Anthem Blue Cross California Commercial Clinical Policy

Anthem Blue Cross California Adstiladrin (nadofaragene firadenovec-vncg) Form

Effective Date

09/18/2023

Last Reviewed

08/18/2023

Original Document

  Reference



Publish Date:
09/18/2023

Last Review Date:
08/18/2023

Overview

Coding References Clinical Criteria Document History

Overview

This document addresses the use of Adstiladrin (nadofaragene firadenovec-vncg), a novel adenovirus vector-based gene therapy, for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. This is the first gene therapy approved in bladder cancer. Adstiladrin is an intravesical therapy that is administered every 3 months. It is designed to deliver a copy of the interferon-alfa 2b (IFNα2b) gene to the bladder urothelium, leading to transient local expression of IFNα2b, which is thought to have anti-tumor effects.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Adstiladrin (nadofaragene firadenovec-vncg)
Requests for Adstiladrin (nadofaragene firadenovec-vncg) may be approved if the following criteria are met:

  1. Individual is 18 years of age or older (Label); AND
  2. Individual has a diagnosis of Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors; AND
  3. Individual is ineligible for or have elected not to undergo cystectomy (NCCN Bladder Cancer Guidelines); AND
  4. Used as intravesical instillation; AND
  5. Individual has an Eastern Cooperative Oncology Group (ECOG) status of 0-2.

Requests for Adstiladrin (nadofaragene firadenovec-vncg) may not be approved when the above criteria are not met and for all other indications.

Quantity Limits

Adstiladrin (nadofaragene firadenovec-vncg) Quantity Limits
Adstiladrin (nadofaragene firadenovec-vncg) 3 X1011 viral particles (vp)/mL vial 4 vials every 90 days

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

  1. HCPCS J9029
  1. ICD-10 Diagnosis C67.0-C67.9 Z51.11-Z51.12

Document History

Revised: 08/18/2023