(34) Short-term impact on healthcare costs after modification to PCSK9i therapy clinical criteria

Background: : To maintain clinically-appropriate access and utilization for proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) aligning with evidence-based care, the clinical criteria were modified – removing the requirement of prior ezetimibe use, reducing the threshold for low-density lipoprotein cholesterol (LDL-C) from ≥70mg/dL to ≥55mg/dL, and prolonging initial approval duration.

Objective: : To evaluate the impact of PCSK9i clinical criteria modification, effective January 1, 2024, on the total all-cause costs’ trend for patients with a submitted PCSK9i claim.

Methods: : Commercially-insured patients with a new submitted PCSK9i claim identified using NDC/GPI codes between 1/1/2023-6/30/2024 from the Healthcare Integrated Research Database (HIRD®) were included. Guideline-directed therapy (GDT) per ACC/AHA clinical guideline pre-requisites include – presence of atherosclerotic cardiovascular disease (ASCVD) and/or type 2 diabetes mellitus (T2DM) diagnosis; LDL-C level ≥70mg/dL (part of previous clinical criteria); prior ezetimibe use (part of previous clinical criteria); prior statin use; and high/moderate intensity statin at the time of the latest PCSK9i claim. Quarterly per-patient-per-month (PPPM) all-cause healthcare costs were computed from Q1 2023-Q2 2024 to assess trend. Pre- and post-criteria change to PPPM costs were compared using identical time periods in 2023 and 2024 to control for seasonality.

Results: : Patients with a submitted PCSK9i claim increased from 18,012 in Q1 2023 to 26,712 in Q2 2024. Quarterly median patient age was unchanged over 1.5 yrs of observation (range: 59-60 yrs), as was proportion of males (range 57.2%-58.6%). GDT based on proportion of patients with ASCVD/T2DM (75.1% vs 72%), LDL-C ≥70mg/dL (80.9% vs 81.1%), ezetimibe (31.2% vs 30.7%), any statin use (63.5% vs 66.8%), high-intensity statin use (40.1% vs 42.5%), and moderate-intensity statin use (27.2% vs 29.9%) were similar in first half of 2023 vs 2024 after modification to the PCSK9i clinical criteria. Mean all-cause PPPM costs trended from $1,880 in Q1 2023 to $1,903 in Q2 2024. Comparing Q1 2023 ($1,880) to Q1 2024 ($1,844) and Q2 2023 ($1,982) to Q2 2024 ($1,903), there was no appreciable change in all-cause PPPM costs following the modification.

Conclusions: : PCSK9i clinical criteria modification aligning with evidence-based care did not have any impact on all-cause costs in the first 6 months post-policy change. Policy updates evolving with evidence and guidelines can enhance clinically appropriate drug access and utilization without significant changes in patient costs.

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