CurrentBlue Cross Blue Shield - MassachusettsPolicy 159

Nadofaragene firadenovec (Adstiladrin) for BCG‑unresponsive non‑muscle invasive bladder cancer

Medical necessity and prior authorization requirements for use of intravesical nadofaragene firadenovec (Adstiladrin) to treat BCG‑unresponsive high‑risk non‑muscle invasive bladder cancer in eligible Blue Cross Blue Shield Massachusetts members.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyNadofaragene firadenovec (Adstiladrin) for BCG‑unresponsive non‑muscle invasive bladder cancer

Policy CodePolicy 159

Change TypeNo material change

Effective DateJun 8, 2023

Next Review Date

Key ActionSubmit prior authorization requests via Authorization Manager and complete the Adstiladrin prior authorization form (policy 193) with required clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

up to 6 moinitial approval

12 morenewal interval

J9029HCPCS

≈53%CIS CR rate

9.7 momedian CR duration

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Coverage Criteria for Nadofaragene firadenovec (Adstiladrin)

inv-01: Initial Approval

Covered when ALL of the following are met:

Initial approval: 1) Diagnosis of non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors; AND 2) High‑risk disease that is unresponsive to Bacillus Calmette‑Guérin (BCG) defined as either: persistent disease following adequate BCG therapy (at least 5 of 6 induction doses followed by at least 2 of 3 maintenance doses, or at least 2 of 6 doses of an additional induction) OR T1 disease following a single induction course of BCG; AND 3) Disease recurrence after an initial tumor‑free state following adequate BCG therapy as defined above; AND 4) Transurethral resection of bladder tumor (TURBT) performed to remove all resectable disease (Ta and T1 components); AND 5) Patient is not currently receiving systemic therapy for bladder cancer; AND 6) No extra‑vesical (urethra, ureter, renal pelvis), muscle‑invasive (T2‑T4), or metastatic urothelial carcinoma; AND 7) Patient has not received prior adenovirus‑based therapies; AND 8) No hypersensitivity to interferon alfa; AND 9) Patient is not immunosuppressed or immunodeficient.

From initial approval section

inv-02: Continued Approval / Renewal

Covered for renewal when ALL of the following are met:

Continued approval: 1) Disease response to treatment defined by stabilization of disease or decrease in tumor size or tumor spread; AND 2) Continues to meet initial approval criteria; AND 3) Absence of unacceptable drug toxicity (e.g., disseminated adenovirus infection); AND 4) For subsequent renewals, the patient has not experienced a high‑grade or CIS recurrence; AND 5) For the first renewal request, the patient had a complete response to initial therapy defined as negative cystoscopy (with TURBT/biopsies as applicable) and urine cytology.

From continued approval section

inv-03: Investigational / Not Covered Indications

Not covered: Use of Adstiladrin (nadofaragene firadenovec‑vncg) for any other oncologic indication is considered investigational and is not covered.

From continued approval section

Patients are excluded from coverage if they have extra‑vesical disease involving sites such as the urethra, ureter, or renal pelvis, or if they have muscle‑invasive disease (T2–T4) or metastatic urothelial carcinoma. Coverage also requires the patient to have undergone transurethral resection of bladder tumor (TURBT) to remove all resectable Ta/T1 disease and to meet other baseline eligibility criteria; presence of any of the above excluded disease states disqualifies the patient from treatment with nadofaragene firadenovec (Adstiladrin) under this policy.

Use of Adstiladrin (nadofaragene firadenovec‑vncg) for any oncologic indication other than BCG‑unresponsive high‑risk non‑muscle invasive bladder cancer (NMIBC) is considered investigational and is not covered under this policy.

Coding and Billing Codes

HCPCS CodesHCPCSCovered

J9029

Injection nadofaragene firadenovec-vncg per therapeutic dose

ICD-10 Procedure CodesICD-10

XW033F3

Introduction of Other New Technology Therapeutic Substance into Peripheral Vein Percutaneous Approach New Technology Group 3

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for nadofaragene firadenovec (Adstiladrin). Providers must submit requests via Authorization Manager. Initial approvals are for up to 6 months and requests for commercial members must meet medical policy guidelines.

Initial approval duration: up to 6 months
Drug: nadofaragene firadenovec (Adstiladrin)
Authorization submission: Authorization Manager (available 24/7)
Out-of-network fax: 888-973-0726

Note

Provider Submission Notes

Providers should ensure the servicing provider NPI (surgeon) and facility NPI are entered correctly when submitting requests; enter the servicing provider's NPI, not the billing group. Requests should include required clinical documentation demonstrating the member meets medical necessity criteria (see policy criteria).

Enter servicing provider NPI (surgeon) — not billing group

Definitions

BCG‑unresponsive — definition and criteria (high‑risk disease unresponsive to BCG after adequate BCG)

DefinitionHigh‑risk non‑muscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette‑Guérin (BCG).

Criteria — adequate BCGPersistent disease after adequate BCG defined as at least 5 of 6 doses of initial induction plus at least 2 of 3 maintenance doses, OR at least 2 of 6 doses of an additional induction course.

Alternate BCG‑unresponsive scenarioStage T1 disease following a single induction course of BCG qualifies as BCG‑unresponsive.

Recurrence requirementDisease recurrence after an initial tumor‑free state following adequate BCG (as defined above) meets the BCG‑unresponsive definition.

Associated procedural requirementTransurethral resection of bladder tumor (TURBT) must have been performed to remove all resectable Ta and T1 disease prior to therapy.

Exclusions related to disease extent

Background

Nadofaragene firadenovec (Adstiladrin) is an intravesical, replication‑deficient adenoviral vector gene therapy that delivers the gene for interferon alfa‑2b directly to the bladder urothelium. It is indicated in this policy for patients with BCG‑unresponsive high‑risk NMIBC as an alternative to immediate cystectomy in appropriate candidates; BCG remains the standard first‑line intravesical therapy, and nadofaragene is intended for patients who meet the policy’s specific BCG‑unresponsive criteria.