CMS issues permanent reimbursement code for Anktiva

The Centers for Medicare & Medicaid Services (CMS) have issued the Healthcare Common Procedure Coding System (HCPCS) J-code J9028 for billing and reimbursement of nogapendekin alfa inbakicept-pmln (Anktiva; N-803), ImmunityBio announced in a news release.¹

Anktiva is currently being assessed in the phase 2/3 QUILT3.032 trial.

The J-code became effective on January 1, 2025. Anktiva was approved by the FDA in April 2024 for use in combination with BCG for the treatment of patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

“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, in the news release.¹ Soon-Shiong is the Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio.

According to the company, J-codes are “unique identifiers used by U.S. government and commercial payers, as well as physicians and their office staff, to streamline the billing and reimbursement process for intravesically administered therapies and certain other treatments.”

Data on Anktiva

Anktiva is currently being assessed in the phase 2/3 QUILT3.032 trial (NCT03022825), which is evaluating the therapy in combination with BCG in patients with BCG-unresponsive NMIBC with CIS. Data from 100 patients enrolled in the study were shared in November 2024, showing a high rate of complete response among those who received the IL-15 superagonist in combination with BCG.²

At the time of data cutoff (November 2024), 71% of patients achieved a complete response following treatment. Among the responders, the duration of response ranged as long as 54 months.

These findings are consistent with previous data from the QUILT-3.032 trial, which were published in NEJM Evidence in November 2022.³ In this report, the CR rate was 71% among the 82 patients enrolled in cohort A of the trial.

According to ImmunityBio, “This data update will be submitted to the European Medicines Agency (EMA) in a Marketing Authorization Application (MAA) for ANKTIVA in the European Union (EU), which is anticipated during Q4 2024.”

Overall, the phase 2/3, open-label, multicenter QUILT 3.032 study assessed the use of N-803 across 3 patient cohorts. Cohorts A and C in the trial included patients with BCG-unresponsive bladder CIS with or without Ta/T1 papillary tumors who received N-803 plus BCG (cohort A) or N-803 alone (cohort C). The trial also enrolled patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC who received N-803 plus BCG (cohort B).

The primary end points for the trial were the incidence of complete response at 3 and 6-month timepoints for cohorts A and C, and disease-free survival at 12 months for cohort B. Secondary end points for cohort A are durability, cystectomy avoidance, progression-free survival, disease-specific survival, and overall survival.

The QUILT 3.023 study remains ongoing to assess the durability of response and overall survival among patients with BCG-unresponsive NMIBC with CIS. Final study completion is expected in October 2028.⁴

References

1. ImmunityBio announces permanent J-code (J9028) for ANKTIVA is now effective. News release. ImmunityBio. Published online and accessed January 6, 2024. https://immunitybio.com/immunitybio-announces-permanent-j-code-j9028-for-anktiva-is-now-effective/

2. ImmunityBio completes ANKTIVA’s post-approval enrollment of the 100th patient in BCG unresponsive NMIBC CIS trial and reports a complete response rate of 71% with a durable duration of response ranging up to 54 months. News release. ImmunityBio. November 19, 2024. Accessed January 6, 2024. https://www.businesswire.com/news/home/20241119975432/en/ImmunityBio-Completes-ANKTIVA%E2%80%99s-Post-Approval-Enrollment-of-the-100th-Patient-in-BCG-Unresponsive-NMIBC-CIS-Trial-and-Reports-a-Complete-Response-Rate-of-71-with-a-Durable-Duration-of-Response-Ranging-Up-to-54-Months

3. Chamie K, Chang SS, Kramolowsky E, et al. IL-15 superagonist NAI in BCG-unresponsive non-muscle-invasive bladder cancer. NEJM Evid. 2023;2(1):EVIDoa2200167. doi:10.1056/EVIDoa2200167

4. 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. ClinicalTrials.gov. Last updated April 8, 2024. Accessed November 19, 2024. https://clinicaltrials.gov/study/NCT03022825