Pharmacy Prior Authorization Criteria

Adstiladrin (nadofaragene firadenovec-vncg)

For diagnosis of non-Muscle Invasive Bladder Cancer (NMIBC)
Indicated 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.

Prior Authorization (Initial Authorization)

Length of Approval: 6 months [B-C, 1, 5]

AND

AND

AND

Patient has received an adequate course of Bacillus Calmette Guérin (BCG) therapy defined as the administration of at least 5 of 6 doses of an initial induction course plus one of the following: [A, 2, 5]

AND

Persistent disease following adequate BCG therapy
Disease recurrence after an initial tumor-free state following adequate BCG therapy
T1 disease following a single induction course of BCG

AND

AND

The patient does not have extra-vesical (i.e., urethra, ureter, or renal pelvis), muscle invasive (T2-T4), or metastatic urothelial carcinoma [1]

Prior Authorization (Reauthorization)

Length of Approval: 12 months [C-D, 1, 5]

2024-08-13, 2023-09-21

Adstiladrin prescribing information. Kuopio, Finland: Ferring Pharmaceuticals; December 2022.
Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. Lancet Oncol. 021;22(1):107-117. doi:10.1016/S1470-2045(20)30540-4[PubMed 33253641]
clinicaltrials.gov. Adstiladrin (=Instiladrin) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Available at: https://clinicaltrials.gov/search?term=nct02773849. Accessed August 9, 2023.
Chang SS, Boorjian SA, Chou R et al: Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline (2020). Available at: https://www.auanet.org/guidelines-and-quality/guidelines/bladder-cancer-non-muscle-invasive-guideline. Accessed August 9, 2023.
FDA Review Adstiladrin. Available at: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/adstiladrin. Accessed August 8, 2023.

BCG is typically given weekly for 6 weeks at induction followed by maintenance of 3 weekly instillations at month 3, 6, 12, 18, 24, 30, and 36. Two 6-week BCG induction courses should be completed before the patient is considered non responsive to the therapy. Adequate BCG was defined as the administration of at least five of six doses of an initial induction course plus either at least two of three doses of maintenance therapy or at least two of six doses of a second induction course [2]
After the first administration of Adstiladrin, patients with no evidence of high-grade disease continue to receive further treatment with Adstiladrin every three months up to Month 12. Thereafter, patients continue to receive Adstiladrin every 3 months, at the discretion of the investigator, provided there is no evidence of high grade disease [5]
Patients received 75 mL (3 x 1011 vp/mL) Adstiladrin administered intravesically once every 3 months for up to 12 months. All patients with an absence of high-risk recurrence or progression were offered continued treatment every 3 months beyond 12 months [1]