CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Anktiva (nogapendekin alfa inbakicept-pmln) coverage criteria

Defines authorization and coverage criteria for Anktiva (nogapendekin alfa inbakicept-pmln) in cancer treatment, primarily for BCG-unresponsive nonmuscle invasive bladder cancer, and describes documentation, exclusions, and coding for providers and payers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAnktiva (nogapendekin alfa inbakicept-pmln) coverage criteria

Policy CodePolicy N/A

Change TypeExclusions expandeddosing and duration limits added

Effective DateJun 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization for Anktiva (J9028) and document indication, concurrent BCG use, dosing (≤400 mcg single dose) and duration (≤37 months) with supporting FDA labeling or accepted compendia/guidelines.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1502 Anktiva policy.

Updated exclusion criteria for Anktiva.

Added maximum treatment duration limit of 37 months and single dose limit of 400 mcg.

37 monthsmaximum treatment duration

400 mcgsingle dose maximum

J9028HCPCS code

BCG‑unresponsive NMIBC

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Coverage Criteria for Anktiva (nogapendekin alfa inbakicept-pmln)

Initial and continuation coverage conditions

Covered when ALL of the following are met

Covered Indication: Adult patient with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors

Per Bladder Cancer section

Concurrent Therapy: Anktiva must be administered with Bacillus Calmette-Guérin (BCG)

Concurrent BCG required per Bladder Cancer section

Evidence Support: Use is supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature

Per Purpose section requiring supporting evidence

Dosing and Duration Limits: Treatment does not exceed 37 months and single dose does not exceed 400 mcg<= 37 months; <= 400 mcg

Limits specified in exclusions/thresholds

Coverage excludes requests when any of the following operational limits or exclusion conditions apply: disease progression occurred while the member was taking Anktiva; Anktiva is ordered without concurrent administration of BCG; treatment duration would exceed 37 months; or a single intravesical dose would exceed 400 mcg. Additionally, requests for use in off‑label indications that lack sufficient evidence per the policy (i.e., not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature) are excluded.

Off‑label or investigational uses of Anktiva are not approvable unless the requested indication is supported by adequate evidence as defined by the policy. Acceptable support includes documentation that the patient and regimen are adequately represented in published evidence and that outcomes are clinically meaningful. Evidence must generally be supported by CMS‑recognized compendia or acceptable peer‑reviewed literature; case reports and meeting abstracts without full peer‑reviewed articles are not considered sufficient.

Regimen	Indication	HCPCS code	Notes / Limits
Anktiva (nogapendekin alfa inbakicept-pmln) intravesical administration, given concurrently with Bacillus Calmette–Guérin (BCG)	BCG‑unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors	J9028 — Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram	Coverage per FDA labeling and/or accepted compendia; subject to dosing and duration limits (single dose ≤ 400 mcg; total treatment duration ≤ 37 months). Prior authorization required and use must be supported by required documentation.

Billing and Coding

Applicable HCPCS CodesHCPCSCovered

J9028

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

inv-05: Single dose limit — operational dosing limit for a single administration

Single dose maximum400 mcg per single administration

Operational limit sourceListed as an exclusion: dosing exceeds single dose limit of 400 mcg

ApplicationLimit applies to each intravesical administration of Anktiva (J9028)

inv-06: Maximum treatment duration — operational duration limit

Maximum treatment duration37 months

Operational limit sourceListed as an exclusion: treatment exceeds the maximum duration limit of 37 months

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for Anktiva (J9028). Requests must reference FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS standards.

Affected code: J9028

Documentation Required

Continuation Provision

Continuation (renewal) requests may be granted only when ALL conditions are met: the member has not experienced disease progression on Anktiva; the medication was used within the last year without a lapse >30 days of active authorization; and no additional medications are being added to the continuation request.

Documentation Required

Required Supporting Evidence and Documentation

Key Definitions

inv-12: Covered indication — BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with CIS

Covered indication (short)BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS)

PopulationAdult patients with NMIBC with CIS, with or without papillary tumors

Concurrent therapy requirementMust be administered with Bacillus Calmette–Guérin (BCG)

Support and limitsUse must align with FDA labeling/accepted compendia; dosing and duration limits (<=400 mcg single dose; <=37 months total) apply

Line of Therapy

Line of therapy specification

Indication: BCG-unresponsive NMIBC with CIS; used in adults with concurrent BCG

Line of therapy not otherwise specified

Background

Anktiva (nogapendekin alfa inbakicept‑pmln) is indicated for intravesical use in adult patients with BCG‑unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, when used concurrently with Bacillus Calmette‑Guérin (BCG). Use must align with FDA labeling or accepted compendia/guidelines and be supported by the documentation required for prior authorization.