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:
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, as evidenced by paid claims or pharmacy printouts.
Other
-
The individual has another FDA labeled indication for guselkumab (Tremfya) IV;
or
-
The individual has another indication supported in compendia for the requested agent and route of administration;
and
-
If the individual has an FDA approved diagnosis, ONE of the following:
-
The individual's age is within FDA labeling for the requested indication for guselkumab (Tremfya) IV;
or
-
The prescriber has provided information in support of using guselkumab (Tremfya) IV for the individual's age for the requested indication;
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
-
ONE of the following:
-
The prescribing information for guselkumab (Tremfya) IV does NOT limit the use with another immunomodulatory agent;
and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).
-
The individual will NOT be using guselkumab (Tremfya) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors;
or
-
The individual will be using guselkumab (Tremfya) IV in combination with another immunomodulatory agent AND BOTH of the following:
-
The prescribing information for guselkumab (Tremfya) IV does NOT limit the use with another immunomodulatory agent;
and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required)
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
