Prior Authorization Criteria for Approval

Initial Evaluation

Myalept will be approved when ALL of the following are met:

1. The patient has leptin deficiency associated with a diagnosis of either congenital generalized lipodystrophy (CGL) or acquired generalized lipodystrophy (AGL)
   AND
2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
3. The prescriber has provided the patient’s baseline levels for HbA1C, triglycerides, and fasting insulin, measured prior to beginning therapy with the requested medication
   AND
4. The patient also has at least ONE of the complications related to lipodystrophy: diabetes mellitus, hypertriglyceridemia (200 mg/dL or higher), and/or high fasting insulin (30 μU/mL or higher)
   AND
5. The patient has tried and had an inadequate response to maximum tolerable dosing of a conventional medication for the additional diagnosis
   AND
6. The patient does NOT have any FDA labeled contraindication(s) to the requested medication
   AND
7. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 12 months

Renewal Evaluation:

Myalept will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested medication through the plan's Prior Authorization criteria
   AND
2. The patient has leptin deficiency associated with a diagnosis of either congenital generalized lipodystrophy (CGL) or acquired generalized lipodystrophy (AGL)
   AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
4. The patient has had improvement or stabilization with the requested medication as indicated by change from baseline level of at least ONE of the following:
   1. HbA_1C
   2. Triglycerides
   3. Fasting insulin
      AND
5. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
6. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 12 months

Conventional medication examples include:

Hypertriglyceridemia: statins, fenofibrates, Omega-3-Acid Ethyl Esters (generic Lovaza)

Diabetes/high fasting insulin: insulin, sulfonylurea/sulfonylurea combination, metformin/metformin combination

Note: list is not all-inclusive.