ModifiedPeach State Health PlanPolicy CP.PHAR.461

Nadofaragene firadenovec-vncg (Adstiladrin) coverage

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Defines medical necessity criteria, dosing, and authorization requirements for Adstiladrin for treatment of high-risk BCG-unresponsive non-muscle invasive bladder cancer in adult members of Peach State Health Plan.

Policy Summary

PayerPeach State Health Plan

PolicyNadofaragene firadenovec-vncg (Adstiladrin) coverage

Policy CodePolicy CP.PHAR.461

Change TypeMaterial revisions and coding updates

Effective DateDec 16, 2022

Next Review Date

Key ActionPrior authorization required; submit documentation demonstrating member meets initial or continued therapy criteria (including BCG-refractory status, specialist involvement, age, cystectomy candidacy, and dosing limits).

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J9029 for intravesical instillation of nadofaragene firadenovec-vncg.

Removed initial requirement for clinically significant elevated liver or renal function tests per prescribing information.

Added option for 'prescribed by or in consultation with a urologist' and added off-label indication for Ta/T1 high-grade disease without CIS per NCCN; removed requirement for intravesical chemotherapy and added requirement that member is not a candidate for cystectomy; increased approval duration from 3 to 6 months.

Revised HCPCS code description for J9029.

Adults ≥18minimum age for coverage

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ModifiedPeach State Health PlanPolicy CP.PHAR.461

Nadofaragene firadenovec-vncg (Adstiladrin) coverage

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Policy Summary

PayerPeach State Health Plan

PolicyNadofaragene firadenovec-vncg (Adstiladrin) coverage

Policy CodePolicy CP.PHAR.461

Change TypeMaterial revisions and coding updates

Effective DateDec 16, 2022

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J9029 for intravesical instillation of nadofaragene firadenovec-vncg.

Removed initial requirement for clinically significant elevated liver or renal function tests per prescribing information.

Revised HCPCS code description for J9029.

Adults ≥18minimum age for coverage

maximum total doses authorized

75 mLmaximum single dose

6 monthsapproval duration

removedremoved lab requirement

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for Initial Approval (Non-Muscle Invasive Bladder Cancer):

Initial Approval - NMIBC: 1. Diagnosis of non‑muscle invasive bladder cancer characterized as one of the following: a) carcinoma in‑situ (CIS) only; b) Ta/T1 high‑grade disease with concomitant CIS; or c) Ta/T1 high‑grade disease without CIS (off‑label). 2. Prescribed by or in consultation with an oncologist or urologist. 3. Age ≥ 18 years. 4. Member is refractory to BCG treatment (see Appendix D). 5. Member is not a candidate for cystectomy. 6. If the request is for a dose increase, one of the following must be met: a) new dose does not exceed 75 mL (4 vials) of 3 x 10^11 viral particles (vp)/mL; or b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). 7. Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: 6 months (1 dose only)

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy (Non-Muscle Invasive Bladder Cancer):

Continued Therapy - NMIBC: 1. Member is currently receiving Adstiladrin via the Centene benefit, or documentation supports current receipt for a covered indication with at least 30 days of therapy. 2. Member is responding positively to therapy as evidenced by freedom from high‑grade disease recurrence on cytology, cystoscopy, and/or biopsy. 3. Member has not yet received 4 total lifetime doses of Adstiladrin. 4. If the request is for a dose increase, one of the following must be met: a) new dose does not exceed 75 mL (4 vials) of 3 x 10^11 vp/mL every 3 months; or b) new dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Approval duration: 6 months (1 dose only; total of four doses per lifetime)

Other Indications / Off-label pathway

Other/Off-label requests:

Other diagnoses/indications: 1. If the drug has had a label change within the last 6 months not yet reflected in this policy, refer to the applicable formulary/no‑coverage or non‑formulary policy for the line of business as listed in the policy. 2. If the requested use (diagnosis, age, dosing regimen) is not listed under section III and criterion 1 does not apply, refer the request to the off‑label use policy for the applicable line of business (see CP.CPA.09, HIM.PA.154, or CP.PMN.53 as appropriate).

See referenced policies for process

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid).

For certain coverage scenarios the policy requires that the member is not a candidate for cystectomy; this requirement was added in the 4Q 2024 review and is part of the initial therapy criteria that must be satisfied for authorization.

Uses that are non‑FDA approved and that are not supported by the referenced off‑label use policies or by the plan’s evidence of coverage will not be authorized under this policy.

Initial Therapy Criteria and Dosing

Initial Therapy

Initial therapy dosing and criteria:

Initial therapy nodes: • Initial dosing options: 1 x 10^11 vp/mL OR 3 x 10^11 vp/mL with retreatment permitted at months 4, 7, and 10. • Maximum single‑dose/maximum regimen: up to 75 mL (4 vials) of 3 x 10^11 vp/mL; total of four doses lifetime. • Dosing must be FDA‑approved or, for off‑label use, supported by NCCN or peer‑reviewed literature (prescriber to submit evidence for doses exceeding standard limits).3 x 10^11 vp/mL; up to 75 mL (4 vials)

Initial approval duration: 6 months (1 dose only)

Initial therapy criteria

Initial criteria and requirements as revised in 2023-2024 reviews:

Initial authorization considerations: • Removed the initial requirement for clinically significant elevated liver or renal function tests per prescribing information. • Oncology dosing criteria expanded to allow doses supported by practice guidelines or peer‑reviewed literature.

Continuation / Continued Therapy Criteria

Continued Therapy

Continued therapy criteria for NMIBC:

Continued therapy nodes: 1. Member currently receiving drug via Centene benefit or documentation supports ≥30 days of therapy. 2. Positive response to therapy with absence of high‑grade recurrence on cytology, cystoscopy, and/or biopsy. 3. Total lifetime doses received are fewer than 4. 4. Dose increases must not exceed 75 mL (4 vials) of 3 x 10^11 vp/mL every 3 months unless supported by practice guidelines or peer‑reviewed literature (prescriber must submit evidence).

Approval duration: 6 months per dose

Continuation therapy duration

Approval duration and continuation criteria updated:

Continuation/Approval duration: Approval duration for each authorized dose increased from 3 months to 6 months per 4Q 2024 review. Total lifetime doses remain limited to four.

Step Therapy / Prior Treatment Requirements

Step	Requirement
1
Member must be refractory to BCG (see Appendix D for definition of BCG‑unresponsive/refractory).

Step	Change / Rationale
1
Requirement for prior intravesical chemotherapy (previously including valrubicin) was removed per NCCN; earlier policy versions had required prior intravesical chemotherapy.

Coding

Covered HCPCS Codes (informational)HCPCS

J9029

Intravesical instillation, nadofaragene firadenovec-vncg, per therapeutic dose

Covered HCPCS CodesHCPCSCovered

J9029

Intravesical instillation, nadofaragene firadenovec-vncg, per therapeutic dose

Previously referenced / removed HCPCSHCPCS

J3590	Unclassified biologics (removed from policy references)
C9399	Unclassified drugs or biologicals (removed from policy references)

Maximum single dose concentration and volume

Maximum single-dose concentration3 x 10^11 vp/mL

Maximum single-dose volumeUp to 75 mL (4 vials)

Total doses allowedSee quantity limits — policy limits total to 4 lifetime doses

Quantity Limits

Adstiladrin (nadofaragene firadenovec-vncg)

ProductAdstiladrin (nadofaragene firadenovec-vncg)

Lifetime dose limit4 doses per lifetime

Single-dose maximumUp to 75 mL (4 vials) of 3 x 10^11 vp/mL

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required — must meet initial or continued therapy criteria

Prior authorization is required for Adstiladrin; requests must meet the policy's initial or continued therapy criteria including diagnosis, BCG-refractory status, prescriber specialty, age, cystectomy candidacy, and dosing limits. Approval duration is 6 months (1 dose only) for initial and continued therapy and total lifetime doses are limited to four.

Initial criteria include diagnosis of NMIBC (CIS only; Ta/T1 high-grade with concomitant CIS; or Ta/T1 high-grade without CIS [off-label]), prescribed by or in consultation with an oncologist or urologist, age ≥18, refractory to BCG, not a candidate for cystectomy, and dosing within permitted limits.
Continued therapy requires documentation of current therapy (≥30 days), positive response (no high‑grade recurrence), fewer than 4 lifetime doses, and dosing within permitted limits.

Site of Care

Billing Rule

Intravesical instillation — office/hospital outpatient

Intravesical instillation is the billed route for Adstiladrin; HCPCS J9029 describes intravesical administration (per therapeutic dose).

Note

Intravesical administration — office

Adstiladrin is administered intravesically in an office setting (site-specific details not enumerated in this excerpt); ensure documentation supports intravesical administration.

Definitions

BCG-unresponsive (refractory)

DefinitionBCG-unresponsive (refractory) includes: persistent or recurrent CIS alone or with recurrent Ta/T1 within 12 months of adequate BCG therapy; recurrent high-grade Ta/T1 within 6 months of adequate BCG; or T1 high-grade at first evaluation after induction BCG.

Adequate BCG — examplesAt least 5 of 6 doses of initial induction plus ≥2 of 3 maintenance doses OR at least 5 of 6 induction doses plus ≥2 of 6 doses of a second induction course.

Tumor descriptorsTa = papillary tumors; T1 = tumor into connective tissue of bladder wall but not muscle layer.

CIS

TermCIS

DefinitionCarcinoma in-situ of the bladder.

Background

Adstiladrin (nadofaragene firadenovec‑vncg) is described in the policy; the 4Q 2024 updates added several policy clarifications including off‑label language per NCCN and procedural requirements. The clinical policy notes administrative changes and reinforces that non‑FDA uses require supporting documentation per off‑label policies and that coding and coverage determinations follow the policy’s stated criteria.

Policy Summary

PayerPeach State Health Plan

PolicyNadofaragene firadenovec-vncg (Adstiladrin) coverage

Policy CodePolicy CP.PHAR.461

Change TypeMaterial revisions and coding updates

Effective DateDec 16, 2022

Next Review Date

SourceLink

On This Page

Prescriber requirement: Medication must be prescribed by or in consultation with an oncologist or urologist (option added in 4Q 2024 review).

Prior authorization and billing — use HCPCS J9029

Use HCPCS code J9029 to request prior authorization and to bill intravesical instillation of nadofaragene firadenovec-vncg; code descriptions are informational and claims should follow current professional coding guidance.

J9029 = Intravesical instillation, nadofaragene firadenovec-vncg, per therapeutic dose.
Addition and revisions to J9029 are documented in the policy (added 05.24.23; description revised 03.11.24; referenced in 4Q 2024 updates).

Step Therapy

BCG required as prior therapy context — member must be BCG‑refractory

BCG (Bacillus Calmette-Guérin) is listed as a therapeutic alternative; the member must be refractory to BCG per the policy definitions before Adstiladrin is considered.

Appendix B lists BCG as a therapeutic alternative with standard intravesical dosing.
Policy requires ‘Member is refractory to BCG (see Appendix D)’ as part of initial approval criteria.

Step Therapy

Step therapy change — prior intravesical chemotherapy requirement removed

The policy no longer requires prior intravesical chemotherapy (previously including valrubicin); this step therapy change aligns with NCCN updates and is reflected in the policy revisions.

1Q 2022 and subsequent reviews revised prior valrubicin requirement to intravesical chemotherapy, and later removed the intravesical chemotherapy requirement per NCCN.
Policy history documents removal of prior intravesical chemotherapy requirement in 4Q 2024 updates.

Documentation Required

Required documentation — submit office notes, labs, and clinical information

Provider must submit supporting clinical documentation with the prior authorization request, such as office chart notes, laboratory results, and other relevant clinical information demonstrating the member meets all approval criteria.

Documentation should demonstrate diagnosis, BCG‑refractory status (per Appendix D), prescriber specialty/consultation, treatment history, response assessments (cytology, cystoscopy, biopsy), and dosing rationale.
If a dose increase is requested and exceeds standard limits, prescriber must submit supporting evidence from practice guidelines or peer‑reviewed literature.

Note

Policy governance — coverage subject to plan terms and legal/regulatory requirements

Coverage decisions follow the Health Plan's terms, conditions, exclusions, and limitations and are subject to applicable state and federal requirements; the clinical policy is a guide to medical necessity and is not a contract or guarantee of payment.

The Health Plan may change, amend, or withdraw this clinical policy and additional policies may be developed as needed.
If discrepancies exist between the policy effective date and legal/regulatory requirements, the law governs.

Denial Risk

Denial risk — missing supporting documentation may trigger denial

Failure to submit required documentation (office notes, labs, or other clinical information) that supports the member meets all approval criteria may result in an adverse determination (denial).

Denials may be issued when documentation does not demonstrate diagnosis, BCG‑refractory status, treatment history, response, or adherence to dosing and quantity limits.

Billing Rule

Coding does not guarantee coverage — verify current coding guidance

Inclusion of HCPCS code J9029 (or exclusion of other codes) in the policy does not guarantee coverage; providers must reference current professional coding guidance when submitting claims.

Policy explicitly states codes are for informational purposes only and do not guarantee coverage.
Providers should verify the most up-to-date coding guidance prior to claim submission.

ContextListed in Appendix A abbreviation key for policy definitions.

Intravesical instillation (J9029)

Procedure descriptorIntravesical instillation of nadofaragene firadenovec-vncg is billed using HCPCS code J9029 as the per therapeutic dose descriptor.

Billing guidanceJ9029 included in policy coding lists for prior authorization and claims (added 05.24.23 and referenced in later updates).

Site of care relevanceUsed for intravesical administration in office or hospital outpatient settings per policy coding section.