CurrentBaylor Scott & White Health PlanPolicy 314

Nogapendekin alfa inbakicept (Anktiva) for BCG-unresponsive NMIBC

Covers medical necessity and prior authorization requirements for intravesical nogapendekin alfa (Anktiva®) in adults with BCG-unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ, for Baylor Scott & White Health Plan members.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyNogapendekin alfa inbakicept (Anktiva) for BCG-unresponsive NMIBC

Policy CodePolicy 314

Change TypeNew policy with coding and renewal limits

Effective DateDec 1, 2025

Next Review DateNov 11, 2026

Key ActionSubmit prior authorization with documentation that the patient is ≥18, has BCG‑unresponsive NMIBC with CIS, and that nogapendekin will be used per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria and prior authorization requirements for nogapendekin alfa inbakicept (Anktiva®) for BCG-unresponsive NMIBC.

Included maximum treatment authorization of 24 maintenance doses and renewal criteria.

Updated HCPCS and CPT codes and added ICD-10 codes relevant to bladder cancer.

18+Minimum patient age for coverage

24Maximum maintenance doses authorized

62%Reported complete response rate

J9028

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HCPCS drug code added

Coverage and Medical Necessity Criteria

Initial Therapy Criteria

Covered when ALL of the following are met

Initial coverage criteria: 1) Member is 18 years or older; AND 2) Nogapendekin alfa is prescribed by or in consultation with a physician who specializes in oncology or urology; AND 3) Member has documentation of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with: a) high-grade; AND b) predominant urothelial (transitional cell) histology; AND c) meets one of the FDA BCG-unresponsive definitions: i) persistent or recurrent CIS within 12 months of receiving at least 5 of 6 doses of initial BCG induction plus at least 2 doses as part of maintenance treatment or 2 doses of a second induction; OR ii) recurrent high-grade Ta/T1 within 6 months of receiving at least 5 of 6 doses of initial BCG induction plus at least 2 doses as part of maintenance treatment or 2 doses of a second induction; OR iii) T1 high-grade disease at the first evaluation following 5 of 6 doses of BCG as an initial induction course; AND 4) Nogapendekin will be prescribed in combination with BCG; AND 5) Nogapendekin will be dosed and administered according to FDA-approved labeling; AND 6) Member meets one of the following: a) documented trial and failure, intolerance, or contraindication to pembrolizumab AND nadofaragene firadenovec; OR b) member is established on nogapendekin; OR c) applicable Texas mandates (HB1584, TIC sec. 1369.213, or TIC sec. 1369.0546).

Exact nested logic follows policy text.

Continuation / Renewal Criteria

Renewal requests are approved when ALL of the following are met

Renewal criteria: 1) Member continues to meet all initial criteria; AND 2) Member has manageable or no side effects; AND 3) Documentation indicates there is no evidence of disease recurrence or progression; AND 4) Member has not exceeded the FDA‑approved labeled dosing of 24 maintenance doses.

Approval duration is the shortest of clinically appropriate indication, 6 months, or requested duration; authorization not to exceed 24 maintenance doses per treatment.

Coverage of services described in this policy is subject to the terms of the member’s benefit plan. Medical necessity as defined by this policy does not ensure the benefit is covered; benefits, exclusions, limitations, and conditions of coverage are determined by the applicable Evidence of Coverage (EOC) or Summary Plan Description (SPD). In the event of any discrepancy, the plan document supersedes this policy.

The presence of a CPT or diagnosis code in this policy is informational and does not guarantee reimbursement. Inclusion of a code in this policy does not guarantee that it will be reimbursed; the member must meet the medical necessity criteria set forth in this policy for payment to be considered.

Relevant Billing and Coding

CPT CodesCPTCovered

51720

Bladder instillation of anticarcinogenic agent (including retention time)

HCPCS CodesHCPCSCovered

J9028

Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram

ICD-10 CodesICD-10

C67.0	Malignant Neoplasm of Trigone of Bladder
C67.1	Malignant Neoplasm of Dome of Bladder
C67.2	Malignant Neoplasm of Lateral Wall of Bladder
C67.3	Malignant Neoplasm of Anterior Wall of Bladder
C67.4	Malignant Neoplasm of Posterior Wall of Bladder
C67.5	Malignant Neoplasm of Bladder Neck
C67.6	Malignant Neoplasm of Ureteric Orifice
C67.7	Malignant Neoplasm of Urachus
C67.8	Malignant Neoplasm of Overlapping Sites of Bladder
C67.9	Malignant Neoplasm of Bladder, Unspecified

1–10 of 11

1/2

inv-08: Maximum maintenance doses

Maximum maintenance doses authorized24 maintenance doses (authorization not to exceed a maximum of 24 maintenance doses per treatment)

Approval duration limitsApproval duration is the shortest of clinically appropriate indication, 6 months, or requested duration

Renewal criterion related to dosingRenewal denied if member has exceeded FDA‑approved labeled dosing of 24 maintenance doses

Provider Requirements and Administrative Actions

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Requests for nogapendekin alfa (Anktiva®) require prior authorization and must document that the member meets the BCG‑unresponsive NMIBC criteria and other medical necessity requirements. Review the plan EOC/SPD for member‑specific benefits and Medicare LCD/NCD or Texas Medicaid guidance where applicable.

Provider must include documentation demonstrating BCG‑unresponsive NMIBC with CIS and required induction/maintenance BCG dosing and timelines.
Nogapendekin alfa is considered only when prescribed by or in consultation with an oncology or urology specialist.
Failure to obtain required prior authorization may result in claim denial; see member EOC/SPD for coverage details.

Step Therapy

Step Therapy / Texas Waiver Rules

Step therapy rules — Texas statutory waivers apply in specific situations. If step therapy would otherwise require trial/failure of a preferred agent (e.g., pembrolizumab), the Texas mandates below may waive that requirement when criteria are met or when contraindications are documented.

Clinical Background

Non‑muscle invasive bladder cancer (NMIBC) is commonly managed with transurethral resection of bladder tumor (TURBT) followed by intravesical therapy; Bacillus Calmette‑Guérin (BCG) is a standard intravesical treatment for high‑risk disease. A substantial proportion of patients—commonly reported in the literature as approximately 30–50%—become BCG‑unresponsive and face an increased risk of disease progression. Radical cystectomy is the standard of care for many patients with high‑risk BCG‑unresponsive disease but may be unsuitable or declined by some individuals. Nogapendekin alfa inbakicept (Anktiva®) is an intravesical interleukin‑15 receptor agonist approved for adult patients with BCG‑unresponsive NMIBC with carcinoma in situ (CIS); pivotal single‑arm trial data reported a complete response (CR) rate of 62%, with a prolonged duration of response in responders.

Key Definitions

inv-14: BCG-unresponsive — FDA definition

FDA definition — CIS timing thresholdPersistent or recurrent carcinoma in situ (CIS) within 12 months after adequate BCG (at least 5 of 6 doses of initial induction plus ≥2 doses as maintenance or 2 doses of a second induction)

FDA definition — Ta/T1 timing thresholdRecurrent high‑grade Ta or T1 disease within 6 months after adequate BCG (at least 5 of 6 doses of initial induction plus ≥2 doses as maintenance or 2 doses of a second induction)

FDA definition — immediate T1 criterionT1 high‑grade disease at the first evaluation following 5 of 6 doses of BCG as an initial induction course

Policy Changes and Revision History

2025-12-01Effective date

Policy became effective for nogapendekin alfa inbakicept (Anktiva®) for BCG-unresponsive NMIBC.

2025-11-11Last review

Clinical policy last reviewed; criteria and coding finalized prior to effective date.

2025-11-11Next review date set

Next scheduled review set for 2026-11-11.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyNogapendekin alfa inbakicept (Anktiva) for BCG-unresponsive NMIBC

Policy CodePolicy 314

Change TypeNew policy with coding and renewal limits

Effective DateDec 1, 2025

Next Review DateNov 11, 2026

Key ActionSubmit prior authorization with documentation that the patient is ≥18, has BCG‑unresponsive NMIBC with CIS, and that nogapendekin will be used per FDA labeling.

SourceLink

On This Page

Step therapy may be waived when Texas Mandate HB1584 (TIC §1369.213) criteria are met (best practices, peer‑reviewed evidence, FDA approval).
Step therapy may be waived under TIC §1369.0546 when clinical documentation shows contraindication or expected ineffectiveness/harm.
If pembrolizumab is a required preferred agent per step policy, document trial/failure, intolerance, or contraindication to pembrolizumab to support medical necessity when applicable.

Documentation Required
Documentation Requirements
Documentation Required. Provider must submit clinical documentation showing the member is ≥18 years old, that nogapendekin alfa is prescribed by or in consultation with an oncology or urology specialist, and that the member meets the BCG‑unresponsive NMIBC criteria (including BCG dosing history, histology, and timing of recurrence/persistence). Also include prior treatment history (e.g., pembrolizumab, nadofaragene) or reasons for waiver under Texas statute when applicable.
Proof of age ≥18 (medical record or ID).
Specialist prescriber or documentation of consultation with oncology or urology.
BCG treatment history documenting induction and maintenance dosing and timelines to meet BCG‑unresponsive definition.
Histopathology confirming predominant urothelial histology.
Documentation of trial/failure, intolerance, or contraindication to pembrolizumab and nadofaragene when relevant, or documentation supporting applicability of Texas mandates to waive step therapy.

Denial Risk
Denial Risk for Missing Prior Authorization
Denial Risk for Missing Prior Authorization. Failure to obtain required prior authorization or to submit sufficient supporting documentation (age, specialist prescriber/consult, BCG‑unresponsive evidence, prior therapy or waiver justification) may result in claim denial. Providers and members should consult the member's EOC/SPD for coverage limits and appeal rights.
Missing or incomplete proof of BCG‑unresponsive NMIBC or specialist involvement increases denial risk.
If Texas statutory waivers are claimed, include supporting clinical evidence or literature to avoid denials.
For Medicare or Medicaid members, ensure any applicable NCD/LCD or TMHP requirements are met to prevent denial.

2025-12-01Material change - policy addition

Added coverage criteria and prior authorization requirements for nogapendekin alfa inbakicept (Anktiva®) for BCG-unresponsive NMIBC, including initial coverage conditions and prescriber requirements.

2025-12-01Material change - dosing/renewal limits

Specified approval duration parameters and a maximum of 24 maintenance doses with renewal criteria tied to lack of disease progression and tolerability.

2025-12-01Coding updateLatest

Updated coding section to include HCPCS J9028, CPT 51720, and relevant bladder cancer ICD-10 diagnosis codes.