CurrentEmblemHealthPolicy N/A

Adstiladrin (nadofaragene firadenovec-vncg) — Coverage Criteria

Defines medical necessity and coverage criteria for intravesical Adstiladrin in members with high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC), including prior authorization, exclusions, dosing and duration limits for EmblemHealth lines of business managed by Evolent.

Policy Summary

PayerEmblemHealth

PolicyAdstiladrin (nadofaragene firadenovec-vncg) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversionpolicy replacement

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and bill Adstiladrin per therapeutic dose using J9029.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1472 Adstiladrin policy.

1drug billing code listed

BCG‑unresponsive CIScovered indication

Max 12 mo / 4 dosestreatment duration limit

75 mL @ 3E11 vp/mLdosage cap

Coverage Criteria for Adstiladrin (nadofaragene firadenovec-vncg)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Primary indication: Member has high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS), with or without papillary tumors, and Adstiladrin (nadofaragene firadenovec-vncg) will be used as monotherapy for intravesical instillation

BCG-refractory definitions (one required): Persistent or recurrent CIS (with or without recurrent Ta/T1) within 12 months of adequate BCG OR recurrent high-grade Ta/T1 within 6 months of completion of adequate BCG OR T1 high-grade disease at first evaluation after induction BCGAdequate BCG defined as at least 5 of 6 induction doses plus either ≥ 2 of 3 maintenance doses or ≥ 2 of 6 doses of a second induction course

Exclusions and limitations for Adstiladrin (nadofaragene firadenovec-vncg) include: disease progression while receiving Adstiladrin and prior treatment with adenovirus-based drugs. Members with extra-vesical disease (urethra, ureter, or renal pelvis), muscle-invasive disease (T2–T4), or metastatic urothelial carcinoma are excluded. Requests exceeding dosing or duration limits will be denied: single-dose volume/concentration must not exceed 75 mL at 3 x 10^11 viral particles (vp)/mL, and treatment must not exceed 12 months or 4 doses if a complete response was achieved. Finally, use considered investigational or off-label without sufficient evidence is excluded; case reports and meeting abstracts without full peer-reviewed articles are not acceptable evidence.

Policy Summary

PayerEmblemHealth

PolicyAdstiladrin (nadofaragene firadenovec-vncg) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversionpolicy replacement

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and bill Adstiladrin per therapeutic dose using J9029.

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.

Use of Adstiladrin for indications that are investigational or off-label is considered not medically necessary when the evidence does not meet CMS-recognized compendia or acceptable peer-reviewed literature standards. Determinations of sufficiency consider whether the patient and tumor characteristics, the administered regimen, and the reported outcomes are adequately represented in the published evidence, whether outcomes are clinically meaningful (e.g., ASCO-recommended thresholds), and whether the study design is appropriate. Isolated case reports and abstracts without full peer-reviewed publications are explicitly insufficient to support coverage.

Regimen / Indication	HCPCS code (per therapeutic dose)	Single-dose limit	Maximum treatment duration	Coverage status
Adstiladrin intravesical instillation as monotherapy for high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer (carcinoma in situ with or without papillary tumors)	J9029 — Intravesical instillation, nadofaragene firadenovec‑vncg, per therapeutic dose	75 mL at a concentration of 3 x 10^11 viral particles (vp)/mL	Up to 12 months total or up to 4 doses if the patient achieved a complete response	Covered with criteria

Coding and Dosage Limits

Covered HCPCS CodesHCPCSCovered

J9029

Intravesical instillation, nadofaragene firadenovec-vncg, per therapeutic dose

Single-dose viral particle concentration and volume

Single-dose limit75 mL at a concentration of 3 x 10^11 viral particles (vp)/mL

Dose formatIntravesical instillation per therapeutic dose (billable as J9029)

Applicable settingFor Adstiladrin (nadofaragene firadenovec-vncg) intravesical use only

Maximum treatment duration

Maximum duration12 months

Alternate cap if complete responseUp to 4 doses if the patient achieved a complete response

Exceeding limitsTreatment beyond these limits is an exclusion and may be denied

Provider Requirements, Authorization, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adstiladrin (nadofaragene firadenovec‑vncg). Bill using HCPCS code J9029 per therapeutic dose.

Prior authorization required.
Billing: use J9029 per therapeutic dose.

Note

Therapy Positioning

Adstiladrin is indicated as intravesical monotherapy for members with high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer (carcinoma in situ [CIS] with or without papillary tumors). Use only for patients refractory to adequate BCG as defined by persistent or recurrent CIS within 12 months of adequate BCG, recurrent high‑grade Ta/T1 within 6 months of adequate BCG, or T1 high‑grade at first evaluation after induction BCG. Administration is by intravesical instillation.

Indication: intravesical monotherapy for high‑risk BCG‑unresponsive NMIBC (CIS ± papillary).
Patient must be refractory to adequate BCG per defined criteria.
Administration route: intravesical instillation.

Documentation Required

Required Supporting Evidence

Authorization must be supported by FDA labeling, CMS‑recognized compendia, NCCN or ASCO guidelines, or acceptable peer‑reviewed literature per policy.

Required supporting evidence: FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature.

Denial Risk

Denial Triggers and Exclusions

Do not authorize or approve when any of the following apply: disease progression on Adstiladrin, prior adenovirus‑based treatment, extra‑vesical or muscle‑invasive or metastatic urothelial carcinoma, dosing exceeding single‑dose limit (75 mL at 3 x 10^11 vp/mL), treatment duration >12 months or >4 doses after complete response, or investigational/off‑label uses not supported by recognized compendia or adequate peer‑reviewed evidence.

Denial triggers: disease progression while on Adstiladrin.
Denial triggers: prior treatment with adenovirus‑based drugs.
Denial triggers: extra‑vesical (urethra/ureter/renal pelvis), muscle‑invasive (T2‑T4), or metastatic disease.
Denial triggers: dosing exceeds 75 mL at 3 x 10^11 vp/mL per dose.
Denial triggers: treatment exceeds 12 months or 4 doses (if CR achieved).
Denial triggers: investigational/off‑label indications not supported by CMS compendia or acceptable peer‑reviewed literature.

Therapy Positioning and Salvage Use

Salvage — Line of Therapy

Line of therapy: Used as intravesical monotherapy for high-risk BCG-unresponsive non-muscle invasive bladder cancer after failure of adequate BCG (positioned as salvage therapy refractory to local intravesical BCG)

Key Definitions

BCG-refractory CIS definition

DefinitionPersistent or recurrent carcinoma in situ (CIS) within 12 months of receiving adequate BCG

Adequate BCG — inductionAt least 5 of 6 doses of an initial induction course

Adequate BCG — maintenance/second inductionPlus either at least 2 of 3 maintenance doses or at least 2 of 6 doses of a second induction course

Background

Adstiladrin (nadofaragene firadenovec-vncg) is an intravesical gene therapy indicated for members with high-risk BCG-unresponsive non‑muscle invasive bladder cancer, including carcinoma in situ (CIS) with or without papillary tumors. It is administered as intravesical monotherapy and is positioned for patients who have failed adequate BCG therapy. The policy references pivotal clinical literature and prescribing information as the basis for coverage when criteria are met.