PEB-Pacific Edge

[LoungeLizard]

Novitas not exactly covering themselves in glory here. Botched the first decision, told to try again and now still unable to reach a conclusion. Very prejudicial to PEB and opens Novitas up to a legal challenge. Like others, I'm feeling a bit more positive that ultimately Novitas might find some way to withdraw the LCD, as clearly the whole industry supports the PEB position. The delay isn't good for investors though and the SP will stay in the doldrums until a decision is made.

[LoungeLizard]

NOVITAS CONFIRMS MEDICARE COVERAGE REVIEW EXTENSION
 
 DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes that Novitas, the Medicare Administrative Contractor (MAC) with responsibility for Pacific Edge's US lab, has confirmed that it has been granted an extension to finalize or withdraw the Local Coverage Determination (LCD) 'Genetic Testing for Oncology' (DL 39365).
 
 In a post on its website on Friday (Saturday morning NZDT), the MAC noted: "Novitas is considering all the feedback from interested parties regarding the Genetic Testing for Oncology LCD. An extension has been granted by the [Centers for Medicare & Medicaid Services ] in order for all comments to be considered thoroughly. Future updates will be published to this website and the Medicare Coverage Database."
 Pacific Edge expected the LCD, which could impact Medicare coverage of its Cxbladder tests, to be withdrawn or finalized last Thursday evening (NZDT), i.e. within 365 days of the initial posting.
 
 The continued deliberation on the LCD means that Pacific Edge's tests Cxbladder Triage, Detect and Monitor continue to receive reimbursement from Medicare and Medicare Advantage payers in line with historical reimbursement rates, subject to medical necessity guidelines.
 
 Pacific Edge continues to expect Novitas to finalize the LCD, but the timeframe is unknown. It will update shareholders as it gains certainty on the status of the LCD and the timeline for its resolution, but will not be making further comment on the matter until then.

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No news is good news??

[winner (n)]

Hey Leftie ...you left off you GLH          

[Magic78]

From the last investor update:

'Pacific Edge has made what we believe is a compelling case for the Centers for Medicare and Medicaid
Services (CMS) to price Cxbladder Detect+ via 'Crosswalk', a process that acknowledges the advancement of incorporating both RNA and DNA markers for the detection of bladder cancer in patient samples.'

As per https://docs.google.com/spreadsheets/d/1gjxwx0ZAn8hzJcRRLfUwshiRAJ8RKwoX/edit?gid=667456751#gid=667456751

The CMS advisory panel has voted CxBladder Detect+ (0420U) to be 'gapfill' rather than 'crosswalk', so could be 12 months before pricing is confirmed.

[Left Field]

The case for PEB CxBladder  keeps getting stronger......hard for the US authorities to ignore this unprecedented endorsement.
Market seems to like it so far today.

(from email to PEB shareholders)

Dear Shareholder,

Pacific Edge welcomes an editorial in the American Urological Association's Journal of Urology supporting the use of Cxbladder to reduce unnecessary cystoscopies on patients at risk of bladder cancer.

Published in the September issue2, the editorial - entitled 'What Is the Future of Cystoscopy for Detecting Urothelial Carcinoma?' – focuses heavily on evidence pointing to the clinical value of Cxbladder in helping clinicians to evaluate patients both presenting with hematuria and those under surveillance for bladder cancer recurrence, specifically citing the recent STRATA3 study that demonstrated the clinical utility of Cxbladder Triage.

The editorial notes: "Although these novel biomarker studies raise important questions about evaluating patients at risk for UCB4, these tests have the potential to improve the management of our patients with suspected UCB who would otherwise require an invasive procedure for diagnosis. This also holds true for nonmuscle-invasive bladder cancer patients who require cystoscopic surveillance."

Pacific Edge Chief Executive Dr Peter Meintjes said: "We are delighted to see our Cxbladder test recognized in the Journal of Urology editorial. Such supportive commentary on our recent clinical evidence in such an influential urology journal shows how leading urologists are coming to understand the clinical value of our tests in hematuria evaluation and monitoring patients for the recurrence of bladder cancer.

"It reinforces both our first-mover advantage in the commercialization of urine biomarkers of bladder cancer and the importance of clinical utility studies in updating the standard of care. It also provides further validation of our investment in medical affairs to educate the urological community on the value of our tests and our investment into our clinical research program, which we have configured to deliver the end points required for coverage decisions and guideline inclusion. We expect this editorial to build further momentum in the adoption of Cxbladder."

Authored by Journal of Urology Assistant Editor Christopher Anderson, the editorial first critiques the AUA's guidelines for the evaluation of asymptomatic microscopic hematuria, which it says results in urologists performing many unnecessary cystoscopies and missing opportunities to evaluate at-risk patients.

It then focuses on the clinical evidence to overcome these limitations, regularly referencing Pacific Edge's STRATA study, which was published in the May edition of the Journal of Urology. The study showed clinicians undertook 59% fewer cystoscopies if they were able to use the information generated by a Cxbladder Triage test. The editorial also notes the potential cost savings that come from reducing unnecessary procedures using non-invasive urine-based biomarkers such as Cxbladder. 

The editorial concludes by acknowledging the continued need for cystoscopy in bladder cancer diagnosis but underscores the importance of reducing negative cystoscopies.

"If these biomarkers are employed in the first-line setting, it may ultimately improve appropriate hematuria referrals to urology and avoid the referral delays that some hematuria patients face... we are challenged to understand these tests, educate patients about them, and determine how to best incorporate them into our practice."
 

[Left Field]

PEB progress in Asia

Pacific Edge today announces its medical presence at the UAA Congress to be held in Bali this week (September 5-8), which has attracted a record attendance of more than 2800 urologists.

Pacific Edge CEO, Dr Peter Meintjes will present the clinical utility evidence from the STRATA study to an APAC audience for the first time. STRATA is the first randomly controlled trial of a urine-based biomarker for hematuria evaluation ever completed. It demonstrated that presenting clinicians with a Cxbladder Triage result led to a 59% reduction in cystoscopies, the primary endpoint of the study.

Supporting Pacific Edge's presence at the meeting are independent presentations by Dr Arjun Guduguntla of Northern Health in Melbourne who will be presenting on Proposed novel surveillance schedule using Cxbladder Monitor for patients on annual bladder surveillance and Dr Prasanth Anton Sagayanathan from Sunshine Coast University Hospital who will be presenting on Clinical utility of Cxbladder in detecting bladder cancer in a far north Queensland (Australia) population.
 
Pacific Edge Chief Executive Dr Peter Meintjes said: "It is outstanding to see our long-standing customer and clinical study partners in Australia sharing their experience of Cxbladder with the broader community in the Asia Pacific region. Real world evidence is the ideal complement to the clinical utility evidence generated from our core evidence generation program and the UAA Congress provides a great platform to communicate this evidence to APAC urologists."
 
Prior to the activities at the UAA Congress Dr Meintjes visited Malaysia for a ceremonial signing of an already-signed distribution agreement with Premier Integrated Labs supported by New Zealand Trade and Enterprise and attended by the Prime Minister, the Right Honourable Christopher Luxon at the Shangri-La hotel in Kuala Lumpur. Premier Integration Labs is the sole supplier of laboratory services to IHH Healthcare – that includes the three largest individual hospitals in Malaysia3.
 
Pacific Edge Chief Executive Dr Peter Meintjes said: "This partnership represents a further advance in our strategy to expand the availability of Cxbladder and improve patient lives across key international markets.

[LoungeLizard]

You have to hand it PEB management - they have done as a good a job as they could have to make Novitas reconsider what clearly seems to be  bad, unfounded decision to remove coverage. Speaking of Novitas - how much longer do they need to finalise the LCD? There's not even a timeline for an eventual decision now. Bad for the PEB, the industry, investors and patients. 

[Left Field]

You have to hand it PEB management - they have done as a good a job .......

PACIFIC EDGE CHAIRMAN DELAYS RETIREMENT

DUNEDIN, New Zealand - Cancer diagnostics company Pacific Edge (NZX, ASX:
PEB) today announces Chris Gallaher has accepted a Board request to delay his
planned retirement, originally set for the end of this year after a handover
to a successor.

The Board has asked Mr Gallaher to remain as Chair into 2025 to provide
stability and confidence to Pacific Edge and its stakeholders amid the
continued uncertainty over the Medicare coverage status for the company's
Cxbladder tests and the ongoing process to recruit his successor.

In July Novitas, the Medicare Administrative Contractor (MAC) with
responsibility for Pacific Edge's US lab, confirmed that it had been granted
an extension beyond the normal statutory timeline to finalize or withdraw the
draft Local Coverage Determination (LCD) 'Genetic Testing for Oncology' (DL
39365).

Mr Gallaher said: "As I signaled in our annual report in June, the Board
expects the process to recruit my successor to ramp up after the Novitas
determination. Consequently, the Board believes that delaying my retirement
at least until the LCD is finalised will enable us to make a smooth handover
to the new Chair, which is in the best interests of the company and all its
stakeholders. I am happy to provide this continuity."

Good move.

[Magic78]

Any thoughts on what this might mean for PEB? https://www.discoveriesinhealthpolicy.com/2024/09/novitas-no-lcd-but-documents-required.html?m=1

[LoungeLizard]

Any thoughts on what this might mean for PEB? https://www.discoveriesinhealthpolicy.com/2024/09/novitas-no-lcd-but-documents-required.html?m=1

Well spotted.

Really hard to tell what it all means, given Novitas and the US Health industry in general seem to work in mysterious ways

My initial take, without more detail, would be that this could just be Novitas keeping things in a holding pattern. They obviously seem reluctant to make an actual binding decision on the LCD, perhaps pending the FDA getting involved in regulating laboratory tests. So maybe this is just them tightening up the documentation side - crossing the t's and dotting the i's. I suppose the positive spin is that PEB will continue to get coverage for the foreseeable future, but on the negative side there's still the on-going uncertainty. Probably a neutral event then?

[Left Field]

Yes well spotted, thanks Magic.

I think this is just an administration matter to improve accountability and will have little effect on  legitimate science backed operators like PEB.

USA authorities were caught by the Theranos Elizabeth Holmes case and many of  the subsequent  changes should be seen in this light.

https://edition.cnn.com/2022/11/18/tech/elizabeth-holmes-theranos-sentencing/index.html

[LoungeLizard]

Yes well spotted, thanks Magic.

I think this is just an administration matter to improve accountability and will have little effect on  legitimate science backed operators like PEB.

USA authorities were caught by the Theranos Elizabeth Holmes case and many of  the subsequent  changes should be seen in this light.

https://edition.cnn.com/2022/11/18/tech/elizabeth-holmes-theranos-sentencing/index.html

I had forgotten about her and that whole episode. Once bitten twice shy for the regulators perhaps.

[Left Field]

An update and further delay....... however reimbursement continues...

https://www.nzx.com/announcements/437962

Pacific Edge also notes the Centers for Medicare & Medicaid Services (CMS) has indicated - through a meeting with stakeholders that included The Coalition for 21st Century Medicine (C21) - that it had agreed to an extension to deliberations on the draft Local Coverage Determination (LCD) 'Genetic Testing for Oncology' (DL 39365) to ensure Pacific Edge's Medicare Administrative Contractor, Novitas, had time to respond to a large volume of detailed comments and because the LCD raises unique issues. Novitas confirmed it had been granted an extension to finalize, retire or start over on the draft LCD in late July.
 
 Given these developments Pacific Edge does not expect these matters to be resolved ahead of the company's Annual Shareholder Meeting (ASM) in Auckland on 24 September 2024, which contrasts to the previous expectations communicated in Pacific Edge's Q1 24 investor update released to the NZX and ASX on 10 July
2024.......

 .......Despite the deliberations over the draft LCD, Pacific Edge continues to receive reimbursement for tests performed for Medicare and Medicaid patients – as it has without interruption since July 2020 including more than two years since the draft LCD was first published. In the event of a total or partial non-coverage determination, reimbursement will continue until at least 45 days after the LCD is publicly notified.
 
 In the Q1 24 investor update Pacific Edge also noted CMS could make a pricing decision on the company's Cxbladder Detect+ test before the ASM on September 24. That remains a possibility

[LoungeLizard]

Another essentially neutral announcement which doesn't change things as they stand. Could be significant though if the AUA does favourably (for PEB) amend their guidelines:

"The review of the AUA microhematuria guideline, which was last amended 2020, is potentially significant as guidelines play a substantial role in medical reimbursement policy for Medicare and all other payers. They also have a significant influence over the practices of individual urologists."
 

[Pierre]

Another essentially neutral announcement which doesn't change things as they stand. Could be significant though if the AUA does favourably (for PEB) amend their guidelines:

"The review of the AUA microhematuria guideline, which was last amended 2020, is potentially significant as guidelines play a substantial role in medical reimbursement policy for Medicare and all other payers. They also have a significant influence over the practices of individual urologists."
 

Cause for cautious optimism IMHO. Why would AUA be reviewing guidelines if they weren't looking to update them in line with new initiatives and procedures - including potentially CxBladder?
In the meantime, the dollars continue to come in for PEB.