Adstiladrin (nadofaragene firadenovec) intravesical therapy — Coverage Criteria
Customize your policy alerts
Sign up for all Aspirus Arise policy alerts
Know when Aspirus Arise releases new policies or updates existing guidance.
Monitor payer policy activity
Prior-authorization and coverage criteria for Adstiladrin for adults with high-risk BCG-unresponsive non‑muscle invasive bladder cancer (NMIBC) with CIS with or without papillary tumors, for Aspirus Arise plans.
Approval duration language changed to 'approve for the duration noted' and initial therapy approval set to 4 months to allow 2 doses (3 months apart).
Added requirement that Adstiladrin be prescribed by or in consultation with a urologist or oncologist.
Reworded indication option to 'Patient has Ta/T1 papillary tumors without CIS.'
Recommended Authorization Criteria
FDA-Approved Indication: Non-Muscle Invasive Bladder Cancer
Approve for the duration noted if the patient meets ONE of the following (A or B):
Coverage is recommended only when the patient meets the specific requirements described in the Recommended Authorization Criteria. Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. The criteria will be updated as new published data become available; requests that do not meet the listed criteria should not be approved.
Requests for Adstiladrin that fall outside the situations enumerated in the Recommended Authorization Criteria are considered not medically necessary and are not recommended for approval. No additional explicit "not medically necessary" conditions are provided beyond this exclusion statement; reviewers should deny requests that are not supported by the listed criteria.
Coding and Eligibility
| No codes listed |
Authorization, Prescribing, and Operational Rules
Prior Authorization and Approval Duration
Prior Authorization is recommended for Adstiladrin. Initial approvals are recommended for 4 months to allow two doses (given 3 months apart). Continuation (for patients currently receiving Adstiladrin) approvals are recommended for 3 months to allow a single dose 3 months after the most recent dose. All approvals are provided for the duration noted and extended approvals are allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside the established dosing documented in this policy will be reviewed on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist).
- Initial approval: 4 months (allows 2 doses, 3 months apart)
- Continuation approval: 3 months (allows single dose 3 months after most recent)
- All approvals provided for the duration noted; extended approvals allowed if criteria continue to be met
- Requests for non-standard doses considered case-by-case
Step Therapy / Exceptions
No formal step therapy requirements are specified. However, requests for dosing outside the documented dosing schedule may be reviewed and considered on a case-by-case basis.
- No step therapy required
- Exceptions for doses outside documented dosing reviewed case-by-case
Prescriber Requirements and Denial Triggers
Adstiladrin must be prescribed by or in consultation with a urologist or oncologist. Prior Authorization is recommended. Requests that do not meet the Recommended Authorization Criteria (including indication, age, BCG‑unresponsive status, tumor type, or prescriber requirements) or requests for indications not listed in the criteria will not be recommended for approval.
- Must be prescribed by or in consultation with a urologist or oncologist
- Prior Authorization recommended
- Denial triggers: requests not meeting the Recommended Authorization Criteria or for unlisted indications
Key Definitions
Background
Adstiladrin (nadofaragene firadenovec) is a non-replicating adenoviral vector–based intravesical gene therapy approved for treatment of high-risk, BCG-unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors, in adults. It is intended to be administered intravesically per the labeled regimen for this indication.
Policy Changes
Approval duration language updated: initial therapy approval set to 4 months (allowing 2 doses) and approvals provided 'for the duration noted'; added 3-month approval option for patients currently receiving Adstiladrin when prescribed by or in consultation with a urologist or oncologist.
New policy created for Adstiladrin for Non‑Muscle Invasive Bladder Cancer (initial review date 2023-06-14).
Policy effective date recorded.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.