Medical Drug Criteria (MDC)

Policy Num:       P1.002.013
Policy Name:     Adstiladrin® (nadofaragene firadenovec-vncg)
Policy ID:          [P1.002.013] [Ac/L/ M/ P+ ] [0.00.00]

Last Review:       February 20, 2025
Next Review:      February 20, 2026
 

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

Adstiladrin may be considered medically necessary if the conditions indicated below are met.

Prior-Approval Requirements Age 18 years of age or older

Patient must have the following: Non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS)

AND ALL of the following:

1. Bacillus Calmette-Guerin (BCG)-unresponsive

2. Patient is considered high-risk

Policy Guidelines

Coverage eligibility for the use of nadofaragene firadenovec-vncg (Adstiladrin) will be considered when all of the following criteria are met:

Initial

o Patient has a diagnosis of non-muscle invasive bladder cancer (NMIBC); AND
o Patient has high-risk Bacillus Calmette-Guérin (BCG)-unresponsive disease (i.e.,
persistent or recurrent disease unresponsive to >2 courses of BCG in the last 12
months); AND
o ONE of the following:
 ▪ Patient has carcinoma in situ (CIS) with or without high-grade papillary
Ta/T1 tumors; OR
 ▪ Patient has high-grade papillary Ta/T1 tumors without CIS; AND
o Dose will not exceed 75 mL every three months. 

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. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

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