Application of PCSK9 Inhibitors in Practice

Area of Science:

• Cardiovascular Medicine
• Pharmacology
• Health Services Research

Background:

• Protein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) represent a significant advancement in managing hypercholesterolemia and atherosclerotic risk.
• Numerous reports indicate substantial barriers to patient access for these novel therapies.
• A structured clinical model was developed to facilitate the provision of PCSK9i to eligible patients.

Purpose of the Study:

• To evaluate the real-world follow-up experience of PCSK9 inhibitor therapy in a large patient cohort.
• To assess the effectiveness of a practice model in overcoming access barriers for PCSK9 inhibitors.
• To analyze insurance approval rates, patient out-of-pocket costs, and treatment outcomes.

Main Methods:

• A retrospective analysis of 271 patients receiving PCSK9i therapy between July 2015 and August 2018.
• Data collection focused on insurance approval, appeals, time to approval, out-of-pocket expenses, and adverse events.
• Lipid profiles, including LDL cholesterol and Lp(a), were compared to baseline values.

Main Results:

• A 97% insurance approval rate was achieved, with 28% of prescriptions requiring at least one appeal.
• The median time from initial visit to insurance approval was 15 days.
• Median reductions in LDL cholesterol and Lp(a) at 1 year were 60% and 23%, respectively, comparable to clinical trial data.
• Over 50% of patients were statin intolerant, and only 2.3% discontinued therapy due to cost.

Conclusions:

• The developed practice model effectively facilitates access to PCSK9 inhibitor therapy for eligible patients.
• PCSK9i therapy is largely affordable and well-tolerated in a real-world setting.
• The study confirms the applicability of clinical trial findings regarding lipid reduction and tolerability to a broader patient population.