CurrentAetnaPolicy N/A

Adstiladrin (nadofaragene firadenovec-vncg) Precertification Request Coverage Criteria

Precertification form and requirements for Aetna coverage review of Adstiladrin for treatment of high‑risk non‑muscle invasive bladder cancer with carcinoma in situ; guidance for providers submitting initiation or continuation requests.

Policy Summary

PayerAetna

PolicyAdstiladrin precertification request (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the precertification form (or Medicare-specific form for MA Part B) with required clinical information including BCG responsiveness and NMIBC with CIS status.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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1drug covered

BCG responseinitiation question

MA Part BMedicare note

Coverage Criteria and Precertification Requirements

Precertification clinical criteria

Precertification review requires completed clinical information; initiation and continuation requests collect different items.

Initiation request requirements: For initiation: provider must indicate that the request is for Adstiladrin (nadofaragene firadenovec-vncg) and complete product fields (dose and frequency), state whether the medication is being prescribed for high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), and state whether the disease is responsive to Bacillus Calmette-Guerin (BCG).

Form fields must be completed; see Product Information and Clinical Information sections.

Continuation request requirements: For continuation: provider must document whether there is evidence of unacceptable toxicity or disease recurrence while on the current regimen and provide date of last treatment where applicable.

Form fields must be completed to allow precertification review.

For Medicare Advantage Part B members, providers must use the Medicare-specific request form rather than this Aetna precertification form. Do not submit this form for Medicare Advantage Part B requests; follow the Medicare form instructions when requesting precertification for those members.

Policy Summary

PayerAetna

PolicyAdstiladrin precertification request (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the precertification form (or Medicare-specific form for MA Part B) with required clinical information including BCG responsiveness and NMIBC with CIS status.

SourceLink

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Initial Therapy — Documentation Needed for New Treatment

Initial therapy

Initial therapy requests require specification of product, dose, frequency, and clinical details.

Initial therapy submission: Provide product name (Adstiladrin [nadofaragene firadenovec-vncg]), dose, and frequency as requested on the form; include primary ICD code and indicate whether the medication is being prescribed for high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).

Complete Product Information (dose, frequency) and Diagnosis fields.

BCG responsiveness: Indicate whether disease is responsive to Bacillus Calmette-Guerin (BCG) (Yes/No).

Response to BCG is requested to inform authorization decisions.

Provider Actions — What to Submit and Risks if Incomplete

Prior Authorization

Prior Authorization Required

Precertification is required — providers must complete and submit the Adstiladrin (nadofaragene firadenovec-vncg) precertification form (or the Medicare Advantage Part B-specific form for MA Part B members). All fields must be completed and legible for review.

Aetna Precertification Phone: 1-866-752-7021 (TTY: 711)
Fax: 1-888-267-3277
For Medicare Advantage Part B: use the Medicare request form

Documentation Required

BCG responsiveness query

The precertification form includes a specific query about prior BCG (Bacillus Calmette-Guérin) responsiveness. Providers must indicate whether the disease is responsive to BCG (Yes/No) because BCG responsiveness may affect coverage decisions.

Documentation Required

Required submission documents

Required submission documents: the completed precertification form with patient demographics, insurance information, prescriber and dispensing details, requested product (including dose and frequency), and full clinical information. For initiation requests include documentation that the medication is prescribed for high‑risk NMIBC with carcinoma in situ (CIS) and answer the BCG responsiveness question. For continuation requests include the date of last treatment and documentation addressing whether there is evidence of unacceptable toxicity or disease recurrence on the current regimen. Incomplete or illegible forms or missing clinical documentation may result in denial or delay of precertification.

Patient information: name, DOB, contact, weight/height, allergies
Prescriber information: name, specialty, licensure, NPI, contact and office info
Product information: requested product, dose, frequency
Clinical information: indication (high‑risk NMIBC with CIS for initiation), BCG responsiveness (Yes/No), for continuation — date of last treatment and evidence of toxicity or recurrence

Denial Risk

Incomplete clinical information — risk of delay or denial

If required clinical information is incomplete, missing, or illegible (for either initiation or continuation requests), the request may be delayed or denied. Ensure all required fields on the precertification form are completed — missing BCG responsiveness response, absent documentation of CIS status, or lack of toxicity/recurrence information for continuation requests are common reasons for denial.

Question	Response options	Purpose / Use
Is the disease responsive to Bacillus Calmette-Guerin (BCG)?	Yes; No	Captured on the precertification form to inform authorization decisions and step-therapy considerations (used to assess prior BCG response when evaluating initiation or continuation of Adstiladrin).

Background

Adstiladrin (nadofaragene firadenovec-vncg) is the product specified on this precertification request and the form is intended to support authorization for intravesical treatment of bladder cancer. The form collects product information (requested agent, dose, and frequency), diagnosis codes, and detailed clinical information required for precertification review.

The clinical section requires completion for all requests. For initiation requests the provider must indicate whether the request is for high-risk non‑muscle invasive bladder cancer with carcinoma in situ (CIS) and whether the disease was responsive to Bacillus Calmette‑Guérin (BCG); for continuation requests the form asks for the date of last treatment and documentation of unacceptable toxicity or disease recurrence. Missing or incomplete responses may prevent completion of the precertification review.

The form also captures administration/site-of-care details (place of administration such as office, infusion center, or home) and contact information for precertification submission; the Aetna precertification contact information appears on the form for non‑Medicare Advantage Part B submissions.

Primary ICD Code	Primary diagnosis ICD code — to be specified
Secondary ICD Code	Secondary diagnosis ICD code — to be specified

OpenPayer

Adstiladrin (nadofaragene firadenovec-vncg) Precertification Request Coverage Criteria

Coverage Criteria and Precertification Requirements

Initial Therapy — Documentation Needed for New Treatment

Continuation Therapy — Ongoing Treatment Documentation

Coding — Diagnosis and Administration Codes

Provider Actions — What to Submit and Risks if Incomplete

Site of Care and Dispensing

Step Therapy / Prior Treatment Considerations

Definitions

Background