Prior Authorization Criteria for Anktiva Effective November 1, 2024

Date: October 16, 2024

Attention: All Providers

Prior authorization effective date: November 1, 2024

Call to action: The purpose of this communication is to inform providers that on October 1, 2024, Anktiva became a benefit of Medicaid and CHIP. Health and Human Services commission (HHSC) will require prior authorization for Anktiva (procedure code C9169) for Medicaid and CHIP, effective November 1, 2024.

Anktiva (Nogapendekin Alfa Inbakicept-pmln) 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.

Length of Authorization: 6 months

Criteria for Initial Approval:

1. Patient is at least 18 years of age or older; AND
2. Patient has a confirmed documentation of NMIBC with CIS with or without papillary tumors; AND
3. Patient disease is high-risk and BCG-unresponsive, defined by ANY of the following
   1. Persistent disease following adequate BCG therapy; OR
   2. Disease recurrence after an initial tumor-free state following adequate BCG therapy; OR
   3. T1 disease following a single induction course of BCG; AND
4. Patient is to be treated with Anktiva in combination with BCG; AND
5. Patient has undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease including Ta and T1 components; AND
6. Patient does not have any metastatic urothelial carcinoma

Criteria for Continuation of therapy:

1. Patient has met all initial requirements for initial approval and is currently being treated with Anktiva with no adverse reactions; AND
2. Patient has not experienced signs of unacceptable toxicity defined by ANY of the following
   • Hematuria; OR
   • Dysuria; OR
   • Micturition urgency

Next step for providers: Providers should refer to theTexas Medicaid Provider Procedures Manual (TMPPM),Outpatient Drug Services Handbook for more details on the clinical policy and prior authorization requirements.

Note: If request is for a non-FDA approved dose, indication, or age medical rational must be submitted in support of therapy (such as high-quality peer reviewed literature, acceptable compendia or evidence based practice guidelines) and exceptions will be considered on a case-by-case basis. 

If and when there any updates or changes related to the coverage for Anktiva, we will promptly communicate those changes to you.

If you have any questions, please email Provider Relations at: providerrelations@texaschildrens.org

For access to all provider alerts,log into: www.texaschildrenshealthplan.org/provideralerts