Medical Drug Criteria (MDC)

Policy Num:       M5.001.024
Policy Name:     Adstiladrin® (nadofaragene firadenovec-vncg)
Policy ID:          [M5.001.024] [Ac/MA M / P+ ][0.00.00]

Last Review:       February 20, 2025
Next Review:      October 20, 2025
 

Related MDC: NONE

Adstiladrin® (nadofaragene firadenovec-vncg)

Summary

ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus CalmetteGuérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. 

Policy Statements

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria

• Patient does not have a hypersensitivity to interferon alfa; AND

• Patient is not immunosuppressed or immunodeficient; AND

• Therapy will be used for intravesical instillation only; AND

• Used as a single agent; AND

Bladder Cancer 

• Patient has a diagnosis of non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (with or without papillary tumors); AND

• Patient has high-risk disease that is unresponsive to Bacillus Calmette-Guerin (BCG) (defined as persistent disease following adequate BCG therapy**, disease recurrence after an initial tumor-free state following adequate BCG therapy**, or T1 disease following a single induction course of BCG); AND

• Patient has undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease (Ta and T1 components); AND

• Patient does NOT have extra-vesical (i.e., urethra, ureter, or renal pelvis), muscle invasive (T2-T4), or metastatic urothelial carcinoma

**Note: Adequate BCG therapy is defined as ≥5 of 6 induction doses plus ≥2 doses of maintenance or of 2nd induction

 FDA Approved Indication(s);  Compendia Recommended Indication(s);  Orphan Drug

Policy Guidelines

Renewal Criteria 

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and indication-specific relevant criteria as identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND 
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: disseminated adenovirus infection, etc.; AND
  • First Renewal: Patient has a complete response (CR) to initial therapy (after 3 months) defined as a negative result for cystoscopy [with TURBT/biopsies as applicable] and urine cytology*; OR
  • Subsequent Renewals: Patient has not experienced a high-grade or CIS recurrence

*Note: If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, providers should consider cystectomy.

DOSAGE/ADMINISTRATION

REQUIRED MEDICAL INFORMATION

Submission of medical records (chart notes) related to the medical necessity criteria is REQUIRED on all requests for authorizations. Records will be reviewed at the time of submission. Please provide documentation related to diagnosis, step therapy, and clinical markers (i.e. genetic and mutational testing) supporting initiation when applicable. Medical records may be submitted via direct upload through the PA web portal or by fax.

EXCLUSION CRITERIA

NONE

BENEFIT APPLICATION

As stated in the policy.

OTHER CRITERIA

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals.

No Medicare National Coverage Determination (NCD) or Local Coverage Determinations (LCDs), and Local Coverage Article (LCAs) was identified for this drug.

References

1. Adstiladrin [package insert]. Kuopio, Finland; Ferring Pharm, Inc; September 2023.Accessed April 2024.

2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for nadofaragene firadenovec. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2024.

3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 2.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL
COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2024. 

4. Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, openlabel, repeat-dose clinical trial. Lancet Oncol. 2021 Jan;22(1):107-117. doi: 10.1016/S1470-
2045(20)30540-4. Epub 2020 Nov 27.

Codes

Applicable Modifiers

As per payment guidelines

Policy History