Abstract
BACKGROUND: Early uptake of novel cholesterol-lowering therapies was limited by extensive utilization management practices and high cost. Whether similar challenges affected access to bempedoic acid (BA) is unknown. METHODS: For all patients prescribed BA from the date of FDA approval (February 2020) through 12/31/2022 identified using nationwide pharmacy transaction data, we assessed whether their first prescription was approved or rejected. Multivariable logistic regression was performed to assess factors associated with approval. Among those approved, prescription fill rates were evaluated by out-of-pocket cost. For those with rejected prescriptions, changes in lipid-lowering therapy after rejection were described. RESULTS: Of 116,176 patients (median age 67 years; 56.6 % women) initially prescribed BA, 80,056 (68.9 %) received approval. Factors associated with approval included: commercial insurance (odds ratio [OR] 1.62 [95 % confidence interval (CI) 1.56, 1.68] vs. government insurance, P < 0.001), cardiology specialty prescriber (OR 1.39 [1.34, 1.44] vs. primary care physicians, P < 0.001), and prescriber volume (OR 1.44 [1.38, 1.51] for fourth [highest] quartile vs. first [lowest] quartile prescribers, P < 0.001). Of those who received approval, 82.4 % (n = 65,969) filled the prescription, while 17.3 % (n = 14,087) abandoned the prescription. Abandonment rates increased with increasing patient OOP costs. Escalation in an alternative lipid-lowering therapy over the subsequent year was observed in 36.2 % and 33.3 % of patients with rejected and abandoned prescriptions, respectively. CONCLUSION: Nearly half of patients prescribed BA failed to receive therapy due to a combination of payer rejections and prescription abandonment. Arduous utilization management criteria or high OOP costs put patients at high risk for failure of therapy initiation.