Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The physician reviewer found in this patients 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. Finally, although PCSK9 inhibitors have not been studied widely as monotherapy, they do have convincing incremental benefit relative to statins alone, providing supportive evidence of their effectiveness when statin therapy is not tolerated. The current medical evidence supports the requested medication in this clinical setting. All told, Praluent 75 mg is medically necessary for the treatment of this patient. Findings:  The physician reviewer found that The physician reviewer found in this patients 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. Finally, although PCSK9 inhibitors have not been studied widely as monotherapy, they do have convincing incremental benefit relative to statins alone, providing supportive evidence of their effectiveness when statin therapy is not tolerated. The current medical evidence supports the requested medication in this clinical setting. All told, Praluent 75 mg is medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in cardiovascular disease and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.