Plenty of meetings going on with Novitas.Question is are we amongst them.cheers
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Thanks for that. I found interesting information about CxBladder's lack of inclusion in the LCD that may be worth comparing to the announcement in Feb.
"CxBladder
The literature submitted for the requested addition of the CxBladder panel was carefully reviewed. After consideration of the literature, NCCN rating, and relevance to the Medicare population, the CxBladder panel will continue to be non-covered at this time. The molecular/genomic testing mentioned in the NCCN Guidelines for Bladder cancer shared no commonality in the CxBladder test and the genetic alterations that should be included by NCCN guidelines. Additionally, those genomic/molecular tests mentioned in the NCCN guidelines only achieved a 2B level of recommendation. Further, the clinical utility and clinical validity was not supported in the literature and was not generalizable to the Medicare population."
I am pretty sure this LCD info was released late 2019, but can't see the reference to a date on the page.
If this is the case, what is stated above about the NCCN guidelines - "the NCCN Guidelines for Bladder cancer shared no commonality in the CxBladder test" - would be a little strange since in this news release earlier in 2019, PEB says CxBladder was referenced by name in the NCCN guidelines.
If anyone has more insights, I would love to hear your thoughts.
For now, I am left a little confused and this is all well above my pay grade.
This from January
CMS coverage pending
CMS coverage pending
Pacific Edge 6 January 2020 Outlook
Download PDF
Company outlook
Healthcare equipment
& services
6 January 2020
Business description
Pacific Edge develops and sells a portfolio of molecular diagnostic tests based on biomarkers for the early detection and management of cancer. Tests utilising its Cxbladder technology for detecting and monitoring bladder cancer are sold in the US, New Zealand, Australia and Singapore.
Next events
LCD inclusion
Q2 CY20
Analysts
Maxim Jacobs
+1 646 653 7027
Wiktoria O’Hare
+1 646 653 7028
healthcare@edisongroup.com
Edison profile page
Pacific Edge is a research client of Edison Investment Research Limited
Pacific Edge continues to make progress commercialising its Cxbladder suite of bladder cancer diagnostics products, with three of the four Cxbladder tests available in the US market. Cxbladder was recently included in the National Comprehensive Cancer Network (NCCN) guidelines for bladder cancer. The company also submitted an updated evidence dossier to its Medicare Administrative Contractor (MAC), which may decide in Q2 CY20 whether Cxbladder will be included in a Local Coverage Determination (LCD) by the US Centers for Medicare and Medicaid Services (CMS). This will be a key milestone for the company as approximately 47% of US lab throughput for the company is for patients covered by CMS.
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Getting closer to CMS reimbursement
Pacific Edge has completed two of the three components necessary for national reimbursement in the US, namely CPT codes and a national price of US$760 per test. The final milestone is to gain inclusion in an LCD, which would enable consistent payments from CMS (which covers patients representing about 47% of US lab throughput for Cxbladder tests) and likely be transformational for the company from a test adoption, revenue and cash flow standpoint.
Cxbladder sales increased 12.4% in H120
The company reported an increase in Cxbladder sales of 12.4% in the first half of FY20 with a 10.1% increase in total laboratory throughput. Sales in the rest of the world (primarily Australia, New Zealand and Singapore) were particularly strong and were up 53.6% compared to the same period last year.
Must be another Capital Raising coming up. Still have doubts about the success of PEB. But for those holding good luck for the ride.
To me it looks like it's a draft for public review, which was published 31/10/19 with the review process to complete on 15/12/19 (Those dates are at the bottom). It seems that it is unequivocal in not recommending CXBladder for inclusion:
Consistent with the NCCN rating and literature review, the following Biomarker Panel will continue to be considered not medically reasonable and necessary:
CxBladder
NCCN Guidelines 4.201988 Bladder Cancer, for cTa high grade, cT1, and Tis, follow-up is recommended with a urinary cytology and cystoscopy at 3 to 6 month intervals for the first 2 years, and at longer intervals as appropriate thereafter. Imaging of the upper tract should be considered every 1 to 2 years for high-grade tumors (see Follow-up algorithm). Urine molecular tests for urothelial tumor markers are now available.88(p68)
Follow-up urine cytology every 3 months and consider urinary urothelial tumor markers (category 2B) for high risk, non-muscle-invasive bladder cancer at year one and annually up to 10 years and then as clinically indicated. Molecular/genomic testing should include analysis by RT-PCR for FGFR3 or FGFR2, and for FGFR, RGQ.88(p79)
As one can see when molecular/genomic testing mentioned in the NCCN Guidelines Version 4.2019 Bladder cancer, there is no shared commonality in the CxBladder test and the genetic alterations that should be included by NCCN guidelines, and even those mentioned in NCCN guidelines, are a 2B level of recommendation.
Davidson PJ, et al. (2019),89 is an observational cohort study conducted in New Zealand. The addition of CxBT to the routine investigation of hematuria was carried out following consensus between local clinicians. No other change to clinical practice was made and there was no randomization or control group. The review did not require ethical approval, as it constituted monitoring and improvement of usual patient care carried out by the Canterbury DHB.163 No blinding with diagnosis based on histology and cystoscopy. The results were the development of theoretical pathway. The patients were coached in the test and what it meant. This was carried out within one health board district in New Zealand with little follow-up. The limitation is a mandatory protocol pathway and no documented clinical utility, but healthcare insurer utility. The generalizability to the Medicare population was not specified. Seven year mean difference in patients not referred and referred patients with the older group referred to urologist. Nine year medial age difference. Proposed pathway for less than one year of data is not enough data to support a change of decision.
Konety B, et al. (2019),90 is a retrospective study of pooled data from three prospective clinical trials and one real world clinical study in which 1784 patients with hematuria or previously diagnosed UC provided 852 samples. According to the authors, CxBladder ruled out 35% of patients and NPV of 97% compared to 93% for cytology. CxBladder correctly adjudicated all patients diagnosed with UC among those with atypical cytology and equivocal cystoscopy and outperformed cytology for accurately identifying patients who do not have UC.162 The limitation is this was open access and not peer reviewed with a significant conflict of interest by the authors. Clinical utility is not part of this study and was only theorized. The generalizability to the Medicare population was not specified in the original article. However, in the supplemental table 3, the age in each study was given but not in relationship to the findings. The clinical utility was not documented.
The dismissal of CXBladder's relevancy to the NCCN guidelines is pretty strange and a concern to me, and looks to completely contradict the NZX announcement (https://www.nzx.com/announcements/337654)
The parent document (the actual LCD - https://tinyurl.com/ya8yfezu) was last updated on 14/11/19, so it looks like these recommendations are still being reviewed or have not been accepted.
Interestingly the actual LCD shows that CXBladder has twice been considered for inclusion and twice been rejected in 2017 and 2018 (change history at the bottom)
Things may change rapidly now our arrangement with kaiser has come to fruition but do think this needs to be made clear sooner rather than later
Interesting that they don't mention the Georgieva (2019) study in their discussions. Looks to be dated Dec 2019 so couldn't have included the Madhusudan (2020) study although David D did say they had successfully submitted that study to the evidence dossier with Novitas for review.
David also mentioned they submitted the evidence dossier in August and the review commenced in December. Makes me wonder, given this proposed LCD is dated December 19, is this what's being reviewed? or maybe part of it?
In the NCCN guidelines, I also don't see a "direct reference" to CxBladder which they mention in their guidelines announcement . The guideline mentions "urinary urothelial biomarkers" with no specific mention of CxBladder.
Given the uptake from Kaiser though, I'm sure the other big healthcare systems will seriously look at signing contracts. Who knows, maybe PEB doesn't really need the LCD after all.....;)
In the NCCN guidelines, I also don't see a "direct reference" to CxBladder which they mention in their guidelines announcement . The guideline mentions "urinary urothelial biomarkers" with no specific mention of CxBladder.
Probably used the wrong word there in the guidelines announcement. "Inference" might have been better.
It mentions "Urinary urothelial biomarkers" which CXBladder seems to be categorized as.
There is no specific mention of cxBladdder or any other specific biomarker for that matter.
Get the feeling that CXBladder is breaking new ground in this area with NCCN which would seem to be fairly well entrenched.
I guess we should be thankful they dont form part of any Rapid Response requirements.