CurrentViva HealthPolicy IC-0753

Anktiva (nogapendekin alfa inbakicept-pmln) (Intravesical)

Medical policy governing coverage criteria, dosing, and authorization for intravesical Anktiva in adults with non‑muscle invasive bladder cancer (CIS) unresponsive to BCG for Viva Health members.

Policy Summary

PayerViva Health

PolicyAnktiva (nogapendekin alfa inbakicept-pmln) (Intravesical)

Policy CodePolicy IC-0753

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization documenting diagnosis, prior adequate BCG therapy, and required cystoscopy/urine cytology for renewal.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

400 mcgper-dose dose

36max total doses

J9028HCPCS

>=18min age

CISindicated dx

Coverage Criteria for Anktiva (nogapendekin alfa inbakicept-pmln)

Policy Summary

PayerViva Health

PolicyAnktiva (nogapendekin alfa inbakicept-pmln) (Intravesical)

Policy CodePolicy IC-0753

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization documenting diagnosis, prior adequate BCG therapy, and required cystoscopy/urine cytology for renewal.

SourceLink

On This Page

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Initial Approval Criteria

Covered when ALL of the following are met

Age: Patient is at least 18 years of age

Diagnosis: Non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors

Disease risk and prior therapy: High-risk disease that is unresponsive to BCG defined as persistent or recurrent CIS alone or with Ta/T1 disease within 12 months of completion of adequate BCG therapywithin 12 months

Adequate BCG therapy is defined as ≥5 of 6 induction doses plus either ≥2 doses of maintenance therapy or a second induction

Resection: Patient has undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease (Ta and T1 components); residual CIS not amenable to complete resection, fulguration, or cauterization is permitted

No advanced disease: Patient does NOT have muscle invasive (T2-T4), locally advanced, metastatic, or extravesical (urethra, ureter, or renal pelvis) bladder cancer

Renewal Criteria

Renewal provided when ALL of the following apply

Continued eligibility: Patient continues to meet the indication-specific relevant criteria (e.g., concomitant therapy requirements, performance status) as identified in Initial Approval Criteria

Disease response defined as stabilization of disease or decrease in tumor size or spread; first renewal: complete response (CR) after 6 doses (≈3 months) defined by negative cystoscopy [with TURBT/biopsies as applicable] and urine cytology OR need for a second 6-dose induction if no CR; subsequent renewals: no high-grade or CIS recurrence and for patients at month 25 or later an ongoing CR requiring continued treatment

Toxicity: Absence of unacceptable toxicity from the drug (examples include grade 3 or 4 hematuria)

Duration cap: Patient has not received greater than 37 months of therapy<=37 months

(Total maintenance dosing limited as specified)

Coding — HCPCS, NDC, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J9028

Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram; 1 billable unit = 1 mcg

NDCNDC

81481-0803-xx

Anktiva 400 mcg/0.4 mL solution in a single-dose vial: 81481-0803-xx

Covered Diagnosis CodesICD-10Covered

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 12

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Provider Actions, Authorization & Documentation Requirements

Prior Authorization

Authorization limits & HCPCS

Prior authorization is required. Authorization limits: induction dosing up to 12 weekly doses of 400 mcg (400 billable units per dose) and maintenance dosing as specified in the policy (400 units once weekly for three weeks at months 4, 7, 10, 13, 19, 25, 31, and 37 for a total of 24 maintenance doses). Total authorized therapy may be provided for up to 37 months (up to a total of 36 doses).

Induction: 400 billable units once weekly up to 12 doses.
Maintenance: 400 billable units once weekly for three weeks at months 4, 7, 10, 13, 19, 25, 31, and 37 (total of 24 doses).
Length of authorization: Initial coverage 6 months; may be renewed up to a maximum of 37 months (up to 36 total doses).

Denial Risk

Ineligible disease stage

Coverage is limited to patients with non‑muscle invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS) and meet the definition of BCG‑unresponsive disease. Patients with muscle invasive (T2‑T4), locally advanced, metastatic, or extravesical disease (urethra, ureter, or renal pelvis) are not eligible for coverage.

Ineligible: any muscle invasive (T2‑T4), locally advanced, metastatic, or extravesical bladder cancer.
Covered disease: NMIBC with CIS (with or without papillary tumors) that is BCG‑unresponsive.

Documentation Required

Prior BCG requirement; Diagnosis and prior therapy documentation

Documentation required with the prior authorization request: submit diagnosis codes consistent with Appendix 1 and evidence of prior adequate BCG therapy. Adequate BCG is defined as ≥5 of 6 induction doses plus either ≥2 doses of maintenance therapy or ≥2 doses of a second induction. Documentation should also include TURBT operative notes and pathology/biopsy reports as applicable and cystoscopy/urine cytology results to confirm BCG‑unresponsive CIS (persistent or recurrent CIS within 12 months after adequate BCG).

Diagnosis codes: submit one of the ICD‑10 codes listed in Appendix 1 (e.g., C67.x, D09.0, Z85.51).
Prior BCG requirement: patient must be BCG‑unresponsive — defined as persistent or recurrent CIS (alone or with Ta/T1) within 12 months of completion of adequate BCG therapy.
Prior therapy documentation: operative note for TURBT (if performed), pathology/biopsy reports, cystoscopy results, and urine cytology as applicable.

Definitions and Clinical Terms

Adequate BCG therapy — definition

DefinitionAdequate BCG therapy = ≥5 of 6 induction doses plus either ≥2 doses of maintenance therapy or of a second induction therapy.

ContextApplies when determining BCG-unresponsive disease for coverage of intravesical Anktiva in NMIBC with CIS.

Timing relevanceUsed to assess recurrence or persistence within 12 months after completion of adequate BCG therapy.

Documentation requiredProviders must document prior BCG dosing consistent with this definition when requesting authorization.

Complete response (CR) — definition

DefinitionComplete response (CR) at first renewal (after 3 months/6 doses) = negative cystoscopy (with TURBT/biopsies as applicable) and negative urine cytology.

Assessment timingEvaluated after the initial 6-dose induction course (approximately 3 months).

If no CRIf no CR at first renewal, a second 6-dose induction course may be required.

Documentation requiredSubmit cystoscopy results (and TURBT/biopsy reports if performed) plus urine cytology to support renewal requests.

Background on Anktiva and Indication

Anktiva (nogapendekin alfa inbakicept-pmln) is administered intravesically in combination with Bacillus Calmette-Guérin (BCG) for adult patients with non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), either with or without papillary tumors. The treatment program includes an induction course followed by scheduled maintenance instillations and is intended to continue until disease recurrence or progression, unacceptable toxicity, or reaching the protocol-specified maximum duration.

Adequate BCG therapy—required to establish BCG‑unresponsive disease—is defined as ≥5 of 6 induction doses plus either ≥2 maintenance doses or a second induction course. Anktiva dosing is given intravesically at 400 mcg per instillation (see dosing/authorization sections for induction and maintenance frequency and total duration limits).