Diagnosis: Transient ischemic attack/cerebrovascular accident (TIA)/CVA)

Treatment: Livalo 2 milligrams OR tablets

The insurer denied Livalo 2 milligrams OR tablets. The denial was upheld.

This is a female patient who was seen as an outpatient in her Cardiologist's office in spring of 2019. Two weeks prior to this, she had symptoms consistent with a transient ischemic attack/cerebrovascular accident (TIA)/CVA). She was admitted to a hospital for a CVA workup, which was negative. The office notes stated that a carotid duplex showed no evidence of carotid artery stenosis. A venous duplex revealed no evidence of deep vein thrombosis (DVT) and an EKG revealed no evidence of arrhythmia. Medication history revealed that she was taking atorvastatin 40 mg daily and discontinued it due to leg cramps; she was subsequently started Livalo 2 milligrams daily. Further review of the patient's medications indicated that she discontinued taking Crestor 5 mg daily and Lipitor 40 mg daily due to leg cramps. The conclusion was that there was no hemodynamically significant stenosis of the bilateral lower extremities.

All FDA-approved statins have been shown to reduce cardiovascular risk; the magnitude of the reduction is related to the magnitude of LDL-C lowering. Atorvastatin and rosuvastatin at their highest approved doses are the most effective in lowering LDL-C levels and their beneficial effects on clinical outcomes are well-documented. All of the statins except pitavastatin and pitavastatin magnesium are available generically. Dosage adjustments are not required with atorvastatin or fluvastatin in patients with severe renal impairment. Pravastatin, rosuvastatin, and pitavastatin are not metabolized by CYP isozymes and are less likely to interact with other drugs.

Oral pitavastatin (Livalo®) is a competitive HMG-CoA reductase for the reduction of elevated total cholesterol and low-density lipoprotein cholesterol (LDL-C) levels in adults with primary hypercholesterolemia and combined (mixed) dyslipidemia. Pitavastatin is an effective treatment option in adults with primary hypercholesterolemia and combined (mixed) dyslipidemia, including those at risk of developing type 2 diabetes.

The carrier's denial of coverage for Livalo 2 milligrams OR tablets is upheld. The medical necessity is not substantiated.