American Journal of Cardiovascular Drugs

, Volume 19, Issue 6, pp 553–559 | Cite as

Assessment and Management of Patients with Hyperlipidemia Referred for Initiation of PCSK9 Inhibitor Therapy: A Lipid Clinic Experience

  • James J. MaciejkoEmail author
  • Ryan Jamoua
  • Premchand Anne
Therapy in Practice



Previous studies have reported that monoclonal antibodies against proprotein convertase subtilisin/kexin type 9 (PCSK9) in clinical practice have been underutilized due to several barriers, including high cost, stringent insurance authorization, patient cost-sharing and insufficient documentation of a patient’s medical history. The purpose of our study was to determine if prescribing PCSK9 inhibitors only to patients meeting the established indications would significantly improve the approval rate and utilization.


We conducted a review and analysis of the medical records of patients referred by their physician to a hospital-based lipid clinic over a 20-month period specifically for initiation of a PCSK9 inhibitor.


There were 180 patients referred to our lipid clinic by their cardiologist or internist specifically for initiation of a PCSK9 inhibitor. Only 76 (42%) of these patients met the approved indications for this therapy and were provided PCSK9 inhibitor prescriptions. All received insurance approval within 3 weeks. Three did not initiate therapy due to excessive out-of-pocket cost, three discontinued therapy after two injections because of intolerable side effects (rhinorrhea), with the remaining 70 patients starting and continuing therapy, long-term. The remaining 104 patients were not given a PCSK9 inhibitor prescription and were treated with oral lipid-lowering medications.


Our findings suggest that those physicians who referred patients to our lipid clinic specifically for initiation of a PCSK9 inhibitor were not aware of the established indications. By prescribing a PCSK9 inhibitor to only those patients meeting the established indications, 100% obtained approval. Therefore, to achieve higher insurance approval rates and utilization, it is essential that physicians understand the indications for PCSK9 inhibitor therapy and prescribe them only to patients meeting the established indications.


Compliance with Ethical Standards


There was no funding for this study.

Conflict of interest

Dr. Maciejko receives speaker honoraria from Amgen. Dr. Maciejko declares no conflict of interest in the participation of this study, the evaluation of the data and the preparation of the manuscript. Dr. Anne declares he has no conflict of interest. Dr. Jamoua declares he has no conflict of interest.

Ethical approval

This article does not contain any studies/procedures with human participants by any of the authors.

Informed consent

This was a retrospective chart review, and the IRB at Ascension St. John Hospital has deemed that informed consent was not required. This study was approved by the IRB at Ascension St. John Hospital.


  1. 1.
    Artenstein AW, Opal SM. Propertein convertases in health and disease. New Engl J Med. 2011;365:2507–18.CrossRefGoogle Scholar
  2. 2.
    Cohen JC, Boerwinkle E, Mosley TH Jr, Hobbs HH. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. New Engl J Med. 2006;354:1264–72.CrossRefGoogle Scholar
  3. 3.
    Abifadel M, Varret M, Rabes JP, et al. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet. 2003;34:154–6.CrossRefGoogle Scholar
  4. 4.
    Leren TP. Mutations in the PCSK9 gene in Norwegian subjects with autosomal dominant hypercholesterolemia. Clin Genet. 2004;65:419–22.CrossRefGoogle Scholar
  5. 5.
    Navarese EP, Kolodziejczak M, Schulze V, et al. Effects of propertein convertase subtilisin/kexin type 9 antibodies in adults with hypercholesterolemia. Ann Intern Med. 2015;163:40–51.CrossRefGoogle Scholar
  6. 6.
    Sampietro T, Bigazzi F, Sbrana F, Toma M, Dal Pino B. Personalized regimen for PCSK9 inhibitors: a therapeutic option that maintains efficacy and reduces costs. J Clin Lipidol. 2018;12:1324–5.CrossRefGoogle Scholar
  7. 7.
    Food and Drug Administration (FDA). BLA approval. BLA 125559. Published July 24, 2015. Accessed 28 Dec 2018.
  8. 8.
    Food and Drug Administration (FDA). BLA approval. BLA 125522/Original 1. Published July 24, 2015. Accessed 28 Dec 2018.
  9. 9.
    Sabatine MS, Giufliano RP, Keech AC, et al. FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. New Engl J Med. 2017;376 (18):1713–1722.CrossRefGoogle Scholar
  10. 10.
    Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome. New Engl J Med. 2018;379(22):2097–107.CrossRefGoogle Scholar
  11. 11.
    Kazi DS, Moran AE, Coxson PG, et al. Cost-effectiveness of PCSK9 inhibitor therapy in patients with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease. JAMA. 2016;316(7):743–53.CrossRefGoogle Scholar
  12. 12.
    Navar AM, 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(11):1217–25.CrossRefGoogle Scholar
  13. 13.
    Dangi-Garimella S. Amgen announces 60% reduction in list price of PCSK9 inhibitor evolocumab. Amer J Managed Care, October 24, 2018. Downloaded on December 28, 2018 from Accessed 28 Dec 2018.
  14. 14.
    Casalino LP, Nicholson S, Gans DN, et al. What does it cost physician practices to interact with health insurance plans? Health Aff (Milwood). 2009;28(4):w533–43.CrossRefGoogle Scholar
  15. 15.
    Cohen JD, Cziraky MJ, Jacobson TA, Maki KC, Karalis DG. 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(4):891–900.CrossRefGoogle Scholar
  16. 16.
    Guyton JR, Bays HE, Grundy SM, Jacobson TA. An assessment by the statin intolerance panel; 2014 update. J Clin Lipidol. 2014;8:572–81.CrossRefGoogle Scholar
  17. 17.
    Austin MA, Hutter CM, Zimmem RL, Humphries SE. Genetic causes of monogenic heterozygous familial hypercholesterolemia: a HUGE prevalence review. Am J Epidemiol. 2004;160:407–20.CrossRefGoogle Scholar
  18. 18.
    Nordestgaard BG, Chapman MJ, Humphries SE, et al. Familial hypercholesterolaemia is underdiagnosed and undertreated in the general population: guidance for clinicians to prevent coronary heart disease: consensus statement of the European Atherosclerosis Society. Euro Heart Jl. 2013;34:3478–90.CrossRefGoogle Scholar
  19. 19.
    Scott A, Zahradnik TM, Squier K, et al. Diagnostic accuracy of ultrasound and MRI for Achilles tendon xanthoma in people with familial hypercholesterolemia: a systematic review. J Clin Lipidol. 2019;13:40–8.CrossRefGoogle Scholar
  20. 20.
    Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults; a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:2889–934.CrossRefGoogle Scholar
  21. 21.
    Grundy SM, Stone NJ, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: executive summary. J Am Coll Cardiol. 2018. Scholar
  22. 22.
    Garber, JR, Cobin, RH, Gharib, H, et al. for the American Association of Clinical Endocrinologists and American Thyroid Association Taskforce on Hypothyroidism in Adults. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocr Pract. 2012;18:e2–e46.Google Scholar
  23. 23.
    Holick MF. Vitamin D deficiency. New Engl J Med. 2007;357:266–81.CrossRefGoogle Scholar
  24. 24.
    Karmisholt J, Anderson S, Laurberg P. Variation in thyroid function tests in patients with stable untreated subclinical hypothyroidism. Thyroid. 2008;18:303–8.CrossRefGoogle Scholar
  25. 25.
    Forrest KY, Stuhldreher WL. Prevalence and correlates of vitamin D deficiency in US adults. Nutr Res. 2011;31:48–54.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Division of Cardiology, Department of Internal MedicineAscension St. John Hospital, Valade Cardiovascular Outpatient CenterDetroitUSA
  2. 2.Department of Internal MedicineWayne State University School of MedicineDetroitUSA

Personalised recommendations