Who is paying for xiaflex in Peyronie's?

Is insurance going to reimburse the 40k treatment? I can't imagine how it is going to sell if/when insurance companies start to decline this.

 

That's going to be so annoying for the 130 patients a year who fit the proper patient profile

 

Absolutely no payer will cover this given approval, which is a very questionable based upon the marginal patient benefit.

 

Just curious - why would there only be 130 patients who fit (and would be covered)? Wouldn't anyone with Peyronie's be able to use it and get reimbursed? Or, are they literally sticking to the same criteria as the trial ("the perfect patient" with 30-90 degree curve, no calcification, etc).

On one hand, it would be the only drug, but on the other hand 40k for 30% improvement sounds like a huge question mark for insurance. Then again, they did cover prostate cancer drug for 90k that let people live about 3 more months...so it seems like it's up in the air.

 

Don't compare cancer to sexual improvement

 

I am throwing a party the day this drug DOES NOT receive approval!!!

Come along, bring some potato chips and we will share stories about who ran this place into the ground the most.

 

First, the drug will be used strictly by the label or it will not be reimbursed. Second, no Doctor is going to take the risk of buying and billing at this cost. Third, this is going to be catagoeized as a "life style" drug and therefore a non formulary item. All of these lead to one conclusion. Peyronies is not going to gain anything for us.

 

Yes, the price is outrageous...has there been any talk of lowering it (or raising it)?

I assumed they are betting doctors will submit for reimbursement regardless of the criteria...unless insurance companies going to require documented proof of the deformity before they reimburse.

As far as it being a lifestyle drug...I suppose that's possibly. It definitely causes ED ... so that puts it mildly in the lifestyle category - but the effects can be worse than that. And lifestyle drugs (v) are covered to an extent. (If I typed out the full name it would not post). A bent finger (duputreyns) doesn't seem to be worse than what a lot of Peyronie's patients deal with...and those have gotten approval (though I know it is not 100%)

 

I am comparing 3 extra months (while dying) from prostate cancer for 90k on Provenge to 20-40 years of having a deformed (mostly non-functional) penis for 40k on xiaflex.

I don't see a problem with the comparison. If I had to choose, I'd give up 3 months of my life to not have deformed penis for half of my adult life.

 

Peyronie disease patients are still functional. A curve doesn't mean it doesn't work or it hurts. It just means there is a curve. There are always exceptions and severe cases but mostly patients can still ejaculate and urinate without issue. Is it pretty? No. So its primarily a cosmetic problem and severe patients may be able to wrestle an insurance company into paying. But more importantly, the drug provides a minimal benefit to only a specific type of patient as detailed in the study

Do your homework

 

Difference is the finger is dysfunctional. A curved penis just looks bad but most peyronie patients still urinate and ejaculate without issue. Docs and managed care are not going to jump on this. A few patients with high income might. Another tough sell for us . I can already hear the conference calls about quota adjustments. Uuuughh....

 

Actually, you need to do your homework. Here are the facts from the leading journal in the field in 2002:

Kadioglu A, Tefekli A, Erol B, Oktar T, Tunc M, Tellaloglu S
The Journal of Urology [2002, 168(3):1075-1079]

"Of the men 54.4% complained of erectile dysfunction" It also describes that this increases with age (no surprise).

In another study 41% reported erectile dysfunction and 46% reported painful erections.

Source:
U. Schwarzer, F. Sommer, T. Klotz, M. Braun, B. Reifenrath, U. Engelmann
20 DEC 2001 British Journal of Urology

You can look it up for yourself, and as you can see 41-54% is not an "exception" - it's the situation for the average patient.

And virtually every non-academic (Mayo clinic, etc) source shows that it is related to both ED and in some cases severe depression as well, especially if people get it when they are young.

Whether this makes it a lifestyle drug is still questionable, but the empirical, published, research does not support that view.

I DO agree with you that health insurance will look for every way not to pay for it, however. Urologists I have talked to are very eager for its approval because surgery has a tremendous amount of drawbacks, unlike NA for Duputreyn's, Peyronie's surgery is filled with risks from further ED to loss of sensation to loss of (more) size).

There is a case to sell this drug, but people need to be informed. That all being said, it also has severe risks such as penile fracture (3 happened in the trial) - if it starts dissolving the tunica albuginea in addition to the the scar plaque alone. There is no clear line between the scar and tunica in PD (despite the diagrams) - it's all sort of bound together. So, despite any debate about Peyronie's ED, it is still not a great drug regardless. It could help ED by fracturing the scar tissue and allowing more expansion - but naturally erectile quality was not measured in the study objectively (only via survey).

 

41-54% of pts with Peyronie's can't have sex due to ED (sources cited above). That's worse than a finger being bent. There are men who have both (similar gene involved), and they are much more unhappy with Peyronie's than w/ Duputreyn's. Also, there are psychological effects due to 20-50% loss of size of your penis (it's not just a curve). Regarding it being cosmetic, then why are acne drugs covered by insurance? You can live with acne. It doesn't impair functioning (other than psychological - in which case a bent penis is worse). Not only is Peyronie's an aesthetic problem, but it is a functional problem in half of the cases.

Anyway, I am arguing w/ you as if I'd argue with an insurance company. We're both on the same side. A lot of people are going to be screwed if they start denying the claims. So far I am not seeing a reason, other than the "on label - perfect patient" thing which may happen.

 

Acne meds do not cost $40k

 

Actually, I think a lot less peop will be getting screwed if insurance companies deny these claims.

 

Does our study look at ED? No
How would anyone delineate between physical vs psychological ED?
Many peyronies patients suffer from psychological ED.

Who's paying 30-40K for ED or cosmetic surgury with limited outcome and potential recurrence in X # of years? Probably not as many as we are forecasting.

 

Has anything ever come close to what has been forecasted with this company? Get real!

 

What are you basing this on? The two medical articles above don't say a word about psychological ED. The reality is, if a penis has a layer of scar tissue on top or the side - it cannot maintain the rigidity of a normal erection - no matter how psychologically stable a person is. So, there's no need for a delineation between psychological and physiological ED - just try blowing up a balloon after you wrap it in tape. Ask the balloon if it isn't blowing up because it's depressed or because it's wrapped in tape.

Also, "mean change in symptom bother score" was an outcome, and this was a survey that included ED. They limited the Phase 3 study to men in stable relationships so that they could ask extensive details about their sex lives...and they showed an improvement vs. placebo.

Why do insurance companies pay for visits to urologists (marking this as their diagnosis code) if this is purely cosmetic? Insurance companies don't want to pay for anything, so you'd think if someone went to their doctor with a bent penis, they would have started denying these claims a decade ago since it's just "cosmetic". On the contrary. Insurance covers thousands of dollars in verapamil injections (which are not even FDA approved for this & largely ineffective) and ultrasounds (not entirely necessary to diagnose).

Furthermore, with this cosmetic issue raised, why do so many insurance companies cover breast reconstruction? By the logic of many posts here: A $50,000 breast reconstruction will get covered (and this certainly has no "function") but Peyronie's injections will not. Why is that?

$30-40k is nothing considering that men have to live with this for 20-30 years...which is about how long women have to live after a mastectomy. Someone mentioned acne - well, taking an acne drug for 20-30 years would be over $100k retail.

Recurrence is unclear, though you seem to have some source of wisdom (that is not cited) about it. The literature is clear that the vast majority of patients do not progress after 1 year. Even if the scar tissue worsens 20 years later, there will never be a way to tell recurrence apart from disease progression, and that will be another way for Auxilium to make more money.

 

What are you smoking??? Your distorted presentation of facts is laughable.
mean change in symptom bother score???? What specific symptoms? What universally accepted scale was used??? You can't answer these questions because no psych study or survey has been done

You have no recurrence data but dupuys as a surrogate would say a significant # of patients will recur with 5 years.

Stop comparing to cancer or breast reconstruction. It is a curve that forms when erect. That's it.
We need more studies and evidence to sell this properly

 

The only one that should be laughing is me, since your posts are so clueless, I don’t know where to begin. However, it’s actually more scary than funny that you might be responsible for representing this drug.

My "distorted perception of facts" is actually from cited academic literature (that I provided). You - on the other hand - spew false statements (posing as fact) like "ED is psychological in Peyronie's" or similar...and you provide no citations. Then, you ask me to back MY claims up? That was already done. Let’s see you back your claims up now.

Wrong - I am a little shocked you are not able to find your own company’s clinical trial press release and/or understand the data presented, as evidenced by you asking "what is mean change in symptom bother score" (with 3 question marks) and "no psych study or survey has been done." I would post the link, but then this post might not appear. So, here were the primary PSYCH outcome measures (plus one pain one) - funny how you adamantly deny they exist:

“Primary: Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie’s Disease Symptom Bother “
“Primary: Change From Baseline in PDQ Intercourse Constraint”
“Primary: Change From Baseline in PDQ Intercourse Discomfort”
“Primary: Change From Baseline in PDQ Penile Pain”

The surveys given were either custom made for this study or from validated scales of sexual function ("validated" means they have been with factor analysis and test-retest reliability – if you know what these things are). The same psychometrically validated surveys that have been used in 100s of studies – from sexual health research in academia to pharma. The “mean symptom bother score” is what is reported on the Auxilium website. This is a combination of factors taken from the surveys given to the patients at the start and end of the trial.

If you could look up your own company’s research, I would’t have had to do all of that copying and pasting – but it’s slightly satisfying to show you how wrong you are when you make comments like “Your distorted presentation of facts is laughable” since you are the immensely uninformed, clueless one here.

It could recur after surgery too. So, what is your point in dwelling on recurrence data?

The two are different diseases with different causal factors. For one thing, the cords form next to the tendon. And, the tendon is otherwise healthy. In Peyronie’s – they bind to the healthy tissue that has (in many cases) been damaged in some way. The disease is stable at 1 year, unlike dupuytren's contracture which usually occurs in more than one finger. They are not the same.

“That’s it” in your mind, but that’s not "it" in reality. I already demonstrated you were wrong by citing 2 leading urology journals that demonstrated 50% of patients have ED with this. Also, I pointed out that over 40% have pain, based on empirical journals. Then, you replied by saying the “ED was psychological” for which you had no source – and this was simply pulled out of your ass and stated as fact. Since you know nothing of the relevant anatomy, I tried to provide you with a simple analogy to a balloon wrapped in tape. I thought that might help. Apparently, it was over your head.

Also, since you (or another anon) said this is a “purely cosmetic drug” that would never be covered by insurance, I am comparing it to similar cases. People seem hung up on the (false belief) that it does not affect function. So, I am asking you why insurance would pay for breast reconstruction (after a mastectomy) but not for this - because a fake breast has no function. I’d like to hear the reasoning. And, “reconstruction” means the cancer is gone. I did not say “why would they pay for the mastectomy?” I said – “why would they pay for reconstruction.” Sorry you missed the analogy (you seem to be missing quite a bit) – but that was not a comparison to cancer. It was a comparison to a very expensive procedure that is totally unnecessary, functionally. But, many insurance companies pay. Insurance companies pay for urology visits when the diagnosis code is Peyronie’s disease. Why would they do that if this is a cosmetic consult?

On the other hand, if they make doctors verify that every patient fits all 150 criteria that the trial subjects fit, then there will be a problem.

There’s no point to continue further since you apparently want to believe what is in your head – only – and not what is actually in front of you (on your own company’s website, in journals, or on clinical trial sites). So, when you come to this board to whine about how much you hate your job, can't sell, or can't get promoted - review this thread. The way you lack the capacity to think (particularly by analogy), are highly contentious, spread false statements with zero hesitation, and can't learn from reading are probably contributing factors. Bye!