Zavesca — Blue Cross Blue Shield of New Mexico

Niemann-Pick type C disease

Initial criteria

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. If the requested agent is Zavesca or Opfolda (or the generic equivalent miglustat), the patient has a diagnosis of Niemann-Pick type C disease AND the requested quantity (dose) does NOT exceed 600 mg per day OR
3. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following applies:
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 OR
C. BOTH of the following: (1) the requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND (2) there is support of therapy with a higher dose for the requested indication

12 months