Higher CMS Price for Cxbladder Triage Plus Raises Coverage Hurdles

CMS Finalises Higher Price for Cxbladder Triage Plus

Pacific Edge, a New Zealand-based cancer diagnostics company, has received a significant boost with the US Centers for Medicare & Medicaid Services (CMS) recommending a final reimbursement price of US$1,328.32 for its Cxbladder Triage Plus test. This figure notably surpasses the US$1,018 draft price proposed earlier in April, underscoring the test’s innovative approach and clinical value.

The Cxbladder Triage Plus test, designed to assist clinicians in evaluating patients presenting with hematuria (blood in urine), combines DNA and RNA analysis through a sophisticated algorithm. This multimodal technology aims to improve the accuracy of risk stratification, enabling more precise identification of patients at high, intermediate, or low risk of urothelial carcinoma, a common form of bladder cancer.

Implications for Medicare Coverage and Market Adoption

While the CMS price recommendation is a critical milestone, coverage by the Medicare Administrative Contractor Novitas remains pending. Currently, Novitas lists the test as non-covered under its local coverage determination for genetic testing in oncology. Pacific Edge plans to submit a reconsideration request following the publication of the DRIVE Study, which is undergoing peer review and expected to provide further clinical validation.

Hematuria evaluation tests represent a substantial portion, approximately 83%, of Pacific Edge’s US laboratory throughput. The new price of US$1,328.32 is a meaningful uplift compared to the US$760 reimbursement for existing tests, potentially enhancing the company’s revenue profile. Upon securing coverage, Pacific Edge intends to prioritize transitioning patients from the existing Triage test to the more advanced Triage Plus.

Strategic and Clinical Significance

Dr Peter Meintjes, Pacific Edge’s Chief Executive, highlighted the company’s investment in developing Triage Plus and its potential to reduce unnecessary procedures, thereby generating savings for the Medicare system. The test’s improved performance could allow clinicians to focus resources on patients who need them most, improving both patient outcomes and healthcare efficiency.

The final CMS price is subject to a 60-day notice and comment period but is generally expected to take effect from January 1, 2026. This development positions Pacific Edge to strengthen its foothold in the US diagnostics market, particularly as Cxbladder tests gain recognition, including inclusion in the American Urological Association’s microhematuria guideline.