Diagnosis: Cardiac/Circulatory Problems.
Treatment: Pharmacy/Prescription Drugs/Nexlizet.
The insurer denied Nexlizet.
The denial is upheld.

This case involves a male with a history of atherosclerotic cardiovascular disease, and angina, who has reported intolerances to statin therapy including Crestor, Lipitor, Zocor as well as ezetimibe. The patient has been treated with Nexlizet for treatment of hyperlipidemia. The patient's health plan has denied coverage for Nexlizet on the grounds it does not meet prescription benefit exception criteria as there has been no documentation provided regarding intolerance, failure, or contraindications to Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors Repatha and Praluent. The use of Nexlizet in this case is the subject under review.

The health plan's determination is upheld.

Based on the records provided for review of this case, there is no documentation indicating that the formulary medications, Repatha or Praluent, will be less effective, have adverse effects, on would be contraindicated for the treatment of this patient's cardiovascular disease and hyperlipidemia. In addition, based on results of the FOURIER trial published in the New England Journal of Medicine in 2017, patients treated with evolocumab in addition to statin therapy with baseline low density lipoprotein (LDL) cholesterol 70 milligrams per deciliter (mg/dL) or greater demonstrated significant reduction in LDL cholesterol as well as in the composite primary endpoint of cardiovascular death, myocardial infarction, stroke, hospitalization for angina, or coronary vascularization (1). Therefore, the formulary PCSK9 inhibitors appear to be a very good medical option for this patient given his statin intolerances.
There has been no documentation that the formulary medications, Repatha or Praluent, would be less effective or contraindicated for this patient.