CurrentAnthemPolicy CC-0230

Adstiladrin (nadofaragene firadenovec-vncg)

Medical-benefit clinical coverage criteria and billing/coding guidance for Adstiladrin (intravesical nadofaragene firadenovec-vncg) for adult patients with BCG-unresponsive or intolerant high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors, including NCCN 2A uses and quantity limits.

Policy Summary

PayerAnthem

PolicyAdstiladrin (nadofaragene firadenovec-vncg)

Policy CodePolicy CC-0230

Change TypeAnnual reviews, coding updates, criteria additions, quantity limit

Effective Date

Next Review Date

Key ActionApproval requires documentation that the patient meets all clinical criteria: age ≥18, intravesical route, BCG-unresponsive/intolerant high-risk NMIBC with CIS ± papillary tumors, and intended use as initial management or for cytology-positive/imaging- and cystoscopy-negative recurrent/persistent disease.

POLICY UPDATE CHANGES

02/21/2025 - Annual Review: No changes. Coding Reviewed: Updated description for J9029. Added ICD-10-CM D09.0.

05/22/2025 - Coding update only: Removed ICD-10-CM Z51.11.

02/23/2024 - Added NCCN 2A recommendation criteria for cytology-positive, imaging- and cystoscopy-negative recurrent or persistent disease.

08/18/2023 - Updated quantity limit to 4 vials per 90 days.

02/24/2023 - New criteria document created and J9029 HCPCS added; J9999 deleted.

18+Required age threshold (years)

4Quantity limit

Coverage Summary & Decision Criteria

Medical-benefit coverage for Adstiladrin (nadofaragene firadenovec-vncg) is covered with criteria for adult patients with BCG-unresponsive or intolerant high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Indicated uses include initial management and treatment of cytology-positive, imaging-negative, cystoscopy-negative recurrent or persistent bladder disease per NCCN 2A guidance. Quantity limits apply (see policy), and administration is via intravesical instillation every 3 months.

Not Approved

Requests may not be approved when the above criteria are not met or for other indications not listed above.

ALL of the following

Use for indications other than BCG-unresponsive/intolerant high-risk NMIBC with CIS with or without papillary tumors
Any request that fails to meet all required criteria in the approval criteria tree

Authorization, Documentation & Billing Requirements

Prior Authorization

Prior authorization required / clinical review

Approval requires documentation that the patient meets all clinical criteria: age >= 18, intravesical instillation route, diagnosis of BCG-unresponsive or intolerant high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors, and intended use consistent with either initial management or treatment of recurrent or persistent disease that is bladder cytology-positive, imaging-negative, and cystoscopy-negative.

J9029

Billing Rule

Quantity limit billing

Quantity limit for Adstiladrin is 4 vials per 90 days. Claims exceeding this limit may be denied or may be subject to prior authorization review.

Limit: 4 vials per 90 days
Adstiladrin 3 x 10^11 vp/mL vial
J9029

Applicable Codes

HCPCS (drug administration / billing)HCPCSCovered

J9029

Intravesical instillation, nadofaragene firadenovec-vncg, per therapeutic dose [Adstiladrin]

ICD-10 Diagnosis (applicable diagnoses listed for informational purposes)ICD-10

C67.0-C67.9	Malignant neoplasm of bladder
D09.0	Carcinoma in situ of bladder [Non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS)]
Z51.12	Encounter for antineoplastic immunotherapy

Coding updates: the HCPCS description for J9029 was updated (reviewed 02/21/2025). ICD-10-CM code D09.0 (Carcinoma in situ of bladder) was added on 02/21/2025. Separately, ICD-10-CM Z51.11 was removed from the coding list (05/22/2025).

Evidence and Guideline Support

Evidence summary: NCCN issues a 2A recommendation for Adstiladrin use in BCG-unresponsive, high-risk NMIBC with CIS (Bladder Cancer V6.2024, revised January 17, 2025). Key clinical evidence includes a single-arm, open-label, repeat-dose trial reported in Lancet Oncology (2021) demonstrating activity of intravesical nadofaragene firadenovec in BCG-unresponsive NMIBC.

Key thresholds

Quantity limit4 vials every 90 days (Adstiladrin 3 x 10^11 vp/mL vial)

Age>= 18 years

Background & Definitions

Adstiladrin is an intravesical adenovirus vector gene therapy designed to deliver the interferon-alpha 2b (IFNα2b) gene to the bladder urothelium, producing transient local expression of IFNα2b with anti-tumor effects. It is indicated for BCG-unresponsive high-risk NMIBC with carcinoma in situ (with or without papillary tumors) and is administered intravesically every 3 months. The NCCN includes this use with a 2A recommendation, including initial management and certain cytology-positive recurrent/persistent disease scenarios.

Definitions:

• BCG-unresponsive: Clinical designation for high-risk NMIBC that does not respond to or is intolerant of Bacillus Calmette-Guérin therapy (policy expects documentation of this status).

• Intravesical instillation: Delivery of therapy directly into the bladder via catheterization.

Policy Revision Timeline

05/22/2025coding_update

Coding update only: Removed ICD-10-CM Z51.11.

02/21/2025annual_review

Annual review with no clinical changes. Coding reviewed: updated description for J9029 and added ICD-10-CM D09.0.

02/23/2024criteria_added

Added NCCN 2A recommendation criteria allowing use for cytology-positive, imaging- and cystoscopy-negative recurrent or persistent bladder disease.