Oncology (Intravesical) - Adstiladrin UM Medical Policy
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Defines prior authorization and medical necessity criteria for coverage of Adstiladrin in adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC); applies to all UCare plans.
Approval duration language was changed (previously 1 year; now 'approve for the duration noted') and initial therapy approval period clarified to 4 months to allow 2 doses.
Policy name updated to 'Oncology (Intravesical) - Adstiladrin UM Medical Policy'.
Initial therapy criteria now require either CIS or high-grade papillary Ta/T1 without CIS; carcinoma in situ language was narrowed in a subsequent revision.
Recommended Authorization Criteria
FDA-Approved Indication
Approve if the patient meets ONE of the following (A or B):
A) Initial Therapy
Initial therapy criteria
- i: Patient is ≥ 18 years of age
- ii: Patient has high-risk, Bacillus Calmette-Guerin (BCG)-unresponsive disease
iii
- iii.a: Patient has carcinoma in situ (CIS)
- iii.b: Patient has high-grade papillary Ta/T1 tumors without CIS
- iv: Medication is prescribed by or in consultation with a urologist or an oncologist
B) Currently receiving Adstiladrin
i
- i.a: Patient is in remission both on cytology and cystoscopic examination
- i.b: Patient has cytology-positive, imaging- and cystoscopy-negative, recurrent or persistent disease
- ii: Medication is prescribed by or in consultation with a urologist or an oncologist
Dose/interval requirement for approvals
Coverage is recommended only when the patient meets the specific Recommended Authorization Criteria outlined elsewhere in this policy. Coverage is not recommended for circumstances that are not listed in those criteria. The criteria may be revised as new published data become available, and decisions should follow the most current policy language.
Use of Adstiladrin for indications or clinical situations outside the Recommended Authorization Criteria in this policy is not recommended for approval.
Dosing and Administration
| Regimen | Indication | Dose / Interval | Coverage status |
|---|---|---|---|
| Intravesical instillation | BCG-unresponsive high-risk non‑muscle invasive bladder cancer (including carcinoma in situ or high‑grade papillary Ta/T1 without CIS) | 75 mL instilled into the bladder via urinary catheter once every 3 months | Covered with criteria (see FDA‑Approved Indication and approval durations) |
Codes and Age Requirements
| n/a | No explicit CPT/HCPCS/ICD-10 codes listed in policy document |
Authorization, Documentation, and Exceptions
Prior Authorization Required
Prior authorization recommended for medical benefit coverage of Adstiladrin. Approval is recommended for patients who meet the Criteria and Dosing for the listed indication. Extended approvals may be granted if the patient continues to meet the Criteria and Dosing. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Adstiladrin, approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., urologist or oncologist).
- Prior authorization recommended — Effective date: 2023-11-15
- Prescriber requirement: prescribed by or in consultation with a urologist or oncologist
- Approval duration aligns with the Criteria: initial approvals (4 months to allow 2 doses) or continuation approvals (3 months to allow a single dose)
Exceptions Process
Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (for example, the Medical Director or a Pharmacist). Such exceptions require submission of supporting clinical rationale and relevant documentation demonstrating why standard dosing is not appropriate and how safety and efficacy will be monitored.
- Exceptions considered only by clinician review (Medical Director or Pharmacist)
- Provide clinical rationale and supporting documentation when requesting doses outside policy dosing
Required Documentation
Documentation submitted with authorization requests must demonstrate the patient’s age, disease status consistent with BCG‑unresponsive high‑risk non‑muscle invasive bladder cancer (NMIBC), prior treatment history relevant to BCG unresponsiveness, and that the prescriber is a urologist or oncologist or consulted with one. For initial therapy include evidence supporting CIS or high‑grade Ta/T1 tumor status as applicable. For continuation therapy include recent cytology and cystoscopy findings documenting remission or cytology-positive, imaging- and cystoscopy‑negative recurrent/persistent disease. Also include dosing schedule justification when applicable.
- Must document patient age (≥ 18 years)
- Must document BCG‑unresponsive high‑risk NMIBC status and tumor subtype (CIS or high‑grade Ta/T1) as applicable
- For continuation therapy, include cytology and cystoscopy findings or documentation of cytology-positive/imaging- and cystoscopy-negative disease
- Include prescriber specialty or documentation of consultation (urology or oncology)
Nonconforming Requests
Requests that do not meet the Recommended Authorization Criteria or the dosing specified in this policy are not recommended for approval. If a request lacks sufficient documentation to demonstrate criteria are met, it will not be recommended for approval unless adequate supporting information is provided.
- Nonconforming requests — will not be recommended for approval
- Insufficient documentation — provide complete clinical records to avoid denial
Therapy Positioning
First-line
Key Definitions
Background and Rationale
Adstiladrin (nadofaragene firadenovec) is an intravesical, non-replicating adenoviral vector–based gene therapy indicated for adults with BCG-unresponsive high‑risk non‑muscle invasive bladder cancer (NMIBC). It is administered as an intravesical instillation per the dosing regimen described in this policy, and coverage decisions should align with the FDA‑approved indication and the policy’s Recommended Authorization Criteria.
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