CurrentEmblemHealthPolicy MG.MM.PH.392

Adstiladrin (nadofaragene firadenovec-vncg) intravesical suspension

Medical policy governing coverage and authorization criteria for Adstiladrin for treatment of adult patients with high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) within EmblemHealth/ConnectiCare plans.

Policy Summary

PayerEmblemHealth

PolicyAdstiladrin (nadofaragene firadenovec-vncg) intravesical suspension

Policy CodePolicy MG.MM.PH.392

Change TypeCriteria additions and removalscoding updates

Effective DateAug 10, 2023

Next Review DateFeb 9, 2025

Key ActionSubmit prior authorization with clinical documentation (including TURBT results, cystoscopy and urine cytology) demonstrating the patient meets initial or renewal criteria.

SourceLink

POLICY UPDATE CHANGES

Removed from initial criteria Patient meets ONE of the following (i OR ii): i. Patient has carcinoma in situ (CIS) with or without high-grade papillary Ta/T1 tumors; OR ii. Patient has high-grade papillary Ta/T1 tumors without CIS; AND Medication is used for ONE of the following (i OR ii): Initial treatment; OR Cytology- and bladder-biopsy positive, imaging- and cystoscopy-negative, recurrent, or persistent disease.

Addition of requirement that patient has undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease (Ta and T1 components).

Addition of exclusion that patient does NOT have extra-vesical, muscle invasive (T2-T4), or metastatic urothelial carcinoma.

Addition of Limitations: no hypersensitivity to interferon alfa; not immunosuppressed or immunodeficient; intravesical use only; used as single agent.

Addition of ICD‑10 diagnosis codes for malignant neoplasms of bladder, carcinoma in situ of bladder, and personal history of bladder cancer.

12 monthsLength of authorization

75 mL q3 monthsDose and frequency

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J9029Applicable HCPCS

55566-1050-01Applicable NDC

Coverage and Authorization Criteria

Coverage is limited by the following contraindications and operational limitations. Approvals require that the patient: does not have a hypersensitivity to interferon alfa; is not immunosuppressed or immunodeficient; will receive therapy by intravesical instillation only; and that Adstiladrin will be administered as a single agent (i.e., not combined with other intravesical or systemic antineoplastic therapies).

These limitations reflect recent policy revisions and are prerequisites for medical necessity determination. Documentation submitted for prior authorization should explicitly address hypersensitivity status, immune competence, planned route of administration, and the single‑agent treatment intent.

Adstiladrin is not covered for disease that extends beyond the approved indication. Specifically, therapy is excluded for patients with extra‑vesical involvement (defined to include urethra, ureter, or renal pelvis), muscle‑invasive disease (T2‑T4), or metastatic urothelial carcinoma.

Per the revision history and initial approval criteria, absence of extra‑vesical, muscle‑invasive, or metastatic disease is a required precondition for approval; documentation of staging (clinical, imaging, and/or pathology) must demonstrate these exclusions are not present.

Applicable Codes

Applicable Procedure/HCPCS CodesHCPCSCovered

J9029

Injection, nadofaragene firadenovec-vncg, per therapeutic dose

Applicable NDCsNDC

55566-1050-01

Adstiladrin suspension

Applicable ICD-10 Diagnosis CodesICD-10Covered

C67.0	Malignant neoplasm of trigone of bladder
C67.1	Malignant neoplasm of dome of bladder
C67.2	Malignant neoplasm of lateral wall of bladder
C67.3	Malignant neoplasm of anterior wall of bladder
C67.4	Malignant neoplasm of posterior wall of bladder
C67.5	Malignant neoplasm of bladder neck
C67.6	Malignant neoplasm of ureteric orifice
C67.7	Malignant neoplasm of urachus
C67.8	Malignant neoplasm of overlapping sites of bladder
C67.9	Malignant neoplasm of bladder, unspecified

1–10 of 12

1/2

Provider Requirements and Documentation

Prior Authorization

Prior authorization required — approval length and dosing limits

Prior authorization is required and must demonstrate the member meets the coverage criteria. Approvals are issued for 12 months. Dosing is limited to 75 mL of Adstiladrin at a concentration of 3 × 10^11 vp/mL instilled into the bladder once every 3 months.

Prior authorization must document that patient meets all initial approval criteria (age ≥18, high‑risk BCG‑unresponsive NMIBC, TURBT to remove all resectable disease, no extra‑vesical/muscle invasive/metastatic disease, and prescribed by or in consultation with a urologist or oncologist).
Authorization length: 12 months.
Dose limit: 75 mL per instillation at 3 × 10^11 vp/mL, administered once every 3 months.

Step Therapy

Step therapy / specialty prescriber

No step therapy sequence is specified for Adstiladrin. The medication must be prescribed by, or in consultation with, a urologist or an oncologist.

Definitions and Background

Adstiladrin (nadofaragene firadenovec-vncg) — key facts

Product name (generic and brand)Nadofaragene firadenovec-vncg (Adstiladrin)

Therapeutic classNon-replicating adenoviral vector gene therapy

Mechanism of actionAdenoviral vector delivers a gene encoding human interferon alfa-2b (IFNα2b) to bladder urothelium resulting in local IFNα2b expression with anticipated antitumor effects

Route of administrationIntravesical instillation into the bladder

Target tissueBladder urothelium

High‑risk BCG‑unresponsive NMIBC — definition and scope

Policy Revision History

2025-02-09policy_revisionLatest

Removed prior initial-criteria language that specified alternative presentations (CIS with/without high-grade Ta/T1 or high-grade Ta/T1 without CIS) and clarified initial eligibility by adding TURBT requirement to remove all resectable disease and excluding extra-vesical, muscle-invasive (T2–T4), or metastatic urothelial carcinoma; also added limitations regarding hypersensitivity to interferon alfa and immunosuppression/immunodeficiency.

codes_added

Added ICD-10 diagnosis codes for malignant neoplasms of the bladder, carcinoma in situ of bladder, and personal history of bladder cancer (C67.x, D09.0, Z85.51).

Policy Summary

PayerEmblemHealth

PolicyAdstiladrin (nadofaragene firadenovec-vncg) intravesical suspension

Policy CodePolicy MG.MM.PH.392

Change TypeCriteria additions and removalscoding updates

Effective DateAug 10, 2023

Next Review DateFeb 9, 2025

Key ActionSubmit prior authorization with clinical documentation (including TURBT results, cystoscopy and urine cytology) demonstrating the patient meets initial or renewal criteria.

SourceLink

On This Page

Specialty prescribing: Prescribed by or in consultation with a urologist or an oncologist (per initial approval criteria).

Documentation Required

Clinical documentation to support request

Submit clinical evidence that the patient meets initial or renewal criteria to support the prior authorization request. Documentation should demonstrate diagnosis, staging, prior procedures, and treatment response as applicable.

TURBT operative report and pathology confirming removal of all resectable disease (Ta/T1 components).
Cystoscopy findings and urine cytology reports (including negative cystoscopy/biopsies for first renewal when applicable).
Documentation of disease extent/staging to exclude extra‑vesical, muscle invasive (T2‑T4), or metastatic disease.
Treatment history confirming BCG‑unresponsive status and any prior therapies.

Denial Risk

Documentation required for review — missing evidence may lead to denial

Failure to submit the required clinical evidence that the member meets the criteria will prevent proper review and may result in denial. Reviewers should confirm required documents are present before authorization determination.

If TURBT, cystoscopy, cytology, staging, and prior BCG documentation are not provided, the request may be denied for insufficient documentation.
Clinical review should verify age, BCG‑unresponsive status, TURBT completion, exclusion of muscle invasive/metastatic disease, and specialty prescribing.

Adult patients (age ≥ 18) with non‑muscle invasive bladder cancer (NMIBC)

Clinical designationHigh‑risk, BCG‑unresponsive NMIBC

Included disease featuresCarcinoma in situ (CIS) with or without papillary (Ta/T1) tumors

Required preconditionTransurethral resection of bladder tumor (TURBT) to remove all resectable Ta and T1 disease

Exclusions re extentDoes NOT include extra‑vesical (urethra, ureter, renal pelvis), muscle‑invasive (T2‑T4), or metastatic urothelial carcinoma

Adstiladrin (nadofaragene firadenovec‑vncg) is an intravesical, non‑replicating adenoviral vector gene therapy that delivers a gene encoding human interferon alfa‑2b to the bladder urothelium to produce local expression of IFNα2b and intended antitumor effects. It is indicated for adult patients with high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) including carcinoma in situ with or without papillary tumors.

In clinical use, Adstiladrin is administered by intravesical instillation into the bladder via urinary catheter. The policy requires that patients be age ≥ 18, have undergone transurethral resection of bladder tumor (TURBT) to remove all resectable Ta/T1 disease, and that dosing follow the approved schedule (75 mL instilled every 3 months at 3 × 10^11 vp/mL).

Policy effective date recorded as 2023-08-10.