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Nodapendekin alfa inbakicept (Anktiva) Form

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Nodapendekin alfa inbakicept (Anktiva)

Indications

(1) Member is 18 years or older; AND 2. Nogapendekin alfa is prescribed by or in consultation with a physician who specializes in oncology or urology; AND 3. Member has documentation of BCG unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with all of the following: a. High-grade; AND b. Predominant urothelial (transitional cell) histology AND c. BCG unresponsive defined by one of the following: i. Persistent or recurrent CIS within 12 months of receiving at least 5 of 6 doses of an initial BCG induction PLUS at least 2 doses as part of maintenance treatment or 2 doses of a second induction; OR ii. Recurrent high-grade Ta/T1 disease within 6 months of receiving at least 5 of 6 doses of an initial BCG induction PLUS at least 2 doses as part of maintenance treatment or 2 doses of a second induction; OR iii. T1 high-grade disease at the first evaluation following 5 of 6 doses of BCG as an initial induction course AND 4. Nogapendekin will be prescribed in combination with BCG; AND MEDICAL COVERAGE POLICY SERVICE: Nogapendekin alfa inbakicept (Anktiva®) Policy Number: 314 Effective Date: 12/1/2025 Last Review: 11/11/2025 Next Review: 11/11/2026 Page 2 of 6 5. Nogapendekin will be dosed and administered according to FDA approved labeling; AND 6. Member meets one of the following: a. Documented trial and failure, intolerance, or contraindication to pembrolizumab (Keytruda) AND nadofaragene firdenovec-vncg (Adstiladrin); OR b. Member is established on nogapendekin; OR c. Texas Mandate HB1584, Texas Insurance Code (TIC) sec. 1369.213, or TIC sec. 1369.0546 are applicable Renewal requests 1. Member meets all initial criteria; AND 2. Member has manageable or no side effects; AND 3. Documentation should indicate there is no evidence of disease recurrence or progression; AND 4. Member has not exceeded the FDA approved labeled dosing of 24 maintenance doses Approval duration is the shortest of clinically appropriate indication, 6 months, or requested duration. Authorization not to exceed a maximum of 24 maintenance doses per treatment. BACKGROUND: Bladder cancer is the sixth most common type of cancer in the U.S. The American Cancer Society (ACS) estimates that 83,730 new cases of bladder cancer will be diagnosed in the U.S. in 2021, and that 17,200 people will die of the disease. Bladder cancer incidence increases with age; the average age at diagnosis is 73 years. The disease is approximately 3 times more common in men than in women. According to the National Cancer Institute (NCI), an estimated 723,745 people were living with bladder cancer in the U.S. in 2018. Urothelial carcinoma, also known as transitional cell carcinoma, accounts for 90% of bladder cancers diagnosed in the U.S. (ACS, 2019a). Approximatively 75% of patients with urothelial carcinoma have non-muscle invasive bladder cancer (NMIBC), also known as "superficial" bladder cancer. The primary treatment for NMIBC is TURBT. Patients who underwent TURBT during diagnostic work- up typically undergo a second, more extensive TURBT after diagnosis is confirmed. Adjuvant intravesical therapy with bacillus Calmette-Guérin (BCG) is strongly recommended for patients with newly diagnosed high-risk NMIBC; these patients have a 60% to 70% chance of cancer recurrence and a 10% to 45% chance of progression to muscle-invasive or metastatic bladder cancer within 5 years. Although intravesical BCG in addition to repeat TURBT is an effective primary treatment for NMIBC, 30% to 50% of patients have disease unresponsive to BCG, increasing their risk for cancer progression and mortality. The U.S. Food and Drug Administration (FDA) defines BCG-unresponsive NMIBC as being at least 1 of the following (FDA, 2018):  Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy MEDICAL COVERAGE POLICY SERVICE: Nogapendekin alfa inbakicept (Anktiva®) Policy Number: 314 Effective Date: 12/1/2025 Last Review: 11/11/2025 Next Review: 11/11/2026 Page 3 of 6  Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy  T1 high-grade disease at the first evaluation following an induction BCG course The standard of care for patients with high-risk BCG-unresponsive NMIBC is radical cystectomy, which is potentially curative. However, radical cystectomy is associated with substantial morbidity and decreased quality of life; many patients are either unfit or unwilling to undergo the surgery. The FDA has approved intravenously-administered pembrolizumab (Keytruda®) and nadofaragene firadenovec- vncg (Adstiladrin®) for high-risk BCG-unresponsive NMIBC in patients with CIS with or without papillary tumors. The U.S. Food and Drug Administration (FDA) approved ImmunityBio’s nogapendekin alfa inbakicept- pmln (Anktiva®) plus Bacillus Calmette-Guérin (BCG) on April 22, 2024, for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. It is a first-in-class interleukin (IL)-15 receptor agonist and administered intravesically. Efficacy of Anktiva was evaluated in the Phase 2/3 QUILT-3.032 trial (NCT03022825), a single-arm, multicenter study of 77adults with BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary disease following transurethral resection. The complete response (CR) rate was 62%, with 95% confidence interval (CI) 51% - 73%. The duration of response (DOR), as of the November 2023 cut-off, was more than 47 months and ongoing. The final median DOR has yet to be determined. The prolonged DOR beyond 24 months with Anktiva/BCG exceeds the benchmark for the magnitude of meaningful clinical results suggested by a panel of experts from the International Bladder Cancer Group (IBCG). In total, 58% of patients with a CR had a DOR ≥12 months and 40% had a DOR ≥24 months. Adverse events were consistent with those reported with BCG alone. Texas Mandate HB1584 and Texas Insurance Code (TIC) sec, 1369.213 state step therapy will not be required for a non-preferred drug when use is 1) consistent with best practices for the treatment of stage-four advanced, metastatic cancer or an associated condition; 2) supported by peer-reviewed, evidence-based literature; AND 3) approved by the United States Food and Drug Administration TIC sec. 1369.0546 states step therapy will not be required for a non-preferred drug when use is contraindicated or expected to be ineffective or cause harm based on submitted clinical documentation and/or medical literature. CODES: Important note: Due to the wide range of applicable diagnosis codes and potential changes to codes, an inclusive list may not be presented, but the following codes may apply. Inclusion of a code in this section does not guarantee that it will be reimbursed, and patient must meet the criteria set forth in the policy language. CPT Codes: 51720 Bladder instillation of anticarcinogenic agent (including retention time) MEDICAL COVERAGE POLICY SERVICE: Nogapendekin alfa inbakicept (Anktiva®) Policy Number: 314 Effective Date: 12/1/2025 Last Review: 11/11/2025 Next Review: 11/11/2026 Page 4 of 6 HCPCS Codes: J9028 - Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram ICD10 codes: C67.0 Malignant Neoplasm of Trigone of Bladder C67.1 Malignant Neoplasm of Dome of Bladder C67.2 Malignant Neoplasm of Lateral Wall of Bladder C67.3 Malignant Neoplasm of Anterior Wall of Bladder C67.4 Malignant Neoplasm of Posterior Wall of Bladder C67.5 Malignant Neoplasm of Bladder Neck C67.6 Malignant Neoplasm of Ureteric Orifice C67.7 Malignant Neoplasm of Urachus C67.8 Malignant Neoplasm of Overlapping Sites of Bladder C67.9 Malignant Neoplasm of Bladder, Unspecified D09.0 Carcinoma in situ of bladder ICD10 Not covered: POLICY HISTORY: Status Date Action New 10/14/2024 New policy Update 8/11/2025 Removed, Medicare NCD/LCD Interqual statement for clarity. Update 10/13/2025 Updated beginning note to align with standard language, Added criteria title to align with standard language, Updated formatting of age requirement, Updated to standard language for indication and prescriber, Streamlined urothelial cell histology language, Added language to clarify BCG unresponsive definitions, Added standard language for dosing and administration, Added renewal criteria, Added maximum treatment authorization, Added CPT Code, Updated HCPCS codes, Added ICD-10 codes, Updated reference note to align with standard language, Updated references to AMA style. REFERENCES: The following scientific references were utilized in the formulation of this medical policy. BSWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available, and they are not included in the list, please forward the reference(s) to BSWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order. MEDICAL COVERAGE POLICY SERVICE: Nogapendekin alfa inbakicept (Anktiva®) Policy Number: 314 Effective Date: 12/1/2025 Last Review: 11/11/2025 Next Review: 11/11/2026 Page 5 of 6 1. Adstiladrin [package insert]. Kastrup, Denmark: Ferring Pharmaceuticals; 2024. Accessed August 16, 2024. https://ferringusa.com/wp-content/uploads/sites/12/2024/05/ADSTILADRIN-USPI-CLEAN-5.2024.pdf 2. Adstiladrin. NCCN Drugs & Biologics Compendium. Accessed August 16, 2024. https://www.nccn.org/professionals/drug_compendium/content/ 3. Anktiva [package insert]. Culver City, CA: ImmunityBio, Inc.; 2024. Accessed August 16, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf 4. Anktiva. NCCN Drugs & Biologics Compendium. Accessed August 16, 2024. https://www.nccn.org/professionals/drug_compendium/content/ 5. MedlinePlus. Bladder Cancer. National Library of Medicine. Published 1999. Accessed August 16, 2024. https://medlineplus.gov/bladdercancer.html 6. National Cancer Institute. Cancer of the urinary bladder—Cancer stat facts. Surveillance, Epidemiology, and End Results Program. Updated 2024. Accessed August 16, 2024. https://seer.cancer.gov/statfacts/html/urinb.html 7. Chamie K, Chang SS, Kramolowsky E, et al. IL-15 superagonist NAI in BCG-unresponsive non–muscle-invasive bladder cancer. NEJM Evid. 2023;2(1):EVIDoa2200167. doi:10.1056/EVIDoa2200167 8. Chang SS, Boorjian SA, Chou R, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol. 2016;196(4):1021-1029. doi:10.1016/j.juro.2016.06.049 9. Chehroudi AC, Black PC. Emerging intravesical therapies for the management of bacillus Calmette-Guérin (BCG)- unresponsive non-muscle-invasive bladder cancer: Charting a path forward. Can Urol Assoc J. 2020;14(6):204-213. doi:10.5489/cuaj.6101 10. American Cancer Society. Key statistics for bladder cancer. Updated 2024. Accessed August 16, 2024. https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html 11. Keytruda [package insert]. Whitehouse Station, NJ: Merck & Co, Inc.; 2024. Accessed August 16, 2024. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf 12. Keytruda. NCCN Drugs & Biologics Compendium. Accessed August 16, 2024. https://www.nccn.org/professionals/drug_compendium/content/ 13. Matulewicz RS, Steinberg GD. Non–muscle-invasive bladder cancer: Overview and contemporary treatment landscape of neoadjuvant chemoablative therapies. Rev Urol. 2020;22(2):43-51. 14. Packiam VT, Johnson SC, Steinberg GD. Non–muscle-invasive bladder cancer: Intravesical treatments beyond bacille Calmette-Guérin. Cancer. 2017;123(3):390-400. doi:10.1002/cncr.30392 15. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). 2024. Accessed June 27, 2024. https://www.nccn.org 16. American Cancer Society. What is bladder cancer? Updated 2024. Accessed August 16, 2024.? 

Effective Date

NA

Last Reviewed

NA

Original Document

  Reference



MEDICAL COVERAGE POLICY SERVICE: Nogapendekin alfa inbakicept (Anktiva®) Policy Number: 314 Effective Date: 12/1/2025 Last Review: 11/11/2025 Next Review: 11/11/2026

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Important note: Unless otherwise indicated, medical policies will apply to all lines of business. Medical necessity as defined by this policy does not ensure the benefit is covered. This medical policy does not replace existing federal or state rules and regulations for the applicable service or supply. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan documents. See the member plan specific benefit plan document for a complete description of plan benefits, exclusions, limitations, and conditions of coverage. In the event of a discrepancy, the plan document always supersedes the information in this policy. SERVICE: Nogapendekin alfa inbakicept (Anktiva®) PRIOR AUTHORIZATION: Required POLICY: Please review the plan’s EOC (Evidence of Coverage) or Summary Plan Description (SPD) for details. For Medicare plans, please refer to appropriate Medicare NCD (National Coverage Determination) or LCD (Local Coverage Determination). If there are no applicable NCD or LCD criteria, use the criteria set forth below. For Medicaid plans, please confirm coverage as outlined in the Texas Medicaid Provider Procedures Manual | TMHP (TMPPM). Texas Mandate HB154 is applicable for Medicaid plans.
Baylor Scott & White Health Plan (BSWHP) may consider nogapendekin alfa inbakicept (Anktiva®) medically necessary when documentation is submitted showing ALL of the following criteria are met:
Universal Criteria Applied To All Requests

  1. Member is 18 years or older; AND
  2. Nogapendekin alfa is prescribed by or in consultation with a physician who specializes in oncology or urology; AND
  3. Member has documentation of BCG unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with all of the following: a. High-grade; AND b. Predominant urothelial (transitional cell) histology AND c. BCG unresponsive defined by one of the following: i. Persistent or recurrent CIS within 12 months of receiving at least 5 of 6 doses of an initial BCG induction PLUS at least 2 doses as part of maintenance treatment or 2 doses of a second induction; OR ii. Recurrent high-grade Ta/T1 disease within 6 months of receiving at least 5 of 6 doses of an initial BCG induction PLUS at least 2 doses as part of maintenance treatment or 2 doses of a second induction; OR iii. T1 high-grade disease at the first evaluation following 5 of 6 doses of BCG as an initial induction course
    AND
  4. Nogapendekin will be prescribed in combination with BCG; AND

MEDICAL COVERAGE POLICY SERVICE: Nogapendekin alfa inbakicept (Anktiva®) Policy Number: 314 Effective Date: 12/1/2025 Last Review: 11/11/2025 Next Review: 11/11/2026

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  1. Nogapendekin will be dosed and administered according to FDA approved labeling; AND

  2. Member meets one of the following: a. Documented trial and failure, intolerance, or contraindication to pembrolizumab (Keytruda) AND nadofaragene firdenovec-vncg (Adstiladrin); OR b. Member is established on nogapendekin; OR c. Texas Mandate HB1584, Texas Insurance Code (TIC) sec. 1369.213, or TIC sec. 1369.0546 are applicable

    Renewal requests

  3. Member meets all initial criteria; AND
  4. Member has manageable or no side effects; AND
  5. Documentation should indicate there is no evidence of disease recurrence or progression; AND

  6. Member has not exceeded the FDA approved labeled dosing of 24 maintenance doses

    Approval duration is the shortest of clinically appropriate indication, 6 months, or requested duration. Authorization not to exceed a maximum of 24 maintenance doses per treatment. BACKGROUND: Bladder cancer is the sixth most common type of cancer in the U.S. The American Cancer Society (ACS) estimates that 83,730 new cases of bladder cancer will be diagnosed in the U.S. in 2021, and that 17,200 people will die of the disease. Bladder cancer incidence increases with age; the average age at diagnosis is 73 years. The disease is approximately 3 times more common in men than in women. According to the National Cancer Institute (NCI), an estimated 723,745 people were living with bladder cancer in the U.S. in 2018.
    Urothelial carcinoma, also known as transitional cell carcinoma, accounts for 90% of bladder cancers diagnosed in the U.S. (ACS, 2019a). Approximatively 75% of patients with urothelial carcinoma have non-muscle invasive bladder cancer (NMIBC), also known as "superficial" bladder cancer.
    The primary treatment for NMIBC is TURBT. Patients who underwent TURBT during diagnostic work- up typically undergo a second, more extensive TURBT after diagnosis is confirmed. Adjuvant intravesical therapy with bacillus Calmette-Guérin (BCG) is strongly recommended for patients with newly diagnosed high-risk NMIBC; these patients have a 60% to 70% chance of cancer recurrence and a 10% to 45% chance of progression to muscle-invasive or metastatic bladder cancer within 5 years. Although intravesical BCG in addition to repeat TURBT is an effective primary treatment for NMIBC, 30% to 50% of patients have disease unresponsive to BCG, increasing their risk for cancer progression and mortality. The U.S. Food and Drug Administration (FDA) defines BCG-unresponsive NMIBC as being at least 1 of the following (FDA, 2018):  Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy

MEDICAL COVERAGE POLICY SERVICE: Nogapendekin alfa inbakicept (Anktiva®) Policy Number: 314 Effective Date: 12/1/2025 Last Review: 11/11/2025 Next Review: 11/11/2026

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 Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy  T1 high-grade disease at the first evaluation following an induction BCG course The standard of care for patients with high-risk BCG-unresponsive NMIBC is radical cystectomy, which is potentially curative. However, radical cystectomy is associated with substantial morbidity and decreased quality of life; many patients are either unfit or unwilling to undergo the surgery. The FDA has approved intravenously-administered pembrolizumab (Keytruda®) and nadofaragene firadenovec- vncg (Adstiladrin®) for high-risk BCG-unresponsive NMIBC in patients with CIS with or without papillary tumors. The U.S. Food and Drug Administration (FDA) approved ImmunityBio’s nogapendekin alfa inbakicept- pmln (Anktiva®) plus Bacillus Calmette-Guérin (BCG) on April 22, 2024, for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. It is a first-in-class interleukin (IL)-15 receptor agonist and administered intravesically. Efficacy of Anktiva was evaluated in the Phase 2/3 QUILT-3.032 trial (NCT03022825), a single-arm, multicenter study of 77adults with BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary disease following transurethral resection. The complete response (CR) rate was 62%, with 95% confidence interval (CI) 51% - 73%. The duration of response (DOR), as of the November 2023 cut-off, was more than 47 months and ongoing. The final median DOR has yet to be determined. The prolonged DOR beyond 24 months with Anktiva/BCG exceeds the benchmark for the magnitude of meaningful clinical results suggested by a panel of experts from the International Bladder Cancer Group (IBCG). In total, 58% of patients with a CR had a DOR ≥12 months and 40% had a DOR ≥24 months. Adverse events were consistent with those reported with BCG alone. Texas Mandate HB1584 and Texas Insurance Code (TIC) sec, 1369.213 state step therapy will not be required for a non-preferred drug when use is
1) consistent with best practices for the treatment of stage-four advanced, metastatic cancer or an associated condition; 2) supported by peer-reviewed, evidence-based literature; AND 3) approved by the United States Food and Drug Administration TIC sec. 1369.0546 states step therapy will not be required for a non-preferred drug when use is contraindicated or expected to be ineffective or cause harm based on submitted clinical documentation and/or medical literature. CODES: Important note: Due to the wide range of applicable diagnosis codes and potential changes to codes, an inclusive list may not be presented, but the following codes may apply. Inclusion of a code in this section does not guarantee that it will be reimbursed, and patient must meet the criteria set forth in the policy language.

CPT Codes: 51720 Bladder instillation of anticarcinogenic agent (including retention time)

MEDICAL COVERAGE POLICY SERVICE: Nogapendekin alfa inbakicept (Anktiva®) Policy Number: 314 Effective Date: 12/1/2025 Last Review: 11/11/2025 Next Review: 11/11/2026

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HCPCS Codes: J9028 - Injection, nogapendekin alfa inbakicept-pmln, for intravesical use, 1 microgram

ICD10 codes: C67.0 Malignant Neoplasm of Trigone of Bladder C67.1 Malignant Neoplasm of Dome of Bladder C67.2 Malignant Neoplasm of Lateral Wall of Bladder C67.3 Malignant Neoplasm of Anterior Wall of Bladder C67.4 Malignant Neoplasm of Posterior Wall of Bladder C67.5 Malignant Neoplasm of Bladder Neck C67.6 Malignant Neoplasm of Ureteric Orifice C67.7 Malignant Neoplasm of Urachus C67.8 Malignant Neoplasm of Overlapping Sites of Bladder C67.9 Malignant Neoplasm of Bladder, Unspecified D09.0 Carcinoma in situ of bladder ICD10 Not covered:

POLICY HISTORY: Status Date Action New 10/14/2024 New policy Update 8/11/2025 Removed, Medicare NCD/LCD Interqual statement for clarity. Update 10/13/2025 Updated beginning note to align with standard language, Added criteria title to align with standard language, Updated formatting of age requirement, Updated to standard language for indication and prescriber, Streamlined urothelial cell histology language, Added language to clarify BCG unresponsive definitions, Added standard language for dosing and administration, Added renewal criteria, Added maximum treatment authorization, Added CPT Code, Updated HCPCS codes, Added ICD-10 codes, Updated reference note to align with standard language, Updated references to AMA style.

REFERENCES:

The following scientific references were utilized in the formulation of this medical policy. BSWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available, and they are not included in the list, please forward the reference(s) to BSWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order.

MEDICAL COVERAGE POLICY SERVICE: Nogapendekin alfa inbakicept (Anktiva®) Policy Number: 314 Effective Date: 12/1/2025 Last Review: 11/11/2025 Next Review: 11/11/2026

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  1. Adstiladrin [package insert]. Kastrup, Denmark: Ferring Pharmaceuticals; 2024. Accessed August 16, 2024. https://ferringusa.com/wp-content/uploads/sites/12/2024/05/ADSTILADRIN-USPI-CLEAN-5.2024.pdf
  2. Adstiladrin. NCCN Drugs & Biologics Compendium. Accessed August 16, 2024. https://www.nccn.org/professionals/drug_compendium/content/
  3. Anktiva [package insert]. Culver City, CA: ImmunityBio, Inc.; 2024. Accessed August 16, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf
  4. Anktiva. NCCN Drugs & Biologics Compendium. Accessed August 16, 2024. https://www.nccn.org/professionals/drug_compendium/content/
  5. MedlinePlus. Bladder Cancer. National Library of Medicine. Published 1999. Accessed August 16, 2024. https://medlineplus.gov/bladdercancer.html
  6. National Cancer Institute. Cancer of the urinary bladder—Cancer stat facts. Surveillance, Epidemiology, and End Results Program. Updated 2024. Accessed August 16, 2024. https://seer.cancer.gov/statfacts/html/urinb.html
  7. Chamie K, Chang SS, Kramolowsky E, et al. IL-15 superagonist NAI in BCG-unresponsive non–muscle-invasive bladder cancer. NEJM Evid. 2023;2(1):EVIDoa2200167. doi:10.1056/EVIDoa2200167
  8. Chang SS, Boorjian SA, Chou R, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol. 2016;196(4):1021-1029. doi:10.1016/j.juro.2016.06.049
  9. Chehroudi AC, Black PC. Emerging intravesical therapies for the management of bacillus Calmette-Guérin (BCG)- unresponsive non-muscle-invasive bladder cancer: Charting a path forward. Can Urol Assoc J. 2020;14(6):204-213. doi:10.5489/cuaj.6101
  10. American Cancer Society. Key statistics for bladder cancer. Updated 2024. Accessed August 16, 2024. https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html
  11. Keytruda [package insert]. Whitehouse Station, NJ: Merck & Co, Inc.; 2024. Accessed August 16, 2024. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
  12. Keytruda. NCCN Drugs & Biologics Compendium. Accessed August 16, 2024. https://www.nccn.org/professionals/drug_compendium/content/
  13. Matulewicz RS, Steinberg GD. Non–muscle-invasive bladder cancer: Overview and contemporary treatment landscape of neoadjuvant chemoablative therapies. Rev Urol. 2020;22(2):43-51.
  14. Packiam VT, Johnson SC, Steinberg GD. Non–muscle-invasive bladder cancer: Intravesical treatments beyond bacille Calmette-Guérin. Cancer. 2017;123(3):390-400. doi:10.1002/cncr.30392
  15. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).
  16. Accessed June 27, 2024. https://www.nccn.org
  17. American Cancer Society. What is bladder cancer? Updated 2024. Accessed August 16, 2024. https://www.cancer.org/cancer/types/bladder-cancer/about/what-is-bladder-cancer.html Note: Health Maintenance Organization (HMO) products are offered through Scott and White Health Plan dba Baylor Scott & White Health Plan, and Scott & White Care Plans dba Baylor Scott & White Care Plan. Insured PPO and EPO products are offered through Baylor Scott & White Insurance Company. Scott and White Health Plan dba Baylor Scott & White Health Plan serves as a third-party administrator for self-funded employer-sponsored plans. Baylor Scott & White Care Plan and Baylor Scott & White Insurance Company are wholly owned subsidiaries of Scott and White Health Plan. These companies are referred to collectively in this document as Baylor Scott & White Health Plan.

MEDICAL COVERAGE POLICY SERVICE: Nogapendekin alfa inbakicept (Anktiva®) Policy Number: 314 Effective Date: 12/1/2025 Last Review: 11/11/2025 Next Review: 11/11/2026

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RightCare STAR Medicaid is offered through Scott and White Health Plan in the Central Texas Medicaid Rural Service Area (MRSA); FirstCare STAR is offered through SHA LLC dba FirstCare Health Plans (FirstCare) in the Lubbock and West MRSAs; and FirstCare CHIP is offered through FirstCare in the Lubbock Service Area.

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