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TOPIC: !!Reimbursement prices under Japanese Regen Law!!

!!Reimbursement prices under Japanese Regen Law!! 22 Nov 2015 12:24 #5519

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This was tweeted tonight :grin: :grin:

Surely the old-timers remember the discussions on therapy pricing when Osiris got their Canadian approval to treat juvenile GvHD. Randal Mills their CEO was talking 100.000 $ per shot and it was anticipated that two treatments (shots) were required per patient... :whistle:

That might fly in the US or Canadian system, but as you can see in the image below- not under Japanese conditions...they are more geared to low cost apps like Cytori will be offering in the future I presume :yep:

Just take 1$ is worth 100 Yen for simplicity sake..


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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

!!Reimbursement prices under Japanese Regen Law!! 22 Nov 2015 12:30 #5520

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Peak sales in six years than will be 2 Mio $ and contribution margin 10% or 200M $,

I bet MesoBlast and JCR have been thinking about different numbers. :winky:

But maybe this is the 70% reimbursement part and 30% patient share is still to be added.. :whistle:

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!!Reimbursement prices under Japanese Regen Law!! 22 Nov 2015 13:00 #5521

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Thanks Fas but not getting your figures

"***Peak sales in six years than will be 2 Mio $ and contribution margin 10% or 200M $,***

Looking at the bottom right box in the graphic... of peak sales 3.5 billion JPY

I get $29.412 million dollars in sales for that year 6 of estimated peak sales (Conversion 119 JPY to $1 USD)

Can you explain the 2 million and 200 million figures ?

I agree this doesn't seem at first look to include the 30% patient contribution but we should confirm.

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!!Reimbursement prices under Japanese Regen Law!! 22 Nov 2015 13:33 #5523

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Can you explain the 2 million and 200 million figures ?


Yes- I was simply to quick in writing this. :evil:

But 260 patients (which seems a lot for juvenile patients in one year) times 8K I took which is 2.080K or 2 Mio.

Should have been 4 weeks x 2 treatments = 8 x lets say 8.600$ per treatment = 17.888K or 18 Mio. Mesoblast and probably JCR too have a manufacturing agreement with Lonza- who are not all that cheap.

Basically the conclusion would be that this will NOT be a gold mine... :grin:

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!!Reimbursement prices under Japanese Regen Law!! 22 Nov 2015 20:31 #5525

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Good find re Japanese reimbursement policy. Mesoblast not looking so hot given the poor capital raising attempt in the USA and its having only one years cash on hand. TEVA will probably not fund the CHF trials after the initial data analysis unless it is stellar, and that does not appear to be the case.

They are not really in a better position than CYTX. Scleroderma is closer than any other indication to receiving review and hopefully approval. Lets hope that the US and EU trials enroll quickly. A strong OA phase II data set would also put us ahead.

Japan is at the forefront of liberalizing the use of regenerative medicine inorder to improve the health care of its aging demographic in a COST EFFECTIVE MANNER. The pricing policy for TEMCELL is indicative of that priority. CYTX is well placed to provide what all hard up medical/health care systems sorely need: cost efficient medical care. Lets hope the Japanese can get over their "made in Japan" fixation with iPSC and go for the low hanging fruit that autologous ADRC represent.

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!!Reimbursement prices under Japanese Regen Law!! 22 Nov 2015 22:21 #5526

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Fas,thanks. Where exactly did that come from do you have the original link? I'd like to understand what the numbers mean and where they come from.

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!!Reimbursement prices under Japanese Regen Law!! 23 Nov 2015 01:53 #5527

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I took the info from a re-tweet by Lee Buckler, who re-tweetet the following :

Twitter Account of Colin Lee Novick

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

!!Reimbursement prices under Japanese Regen Law!! 26 Nov 2015 07:23 #5534

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Melbourne, Australia; and New York, USA; 26 November 2015: Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today announced that its licensee in Japan, JCR Pharmaceuticals Co. Ltd., has received notification that the Japanese Government’s National Health Insurance (NHI) body has formally set the price for the mesenchymal stem cell product TEMCELL® HS Inj., effective from today. JCR announced that the launch of TEMCELL for the treatment of acute graft versus host disease (aGVHD) after an allogeneic bone marrow transplant (BMT) is anticipated in February 2016. Under its agreement with JCR, Mesoblast is entitled to receive royalties and other payments at pre-defined thresholds of cumulative net sales. The approved and reimbursed dosing regimen in Japan for TEMCELL is as follows:

• For all patients, eight doses of 2 million cells/kilogram, delivered as an intravenous infusion.
• For patients with persistent symptoms beyond four weeks, a further weekly dose of 2 million cells/kilogram may be given for four additional weeks.

Reimbursement for TEMCELL has been authorized by NHI at ¥868,680 (A$9,767 / US$7,079) per bag of 72 million cells. In Japan, the average adult patient is expected to receive 16 or up to 24 bags of 72 million cells. On this basis, Mesoblast expects a treatment course of TEMCELL in an adult Japanese patient to be reimbursed at ¥13,898,880 (A$156,000 / US$113,000) or up to ¥20,848,320 (A$234,000 / US$170,000).
United States

Mesoblast believes it is well positioned to have the first industrially manufactured allogeneic cell-based product approved in the United States, with its product candidate for the treatment of steroid refractory aGHVD in children.

The Company expects to complete recruitment of its open label, 60-patient Phase 3 trial in children with steroid-refractory aGVHD in the fourth quarter of 2016 and to announce top-line interim results of the trial during the third quarter of 2016. This interim analysis may support a Biologics License Application (BLA) regulatory filing by the end of 2016. In the US, pricing reimbursement methodology is expected to consider the burden of illness associated with steroid-refractory aGVHD as well as health utilization costs, and may result in a higher price than in Japan. This life-threatening illness is designated as an orphan indication.

According to the Center for International Blood and Marrow Transplant Research, there are approximately 30,000 allogeneic BMTs globally. In the US, there are expected to be 8,900 allogeneic BMTs in 2015, with 25% of all cases in the pediatric population. Of these patients, 50% are expected to develop aGVHD. Liver or gastrointestinal involvement occur in up to 40% of all patients with aGVHD and are associated with the greatest risk of death, with mortality rates of up to 85%. Currently, in the US there are no approved therapies for patients with steroid-refractory aGVHD.

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!!Reimbursement prices under Japanese Regen Law!! 30 Nov 2015 06:23 #5535

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It is interesting to read that MSB´s estimate of number of treatments is double that of what the Japanese authority apparently think-

16 up to a max of 24 by MSB and 8 up to a max of 12 according to the form in the first post. :whistle:


It will be interesting to see how the GvHD application works out in the US. Surely most of us remember the problems Osiris and Randal Mills had with getting the therapy approved in the US although they were successful in Canada and New zealand I believe. Despite those approvals I never read of patients actually having been treated with the cells though... :really:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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