Despite patient and provider interest, the use of PCSK9i therapy remains limited in
clinical practice. High annual listed prices have created intense payer scrutiny and
frequent health plan denials, with national approval rates in the range of 30% to
Our goal was to validate the strategies for increasing PCSK9i approval rates and to
present a framework for successful PCSK9i prescribing in clinical practice.
In Sept 2015, a systematic team-based approach was developed and implemented at our
institution. The approach centered on a preventive team of 3 senior staff cardiologists,
1 nurse practitioner, 1 physician assistant, 1 care coordinator, 1 pharmacist, and
1 pharmacy technician. The team was responsible for gathering and compiling the required
documents to support an approval, as well as collaborating with the in-house pharmacy
to complete PA and appeals processes.
In the total study population, 141 (71.9%) were approved for PCSK9i therapy at first
submission and 55 (28.1%) were rejected. Of those initially rejected, 48 (85.7%) appealed
and all 48 who appealed (100.0%) were ultimately approved. The final coverage decision
was 189 (96.4%) approved and 7 (3.6%) rejected.
Our study highlights the presence of modifiable barriers in the PCSK9i approval process.
Given the crucial role of health care teams in overcoming these modifiable barriers,
we developed a simple stepwise algorithm for navigating the PCSK9i approval process.
Our algorithm can help relieve busy providers of heavy administrative burdens and
facilitate greater accuracy, standardization, and efficiency in documentation.