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

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 enrollees 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.  This patient does not fit either of these patient groups since there is no obstructive coronary disease on angiography, no documented coronary ischemia and no documentation to support heterozygous familial hypercholesterolemia. These diagnoses require not only elevated LDL levels that significantly exceed 180 mg/dl, but also a combination of physical examination findings (arcus cornealis below the age of 45, tendon xanthomata), a strong family history of premature coronary disease (younger than 50 years in second-degree relative or younger than 55 years in first-degree relatives) and documented genetic defects related to cholesterol metabolism according to published criteria (Raul, and Santos).  The documentation does not support the patient meets criteria for this diagnosis. PCSK9 inhibitors have not been studied in other patient populations such as this patient.  In addition, current guidelines that are endorsed by several national organizations do not recommend the use of PCSK9 inhibitors in this primary prevention setting (Stone, et al.).  There are other medications such as ezetimibe that are safe, have lower side effect profiles, have associated improved outcomes and have not been documented to be tried or not tolerated in this patient (Hammersley and Signy). Finally, there is no indication in the medication prescribing information that a latex allergy constitutes a contraindication to Repatha. There is also no documentation that Repatha has been tried and not tolerated.  Therefore, in this patients case, Praluent 75 mg/mL pen injector once every two weeks has not been demonstrated as medically necessary for the treatment of this patients medical condition.Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. 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.