Repatha Sureclick denials: what the review data shows

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Repatha SureClick 140 mg/mL. Findings: The physician reviewer found that The American College of Cardiology (ACC) has developed an expert consensus decision pathway regarding the role of non-statin therapies for low density lipoprotein (LDL) cholesterol lowering in patients for management of atherosclerotic cardiovascular disease risk. As noted by the ACC, Repatha may be considered when the goals of therapy have not been achieved on maximally tolerated statin and ezetimibe in higher risk patients with clinical atherosclerotic cardiovascular disease or in the setting of familial homozygous or heterozygous hypercholesterolemia. The records provided for review indicate that this patient has a contraindication to statin therapy given his unexplained elevated liver function tests.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Repatha Sureclick for treatment of the enrollee who has a history of coronary artery disease and hyperlipidemia. Findings: The physician reviewer found that the documentation provided supports the medically necessity for the requested medication in this clinical setting. Based on the records, this patient has increased coronary risk, marked hyperlipidemia with documented statin intolerance and up to moderate coronary stenosis on prior coronary CT angiogram. In this circumstance, the patient’s increased risk and coronary CT angiogram results provide enough evidence, to recommend aggressive lipid reduction with high intensity medication according to standard secondary prevention guidelines.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Repatha Sureclick injection. Based on the records provided for review, this patient has some coronary risk and is intolerant of two statin medications. However, the patient does not have clinical cardiovascular disease, typically defined as prior myocardial infarction or other coronary syndrome, non-hemorrhagic stroke, or symptomatic peripheral arterial disease. There is also a lack of documentation supporting a history of homozygous familial hypercholesterolemia or heterozygous hypercholesterolemia. While proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors have been shown to reduce low-density lipoprotein (LDL) cholesterol, they have not been sufficiently studied in the primary prevention setting such as with this patient.

Nature of Statutory Criteria/Case Summary: an enrollee has requested authorization and coverage for Repatha Sureclick. Findings: The physician reviewer found that based on the records provided for review, the patient is a coronary risk including elevated LDL but no known coronary disease, a low coronary calcium score in 2014 and no documented ischemia on nuclear stress testing performed. In this circumstance of coronary risk without documented coronary ischemia or coronary disease and without a diagnosis of familial homozygous or heterozygous hyperlipidemia treatment with the PCSK9 inhibitor Repatha is not medically necessary and not considered standard accepted practice in the medical community.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Repatha Sureclickwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.