Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cardiac/Circulatory Problems/Coronary Artery Disease/CAD
Treatment: Pharmacy/Prescription Drugs

The health plan denied the requested prescription medication as not medically necessary. The health plan's determination is overturned.

This case involves a female with a history of coronary artery disease, left anterior descending (LAD) and right coronary artery (RCA) stents, chronic hypertension, severe hyperlipidemia, chronic heart failure, type 2 diabetes mellitus type, and obesity. Review of the patient records indicate intolerance to multiple previously tried statin medications causing significant myalgias. The patient has previously been treated with Atorvastatin, Rosuvastatin, and Pravastatin, all of which have caused myalgias. A recent coronary angiogram demonstrated nonobstructive coronary artery disease and patent stents. Review of this patient's most recent lipid panel showed severe hyperlipidemia, total cholesterol 339 , triglycerides 187 , and her low intensity lipoprotein (LDL) had increased from 121 to 227 . The patient's provider has prescribed Repatha 140 milligrams (mg) /milliliter (mL) SC (subcutaneous) for the treatment of severe hyperlipemia, LDL reduction, and cardiovascular risk reduction. However, the patient's health care plan has denied coverage for Repatha due to inadequate medical documentation and lack of medical necessity.
At issue is the medical necessity of the requested prescription medication.

I recommend that the patient's health plan determination be overturned, in whole, and coverage be granted for Repatha to aggressively and effectively treat this patient's hyperlipidemia, high LDL, and lower her overall cardiovascular risk.

Yes, Repatha is medically necessary to aggressively lower the patient's lipid levels including high LDL and reduce the patient's overall cardiovascular risk. I agree with the provider's recommendation that starting Repatha in this case is the best option for management of the patient's hyperlipidemia.
Based on records provided for review of this case, this patient has significant intolerance to several statin medications all of which cause significant myalgia's prohibiting further use. In addition, the patient has severe cardiovascular disease including prior coronary stents and persistent severe hyperlipidemia including a very elevated LDL. For this reason, the patient's treating physician has appropriately recommended Repatha for aggressive treatment of hyperlipidemia, LDL lowering, and cardiovascular risk reduction. Peer-reviewed medical literature has shown the significant lipid-lowering effect and cardiovascular benefit of Repatha (evolocumab) in patients at high cardiovascular risk who have failed or intolerant to statin therapy [1]. In the major randomized trial evaluating the efficacy of Repatha (evolocumab) on background statin therapy in patients at high cardiovascular risk, compared to placebo patients treated with Repatha demonstrated a 59% reduction in LDL, and the primary end point of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was also significantly reduced (1344 patients [9.8%] vs. 1563 patients [11.3%]; hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; P< 0.001) [2]. Based on the patient's clear evidence of high cardiovascular risk status, poorly controlled hyperlipidemia, and intolerance to multiple statin medications, Repatha is medically appropriate and necessary in this case.