Pacific Edge Notified of Positive LCD Decision in USA

Company Announcement
3 July 2020


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
1

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
2
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

1
NOVITAS is the CMS’s Medicare Administrative Contractor (MAC) for Pacific Edge’s USA commercial reimbursement for
CMS patients. MACs regionally manage policy and payment related to reimbursement and act as the fiscal intermediary
for Medicare. MACs manage provider claims for payment and establish regional policy guidelines, called Local Coverage
Determinations (LCDs).

2
Administrative MAAA CPT Codes are issued by the American Medical Association (AMA) Current Procedural Terminology
(CPT®) Editorial Panel and are a key component of the reimbursement process in the USA.

Company Announcement
3 July 2020

million members and annual operating revenue of $84.5b
3
. 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

3
Kaiser Permanente Fast Facts https://about.kaiserpermanente.org/who-we-are/fast-facts

Company Announcement
3 July 2020

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.