Galafold — Blue Cross Blue Shield of Montana

Initial criteria

• Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
• 1. The requested quantity (dose) does NOT exceed the program quantity limit OR
• 2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
• A. BOTH of the following:
• 1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
• 2. There is support for therapy with a higher dose for the requested indication OR
• B. BOTH of the following:
• 1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
• 2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit

Approval duration

6–12 months