ANKTIVA (nogapendekin alfa inbakicept-pmln)

ANKTIVA (nogapendekin alfa inbakicept-pmln)

Office-Administration- intravesical instillation

Diagnosis considered for coverage:

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

Coverage Criteria:

For diagnosis of Non-Muscle Invasive Bladder Cancer (NMIBC):

• 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 OR 
  • 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 OR 
  • Disease recurrence after an initial tumor-free state following adequate BCG therapy OR
  • 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

Reauthorization Criteria:

For diagnosis of Non-Muscle Invasive Bladder Cancer (NMIBC):

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

Coverage Duration: 

• Initial: 6 months
• Reauthorization: 1 year 

Dosing: 

For diagnosis of Non-Muscle Invasive Bladder Cancer (NMIBC):

• For Intravesical Use Only. Do NOT administer by subcutaneous or intravenous or intramuscular routes.
  • For induction: Anktiva is recommended at a dose of 400 mcg administered intravesically with BCG once a week for 6 weeks. A second induction course may be administered if complete response is not achieved at month 3.
  • For maintenance: After BCG and Anktiva induction therapy, Anktiva is recommended at a dose of 400 mcg administered intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13 and 19 (for a total of 15 doses). For patients with an ongoing complete response at month 25 and later, maintenance instillations with BCG may be administered once a week for 3 weeks at months 25, 31, and 37 for a maximum of 9 additional instillations.
• The recommended duration of treatment is until disease persistence after second induction, disease recurrence or progression, unacceptable toxicity, or a maximum of 37 months.

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• For Intravesical Use Only. Do NOT administer by subcutaneous or intravenous or intramuscular routes.
• After preparation (see package insert for details), the admixture of Anktiva in combination with BCG is instilled into the bladder via a catheter. After instillation is complete, the catheter is removed. The Anktiva in combination with BCG admixture is retained in the bladder for 2 hours and then voided. Patients unable to retain the suspension for 2 hours should be allowed to void sooner, if necessary. Do not repeat the dose if the patient voids before 2 hours.

Policy Updates:

• 12/01/2024 – New policy for Anktiva approved by WHA P&T Committee. (P&T, 11/20/2024)

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.