ModifiedAnthemPolicy CC-0264

Anktiva (nogapendekin alfa inbakicept-pmln) — Coverage Criteria

Medical necessity and prior authorization criteria for Anktiva (intravesical nogapendekin alfa inbakicept-pmln) for treatment of BCG-unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ, for Anthem members.

Policy Summary

PayerAnthem

PolicyAnktiva (nogapendekin alfa inbakicept-pmln) — Coverage Criteria

Policy CodePolicy CC-0264

Change TypeCMS coding updateannual review

Effective Date07/01/2025

Next Review Date05/16/2026

Key ActionSubmit prior authorization demonstrating patient is ≥18, treated intravesically for BCG‑unresponsive high‑risk NMIBC with CIS, ECOG 0–2, and used with BCG.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS J9028; removed prior placeholder and other HCPCS codes per CMS coding update.

Annual Review: No criteria changes. Added references. Coding Reviewed: No changes.

1HCPCS code listed

3ICD-10 code ranges/entries

18+Minimum patient age (yrs)

ECOG 0-2Required performance status

Policy Overview & Key Facts

inv-06: ECOG Performance Status

ECOG performance status range0-2

Source guidanceRequired as part of initial approval criteria for Anktiva (nogapendekin alfa inbakicept-pmln)

Clinical contextUsed to assess patient functional status when considering intravesical therapy in BCG‑unresponsive high‑risk NMIBC

18+Minimum patient age (years)

1HCPCS codes listed

3ICD-10 codes/entries

0-2

Policy Summary

PayerAnthem

PolicyAnktiva (nogapendekin alfa inbakicept-pmln) — Coverage Criteria

Policy CodePolicy CC-0264

Change TypeCMS coding updateannual review

Effective Date07/01/2025

Next Review Date05/16/2026

Key ActionSubmit prior authorization demonstrating patient is ≥18, treated intravesically for BCG‑unresponsive high‑risk NMIBC with CIS, ECOG 0–2, and used with BCG.

SourceLink

On This Page

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Coverage Criteria for Anktiva (nogapendekin alfa inbakicept-pmln)

COVERAGE CRITERIA

Requests for Anktiva may be approved if ALL of the following are met:

Approval criteria

Age: Individual is 18 years of age or older>=18 years
(Label, NCCN 2A)
Route: Drug is being used as intravesical instillation
Diagnosis of Bacillus Calmette-Guerin (BCG) unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors
(Label)
Performance status: ECOG performance status of 0-2ECOG 0-2
Concomitant therapy: Used in combination with Bacillus Calmette-Guerin (BCG)

Exclusions - not approved if any of the following

Muscle invasive disease: Individual has muscle invasive (T2-T4) urothelial carcinoma
Locally advanced or metastatic: Individual has locally advanced or metastatic urothelial carcinoma
Extra-vesical disease: Individual has extra-vesical urothelial carcinoma (urethra, ureter, or renal pelvis)

INITIAL THERAPY CRITERIA

Initial approval requires ALL of the following:

Initial therapy criteria

Age: >=18 years
Route: Intravesical instillation
Diagnosis: BCG-unresponsive high-risk NMIBC with CIS (with or without papillary tumors)
ECOG performance status 0-2ECOG 0-2

Anktiva is not indicated for patients with muscle-invasive (T2–T4), locally advanced, metastatic, or extra‑vesical urothelial carcinoma. Requests will not be approved when the individual has muscle‑invasive disease or tumor spread beyond the bladder (for example involvement of the urethra, ureter, or renal pelvis).

If the listed coverage criteria for BCG‑unresponsive, high‑risk NMIBC with carcinoma in situ (with or without papillary tumors) are not met, use of Anktiva for other indications is considered not medically necessary and will not be approved.

Coding (HCPCS & Diagnosis Codes)

HCPCSHCPCS

J9028

Injection, nogapendekin alda inbakicept-pml, for intravesical use, 1 mcg [Anktiva]

ICD-10 DiagnosisICD-10

C67.0-C67.9	Malignant neoplasm of bladder
D09.0	Carcinoma in situ of bladder
Z85.51	Personal history of malignant neoplasm of bladder

inv-12: ECOG performance status definition (DEFINITIONS)

Scale range0 = Fully active to 5 = Dead

0Fully active, able to carry on all pre-disease performance without restriction

1Restricted in physically strenuous activity but ambulatory and able to do light or sedentary work

2Ambulatory, capable of self-care, unable to carry out work activities; up and about >50% of waking hours

3-53 = Limited self-care, confined to bed/chair >50% waking hours; 4 = Completely disabled; 5 = Dead

inv-13: Metastasis definition (DEFINITIONS)

DefinitionMetastasis is the spread of cancer from one part of the body to another; a metastatic tumor contains cells like those in the original primary tumor

Clinical implicationPresence of metastatic disease is an exclusion for Anktiva coverage (requests will not be approved)

Coding contextRelevant when assessing exclusion criteria for urothelial carcinoma involving distant sites

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Anktiva (nogapendekin alfa inbakicept-pmln). Requests will be approved only when the clinical criteria below are met.

Prior authorization required for Anktiva (nogapendekin alfa inbakicept-pmln).
Approval allowed when ALL clinical criteria met (see documentation requirements).

Step Therapy

There are no step therapy requirements specified for Anktiva in this policy.

No step therapy required.

Documentation Required

Required Documentation

Providers must submit documentation to support the prior authorization request. Include patient age, administration route, diagnostic details, prior BCG treatment history, and assessment of response.

Patient age (must be ≥ 18 years).
Route of administration: intravesical instillation.
Diagnosis: BCG‑unresponsive, high‑risk non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS); note presence/absence of papillary tumors.
ECOG performance status (must be 0–2).
Prior BCG treatment history and documentation that therapy is being used in combination with BCG.
Clinical records documenting response assessment and that patient does NOT have muscle‑invasive (T2‑T4), locally advanced, metastatic, or extra‑vesical urothelial carcinoma.

Denial Risk

Denial Triggers

Requests will be denied when the patient has muscle‑invasive, locally advanced, metastatic, or extra‑vesical urothelial carcinoma or when the request does not meet the specified clinical criteria or is for an off‑label indication.

Muscle‑invasive disease (T2–T4) — denial trigger.
Locally advanced or metastatic urothelial carcinoma — denial trigger.
Extra‑vesical involvement (urethra, ureter, or renal pelvis) — denial trigger.
Requests not meeting all required criteria (age, intravesical use, BCG‑unresponsive high‑risk NMIBC with CIS, ECOG 0–2, used with BCG) — denial trigger.
Off‑label indications or other non‑specified uses — denial trigger.

Policy Revision History

2025-05-16Annual reviewLatest

Annual review completed; no clinical criteria changes and references were added (coding reviewed, no coding changes).

2024-11-25Coding update (CMS)

CMS coding update: HCPCS J9028 added effective 2025-01-01; prior HCPCS C9169 and J9999 removed and ICD-10-CM codes C67.0-C67.9, D09.0, and Z85.51 added to the document.

2024-06-10Document creation / select review

New criteria document for Anktiva PA created; initial coding included HCPCS J9999 and C9399 (later updated), with CMS change removing C9399 and adding C9169 effective 2024-10-01.

OpenPayer