CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Adstiladrin (nadofaragene firadenovec‑vncg) intravesical therapy — coverage criteria

Defines accepted indications, contraindications, exclusions, coding, and utilization management requirements for Adstiladrin intravesical therapy for high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer; applies to providers submitting medication requests to Evolent/NHPRI.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdstiladrin (nadofaragene firadenovec‑vncg) intravesical therapy — coverage criteria

Policy CodePolicy N/A

Change TypeClarification and template conversion (includes continuation request clarifications)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for J9029 and document FDA labeling or guideline/compendia support.

SourceLink

POLICY UPDATE CHANGES

Updated 'continuation request' verbiage.

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

Updated references.

BCG‑unresponsive CISprimary covered indication

12 months / 4 dosesmaximum treatment duration

75 mL @ 3x10^11 vp/mLsingle dose limit

J9029billing code

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Coverage Criteria for Adstiladrin

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial coverage for Adstiladrin: 1) Member has high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in situ (CIS), with or without papillary tumors; AND 2) Adstiladrin (nadofaragene firadenovec‑vncg) will be used as monotherapy for intravesical instillation; AND 3) Member is refractory to local (intravesical) BCG therapy as defined by the policy (BCG‑refractory definitions: persistent or recurrent CIS within 12 months of adequate BCG [≥5/6 induction doses plus ≥2/3 maintenance or ≥2/6 second induction], recurrent high‑grade Ta/T1 within 6 months of adequate BCG, or T1 high‑grade disease at first evaluation after induction BCG [≥5/6 doses]).

Supports FDA‑approved indication and requires supporting documentation per FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature.

Requests for Adstiladrin (nadofaragene firadenovec‑vncg) will be excluded when any of the following applied conditions are present: disease progression while receiving Adstiladrin, prior exposure to adenovirus‑based therapies, or evidence of disease outside the bladder (extra‑vesical involvement of the urethra, ureter, or renal pelvis). Coverage is also not provided for muscle‑invasive (T2‑T4) or metastatic urothelial carcinoma.

Use of Adstiladrin for indications that lack adequate supporting evidence is considered investigational and not approvable. Examples include uses supported only by case reports or meeting abstracts without a full peer‑reviewed publication, or off‑label indications not endorsed by CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy requires that the clinical population, regimen, and outcomes be adequately represented in the published evidence and that study designs provide meaningful, generalizable results before coverage will be authorized.

Covered Regimens and Dosing

Regimen	Billing code	Dose / concentration	Single-dose volume limit	Maximum treatment duration / notes
Adstiladrin (nadofaragene firadenovec‑vncg) intravesical instillation; intravesical monotherapy for high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer (CIS, with or without papillary tumors)	J9029	Per therapeutic dose at a concentration of 3 x 10^11 viral particles (vp)/mL	75 mL	Treatment duration limited to 12 months, or up to 4 doses if a complete response is achieved

Coding and Quantity Limits

Covered HCPCS CodesHCPCSCovered

J9029

Intravesical instillation, nadofaragene firadenovec-vncg, per therapeutic dose

inv-05: Single dose limit — 75 mL at a concentration of 3 x 10^11 viral particles (vp)/mL

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

Applicable productAdstiladrin (nadofaragene firadenovec-vncg)

Billing guidanceDose billed per therapeutic instillation (J9029)

Exclusion consequenceRequests exceeding this single dose limit will be excluded (denied)

inv-06: Maximum treatment duration — 12 months or 4 doses (if patient achieved a complete response)

Maximum treatment duration12 months or 4 doses (if the patient achieved a complete response)

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adstiladrin (J9029) intravesical therapy. Coverage is limited to use as monotherapy for intravesical instillation in members with high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, who meet the documented BCG‑refractory criteria and other policy clinical requirements.

Prior authorization required for J9029 (Adstiladrin)
Coverage limited to high‑risk BCG‑unresponsive NMIBC with CIS +/- papillary tumors
Must be used as monotherapy for intravesical instillation

Step Therapy

Step‑therapy / Prior Treatment Requirement

Adstiladrin must be used as monotherapy for intravesical instillation in members who are refractory to local (intravesical) BCG therapy. Requests should document prior adequate BCG exposure (e.g., at least 5 of 6 induction doses plus appropriate maintenance or re‑induction dosing) and the specific BCG‑refractory pattern (persistent/recurrent CIS within 12 months, recurrent high‑grade Ta/T1 within 6 months, or T1 high‑grade at first evaluation after induction).

Line of Therapy Designation

Second-line

Line of therapy: Adstiladrin is indicated for BCG‑unresponsive disease after adequate prior intravesical BCG (as defined by the BCG‑refractory criteria); intended as an alternative to radical cystectomy in BCG‑unresponsive non‑muscle invasive bladder cancer.

Policy requires prior BCG exposure meeting adequacy definitions.

Key Definitions

inv-12: BCG‑refractory CIS — definition for persistent or recurrent CIS within 12 months of adequate BCG

DefinitionPersistent or recurrent carcinoma in situ (CIS), with or without recurrent Ta/T1, occurring within 12 months of receiving adequate BCG

Adequate BCG definedAt least 5 of 6 doses of an initial induction course plus either ≥2 of 3 doses of maintenance therapy or ≥2 of 6 doses of a second induction course

IncludesCIS that is persistent after or recurs within 12 months of adequate BCG exposure

ContextUsed to determine eligibility for Adstiladrin in BCG‑unresponsive non‑muscle invasive bladder cancer

Background

Adstiladrin (nadofaragene firadenovec‑vncg) is an intravesical gene therapy indicated for high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer, particularly carcinoma in situ (CIS) with or without papillary tumors. Coverage is limited to intravesical monotherapy per the labeled indication and is subject to dosing and duration limits: a single dose volume limit of 75 mL at a concentration of 3 x 10^11 viral particles (vp)/mL, and a maximum treatment duration of 12 months (or up to 4 doses if the patient achieves a complete response).