CurrentMass General Brigham Health PlanPolicy 068

Medical Necessity Guidelines Adstiladrin (nadofaragene firadenovec-vncg)

Medical necessity guidelines for use of Adstiladrin (nadofaragene firadenovec-vncg) in adults with high-risk BCG-unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ, including prior authorization requirements and dosing/continuation criteria across Mass General Brigham Health Plan lines of business.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMedical Necessity Guidelines Adstiladrin (nadofaragene firadenovec-vncg)

Policy CodePolicy 068

Change TypeOff-cycle additions and annual review

Effective DateOctober 2023

Next Review Date

Key ActionObtain prior authorization and document BCG‑unresponsive high‑risk NMIBC status, TURBT, and dosing history.

SourceLink

POLICY UPDATE CHANGES

Updated prior authorization table and added variation for One Care and SCO members; added Prime Therapeutics information for commercial members.

MassHealth variation added for ACO members and MassHealth coverage added previously.

Reformatted policy and updated summary of evidence and references.

75 mLrecommended intravesical dose

12 monthsmax continuation

J9029billing code

53% @3mo

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Coverage Criteria for Adstiladrin (nadofaragene firadenovec-vncg)

inv-01: Initial Therapy

Authorization may be granted when ALL of the following are met:

Initial Approval: Member is ≥18 years of age; has non‑muscle invasive bladder cancer with carcinoma in situ (with or without papillary tumors); has high‑risk disease that is BCG‑unresponsive defined as ONE of the following: (a) Stage T1 disease following a single induction course of BCG; OR (b) persistent or recurrent disease following at least 5 of 6 doses of an initial induction course of BCG plus either at least 2 of 3 doses of maintenance therapy OR at least 2 of 6 doses of an additional induction course; AND has undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease (Ta and T1 components).

BCG‑unresponsive definitions include multiple logical options; the overall gate is that one of the BCG failure patterns must be present.

inv-02: Dosing and Administration

Dosing and administration requirements:

Dosing: Adstiladrin administered by intravesical instillation only: 75 mL at a concentration of 3 x 10^11 viral particles per mL, instilled into the bladder via urinary catheter once every 3 months; premedicate with an anticholinergic prior to instillation; leave study drug in bladder for 1 hour following instillation.

Follow intravesical administration procedure exactly.

inv-03: Continuation Therapy

Continuation of therapy (additional courses up to 12 months) when ALL of the following are met:

Continuation: Member continues to meet the criteria for initial approval; there is disease response to treatment defined as stabilization of disease or decrease in size of tumor or tumor spread; and there is absence of unacceptable toxicity to the drug.Up to 12 months total

If carcinoma in situ (CIS) does not have a complete response at 3 months or CIS recurs, providers should consider cystectomy.

Adstiladrin is not covered for treatment of urothelial carcinoma that is extra‑vesical (defined to include the urethra, ureter, or renal pelvis), muscle‑invasive disease (stages T2–T4), or metastatic disease. Additional exclusions include members who are currently receiving systemic therapy for bladder cancer, those who have received prior adenovirus‑based therapies, members with hypersensitivity to interferon alfa, and members who are immunosuppressed or immunodeficient.

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Use of Adstiladrin in any patient who meets one or more of the contraindications listed in the Exclusions section (for example, extra‑vesical, muscle‑invasive, or metastatic urothelial carcinoma; current systemic bladder cancer therapy; prior adenovirus‑based therapy; hypersensitivity to interferon alfa; or immunosuppression/immunodeficiency) is not medically necessary.

Coding and Dose Information

Authorized CodeHCPCS

J9029

Injection, nadofaragene firadenovec-vncg, per therapeutic dose

inv-07: Dose concentration and volume

Recommended dose concentration3 x 10^11 viral particles per mL

Recommended volume per instillation75 mL

Administration frequencyInstilled once every 3 months via urinary catheter

Route and dwell timeIntravesical instillation only; leave in bladder for 1 hour after instillation

PremedicationPremedicate with an anticholinergic prior to instillation

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required

Prior authorization is required for Adstiladrin for Medicare Advantage, Mass General Brigham ACO, One Care/SCO, and Commercial/Qualified Health Plan members; commercial prior authorization is managed by Prime Therapeutics.

Authorized billing code: J9029 (see coding table).

Step Therapy

Step therapy — BCG‑unresponsiveness required, not a step sequence

The policy does not impose a formal step‑therapy sequence; instead, authorization requires documented BCG‑unresponsiveness as defined in the criteria (specific patterns of failure after induction and/or maintenance BCG).

BCG‑unresponsive definitions include stage T1 after a single induction, or persistent/recurrent disease after ≥5 of 6 induction doses plus required maintenance or additional induction dosing.

Background

Adstiladrin (nadofaragene firadenovec‑vncg) is delivered intravesically as a nonreplicating adenovirus vector gene therapy designed to transfer the gene for interferon alfa‑2b (IFNα2b) to urothelial cells. It is intended for adult patients with high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in situ as a bladder‑preserving treatment option; clinical trial data demonstrate initial complete response in a proportion of patients but only a minority maintain response at later follow‑up.

Definitions

inv-13: BCG‑unresponsive

Applicable disease stateHigh‑risk non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors

BCG‑unresponsive definitions (any one required)1) Stage T1 disease following a single induction course of BCG; OR 2) Persistent or recurrent disease after ≥5 of 6 doses of an initial induction BCG course plus either ≥2 of 3 doses of maintenance therapy OR ≥2 of 6 doses of an additional induction course.

Age requirementMember is 18 years of age or older

Clinical implicationPolicy requires demonstration of one of the specified BCG failure patterns to qualify as BCG‑unresponsive high‑risk disease

inv-14: TURBT

TURBT requirementMember must have undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease (Ta and T1 components) prior to administration