Last Review Date: 05/02/2024

Date of Origin: 02/02/2023

Dates Reviewed: 02/2023, 05/2023, 05/2024

1. Length of Authorization

Coverage will be provided initially for 3 months and may be renewed every 6 months thereafter.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Adstiladrin suspension 3 × 10¹¹ viral particles (vp)/mL (20 mL single-dose vial): 4 vials every 3 months

2. Max Units (per dose and over time) [HCPCS Unit]:

• 1 billable unit (1 dose) every 3 months

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• 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 † ‡ ^1-4

• 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 2^nd induction

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,4

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.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9029 – Intravesical instillation, nadofaragene firadenovec-vncg, per therapeutic dose; 1 billable unit = 1 dose

NDC:

• Adstiladrin suspension, with nominal concentration of 3 × 10¹¹ viral particles (vp)/mL in a carton of four frozen single-dose vials with an extractable volume of 20 mL/vial: 55566-1050-xx

7. 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, open-label, repeat-dose clinical trial. Lancet Oncol. 2021 Jan;22(1):107-117. doi: 10.1016/S1470-2045(20)30540-4. Epub 2020 Nov 27.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A