Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of ustekinumab (Stelara) IV may be considered medically necessary when the following criteria are met:
For Crohn's Disease (CD):
-
The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route);
and
-
The individual must have had a three (3)-month trial of vedolizumab (Entyvio) or risankizumab-rzaa (Skyrizi), as
evidenced by paid claims or printouts.
For Ulcerative Colitis (UC):
-
The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route);
and
- The individual must have had a three (3)-month trial of vedolizumab (Entyvio), as evidenced by paid claims or pharmacy printouts.
NOTE:
If approved, ustekinumab (Stelara) IV will be allowed as a single intravenous infusion.
The use of ustekinumab (Stelara) IV for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Ustekinumab (Stelara) IV for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.
Procedure Code
