Firdapse — Blue Cross Blue Shield of New Mexico

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 members residing in Ohio AND plan is Fully Insured or HIM Shop (SG): BOTH of the following must be met: A. The patient does NOT have any FDA labeled contraindications to the requested agent AND B. ONE of the following: 1. The patient has another FDA labeled indication for the requested agent and route of administration OR 2. The patient has another indication that is supported in compendia for the requested agent and route of administration OR 3. The prescriber has submitted TWO articles from major peer-reviewed professional medical journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use(s) as generally safe and effective (accepted study designs include randomized, double blind, placebo controlled clinical trials; case studies not acceptable)

Reauthorization criteria

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

Approval duration

6–12 months