Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Nogapendekin alfa inbakicept-pmln (Anktiva) may be considered medically necessary when the following criteria are met:
-
Individual is 18 years of age or older;
and
-
Individual has BCG unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (defined as persistent or recurrent CIS alone or with Ta/T1 disease within 12 months of completion of adequate BCG therapy);
and
-
Individual is unresponsive to treatment with Bacillus Calmette-Guerin (BCG) as defined by:
-
Individual experienced persistent disease following administration of at least five (5) of six (6) doses of an initial induction course of BCG followed by at least two (2) of three (3) doses of maintenance therapy or two (2) of six (6) doses of an additional induction course;
or
-
Individual experienced disease recurrence after an initial tumor-free state following of at least five (5) of six (6) doses of an initial induction course of BCG followed by at least two (2) of three (3) doses of maintenance therapy or two (2) of six (6) doses of additional induction course;
or
-
Individual has a stage T1 papillary tumor following a single induction course of BCG;
and
- Duration of treatment is a maximum of 37 months.
Compendia Sources
Nogapendekin alfa inbakicept-pmln (Anktiva) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of Nogapendekin alfa inbakicept-pmln (Anktiva) 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
