Praluent denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The physician reviewer found in this patient’s case, the records document known vascular disease and severe hyperlipidemia with documented intolerance to several statin medications. Praluent is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor studied in and approved for patients with heterozygous familial hypercholesterolemia or for patients with documented atherosclerotic vascular disease who require additional lowering of low-density lipoprotein (LDL) cholesterol. This patient fits the latter criteria. PCSK9 inhibitors have been demonstrated to be effective at lowering LDL cholesterol and are associated with improved cardiovascular outcomes in this setting. In addition, treatment with ezetimibe in this setting would not be expected to result in LDL reduction near the recommended goal reduction required in this patient.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Praluent 150 mg/mL for treatment of the enrollee’s hyperlipidemia. Findings: The physician reviewer found that the patient in this case has CAD, has sustained a myocardial infarction, underwent a coronary artery bypass graft, and was treated with multiple percutaneous interventions and stenting procedures. In addition, he is noted to be a diabetic and has failed treatment with maximally tolerated doses of high potency statins including rosuvastatin and atorvastatin as well as simvastatin and pravastatin. Adjunctive therapy with Zetia, Welchol, and Niaspan has been documented with failure of treatment. The patient’s most recent LDL was 142 mg/dL, which is significantly above goal of less than 70 mg/dL. The National Lipid Association guidelines support reduction of LDL levels in patients such as the patient in this case.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Praluent 75 mg /mL pen injector once every two weeks. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee’s medical history.The submitted documentation fails to demonstrate the medical necessity of the requested medication. The medical records document increased coronary risk including hyperlipidemia (LDL 183 mg/dl), statin intolerance and no documented obstructive coronary disease on recent angiography. Repatha (evolocumab) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor studied in and approved only for patients with heterozygous familial hypercholesterolemia or for patients with documented clinical coronary disease who require additional lowering of LDL cholesterol.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Praluent for treatment of the enrollee who has a history of chronic lipid issues. Findings: The physician reviewer found that The American College of Cardiology (ACC) has developed an expert consensus decision pathway (2016) regarding the role of non-statin therapies for LDL cholesterol lowering for management of atherosclerotic cardiovascular disease risk (ASCVD). There are several points, which are relevant to this case. The 2013 ACC/American Heart Association cholesterol guideline identified four major statin benefit groups for atherosclerotic cardiovascular disease risk reduction.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Praluent, then check the rights and deadlines that apply to your plan.