Diagnosis: Endocrine/Metabolic/Nutritional.Other/Hyperlipidemia
Treatment: Pharmacy/Prescription Drugs/Livalo 4mg (milligrams) tablet
The health plan denied the requested medication Livalo 4 mg tablet as not medically necessary. The health plan's determination is overturned.

The patient is a man with a history of hypertension, hyperlipidemia, chronic obstructive pulmonary disease (COPD), coronary artery disease and multiple percutaneous coronary interventions. He developed myopathy and creatine kinase elevation with Atorvastatin 20 milligrams (mg) daily. He was also intolerant to Rosuvastatin 5 mg daily, Pravastatin 40 mg daily and, per the appeal letter, Simvastatin and Lovastatin. He has been treated with Pitavastatin (Livalo) 4 mg daily and has tolerated it well. Continued coverage for Pitavastatin is at issue.

I overturn the health plan's determination that Pitavastatin is not medically necessary in this instance.

The patient has experienced adverse effects with several of the formulary agents including Rosuvastatin, Atorvastatin, Lovastatin, Pravastatin and Simvastatin. The remaining formulary agent that the patient has not tried is Fluvastatin. Pitavastatin is less likely to cause adverse effects and is likely to result in a greater reduction in this patient's low-density lipoprotein (LDL) cholesterol level as compared to Fluvastatin.

This man meets accepted criteria for a diagnosis of statin intolerance in that he has been intolerant to two or more statins, including one at the lowest recommended starting dose. He has tolerated Pitavastatin. While he has not had a trial of Fluvastatin, due to its unique metabolic properties, Pitavastatin has been associated with significantly less muscle toxicity than other statins and has been shown to be tolerated by a substantial proportion of patients previously intolerant to other statins. Pitavastatin is also the most potent statin on a milligram-by-milligram basis, with significant reductions in LDL cholesterol levels seen with doses as low as 1 mg daily. The ability to treat with such low doses further minimizes the risk for adverse effects. Thus, Pitavastatin offers the advantage of reducing the risk for myotoxicity in high-risk patients. Given this man's history of intolerance to six other statins, Pitavastatin would be the least likely to cause adverse effects. Moreover, maximum dose Pitavastatin (4 mg daily) results in a 40-45% reduction in LDL cholesterol levels whereas maximum dose Fluvastatin (80 mg daily) reduces levels by approximately 35-38%.