ADSTILADRIN (nadofaragene firadenovec-vncg)

ADSTILADRIN (nadofaragene firadenovec-vncg)

Office-Administration – intravesical instillation only

Diagnosis considered for coverage:

• Non-Muscle Invasive Bladder Cancer (NMIBC): Indicated 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. 

Coverage Criteria:

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

• Diagnosis of high-risk, non-Muscle Invasive Bladder Cancer (NMIBC); AND
• One of the following:
  • Tumor is carcinoma in situ (CIS)
  • Ta/T1 high grade disease; AND
• Patient is not eligible for or has elected not to undergo cystectomy; 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:
  • At least two of three doses of maintenance therapy
  • At least two of six doses of a second induction course; AND
• Tumor is BCG unresponsive as defined by one of the following:
  • 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 
• The patient has had all resectable disease (Ta and T1 components) removed; AND
• The patient does not have extra-vesical (i.e., urethra, ureter, or renal pelvis), muscle invasive (T2-T4), or metastatic urothelial carcinoma.

Reauthorization Criteria:

For diagnosis of NMIBC:

• Patient does not show evidence of progressive disease while on therapy.

Coverage Duration: 

• Initial: 6 months
• Reauthorization: 1 year

Dosing:

NMIBC:

• The recommended dose of ADSTILADRIN is 75 mL at a concentration of 3 x 10¹¹ viral particles (vp)/mL instilled once every three (3) months into the bladder via a urinary catheter.

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• 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.
• 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.
• 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.

Policy Updates:

• 03/1/2024 – New policy approved by WHA P&T Committee. (P&T, 02/20/2024) 

References:

• 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 November 2, 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 November 2, 2023. 
• FDA Review Adstiladrin. Available at: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/adstiladrin. Accessed November 2, 2023.