Nadofaragene firadenovec-vncg (Adstiladrin) is a non-replicating recombinant adenovirus gene therapy designed to deliver a copy of a gene encoding a human interferon-alfa 2b to the bladder urothelium after administration intravescally into the bladder.

Nadofaragene firadenovec-vncg (Adstiladrin) may be considered medically necessary in individuals 18 years and older with ALL of the following criteria are met:

Bladder Cancer

·       Individual has a diagnosis of non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors; and

·       Individual is unresponsive to treatment with Bacillus Calmette-Guerin (BCG) as defined by:

        o   Individual experienced persistent disease following administration of at least five (5) of six (6) doss 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

        o   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 an additional induction course; or

        o   Individual has a stage T1 papillary tumor following a single induction course of BCG; and

·       Individual is not currently receiving systemic therapy for bladder cancer; and

·       Individual has not received any prior treatment with adenovirus-based therapyies.

The use of nadofaragene firadenovec-vncg (Adstiladrin) for any other oncologic indication is considered not medically necessary.

Nadofaragene fradevnovec-vncg (Adstiladrin) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.