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Discussion Starter · #1 ·
Looking for advice here...

I have dealt with IBS for most of my life, tried many of the treatment regimes, and finally found a doctor to put me on Lotronex. It was a life changing drug for 6 months, then came health care reform, company changing insurance providers, and now a denial of coverage from UHC (high-deductible HSA). Obviously it is an off-label Rx, as are many prescriptions written every day, but after multiple appeals through my gastroenterologist, I feel like we have hit a dead end. At this point, I don't think I can justify $1000 a month out of pocket.

Has anyone encountered this, and if so, were you able to eventually get your health care provider to bend? Any known loopholes? Help through Prometheus? I may even pay out of pocket for a new health insurance provider, as it would likely be a cheaper option than $1000/month plus additional health care expenditures within the family. Any men with a provider that does cover Lotronex?

Any help is appreciated.

Thanks
 

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Discussion Starter · #2 ·
Surprised with as many views, no other have had experience with this. As an update, I have been in contact with Prometheus. At this point, there are no plans to add men to the label. Any ideas why men were excluded from the label in the first place? Strictly a numbers thing, or were there more adverse effects in men? Despite the lack of replies, thanks for those with interest.
 

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They were excluded because all of the studies were done with females. IBS happens a bit more frequently with females. So sorry we are not much help here.
 

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That isn't quite true,

The Phase III trials were done with females.

That is because the rules changed and Phase I and Phase II must be done in both genders (unless there is something that one gender doesn't have like a prostate or a womb).

In the Phase II they also had do to breakdown where they looked at the data by gender. In that analysis they found that men did not respond to Lotronex and women did so they were only allowed to do the Phase III in women. They can't just do it in women only all the way along because they feel like it.

One study I worked on early after the rules changed forced us to include men (as it was a pilot study and no evidence to exclude men) even though mostly we were looking at diet and breast cancer, but the diet could effect colo-rectal cancer as well.

Some of the Phase IV (post marketing) studies have used men. One found that an extremely small percentage of men respond to one measure of the drug working (not symptom relief, but some gut motility measure). So small that you would probably not find it to work significantly better than placebo in most clinical trials.

Now if you are one of the few men it might work for you (it only works in about 45-50% of women, but when it works it can work very well).

Check with Prometheus seeing as you seem to have run the appeal gauntlet with the insurance company.
 

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Discussion Starter · #5 ·
Thanks Kathleen, dealing with the FDA in my own profession, I wasn't sure if it was an n/cohort/sample size issue or if it was based on true evidence based results. I felt if it were the former, I could get some traction with strengthening another appeal with the insurance carrier. Since it appears to be the later, I doubt it is worth my efforts.

Surprised there would be a difference in gut serotonin receptors between the sexes, and could not come up with much doing a brief (very brief) primary lit. search. I can understand why it would only work in 45-50% of women as IBS seems to be a catch all or rule out diagnosis. Any speculation by the authors why it was much less in men?

Thanks again!
 

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I really don't know if we know of a really good reason for most of the drugs that act differently in the genders.

I know that some of the ones that caused them to start forcing people to even use women at all in clinical drug trials were not things that really were obvious as to why they either don't work in one gender or the other.

I suspect it may be at least in some cases how the having to metabolize the sex hormones effect how some drugs are metabolized (if men need more of one enzyme and women more of another then you might either activate or deactivate a drug more). It may also be how the hormone levels effect receptors or things like that which you might not expect. (one gender makes more or less of the targetted receptor, etc).

http://www.ncbi.nlm.nih.gov/pubmed/12036391 lists some of the things that are generally involved in this sort of thing.
 

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I have been using Lotronex for a few months now and its helping some. Prometheus does offer a savings program. There is a $500 coupon to use with every prescription. So, you pay the difference after the $500 is taken off. It has been a lifesaver for me.... because like you I can not justify $1000 a month in medication. I take the .5MG twice a day. I pray they never take this savings program away, or I will have to stop taking it. You an find the coupon online on the Lotronex website. Hope this helps.
 

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Scott,

I apologize for not seeing your post months ago. My husband takes Lotronex and has the coverage denied every year. I appeal every year and get approval for just that year. He was covered by the current pharmacy provider way back when and continued to be covered when the provider was switched to a new one (under the same insurance). When it switched back, they said no. It is a pain to appeal every year, and quite stressful as he cannot appeal until he sees the doctor, and then has no way to fill the new prescription, but it is better than not being covered. Have you checked out the appeal processs of your company?
 
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