Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Nadofaragene firadenovec-vncg (Adstiladrin) may be considered medically necessary in individuals 18 years and older when 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:
- 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 an additional induction course; or
- 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 therapies; or
Compendia Sources
Nadofaragene firadenovec-vncg (Adstiladrin) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.
The use of nadofaragene firadenovec-vncg (Adstiladrin) 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
