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

ABSTRACT

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.