Xiaflex

[ThisWontWork]

You should be aware that Auxilium did exclude results that did not fit the bill. All participants in the trial that had none or limited effect of the injections were excluded in the final result (34%).

This is nothing but a big SCAM !!!

[damian]

ThisWontWork

All participants in the trial that had none or limited effect of the injections would be the other 66%!!? or am I wrong??

[Njnist]

You should be aware that Auxilium did exclude results that did not fit the bill. All participants in the trial that had none or limited effect of the injections were excluded in the final result (34%).

This is nothing but a big SCAM !!!

What do you think of the results musicman had?

[Mentos]

For how long this procedure has been talked about I would have thought there would have been more excitement for this approval. I really hope it helps a lot of people!!  

[MattFoley]

I spoke with Dr. Lue about Xiaflex and he has a lot of confidence in it and he's ready to start treatment immediately.

[jnstrawn]

ThisWontWork

Then don't take it!

[addboy]

Here's a good article about the recent Xiaflex approval:
Nonsurgical Peyronie's Option Gets FDA OK

Very promising and includes opinions from a Dr. Gelbard who's been administering this since the 1980's.  

[MikeSmith0]

All participants in the trial that had none or limited effect of the injections would be the other 66%!!? or am I wrong??

The way the results are presented is this:  The average improvement was 34% - overall... so with for everyone like musicman, there was 1 guy who had much more limited results, so the average improvement was 34% ... note that this isn't a 34% angle decrease, just a 34% change.  So, the average person went from 50 degrees to 33 degrees after 8 injections or 40 degrees to 26.  This is based on $32,000 of xiaflex (from current prices) + doctor visit fees...which makes me concerned about coverage from insurance.  Some people had amazing results like Musicman...lucky guy - if there's a such thing as "luck" in the Peyronies Disease world...that is definitely it!  Congrats musicman if you are still reading this.  Amazing recovery.

The trials differed...some had 30% xiaflex improvement vs 11% placebo:
http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1693677&highlight

[nemo]

It's clear there are two camps on Xiaflex - the naysayers and the hopers (perhaps a third, as well: the haters).  

I think we have to view this in a larger sense - in the history of this horrible condition, this is the first time a government agency has reviewed data and approved a treatment for this condition.  We bemoan the fact that so few doctors, urologists or laypeople know anything about our affliction - that we suffer in anonymity in such small numbers that no pharmaceutical or research universities will throw any money at the problem.  

Well here is an example - the first! - of a pharmaceutical company throwing money at the problem, and the US Federal Government reviewing and approving it as a viable treatment.  I don't care what kind of axe you may have to grind with Xiaflex - that is a major step forward in finding a true cure for this condition.  

Maybe this isn't it, but we're a hell of a lot closer today than we were two days ago.  The approval of Xiaflex offers hope, even if you never intend on getting the treatment.

Nemo

[George999]

I think it is very important to emphasize that the FDA Xiaflex approval is a CONDITIONAL APPROVAL.  It is ONLY approved for use by TOP PEYRONIE'S EXPERTS, not by just any general urologist.  What was learned during the trials was that the level of success was highly linked to the skill and training of the practitioner.  The importance of this cannot be overstated.  I am one of the last ones around here to have any confidence in the FDA, but in this regard they may well be on the right track.

[loyalty]

For all the naysayers (and haters) out there, remember that this trial was designed to compare the effects of Xiaflex with placebo, and eliminate as much as possible other factors.  Therefore during the trial we were NOT allowed to use traction or Pentox, etc (we were allowed to use PDE-I's however).  My curve decreased from 30 to 18 degrees.  Would it have improved more if I could have used traction and Pentox? I would bet my medical license that it would have.  The doctors who will now be treating patients with Xiaflex will now be free to recommend those other treatments and will then learn if there may be a synergistic effect.

[MikeSmith0]

I don't know if the "naysayers" and "haters" comments are being directed at me (or "ThisWontWork") - but if I made comments on the drug that you don't agree with, please say what the comment is & why you disagree.  I have never had a true "fight" with anyone on this message board in 4 years - which I can't say for other internet forums.  We are all in this crappy  boat together here - and this forum has been a tremendous support.  

That being said, I have only been referring to the hard black and white data from the trials and what I have read from patients that is on here.  I am only speculating about insurance, as most people have been - even within Auxilium (see cafepharma).  I've been on this board for nearly 4 years, so I've heard many stories about the trial via private emails in particular - and I experienced Auxilium firsthand myself as I described in some old posts.  I started the trial thread myself two years ago, after all - so I've heard a lot privately.  So, these are the main (objective) issues with them that emerged over the years:

1.  There was a situation where a person went through the whole trial, put 1200 miles on his car, stayed in hotels for 10 nights, had 8 injections of placebo, had numerous blood tests, numerous penile exams and Caverject injections to measure in front of nurses and docs...for nothing.  When he moved to another state, Auxilium arbitrarily excluded him from getting the real drug (even though moving was never an issue in the informed consent).  He did miss a final visit out of 20 or so...at the end, and they had all the final measurements anyway.  If Auxilium "cared" about anything other than money, they would have mailed him the final questionnaire - and they would have given him the real drug for spending nearly a year in the study and getting his penis injected a dozen times.  But, they do not really care about people or spreading Peyronies Disease awareness...they care about money.  There was no way for this patient to even reach the company.  He spent months trying to contact them through their call center and through the study center - nobody would escalate his issue - he had to randomly type combinations of executives names @ auxilium.com to finally reach someone.  Nice, huh?  And the final result of this situation was that he got a letter clearly written by a lawyer- given its legalese - which is disgusting considering the time, money, and pain the person went through.  The letter quotes verbal statements he never made that "he never wanted the real drug anyway".  These were lies.  I am sure the PDF of this letter can be found and posted. His letter to the company is here:
Open Letter To Auxilium - Breach of Obligations to a Clinical Trial Patient - Peyronies Society Forums

2.  Auxilium Collagenase (Xiaflex) for Peyronies Disease - Clinical Trial Side Effects and Discussion  
Two patients severely damaged by xiaflex in the trial - the top one received NO support from Auxilium (and is permanently scarred) and the other received support, but it took a full year for him to heal.  When the patient finally had de-gloving many years later (for grafting or nesbit - I can't remember), the tissue didn't heal properly on the left side because of what xiaflex did - even years later.  Also, his study doctor was horrible and should've been kicked out of running trials, but Auxilium needs its numbers and doesn't care if a study doctor causes complications like this.

So far, the product worked miracles for 1 person here: Musicman.  As of yet (per reading many comments on news articles after the approval) not much has changed.  Though I do not think internet comments are that telling of real world opinion, most reactions to the news story have just been rude jokes about bent penises.

George, yes I noticed a "training program" that they seem to want to fast track a number of doctors who can be "top peyronie's experts" - but maybe we are reading different things?  I am talking about what is here http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-presentations  - on the Dec 6 presentation they allude to how they are going to train docs through the Auxilium Advantage program.  Two of the "experts" who were trained for the trial did this damage: Auxilium Collagenase (Xiaflex) for Peyronies Disease - Clinical Trial Side Effects and Discussion  - I know the name of the doctor and he has horrible online reviews.

Loyalty - you won't be able to use pentox if you get xiaflex because you'll risk increased bleeding.  You say you have a medical license, so you should know pentox has been associated with bleeding and/or prolonged prothrombin time.  www.sanofi.ca/products/en/trental.pdf‎    So far, we don't know the restrictions that are going to be put on prescribers anyway.  Many AUXL reps think that it will ONLY be allowed for the same patient group who was  in the trial (no hinge, calcification, hourglass, 30-60 degrees only, etc)  under the same conditions.  Why would you want to be on a drug that could increase bleeding when one major risk of xiaflex is bleeding / blood blisters?

I wouldn't wish Peyronies Disease on anyone except maybe my worst enemy - and this is not about the patients at all...it's about Auxilium's behavior.  If you want to talk about the drug, read the blog above - it is very interesting.  Xiaflex will not treat generalized fibrosis or tunical thickening beyond a plaque...the collagenase molecule is also enormous and so is collagen...so it doesn't break as easily as they want to have people think.   Anyway, it's great there's something new out there after 300 years - but the people behind it have done shady things to patients, and there is no denying that.  They are also extremely vague about who should get the drug (deliberately) in the PPT they delivered on Dec. 6.  Why can't they figure out who would be a candidate and who would not?  They had 4+ years!  So, now they just want to sell it to everyone and let it be open season to experiment on peyronie's patients while they get paid $3200 a vial to do it?  Totally irresponsible...but profitable!  Of course.  

This is a company run by shady people who pay themselves millions while delivering very little.  Pfizer dropped its association with them a long time ago...and nobody knows exactly why, but they know what they're doing.

[loyalty]

The risk of increased bleeding with Pentox in someone treated with Xiaflex is a theoretical concern but in my opinion, the risk would be insignificant and far outweighed by the potential benefits.  There are studies in which fairly large doses of Pentox were given IV (much larger than the oral doses used for Peyronies when bioavailability is considered), prior to and continuing for 3 hrs after Coronary Artery Bypass surgery.  If Pentox can be studied in CABG, in which the chest is opened by splitting the sternum in half and leg vein segments are grafted onto coronary arteries, then it could certainly be studied in Xiaflex treatment where the injection is made with a tiny 30 gauge needle.

  Journal of Cardiothoracic Surgery | Full text | Effect of pentoxifylline on preventing acute kidney injury after cardiac surgery by measur ing ur inary neutrophil gelatinase - associated lipocalin

"We performed a double blind randomized clinical trial, enrolling 28 consecutive patients undergoing elective coronary artery bypass graft (CABG) surgery. Patients were divided into two groups, one to receive Pentoxifylline 5 mg/kg intravenous bolus injection, followed by 1.5 mg/kg/h continuous intravenous infusion until 3 hours after cessation of CPB and the other group received placebo. UNGAL was measured before, 3 and 24 hours after surgery".

See also

Preoperative oral pentoxifylline for manage... [Heart Surg Forum. 2009] - PubMed - NCBI

[MikeSmith0]

The risk of increased bleeding with Pentox in someone treated with Xiaflex is a theoretical concern

Well, that's good then...thanks for the article.  Honestly, I just was going off the PDR.  But, based on what you wrote - I agree there might be some synergies if taken together.  

The best approach will probably be traction, pentox, and xiaflex in the right area with the right dose - which is also something that seems to be a question mark right now.  They instruct docs to put it in the area of maximum curvature, but one dose for all plaques and all men is an odd way to dispense the drug because plaques come in different sizes.  And what if the tension is being held by thicker areas on the plaque vs. the area of maximum curve? Nobody really knows these things yet.  This isn't xiaflex hate...just my concern about how it will be administered for the best results.  I think it's going to be "field tested" in this regard...when it should have been tested by them before approval.  

[jackp]

George999

As you may be aware my wife and I did a Peyronies Awareness video in July for Xiaflex.  I will tell you and all the guys raising a fuss that some of the problems with the trials were improperly screened doctors and patients.  Men received Xiaflex that did not qualify for it and that is part of the problem, and I fear will be for some time. Patients demanding it and doctors doing it to get them off there back, yes and also the money.    

I made it clear in the video and to the reps that general practice urologist should not be allowed to administer it. Proper screening of the patient is a must.  I know men her that are clamoring for it that do not meet the protocol.  If they find a doctor to administer it that could lead to trouble.

In a nut shell Xiaflex is not a silver bullet.  It is a first step in help men with preyronies.  With Xiaflex hopefully the awareness of peyronies will spur others to help develop drugs and treatments that will help us.

Just my 2 cents.

Jackp
http://jackp-penileimplant.blogspot.com

[George999]

Thanks Jack for the excellent and balanced feedback.  I think you are hitting the problem right on the spot.  Hopefully the FDA will make sure only highly qualified docs get their hands on this treatment.  It seems to me like the kind of treatment, like hand surgery for example, that should be a virtual specialty in and of itself.  But their are a lot of docs, well intentioned or otherwise, that like to get their hands on things like this and in terms of the way they administer the treatments they are just real clods.  Its not new, we've seen it with other treatments as well.  This definitely should be a restricted drug.  Thats the way I read the FDA on it and I hope I got it right.

[RoyHobbs]

I think Nemo was the first to point out the most important takeaway from all of this: more people know about our affliction today than at anytime in its 300 year history. I would wager that there were more news articles written yesterday about peyronies than all other days combined. That's a win no matter what xiaflex does.

Some will see improvement. I bet most will not. Some will suffer averse side effects. Some will be totally fine. In a year or two we will know a heck of a lot more about this drug. In ten years we may learn of some horrific story about what can happen with this drug, or we might read about a miracle that came for someone who gave up all hope.

There are lots of drugs and lots of patients who have these types of stories. At least Peyronies is in the conversation. Maybe now there will be less knucklehead urologists getting in the way of making some man's life better.

-Roy

[james1947]

I will second RoyHobbs.
I also think that the most important thing with Xiaflex is the awareness to Peyronies.

James  

[George999]

I think that Xiaflex is just one more tool in the toolkit.  What remains to be seen, as several have already noted, is what some of the top Peyronie's docs in the country will be able to accomplish with it now that they have the chance to apply their skills and experience to it.  So I think it is really a bit to soon to evaluate the potential of Xiaflex simply based on the research data.  The fact that some have experienced major benefit from it is an indication that with the right technique it could hold a lot more promise than might be obvious from the current data.  There is also the possibility that clinical experience might create openings for treatment of at least some of those who would not currently be considered satisfactory candidates.  So now its available without strict research guidelines and I just can't wait to see what the really sharp and creative practitioners like Lue, Levine, etc. might be able to accomplish with it.  As has been very correctly noted before, Xiaflex is NOT a silver bullet, but it is a very promising new tool unlike any others previously available.  And that is pretty exciting to me.  So I remain very   about it.

[dioporcolorisolvo]

Some experiences of Xiaflex have been very negative.
Did you read this blog?

Auxilium Collagenase (Xiaflex) for Peyronies Disease - Clinical Trial Side Effects and Discussion

[IhatePD]

I know my urologist is very positive about Xiaflex. He was part of the clinical trials  and treated eight patients (all of them doctors some traveling from as far a Texas to the Philadelphia area). Two of them were very successful and the other six were not. He said that the six who were not successful were calcified or partially calcified and he did not expect to see improvement for them. The two successful ones had pliable plaques and he thought they would be successful. He feels that I am a good candidate for Xiaflex. My next visit is in five months and I will very seriously consider using it. I am planning on letting him practice on others first.

My understanding is that the two or three patients that had penal fractures were caused by improper "modeling". After the patient is injected with the Xiaflex, the doctors stretch the penis to break up the plaque a day later. In the cases where the fractures occurred, the patient had an erection or close to an erection and the doctors tried to stretch the plaque against the curve and ended up fracturing the penises. The swelling and bruising doesn't scare me too much but a fracture does.

My original urologist was not part of the trials but he had a patient who was and he said the he had a 80-90% improvement.

[restore]

I was reading the news about xiaflex now being approved, but only for 30 degree curves or worse.  My curve has improved to less than 30 degrees, but I can still feel the lumps in my shaft.  Also narrowing at the end of my penis and soft glans.  I was hoping I could be treated with this medicine.  

[MikeSmith0]

IHatePD - That's interesting, but why did they have a partial erection?  The modeling was supposed to be done in a flaccid state in the trial.  

Restore - can you post a link to where you saw it restricted to those with 30 degrees or more?  This was speculated on CafePharma a while ago - and insiders at Auxilium were saying that it would be restricted to the same group as the study group (30 degrees / max 90, no hourglassing, no calcium) - but this was purely speculation.  I think it is a huge problem to limit it to 30 degrees because many of us started out with that and got worse.

I wonder if urologists are going to revise their "stable for a year" rule too - because again - that first year is when 90% of the damage was done.  In the study, you had to be stable for at least a year...so this might be another restriction.  

[damian]

dioporcolorisolvo

This is the penis of one guy on these photos, I'm pretty sure. I can understand that he's frustrated for this kind of side effects, but he's somehow representing it like every second guy treated with xiaflex, will get the same sh*t. Life is risk.

[MikeSmith0]

This is the penis of one guy on these photos....he's somehow representing it like every second guy treated with xiaflex, will get the same sh*t. Life is risk.

There are two guys on the blog.  It says "Another Patient after collagenase injection in the clinical trial" between pic 2 and 3. The second guy had the hematoma under the shaft that took a year to resolve.  The top guy had blood blisters with permanent scarring on the top left of the shaft.

90% will get bruising, 50% swelling, 22.5% contusion  - see the statistics here:
The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease - Study Results - ClinicalTrials.gov

For some reason they are only reporting 111 participants, when I think there were closer to 300...but there were several different divisions in their studies.  Not everyone is going to get that side effect, but some will.  Some people will get liver disease from tylenol, but not 22.5%.  To be clear - I am not anti-xiaflex.  I am just not a fan of their data presentation (e.g., lumping side effects like this as "edema" or "contusion" when they're far more serious, not reporting penile size change data even though it was collected & matters to a lot of people, etc) and how they are not clearly defining who will benefit most...they are just going to reap the profits of $3200 per vial while urologists experiment & write journal articles to say who got the most benefit & how.  Medicine is always evolving, but I don't think patients should be experimented on at their own cost with these kinds of side effects.  They should have determined why people did or did not benefit in the trial - and they should have determined what the best way to inject was (the point of maxim curvature is a guess - not an empirical choice).  They should not be giving 1 dose for all patients regardless of plaque size, but they never did a study to determine size-dependent dosing.  All of this would have cost them more time and money - and they did the bare minimum to get FDA approval so docs could do the remaining research for free.  

[damian]

If they put the criteria in the trials that high, it would never got approved. I think it has huge potential. It just needs enough experience.

[DO]

My doctor in NYC just told me Xiaflex was approved! I did do the VI for 7 months! Yesterday was my six month follow up... He can not believe how well it worked for me! He told me it was not the norm! I give him credit because of his skill of injections, I listened to him with traction use and VED. I use many of the supplements recommended here. I am to  finish up the last of the Pentox in the next month or so. I will continue on the Cialis and some of the supplements. I do not have to see him again in a year!
I am so thankfull  many of the guys here who shared advise, and their stories. I helped me to stay focused and added to my healing!
The benefit was not perfect but I am very happy with the results.
wishing you all the power of healing and perserverence to get past the worse disease that any guy could have!
Dan

[james1947]

DO

Happy to read your post.
It will be very helpful if you will open a topic with detailed chronological peyronies symptoms and the use of medications, supplements,tracking and VED at:
Improvement - Accounts of improvements in deformity or erection. - PDS - Peyronies Society Forums

James

[MattFoley]

I've got to check with Dr. Lue and see when he's doing the shots.

[restore]

FDA approves first drug treatment for Peyronie's disease

[agent0]

so i went to check with my uro and he said that he'l get xiaflex around January to march, and he said he'l call me once they get it.

my problem is with my nerves. iv been numb for a while now and he said that the scar tissue could possibly be affecting my nerves, which is causing my penis to become numb.

i don't have a bend. i have a dent though.

he also said that xiaflex might have alot of risk to it, like infection. my question is to the people who were in the trial, could you lose any size from xiaflex?

could xiaflex cause more scar tissue from injecting it into your penis? could xiaflex decrease erection quality?

also im quitting cigarettes through smoking e-cigarettes does anyone know if they are actually harmful?

i was thinking to myself maybe my penile tissue is so damaged down there which is causing me to be sooo numb, or maybe its the scar tissue conflicting with my nerves another words, maybe

its putting pressure on the nerves is causing me to go numb. in the end, i don't know. my MRI 's and my Doppler came back fine. my uro said i do have scar tissue and he said it was little but it

was really deep. he said that could be causing the numbness. the most scariest thought of all is if im gonna be numb forever. i don't know what will happen to me in the future, but if im numb

im pretty sure its gonna be grimm. so know my plan is to wait for my uro to call me for the injection and pray to god xiaflex brings my nerves back. also i know my back is fine because i took an

MRI for that also.

[MattFoley]

"also im quitting cigarettes through smoking e-cigarettes does anyone know if they are actually harmful?"


That's how I got Peyronie's. Smoking is horrifically bad for the penis. If I hadn't taken up smoking at the age of 46, I would never know what Peyronie's is. You need to stop and never look back. E-cigarettes are not harmful to the penis. It's the tar that does the damage.

[agent0]

yeah im definitely quitting. its just the stress of being numb that really gets to me. im switching over to ecigs since its a healthier alternative.

[MattFoley]

I took Chantix to quit smoking. It's an amazing drug that has few side effects and it makes you hate smoking. I highly recommend it. Xiaflex will be a much more effective drug if you're not smoking.

[dioporcolorisolvo]

There is no correlation between peyronie and smoking.

[MattFoley]

I wish you were right. But sadly and tragically, you're incorrect. Dr. Lue verified that smoking could very well cause Peyronie's.

Also, http://www.ncbi.nlm.nih.gov/pubmed/11752860

[james1947]

In my opinion is correlation between almost everything and smoking and in my opinion mainly because of the reduced oxygen supply while smoking.
Also many researches had been done on other damages that smoking is doing, including ED.

James

[MattFoley]

The really screwed part of this is that I only smoked for a few months before the Peyronie's struck. Total stupidity.

[nemo]

Guys I think we have a tendency to look for a cause and ascribe our Peyronies Disease to something distinct like smoking or Propecia or beta blockers, or a high glycemic diet, or whatever ... it's human nature and gives us some tiny degree of sanity to think we know a cause at least.  In truth, I think we're often times just connecting dots that may not be connected or only partially connected. I think the truth is we're genetically predisposed (or at risk) of developing Peyronies Disease - the gene wheel was spun at our birth and we lost.  There are guys out there who have sex accidents and never get Peyronies Disease - same with smoking, inflammatory diet, no exercise, etc., etc. ... they don't get Peyronies Disease.  We do, because it's a defect in our genetic code.

I think we just have to accept that for many of us, there is no smoking gun - there's only now "do the best we can with the hand we've been dealt."

Best,
Nemo

[Mentos]

I could not disagree with you more Nemo but I still got much respect for you.  Have you looked into epi genetics at all? Check out the study I posted about meditation causing a decrease in gene expression related to inflammation. My hypothesis is that there was an underlying psychological stress be it aging, etc that possible on relation to sex trauma caused peyronies. However this has not been tested.

My point being looking at our genes in such a deterministic view is not only scientifically incorrect as we are learning but also places is as helpless victim

Cheers

[james1947]

I definitely agree that genetics may be the main factor, I know for sure my father had it
I even can say for sure that traumas to my penis didn't developed to Peyronies, except the last one some five years ago
From the other side, is good to eliminate any risk that may "wake-up"  this genetic factor

James

[nemo]

James, I learned my Dad developed Peyronie's too, in his 70s!  No pain, just woke up one night with a bend. And BOTH my parents had a mild case of Dupuytren's in their hands.  How's that for drowning in the gene pool!  

Nemo

[Mentos]

we share 60% of our genes with a banana, 90% with a mouse, and more than 99% with a chimpanzee.  This is fact.

....

Reinventing The Body, Resurrecting The Soul is based on breakthrough ideas that have recently come to us from the worlds of biology and physics.
We know - and have known all along - that our body is not a structure. Rather, it is a process. When we experience the body as a process, we recognize that it never stands still.
The fact is that the body we have right now is not the body we had one year ago.
Our stomach recycles every 5 days.
Our skeleton recycles every 3 months.
Even the DNA which stores memories of millions of years of evolutionary time - the actual raw material of our DNA changes every 6 weeks.
So, you do in fact reinvent your body once a year.
But, you reinvent it the same way over and over again. It retains the same patterns; it has the same illnesses; it has the same problems.
Reinventing the body is based on 5 breakthrough ideas:
1. Your physical body is a fiction. 2. Your real body is energy.
3. Awareness has magic.
4. You can improve your genes. 5. Time isn't your enemy.

[nemo]

Guys this threat is getting WAY off track (I'm guilty too).  Let's try to keep it strictly about Xiaflex for the benefit of guys searching for the latest on Xiaflex.  

Nemo

[MattFoley]

we share 60% of our genes with a banana,

Well that explains why my dick looks like one.  

[jnstrawn]

My doctor tells me Xiaflex will not be available to him for treatment of Peyronie's for another two months. What do you guys hear?

[james1947]

Nemo is right, we got really out of the topic.
Please stop posting anything not connected to Xiaflex and Treatment results (including me)

James

[MattFoley]

I spoke to Dr. Lue's office and his nurse told me that Lue would be most likely ready to perform the injections by around March 1st, 2014. The nurse also said that they are making sure they are ready to handle the insurance companies as well so we can get coverage for the Xiaflex treatment.

[james1947]

It will be good news for many if the insurance will pay for Xiaflex.
Thanks for the info Matt.

James

[MattFoley]

You're welcome, James.

I think the urologists who are going to be administering Xiaflex are already gearing up to deal with the insurance companies who are going to naturally balk at the cost. But since the FDA has approved this as the only non-surgical treatment solution for Peyronie's, the insurance companies are ultimately going to have to give in.


Here's some good info that "PeyroniesMan" provided:

"After making contact with Health Well Foundation, Auxilium's representatives and patients already in process. I have more information on Xiaflex and the coverage, and possible reduction in costs to you, the patient. This is the old good news/bad news thing. (Like we aren't already used to that!) So here is what has been told and what I have garnered through my discussions. From my perspective it is understood by Auxilium that the cost of Xiaflex will be out of range for some of us, but at least they are endeavoring to make that cost slightly tolerable. I, for one, sit in that "out of range" class. Hope this helps you guys!

Auxilium Advantage is a patient support program for patients and providers at 800-743-2382, 8:00 am-8:00 pm, EST. Currently, there are some payers that will cover Xiaflex for Peyronie's Disease without any hoops to jump though (Medicare, Tricare, Kaiser, VA). There will be some commercial payers that will cover Xiaflex for Peyronie's Disease, but will be requiring a prior authorization right out of the gate (i.e. Aetna, Coventry, United Health Care) The majority of the commercial payers will not recognize Xiaflex for Peyronie's Disease on their Medical Policy for a minimum of 6 months (this is common practice with many insurance payers with ANY newly approved FDA drug). However, just because a payer will not recognize it on their medical policy, doesn't mean there are not ways to get the drug approved (i.e. Prior Authorization (PA), Letter of Medical Necessity (LMN), Appeal Letters, etc). What the Health Well Foundation wil do as Senior Reimbursement Counselors is provide patient support services for the Health Care Provider's office and most importantly the patient. Equally important, when an appeal is denied, they will get the Key Account Directors involved to speak to medical directors of the insurance payers who denied it to try to get them to approve it.

Important Safety Information (ISI) for Xiaflex for Peyronie's Disease is now available at www.xiaflex.com.

Auxilium Advantage Xiaflex copay program: will assist qualified patients with up to $1000 for their out-of-pocket costs for each vial of Xiaflex. This program is available for commercially insured and uninsured patients. Cannot have Medicare, Medicaid, VA , or Tricare (or any state or federally funded insurance). www.xiaflex.com.

Auxilium Advantage Patient Assistance Program (PAP): offers Xiaflex to eligible patients without health insurance benefits who meet specific program criteria including income requirements. Patient's income must lower or at 250% Federal Poverty Level to qualify. Patient must submit one of the following 1040-EZ, 1040, 4506-T Request for Transcript of Tax Return, SS Letter, or Notarized letter for income verification. PAP Application form will be filled out by HCP and patient and must be sent to Auxilium Advantage by the provider. Once the patient is approved, Xiaflex is free (no cost to the patient). www.xiaflex.com.

Alternate Resource-Not part of Auxilium Advantage- "The Healthwell Foundation":
800-675-8416 - Open 9:00am-5:00pm (EST) www.healthwellfoundation.org
Must have form of insurance that covers medication (Medicare, Medicaid or Commercial)

Patient's insurance must cover the mediation for at least $25.00. Cannot have a HSA, HRA or Discount Plan. Patients income must be up to 400% Federal Poverty Level to qualify. If patients qualify, they are given $5,600.00 per calendar year

www.xiaflexrems.com is the website that Health Care Providers will need to access in order to be REMS certified to administer Xiaflex as well as have their Health Care Setting REMS certified as a "ship to location" to receive the medication. These are FDA Requirements."