Triage Plus Price Set To Lift Pacific Edge's Economics

Pacific Edge notes today that the draft ‘Gapfill’ prices for Cxbladder Triage Plus2 have been published by the US Centers for Medicare & Medicaid Services (CMS) proposing a draft price for the test of US$1,018.44.

When finalized, the CMS price for Triage Plus sets the amount Pacific Edge will be reimbursed for all patients with Medicare and Medicare Advantage insurance. This will be subject to Pacific Edge’s Medicare Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently listed as non-covered on Novitas’ ‘Genetic Testing in Oncology: Specific Tests (L39365)’ Local Coverage Determination (LCD). Private health insurance companies make separate coverage and pricing decisions based on their own medical policy and contracting for a test.

In the Gapfill process CMS asks each MAC to propose prices for any new testing services based on estimates of the resources needed to develop and run the test, then recommends the median of those prices as its final price. The seven MACs responsible for processing Medicare claims across various jurisdictions in the United States have published their draft pricing for Triage Plus. While Novitas priced Triage Plus at US$1,587.69, due to its agreements with multiple MACs, the price provided by MolDX3 is the de facto median price, because MolDX pricing is used in 28 of the 50 states. The draft pricing for MolDX was US$1,018.44, and subject to public comments that are due by 28 June 2025, and some possible adjustment based on those comments, CMS is expected to make that price effective on 1 January 2026.

Hematuria evaluation tests currently represent around 81% of Pacific Edge’s total US laboratory throughput4. The US$1,018.44 price is a meaningful increase compared to the US$760 CMS price of our existing tests, because it increases the margin and margin percentage per test and improves the profitability of operating our front-line sales force. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage a priority, noting that Detect tests are being migrated to Triage tests effective immediately given the February 2025 inclusion of Triage in the American Urological Association’s microhematuria guideline.

Pacific Edge expects to submit a reconsideration request for coverage of Triage Plus as soon as the analytical validation (AV) and clinical validation (CV) studies have been published. The AV publication is being reviewed by the submitting authors and the CV publication, the DRIVE study5, has already been submitted for publication.

Pacific Edge Chief Executive Dr Peter Meintjes said: “We are very pleased that both MolDX and Novitas have recognized the novelty of Triage Plus in their pricing determinations with prices of US$1,018.44 and US$1,587.69 respectively. We have invested significant resources in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs analyzed by a novel algorithm that provides dramatic performance improvement over existing tests and can be used on a broader patient population to assist clinicians to manage their hematuria patients as high, intermediate or low risk.

“The resources needed to develop, validate and operate Triage Plus commercially are substantial, thus necessitating a higher price, but importantly when Triage Plus’ performance characteristics6 are used in our existing budget impact model7 we observe that the improved performance characteristics has the potential for even greater savings to the Medicare system by reducing more unnecessary procedures and allowing clinicians to spend more time and clinical resources on those who need it most.”

Notes:

1 PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act.

2 Cxbladder Triage Plus has CPT Code 0420U and has not yet completed the administrative name change from Cxbladder Detect+.

3 MolDX is a coverage and reimbursement program run by the Palmetto MAC that provides unique test registrations and technical assessments for molecular diagnostics products to which other MACs can subscribe. The majority of MACs have elected to do so, but Novitas and National Government Services do not.

4 Half year to 30 September 2024.

5 Detection and Risk stratification In Veterans presenting with hematuria: Savage S.J., et al (2025) The Prognostic Performance of Cxbladder Triage Plus for the Identification and Priority Evaluation of Veterans at Risk for Urothelial Carcinoma: The Drive Study, Abstract submitted to the AUA 2025 meeting.

6 Lotan Y, Raman JD, Konety B, Daneshmand S, Schroeck F, Shariat SF, Black P, de Lange M, Asroff S, Goldfischer E, Efros M, Chong KT, Huang E, Chua HL, Wu QH, Yeow S, Lau W, Yong J, Eng M. Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. J Urol. 2022 Dec 30:101097 JU0000000000003126.

7 Tyson MD, Abouassaly R, Durant A, Smith AB, Seemann K, Shoskes DA. Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients. Urol Pract. 2024 Jan;11(1):54-60. doi: 10.1097/UPJ.0000000000000489. Epub 2023 Nov 1. PMID: 37914255.

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