Cardiac Rx 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: The patient has been diagnosed with atherosclerotic heart disease of native coronary artery without angina. The patient was noted to be taking Zetia 10 mg and simvastatin 10 mg. The provider noted the patient’s low-density lipoprotein (LDL) level increased to 110 mg/dl while taking Zetia. The patient reported intermittent pain with exertion. His diagnoses included hypertension and hyperlipidemia. The patient’s low-density lipoprotein (LDL) cholesterol level was 174 mg/dl. In the Health Plan Prescription Drug Prior Authorization or Step Therapy Exception Request Form, the provider noted the patient had tried and failed Zetia, simvastatin, and atorvastatin. The documentation noted that simvastatin caused leg pain. The patient also been treated with stent procedures.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for Prolia (denosumab) subcutaneous injections. Osteoporosis is one of the most frequent diseases in postmenopausal women, leading to an increased fracture risk due to the physiologic loss of the bone protective effects of estrogen. Joint guidelines by the International Osteoporosis Foundation (IOF) recommend the use of dual energy x-ray absorptiometry (DEXA) screening early in the evaluation of bone health for patients with breast cancer. The IOF guidelines further recommend that antiresorptive therapy should be considered in all patients with a bone mineral density (BMD) T-score less than -2.0 or two risk factors including a BMD T-score less than -1.0.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Nexletol. Bempedoic acid has demonstrated efficacy in lowering LDL-cholesterol (LDL-C) as both monotherapy and in combination with ezetimibe. A fixed-dose combination of bempedoic acid and ezetimibe reduces LDL-C by approximately 40%, which is comparable to two-thirds the amount of LDL-C lowering typically achieved with proprotein convertase subtilisin–kexin type (PCSK9) inhibitors. Bempedoic acid offers the potential for further LDL-C lowering in statin-intolerant patients or in those requiring further LDL-C reduction despite maximally tolerated statin therapy. The U.S.

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 Cardiac Rx, then check the rights and deadlines that apply to your plan.