Thread for Guys in Xiaflex Trial - Currently or Previously

[Humorous3]

Cycle 4, shot 1. As usual, the shot went well. This is the next to last shot.

There's good news and bad news concerning the measurements, which is after three cycles of Xiaflex injections (18 weeks).  The bad news is there was no change in the angle so I'm still at 35 degrees. Since I started at 60 degrees, my decrease is 25 degrees. However, the good news is flaccid length has increased by 2cm which is 13/16 inch. That seems pretty good, but I've nothing to compare it to.

I know Mike would like to know about any changes in girth since that has been a concern of his. While I can't say for sure it's increased, since I never measured it before, I do believe in has increased.  

I'd like the others in the study to post their "End of Cycle 2/3/4" measurements in the same way. (The nurse has these measurements. By using her data the results will be more "scientific".) Indicate start degrees, end of Cycle x degrees, total change, plus change in flaccid length. (Please keep in mind the end of Cycle 3 is the beginning of Cycle 4.) It would be interesting to see if there is a correlation between degree change and increased length. In my case the change would seem to be slightly less than 1mm per degree.

I expect to post shot two results tomorrow.

Humorous

[bigk]

Humorous3:  As I recall you had indicated that you gained 10% for each of the previoius two cycles, and if that's true, then you did at least gain another 5% with the 3rd cycle.  If these numbers are correct, then you are least moving in the right direction.  In regard to the flacid length, your gain of 2 cm is just about right.  A 90 degree bend is equal to 6 cm of plaque, and so proportionally, a 25 degree change in bend should equal about 1.7 cm.  I have not read it anywhere, but I would bet that the penile structure is capable of at least doubling in length when stretched.  Whatever that number is, it would be important piece of information for judging and quantifying your 2 cm gain in length.

I think you're still moving in the right direction, but it's becoming obvious that a starting angle of 60 degrees will require more than 4 injecection cycles.  More than likely, you will need at least 6 injection cycles to reach the most optimum end point, and if any of the cycles happen to be administered with a "less than optimal" injection technique or location, then you could possibly need 7 or 8 cycles.

It wouldn't surprise me if Auxillium came out with a "new drug" that is essentially the same formula as Xiaflex, but with a different name.  That way they could employ a different pricing scheme that would keep the overall cost down to something more reasonable.  If you were to use the prices currently charged for dupuytren's injections, then the total cost could easily be more than $50k.  They seem to have extremely tight control of their distribution channels, so I don't think there would be any danger that the hand doctors might start ordering the cheaper drug intended for Peyronie's.  But all of this is conjecture on my part... who knows what they will end up doing.  But one thing is for sure, insurance companies are not going to shell out $50k so that we can get a beautiful hard-on and avoid a lifetime of anti-depressants and therapy.

[ohjb1]

The men who post on this thread, all report some improvement. Are there any forum readers who have not seen any improvement so we can get a more realistic view of Xiaflex. Even Auxillium does not claim 100% success.  

 

[ronners]

Mike Smith and Chopsuey have reported that they have received no 'signficant' improvement despite early signs of success.
This seems to be down to the difficulty the researchers face in 'measuring' imrpovements in an organ which has a shape that is variable to changes in temperature / blood flow etc. It would appear that measurements are taken in the flaccid state too ...

Humourous has seen a 41% improvement in curvature and an improvement in length and he is 3/4 of the way through the trial. The reactions to the drug he has experienced and the results would point towards the assumption that he is recieving the real thing.

In total Auxilium are going for approx 750 open and closed study participants - on this forum we have 4-5 posting their experiences so we know we can't be that objective ...

I have to say that I am encouraged to read about Humourous's results as it would suggest the drug really can alter the the structure of the underlying tissues that cause this condition, something that vitamins, electric shocks and stitches are unable to do ...

thanks for the update Humourous and good luck with your last few shots - can I ask how you and the other the participants feel about the amount of injections involved?? Having read about posters on this forum who have claimed problems as a result of injections it has got me thinking - I wouldn't have an issue with the pain involved but I would be worried that I might be causing more damage .... what are your experiences with the multiple caverject injections as well as the xiaflex shots and what are your thoughts about this in general as you move towards the end of the trial ..??

[MikeSmith0]

However, the good news is flaccid length has increased by 2cm which is 13/16 inch. That seems pretty good, but I've nothing to compare it to.

I know Mike would like to know about any changes in girth since that has been a concern of his. While I can't say for sure it's increased, since I never measured it before, I do believe in has increased.  

Thanks for the info humorous.  Did the flaccid length translate into the same amount of erect length too?  I've noticed changes in my flaccid length in the past (during the traction era) that did not affect erect length.  (I'm talking about flaccid, stretched length).  That's interesting if girth was increased...did you have a narrowed area along with the curve?  Is your plaque just on top?

Ronners, yeah chopsuey and i have not seen changes but 1/3 are in the placebo group...so its not really a comparison yet.

[tresh]

Have just completed third cycle and have shown no improvement in angle or length. Also, none of the injections have caused any bruising whatsoever.  Either I'm getting the placebo or I'm immune to the medication.

[Humorous3]

Humorous3:  As I recall you had indicated that you gained 10% for each of the previoius two cycles, and if that's true, then you did at least gain another 5% with the 3rd cycle.  If these numbers are correct, then you are least moving in the right direction.  In regard to the flacid length, your gain of 2 cm is just about right.  A 90 degree bend is equal to 6 cm of plaque, and so proportionally, a 25 degree change in bend should equal about 1.7 cm.  I have not read it anywhere, but I would bet that the penile structure is capable of at least doubling in length when stretched.  Whatever that number is, it would be important piece of information for judging and quantifying your 2 cm gain in length.

I think you're still moving in the right direction, but it's becoming obvious that a starting angle of 60 degrees will require more than 4 injecection cycles.  More than likely, you will need at least 6 injection cycles to reach the most optimum end point, and if any of the cycles happen to be administered with a "less than optimal" injection technique or location, then you could possibly need 7 or 8 cycles.

It wouldn't surprise me if Auxillium came out with a "new drug" that is essentially the same formula as Xiaflex, but with a different name.  That way they could employ a different pricing scheme that would keep the overall cost down to something more reasonable.  If you were to use the prices currently charged for dupuytren's injections, then the total cost could easily be more than $50k.  They seem to have extremely tight control of their distribution channels, so I don't think there would be any danger that the hand doctors might start ordering the cheaper drug intended for Peyronie's.  But all of this is conjecture on my part... who knows what they will end up doing.  But one thing is for sure, insurance companies are not going to shell out $50k so that we can get a beautiful hard-on and avoid a lifetime of anti-depressants and therapy.

bigk,

Actually it was 10 degrees (not %). You are correct about the "additional" 5 degrees. Good catch and here is the explanation. They take three degree measurements at the initial screening when they do the Doppler, etc.  Mine were 50, 55, and 60. I have been using 55 degrees in my postings because I considered it as an "average". Plus, the nurse said I had 10 degree improvements twice (at end of Cycles 1 and 2) and I am at 35 degrees.  Maybe I can get an explanation from her. Or, since measuring the curve is a bit less exact than measuring a straight line, we can just say it crept in such as 2.5 degrees each of those two times.

Yes, I agree that four cycles/eight injections aren't enough to "get straight". Let's see what the Cycle 4 results are in about six weeks. And, for this example, let's assume I get 10 degrees as I did in the first two cycles. That would be a 35 degree change and put me at 20-25 degrees. During this study Auxilium will stop giving injections when someone reaches a 15 degree angle. So, I agree with your theory that it might take 5-6 injection cycles to reach 0-15 degrees (or maybe more) depending on the individual and the Doctor's skill at "hitting' the plaque.

Your "new drug" idea is an interesting one and I hope they do something to lower the cost as others have projected here in the forum. Somewhere, many months ago, I remember reading that Auxilium would price Xiaflex slightly above or below the cost of surgery. That makes sense to me as I think insurance would be more likely to pay for injections over surgery if the costs of both are similar.  

Humorous

[Humorous3]

There are two other items about this study that I haven't seen mentioned here before.

  1. The Xiaflex dosage strength is different (higher) for those with a 60 degree or greater curve.  (I don't know whether it's 2x, 3x, or whatever.)  On page 4, para 2, the study paperwork says "at a dose of 0.58mg".  

  2. The cost of the Phase 3 study drug, as priced by Auxilium, is around $100,000 per patient.  That is $12,500 per injection.  I don't think this will have any bearing on the retail price.  

For the others in this study, feel free to confirm this.  

Humorous

[Humorous3]

Well, I've had shot 2 of Cycle 4, which is my last Xiaflex injection.  My body's reaction was much better this time as compared to after any previous shot 2 reaction. Swelling and discoloration was only moderate - no purple eggplant with severe swelling (75-100%) and no blood blisters as I had after some earlier injections (always after shot 2).  

The next thing for me is to look forward to the measurements in about six weeks.

Humorous

[restore]

There are two other items about this study that I haven't seen mentioned here before.

  1. The Xiaflex dosage strength is different (higher) for those with a 60 degree or greater curve.  (I don't know whether it's 2x, 3x, or whatever.)  On page 4, para 2, the study paperwork says "at a dose of 0.58mg".  

  2. The cost of the Phase 3 study drug, as priced by Auxilium, is around $100,000 per patient.  That is $12,500 per injection.  I don't think this will have any bearing on the retail price.  

For the others in this study, feel free to confirm this.  

Humorous

I don't think I can afford this drug, if it ever is approved.  Yikes!

[bigk]

There are two other items about this study that I haven't seen mentioned here before.

  1. The Xiaflex dosage strength is different (higher) for those with a 60 degree or greater curve.  (I don't know whether it's 2x, 3x, or whatever.)  On page 4, para 2, the study paperwork says "at a dose of 0.58mg".  

  2. The cost of the Phase 3 study drug, as priced by Auxilium, is around $100,000 per patient.  That is $12,500 per injection.  I don't think this will have any bearing on the retail price.  

For the others in this study, feel free to confirm this.  

Humorous

Good catch regarding my errant use of the "%" symbol vs. "degrees".  In regard to your reference to the "study paperwork", I would very much like to read it.  Is this something that you have on paper, or is it available somewhere online?  If you only have a paper copy, I would be grateful if you could somehow send me a scanned copy.  The more technical the paper, the more I would be interested in reading it.

In regard to your reference to 0.58 mg of collagenase, this is the same amount that they use for Dupuytren's injections.  With Dupuytren's, the vial starts out with 0.9 mg of collagenase, which is then reconstituted with 0.39 ml of solution.  And from the 0.39 ml of solution, the Doctor draws out 0.25 ml of solution.  So if 0.25 ml is drawn from the vial containing 0.39 ml, then you are essentially drawing out 64% of the collaganase that was in the vial (0.25/0.39 equals 0.64).  And if you calculate 64% of the original 0.9mg that was available in the vial, the result is 0.58mg.  So I think you are getting the exact same dose that they use for Dupuytren's.

[chefcasey]

There are two other items about this study that I haven't seen mentioned here before.

  1. The Xiaflex dosage strength is different (higher) for those with a 60 degree or greater curve.  (I don't know whether it's 2x, 3x, or whatever.)  On page 4, para 2, the study paperwork says "at a dose of 0.58mg".  

  2. The cost of the Phase 3 study drug, as priced by Auxilium, is around $100,000 per patient.  That is $12,500 per injection.  I don't think this will have any bearing on the retail price.  

For the others in this study, feel free to confirm this.  

Humorous

I don't think I can afford this drug, if it ever is approved.  Yikes!

I think it will be much less expensive depending on how widely the drug gains acceptance if approved.  My guess is that if it does, all Peyronies Disease specialists will begin to use it as they've been following it very closely.  It may take some time for general urologists to come through after that.  The official % of people with Peyronies Disease is anywhere from 1-10% of men, but most Peyronies Disease specialists believe it to be in the 9-10% range, although we don't know exactly what % of men actually seek treatment due to this being an embarrassing subject.  Nevertheless, even by the most conservative estimates, it should be in the millions of men that seek treatment in the U.S. and obviously much more if other countries are included.  With these large numbers, the company would benefit from huge economies of scale to regain their initial investment and reducing production costs if it becomes a viable treatment, and thus bringing the cost to us and the insurance companies way down.  The insurance companies will get on board too if the price drops far enough to where it is a cheaper option than surgery, which from what I've read can be anywhere from 40-100k.

The real issue is how well it performs in the trial.  If it doesn't do so well, it will probably just be a slightly better option than the old verapamil injections and won't be widely used.  Let's just hope for the sake of our penises and wallets that it does perform well and gains worldwide acceptance and usage.

[Ben]

I totally agree. Where is the point for Pfizer to craft a drug that nobody can affrod ? If Xiaflex can improve our condition it will be a blockbuster in term of sales.
The main question is : is it efficient ? The money matter (at least for me) is not the main problem.

[chefcasey]

I'm sure they've already done the math, finding the amount of sales for a breakeven point etc.  I believe it's already approved for the hand contracture, and that's less common then Peyronies Disease, so I assume there's some big bucks to be made with us.

[MikeSmith0]

 " 2. The cost of the Phase 3 study drug, as priced by Auxilium, is around $100,000 per patient.  That is $12,500 per injection.  I don't think this will have any bearing on the retail price.  "

Are you sure it is the study drug ?  This doesn't make sense since it is on the open retail market for 4000 per vial already.  That would be 36k per patient - retail.  The retail dose is the same as the dose on the study information sheet (0.58 mg).

If you add in the doctor's fees, coordination costs, blood tests, trimix injections, insurance, patient reimbursement, etc... the cost of this study is probably 100,000 per patient.  But, the drug itself is not any more than 8k per cycle and that's retail.  And that was when it came out - it might have dropped a little... I originally saw those numbers a while back on the Dupuytren's board.  It could've gone down in price if people weren't having good results with 1 or 2 treatments and needed more (or risk docs starting to abandon it).

It'll be like 3-4k per injection... 6-8k per cycle.  You can get it now for that if you had Dupuytren's.  They might even lower it more if this trial shows a big difference with the guys who had 4 cycles (last trial only had 3) for results...or insurance might cut you off after 4 cycles.  Plus doctors & their pharmacies will mark it up like any injectable drug.  Depending on your doc, you'll have a visit fee and/or facility fee.

Ben, it has already been shown to be effective - but they only studied 3 cycles...and the effects were about 25% of the curve reduced, which isn't great...and I'd love to know if the scar comes back too a year later...or if it heals properly the second time around.    

[Humorous3]

Mike,

I think we're comparing apples and oranges here.  The cost of the study drug is an internal accounting matter while the retail price is totally different.  I understand they have priced it for Dupuytren's but maybe they computed the study drug cost like a car prototype - extremely expensive.  Or, as you mention, maybe they are including the total study costs.  The only reason I mentioned it was because it seemed so extraordinarily high.  And, I did add that I didn't think it would have anything to do with the retail price.

Do we have any accountants on the board that could shed some light on this?

Humorous

[Old Man]

Note to all:

Adding my 2 cents about the cost of any product that is presented to the public for use. At one time, I was the chief purchasing agent for a large aircraft engine manufacturer in the U.S. When we produced a new engine to the market, all costs from whatever source in the company were gathered by our accounting and pricing department to be included into the retail price for the market.

So, bottom line, any and all costs all the way from the individual parts of the engine, engineering time, production time, trials and testing time along with shipping and handling were included in the market price.

Therefore, all costs whatever source relating to the product are included into the sales price of the end product. In the case of a medication, when it is administered by a doctor or a hospital, even these costs are added to the bill when presented to the patient. So, that is why Xiaflex is costing so much on the first presentation to the public. As time goes on and the amount of distribution continues, the cost may or may not go down based on the quantity being produced and sold.

Old Man

[restore]

This is all disheartening.  From all the discussions, and everything I've read so far, this drug is not a cure.  And if I will eventually be asked to pay $100K for the full round of treatments, at least for me, it would have to be a cure.

That said,  I realize my Peyronie's is still in the acute phase with minor bend, I may feel differently if the disease progresses further.  

[bigk]

This is all disheartening.  From all the discussions, and everything I've read so far, this drug is not a cure.  And if I will eventually be asked to pay $100K for the full round of treatments, at least for me, it would have to be a cure.

That said,  I realize my Peyronie's is still in the acute phase with minor bend, I may feel differently if the disease progresses further.  

I think it's "not a cure" because they are not using enough injection cycles.  If you were to start out with an angle of 30 degrees, then Xiaflex could probably provide a "cure".  But if you start out with a 90 degree angle, then the chances that you can be "cured" with four injection cycles are slim to none.  Right now I'm somewhere around 38 degrees, so I'm hopeful that I really can be "cured" with this drug.

[ronners]

Guys ...

Why would a drugs company try to sell a treatment for 100,000 dollars when surgery costs a tenth of the price ...?? for any product to succeed it needs to be sensibly priced within its market place ...

Why would you be limited to 4 injection cycles when more might help further ..?? The answer is that this is a trial and it is simply designed to get the drug approved by the relevant authorities around the world so that the drug can be shown to be safe and effective and then marketed and sold by auxilium and pfizer ...

[Worried Guy]

The price will come down.  It is like anything!  When the xbox first went on sale it cost £350.  Now you can get them for £129 with a few games attached.  It is also about supply. The more you produce the cheaper it is to make. The more you sell the easier it is to make profit so you can lower the price.  The more a hospital buys the better a deal they can bargain with.

[Luciano]

The price will come down.  It is like anything!  When the xbox first went on sale it cost £350.  Now you can get them for £129 with a few games attached.  It is also about supply. The more you produce the cheaper it is to make. The more you sell the easier it is to make profit so you can lower the price.  The more a hospital buys the better a deal they can bargain with.

What I dont understand is I thought xiaflex allready existed and is approved and is used for dupuy contractions.
If a I had dupuy, a doctor could give me a xiaflex injections treatment (i read somewhere it is about 5000,-$)

Up to now I thought the xiaflex trials are to see if it also works for Peyronies.
Am I wrong? And is it a different xiaflex used for peyronies than for dupuys contractions?

Luc

[bigk]

The price will come down.  It is like anything!  When the xbox first went on sale it cost £350.  Now you can get them for £129 with a few games attached.  It is also about supply. The more you produce the cheaper it is to make. The more you sell the easier it is to make profit so you can lower the price.  The more a hospital buys the better a deal they can bargain with.

What I dont understand is I thought xiaflex allready existed and is approved and is used for dupuy contractions.
If a I had dupuy, a doctor could give me a xiaflex injections treatment (i read somewhere it is about 5000,-$)

Up to now I thought the xiaflex trials are to see if it also works for Peyronies.
Am I wrong? And is it a different xiaflex used for peyronies than for dupuys contractions?

Luc

The formula being used for Peyronie's is identical to the one approved for Dupuytren's.  But with Dupuytren's, the Doctor actually snaps or breaks the weakened cord, which is not an option for Peyronie's.  With Peyronie's they are trying to "dossolve" (for lack of a better word) the plaque, which requires quite a few more injections.

[Luciano]

The formula being used for Peyronie's is identical to the one approved for Dupuytren's.  But with Dupuytren's, the Doctor actually snaps or breaks the weakened cord, which is not an option for Peyronie's.  With Peyronie's they are trying to "dossolve" (for lack of a better word) the plaque, which requires quite a few more injections.

Thanks for the info
but then the pricing should be clear.. and be the same on a per/injection (at same dosage) base.
I meen if  15 x 20 cc injections are used for dupuytrens and cost 5000$
I would suspect if 4 series of 15 injections are used  for peyronies then the cost would be 20000$
(these are just examples as I dont know exactly how many are needed for dupuytrens, but I meen they will have to make a price similar on a cc/concentration base, and cant suddenly jump to 100k$)

L.

[Old Man]

Note to all:

According to my hand surgeon who did my DC surgery in 2009, a two injection ampule of Xiaflex used for DC would cost him around $3,000.00. Adding his office visit and administration costs to that, he would charge about $3,500.00 for the two shots.

So, using that as a base (if these figures are correct) one can figure an approximate cost of what the injections for Peyronies Disease would cost. However, nobody seems to know how injections would be necessary to "treat/cure" Peyronies Disease.

Old Man

[ronners]

All of the calculations and assumptions about costs that people are making on this thread are derived from costs associated with the treatment of dupuytrens contracture ...

However, as several have tried to point out already, this really doesn't mean that xiaflex for the treatment of peyronie's will be priced the same way ... There are already differences in terms of branding (Xiaflex is marketed as Xiapex in Europe for the treatment of DC) and there are different healthcare systems in place all over the world (i.e. not everyone uses private insurance to pay for treatments).

Simply and logically, for a product to sell, it has to be priced competetively and be affordable regardless of whether it's insurance companies, governments or individuals that are paying for it ... some of the costs projections on this thread in my opinion are unrealistic and unfounded

[MikeSmith0]

All of the calculations and assumptions about costs that people are making on this thread are derived from costs associated with the treatment of dupuytrens contracture ...

However, as several have tried to point out already, this really doesn't mean that xiaflex for the treatment of peyronie's will be priced the same way ... There are already differences in terms of branding (Xiaflex is marketed as Xiapex in Europe for the treatment of DC) and there are different healthcare systems in place all over the world (i.e. not everyone uses private insurance to pay for treatments).

Simply and logically, for a product to sell, it has to be priced competetively and be affordable regardless of whether it's insurance companies, governments or individuals that are paying for it ... some of the costs projections on this thread in my opinion are unrealistic and unfounded

I can't think of any drugs that have 2 separate FDA approvals that are priced differently for each indication.  I think it would be a problem for the entire distribution channel to say "these are the Peyronies Disease bottles - and you have to charge X for them -- and these are the DC bottles - and you have to charge X+$1000 for them".   Is that even legal to do?  It seems shady.  Urologists would just have their orthopedic surgeon friends order them cheaper vials or vice versa... they wouldn't even get in trouble for it once it is FDA approved.

I know viagra is approved for a heart condition... and it goes under a different name -- but I don't think this affects the price.  It does affect how some insurance plans cover the drug though.

[chefcasey]

You're right about the R & D costs Mike.  Plus the fact that most other countries set price ceilings on treatments that make the profit margins really thin, so the only way they can recoup the costs is by charging higher prices to the americans.  It may suck for us, but without it, the profit motive for R & D wouldn't be there and we would not have as many drugs as we have today.  The initial fixed costs such as R & D, plant and lab facilities and machinery are always quite high in pharmaceuticals because of just like you said, it's extremely difficult to get drugs to market.  If these trials do well and xiaflex becomes part of the new "gold standard" of Peyronies Disease treatment, then increased production will most likely lower the average cost of production per unit of the drug.  So during the trials, if the avg. cost is 100k,  then by having it produced in mass it may be somewhere around 50-60k for all the cycles, assuming the usage rights don't change and no one else produces it. It wouldn't be priced differently than the kind used for DC, but DC is even rarer than Peyronies Disease, so adding this new demand for the drug would increase production significantly.

The insurance companies here in the U.S. will look at it statistically like anything else...i.e what is the % of patients that will ultimately need surgery times the avg. cost of surgery etc., and how much the use of xiaflex reduces that to calculate what they'll cover.  Now I've heard of people having grafting surgery with Dr. Levine, where the cost to the patient is anywhere from to 5-15k, and the bill he sends to the insurance company being 40k.  That being said, the insurance companies may cover a very good portion of it.  

[ronners]

I can't think of any drugs that have 2 separate FDA approvals that are priced differently for each indication.  I think it would be a problem for the entire distribution channel to say "these are the Peyronies Disease bottles - and you have to charge X for them -- and these are the DC bottles - and you have to charge X+$1000 for them".   Is that even legal to do?  It seems shady.  Urologists would just have their orthopedic surgeon friends order them cheaper vials or vice versa... they wouldn't even get in trouble for it once it is FDA approved.

I know viagra is approved for a heart condition... and it goes under a different name -- but I don't think this affects the price.  It does affect how some insurance plans cover the drug though.

Auxilium and Partners have a right to sell the drug to whom and how they want ... The Distribution channels on their website seem very tight and what you are describing above about urologists selling their vials to hand surgeons and vice versa is illegal here in the UK (I'm unaware of how it works in the US) ... I'm not so sure that specialist urologists and orthopedic hand surgeons would look to be arbitraging vials of xiaflex between each other on a grand scale to exploit price differentials and it would appear that the distribution network that Auxilium has in place would make this difficult ...

Here is just one example of a drug that is looking at different pricing strategies for different indications -

http://medikol.co.uk/mediKOL%20Brief%205...ing_Sept%2009.pdf

This article is interesting as the principles are similar - the conclusion at the end comes back to affordability ... Drugs are also priced differently in different countries ... It is my opinion that if Xiaflex is priced at the level of some of the estimates on this thread then it becomes intrinsically unaffordable - If it is unaffordable in the US where the income per head is at one of the highest levels in the developed world then it will definitely be unaffordable elsewhere. This doesn't make commercial sense from a business perspective - it's my opinion that you will see a different pricing structure for different indications.

[Worried Guy]

It i still a very new drug.  It was only approved for Dupuytren's use in early 2010.  Most individual hospitals in the UK have not even approved it yet let alone started to use it.  Pfizer whilst stating at the moment that it should not be used for peyronie's will be very pleased if it could open up a new market for them.  They will not let this opportunity pass.  I'm confident if this stuff works we will be seeing it on the NHS in the next 5 years.  I was told by my Uro that I just missed out on the UK trial by a few weeks.  His words were  "Don't worry, if it is a successful trial the chances are you can have it after"

[BSSS]

well my 2 cents..... I would think if anything that the drug - at least at first - would be priced a little higher for peyronie's just from the simple fact that it has to be profitable for shareholders, especially if it's true (as someone mentioned earlier) that there are more peyronie's sufferers than DC sufferers.  If there's one thing true about drug companies in the US, it's that the drug will be priced high to start with due to demand.  

[MikeSmith0]

Ronners, the US healthcare system is a giant mess which does not work under any logical or capitalist principles.

For example, medicare just approved payment for men with late-stage terminal prostate cancer that will give them 4 months longer to live -  for $93,000.  Simultaneously, medicare is restricting more and more of what they will cover that is not anywhere near as expensive.. but they approved this. Of course that is a life or death issue but 93k is a pretty big price tag for 4 months.  And, it's free if you are over 65 (medicare is government health insurance all Americans get over 65).  However, needing  15k surgery might get turned down for no reason.

Pricing here is not made for people, unless something is over the counter. When Claritin went over the counter, they did worse for a while, because Zyrtec (its competitor) was still RX.  So, you either paid $20 for Claritin or a much cheaper amount for (insurance covered) zyrtec - assuming your co-pay was under $20.   In the USA, if you have MS, CF, HIV, or Cancer, you will have an annual drug bill of $30,000 a year...(or more).  Insurance pays... unless you don't have insurance then you're fairly screwd & can sometimes work with public aid or with the drug companies...but that's hit or miss.  I have no idea how it works in the UK.  The point is - drug companies can get away with outrageous prices all they want.  Doctors hands are not tied at all when it comes to off-label drugs, but if a drug company has tight distribution channels, then things change.  I have no idea how they stock & ship xiaflex or if there are intermediaries, wholesalers, etc... there are drugs on the market that have similarly restrictive distribution channels...usually these are for 1 indication though.  

I have no idea what the system is like in the UK...but based on what you said - there's a lot more leniency here for docs to do a lot of things - particularly outside of managed care environments (in private practice).  I saw the link but I have never seen something like that here.  I don't work in healthcare though so I dont know.    

[Worried Guy]

Well I can only go form what my Uro told me.  Under the labour party, at the start of their leadership, we had a postcode lottery where basically you got differing treatment depending on where you lived within England and Wales.  This has all changed as you can now choose which doctor and which hospital you want to visit anywhere in the country.  You go to your GP and tell him where you want to go.  He then looks on the system and gives you a password.  You then go home and call the national centre and they arrange an appointment which best suits you.  My first appointment took 2 weeks and was at a private hospital paid for by the NHS in the closest city to me.  I was not that pleased with the outcome and went back to my GP for another password and booked an appointment in London at UCLH with the UK's leading peyronie's team.  I then had to wait 6 weeks.  Had a very good service whilst I was there.  I was told that I had just missed out on the Xiaflex trial but not to worry if it was a success I would likely get it after. I was told that my Uro carried out the UK VED study and that VED could stop it getting worse and even improve the situation.  I was referred to the VED clinic they have their to start VED and was told I will probably not have to pay for the VED equipment.  All this was free (paid for by our higher tax system) Just waiting for my VED appointment.

Oh and 6 weeks of pentox cost me £7.40 with my prescription.  If I was in Scotland, Wales or NI it woud have been free.  That is annoying but £7.40 is not that much.

[ronners]

Thanks for the info mike and worried guy - I guess we'll just have to wait and see - If approved, Pfizer owns the rights to sell the drug in the UK and Europe so maybe there will be differences in the manner and price at which the two companies operate at ... There are certainly some big differences in our healthcare systems as pointed out by mike ..

Auxilium has priced the xiaflex treatment for Dupuytren's at a level that, on average, is the same or just below the costs of surgery for the condition (about 5400 dollars is the average that they expect a dupuytrens patient to pay) ... Importantly they made a point of stating this when the drug was approved and they were starting to sell it - At the very least this indicates that the company realises that the price of their treatment has to be based upon the treatments that are currently available to patients. However, in the case of Peyronie's the cost and type of surgery can vary dramatically so it will be interesting to see what, if any, benchmark they use ...

One thing I feel for certain is that if the drug is approved it will be available a lot sooner in the US that in the UK / Europe ... In the US, Xiaflex was granted approval in FEB 2010 for Dupuytrens and launched a short while later - In Europe it was only granted approval last month and Pfizer intend to start marketing the drug in the second half of the year!! This is despite the approval applications going in at roughly the same time ...

can't a guy just jab a needle full of ganregnous enzymes into his dick anymore without having to wait around for years on end!! I mean jeez ..!!

[Worried Guy]

I guess they will have to recoup R&D costs and once they have done that can sell it cheaper.  I would imagine it will be in the USA before the UK.  The NHS is facing some pretty major cuts which is a fear of mine.  Pfizer are actually closing their UK plant making 2400 unemployed directly and god knows how many indirectly.  These are tough times.  Lets hope there is enough in the kitty for us peyronie's sufferers.

[ohjb1]

Is there anyone on this forum who is in the open label study. If so, would you please tell me how long before your side effects of Xiaflex injections such as swelling, redness etc. resolved and the appearence returned to normal.
Thank you.  

[MikeSmith0]

can't a guy just jab a needle full of ganregnous enzymes into his dick anymore without having to wait around for years on end!! I mean jeez ..!!

lol

If you left the UK, do they pay for anything to be treated in the USA?  My insurance doesn't pay for anything outside the USA unless it is an emergency, then there's some process they have to pay back the country / hospital / doctor involved.  But, i couldn't go to a consult in any other country w/ my insurance. I don't even know if I could see a doc in London for cash, could I?  Let's say you were the ones who developed / approved the drug.  Is it 100% controlled by the government - or can you see a doc for a fee that you pay?

[Chipped]

I'm new to forum and been just been reading about Xiaflex. I think one thing the UK users haven't really factored in regarding xiaflex is economies of scale. Xiaflex may cost $5000 ect (matching surgery) in the US were the heathcare system is fragmented by many (comparitively) small buyers. But with the NHS's huge purchase capacity (one of its main advantages) it highly likely the NHS Confederation could negotiate a significant discount. They potentially could bring the price down to say 20% or 30% below the average parity cost of surgery. If that turns out to be the case, then Xiaflex will be cheaper alternative and make surgery largely obsolete. Since the NHS is always hungery for savings, getting Xiaflex to patients may end being a high priority.

[Worried Guy]

Chipped you are probably right! The NHS employs 1.7 million people and has a budget of £110 billion (the same size as Chile or Czech Republics whole economy) they should be able to strike a bargain.  

[Worried Guy]

Mike, I believe only in very special cases the NHS will pay for you abroad.  I believe you can pay for healthcare if you are from another county but it could be a fair wack!

[Humorous3]

Is there anyone on this forum who is in the open label study. If so, would you please tell me how long before your side effects of Xiaflex injections such as swelling, redness etc. resolved and the appearence returned to normal.
Thank you.

Ohjb,

If you are referring to the US open label study, I believe that will not begin until after the current Phase 3 study ends which is late this year (for me) and maybe next spring for others.  

However, addressing your question of side effects, look at earlier posts in this forum by me and several others who are in the Phase 3 study.  There are 4-5 of us posting the results of every cycle.  (A cycle is six weeks long.)  To give you an idea of how far back to go, my first post for Cycle 1 injections and the results/side effects was posted Nov 28, 10.  In addition to my posts, other posts to look for are from BSSS, ChopSuey, Matthewfamily, and MikeSmith.  (If I've left anyone off, please make an additional post.)  Hope this helps.  

Humorous

[Worried Guy]

Is there a link where you are posting your results together?  I would like to know how you guys are getting on!

[Humorous3]

Is there a link where you are posting your results together?  I would like to know how you guys are getting on!

Worried Guy,

This thread is where we are posting.  (Re-read the title.)  You just have to go back (down the pages(s)).  Look at my last post (the one you responded to) for a starting point and names to look for.

Humorous

[Worried Guy]

Sorry Humorous3, I should have looked back.  Thought there might have been a condensed page like there is for VED and progression in general.  I guess it is a little early to create one of those.  Sounds like you have had pretty good results so far!!  Lets hope it continues with your next shot.

[BSSS]

Is there anyone on this forum who is in the open label study. If so, would you please tell me how long before your side effects of Xiaflex injections such as swelling, redness etc. resolved and the appearence returned to normal.
Thank you.

Ohjb,

If you are referring to the US open label study, I believe that will not begin until after the current Phase 3 study ends which is late this year (for me) and maybe next spring for others.  

However, addressing your question of side effects, look at earlier posts in this forum by me and several others who are in the Phase 3 study.  There are 4-5 of us posting the results of every cycle.  (A cycle is six weeks long.)  To give you an idea of how far back to go, my first post for Cycle 1 injections and the results/side effects was posted Nov 28, 10.  In addition to my posts, other posts to look for are from BSSS, ChopSuey, Matthewfamily, and MikeSmith.  (If I've left anyone off, please make an additional post.)  Hope this helps.  

Humorous

Humurous,

Looks like they may be already recruiting for the open label study and it appears it may be included in phase three of the trials?

http://clinicaltrials.gov/ct2/show/NCT01243411?term=peyronie%27s&rank=1

Says 300 participants and it looks 'international' I saw one study recently that indicated it was invitation only, so I'm wondering if Auxillium has changed the study requirements?

[BSSS]

  Re: Xiaflex
« Reply #273 on: Today at 05:08:30 PM »  

--------------------------------------------------------------------------------


I posted this on the Xiaflex thread and wanted to post it here as well.  Hope it's not too confusing.  I quoted myself there to share new info:


not yet.....I've been through the first series of injections.  I also didn't notice much if any change erect.  I don't have a compass to measure angle, but at first glance it appears about the same.
I definitely do not have the hinge effect although I was concerned about modeling the first few days.


I do want to follow up this post with some notice of a change.  I've seen some difference in my angle when erect.  I didn't at first but the angle is less sharp, or more gradually curved.  I really couldn't put a number on it at this point and the info is anecdotal of course, but none the less encouraging. I did round one of injections several weeks ago and have been pretty good about remembering the modeling.
BSSS  

[taurian]

 
Hello fellow trial participants!
I live in Sydney, Australia where the trial has just commenced.  I have completed Cycle 1 last week and already can see an improvement from the measured baseline of 50 degrees to about 30 degrees currently.  The swelling took about 4 days to subside and the purple bruising a few days longer.  I'm inclined to think I am in the active drug group, although i know that placebo effects can also be convincing (deluding is perhaps a better word)!  I guess the truth will be revealed on measurement day at the commencement of Cycle 2.  Apparently placebo effects are greater for treatments that are more costly to the participant in terms of things like inconvenience and discomfort, as well as things like credibility.  Judging from my experience, this trial scores pretty high on all these factors.

My thanks to the initiator of this forum, and to previous contributors - it's good to know what others are experiencing and thinking....

Taurian

[bigk]

Hello fellow trial participants!
I live in Sydney, Australia where the trial has just commenced.  I have completed Cycle 1 last week and already can see an improvement from the measured baseline of 50 degrees to about 30 degrees currently.  The swelling took about 4 days to subside and the purple bruising a few days longer.  I'm inclined to think I am in the active drug group, although i know that placebo effects can also be convincing (deluding is perhaps a better word)!  I guess the truth will be revealed on measurement day at the commencement of Cycle 2.  Apparently placebo effects are greater for treatments that are more costly to the participant in terms of things like inconvenience and discomfort, as well as things like credibility.  Judging from my experience, this trial scores pretty high on all these factors.

My thanks to the initiator of this forum, and to previous contributors - it's good to know what others are experiencing and thinking....

Taurian

I have a question about how they measure the angle.  I have a plaque located on the top, and a digital photograph taken from the side shows the angle to be different on the top (concave) side vs. the bottom (convex) side.  The angle on the top side is always the largest of the two, and conversely, the angle on the bottom is the smallest.  It would seem reasonable to simply average the top and bottom angles, but I'm wondering if the doctors are only using one of the two angle measurements?

[MikeSmith0]

Is there anyone on this forum who is in the open label study. If so, would you please tell me how long before your side effects of Xiaflex injections such as swelling, redness etc. resolved and the appearence returned to normal.
Thank you.

Ohjb,

If you are referring to the US open label study, I believe that will not begin until after the current Phase 3 study ends which is late this year (for me) and maybe next spring for others.

He's in the open label study now bc he got the placebo in phase 2.   very small group of guys in this group.   he had 3 cycles of the placebo.  

[BSSS]

Hello fellow trial participants!
I live in Sydney, Australia where the trial has just commenced.  I have completed Cycle 1 last week and already can see an improvement from the measured baseline of 50 degrees to about 30 degrees currently.  The swelling took about 4 days to subside and the purple bruising a few days longer.  I'm inclined to think I am in the active drug group, although i know that placebo effects can also be convincing (deluding is perhaps a better word)!  I guess the truth will be revealed on measurement day at the commencement of Cycle 2.  Apparently placebo effects are greater for treatments that are more costly to the participant in terms of things like inconvenience and discomfort, as well as things like credibility.  Judging from my experience, this trial scores pretty high on all these factors.

My thanks to the initiator of this forum, and to previous contributors - it's good to know what others are experiencing and thinking....

Taurian

Sounds great Taurian, good luck to you, hope you have continued success!