What the Study Found
- Nearly a third (32%) of first attempts to fill single-source branded drugs were rejected on formulary grounds between 2018 and 2024.
- Formulary rejection rates jumped 67% over the period, from 24.3% in 2018 to 40.7% in 2024, driven mainly by prior authorization and step therapy.
- After a rejection, nearly half of patients (48.4%) got no drug in the same therapeutic class within 90 days.
- Rejections hit exchange (48.7%) and Medicaid managed care (49.8%) plans hardest, versus under 25% for Medicare plans.
You hand over a new prescription, wait a few polite minutes, and then the pharmacist looks up with an apologetic expression. Your insurer has declined it. Not “come back later” or “we need a signature,” but a flat electronic denial that arrives before the pill bottle is even filled.
This happens more often than many would assume. According to a new analysis of American pharmacy claims, it’s happening a lot more frequently than it used to.
These findings come from a study published on July 9 in JAMA. The numbers are surprising. Between 2018 and 2024, approximately one in three initial attempts to fill a branded, single-source drug in the US was denied on the spot.
Joseph Levy at the Johns Hopkins Bloomberg School of Public Health and his team examined a database most of us never think about: the electronic exchanges between pharmacies, insurers, and the clearinghouses that connect them. Their source, IQVIA’s Formulary Impact Analyzer, includes about 57 percent of all US pharmacy claims. The team analyzed a 10 percent sample covering around 1.17 million people and two million initial fill attempts. Each of these attempts marked the moment a prescription met a formulary. The results showed that this moment increasingly ends in rejection.
Overall, 68 percent of those first attempts were paid immediately. The remaining were categorized into two types of denials. About 14.8 percent were turned down because the branded drug prescription was simply not on the insurer’s list. The other 17.2 percent faced what the industry calls utilization management: prior authorization, step therapy, and the paperwork a patient or doctor must navigate before coverage starts.
The paperwork wall keeps getting higher.
Most of the growth is found in the second category. Formulary-based rejections as a whole increased by 67.4 percent during the study period, from 24.3 percent of attempts in 2018 to 40.7 percent in 2024. Much of this increase did not come from insurers removing drugs from their lists outright. Instead, it resulted from more hurdles for drugs that, on paper, are covered. Among individuals with commercial insurance, utilization-management denials jumped from 13.3 percent to 32.4 percent. For Medicaid managed care, they rose from 15.4 percent to a striking 41.7 percent.
Where you get your coverage matters greatly in this context. Someone on a marketplace exchange plan or in Medicaid managed care faced rejection about half the time (48.7 and 49.8 percent respectively), while Medicare Advantage drug plans denied under a fifth of first attempts. Same prescriptions, vastly different chances, depending on the fine print of a plan most patients chose while looking at a comparison table.
The type of drug also tells a story. Diabetes GLP-1 agonists, which include some of the most talked-about medications of the decade, were rejected 35 percent of the time. The weight-loss incretin products in the same general area fared worse: an astonishing 85.1 percent of first attempts were denied. Direct-acting blood thinners, on the other hand, passed through successfully, with over 90 percent paid on the first try. If you want to understand where the cost battles are occurring in American medicine, the rejection rates highlight the path.
What happens after the denial?
This aspect reveals a more serious issue. Levy’s team tracked each rejected prescription for 90 days to see its outcome. It turns out getting turned away isn’t just a detour; it often leads to a dead end. Of the prescriptions initially denied, 38.6 percent eventually reached the patient as the original drug. Another 13 percent arrived as a substitute in the same therapeutic class. However, nearly half, 48.4 percent, went nowhere at all: no original drug, no equivalent, and nothing else in the same class within three months.
For those who eventually received treatment, the wait averaged 12.2 days. This isn’t a major delay for a mild condition, but it can be significant for someone who needs a medication their doctor considers urgent. The authors point out what they cannot determine. A patient denied one drug may have sensibly started another from a different class entirely, which their strict definition wouldn’t capture. Subsequent health outcomes are beyond the scope of this data. What the study measures is access; it’s simply about whether the prescribed drug or a similar one ever made it to the patient.
Looking at every attempt within the sample, the overall picture becomes clear. About 15.5 percent of individuals, nearly one in six, left the pharmacy without receiving either the drug or a similar alternative within the following 90 days. This share more than doubled over the study period for those on commercial, exchange, and Medicare Part D plans. The authors depict the situation as a trade-off instead of a villain’s story. These tools are known to reduce spending, and insurers argue they guide patients toward more affordable, equally effective options while maintaining leverage to negotiate discounts. Yet, the flip side, as this study starkly indicates, includes delayed care, abandoned care, and mounting administrative barriers that hit at the pharmacy counter rather than at the doctor’s office.
Rejections typically occur not when the prescription is written, but when it is filled. This means doctors often prescribe drugs that their patients’ plans won’t easily cover, unaware until the pharmacist informs them. The authors suggest making coverage rules clear at the moment of prescribing, which could prevent many of these avoidable denials from happening. Whether it’s possible to achieve this in a system with numerous payers and complex rules is another question. For now, the pharmacy counter remains the place where the cost struggle in American medicine is settled, one apologetic pharmacist at a time.
- Study type: Retrospective, national, all-payer longitudinal cohort study of adjudicated US pharmacy claims; peer-reviewed, published in JAMA
- Data source: IQVIA Formulary Impact Analyzer, representing ~57% of US pharmacy claims (10% person-level sample); anonymized, patient-level adjudicated outpatient pharmacy transactions
- Exposure: First-time (“initial”) attempt to fill a single-source branded drug (branded molecule with no generic available)
- Comparator: Rejection rates and downstream dispensing outcomes compared across six insurance types (commercial, exchange, Medicare Part D, Medicare Advantage, Medicaid fee-for-service, Medicaid managed care) and over time (2018–2024)
- Main outcomes: (1) rejection for formulary exclusion or utilization management (prior authorization / step therapy); (2) failure to dispense the rejected molecule or a same-class substitute within 90 days
- Sample size: ~1.17 million individuals and ~2 million initial fill attempts
- Duration / timeframe: Claims from January 2018 through September 2024, with 90-day post-rejection follow-up (extended to 180 days in sensitivity analysis)
- Funding / conflicts of interest: Partially funded by Arnold Ventures and the Johns Hopkins–American Enterprise Institute Fellowship Exchange Program; funders had no role in the study. Author disclosures include personal fees from RTI International, an FDA advisory-committee role and equity in Stage Analytics, and one author’s prior CMS employment (CMS had no role).
- Main limitation: Pharmacy-level data may misclassify some refills as initial attempts or miss fills at non-participating pharmacies; rejection reason codes are imprecise; the study observes dispensing but not subsequent clinical or health outcomes.
Reference
Levy, J. F., Alexander, G. C., Vabson, B., & Ippolito, B. N. (2026). Formulary-Related Insurance Denials of Single-Source Branded Drugs in the United States. JAMA. https://doi.org/10.1001/jama.2026.8702
Frequently Asked Questions
Why does a pharmacy rejection matter more than a bit of extra paperwork?
A pharmacy rejection matters because it often becomes the end of the road rather than a brief delay. In this study nearly half of rejected prescriptions led to no medication in the same therapeutic class within 90 days, meaning the paperwork hurdle frequently translated into patients simply going untreated rather than switched to an alternative.
Is it true that insurers are excluding more drugs outright?
Not mainly. The sharp rise in rejections was driven less by drugs being struck off formularies and more by utilization management, the prior authorization and step therapy requirements attached to drugs that are technically covered. Among commercially insured patients, these management-based rejections climbed from 13.3 per cent in 2018 to 32.4 per cent in 2024.
How does whether you get rejected depend on your insurance?
Whether you get rejected depends heavily on your plan type. People on marketplace exchange plans and Medicaid managed care faced rejection roughly half the time, while Medicare Advantage drug plans refused fewer than one in five first attempts, meaning the same prescription can face very different odds depending on the coverage behind it.
Could making coverage rules visible to doctors reduce these rejections?
Making coverage rules visible to doctors could reduce many rejections, since the study found that refusals mostly surface at the pharmacy rather than when a prescription is written. If prescribers could see a plan’s restrictions at the point of prescribing, the authors suggest, a share of these avoidable refusals might never occur, though the sheer number of payers and rules makes that difficult to build.
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