CurrentPremera BluecrossPolicy 5.01.632

Pharmacologic Treatment of Bladder Cancer (Adstiladrin, Anktiva)

Defines medical necessity criteria, documentation, coding, and benefit application for intravesical Adstiladrin (nadofaragene firadenovec‑vncg) and Anktiva (nogapendekin alfa inbakicept‑pmln) for adults with BCG‑unresponsive non‑muscle invasive bladder cancer, for Premera Bluecross medical benefit.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Bladder Cancer (Adstiladrin, Anktiva)

Policy CodePolicy 5.01.632

Change TypeCoding updateclarifications

Effective DateMar 1, 2025

Next Review Date

Key ActionObtain prior authorization (medical benefit) and document BCG‑unresponsive status, cystectomy ineligibility/election, ECOG ≤2, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

Added new HCPCS code J9028 and removed unlisted HCPCS code J9999.

Clarified that non‑formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months.

Clarified that the medications listed are subject to the product's FDA dosage and administration prescribing information.

2Drugs addressed

18+Minimum age

75 mLAdstiladrin dose limit

12 moAuth length

Coverage Criteria

Adstiladrin (nadofaragene firadenovec-vncg) — Initial therapy

Covered when ALL of the following are met:

Adstiladrin initial coverage criteria: Patient is aged 18 years or older

Adstiladrin initial coverage criteria: Patient is ineligible for or has elected not to undergo cystectomy

Documentation of a valid medical rationale is required if alternatives (e.g., pembrolizumab) are not used.

BCG-unresponsive disease (one of)

Persistent or recurrent disease following BCG therapy
BCG-unresponsive definition per policy.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Bladder Cancer (Adstiladrin, Anktiva)

Policy CodePolicy 5.01.632

Change TypeCoding updateclarifications

Effective DateMar 1, 2025

Next Review Date

Key ActionObtain prior authorization (medical benefit) and document BCG‑unresponsive status, cystectomy ineligibility/election, ECOG ≤2, and dosing within limits.

SourceLink

On This Page

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Anktiva (nogapendekin alfa inbakicept-pmln) — Initial therapy

Covered when ALL of the following are met:

Anktiva initial coverage criteria: Patient is aged 18 years or older

Surgical resection: Has had a complete resection of high-grade Ta and/or T1 disease after transurethral resection of bladder tumor (TURBT)

Prior to treatment all individuals with Ta or T1 disease should have undergone TURBT to remove all resectable disease; residual CIS not amenable to complete resection is permitted.

Histologic disease status (one of)

Histologic confirmation of BCG-unresponsive CIS without residual high-grade Ta or T1 disease
Histologic confirmation of BCG-unresponsive CIS with completely resected Ta or T1 disease

Timing of BCG: Has received adequate intravesical BCG therapy within the last 12 months

Adequate BCG = at least 5 of 6 doses of an initial induction course AND at least 2 of 3 doses of maintenance therapy OR at least 2 of 6 doses of a second induction course.

Performance status: ECOG performance status of 2 or less

Coding

Covered HCPCS for AdstiladrinHCPCSCovered

J9029

Injection, nadofaragene firadenovec-vncg (Adstiladrin), per therapeutic dose

Covered HCPCS for AnktivaHCPCSCovered

J9028	Injection, nogapendekin alfa inbakicept-pmln, for intravesical use (Anktiva),1 microgram (new code effective 01/01/25)
C9169	Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram (used to report Anktiva) (Code terminated 01/01/25)

Historical / removed codesHCPCS

J9030	HCPCS code previously added then removed (history entry)
J9999	Unlisted code removed (history entry)

Adstiladrin dosing limit

Adstiladrin dosing limit75 mL once every 3 months

Dose frequencyAt most once every 3 months

Applicable populationAdults meeting policy coverage criteria for intravesical Adstiladrin

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for medical benefit coverage of the medications addressed in this policy. Non-formulary exception reviews and other authorization requests for Adstiladrin (nadofaragene firadenovec-vncg) and Anktiva (nogapendekin alfa inbakicept-pmln) may be approved for up to 12 months when coverage criteria are met.

Applies to medical benefit administration of Adstiladrin and Anktiva
Typical approval length: up to 12 months for initial non-formulary exception and reauthorizations

Step Therapy

Step / Sequence Requirements

Treatment must follow required sequencing and step criteria demonstrating BCG-unresponsive disease and either ineligibility for or election not to undergo cystectomy. Adequate prior BCG must be documented per policy definition.

Patient is aged 18 years or older
Patient is ineligible for or has elected not to undergo cystectomy
BCG-unresponsive disease defined as persistent or recurrent disease following BCG therapy, or T1 disease following a single induction course of BCG
Adequate intravesical BCG therapy = at least 5 of 6 doses of initial induction AND at least 2 of 3 doses of maintenance, OR at least 2 of 6 doses of a second induction course
ECOG performance status ≤ 2
Dose limit for Adstiladrin: 75 mL once every 3 months (follow FDA dosing for listed products)

Documentation Required

Required Documentation

Submit medical record documentation that demonstrates the medical necessity criteria are met. Include objective clinical details and treatment history to support BCG-unresponsive status and cystectomy ineligibility or patient choice.

Office visit notes with diagnosis, relevant history, physical exam, and medication history
Documentation of prior BCG therapy details (dates, doses, induction/maintenance completion per 'adequate BCG' definition)
Evidence of histologic confirmation of CIS and tumor staging/resection details (TURBT results) where applicable
Documentation that the patient is a candidate for cystectomy but is ineligible or has declined, OR documentation of a valid medical rationale for inability to use alternative therapies (e.g., Adstiladrin or pembrolizumab) when required
ECOG performance status recorded in the chart
Treatment dosing and schedule consistent with FDA prescribing information

Definitions

BCG‑unresponsive disease / Adequate BCG therapy

Definition of BCG‑unresponsive diseasePersistent or recurrent disease following BCG therapy OR T1 disease following a single induction course of BCG

Adequate intravesical BCG therapy (per policy)At least 5 of 6 doses of an initial induction course PLUS either ≥2 of 3 maintenance doses OR ≥2 of 6 doses of a second induction course

Timing for Anktiva eligibilityRecurrent CIS alone or with Ta/T1 disease within 12 months of completion of adequate BCG therapy

ECOG performance status

Required ECOG performance statusECOG performance status of 2 or less (≤2)

Population noteApplies to adults considered for intravesical Adstiladrin or Anktiva under this policy

Denial riskRequests with ECOG >2 may be denied per policy denial triggers

Background

Urothelial bladder cancer is most commonly non‑muscle invasive and treatment is guided by tumor stage and grade; management often includes transurethral resection of bladder tumor (TURBT) followed by intravesical therapy for high‑risk disease. Intravesical agents such as Adstiladrin and Anktiva are intended for patients with BCG‑unresponsive non‑muscle invasive bladder cancer—including carcinoma in situ (CIS)—as alternatives for patients who are ineligible for or who elect not to undergo cystectomy. Authorization and ongoing coverage require adherence to the drug‑specific criteria in this policy and to the products’ FDA dosing and administration guidance.

Revision History

2025-03-01Annual review / coding updateLatest

Added new HCPCS code J9028 and removed unlisted HCPCS code J9999; clarified that non‑formulary exception review authorizations for all drugs listed may be approved up to 12 months and that medications are subject to FDA dosing and administration information.

2024-10-01Coding update

Added new HCPCS code C9169 to report Anktiva and removed unlisted code C9399.

2024-09-01Coding update

Removed HCPCS code J9030 (added in error) and added HCPCS code C9399 to report Anktiva.

2024-07-01Annual review

Annual review approved June 11, 2024; added Anktiva coverage criteria and initially added HCPCS code J9030; policy title changed to Pharmacologic Treatment of Bladder Cancer.

2023-07-01Coding update

Added new HCPCS code J9029 for Adstiladrin.

2023-06-01New policy

New policy approved May 9, 2023; added Adstiladrin coverage criteria and HCPCS code J9999 initially reported for Adstiladrin.