Pharmacy Prior Authorization Criteria

Anktiva (nogapendekin alfa inbakicept-pmln)

Indications for Prior Authorization

Anktiva (nogapendekin alfa inbakicept-pmln)

• For diagnosis of non-Muscle Invasive Bladder Cancer (NMIBC)
  Indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Criteria

Anktiva

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of non-Muscle Invasive Bladder Cancer (NMIBC)
AND
• One of the following:
• Tumor is carcinoma in situ (CIS)
• Ta/T1 high grade disease
AND
• Patient is not eligible for or has elected not to undergo cystectomy
AND
• Patient has received an adequate course of Bacillus Calmette Guérin (BCG) monotherapy defined as the administration of at least 5 of 6 doses of an initial induction course plus one of the following:
• At least two of three doses of maintenance therapy
• At least two of six doses of a second induction course
AND
• Tumor is unresponsive to BCG monotherapy as defined by one of the following:
• Persistent disease following adequate BCG therapy
• Disease recurrence after an initial tumor-free state following adequate BCG therapy
• T1 disease following a single induction course of BCG
AND
• Medication is used in combination with Bacillus Calmette-Guérin (BCG) therapy
AND
• The patient has had all resectable disease (Ta and T1 components) removed
AND
• The patient does not have extra-vesical (i.e., urethra, ureter, or renal pelvis), muscle invasive (T2-T4), or metastatic urothelial carcinoma

Anktiva

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-07-09

References

1. Anktiva prescribing information. AGC Biologics. Bothell, WA. April 2024.
2. Chamie, K., Chang, S., Kramolowsky, E., et al. IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer. Available at: https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200167. Accessed June 17, 2024.
3. ClinicalTrials.gov. QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer. Available at: https://www.clinicaltrials.gov/study/NCT03022825?cond=nct03022825&rank=1. Accessed June 17, 2024.

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Revision History

• 2024-07-09: New UM PA Criteria

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