Last Review Date: 05/02/2024

Date of Origin: 05/02/2024

Dates Reviewed: 05/2024

1. Length of Authorization

Coverage will be provided 6 months and may be renewed up to a max of 37 months of therapy (i.e., up to a total of 36 doses).

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Anktiva 400 mcg/0.4 mL solution in SDV: 1 vial weekly for six weeks (may repeat once) as induction, followed by one vial weekly for three weeks at months 4, 7, 10, 13, 19, 25, 31, and 37.

2. Max Units (per dose and over time) [HCPCS Unit]:

• Induction: 400 mcg once weekly up to 12 doses.
• Maintenance: 400 mcg once weekly for three weeks at months 4, 7, 10, 13, 19, 25, 31, and 37 (total of 24 doses).

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Bladder Cancer † ^1-4

• Patient has a diagnosis of non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (with or without papillary tumors); AND
• Patient has high-risk disease that is unresponsive to Bacillus Calmette-Guerin (BCG) (defined as persistent disease following adequate BCG therapy [≥5 of 6 induction doses plus ≥2 doses of maintenance or of 2^nd induction], disease recurrence after an initial tumor-free state following adequate BCG therapy, or Ta/T1 disease following a single induction course of BCG); AND
• Patient has undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease (Ta and T1 components) – Note: Patients with residual carcinoma in situ that is not amenable to complete resection, fulguration, or cauterization is permitted; AND
• Patient does NOT have muscle invasive (T2-T4), locally advanced, metastatic, or extra-vesical (i.e., urethra, ureter, or renal pelvis) urothelial carcinoma

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1-4

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and indication specific criteria as identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: grade 3 or 4 hematuria, etc.; AND

First Renewal:

• • Patient has a complete response (CR) to initial therapy (after 3 months) defined as a negative result for cystoscopy [with TURBT/biopsies as applicable] and urine cytology; OR
  • Patient has not had a complete response (CR) to initial therapy (after 3 months) and requires a second course of induction therapy*

Subsequent Renewals:

• Patient has not experienced a high-grade or CIS recurrence; AND
  • For patients at treatment month 25 or later: Patient is experiencing an ongoing (CR) and will require continued treatment; AND
  • Patient has not received greater than 37 months of therapy (24 doses as maintenance therapy)

*Note: If patients with CIS do not have a complete response to treatment after a second induction course of Anktiva with BCG, reconsider cystectomy.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drugs

NDC:

• Anktiva 400 mcg/0.4 mL solution in a single-dose vial: 81481-0803-xx

7. References

1. Anktiva [package insert]. Culver City, CA; Altor BioSciences, LLC; April 2024. Accessed April 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for nogapendekin alfa inbakicept. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2024.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Bladder Cancer. Version 3.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2024.
4. Karim Chamie et al.  Final clinical results of pivotal trial of IL-15RαFc super-agonist N-803 with BCG in BCG-unresponsive CIS and papillary non-muscle-invasive bladder cancer (NMIBC). JCO 40, 4508-4508(2022). DOI:10.1200/JCO.2022.40.16_suppl.4508.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A