I did not involve the FDA at all in my appeal process.
I researched rituxin and printed out several cases in which it was effective to use as examples. I got a letter of support from my doctor, stating that she recommended it as the next step for me. I copied several pub med and other reputable articles regarding rituxin.
Even with all the above information, my written appeal was denied. I then requested a phone hearing. I had all of the information in front of me during that hearing. Like I said in the above post, I feel it was more my knowledge on my condition and treatment options, and the fact that the doctor on the board from Anthem BCBS had no experience with either, is what won the case for me.
My best advice is go to the hearing prepared, you have a lot of knowledge regarding your condition. Research the treatment/ medication you are looking to get and give them examples similar to your own where it has been successful. Make them aware of other treatments/medications you have tried and failed----especially if they are first line treatments.
Insurance companies always want to assure we have tried first line, less extensive, less expensive treatment options if they are available.