A systematic approach for successful PCSK9 inhibitor prescribing in clinical practice.
BACKGROUND
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 40%.


OBJECTIVE
Our goal was to validate the strategies for increasing PCSK9i approval rates and to present a framework for successful PCSK9i prescribing in clinical practice.


METHODS
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.


RESULTS
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.


CONCLUSION
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.
['Knickelbine|Thomas|T|', 'Jia|Lori|L|', 'White|Susan K|SK|', 'Garberich|Ross F|RF|', 'Oberembt|Sandra J|SJ|', 'Wills|Samantha|S|', 'Miedema|Michael D|MD|', 'Brilakis|Emmanouil S|ES|']
D002784:Cholesterol D011307:Drug Prescriptions D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D000091362:PCSK9 Inhibitors D015842:Serine Proteinase Inhibitors
Alirocumab (Praluent) Atherosclerotic cardiovascular disease (ASCVD) Evolocumab (Repatha) Familial hypercholesterolemia (FH) Low-density lipoprotein cholesterol (LDL-C) Prior authorization