Getting Zytiga before failing chemo?

Hi All

As most of you know, zytiga is approved for use by men whose PCa is no longer responding to HT.  Ted's is responding really well, but still, his doctor is recommending zytiga as an alternative to casodex.  Casodex can be a problem if you have arrythmia, which Ted has (he also had a stroke about 5 years ago).  The doctor said that with his cardiac history, we should be able to get an exception from the FDA that allows him to use zytiga.  He said to stay on casodex until we get that waiver, because the PCa is a much bigger threat than his cardiac stuff. 

I thought, ok, they're going to file some paperwork and get this exception, and at that point will give us a prescription for zytiga.  When we were checking out and getting all the prescriptions, the woman in the office who is their FDA-filing person said we needed a prescription for zytiga, that when we submit it and they won't fill it, she then has the grounds to file for the waiver (at least that's what I took away, I may have been on info overload).  

So we have this prescription, but I'm confused.  How would the pharmacy know that we're a little off-indication?  I would have thought that if we walk in with a prescription from a real doctor, they'd fill it.  

I just don't want to do anything that could hurt our odds of getting the exception.  Does anyone know how this is supposed to work?

thanks   

Caveat: I am not particularly knowledgeable on this but this is what I understand ...

Once the FDA approves a drug, like Zytiga, a doctor may prescribe it for any reason, even if it is not for the purpose in which FDA approval was obtained, hence the term "off label." For example, in my situation, the FDA approved Taxotere for metastatic, hormone-refractory prostate cancer. I just completed adjuvant Taxotere and I am neither metastatic nor hormone-refractory. But, my doctor prescribed it, and, here is the key, my insurance covered it. For Zytiga, in your case, it is really an insurance coverage question. Many insurance companies will not cover a treatment that does not adhere to the FDA approval. So, your first step is have the doctor prescribe it and see how your insurance company reacts. If they reject it, then you start the waiver process, etc. If they accept it, then, congratulations and go for it!

This was our experience: I found out that zytiga was a tier 4 drug through our insurance company. With that knowledge, we told the doctor who did not know that our insurance company would cover it. It was prescribed and it came through a special mail order pharmacy with authorization. We paid 50 dollars for a month's prescription.
Good luck!

You mentioned Sprycel and there is a clinical trial for using it in combo with another drug via Astrazeneca you might search for that one. My onco found a Journal article (newer) about using Sprycel & Chloroquine for hrpca's in the studies (also,both of these are already FDA approved but not used on PCa (yet), off label you would have to buy it with cash if someone currently wishes to try it, if doc writes the Rx), likely you could try this for one month and maybe it costs ($4,000) but it was highly effective on many different strains of PCa tested and very fast results (seen in lab tests in like 24 hours and big results). The results in the article were so remarkable that it is obviously useful in hrpca scenarios. Maybe this is why Astrazeneca jumped into a similar protocol recently with testing Sprycel with their mfg. drug that might be similar to Chloroquine (so they can eventually have a patent for a drug that has interesting results). These combos may be worth keeping an eye to the future on them. You likely have other options in drugs, someone like Dr. Lam, Scholz, Sartor and some others do unique protocols.

FYI- Sprycel in mono therapy was basically not that effective on PCa's, but when in combo with Chloroquine was hugely superior, they tested the drugs separately and in combo and compared all the results, it was day and night to see on the graphs.

I'm guessing most trials are free. Don't know about associated testing (CT scans) etc. The one from the link I shared only lasts 6 months, I think. But they might provide more medicine afterward, which they sometimes do.
If interested you would have to contact the location in the trial link. You could ask your current doctor his opinion, though.