CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Anktiva (nogapendekin alfa inbakicept-pmln) — coverage criteria for BCG‑unresponsive NMIBC with CIS

Defines indications, exclusions, coding, and authorization expectations for use of Anktiva for treatment of BCG‑unresponsive non–muscle‑invasive bladder cancer and related continuation request rules; applies to providers submitting medication requests to Evolent on behalf of Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAnktiva coverage criteria for BCG‑unresponsive NMIBC with CIS

Policy CodePolicy N/A

Change TypeConverted to new guideline templateexclusions and references updated

Effective DateJun 20, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests for Anktiva when used concurrent with BCG and include supporting FDA/ASCO/peer‑reviewed evidence per CMS standards.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC 1502 Anktiva policy.

37maximum treatment duration

400single dose max (mcg)

J9028HCPCS code

BCG‑NMIBCprimary covered indication

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Coverage Criteria for Anktiva

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial therapy for covered indication: Patient is an adult with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors; Anktiva (nogapendekin alfa inbakicept-pmln) will be administered concurrent with Bacillus Calmette-Guérin (BCG); and the requested use is supported by FDA approval, ASCO clinical guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Continuation Therapy — Continuation authorization allowed when ALL of the following are met

Continuation authorization allowed when ALL of the following are met

Continuation criteria: Member has not experienced disease progression while on Anktiva; the medication was used within the last year with no lapse greater than 30 days in active authorization; and no additional medications are being added to the continuation request.

Continuation requests for medications that would otherwise be not-approvable are exempt when these conditions are satisfied.

Exclusions and limits: Requests for Anktiva (nogapendekin alfa inbakicept-pmln) will be denied when any of the following apply: disease progression occurred while the member was taking Anktiva; Anktiva is prescribed without concurrent Bacillus Calmette‑Guérin (BCG) administration; the proposed treatment would exceed the maximum duration of 37 months; a single administered dose would exceed 400 mcg; or the requested use is investigational or off‑label and lacks sufficient supporting evidence or acceptance by the medical community as defined in the guideline (e.g., inadequate representation of patient/cancer characteristics, inadequate regimen representation, lack of clinically meaningful outcomes per ASCO thresholds, reliance on uncontrolled case reports, or abstracts without full peer‑reviewed articles).

Investigational/off‑label statement: Use of Anktiva for indications outside the supported BCG‑concurrent, BCG‑unresponsive non‑muscle‑invasive bladder cancer indication is considered investigational and not medically necessary when the available evidence does not meet the guideline’s standards. Insufficient evidence includes lack of adequate representation of the patient or cancer in published studies, inadequate representation of the regimen under consideration, absence of clinically meaningful outcomes (ASCO‑defined thresholds such as hazard ratio < 0.80 or recommended survival benefit), reliance on uncontrolled case reports, or citation of abstracts without a corresponding full peer‑reviewed publication.

Regimen / Billing	Indication	Administration requirements	Dosing & duration limits
Anktiva (nogapendekin alfa inbakicept-pmln) — billed as HCPCS J9028 (Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram)
BCG‑unresponsive non‑muscle‑invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors
Must be administered concurrent with Bacillus Calmette‑Guérin (BCG)
Must be given within policy dosing and duration limits (single dose not to exceed 400 mcg; total therapy not to exceed 37 months)

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Anktiva (nogapendekin alfa inbakicept-pmln). Requests must document FDA-approved indications, or supporting evidence from ASCO guidelines or peer-reviewed literature that meets CMS standards. Evolent (on behalf of the payer) processes all medication requests; medications not authorized may be deemed not approvable and not reimbursable.

Prior authorization required for Anktiva
Supporting evidence: FDA approval OR ASCO clinical guidelines OR acceptable peer-reviewed literature per CMS standards
Requests processed by Evolent on behalf of the payer

Step Therapy

No step therapy sequence is specified for Anktiva in this policy.

No required prior agents or step sequence

Documentation Required

Required Supporting Documentation

Required supporting documentation must demonstrate the requested use meets FDA approval or is supported by ASCO clinical guidelines or peer-reviewed literature that satisfies CMS Medicare Benefit Policy Manual Chapter 15 standards. Documentation should address whether the patient and disease characteristics, treatment regimen, and reported outcomes are adequately represented by the evidence.

Evidence must be FDA-approved indication OR ASCO guideline OR acceptable peer-reviewed literature
Address representativeness of patient and cancer characteristics in cited evidence
Address whether the administered treatment regimen is represented in the evidence
Demonstrate clinically meaningful outcomes (ASCO-recommended benchmarks where applicable)
Provide study design details to show evidence quality (randomization, control, sample size, etc.)

Denial Risk

Denial Triggers

Triggers for denial include use inconsistent with the clinical criteria or exclusions below. Submit complete supporting documentation to avoid denial.

Disease progression while receiving Anktiva
Use of Anktiva without concurrent administration of BCG for approved NMIBC indication
Treatment duration that exceeds the maximum limit of 37 months
Dosing that exceeds the single-dose limit of 400 mcg
Investigational or off-label use not supported by CMS-recognized compendia or acceptable peer-reviewed literature
Insufficient evidence due to non-representative patient/cancer characteristics, inadequate representation of the treatment regimen, lack of clinically meaningful outcomes, or weak study design (e.g., reliance on single-case reports or abstracts without full peer-reviewed publication)

Background

Background and authorized use: Anktiva (nogapendekin alfa inbakicept-pmln) is authorized for intravesical use in adult patients with BCG‑unresponsive non‑muscle‑invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors, when administered concurrently with BCG. Continued authorization may be permitted when continuation criteria are met (no disease progression on therapy and prior authorization continuity requirements), and medication use is supported by FDA approval, ASCO clinical guidance, or adequate peer‑reviewed literature meeting CMS standards.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAnktiva coverage criteria for BCG‑unresponsive NMIBC with CIS

Policy CodePolicy N/A

Change TypeConverted to new guideline templateexclusions and references updated

Effective DateJun 20, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests for Anktiva when used concurrent with BCG and include supporting FDA/ASCO/peer‑reviewed evidence per CMS standards.

SourceLink

On This Page

OpenPayer

Anktiva (nogapendekin alfa inbakicept-pmln) — coverage criteria for BCG‑unresponsive NMIBC with CIS

Coverage Criteria for Anktiva

Covered Regimens and Administration

Coding and Quantity Limits

Provider Actions and Authorization Requirements

Key Definitions

Line of Therapy Information

Background

Revision History and Policy Changes