THE CLINICAL IMPACT OF FORMULARY RESTRICTIONS: PHARMACY CLAIM DENIALS, DEMOGRAPHIC DISPARITIES, AND HOSPITALIZATION RATES FOLLOWING PRESCRIPTION ABANDONMENT
Author(s)
Joseph Tkacz, MS1, Jennifer Cheng, MS2.
1Senior Principal, Real-World Evidence & HEOR, Veradigm, Chicago, IL, USA, 2Veradigm, Raleigh, NC, USA.
1Senior Principal, Real-World Evidence & HEOR, Veradigm, Chicago, IL, USA, 2Veradigm, Raleigh, NC, USA.
OBJECTIVES: Formulary restrictions are designed to minimize use of inappropriate therapies and reduce healthcare costs without compromising care, but may lead to adverse downstream clinical effects for select patient cohorts. As comprehensive pharmacy denial data are scarce, understanding specific therapeutic denial rates and accompanying outcomes is critical. This study aimed to assess the most commonly denied U.S. pharmaceuticals, along with associated patient characteristics, abandonment rates, and subsequent hospitalizations.
METHODS: Retrospective analysis of the Veradigm Network EHR database linked with Komodo claims. Pharmacy claims with an NCPDP Reject Code of 70 (Product not Covered) or 75 (Prior Authorization Required) were assessed in 2024. Demographics were compared between patients with and without a denial. Patients with a denial and ≥12 months of continuous enrollment were evaluated for class-level prescription abandonment and compared on patient characteristics and hospitalization rates using bivariate hypothesis tests.
RESULTS: Among 106,031,055 total patients, 14,945,951 (14.1%) had a rejection code of interest. Semaglutide (7.4%), tirzepatide (5.5%), and albuterol (5.2%) accounted for the most denied claims; tetracycline for acne had the highest individual denial rate (87.9%). Compared to patients without a denial, those with a denial were older (53.8±19.5 vs. 48.3 ±22.8), and more likely female (61.3% vs. 56.3%), non-Hispanic (63.0% vs. 54.7%), and Medicare beneficiaries (37.7% vs. 29.3%; ps < 0.01). Overall, 44.2% of patients abandoned therapy. Across multiple medication classes, patients who abandoned therapy had significantly higher hospitalization rates than those who eventually received it: BTK inhibitors (34.5% vs. 25.6%), DMARDs (19.0% vs. 12.9%), and antipsychotics (23.3% vs. 19.7%; ps< 0.01).
CONCLUSIONS: Nearly half of U.S. patients facing a policy-based prescription denial abandoned therapy in 2024, which was associated with significantly higher subsequent hospitalizations across various chronic diseases. GLP-1 agonists remain the most denied pharmaceuticals. Patient-centered pharmacy benefit designs that prioritize access are critical to mitigating clinical decline and addressing healthcare disparities.
METHODS: Retrospective analysis of the Veradigm Network EHR database linked with Komodo claims. Pharmacy claims with an NCPDP Reject Code of 70 (Product not Covered) or 75 (Prior Authorization Required) were assessed in 2024. Demographics were compared between patients with and without a denial. Patients with a denial and ≥12 months of continuous enrollment were evaluated for class-level prescription abandonment and compared on patient characteristics and hospitalization rates using bivariate hypothesis tests.
RESULTS: Among 106,031,055 total patients, 14,945,951 (14.1%) had a rejection code of interest. Semaglutide (7.4%), tirzepatide (5.5%), and albuterol (5.2%) accounted for the most denied claims; tetracycline for acne had the highest individual denial rate (87.9%). Compared to patients without a denial, those with a denial were older (53.8±19.5 vs. 48.3 ±22.8), and more likely female (61.3% vs. 56.3%), non-Hispanic (63.0% vs. 54.7%), and Medicare beneficiaries (37.7% vs. 29.3%; ps < 0.01). Overall, 44.2% of patients abandoned therapy. Across multiple medication classes, patients who abandoned therapy had significantly higher hospitalization rates than those who eventually received it: BTK inhibitors (34.5% vs. 25.6%), DMARDs (19.0% vs. 12.9%), and antipsychotics (23.3% vs. 19.7%; ps< 0.01).
CONCLUSIONS: Nearly half of U.S. patients facing a policy-based prescription denial abandoned therapy in 2024, which was associated with significantly higher subsequent hospitalizations across various chronic diseases. GLP-1 agonists remain the most denied pharmaceuticals. Patient-centered pharmacy benefit designs that prioritize access are critical to mitigating clinical decline and addressing healthcare disparities.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR63
Topic
Clinical Outcomes, Health Policy & Regulatory, Real World Data & Information Systems
Topic Subcategory
Reimbursement & Access Policy
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity), Mental Health (including addiction)