Currentharvard pilgrim health carePolicy N/A

Adstiladrin (nadofaragene firadenovec-vncg) — Coverage Criteria for BCG‑unresponsive NMIBC with CIS

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Medical necessity guideline for prior authorization and coverage of Adstiladrin for adults with high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), applicable to the Plan's covered products and subject to benefit terms.

Policy Summary

Payerharvard pilgrim health care

PolicyAdstiladrin (nadofaragene firadenovec-vncg) — Coverage Criteria for BCG‑unresponsive NMIBC with CIS

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2026

Last ReviewDec 8, 2025

Next Review DateJan 1, 2026

Key ActionObtain prior authorization for HCPCS code J9029 and submit supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yrinitial authorization duration

J9029HCPCS prior auth

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Currentharvard pilgrim health carePolicy N/A

Adstiladrin (nadofaragene firadenovec-vncg) — Coverage Criteria for BCG‑unresponsive NMIBC with CIS

Customize your policy alerts

Sign up for all harvard pilgrim health care policy alerts

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Policy Summary

Payerharvard pilgrim health care

PolicyAdstiladrin (nadofaragene firadenovec-vncg) — Coverage Criteria for BCG‑unresponsive NMIBC with CIS

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2026

Last ReviewDec 8, 2025

Next Review DateJan 1, 2026

Key ActionObtain prior authorization for HCPCS code J9029 and submit supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yrinitial authorization duration

J9029HCPCS prior auth

Coverage Criteria for Adstiladrin (nadofaragene firadenovec-vncg)

inv-01: Initial Authorization Criteria

Covered when ALL of the following are met:

Initial criteria: Member is 18 years or older; Member has a diagnosis of non‑muscle‑invasive bladder cancer (NMIBC); Disease is high‑risk with carcinoma in situ (CIS); Provider is an oncologist or urologist; Appropriate dosing per prescribing information; Inadequate response, adverse reaction, or contraindication to Bacillus Calmette‑Guérin (BCG)

Based on Plan criteria aligning with FDA indication and cited clinical trial

inv-02: Reauthorization Criteria

Reauthorization covered when ALL of the following are met:

Reauthorization criteria: Initial criteria is met; No evidence of unacceptable toxicity or disease recurrence

Reauthorization may be granted for 1 year

Coverage is denied for members with known hypersensitivity to interferon alfa or any component of the product. Additionally, the Plan will not cover Adstiladrin for members who are immunocompromised or immunodeficient.

Regimen	Indication / Patient population	Dosing summary
Intravesical nadofaragene firadenovec‑vncg (Adstiladrin)	Treatment of adult patients with high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors; patient is 18 years or older and has had an inadequate response, adverse reaction, or contraindication to intravesical BCG	Per prescribing information: intravesical administration as described in the FDA label (use appropriate dosing per product labeling)

Therapy Line Specification

inv-11: second-line

Line of therapy: Used for patients with BCG‑unresponsive disease after prior BCG (inadequate response, adverse reaction, or contraindication)

Second‑line therapy as alternative for patients with BCG‑unresponsive NMIBC with CIS

Billing and Coding

HCPCS Codes requiring prior authorizationHCPCSCovered

J9029

Injection, nadofaragene firadenovec-vncg, per therapeutic dose

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for HCPCS code J9029 (Injection, nadofaragene firadenovec-vncg, per therapeutic dose). If prior authorization is required, submit supporting clinical documentation pertinent to the service request.

HCPCS: J9029 — Injection, nadofaragene firadenovec-vncg, per therapeutic dose

Prior Authorization

BCG Attempted or Contraindicated

There must be an inadequate response to, an adverse reaction to, or a contraindication to Bacillus Calmette-Guérin (BCG) therapy before Adstiladrin (nadofaragene firadenovec-vncg) will be approved.

Documentation Required

Supporting Documentation

Key Definitions

BCG‑unresponsive NMIBC with CIS — definition and patient population details

TermBCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS)

Population ageAdults 18 years and older

Clinical characterizationHigh-risk NMIBC with carcinoma in situ (CIS), with or without papillary tumors

Prior BCG statusInadequate response, adverse reaction, or contraindication to intravesical BCG therapy is required

Responsible provider specialtiesOncologist or urologist

Supporting evidenceFDA approval based on phase 3 trial reporting 51% complete response rate and median CR duration 9.7 months

Background

Adstiladrin (nadofaragene firadenovec‑vncg) is covered under the Plan with specific authorization limits. Initial authorization is limited to 1 year when the initial criteria are met, and reauthorization may be granted for an additional 1 year if reauthorization criteria are satisfied.