Repatha denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage of Repatha. Repatha (evolocumab) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor studied in and approved by a government regulatore for the treatment of patients with heterozygous familial hypercholesterolemia or for patients with documented atherosclerotic heart disease who require additional lowering of low-density lipoprotein cholesterol (LDL-C). In this case, the patient does not fit either of these criteria.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for Repatha for the treatment of his atherosclerotic cardiovascular disease (ASCVD).With elevated triglyceride as a risk enhancer, treatment guidelines published by the American Heart Association (AHA) and American College of Cardiology (ACC) support lipid-lowering therapy aiming for a 30- 49% reduction in low-density lipoprotein-cholesterol (LDL-C). A randomized controlled trial demonstrated the efficacy of PCSK9 inhibitors such as Repatha that resulted in significant reductions in LDL-C and cardiovascular events in patients with existing ASCVD. However, the study showed superior LDL-C lowering with the PCSK9 inhibitor alirocumab over ezetimibe specifically in statin-intolerant, moderate to high cardiovascular-risk patients.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient is requesting authorization and coverage for Repatha pen injectors. She has been diagnosed with type 2 diabetes mellitus and hyperlipidemia. The patient reported chest pain. The patient’s medical record states she failed multiple statins. Per the provider, treatment with ezetimibe was suboptimal. The patient had reportedly declined to restart statin therapy due to intolerance. The Health Plan denied the request and reported the requested medication is not medically necessary for the treatment of this patient. The American College of Cardiology reports that proprotein convertase subtilisin-kexin type 9 inhibitors should be used for patients with a very high risk of atherosclerotic cardiovascular disease (ASCVD) or established ASCVD.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Repatha. Repatha (evolocumab) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor studied in and approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with heterozygous familial hypercholesterolemia or for patients with documented atherosclerotic heart disease who require additional lowering of low-density lipoprotein cholesterol (LDL-C). In this case, the patient does not fit either of these criteria.

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