CurrentCignaPolicy N/A

Oncology (Intravesical) - Anktiva Prior Authorization Policy

Defines Cigna's prior authorization and medical necessity criteria for coverage of Anktiva as intravesical therapy for BCG-unresponsive high‑risk non‑muscle invasive bladder cancer (CIS) in adults; applies to Cigna-administered health benefit plans unless a customer's plan document states otherwise.

Policy Summary

PayerCigna

PolicyOncology (Intravesical) - Anktiva Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevisions and clarifications (title changeadded 'high‑risk' qualifiernarrowed CIS wording)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and ensure Anktiva is prescribed by or in consultation with a urologist or oncologist, documenting the required clinical criteria and approval duration.

SourceLink

POLICY UPDATE CHANGES

Policy name changed from 'Oncology (Other) - Anktiva PA Policy' to 'Oncology (Intravesical) - Anktiva PA Policy'.

Clarified that for the requirement of BCG-unresponsive disease the qualifier 'high-risk' was added.

For the requirement that the patient has carcinoma in situ, removed the phrase 'with or without papillary tumors'.

Document includes explicit NCCN guideline alignment (NCCN v1.2025) and FDA indication language for Anktiva with BCG in BCG-unresponsive NMIBC with CIS.

≥18Minimum age requirement for initial therapy

6Approval duration for initial therapy (months)

3Approval duration for maintenance therapy (months)

1Indication covered (NMIBC: CIS)

Medical Necessity Criteria for Anktiva (Intravesical)

Relevant Codes and Product

Drug / ProductNDC|HCPCSCovered

Anktiva (nogapendekin alfa inbakicept-pmln intravesical solution)

Specified product name—coverage applies when criteria met. (No NDC or HCPCS codes provided in document.)

Diagnosis codes (expected based on clinical indication)ICD-10

C67.0 - C67.9	Malignant neoplasm of bladder (general group; document does not list explicit ICD-10 codes)
D09.0	Carcinoma in situ of bladder (policy requires CIS)

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Anktiva; approvals are provided for the durations specified in the policy (6 months for initial therapy, 3 months for maintenance).

Initial therapy approvals: 6 months (allows time to complete two courses of induction therapy if needed).
Maintenance therapy approvals: 3 months.

Policy Summary

PayerCigna

PolicyOncology (Intravesical) - Anktiva Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevisions and clarifications (title changeadded 'high‑risk' qualifiernarrowed CIS wording)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and ensure Anktiva is prescribed by or in consultation with a urologist or oncologist, documenting the required clinical criteria and approval duration.

SourceLink

On This Page

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Documentation Required

Specialist involvement required

Anktiva must be prescribed by or in consultation with a urologist or an oncologist due to the specialized evaluation and monitoring required for patients receiving this therapy.

Requirement applies to both initial (A.v) and maintenance (B.iii) therapy approvals.

Denial Risk

Denial risk for off‑label uses

Requests for Anktiva for any use not specified in the policy (i.e., other than BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in situ as defined) are considered not medically necessary and will be denied.

Policy explicitly states Anktiva is not medically necessary for any other use(s); criteria will be updated as new data are available.

Documentation Required

Clinical response documentation for maintenance

For maintenance approval, documentation must demonstrate an ongoing complete response as defined by the policy (either negative cystoscopy with the specified urine cytology findings or positive cystoscopy with biopsy‑proven benign/low‑grade Ta and negative urine cytology).

Ongoing complete response — option a: negative cystoscopy plus (negative urine cytology OR malignant urine cytology attributable to upper tract/prostatic urethra with negative random bladder biopsies).
Ongoing complete response — option b: positive cystoscopy with biopsy‑proven benign or low‑grade Ta NMIBC and negative urine cytology.

Clinical Context

Anktiva is an interleukin‑15 (IL‑15) receptor agonist indicated, in combination with Bacillus Calmette‑Guérin (BCG), for the treatment of BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) in adults with carcinoma in situ. Prior authorization is required and approvals are time‑limited as specified in the policy. The policy was updated to add the qualifier “high‑risk” to the BCG‑unresponsive requirement and to narrow the carcinoma in situ language. (See prescribing information and policy history.)

The National Comprehensive Cancer Network (NCCN) bladder cancer guidelines (version 1.2025) recommend Anktiva for the treatment of BCG‑unresponsive, high‑risk NMIBC with carcinoma in situ (CIS) as a category 2A recommendation, supporting its use in the covered indication described above.

Policy Definitions

Definitions

BCG-unresponsive (high‑risk)Policy requires BCG-unresponsive disease and specifically adds the qualifier 'high-risk' for the covered population; the document does not redefine BCG-unresponsive criteria.

Ongoing complete responseDefined as either (a) negative cystoscopy plus (1) negative urine cytology OR (2) malignant urine cytology if cancer found in the upper tract or prostatic urethra with random bladder biopsies negative; OR (b) positive cystoscopy with biopsy‑proven benign or low‑grade Ta non‑muscle invasive bladder cancer and negative urine cytology.

Policy Changes

2025-04-30materialLatest

Annual revision: added 'high-risk' qualifier to the requirement for BCG-unresponsive disease and removed the phrase 'with or without papillary tumors' from the carcinoma in situ criterion.

2025-04-04non-material

Policy name changed from 'Oncology (Other) - Anktiva PA Policy' to 'Oncology (Intravesical) - Anktiva PA Policy' (cosmetic/organizational change).

2024-05-08non-material

New policy created (initial review date 05/08/2024).

At-a-Glance Policy Highlights

Key Policy Statistics

Minimum age requirement for initial therapyAdult patients (≥18 years)

Approval duration for initial therapy6 months

Approval duration for maintenance therapy3 months

Indication covered (NMIBC: CIS)Carcinoma in situ (CIS) — policy requires CIS for covered indication