A systematic approach for successful PCSK9 inhibitor prescribing in clinical practice

Published:January 16, 2019DOI:


      • 96.4% of patients were approved for PCSK9i therapy.
      • Health care teams can overcome many of the barriers to PCSK9i access.
      • A simple stepwise algorithm can be used to navigate the PCSK9i approval process.
      • Patients denied PCKS9i coverage should focus on appealing for approval.


      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%.


      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.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Journal of Clinical Lipidology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Grundy S.M.
        • Stone N.J.
        • Bailey A.L.
        • et al.
        2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines.
        J Am Coll Cardiol. 2018; ([Epub ahead of print])
        • Lloyd-Jones D.M.
        • Morris P.B.
        • Ballantyne C.M.
        • et al.
        2017 Focused update of the 2016 ACC expert consensus decision pathway on the role of non-statin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology task force on expert consensus decision pathways.
        J Am Coll Cardiol. 2017; 70: 1785-1822
        • Sabatine M.S.
        • Giugliano R.P.
        • Keech A.C.
        • et al.
        Evolocumab and clinical outcomes in patients with cardiovascular disease.
        N Engl J Med. 2017; 376: 1713-1722
        • Schwartz G.G.
        • Steg P.G.
        • Sxarek M.
        • et al.
        Alirocumab and cardiovascular outcomes after acute coronary syndrome.
        N Engl J Med. 2018; 379: 2097-2107
        • Hess G.P.
        • Natarajan P.
        • Faridi K.F.
        • Fievitz A.
        • Valsdottir L.
        • Yeh R.W.
        Proprotein convertase subtilisin/kexin type 9 inhibitor therapy: payer approvals and rejections, and patient characteristics for successful prescribing.
        Circulation. 2017; 136: 2210-2219
        • Navar A.M.
        • Taylor B.
        • Mulder H.
        • et al.
        Association of prior authorization and out-of-pocket costs with patient access to PCSK9 inhibitor therapy.
        JAMA Cardiol. 2017; 2: 1217-1225
        • Knowles J.W.
        • Howard W.B.
        • Karayan L.
        • et al.
        Access to nonstatin lipid-lowering therapies in patients at high risk of atherosclerotic cardiovascular disease.
        Circulation. 2017; 135: 2204-2206
        • Cohen J.D.
        • Cziraky M.J.
        • Jacobson T.A.
        • Maki K.C.
        • Karalis D.G.
        Barriers to PCSK9 inhibitor prescriptions for patients with high cardiovascular risk: results of a healthcare provider survey conducted by the National Lipid Association.
        J Clin Lipidol. 2017; 11: 891-900
        • Marks D.
        • Thorogood M.
        • Neil H.A.
        • Humphries S.E.
        A review on the diagnosis, natural history, and treatment of familial hypercholesterolaemia.
        Atherosclerosis. 2003; 168: 1-14
        • Civeira F.
        Guidelines for the diagnosis and management of heterozygous familial hypercholesterolemia.
        Atherosclerosis. 2004; 173: 55-68
        • Kaufman T.M.
        • Duell P.B.
        • Purnell J.Q.
        • Wójcik C.
        • Fazio S.
        • Shapiro M.D.
        Application of PCSK9 inhibitors in practice: challenges and opportunities.
        Circ Res. 2017; 121: 499-501