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Formulary-Related Insurance Denials of Single-Source Branded Drugs in the United States

JAMA·July 9Open Access
Medicine, General & InternalPractice changingDrug Formulary AccessInsurance Prior AuthorizationRetrospective Cohort StudySingle-Source Branded DrugsMixed

Summary

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What was studied

This retrospective, national, all-payer cohort study examined formulary-based rejections (formulary exclusions, prior authorization, and step therapy) of first-fill attempts for single-source branded drug prescriptions across 1.17 million US patients from January 2018 through September 2024.

Key findings

32% of 2+ million initial fill attempts were rejected — 14.8% for formulary exclusion and 17.2% for utilization management. Of those rejected, 48.4% received no medication in the same therapeutic class within 90 days, and 38.6% eventually got the originally prescribed molecule; average treatment delay was 12.2 days. Rejections rose 67.4% over the study period (24.3% in 2018 → 40.7% in 2024), with highest rates in Medicaid managed care (49.8%) and exchange plans (48.7%).

Study limitations

Claims data cannot capture clinical outcomes (e.g., disease progression, hospitalizations) resulting from delayed or absent treatment. The study covers only outpatient pharmacy claims and may not reflect prescriptions abandoned before submission. Causal inference is limited by the observational design.

Clinical implications

Nearly 1 in 2 patients whose single-source branded drug prescription is initially rejected receives no drug in that therapeutic class within 90 days — clinicians should proactively anticipate denials, document medical necessity early, and have a step-therapy or appeals strategy ready at the point of prescribing.

Caveats

  • Plan-type rejection rates are descriptive; the study does not adjust for differences in drug mix, patient acuity, or therapeutic area across payer types.
  • The 2 million figure refers to fill attempts, not unique individuals (1.17 million patients); sample_size tag reflects attempts as the primary unit of analysis.
  • The study does not report clinical outcomes (e.g., hospitalizations, mortality) linked to treatment gaps, limiting direct patient-harm quantification.

Related Questions

Explore related topics

How does prior authorization affect patient adherence and health outcomes for branded medications?What strategies help clinicians reduce formulary denial rates for specialty drugs?How do step therapy requirements differ across commercial, Medicare, and Medicaid plans?

Publication Details

Year
2026
Journal
JAMA
Sample Size
n=2,000,000
Source
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