasingly running into insurance roadblocks at the pharmacy counter. A newly published study found that denial rates rose dramatically between 2018 and 2024.

The study, led by researchers at the Johns Hopkins Bloomberg School of Public Health and the American Enterprise Institute and published in the Journal of the American Medical Association (JAMA), analyzed more than 2 million first-time prescription fill attempts across commercial insurance, Medicare, Medicaid and Affordable Care Act marketplace plans.

Researchers found that insurers rejected 40.7% of initial attempts to fill brand-name prescriptions in 2024, up from 24.3% in 2018a 67% increase.

The consequences often extended beyond a temporary inconvenience. Among patients whose prescriptions were initially denied, 48.4% did not fill either the prescribed medication or another drug in the same therapeutic class within 90 days. Those who ultimately obtained treatment waited an average of 12 days after the initial rejection.

"We found that insurance restrictions are increasingly shaping whether and when patients receive medications their clinicians prescribe," lead author Joseph Levy, an assistant professor in the Bloomberg School's Department of Health Policy and Management, said in a statement.

"While these policies may help control drug spending, they can also create meaningful barriers to timely treatment and place growing administrative burdens on patients, pharmacists, and clinicians."

Prior authorization a growing hurdle

About one-third of all initial prescription attempts were rejected because of formulary exclusions or utilization management policies, such as prior authorization requirements or step therapy, which require patients to try less expensive medications before insurers will cover the prescribed drug.

The researchers concluded that the growing use of these utilization management tools accounted for most of the increase in denials during the study period. Commercial insurance plans and Medicaid managed care plans experienced some of the largest increases in these restrictions.

Denial rates also varied significantly by drug category. Medications in the incretin classincluding GLP-1 weight-loss drugshad the highest rejection rate at 85%, while oral anticoagulants had one of the lowest rates at 6.7%.

Marketplace plans and Medicaid managed care plans posted the highest overall denial rates, with nearly half of all first-time prescription attempts rejected. Medicare plans generally had lower rejection rates.

Balancing access and costs

The study comes as insurers face mounting pressure to manage spending on expensive brand-name drugs, particularly specialty medications and newer therapies that can cost thousands of dollars per month.

According to the Association for Accessible Medicines, cited by the researchers, brand-name drugs accounted for only about 10% of prescriptions filled in 2024 but represented 88% of total prescription drug spendingabout $700 billion. By contrast, generic drugs and biosimilars made up roughly 90% of prescriptions while accounting for only 12% of spending.

The researchers acknowledged that utilization management can help insurers negotiate lower prices and encourage cost-effective prescribing. However, they suggested that simplifying and standardizing prior authorization requirements, along with providing clinicians with real-time information about insurance coverage, could reduce unnecessary delays in treatment while preserving insurers' ability to manage costs.

The CDC reports hundreds of people have been sickened

By Mark Huffman of ConsumerAffairs

• A nationwide outbreak of the parasite Cyclospora has sickened hundreds of people across at least 31 states, with thousands of additional suspected cases under investigation.

• The illness can cause prolonged watery diarrhea, stomach cramps and fatigue, and health officials believe contaminated fresh produce is the most likely source.

• As a precaution, Taco Bell has temporarily removed several fresh ingredients from the menu at some locations, although health officials have not linked the chain to the outbreak.

A growing outbreak of a foodborne parasite that can cause severe diarrhea has prompted Taco Bell to temporarily remove several fresh produce items from the menus at some restaurants while federal and state health officials search for the source of the contamination.

The illness, known as cyclosporiasis, is caused by the microscopic parasite Cyclospora cayetanensis. According to the Centers for Disease Control and Prevention (CDC), people infected with the parasite often develop watery diarrhea, frequent and sometimes explosive bowel movements, loss of appetite, stomach cramps, bloating, fatigue and nausea. Symptoms typically begin about a week after exposure but can take up to two weeks to appear, making outbreaks difficult to trace.

The CDC has confirmed 843 cases and 86 hospitalizations in 31 states since May 1, though state health officials believe the true number is considerably higher because of reporting delays and unconfirmed illnesses. Michigan has reported the largest number of cases, with thousands of confirmed and suspected infections under investigation. No deaths have been reported.

Taco Bell takes precautionary action

While investigators have not identified Taco Bell as the source of any illnesses, the restaurant chain has removed several fresh ingredients from some locations out of an abundance of caution.

Signs posted at affected restaurants say customers may receive menu items without lettuce, pico de gallo, guacamole, cilantro, and onions because those ingredients are temporarily unavailable. Taco Bell says menu items remain available but are being served without the affected produce where necessary.

The precaution reflects a longstanding pattern in Cyclospora outbreaks, which are frequently linked to fresh produce consumed raw.

Fresh produce under scrutiny

Health officials have not identified a specific food or supplier responsible for this year's outbreak. Historically, Cyclospora outbreaks have been associated with foods such as leafy greens, cilantro, basil, raspberries and other fresh produce that can become contaminated before reaching consumers.

Unlike many bacteria, the parasite is not easily removed by simply rinsing produce. The CDC advises consumers to wash fruits and vegetables thoroughly under running water, avoid cross-contamination in the kitchen and, when practical, cook produce because adequate heat can kill the parasite.

Who is most at risk?

Most healthy people recover without lasting complications, but symptoms can persist for weeks or even recur if left untreated. Older adults, young children, pregnant women and people with weakened immune systems are considered at greater risk for severe illness. Antibiotics are available for confirmed cases.

Health officials continue to investigate the outbreak and have not issued any nationwide recalls or advised consumers to stop eating fresh produce. Instead, they recommend careful food handling and seeking medical attention if diarrhea lasts more than a few days or is accompanied by severe dehydration or other concerning symptoms.