Description
Tildrakizumab-asmn (Ilumya
TM
) is a humanized IgG1/k monoclonal antibody that selectively and specifically binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab (Ilumya) inhibits the release of proinflammatory cytokines and chemokines.
Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Initial Criteria
Tildrakizumab (Ilumya) may be considered medically necessary when the following criteria are met:
-
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 3-month trial of a TNF inhibitor [i.e., infliximab-axxq (Avsola), certolizumab pegol (Cimzia), etanercept (Enbrel), adalimumab (Humira), infliximab-abda (Renflexis), infliximab-dyyb (Inflectra), Infliximab, or infliximab (Remicade)] and an Interleukin (IL)-17 Inhibitor [i.e., ixekizumab (Taltz) or secukinumab (Cosentyx)], as evidenced by paid claims or printouts.
Reauthorization Criteria
The continues use of tildrakizumab (Ilumya) may be considered medically necessary when
ALL
of the following criteria are met:
-
The individual has previously been approved for tildrakizumab (Ilumya) through Blue Cross Blue Shield of North Dakota's precertification process;
and
-
The prescriber has provided documentation that the individual has demonstrated disease stability or beneficial response to therapy;
and
- The individual must continue to meet applicable initial criteria.
The use of tildrakizumab (Ilumya) 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 Codes
