Xiaflex

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j

I don't think anyone has, at this point, a clear idea of how much Xiaflex might be used to treat Peyronie's.  I think all they did in the trials to date was inject "some" and hope for a small improvement.


For Dupuytren's the situation is a little clearer because surgery is common and "success" is fairly well-defined.  It looks like Auxilium is trying to price Xiaflex about 10 cents lower than a typical surgery and is hoping the insurers will pay.  They've apparently sized a "vial" as roughly what would be needed for release of a typical Dupuytren's cord.  

ComeBacKid

After consulting my friend/doctor/peyronies sufferer, he told me the point of FDA trials is only to show safety, more aggressive approaches can be adopted at a later date.  This was like a trial run and they just wanted to clear a few hurdles, they won't go all out until the final race.  

That price doesnt look that bad or steep. The big thing will be is the insurance company going to cover it? And if they do will they deny coverage by asking about a pre-existing condition, which just happened to me the other day over a mix up on another treatment regarding headaches which were sinus related but on paper looked like a brain tumor to my insurance company.

I don't know how an insurance company desides to cover the drug, but just cause its FDA approved doesnt mean it will be covered, sometimes the doctor can write and or call to get the insurance company to pay for a treatment.  

You'd have to think this drug should be covered, I mean its the only main drug for peyroneis other than pentox that has shown to be successful at all outside of surgery.  Surgery can be pricey as well.  

Another point is how many vials will be used in treatment?  Some people have lots of plaque and or calcification, will more or less be needed for some people?  Doppler ultrasounds may be used to indentify location and or thickness/amount of vial needed for treatment.  This could make everyones treatment course different.  There will probably be a base treatment protocol, with a more aggressive approach or less aggressive approach for different people allowed by the doctors.

Comebackid

Fred22

Quote from: ComeBacKid on March 12, 2010, 09:11:05 PM
After consulting my friend/doctor/peyronies sufferer, he told me the point of FDA trials is only to show safety, more aggressive approaches can be adopted at a later date.  This was like a trial run and they just wanted to clear a few hurdles, they won't go all out until the final race.  

That price doesnt look that bad or steep. The big thing will be is the insurance company going to cover it? And if they do will they deny coverage by asking about a pre-existing condition, which just happened to me the other day over a mix up on another treatment regarding headaches which were sinus related but on paper looked like a brain tumor to my insurance company.

I don't know how an insurance company desides to cover the drug, but just cause its FDA approved doesnt mean it will be covered, sometimes the doctor can write and or call to get the insurance company to pay for a treatment.  

You'd have to think this drug should be covered, I mean its the only main drug for peyroneis other than pentox that has shown to be successful at all outside of surgery.  Surgery can be pricey as well.  

Another point is how many vials will be used in treatment?  Some people have lots of plaque and or calcification, will more or less be needed for some people?  Doppler ultrasounds may be used to indentify location and or thickness/amount of vial needed for treatment.  This could make everyones treatment course different.  There will probably be a base treatment protocol, with a more aggressive approach or less aggressive approach for different people allowed by the doctors.

Comebackid

If this drug is proven effective I certainly hope insurance companies decide to cover it.  However, remember that insurance companies make their money by denying coverage.  I know this is not the place for political discussions, but I reaslly wish that congress and the Obama administration could get their act together and do what is right for the American taxpayers, not what is politically expedient.

Fred                                                            

timk


bummedout

Update:

There will be a presentation at the American Urological Association (AUA) 2010 Annual Meeting on June 1, 2010 on the Phase 2b results entitled: Improvement in Penile Curvature and a Patient Reported Outcome Endpoint in Patients with Peyronie's Disease: Results from a Phase II Study of Collagenase Clostridium Histolyticum.

Hopefully there will be good news.
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MedStudent86

Xiaflex- Collagenase Clostridium Histolyticum

Dosing for Dupuytren's contracture is as follows-(Via Epocrate's Drug Dictionary for PDA's,-Oxford Formulary guide)
[0.58mg intralesionally x1]
Max: 3 doses/cord; Info: may repeat q4wk x2 doses


Renal and Hepatic doses are not defined.

Contraindications/Cautions:
Hypersensitive to drug/class/compon. caution if coagulation disorder

Caution Advised:
Antiplatelets
Aspirin
Aspirin/Caffeine/CNS depressant combos
Aspirin/Muscle Relaxant combos
Aspirin/Opiate combos
Bivalirudin
Diclofenac topical
Drotrcogin alfa
Fondaparinux
Heparins
Hydrocodone/Ibuprofen
Ibuprofen/Oxycodone
Lansoprazole/naproxen
NSAID's
Omega-3-Acid
Platelet GP IIb/IIIa inhibitors
Sumatriptran/naproxen sodium(Alleve)
Thrombin Inhibitors
Thrombolytics
Warafarin


Adverse Reactions:

Tendon Rupture
Ligament Damage
Complex regional pain syndrome
Sensory abnormality
Allergic rxn


Common Rxn's:

Peripheral edema
Contusion
Inj site hemorrhage
Injection site rxn
Extremity pain
Tenderness
Injection Site Adema
Pruritus
Lymphadenopathy
Skin Laceration
Lymph Node Pain
Erythema
Axillary Pain

Pharmacology:
Metabolism- Unknown; CYP450: Unknown, Info; Minimal/No systemic absorption

Excretion: Unknown; Half-life:unknown..

Mechanism of Action: Hydrolyzes collagen, resulting in lysis of collagen deposit and enzymatic disruption of cord(collagenase).



Fred22

Today is the day that the results of the Xiaflex trials are presented at the AUA conference.  Anybody heard any news yet?  (Also my birthday, so maybe a really great present).

Fred

SSmithe

I have been looking, but have seen nothing yet...
32 years old.  Peyronies since 22. Stabilized peyronies plaque.  ED.  Trying to stay positive.

Fred22

Quote from: SSmithe on June 01, 2010, 04:53:02 PM
I have been looking, but have seen nothing yet...

Still doesn't seem to be anything on the internet.  I wonder if they even reported the results?  I would have thought there would be more interest here.

Fred

SSmithe

Lots of Xiaflex news today.  This link below is a video with the Auxilium CEO discussing the companies future, Dupuytrens, and Peyronies.  He says Phase III trials for Peyronie's may start later this year... My fingers are crossed.  www.washingtonpost.com/wp-dyn/content/video/2010/06/08/VI2010060803088.html
SSmithe
32 years old.  Peyronies since 22. Stabilized peyronies plaque.  ED.  Trying to stay positive.

Iceman

ok great video - the CEO sees like a nice guy BUT where are all the people wjo were in the trials - why dont we hear anything from them - where have they all gone - why arnt there any results  - are there any positive results out there  - seems like people have just disappeared - no one seems to say anything - we are left in the dark here!!!!!
There might have been 1 or 2 posts on this forum but where are all the other people who took xiaflex??

j

Quote from: Iceman on June 09, 2010, 06:32:00 AM
ok great video - the CEO sees like a nice guy BUT where are all the people wjo were in the trials - why dont we hear anything from them...

I think the bottom line is that very few people having a particular medical problem will actually ever find a web forum (like this one) and of those that do, only a very few will actually post.  And the ones that post may not be a representative sample.

Most people make only rudimentary use of the web, and are very timid about using a search engine like Google.  There seems to be a huge fear of being 'found out' or spied on, especially when a sensitive problem like Peyronie's is involved.


ComeBacKid

Where there any results published?  I watched the clip, seems like they are moving along as scheduled and could see the product on the market in 2011?  But they have est sales for 2011 400 million, is that their estimated sales?  How much have they made on this product to date, does anyone know from their stock profile?  Eventually I'd think you'd have to produce and product that works and sell it, or the share prices will tank, looks like their share prices keep going up, and they havent actually commercialized the product yet?  I'm still slightly skeptical, but the fact that they are moving the product on schedule is a good sign.  The regulatory process will slow down the product somewhat to ensure safety.  

I noticed he didnt mention frozen shoulder, did they give up on that as well?  

Could be the time to reach out to Auxilium with a letter right around the new year, what do you guys think?

Comebackid

joe

Quote from: Iceman on June 09, 2010, 06:32:00 AM
ok great video - the CEO sees like a nice guy BUT where are all the people wjo were in the trials - why dont we hear anything from them - where have they all gone - why arnt there any results  - are there any positive results out there  - seems like people have just disappeared - no one seems to say anything - we are left in the dark here!!!!!
There might have been 1 or 2 posts on this forum but where are all the other people who took xiaflex??

I was in the Xiaflex trial, but I saw no improvement...   I believe I must have received the placebo.   :'(  I am now on Pentox which is helping a lot and have just started with the VED.

-Joe

ohno

Joe, is there anyway to find out whether you got the placebo or not? Won't they tell you? How many injections did you get and over what period? Do you think the injections didn't help (or hurt)? The reason I ask is because Dr. Mulhall told me that it may be the swisscheesing effect that helps with verapamil injections. At the same time it seems that many people are effected negatively from verapamil injections. Anyway, I'm glad you're on pentox and it appears to be working. I would recommend you look into traction and hyperthermia. Thanks and good luck.

Fred22

I talked (by e-mail) with the assistant of a very well known male sexual function specialist who attended the conference and said he heard nothing regarding the reporting of the Xiaflex trial results.  He was also rather negative regarding Xiaflex as an effective treatment.  But who knows?  I'm just wondering why they reported that they would be delivering a paper on the results at the AUA conference and then apparently did not.  (Unless of course my source just missed the meeting, but I doubt that).  

kendotx

My urologist is Dr. Lipshultz at the Baylor College of Medicine in Houston, which is one of the trial sites for Xiaflex. Dr. Lipschultz has a PA who oversees clinical trials and he told me that many of the Xiaflex trial patients had very positive results. He indicated that the trial was very regimented and only one injection was administered per patient during each session. The dosing was the same for every patient and only injected at the site with the greatest plaque density. The penile curvature had to be between 50 and 90 percent. He told me that almost every patient was bruised after each injection, however most noticed significant improvement with their penile curvature. He said most patients noticed a popping sensation during the middle of the night with their nocturnal erections. Just thought I would pass this along for those of you curious about Xiaflex.  

joe

Quote from: ohno on June 11, 2010, 12:35:58 AM
Joe, is there anyway to find out whether you got the placebo or not? Won't they tell you? How many injections did you get and over what period? Do you think the injections didn't help (or hurt)?

They wouldn't tell me at the time, but maybe I could find out now that that phase of the trial is over.  It was a lot of injections, because every time I would get an injection of the study drug, I would have to come back at 1 week and 4 week (I think) intervals for measurements.  On those visits I would get an injection to induce an erection and then at the end an injection to make it go away.  So for every injection of the "drug" I'd receive at least 4 other injections.  I want to say there were maybe 4 cycles of this over 2 months, but I can't remember for sure.  I didn't see any change for better or worse from it.

j

Quote from: kendotx on June 14, 2010, 09:45:16 PM
He said most patients noticed a popping sensation during the middle of the night with their nocturnal erections.

I hope everyone realizes this is very positive news.  It means Xiaflex might actually work for Peyronie's as it's already working for Dupuytren's - by weakening the fibrotic tissue until it can be snapped.  Although an MD won't want to apply force himself and risk damage, the erection process might do it naturally.  The effectiveness of Xiaflex should increase when it's in normal use - not in a controlled trial) and MDs can inject as much as they think is needed.

I think this is - as our Vice President recently said - a BFD.


MedStudent86

If someone could provide me with an e-mail address for Dr.Levine or Dr.Lue...I want to propose using Xiaflex off-the label for the treatment of Peyronie's. Since it is an FDA approved medication with a legitimate medical purpose, I want to find out if it can be used off the label to treat other conditions.  

LWillisjr

I would suggest you be careful about "suggesting" anything to these doctors who have speciallized in treating Peyronies Disease for many eyars now. Don't you think they would already be aware of this. Given the fact that Dr. Levine was involved in the phase II studies I think he is well aware of what Xiaflex can and can't do.
Developed peyronies 2007 - 70 degree dorsal curve
Traction/MEDs/Injections/Surgery 2008 16 years Peyronies free now
My History

ohjb1

I was in the xiaflex trial and received the placebo. No change either way. For those who want to know if they received the placebo or Xiaflex, you should contact the coordinator of the clinical trial at the urologist's office where you received the injections.

One result that is very difficult to understand is that almost 1/2 of men who received the placebo - no modeling also met the end point goal. This information is on the Auxiluium site.  

My urologist made no mention of anyone experiencing a popping sound as someone noted on this forum.    

j

Quote from: ohjb1 on June 17, 2010, 08:45:27 PM
One result that is very difficult to understand is that almost 1/2 of men who received the placebo - no modeling also met the end point goal.

If true, that's bad news as it means the 'end point goal' wasn't based on objective measurements.  ohjb1, since you were in the trial, can you tell us how the 'goal' was defined?  I sure hope it wasn't a patient questionaire with nebulous questions about "satisfaction".  

ComeBacKid

1/2 of men DEF should not have met the end point goal, is that is accurate, either the end point goal wasnt a great accomplishment, or the study has an error.  Sometimes in studies patients will imagine symptoms or improvements.  With my own peyronies the curve changes on how erect or not erect I am, and on the day. But overall I can still the hard plaque is still there, and you can tell it hasn't gotten better.  Maybe I'm assuming to much in that everyone else can tell if their bend is worsening or getting better.  The results from this study appear to be mixed, seems like we haven't gotten a clear cut YES that this work on peyronies, like we saw with DC.

Comebackid

ohno

Ohjb1 - Can you go into detail about your experience with xiaflex? The actual injections? I know it was the placebo. I'm assuming that it is injected much like verapamil (I could be wrong). If so, Dr. Mulhull told me that he was pretty sure that the verapamil did nothing but that the positive reactions could be chalked up to the solution the verapamil was in or just the swisscheesing effect. When they injected you were there multiple injections? If he's right then it would not be so strange that patients with the placebo saw improvement. I'm sorry you got the placebo and no positive results. Thanks

ComeBacKid

OhNO,

Good point on the swiss cheesing effect, I think this is a very possible theory.

Comebackid

j

To me the idea that the injections alone would perforate the plaque enough to make a difference is total wishfull thinking.  2 needle sticks aren't going to make the slightest impact on a mass of hard fibrotic tissue.


ohjb1

ohno - my experience with Xiaflex. Nothing much to say. Was given lidocaine to kill the pain.  Then had essentially no feeling when i was given the injections. Definitely more than one injection per session. Remember the dr saying that he got it right into the plaque. Again, no change either way.

if you go to the auxilium site - goal was decrease in curvature and a questionnaire. Both were an endpoint. Decrease in curvature was a somewhat objective outcome.  However, you must realize that measuring the penile curvature is not totally objective.  It can vary a few degrees with each measurement.      

j

Quote from: ohjb1 on June 18, 2010, 05:05:49 PM
Decrease in curvature was a somewhat objective outcome.  

Can you elaborate on this?  I agree that actually measuring curvature isn't simple.  But there's a huge difference between claiming success based on some sort of actual, repeatable - if imperfect - measurement, versus asking the patient "do you think your curvature is reduced"?  One is scientific, the other is not.  

Looks like I may have curb my enthusiasm.  The FDA just issued a warning letter to Auxilium for a shady marketing brochure which they said  "broadens the indication for Xiaflex, overstates the efficacy of Xiaflex, minimizes the risks associated with the use of Xiaflex and omits material facts."

See this article:
http://articles.moneycentral.msn.com/news/article.aspx?Feed=MY&Date=20100617&ID=11608754&Symbol=PFE


ohjb1

J - Urologist induces erection with injection. measures curvature with a instrument think its called a gonemometer. basically it look like an open compass. its like a high school geometry measuring device and then determines the curvature degree. There can obviously be a few degrees or more variation in this type of procedure.

j

Thanks ohjb1.  It seems to me like the best and simplest way to evaluate the change would be before-and-after photographs, with the camera mounted in something that enforces a consistent angle and position.  Instead they're fooling around with a protractor, trying to find 5 degrees they can claim as an improvement.  

We just need to wait for all the marketing smoke to clear.  Then some real-world MDs - who are NOT receiving checks from Auxilium - will find out what improvement can actually be achieved with Xiaflex.

ComeBacKid

J,

Excellent research to find that article, that is troubling indeed.  Although at least the government safety "police" are doing their job, if they did nothing and the drug was unsafe people would complain.  If they get to aggressive, people will say they are hampering the private market delivery of the drug.  Again we should remember the FDA is there to test safety not efficacy, so it doesnt mean the drug won't work.

The bottom line is , this drug is advancing, eventually they will have to sell it and get insurance companies to cover it, or the investors will quit buying the stock/seeing it as a good company to invest in.  As with any company, eventually they have to "turn" inventory or a product, you can't' just raise capital and do studies forever, or people will dump the stock, and capital will dry up.  I'd say the next 6-12 months we will find out if this drug is the real deal or not.  Lets hope it is!

Comebackid

j

I wonder about the insurance angle.  Auxilium is pricing this stuff sky high - like $3K per injection - and results apparently have been spotty.   If I were to look at this objectively, and not as a guy who might want the treatment - I'd have to question whether it should be covered by insurance at this point.  As we all know, medical costs keep climbing to the sky, and we're expecting insurance companies to hold the line somehow, and to decide what's really worth the money, and what is basically a long shot that should be paid for by  patients willing to take a chance.  If, say, only half the patients get any improvement, and the average improvent is just 5-10 degrees...

Maybe someone who knows more about the insurance business has an opinion on this.

Like I said earlier, I think the reports of "popping" sensations are cause for hope.

Skjaldborg

$3k per Xiaflex shot may seem high, but may look attractive to insurance companies in lieu of more expensive surgeries.

Oddly enough, I don't think I'd want to use Xiaflex until it has been on the market awhile. I currently have full functioning and very minor curvature; I consider my Peyronie's to be more of a cosmetic issue and a psychological burden. I might have a different view if I was in worse condition (or if I get worse down the road).

Even if Xiaflex isn't the magic bullet, I hope it spurs interest in other pharma companies in treating this disease.

-Skjald

ComeBacKid

J,

Keep in mind, most insurance companies don't pay that 3k price, they negotiate a "contract" rate with the doctor/imaging lab/ prescription place.  I just recently was in for a doctor visit which costed $90 for a visit. My insurance companies contract rate was $60, what they got billed in other words.  of that I paid just $4.20.  I've seen original bills as high as $545 negotiated at a contract rate of only $225.  Thats why if you don't have insurance and your paying cash as a walk in customer your getting fleeced like crazy.  Just having insurance alone even if you had to pay 100% of the costs is a better deal.  But most people only pay 10% or have some kind of a copay.  So that 3k pricetage may not be the actual billable rate.

As far as insurance companies deciding what to cover, not sure how that works, I don't know if FDA approval alone wil cause them to cover it.  There is a chance they could not cover it, or at least not right away, which then if you want the shots youll pay out of your pocket, and that full 3k price per shot. But we really have yet to see solid STUDIES showing xiaflex works well in peyronies patients, so we are getting ahead of ourselves.  

Comebackid

Fred22

Quote from: ComeBacKid on June 22, 2010, 03:29:29 PM
J,

Keep in mind, most insurance companies don't pay that 3k price, they negotiate a "contract" rate with the doctor/imaging lab/ prescription place.  I just recently was in for a doctor visit which costed $90 for a visit. My insurance companies contract rate was $60, what they got billed in other words.  of that I paid just $4.20.  I've seen original bills as high as $545 negotiated at a contract rate of only $225.  Thats why if you don't have insurance and your paying cash as a walk in customer your getting fleeced like crazy.  Just having insurance alone even if you had to pay 100% of the costs is a better deal.  But most people only pay 10% or have some kind of a copay.  So that 3k pricetage may not be the actual billable rate.

As far as insurance companies deciding what to cover, not sure how that works, I don't know if FDA approval alone wil cause them to cover it.  There is a chance they could not cover it, or at least not right away, which then if you want the shots youll pay out of your pocket, and that full 3k price per shot. But we really have yet to see solid STUDIES showing xiaflex works well in peyronies patients, so we are getting ahead of ourselves.  

Comebackid

That's true.  And some insurance companies may classify it as "experimental" for a long time after it's FDA approved.

ComeBacKid

I'm sure you could attempt to lobby the insurance company to cover the product, with such an embarrasing topic to talk about, and with intense "loud" pressure, they might just say the hell with it and cover the shots for an individual patient or two.  Maybe Tim or someone who is familiar working for or with insurance companies could tell us how they decide what to cover.  My guess is the more mainstream something is made, the more likely it is to be covered.  Take for example breast cancer screenings.  Due to the womans movement on this issue, and getting loud, and pouding the issue out in the media, insurance companies who didn't cover basic screenings would be chastised, and probably just cover them.  Not to mention the costs savings for detecting cancer early.  

Comebackid

Tim468

I have been a principal investigator of "experimental" drugs (mostly antibiotics) and when they have been approved as safe in a single group of people, it is far easier to the study that drug in another group of people (unless the groups are significantly different)(i.e. growth hormone for dwarfs used in tall people - a no go).

Once the FDA approves Xiaflex for use in DC, it will be used immediately for Peyronie's by some docs, and surely some studies will be done that test it against conventional therapy (whatever that is!).

Tim
52, Peyronies Disease for 30 years, upward curve and some new lesions.

j

People are just now starting to get Xiaflex for Dupuytren's outside of a trial.  I just read a post from a guy who got an immediate denial from his insurer - they still call it "experimental" and apparently wanted to herd him back to a conventional surgery.  But the guy persisted, kept appealing, and his hand surgeon got involved in arguing the case with the insurer, and eventually they relented.  And he had a Xiaflex treatment which he said was very successful.

Insurers have plenty of ways to make you give up and go away.  When I was prescribed (worthless) transdermal verapamil, I tried to get my insurer to pay.  I ended up on the phone futilely trying to explain Peyronie's disease to an absolutely clueless young woman who was probably writing "crazy old baby boomer with ED" on a piece of paper while she pretended to listen.  I rate that day as one of the real low points in my life.  And they never paid anything, and of course it was all a total ripoff anyway.  

For me the bottom line is that Auxilium has to do the work of selling this product to insurers so it appears on their lists and is routinely approved.  I am not going to try to do that for them.  





ComeBacKid

J,

I second your statement.  I've had it battling insurance companies to get coverage.  After awhile you just run out of steam.  Usually the claims process takes weeks upon weeks. Most recently I had a condition that on paper looked like a brain tumor but it wasn't.  Within 3 business days I got a form mailed to me from my health insurance company for pre existing conditions.  Never saw any company in my life move that fast.  I signed it the day I got it, saying this was not a pre existing condition and mailed it back the next day. Then they notified me later the form was late and the claim would not be payed.  I called them up and said how is a form late if i get it one day and mail it back th next day, thats ridiculous, I said you sent me a form and expected in back in like 7 days, what about mail time, the time it takes me to receive it etc.  Then they told me they would pay my claim, and it got paid.

Comebackid

j

Comebackid, your experience is typical.  Insurance companies seem to be perpetually in some degree of internal chaos.  Their big-brained bean counters created a "cost control" system that is choking on its own complexity.  They're always changing the plans, changing the rules, dropping one provider, signing up another, adding requirements and restrictions.   It's up to the patient to sort everything out, find the errors, demand the corrections, appeal the wrong decisions.  It's all driven by you.  

They are masters of passive resistance.  

I think things have gotten a little better in recent years.  We seem to be able to call our insurance company, ask a question and get a coherent and correct answer from someone who doesn't sound like they were hired last week.   Not always, but usually.  


ohno

J - I might have misunderstood you. Are you saying there is a post somewhere about someone getting xiaflex treatment for peyronies off label? If so, would you mind telling me where I can read this post? Thanks

ohjb1

I was in the Xiaflex trial and received the placebo. Just received an email from the urologist that the next phase of the trial will begin in October and was I interested. That is all there is to the email. Does anyone know more about this?

It could just be a matter of wording, but i thought that the company would say that since i received the placebo, in the next phase would get Xiaflex. Am not sure if that is what is going to happen or if they expect me (and others) to again receive the placebo or xiaflex. If so, I will not participate.

I assume there will be many more trial sites and hopefully one closer to home.  

Fred22

Quote from: j on June 28, 2010, 07:20:49 PM
People are just now starting to get Xiaflex for Dupuytren's outside of a trial.  I just read a post from a guy who got an immediate denial from his insurer - they still call it "experimental" and apparently wanted to herd him back to a conventional surgery.  But the guy persisted, kept appealing, and his hand surgeon got involved in arguing the case with the insurer, and eventually they relented.  And he had a Xiaflex treatment which he said was very successful.

Insurers have plenty of ways to make you give up and go away.  When I was prescribed (worthless) transdermal verapamil, I tried to get my insurer to pay.  I ended up on the phone futilely trying to explain Peyronie's disease to an absolutely clueless young woman who was probably writing "crazy old baby boomer with ED" on a piece of paper while she pretended to listen.  I rate that day as one of the real low points in my life.  And they never paid anything, and of course it was all a total ripoff anyway.  

For me the bottom line is that Auxilium has to do the work of selling this product to insurers so it appears on their lists and is routinely approved.  I am not going to try to do that for them.  






I went through the same crap trying to get Cigna (In The Business Of Caring ...NOT!!!).  They finally wore me down and I just bought one from Fitzz.  So their method works.

ComeBacKid

If I wasn't gauranteed the actualy drug in a second round of trials, I would not do it either.  To many unnecessary injections and bruising.  I would demand the drug or not participate.

Comebackid

j

Quote from: ohno on June 29, 2010, 09:23:04 PM
J - I might have misunderstood you. Are you saying there is a post somewhere about someone getting xiaflex treatment for peyronies off label? If so, would you mind telling me where I can read this post? Thanks

No, the case I described was Xiaflex for Dupuytren's.  It's approved for Dupuytren's so it's use is not 'off-label'.

Iceman

so why cant we buy it off label and start jabbing it into our dick??

j

Quote from: Iceman on July 01, 2010, 02:40:43 AM
so why cant we buy it off label and start jabbing it into our dick??
Start checking airline fares to India.  And get a good deal on a kidney while you're there.


MedStudent86

Quote from: Iceman on July 01, 2010, 02:40:43 AM
so why cant we buy it off label and start jabbing it into our dick??

Ok there seems to be some confusion as to what 'off the label' means. You cannot BUY the medication, it is prescription only. Using a drug off the label means that a physician uses a drug to treat a condition which it is not FDA approved for. As an example, an A-typical anti psychotic like Quetiapine Fumarate is used in the treatment of schizophrenia & bi-polar, yet it is often prescribed to treat generalized anxiety disorder and panic attacks, conditions for which the medication is not approved by the FDA to treat. Or a better example would be the use of Pentoxil, we ask that to be prescribed for Peyronie's, but it is not an indication that the drug was originally studied for.

Therefore, you would need to find a Urologist who would be willing to treat your Peyronie's with Xiaflex with an off the label indication. Actually, just about EVERY drug used to treat Peyronie's is an off the label use since there are no drugs that have been studied and approved to treat Peyronie's, even drugs like Verapramil are being used in an off the label indication.  

Briden


I am a patient of Dr. Lue. I sent him an email last night in regards to Xiaflex being an option...here was the response:

   -----Original Message-----

   Subject: Peyronie's treatment question from patient

   Hi Dr. Lue, I hope you are doing well!
   I am one of your patients. My name is --------.  I have aggressive Plaque formation/Peyronie's disease.

   My question: Is Xiaflex an option for treatment for me? Do you know much about it or it's effectiveness? Thanks very much for your time!

   -----Response Message-----

   Xiaflex is not available to treat Peyronie's disease and we do not know when the company will start phase 3 study.

   Best regards,
   Tom