Adstiladrin (nadofaragene firadenovec) — Utilization Management / Coverage Criteria
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Defines utilization management, prior authorization, and coverage criteria for Adstiladrin for adults with high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer (CIS with or without papillary tumors or Ta/T1 papillary tumors without CIS) across all UCare plans.
No material clinical or coverage changes in this revision.
Recommended Authorization Criteria
FDA‑Approved Indication / Authorization Criteria
Coverage of Adstiladrin is recommended in those who meet the following criteria:
Coverage of Adstiladrin is not recommended for circumstances that are not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data are available.
| Dose / Formulation | Dosing interval | Indication | Coverage |
|---|---|---|---|
| Adstiladrin (nadofaragene firadenovec) – intravesical suspension, 75 mL per instillation | Once every 3 months | High‑risk BCG‑unresponsive non‑muscle invasive bladder cancer: carcinoma in situ (CIS) with or without papillary tumors; or Ta/T1 papillary tumors without CIS | Covered with criteria (see authorization criteria) |
Prior Authorization & Prescriber Requirements
Prior authorization required — approvals are time-limited
Prior authorization is recommended for medical benefit coverage of Adstiladrin. Approvals are time-limited: initial approvals are for 4 months to allow two doses (given 3 months apart); approvals for patients currently receiving therapy are for 3 months to allow a single dose 3 months after the most recent dose. Extended approvals may be allowed if the patient continues to meet the Criteria and Dosing.
- Initial approval: 4 months (to allow 2 doses 3 months apart)
- Renewal/ongoing (currently receiving): 3 months (to allow a single dose 3 months after the most recent dose)
Nonstandard dosing requires clinician review
Requests for doses outside the established dosing documented in this policy will be reviewed case-by-case by a clinician (Medical Director or Pharmacist).
- Nonstandard dosing requests are evaluated individually by a clinician
Prescriber specialty and criteria documentation required
Approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition (urologist or oncologist) and documentation that the patient meets the applicable criteria (age, BCG‑unresponsive high‑risk NMIBC subtype, and dosing/administration plan).
- Prescriber must be a urologist or oncologist, or documented consultation with one
- Include documentation that patient meets age and disease subtype criteria and planned 75 mL every 3 months dosing
Denial risk for non‑listed indications
Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria; requests outside the listed indications should be expected to be denied unless criteria are met.
- Do not submit requests for indications not enumerated in the policy's Recommended Authorization Criteria
Product and Billing Codes
| nadofaragene firadenovec-vncg | Adstiladrin® (intravesical suspension) |
Dosing and Regimen Details
| Dose per instillation | Interval | Initial approval duration | Renewal / Currently receiving |
|---|---|---|---|
| 75 mL instilled into the bladder via urinary catheter | Every 3 months | Initial approval: 4 months (to allow 2 doses given 3 months apart) | Renewal approval: 3 months to allow a single dose 3 months after the most recent dose (for patients currently receiving therapy) |
Key Definitions
Therapy Line Positioning
First-line
Clinical Background
Adstiladrin (nadofaragene firadenovec) is a non‑replicating adenoviral vector gene therapy indicated for adults with high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer, including carcinoma in situ (CIS) with or without papillary tumors and Ta/T1 papillary tumors without CIS. The recommended intravesical regimen is 75 mL per instillation every 3 months, consistent with FDA‑approved labeling and NCCN guidance for this indication.
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