ECONOMIC IMPACT OF DELAYED ACCESS TO FINERENONE DUE TO FORMULARY RESTRICTIONS IN CHRONIC KIDNEY DISEASE (CKD) AND TYPE 2 DIABETES (T2D)
Author(s)
Jacob Earl, PharmD, MS1, Brian Hocum, PharmD, MS1, Keith A. Betts, PhD2, Aozhou Wu, PhD2, Arvind Katta, PharmD, MS1, Travis Wang, MS3, Mauricio Beller Ferri, MD, MS1, Zihe Zheng, MBBS, PhD, MHS1, Yunxun Wang, MS1, Jon Mares, DO1, Diana I. Brixner, PhD, FAMCP4.
1Bayer U.S. LLC, Whippany, NJ, USA, 2Analysis Group, Inc., Los Angeles, CA, USA, 3Analysis Group, Inc., Boston, MA, USA, 4University of Utah, Salt Lake City, UT, USA.
1Bayer U.S. LLC, Whippany, NJ, USA, 2Analysis Group, Inc., Los Angeles, CA, USA, 3Analysis Group, Inc., Boston, MA, USA, 4University of Utah, Salt Lake City, UT, USA.
OBJECTIVES: Formulary restrictions can delay finerenone access for patients with CKD and T2D, potentially affecting disease management and causing subsequent economic impacts. This study evaluated healthcare costs and resource utilization (HRU) associated with delayed finerenone access.
METHODS: Adult patients with CKD and T2D who received finerenone with either timely approval (Cohort 1) or delayed approval due to initial rejection (Cohort 2) were identified from the Komodo Research Database based on the first finerenone prescription’s transaction results. Annual all-cause healthcare costs (medical and pharmacy costs, 2024 USD) and HRU frequency (inpatient, emergency room, and outpatient visits) were compared between Cohort 1 and Cohort 2 (overall and by median of length of delay) over the 12 months following the first finerenone prescription written date, using generalized linear models adjusting for key baseline characteristics.
RESULTS: The study included 3,617 patients in Cohort 1 and 376 patients in Cohort 2, with mean ages of 67.4 and 68.2 years and follow-up time of 9.9 and 10.5 months, respectively. Prior authorization and formulary exclusions, accounted for 42.0% and 37.8% of initial rejections in Cohort 2, respectively. Annual total healthcare costs were $42,691 in Cohort 2 and $38,097 in Cohort 1, with an adjusted cost difference (aCD) of $3,947 (95% confidence interval [CI]: -$3,354, $11,248), driven primarily by higher outpatient costs (aCD [95% CI]: $3,701 [-$2,341, $9,742]) in Cohort 2. Compared with timely approval, longer finerenone delays (≥61 days) was associated with higher outpatient cost (aCD [95% CI]: $6,779 [-$4,080, $17,638]). Patterns in HRU outcomes were consistent with cost results, with a higher incidence rate of outpatient visits in the delayed vs. timely approval cohort (38.3 vs. 34.6 visits/person-year).
CONCLUSIONS: Delays in accessing finerenone were associated with higher healthcare costs. Formulary restrictions may hinder timely treatment, undermining the intended cost-containment goals. Patients with delayed access warrant targeted follow-up to improve outcomes.
METHODS: Adult patients with CKD and T2D who received finerenone with either timely approval (Cohort 1) or delayed approval due to initial rejection (Cohort 2) were identified from the Komodo Research Database based on the first finerenone prescription’s transaction results. Annual all-cause healthcare costs (medical and pharmacy costs, 2024 USD) and HRU frequency (inpatient, emergency room, and outpatient visits) were compared between Cohort 1 and Cohort 2 (overall and by median of length of delay) over the 12 months following the first finerenone prescription written date, using generalized linear models adjusting for key baseline characteristics.
RESULTS: The study included 3,617 patients in Cohort 1 and 376 patients in Cohort 2, with mean ages of 67.4 and 68.2 years and follow-up time of 9.9 and 10.5 months, respectively. Prior authorization and formulary exclusions, accounted for 42.0% and 37.8% of initial rejections in Cohort 2, respectively. Annual total healthcare costs were $42,691 in Cohort 2 and $38,097 in Cohort 1, with an adjusted cost difference (aCD) of $3,947 (95% confidence interval [CI]: -$3,354, $11,248), driven primarily by higher outpatient costs (aCD [95% CI]: $3,701 [-$2,341, $9,742]) in Cohort 2. Compared with timely approval, longer finerenone delays (≥61 days) was associated with higher outpatient cost (aCD [95% CI]: $6,779 [-$4,080, $17,638]). Patterns in HRU outcomes were consistent with cost results, with a higher incidence rate of outpatient visits in the delayed vs. timely approval cohort (38.3 vs. 34.6 visits/person-year).
CONCLUSIONS: Delays in accessing finerenone were associated with higher healthcare costs. Formulary restrictions may hinder timely treatment, undermining the intended cost-containment goals. Patients with delayed access warrant targeted follow-up to improve outcomes.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE87
Topic
Economic Evaluation
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity), SDC: Urinary/Kidney Disorders