ImmunityBio's ANKTIVA (nogapendekin alfa inbakicept-pmln) has been granted a permanent J-code (J9028) by the Centers for Medicare & Medicaid Services (CMS), set to take effect on January 1, 2025. This designation is expected to significantly simplify the billing and reimbursement process for healthcare providers administering the drug.
ANKTIVA, an IL-15 superagonist, received FDA approval in April 2024 for use in combination 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. The approval marked a significant advancement in the treatment landscape for this challenging disease.
Clinical Efficacy and Trial Data
ANKTIVA's efficacy is supported by data from the phase 2/3 QUILT 3.032 trial (NCT03022825). Updated results from November 2024, which included 100 patients, demonstrated a 71% complete response rate among patients with BCG-unresponsive NMIBC CIS who received ANKTIVA in combination with BCG. The duration of response in these patients extended up to 54 months. These findings align with earlier data from the QUILT-3.032 trial published in NEJM Evidence, which also reported a 71% complete response rate in cohort A (n=82).
The QUILT 3.032 study is an open-label, multicenter trial evaluating ANKTIVA across three patient cohorts. Cohorts A and C included patients with BCG-unresponsive bladder CIS, with or without Ta/T1 papillary tumors, receiving ANKTIVA plus BCG (cohort A) or ANKTIVA alone (cohort C). Cohort B enrolled patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC who received ANKTIVA plus BCG.
The primary endpoints of the trial were the incidence of complete response at 3 and 6 months for cohorts A and C, and disease-free survival at 12 months for cohort B. Secondary endpoints for cohort A include durability, cystectomy avoidance, progression-free survival, disease-specific survival, and overall survival. The study is ongoing to assess the durability of response and overall survival, with final completion expected in October 2028.
Impact of J-Code
According to ImmunityBio, J-codes are unique identifiers used by U.S. government and commercial payers, as well as physicians, to streamline billing and reimbursement for intravesically administered therapies. The assignment of a permanent J-code is expected to improve patient access to ANKTIVA by simplifying the reimbursement process for healthcare providers.
"The unique J-code for Anktiva is another milestone in our quest to deliver the next generation of immunotherapy beyond T cell activation and enables patients with bladder cancer to benefit from the power of natural killer (NK) cells," said Patrick Soon-Shiong, MD, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio.
With over 200 million medical lives covered through various insurance programs, ImmunityBio has established a strong market presence for ANKTIVA. The new J-code is anticipated to further solidify its position in the competitive landscape of bladder cancer treatments.
