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Metreleptin — Blue Cross Blue Shield of Montana

congenital generalized lipodystrophy (CGL)

Initial criteria

  • The patient has a diagnosis of either congenital generalized lipodystrophy (CGL) or acquired generalized lipodystrophy (AGL)
  • The patient has a diagnosis of leptin deficiency
  • The 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
  • The patient has baseline HbA1c, triglycerides, and fasting insulin levels measured prior to initiating the requested agent
  • The patient has complications related to lipodystrophy (e.g., diabetes mellitus, hypertriglyceridemia ≥200 mg/dL, and/or high fasting insulin ≥30 microU/mL)
  • The patient has tried and had an inadequate response to maximum tolerable dose of a conventional agent for complications related to lipodystrophy
  • The patient has had an inadequate response to lifestyle modification (i.e., diet modification and exercise) AND will continue lifestyle modifications with the requested agent
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or has consulted with such a specialist
  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • ONE of the following: (A) The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR (B) There is information in support of therapy with a higher dose for the requested indication

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • The patient has had stabilization and/or reduction from baseline in at least ONE of the following: HbA1c, triglycerides, and/or fasting insulin
  • The patient will continue lifestyle modifications (i.e., diet and exercise) with the requested agent
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or has consulted with such a specialist
  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • ONE of the following: (1) The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR (2) There is information in support of therapy with a higher dose for the requested indication

Approval duration

12 months