CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Anktiva (nogapendekin alfa inbakicept-pmln) — Coverage Criteria for Intravesical Use with BCG

Defines clinical coverage, prior authorization, and limits for Anktiva used with BCG to treat BCG-unresponsive nonmuscle invasive bladder cancer (CIS ± papillary tumors) in adult members; applies to medications processed by Evolent for Neighborhood Health Plan of Rhode Island lines of business listed.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAnktiva (nogapendekin alfa inbakicept-pmln) — Coverage Criteria for Intravesical Use with BCG

Policy CodePolicy N/A

Change TypeOperationalexclusion criteria updated

Effective DateJun 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization from Evolent for intravesical Anktiva; continuation requests allowed if no progression, prior authorization was active within the last year without >30-day lapse, and no additional medications are added.

SourceLink

POLICY UPDATE CHANGES

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

Updated exclusion criteria for Anktiva.

BCG-unresponsive NMIBCIndication covered

37 monthsTreatment duration limit

400 mcgDosing limit

J9028HCPCS code

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Coverage Criteria for Anktiva

Initial therapy coverage

Covered when ALL of the following are met

Indication and concomitant therapy: Adult member with BCG-unresponsive nonmuscle invasive bladder cancer (CIS with or without papillary tumors) AND Anktiva is administered concurrently with BCG

From indication statement

Supportive evidence: Use is supported by FDA labeling, CMS-approved compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature

Evidence requirements per policy

Continuation therapy coverage

Continuation therapy covered when ALL of the following are met

No progression: Member has not experienced disease progression on Anktiva

Continuation exemption condition

Recent authorization: Requested medication was used within the last year without a lapse >30 days of having an active authorization

Continuation exemption condition

No additional medications: No additional medication(s) are being added to the continuation request

Continuation exemption condition

Coverage exclusions include use of Anktiva (nogapendekin alfa inbakicept-pmln) when there is disease progression while taking Anktiva, or when Anktiva is administered without concurrent BCG. Therapy that exceeds the maximum duration limit of 37 months or dosing that exceeds the single dose limit of 400 mcg is not covered. Requests may also be excluded when the requested use is investigational/off-label and lacks sufficient supporting evidence as defined by the policy (for example, absence of support in CMS-recognized compendia or acceptable peer-reviewed literature, inadequate representation of the patient/cancer characteristics in published evidence, or lack of clinically meaningful outcomes).

Anktiva use is considered investigational or off‑label and not covered when the indication lacks sufficient evidence or is not generally accepted by the medical community. The policy defines insufficient evidence as absence of support from CMS‑recognized compendia or acceptable peer‑reviewed literature and evaluates factors such as whether the clinical characteristics and treatment regimen are represented in published evidence, whether study outcomes are clinically meaningful (for example, ASCO‑recommended thresholds), and the adequacy of the experimental design. Case reports and meeting abstracts without full peer‑reviewed articles generally do not provide adequate supportive evidence.

Regimens and Administration

Regimen	HCPCS / Unit	Single dose limit	Maximum treatment duration	Coverage
Intravesical Anktiva (nogapendekin alfa inbakicept-pmln) administered concurrently with Bacillus Calmette–Guérin (BCG) for BCG‑unresponsive nonmuscle invasive bladder cancer (CIS with or without papillary tumors)	J9028 — Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram	400 mcg	37 months	Covered when criteria met (see policy for required clinical criteria and prior authorization).

inv-06: Single dose limit — 400 mcg

Single dose limit400 mcg per intravesical administration

Related codingHCPCS J9028 (Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram)

Exclusion if exceededRequests where dosing exceeds the single dose limit (400 mcg) may be denied

inv-07: Maximum treatment duration — 37 months

Maximum treatment duration37 months total treatment duration

Exclusion if exceededTreatment courses that exceed 37 months are listed as exclusion criteria and may be denied

Coding and Billing

Applicable HCPCS CodesHCPCSCovered

J9028

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

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Evolent processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Prior authorization required for all Anktiva requests
Evolent is the prior authorization processor for network providers

Step Therapy

Continuation (Step/Renewal) Conditions

Continuation (step/renewal) requests may be exempt from this policy when all continuity conditions are met. Requests that add other medications, show disease progression, or exceed allowed lapses are not eligible for continuation exemption.

Member has not experienced disease progression on the requested medication
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization

Line of Therapy Information

Line of therapy (informational)

Indication: BCG-unresponsive NMIBC (CIS ± papillary) to receive intravesical Anktiva with BCG

Document does not specify line-of-therapy numbering

Definitions

inv-13: Definition — BCG-unresponsive nonmuscle invasive bladder cancer (CIS ± papillary)

DefinitionBCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors

Required concomitant therapyAnktiva must be administered concurrently with Bacillus Calmette–Guérin (BCG)

Exclusion related to responseDisease progression while taking Anktiva is an exclusion for continued coverage

Background

Anktiva (nogapendekin alfa inbakicept-pmln) is an intravesical immunotherapy indicated for use in adult patients with BCG‑unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. Per the policy, Anktiva is administered intravesically in combination with BCG for this indication and coverage is contingent on meeting evidence requirements consistent with FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature.

Policy Revision History

2025-06revisionLatest

Converted to new Evolent guideline template, replaced prior UM ONC_1502 guidance, updated exclusion criteria, and updated references.

2024-06new_policy

Policy originally published (new policy).