Pharmacy Prior Authorization Criteria

Adstiladrin (nadofaragene firadenovec-vncg)

Indications for Prior Authorization

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.

Criteria

Adstiladrin

Prior Authorization (Initial Authorization)

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

• Diagnosis of high-risk, non-Muscle Invasive Bladder Cancer (NMIBC)
AND
• One of the following: [3]
• 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: [A, 2, 5]
• 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: [A, 2, 5]
• 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 [1]
AND
• The patient does not have extra-vesical (i.e., urethra, ureter, or renal pelvis), muscle invasive (T2-T4), or metastatic urothelial carcinoma [1]

Adstiladrin

Prior Authorization (Reauthorization)

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

• Patient does not show evidence of progressive disease while on therapy [1, 5]

P & T Revisions

2024-08-13, 2023-09-21

References

1. Adstiladrin prescribing information. Kuopio, Finland: Ferring Pharmaceuticals; December 2022.
2. 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]
3. 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.
4. 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.
5. FDA Review Adstiladrin. Available at: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/adstiladrin. Accessed August 8, 2023.

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Revision History

• 2024-08-13: 2024 Annual Review
• 2023-09-21: New UM PA program

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