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Prior Authorization Criteria for Nogapendekin Alfa Inbakicept-pmln (Anktiva) Effective November 1, 2024

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Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to Medicaid members who are enrolled in their MCO. Administrative procedures, such as prior authorization, precertification, referrals, and claims and encounter data filing, may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the member’s specific MCO for details.

Effective for dates of service on or after November 1, 2024, prior authorization will be required for nogapendekin alfa inbakicept-pmln (Anktiva), procedure code C9169.

Nogapendekin alfa inbakicept-pmln (Anktiva) is an interleukin-15 (IL-15) receptor agonist indicated to treat adult clients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Prior Authorization Requirements for Nogapendekin Alfa Inbakicept-pmln (Anktiva)

Prior authorization requests for nogapendekin alfa inbakicept-pmln (Anktiva) must be submitted with a Special Medical Prior Authorization (SMPA) Request Form.

Requests for Initial Therapy

Initial therapy for nogapendekin alfa inbakicept-pmln (Anktiva) may be approved for a 6-month duration if all the following criteria are met:

  • The client is 18 years of age or older.
  • The client has a confirmed diagnosis of NMIBC with CIS with or without papillary tumors.
  • The client’s disease is high-risk and BCG-unresponsive, defined as persistent disease following adequate BCG therapy, disease recurrence after an initial tumor-free state following adequate BCG therapy, or T1 disease following a single induction course of BCG.
  • Nogapendekin alfa inbakicept-pmln (Anktiva) is used in combination with BCG.
  • The client has undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease (Ta and T1 components).
  • The client does not have any metastatic urothelial carcinoma.

Requests for Renewal or Continuation of Therapy

For renewal or continuation of therapy of nogapendekin alfa inbakicept-pmln (Anktiva), the client must meet the following requirements:

  • The client continues to have a diagnosis as listed in the initial therapy criteria above and has been treated with nogapendekin alfa inbakicept-pmln (Anktiva) in the past with no adverse reactions.
  • The client has no signs of unacceptable toxicity (e.g., hematuria, dysuria, or micturition urgency) while on treatment with nogapendekin alfa inbakicept-pmln (Anktiva).

For more information, call the TMHP Contact Center at 800-925-9126.