Who’s more to blame for frustration at the pharmacy—insurers changing formularies or prescribers failing to keep up?

Payers of all types—private, governmental, hybrid—commonly turn down prescription claims due to restrictions in their drug formularies. Such rejections have increased markedly over time, and the growing list includes generic as well as branded alternatives. 

As a result, many patients wait for—or never receive—drug treatments deemed appropriate and timely by their doctors. 

Reporting a 67.4% rise in documented formulary rejections between 2018 and 2024, the authors of the large study behind the findings show the trend is not explained by formulary exclusions alone. 

Also contributing: requirements for prior authorization and step therapy, aka “fail first” policies. 

The latter is the name given to payers’ practice of pushing patients to try a lower-cost or otherwise preferred medication before they, the insurers, agree to pay for the drug the physician actually prescribed. 

In the new study, Joseph Levy, PhD, and colleagues at Johns Hopkins Bloomberg School of Public Health note U.S. healthcare’s drift into laborious drug access signals a “continued shift toward more utilization management of covered drugs.” 

“While this may also partly reflect changes in the mix of products entering the sample over time,” Levy and co-authors comment in their discussion section, “it nevertheless indicates a rising administrative burden that prescribers and patients must navigate, even for covered products.”

Empty-handed at the pharmacy counter 

At the same time, prescribers may have to share some of the blame for their own—and by extension their patients’—frustration. 

That’s because Levy and team found that formulary restrictions “commonly manifest at the pharmacy as opposed to the point of prescribing.”

Stated another way: Clinicians are frequently writing prescriptions for drugs that are not covered by a patient’s insurance or for which prior authorization or step therapy is required. 

The study was published July 9 in the Journal of the American Medical Association. 

Numbers paint the picture  

For the research, Levy and colleagues used IQVIA’s Formulary Impact Analyzer to conduct a retrospective, national, all-payer cohort study on 1.17 million individuals attempting to fill 2 million single-source branded drug prescriptions for the first time.

Focusing on a nearly seven-year period ending in September 2024, they found: 

• Of the 2 million attempts to fill, commercial insurance covered 0.84 million, standalone Medicare drug plans covered 0.40 million, Medicare Advantage covered 0.21 million, Medicaid managed care covered 0.10 million and Obamacare exchanges covered 0.06 million. 
   
• More than two-thirds, 68.0%, were paid on the initial fill attempt. The rest were rejected due to formulary exclusion (14.8%) or a requirement for prior authorization or step therapy (17.2%). 
   
• Formulary-based rejections increased 67.4% over the time frame examined, from 24.3% in 2018 to 40.7% in 2024.
   
• Rejections were most common among exchange (48.7%) and Medicaid managed care (49.8%) compared with Medicare prescription drug plans (24.0%) and Medicare Advantage prescription drug plans (19.8%). 
   
• Of attempts that were initially rejected, 38.6% ultimately resulted in the rejected molecule being filled within 90 days, and nearly half (48.4%) resulted in no medication fill in the same therapeutic class within that time frame. 
   
• Treatment initiation was delayed an average of 12.2 days after initial rejection among those ultimately receiving the same molecule or a therapeutic substitute.

Transparency would go a long way 

Commenting on the role underinformed clinicians sometimes play in patients’ unsuccessful attempts to fill “scrips,” Levy and fellow researchers write: 

“Efforts to improve the visibility of utilization management requirements at the point of prescribing may reduce avoidable pharmacy rejections and limit delays for patients. Prior research suggests that prescribers can respond to patients’ financial and coverage incentives, indicating that greater awareness of formulary restrictions could influence prescribing decisions.”

What’s more, Levy and co-researchers comment, policies aimed at streamlining or standardizing prior authorization processes could reduce delays while increasing the odds of prescription fulfillment. 

However, they acknowledge, the “large number of payers and heterogeneity of their coverage rules may complicate efforts to implement such a system.”

Upsides worth the downsides? 

In coverage of the research by Johns Hopkins’s news operation, Levy underscores the powerful role payers often play in “shaping” patient access to prescription medications. 

Formulary restrictions “may help control drug spending, [but] they can also create meaningful barriers to timely treatment,” Levy says.

Such payer policies may also place difficult administrative burdens on patients, pharmacists and clinicians alike, he adds. 

“As utilization management becomes more common,” Levy points out, “it’s important to better understand how these policies affect real-world treatment initiation and patients’ access to medicines.”

The study is available in full for free.