Aquablation granted new category I CPT code for BPH management

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The new Category I code will become effective on January 1, 2026.

The American Medical Association (AMA) has granted a Category I Current Procedural Terminology (CPT) code to Aquablation for the management of benign prostatic hyperplasia (BPH), thus replacing the therapy’s existing Category III CPT code.1

The safety and efficacy of Aquablation were established in the WATER I and WATER II clinical trials.

The safety and efficacy of Aquablation were established in the WATER I and WATER II clinical trials.

The new Category I code will become effective on January 1, 2026. Until then, Aquablation can still be billed using the existing Category III code, 0421T.

According to the AMA, Category III CPT codes are “…temporary alphanumeric codes for new and developing technology, procedures and services. They were created for data collection, assessment and in some instances, payment of new services and procedures that currently don’t meet the criteria for a Category I code.”2 Category I codes are for established and widely used procedures or services.

“We are pleased that Aquablation therapy was approved by the AMA’s CPT Editorial Panel for Category I code status,” said Reza Zadno, CEO of PROCEPT BioRobotics, in the news release.1 “The Category I code designation is a testament to the widespread adoption, safety, and effectiveness of Aquablation therapy in treating BPH. We greatly appreciate the support and guidance the American Urological Association provided throughout this process.”

Data on Aquablation

The safety and efficacy of Aquablation were established in the WATER I (NCT02505919) and WATER II (NCT03123250) clinical trials.

In the pivotal WATER I trial, which supported Aquablation’s FDA clearance in 2017,3 Aquablation demonstrated superior safety and non-inferior efficacy compared with TURP in patients with prostates ranging from 30 mL to 80 mL.4

The primary safety end point for the study was met at 3-month follow-up, with Aquablation demonstrating a lower event rate (Clavien-Dindo persistent Grade 1 or Grade 2 or higher operative complications) vs TURP (26% vs 42%; P = .0149 for superiority).

Further, the study’s primary efficacy end point of a reduction in International Prostate Symptom Score (IPSS) was achieved at 6 months, with a mean IPSS decrease of 16.9 points from baseline for Aquablation compared with 15.1 points for TURP. (P < .0001 for non-inferiority; P = .1346 for superiority). At the study’s final follow-up at 5 years, patients in the Aquablation arm had experienced an average IPSS improvement of 15.1 points, vs 13.2 points in the TURP arm (P = .2764).

Aquablation also demonstrated superior safety and efficacy vs TURP in a subgroup of patients with prostates over 50 mL. In this group, the IPSS reduction was 3.5 points greater across all follow-up visits with Aquablation compared with TURP (P = .0123).

The study also showed a 51% lower risk of retreatment due to recurrent lower urinary tract symptoms at 5 years in the Aquablation arm vs the TURP arm.

Overall, the prospective WATER I trial included 181 patients who had BPH and prostates ranging from 30 to 80 mL. Patients were enrolled across clinical trial sites in the US, UK, Australia, and New Zealand.

The WATER II trial was a prospective, multicenter clinical trial that demonstrated the safety and efficacy of Aquablation in patients with prostates ranging from 80 mL to 150 mL.5 In total, the trial enrolled 101 patients across 16 clinical trial sites in the US and Canada.

The study met its primary safety and efficacy end points at 3 months, which were the incidence of Clavien-Dindo adverse events and the change in total IPSS from baseline, respectively. At 5 years, the average IPSS improved from 22.6 at baseline to 6.8 (P < .001). The average maximum urinary flow rate also improved from 8.6 mL/s at baseline to 17.1 mL/s at 5 years (P < .001).

Further, 96.3% of patients were free from a secondary BPH procedure at 5 years, per Kaplan-Meier estimates.

References

1. PROCEPT BioRobotics announces new CPT category I code from the American Medical Association for Aquablation therapy. News release. PROCEPT BioRobotics. June 17, 2024. Accessed June 18, 2024. https://ir.procept-biorobotics.com/news-releases/news-release-details/procept-biorobotics-announces-new-cptr-category-i-code-american

2. CPT overview and code approval. American Medical Association. Accessed June 18, 2024. https://www.ama-assn.org/practice-management/cpt/cpt-overview-and-code-approval

3. Clinical data on Aquablation therapy. PROCEPT BioRobotics. Accessed June 18, 2024. https://www.procept-biorobotics.com/clinical-data-aquablation/

4. Gilling PJ, Barber N, Bidair M, et al. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. Can J Urol. 2022 Feb;29(1):10960-10968

5. Bhojani N, Bidair M, Kramolowsky E, et al. Aquablation therapy in large prostates (80-150 mL) for lower urinary tract symptoms due to benign prostatic hyperplasia: Final WATER II 5-year clinical trial results. J Urol. 2023 Jul;210(1):143-153. doi:10.1097/JU.0000000000003483

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