Diagnosis: Hyperlipidemia

Treatment: Praluent 75 milligram/milliliter (mg/ml) subcutaneous (SC) solution auto-injector (SOAJ).

The insurer denied coverage for Praluent 75 milligram/milliliter (mg/ml) subcutaneous (SC) solution auto-injector (SOAJ).

The denial is overturned.


This is an adult patient with hypercholesterolemia and transient ischemic attack (TIA). She failed to tolerate multiple statin therapies due to muscle pain. According to medical records provided rosuvastatin 40mg was not tolerated and a previous trial of atorvastatin resulted in similar symptoms. On maximally tolerated rosuvastatin and vascepa cholesterol remained elevated above the recommended target goals. Past medical history is relevant for atherosclerotic vascular disease.

This patient has a history of myositis on multiple statin agents and has an elevated low-density lipoproteins (LDL) cholesterol level on maximally tolerated statin therapy (Crestor 20mg). She cannot tolerate atorvastatin 80mg as this formulary drug is likely to cause an adverse reaction. The patient has a history of TIA and evidence of atherosclerotic cardiovascular disease (ASCVD). Addition of a non-statin agent such Evolocumab in this setting has been associated with significant event rate reduction regardless of serum LDL level. Current American Heart Association and American College of Cardiology guidelines recommend addition of monoclonal antibody PCSK-9 (proprotein convertase subtilisin/kexin type 9) inhibitor therapy to maximally tolerated statin therapy in patients at high risk for future ASCVD events. According to the European Society of Cardiology guidelines this patient with documented ASCVD is considered to have "very high risk" of cardiovascular events. Such patients have a class I indication for treatment with non-statin therapy such as evolocumab when LDL-C (low-density lipoprotein cholesterol) levels are greater than 70. In conclusion, the proposed treatment is medically necessary and is more effective than the insurer suggested medications as the patient has developed diffuse muscle pain on multiple statin therapy and has an elevated LDL cholesterol despite maximally tolerated statin therapy (rosuvastatin 20mg).

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.

The medical necessity for Praluent 75 milligram/milliliter (mg/ml) subcutaneous (SC) solution auto-injector (SOAJ) services is substantiated.