Appeal type: Medical necessity
Decision: Upheld

Diagnosis:
Treatment: Prescription/Pharmacy Drugs-Repatha
The health plan denied the requested treatment of Repatha as not medically necessary. The reviewer has upheld the determination in whole. 

The patient has a history of hypertension, hyperlipidemia, obesity, hepatic steatosis, and abnormal liver function tests. His coronary artery calcium score was 16.62, which placed him in the 46th percentile for his age, race, and sex. Recently, his low-density lipoprotein (LDL) cholesterol level was 141 milligrams per deciliter (mg/dl). At that time, he was on ezetimibe. Prior therapy with statins had been discontinued due to elevated liver function tests (LFTs).

Based on the documentation provided Repatha is not medically necessary.
Repatha (evolocumab) is a member of a class of lipid-lowering agents called Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. At the present time it is Food and Drug Administration (FDA) approved and recommended for use only in patients with established atherosclerotic cardiovascular disease (ASCVD) or those with primary hyperlipidemia, including familial hypercholesterolemia. These indications were selected since these subgroups have the highest risk of future cardiovascular events and were previously studied in phase II and III lipid-lowering trials. While there have been several trials examining the use of PCSK9 inhibitors in other patient subgroups, the data regarding their use in these lower risk groups are limited. Current guidelines, including the 2017 Focused Update of the 2016 American College of Cardiology (ACC) Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk and the 2017 National Lipid Association Update on the Use of PCSK9 inhibitors, do not support the use of PCSK9 inhibitors, such as Repatha, for patients without a diagnosis of ASCVD or primary hyperlipidemia unless their baseline LDL cholesterol level is 190 mg/dl or greater.
This man's coronary artery calcium score previously was 16.62. While this indicated the presence of some atherosclerotic plaque in his coronary arteries, scores in this range suggest minimal disease and a low risk of significant stenosis. No more recent score was provided. Per a panel of experts convened by the American Society for Preventive Cardiology "Clinical ASCVD includes acute coronary syndromes, history of myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial disease presumed to be of atherosclerotic origin, as well as other forms of atherosclerotic vascular disease including significant atherosclerosis of the coronary, carotid, iliofemoral circulations, and the aorta." This patient does not meet this definition. Thus, given the information provided, he cannot be considered to have established ASCVD. In addition, current guidelines do not recommend the use of Repatha unless a patient's LDL cholesterol level remains above goal despite maximally tolerated statin therapy or the patient is statin intolerant. Based on the information provided it is unclear if this patient has true statin intolerance. LFT abnormalities are common in patients on statin therapy and are not, in themselves, an indication for drug discontinuation. Discontinuation is recommended when transaminase levels greater than three times the upper limit of normal occur on two or more occasions or if the patient develops jaundice, and where secondary causes of elevations in hepatic transaminase levels have been ruled out. The records provided do not document that this is the case. Finally, hepatic steatosis (fatty liver) is not necessarily a contraindication to statin therapy; in fact, statins may be beneficial in patients with this condition.