Myalept — Blue Cross Blue Shield of New Mexico

leptin deficiency

Initial criteria

Patient has a diagnosis of either congenital generalized lipodystrophy (CGL) or acquired generalized lipodystrophy (AGL) AND
Patient has a diagnosis of leptin deficiency AND patient does NOT have any of the following: partial lipodystrophy, liver disease (including non-alcoholic steatohepatitis [NASH]), HIV-related lipodystrophy, or metabolic disease (e.g., diabetes mellitus, hypertriglyceridemia) without evidence of generalized lipodystrophy AND
Patient has baseline HbA1c, triglycerides, and fasting insulin levels measured prior to initiating the requested agent AND patient has complications related to lipodystrophy [e.g., diabetes mellitus, hypertriglyceridemia (≥200 mg/dL), and/or high fasting insulin (≥30 microU/mL)] AND
Patient has tried and had an inadequate response to maximum tolerable dose of a conventional agent for complications related to lipodystrophy AND
Patient has had an inadequate response to lifestyle modification (diet and exercise) AND will continue lifestyle modifications with the requested agent AND
Prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or has consulted with a specialist in that area AND
Patient does NOT have any FDA labeled contraindications to the requested agent AND
Requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR there is information supporting therapy with a higher dose

Patient has been previously approved for the requested agent through the plan’s prior authorization process AND
Patient has had stabilization and/or reduction from baseline in at least one of the following: HbA1c, triglycerides, and/or fasting insulin AND
Patient will continue lifestyle modifications (diet and exercise) with the requested agent AND
Prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or has consulted with a specialist in that area AND
Patient does NOT have any FDA labeled contraindications to the requested agent AND
Requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR there is information supporting therapy with a higher dose

12 months