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amifampridine phosphate — Blue Cross Blue Shield of Montana

other FDA labeled indication or compendia-supported indication (for Ohio fully insured or HIM Shop members)

Initial criteria

  • Diagnosis of Lambert Eaton myasthenic syndrome (LEMS) confirmed by at least ONE of the following: (medical records required) A. Neurophysiology study (e.g., nerve conduction studies [CMAP], EMG, repetitive stimulation) OR B. Anti-P/Q-type voltage-gated calcium channels (VGCC) antibody testing
  • If the patient has an FDA labeled indication, then ONE of the following: A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR B. There is support for using the requested agent for the patient’s age for the requested indication
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, oncologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • For Ohio fully insured or HIM Shop (SG) members: ALL of the following must be met: (1) The member resides in Ohio AND (2) The plan is Fully Insured or HIM Shop (SG) AND (3) BOTH of the following: (A) The patient does NOT have any FDA labeled contraindications to the requested agent AND (B) ONE of the following: 1. Patient has another FDA labeled indication for the requested agent and route of administration OR 2. Patient has another indication supported in compendia for the requested agent and route OR 3. Prescriber has submitted two articles from major peer-reviewed journals supporting the use as generally safe and effective

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • The patient has had clinical benefit with the requested agent
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, oncologist), or the prescriber has consulted with such a specialist
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

6–12 months (plan specific); renewal 12 months