CurrentAnthemPolicy CC-0230

Adstiladrin (nadofaragene firadenovec-vncg)

Defines medical necessity and prior authorization criteria for intravesical Adstiladrin in adults with high‑risk, BCG‑unresponsive or intolerant non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), including specific NCCN‑recommended uses.

Policy Summary

PayerAnthem

PolicyAdstiladrin (nadofaragene firadenovec-vncg)

Policy CodePolicy CC-0230

Change TypeReviewed

Effective Date03/26/2026

Next Review Date

Key ActionObtain prior authorization and document age, intravesical administration, and diagnosis consistent with BCG‑unresponsive high‑risk NMIBC with CIS.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum patient age (years)

4quantity limit per 90 days

90ddosing interval

J9029HCPCS

Coverage Criteria for Adstiladrin (nadofaragene firadenovec-vncg)

Approval Criteria (initial and specific recurrent/persistent uses)

Requests may be approved if ALL of the following are met:

Adstiladrin coverage criteria

ONE of
- A: Individual is using as initial management
- B: Individual is using for treatment of recurrent or persistent disease that is bladder cytology-positive, imaging-negative, and cystoscopy-negative

Requests for Adstiladrin (nadofaragene firadenovec-vncg) may not be approved when the required coverage criteria are not met. Specifically, lack of documentation that the patient is ≥ 18 years of age, that the drug will be given by intravesical instillation, that the diagnosis is BCG‑unresponsive or intolerant, high‑risk NMIBC with carcinoma in situ (CIS) (with or without papillary tumors), or that the use aligns with the policy’s listed NCCN 2A scenarios (initial management or the specified recurrent/persistent cytology‑positive setting) are grounds for nonapproval. Requests are also not approved for any indications not listed in the criteria.

Policy Summary

PayerAnthem

PolicyAdstiladrin (nadofaragene firadenovec-vncg)

Policy CodePolicy CC-0230

Change TypeReviewed

Effective Date03/26/2026

Next Review Date

Key ActionObtain prior authorization and document age, intravesical administration, and diagnosis consistent with BCG‑unresponsive high‑risk NMIBC with CIS.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adstiladrin (HCPCS J9029). Requests will be reviewed for age, intravesical route, BCG‑unresponsive/intolerant high‑risk NMIBC with CIS (with or without papillary tumors), and alignment with NCCN 2A sequencing.

Prior authorization required for HCPCS J9029 (Adstiladrin)
Quantity limit: 4 vials per 90 days (Adstiladrin 3 x10^11 vp/mL vial)
Therapy administered intravesically every 3 months per product labeling

Step Therapy

Step Therapy / Sequencing

No step therapy or prerequisite alternative intravesical agents are mandated by this policy. Use should align with NCCN 2A sequencing: as initial management for BCG‑unresponsive high‑risk NMIBC with CIS, or for cytology‑positive, imaging‑negative, cystoscopy‑negative recurrent/persistent disease.

No step therapy specified
Sequencing aligned to NCCN 2A: initial management or treatment for cytology‑positive, imaging‑negative, cystoscopy‑negative disease

Documentation Required

Required Clinical Documentation

Documentation must include proof of age, route of administration, diagnostic details confirming high‑risk NMIBC with CIS, and prior BCG treatment status to support BCG‑unresponsive or intolerant designation.

Documentation of age ≥18
Specify intravesical route (procedure notes or administration record)
Diagnosis documentation: ICD-10 C67.* or D09.0 supporting NMIBC with CIS
Evidence of BCG‑unresponsive or BCG‑intolerant status (treatment dates, number of BCG instillations, response assessments)
Clinical rationale if used as initial management per NCCN 2A or for cytology‑positive, imaging‑negative, cystoscopy‑negative disease

Denial Risk

Denial Risk — Unmet Criteria

Requests will be denied if required criteria are not met, including but not limited to lack of prior authorization, patient under 18, non‑intravesical route, diagnosis not consistent with BCG‑unresponsive/intolerant high‑risk NMIBC with CIS, or missing documentation of prior BCG status.

Denial triggers: patient <18 years old
Denial triggers: route of administration other than intravesical
Denial triggers: diagnosis does not meet BCG‑unresponsive/intolerant high‑risk NMIBC with CIS
Denial triggers: absence of documentation of prior BCG therapy and BCG‑unresponsive/intolerant status when applicable
Denial triggers: requests exceeding quantity limit (more than 4 vials per 90 days) or lacking justification for excess

Definitions

inv-12: BCG‑unresponsive — definition as referenced by the policy

Definition (policy-referenced)BCG-unresponsive refers to patients with high-risk non‑muscle invasive bladder cancer (NMIBC) who are unresponsive or intolerant to Bacillus Calmette‑Guérin (BCG) therapy and who have carcinoma in situ (CIS) with or without papillary tumors; this diagnosis is required for coverage of Adstiladrin.

NCCN contextNCCN provides a 2A recommendation for use in BCG‑unresponsive, high‑risk NMIBC with CIS as initial management or for cytology‑positive, imaging‑ and cystoscopy‑negative recurrent or persistent disease.

PopulationAdults (age ≥18 years) with high‑risk NMIBC and CIS; policy requires age ≥18 for approval.

inv-13: Intravesical instillation — definition and requirement that administration be intravesical

DefinitionIntravesical instillation is administration of the therapy directly into the bladder; Adstiladrin must be used via intravesical instillation for coverage.

Route requirementPolicy requires intravesical use as a condition of approval (listed as criterion II).

Dosing intervalAdministered every 3 months (every 90 days) when used intravesically.

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

OpenPayer

Adstiladrin (nadofaragene firadenovec-vncg)

Coverage Criteria for Adstiladrin (nadofaragene firadenovec-vncg)

Coding and Quantity Limits

Prior Authorization, Documentation, and Provider Requirements

Background on Adstiladrin

Definitions