Innovative Treatment for BCG-Unresponsive NMIBC Receives Permanent HCPCS Code
ImmunityBio, a prominent player in the immunotherapy field, has announced a significant development for their groundbreaking bladder cancer treatment, ANKTIVA® (nogapendekin alfa inbakicept-pmln). As of January 1, 2025, the Centers for Medicare & Medicaid Services (CMS) has assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code for ANKTIVA. This code, J9028, is specifically for the injection of nogapendekin alfa inbakicept-pmln for intravesical use, with each unit representing 1 microgram.
The FDA has approved ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) for treating adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This approval marks a significant step forward in bladder cancer treatment, especially for patients who have not responded to standard BCG therapy.
Dr. Patrick Soon-Shiong, the Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, emphasized the importance of this development. He stated that the unique J-code for ANKTIVA represents another milestone in their mission to deliver next-generation immunotherapy beyond T cell activation, allowing bladder cancer patients to benefit from the power of natural killer (NK) cells.
The need for alternative treatments in NMIBC is evident, as highlighted by Richard Adcock, President and CEO of ImmunityBio. He pointed out that approximately 30-40% of patients with NMIBC fail to respond to standard BCG therapy, while 50% of those who initially respond experience cancer recurrence. The ongoing QUILT 3.032 study has shown promising results for ANKTIVA, with a 71% complete response rate in patients with BCG-unresponsive NMIBC CIS as of November 2024, and a duration of response lasting up to 54 months.
Since its launch in May 2024, ANKTIVA has become widely accessible to patients through various insurance programs, including commercial, VA, DoD, and Medicare. ImmunityBio has successfully secured coverage for over 200 million medical lives through medical reimbursement policies, further expanding access to this innovative treatment.
Commentary by SuppBase columnist Alice Winters:
The introduction of ANKTIVA and its newly assigned J-code marks a significant advancement in the treatment of bladder cancer, particularly for patients who have not responded to conventional therapies. This development is noteworthy for several reasons:
1. Innovative Approach: ANKTIVA represents a shift in immunotherapy by harnessing the power of natural killer (NK) cells, moving beyond traditional T cell activation. This novel approach could potentially open new avenues in cancer treatment.
2. Addressing an Unmet Need: With a substantial portion of NMIBC patients either failing to respond to BCG therapy or experiencing recurrence, ANKTIVA fills a critical gap in treatment options. The impressive 71% complete response rate in the QUILT 3.032 study is particularly encouraging.
3. Improved Access: The assignment of a unique J-code is more than just a bureaucratic formality. It streamlines the billing and reimbursement process, potentially leading to wider adoption and easier access for patients who need this treatment.
4. Duration of Response: The reported duration of response of up to 54 months is remarkable and could significantly improve the quality of life for patients with this challenging condition.
5. Broad Insurance Coverage: ImmunityBio’s success in securing coverage for over 200 million medical lives is a testament to the perceived value of this treatment in the medical community.
However, it’s important to note that while these developments are promising, long-term data on efficacy and safety will be crucial. As with any new treatment, ongoing monitoring for potential side effects and long-term outcomes will be necessary.
Furthermore, the cost-effectiveness of ANKTIVA compared to other treatments will likely be a topic of discussion among healthcare providers and payers. While the J-code facilitates reimbursement, the overall economic impact of this treatment on the healthcare system remains to be seen.
In conclusion, ANKTIVA represents a significant step forward in bladder cancer treatment, offering hope to patients who have limited options. The combination of innovative science, promising clinical results, and improved access through the new J-code positions ANKTIVA as a potentially game-changing therapy in the field of oncology. As more data becomes available and clinical experience grows, it will be interesting to see how this treatment shapes the landscape of bladder cancer management in the coming years.
