Announcement
GENERAL: PEB: Pacific Edge Notified of Positive LCD Decision in USA
11:01am
PEB
03/07/2020 11:01
GENERAL
PRICE SENSITIVE
REL: 1101 HRS Pacific Edge Limited
GENERAL: PEB: Pacific Edge Notified of Positive LCD Decision in USA
PACIFIC EDGE NOTIFIED OF POSITIVE LCD DECISION IN USA
Transformational reimbursement milestone for Pacific Edge with notification
of LCD coverage for CMS patients in the USA. The LCD coverage facilitates
reimbursement for CMS patients using Cxbladder Detect and Cxbladder Monitor.
New Zealand bladder cancer diagnostics provider, Pacific Edge Limited (NZX:
PEB), has been notified by Novitas that the LCD: Biomarkers for Oncology
(L35396) provides coverage for Cxbladder, CPT codes 0012M (Cxbladder Detect)
and 0013M (Cxbladder Monitor), for tests performed on or after July 1, 2020
that are medically necessary.
This includes reimbursement for all Cxbladder tests performed for patients
covered by the Centers for Medicare and Medicaid Services (CMS) across the
USA, at the already determined national CMS price for Cxbladder of US$760 per
test. The CMS provides healthcare coverage for all US citizens over 65 years,
as well as assistance for healthcare coverage to people with low incomes.
CMS tests currently make up approximately 40% of Pacific Edge's current
Commercial Tests in the USA. Pacific Edge will also be seeking to negotiate
reimbursement for the Cxbladder tests that have previously been completed and
invoiced for CMS patients.
CEO of Pacific Edge, David Darling, said: "This is a transformational
milestone for Pacific Edge and the result of a number of years of hard work
and effort from our teams in New Zealand and the USA. This long awaited
outcome results from the generation of substantial clinical evidence,
publication of numerous clinical papers demonstrating the compelling clinical
utility and outperformance of Cxbladder, and growing commercial use of our
tests by urologists in the USA and other markets.
"Coverage under the LCD for our two Cxbladder tests with CPT codes will
unlock access to the CMS revenue which currently represents approximately 40%
of Pacific Edge's commercial sales in the US. The coverage decision is also
expected to positively impact on demand and positive reimbursement decisions
from other healthcare organisations and payers as well. It signals a new
phase in Pacific Edge's commercial journey and we will be pushing hard on the
back of this announcement to gain adoption of Cxbladder by other large scale
healthcare organisations."
The LCD coverage notification comes hot on the heels of the signing of a
commercial agreement with Kaiser Permanente, one of the largest non-profit
healthcare providers in the USA, which was announced by Pacific Edge on 17
June 2020. Kaiser Permanente is one of the largest non-profit healthcare
providers in the US, with over 12 million members and annual operating
revenue of $84.5b . It operates 39 hospitals, 714 medical offices and employs
approximately 23,000 physicians.
Cxbladder is already in commercial use by the majority of the public
healthcare providers in New Zealand and
many have adopted it into their guidelines for both the evaluation of
haematuria and in the monitoring for recurrence of urothelial cancer.
Chair of Pacific Edge, Chris Gallaher, said: "The LCD coverage signals a
major step change for our company with the successful completion of the major
reimbursement milestones in the USA. For a company from New Zealand, this is
a huge achievement and one of which we are very proud. On behalf of the
Board, I would like to thank our team who have worked tirelessly to make this
happen and shareholders for their patience and support as we have worked to
commercialise our Cxbladder technology."
ENDS
For more information, contact David Darling, Chief Executive Officer, Pacific
Edge Ltd, P: +64 (3) 479 5800
For media assistance and imagery, contact Jackie Ellis, P: +64 27 246 2505 E:
jackie@ellisandco.co.nz
OVERVIEW www.pacificedge.co.nz www.pacificedgedx.com
Pacific Edge Limited (NZX: PEB) is a New Zealand publicly listed, cancer
diagnostic company specialising in the discovery and commercialisation of
diagnostic and prognostic tests for better detection and management of
cancer. Its Cxbladder suite of non-invasive, simple to use and accurate
diagnostic tests provide actionable results, and better detection and
management of urothelial cancer. The company is developing and
commercialising its range of Cxbladder bladder cancer tests globally through
its wholly owned central laboratories in New Zealand and the USA. The
company's products have been tested and validated in international
multi-centre clinical studies.
ABOUT Cxbladder Triage www.cxbladder.com
Cxbladder Triage combines the power of the genomic biomarkers with additional
phenotypic and clinical risk factors to accurately identify patients with
haematuria who have a low probability of bladder cancer and may not require a
more extensive urological evaluation. Cxbladder Triage is a tool for use by
clinicians and physicians in primary evaluation of patients
with haematuria and is intended to reduce the need for an expensive and
invasive work-up in patients who have a low probability of having urothelial
carcinoma.
ABOUT Cxbladder Detect www.cxbladder.com
Cxbladder Detect enables the non-invasive detection of bladder and other
urinary tract cancers from a small volume of a patients' urine. Cxbladder
Detect provides clinicians with a quick, cost effective and accurate measure
of the presence of the cancer as an effective adjunct to cystoscopy.
ABOUT Cxbladder Monitor www.cxbladder.com
Cxbladder Monitor allows urologists to monitor bladder cancer patients for
recurrence of the disease. Bladder cancer has a recurrence rate of 50-80% and
requires life-long surveillance. Cxbladder Monitor accurately identifies
patients with a prior history of urothelial cancer (UC) whose Cxbladder
Monitor score shows that they have a low probability of recurrent urothelial
carcinoma. Cxbladder Monitor is designed to be used as the preferred adjunct
test to cystoscopy in the management of patients for ongoing evaluation of
recurrent bladder cancer.
ABOUT Cxbladder Resolve www.cxbladder.com
Cxbladder Resolve identifies those patients who are likely to have aggressive
or more advanced bladder cancer. Cxbladder Resolve, when used as part of the
primary evaluation of haematuria and/or in conjunction with other Cxbladder
tests (Triage, Detect), is designed to assist clinicians by accurately
identifying patients with a high probability of having high grade or late
stage bladder cancer, for whom alternative or expedited treatment options may
be warranted, or who can be prioritised for further investigation in high
throughput settings.
Refer to www.cxbladder.com for more information.
End CA:00355757 For:PEB Type:GENERAL Time:2020-07-03 11:01:47
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