Opfolda — Blue Cross Blue Shield of Montana

Niemann-Pick type C disease

Initial criteria

Requested quantity (dose) does NOT exceed the program quantity limit OR
If the requested agent is Zavesca or Opfolda (or generic equivalent miglustat), the patient has a diagnosis of Niemann-Pick type C disease AND the requested dose does NOT exceed 600 mg per day OR
If the requested quantity (dose) exceeds the program limit, approval requires ONE of the following:
A. BOTH: (1) The requested agent has no 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: (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 cannot be achieved with a lower quantity of a higher strength within the limit OR
C. BOTH: (1) The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND (2) There is support for therapy with a higher dose for the requested indication

12 months