Everyone,
Congrats to all holders over the past few weeks. It has been a fantastic time for all!
I have used snippets of info from this forum over time, so thought I would put down a few notes of my own. Everybody on this Forum knows about the past history of PEB, successes etc but not a lot has been discussed about the US healthcare market for diagnostic tools so I wanted people to discuss the future issues that PEB will face instead of going to and from about whether they will make there 100m sales in 5 years and eliminate peoples forced beliefs in managements predictions as they have no informative basis to disagree with them.
I have been doing a fair chunk of reading over the past few days, trying to establish exactly what the relationships with FedMed and Americas choice mean for CXbladder. Unfortunately they do not mean a lot in my opinion as PEB still needs to get payer reimbursement for CX Bladder to become mainstream. Although these organizations can provide access to CXbladder for Payers which are out of network, they ultimately have no ability to create sales.
I will share with you some readings I have gone through that I strongly advise you to read. Particularly those that will be long term holders of PEB (like myself)
The first is a report completed in 2010 by a company called Health Advances. This was a consulting piece regarding reimbursement for diagnostics. Oncotype Dx, which I have mentioned before is prevalent in the text as a case study. The most interesting thing I found in this report was the rate at which Oncotype DX covered its respective market, the correlation was almost perfect with the % of covered lives (or % of their target market which was covered by insurers) increasing in step with coverage, so basically it became fully utilized by everyone that it was available too. The second important variable to keep in mind is that it took 4 years from the first payer (Kaiser Permanante) to get 90% of coverage. That is exceptionally quick and is something I always thought about CX bladder, 100m in 5 years (rough market share of say 10%) seemed too slow and I was of the belief that as payers approve the product we should see a much quicker uptake as patients 'hopefully' demand it. This is a very good read for those new to the US health care reimbursement structure. (be it old, and a lot has changed)
http://www.healthadvances.com/pdf/no...mbursement.pdf
The second piece which is also interesting, and is an advancement from the first article, is the complete change in diagnostic reimbursement, I am still yet to ascertain what implications this has on CX bladder. The one thing that is good however, is there is a structured system for product reimbursement. There is 1 very important company that PEB has to deal with (actually there are 10) but the first is the most influential as often the other 9 just go with what number 1 says.
Palmetto GBA - http://www.palmettogba.com/palmetto/...sCatHome/MolDx
This company was established in 2011 and is responsible for reimbursement setting of genetic diagnostic tools. If CX bladder is to be covered by Medicare (the important US health care insurer of over 65's) then i assume it will have to pass the grade from Palmetto GBA. This in my opinion is an important to deal to watch for. They will perform a true economic feasability study of CX bladder and establish a reimbursement rate which is comensurate with the value add (so lets hope that CX bladder does eliminate the need for everything, Cytology, fish, TURBT, NMp 22, ultrasound, x-ray, follow up cytoscopies etc). The more it can replace, the greater the value
I was thinking of heading into work to run some numbers as I cant do it on my ipad but payer reimbursement is the single most important step towards PEB being successful.The feasibility study (or as we know them user programs) are a crucial part of product uptake and in the US, user programs are performed by offering discounted products with the aim of full reimbursement once the product has been validated. The discount to total reimbursement value is something I am unsure of also but gives a little bit of upside to PEB's cashflows in the first few years.. ( I hope)
The next is a presentation detailing the new structure for reimbursement of genetic diagnostics. This is sort of a follow on from the 2010 report where recommendations for change were submitted. Having standardised codes in the US makes it a lot easier for individual payers to include CX bladder, and should hopefully see a hastened uptake by all payers in the US. This is the link with Palmetto GBA and their importance in setting a reimbursement code that everyone can rely on.
https://www.acmg.net/docs/ACMG_2013_...ting_Guide.pdf
The next thing I am unsure of, the $ amount that PEB are claiming they can receive from CX-bladder, Hancocks will probably know, Is it code stacked? Or is the code, miscellaneous and created by PEB themselves..
List of current new, Molecular Pathology codes and reimbursment prices
http://www.palmettogba.com/Palmetto/Providers.Nsf/files/MoPath_Claims_Submission_Guidelines.pdf/$File/MoPath_Claims_Submission_Guidelines.pdf
This is another great presentation by health advances. For the math nuts out there, slide 26 is the correct way to determine economic feasibility of a product. Something I will be tackling once I can get all the reimbursement cost information.
http://moleculardiagnostics-cancer.c...in_Pothier.pdf
Well thats my 10 cents anyway. More research to come, particularly in regards to what genetic markers are currenlty covered by medicare and how cxbladders efficacy compares to those!
Enjoy labour day everyone