Prior Authorization Triples Wait Times for Heart Failure Drugs with No Generic Options

Published in JACC: Advances. Lead author Amrita Mukhopadhyay, MD; senior author Saul Blecker, MD, NYU Grossman School of Medicine.

Patients with heart failure whose prescriptions required prior authorization -- insurer approval before coverage kicks in -- took three times as long to fill prescriptions for one class of critical medications and six times as long for another. Those whose SGLT2 inhibitor prescriptions required prior authorization were twice as likely to never fill them at all.

That is the central finding from a study of 2,183 heart failure patients at NYU Langone Health, published in JACC: Advances. The drugs in question, angiotensin receptor-neprilysin inhibitors (ARNIs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors, are pillars of modern heart failure treatment. Clinical trials have shown they substantially reduce the risk of death when added to standard therapy. Neither has a generic alternative. Both can cost hundreds of dollars out of pocket.

The same-day pharmacy problem

The mechanism behind the delays is mundane but consequential. Most patients fill prescriptions the same day as their medical visit. If the pharmacy tells them prior authorization is required and they need to come back in weeks, some simply never return. The prescription sits unfilled, and the patient goes without a medication that clinical guidelines recommend and clinical trials support.

Lead author Amrita Mukhopadhyay, a cardiologist at NYU Grossman School of Medicine, framed the results as evidence that prior authorization may be doing harm when applied to guideline-recommended medications with no generic alternatives. The policies are designed to control costs by steering patients toward cheaper options, but when no cheaper option exists, the primary effect is delay and abandonment.

The study also raised concerns about a chilling effect on prescribing itself. Clinicians who know a drug will require prior authorization may hesitate to prescribe it in the first place, avoiding the administrative burden and the risk that their patient will abandon the prescription.

Disparities built into the system

The findings revealed a troubling pattern in who faces prior authorization requirements. Patients living in lower socioeconomic-status neighborhoods were more likely to have their prescriptions flagged. So were patients who identified as Black or Hispanic. Patients with Medicaid insurance faced prior authorization requirements more frequently than those with commercial insurance.

These disparities are not random. They reflect the structure of insurance coverage in the United States, where Medicaid and lower-tier commercial plans are more likely to impose prior authorization as a cost-control measure. The result is that the patients who face the greatest barriers to accessing evidence-based heart failure treatment are disproportionately those who already face health disparities.

Study senior author Saul Blecker, an associate professor at NYU Grossman School of Medicine, stated that prior authorization requirements may be contributing to the substantial health disparities seen in heart failure care and need careful reexamination.

Previous evidence and current confirmation

The findings align with a body of prior research, including physician and patient surveys, suggesting that prior authorization delays care, increases treatment abandonment, and erodes trust in the healthcare system. But the NYU study provides something the survey literature could not: objective data from electronic health records and pharmacy fill logs showing exactly how long delays lasted and how often prescriptions went unfilled.

The study is the first to examine the impact of prior authorization specifically on ARNI and SGLT2 inhibitor access for heart failure patients -- two drug classes that sit at the top of current treatment guidelines but carry price tags that make them frequent targets for insurer gatekeeping.

The research team tracked 2,183 patients who received new prescriptions between 2021 and 2023, determining whether prior authorization was required and how long it took to fill the prescription within a year. Statistical analyses accounted for race, ethnicity, gender, education, and other demographic and social factors.

Limits of a single-system study

The data come from one healthcare system in New York, and the results may not generalize nationally. Blecker noted that New York state Medicaid offers some of the most comprehensive coverage policies in the country, meaning the barriers linked to prior authorization may be even more pronounced in states with less generous coverage.

The study cannot determine why individual prescriptions went unfilled. Prior authorization is the identified barrier, but patient-level factors -- financial hardship, transportation difficulties, health literacy, competing medical priorities -- may also contribute. Some patients who did not fill prescriptions may have obtained medications through manufacturer assistance programs or other channels not captured in the pharmacy fill logs.

The analysis also cannot establish causation. The association between prior authorization and delayed or abandoned fills is strong and consistent, but the study design is observational. Patients whose insurers require prior authorization may differ from those whose insurers do not in ways the researchers could not fully measure or control for.

The policy question

Prior authorization exists for a reason: controlling healthcare spending by ensuring expensive medications are prescribed appropriately. For drugs with cheaper alternatives, that rationale is straightforward. But ARNIs and SGLT2 inhibitors have no generic substitutes. The prior authorization process does not steer patients toward a cheaper option; it creates a barrier to the only option available.

The study team plans to explore how other elements of insurance design -- copays, coinsurance, and formulary tiers -- affect access to heart failure medications. For now, the data make a specific case: for guideline-recommended drugs with no alternatives, prior authorization appears to function primarily as a barrier, and that barrier falls disproportionately on the patients who can least afford it.