Adstiladrin (nadofaragene firadenovec) for NMIBC — Oncology (Intravesical) - Adstiladrin UM Medical Policy
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Covers prior authorization, coverage criteria, dosing, and approval durations for Adstiladrin intravesical therapy in adults with high-risk BCG-unresponsive non‑muscle invasive bladder cancer; applies to Aspirus Medicare plans and requires specialist prescribing or consultation.
Policy name changed from 'Oncology (Other) - Adstiladrin UM Medical Policy' to 'Oncology (Intravesical) - Adstiladrin UM Medical Policy'.
Approval duration language modified: removed 1 year approval and changed to 'approve for the duration noted'; initial therapy approval defined as 4 months (to allow 2 doses) and continuation approvals of 3 months for ongoing therapy.
Criteria for initial therapy refined to require patient be 6gt;=18, have high-risk BCG-unresponsive disease, have CIS or high-grade Ta/T1 without CIS, and prescribing by or in consultation with a urologist or oncologist.
Added option for approval of patients currently receiving Adstiladrin for 3 months if in remission or cytology-positive with imaging/cystoscopy negative disease and prescribed by or in consultation with urology/oncology.
Coverage Criteria for Adstiladrin (nadofaragene firadenovec)
FDA‑Approved Indication Criteria
Approve when ONE of the following (A or B) is met
Coverage is not recommended for requests that do not meet the Recommended Authorization Criteria. The policy’s authorization criteria define the clinical scenarios in which Adstiladrin (nadofaragene firadenovec) intravesical therapy may be approved; situations outside those listed criteria are not recommended for approval.
This policy’s non‑coverage statement applies to any circumstance not explicitly included in the Recommended Authorization Criteria. Criteria will be updated as new published data become available; until then, coverage is limited to the listed indications and requirements.
Product Coding and Key Attributes
| nadofaragene firadenovec-vncg | Adstiladrin (intravesical suspension) |
Prior Authorization, Documentation, and Prescribing Requirements
Prior authorization recommended; defined approval windows
Prior authorization is recommended for Adstiladrin. Initial approvals should be issued for 4 months to allow two doses (given 3 months apart). Approvals for patients already receiving Adstiladrin should be issued for 3 months. All approvals are provided for the duration noted and require that the medication be prescribed by or in consultation with a physician who specializes in the condition (urologist or oncologist).
- Initial therapy: approve for 4 months to allow 2 doses (3 months apart).
- Currently receiving: approve for 3 months to allow a single dose 3 months after the most recent dose.
- All approvals provided for the duration noted; specialist prescribing/consultation required.
No mandated step therapy; specialist involvement required
No specific step therapy sequence is mandated by this policy. Prescribing or continuation of Adstiladrin must be by or in consultation with a urologist or an oncologist.
- Policy does not require prior medication trials or a step sequence before Adstiladrin.
- Specialist (urology or oncology) prescribing/consultation is required.
Documentation required to support prior authorization
Prior authorization requires documentation that the patient meets age and diagnostic criteria and that the medication is prescribed by or in consultation with an appropriate specialist.
- Proof patient is ≥ 18 years of age.
- Documentation the patient has high‑risk, BCG‑unresponsive disease and meets tumor-type criteria (CIS, or high‑grade Ta/T1 without CIS).
- If requesting continuation, documentation of response status (remission on cytology and cystoscopy OR cytology‑positive with imaging/cystoscopy negative recurrent or persistent disease).
- Evidence that medication is prescribed by or in consultation with a urologist or an oncologist.
Requests outside criteria are not recommended for approval
Requests that do not meet the Recommended Authorization Criteria are not recommended for approval.
- Coverage is not recommended for circumstances outside the listed Recommended Authorization Criteria.
Background and Clinical Context
Adstiladrin is a gene‑therapy product used intravesically for high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer. Prior authorization is recommended and approval is limited to the specific clinical scenarios described in the Recommended Authorization Criteria; requests falling outside those scenarios are not recommended for approval.
Key Definitions
Line of Therapy
first-line
Recommended use setting:
Covered Regimens and Dosing
| Regimen | Dose & Administration | Interval | Coverage Status |
|---|---|---|---|
| Adstiladrin intravesical regimen | |||
| 75 mL of Adstiladrin instilled into the bladder via urinary catheter | |||
| Once every 3 months | |||
| Covered with criteria |
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