Last Review Date: 05/04/2023

Date of Origin: 02/02/2023

Dates Reviewed: 02/2023, 05/2023

I. Length of Authorization

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

II. 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 three months for four doses only

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

• 80 mL every 3 months x four doses

III. 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 [≥5 of 6 induction doses plus ≥2 doses of maintenance or of 2^nd induction], 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

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

IV. Renewal Criteria ^1,4

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and indication specific 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.

V. Dosage/Administration ¹

VI. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drugs (Discontinue on 07/01/2023)
• J9029 – Injection, nadofaragene firadenovec-vncg, per therapeutic dose; 1 billable unit = 1 dose (Effective 07/01/2023)

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

VII. References

1. Adstiladrin [package insert]. Kuopio, Finland; Ferring Pharm, Inc; December 2022. Accessed April 2023.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for nadofaragene firadenovec. National Comprehensive Cancer Network, 2023. 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 2023.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Bladder Cancer. Version 1.2023. National Comprehensive Cancer Network, 2023. 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 2023.
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)

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

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