Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Guselkumab (Tremfya) IV may be considered medically necessary and payable through the medical benefit when the following criteria are met:
Crohn's Disease
-
The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route);
and
- The individual must have failed a 30-day trial with JAK inhibitor (upadacitinib) and 3-month trial of a TNF Inhibitor and ustekinumab, as evidenced by paid claims or printouts.
Ulcerative Colitis (UC)
-
The individual has a diagnosis of moderately to severely active UC;
and
-
The prescriber is a specialist in the area of the individual's diagnosis, or the prescriber has consulted with a specialist in the area of the individual's diagnosis;
and
- The individual must have failed a 3-month trial of a TNF inhibitor and Entyvio, and a 30-day trial with a JAK inhibitor as evidenced by paid claims or pharmacy printouts.
If approved, guselkumab (Tremfya) IV will be allowed as three (3) intravenous infusions over twelve (12) weeks.
The use of guselkumab (Tremfya) 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.
Procedure Code
