ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Adstiladrin (nadofaragene firadenovec-vncg) for non‑muscle invasive bladder cancer

Defines accepted indications, continuation criteria, contraindications, exclusions, dosing limits, coding, and applicable lines of business for Adstiladrin (nadofaragene firadenovec-vncg) intravesical therapy. Applies to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdstiladrin (nadofaragene firadenovec-vncg) for non‑muscle invasive bladder cancer

Policy CodePolicy N/A

Change TypeUpdated template and wordingreferences refreshed

Effective Date

Next Review Date

Key ActionMedication requests are processed by Evolent and must be supported by FDA labeling or CMS‑recognized compendia/NCCN/ASCO or acceptable peer‑reviewed literature consistent with CMS Medicare Benefit Policy Manual Chapter 15.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1472 Adstiladrin policy; updated references.

Updated continuation request verbiage in February 2024 (NCH to Evolent wording).

1Primary HCPCS code listed

1Covered indication (BCG‑unresponsive CIS NMIBC)

4Key exclusion categories listed

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This policy covers with criteria Adstiladrin (nadofaragene firadenovec‑vncg) when used as intravesical monotherapy for members with high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in situ (CIS), with or without papillary tumors, processed by Evolent for Neighborhood Health Plan of Rhode Island lines of business: CHIP, Commercial, Exchange/Marketplace, Medicaid, and Medicare Advantage.

Initial Therapy / Medical Necessity

Covered when ALL of the following are met:

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Continuation Therapy Criteria

Continuation Therapy

Continuation requests exempt from policy when ALL of the following are met:

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title

Documentation Required

Document prior BCG exposure and adequacy

Provider must document prior BCG therapy to demonstrate adequacy and timing. Include dates of BCG administration and the number of doses received for each course to show the patient met the policy's adequate‑BCG thresholds.

Dates of each BCG course (initial induction, maintenance, and any second induction)
Number of doses received in the initial induction (>= 5 of 6 doses)
Number of doses received in maintenance or second induction (>= 2 of 3 maintenance doses OR >= 2 of 6 doses of a second induction course)

Exclusion and Not Medically Necessary Criteria

Exclusion / Not Medically Necessary Criteria

Not covered when ANY of the following exclusion criteria apply:

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title

Denial Risk

Denial if exclusion criteria met

Claims or authorizations may be denied if any exclusion criteria apply. Common triggers for denial include exceeding dosing or duration limits, disease progression or prior adenovirus therapy, presence of more advanced disease, or investigational/off‑label use without sufficient evidence.

Dosing exceeds single‑dose limit of 75 mL at 3 x 10^11 vp/mL
Treatment duration exceeds 12 months or > 4 doses after a complete response
Disease progression while on Adstiladrin
Prior treatment with adenovirus‑based drugs
Extra‑vesical, muscle‑invasive (T2‑T4), or metastatic urothelial carcinoma
Investigational or off‑label use not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature

Applicable Codes

Primary Drug J-codeHCPCSCovered

J9029

Intravesical instillation, nadofaragene firadenovec‑vncg, per therapeutic dose

Billing Rule

Billing limits and dose/duration constraints

Billing and reimbursement are subject to single‑dose and maximum duration/dose constraints. Claims may be denied if dose volume/concentration or total treatment duration/doses exceed the policy thresholds.

Single‑dose limit: <= 75 mL at a concentration of 3 x 10^11 viral particles (vp)/mL
Maximum treatment: <= 12 months OR <= 4 doses (if patient achieved a complete response)
Claims for J9029 may be denied/not reimbursed if these thresholds are exceeded

Provider Actions & Prior Authorization

Prior Authorization

Authorization required and supporting evidence

Evolent processes authorization requests for Adstiladrin and requires that clinical evidence provided align with the FDA product labeling or be supported by CMS‑recognized compendia, NCCN or ASCO guidelines, or acceptable peer‑reviewed literature consistent with Medicare Benefit Policy Manual Chapter 15.

Affected code: J9029
Acceptable evidence: FDA labeling; CMS‑recognized compendia; NCCN; ASCO clinical guidelines; peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15

Documentation Required

Required documentation for prior authorization

For prior authorization, submit documentation that verifies prior BCG exposure met the policy's defined adequacy, demonstrates BCG‑refractory disease, and confirms no disease progression for continuation requests.

Dates and number of BCG doses for each course (initial induction >= 5 of 6 doses; maintenance >= 2 of 3 doses OR second induction >= 2 of 6 doses)
Clinical documentation demonstrating BCG‑refractory criteria (persistent/recurrent CIS or recurrent high‑grade Ta/T1 per policy timeframes)
For continuation: evidence of no disease progression on the requested medication and no lapse > 30 days since active authorization

Clinical Evidence & References

1Primary HCPCS code J9029 listed

1Covered indication: BCG‑unresponsive CIS NMIBC

75 mLSingle‑dose volume limit at 3 x 10^11 vp/mL

12 mo / 4 dosesMaximum treatment duration or doses after complete response

Key evidence includes the pivotal clinical trial: Boorjian SA et al., Lancet: Intravesical nadofaragene firadenovec gene therapy for BCG‑unresponsive NMIBC (single‑arm, open‑label, repeat‑dose trial).

Prescribing information: Adstiladrin prescribing information: Ferring Pharmaceuticals, 2024.

Policy evidence requirements align with FDA labeling and require support from CMS‑recognized compendia, NCCN/ASCO guidance, or acceptable peer‑reviewed literature consistent with the CMS Medicare Benefit Policy Manual Chapter 15; Evolent is responsible for processing medication requests and ensuring supporting evidence meets these standards.

Background & Scope

This policy outlines accepted indications for Adstiladrin (nadofaragene firadenovec‑vncg), requires Evolent to process medication requests, and aligns evidence requirements with FDA labeling, CMS compendia, NCCN/ASCO, or acceptable peer‑reviewed literature per the Medicare Benefit Policy Manual Chapter 15.

Scope includes definitions of accepted indications, continuation criteria, contraindications, exclusions, dosing limits, coding, and applicable lines of business for intravesical therapy; specifically, it covers use for high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer with CIS when BCG‑refractory criteria are met.

Applies to Neighborhood Health Plan of Rhode Island lines of business: CHIP, Commercial, Exchange/Marketplace, Medicaid, and Medicare Advantage.

Thresholds

Adequate BCG dosing (initial induction)>= 5 of 6 doses

Adequate BCG dosing (maintenance or second induction)>= 2 of 3 maintenance doses OR >= 2 of 6 doses of a second induction course

Single dose volume/concentration limit<= 75 mL at 3 x 10^11 vp/mL

Maximum treatment duration / doses after CR<= 12 months or <= 4 doses

BCG‑Refractory CIS: defined as persistent or recurrent carcinoma in situ (± recurrent Ta/T1) within 12 months of adequate BCG (at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 maintenance doses or at least 2 of 6 doses of a second induction course); recurrent high‑grade Ta/T1 within 6 months of completion of adequate BCG (same adequacy thresholds); or T1 high‑grade disease at the first evaluation following an induction BCG course alone (at least 5 of 6 induction doses).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdstiladrin (nadofaragene firadenovec-vncg) for non‑muscle invasive bladder cancer

Policy CodePolicy N/A

Change TypeUpdated template and wordingreferences refreshed

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Adstiladrin (nadofaragene firadenovec-vncg) for non‑muscle invasive bladder cancer

Coverage Summary & Medical Necessity

Continuation Therapy Criteria

Contraindications & Warnings

Exclusion and Not Medically Necessary Criteria

Applicable Codes

Provider Actions & Prior Authorization

Clinical Evidence & References

Background & Scope

Revision History