My first post on this topic got buried somewhere in "Discussion" purgatory, so I am providing an update on my experience as a participant in the Stanford trial for Xeljanz...
After contacting Dr. King at Yale several months ago, he finally got back to me last December to inform me that two doctors at Stanford University are conducting a trial to hopefully replicate his findings. I jumped at the opportunity and got in touch with Dr. Milene Crispin at Stanford. Working with Dr. Justin Ko, they are conducting a trial where participants take 5mg of Xeljanz twice daily for 3 months. Then, we are monitored for 3 months after the drug is finished to see what happens.
Participants in the trial are not privy to results of other trial members, but both doctors have told me they are definitely seeing some positive results on not only patients with AA, but AU as well. I struggled with a 2-year battle of AA back in 2007-8 and then went into complete remission for three years. All my hair grew back. However, I relpased in early 2013 following some very stressful times and a reoccurrence of mercury poisoning, and over the course of that year, watched my hair fall out completely. By January 2014, I was shaving my head and turning to wigs. In June 2014, I began to progress into AU, where I am at to this day. I lost everything.
I did my research on Xeljanz and all its potential risks, and I talked to two friends who have been on JAK Inhibitors for RA (not Xeljanz because it is so new) for the longterm (years), and they are not dropping dead of cancer. There are millions of RA patients out there on JAK Inhibitors, and as long as they are being responsibly monitored by their doctors monthly, I believe the risks are not as bad as the literature warns. Certainly, everyone is different, so I am not going to elaborate on the odds of side effects. But my medical history and bloodwork showed that I am a good candidate for giving Xeljanz a shot. I don't know if any of you have seen them, but there are ads for Xeljanz popping up in magazines. Pfizer is really banking on this drug.
So here is where I am as of this date...I flew up from Los Angeles to Stanford on 01/14/15 for my diagnostic appointment in the trial. Dr. Ko took photos of my scalp and nails, did a small scalp biopsy, walked me through a ton of paperwork, sent me to the lab one floor down to have blood drawn, and sent me home with a co-pay card from Pfizer that will cover a total of $8,000 over the three-month period that I will take the drug. Yes, you read that correctly. Xeljanz costs approximately $3,000 for a one-month supply! Thus, I will be paying $1,000 out-of-pocket over the course of this trial. It is worth it to me to see what happens. I have to pay for my own plane tickets and rental cars during the trial because I must fly up to Stanford each month for 6 months total to be monitored. Thus, if you are considering this trial (or the one at Columbia University) understand that it will cost you.
TODAY, I finally got the Xeljanz in hand after 3 weeks of winding through more red tape than one can imagine possible. The doctors gave me guidelines on how to get the drug using the co-pay card issued from Pfizer for this trial, but depending on one's health insurance company, the process can become one, big cluster-fuck! It certainly was for me. I have Healthnet PPO, just so you know.
Now, you may wonder what my health insurance has to do with this since they will NOT approve Xeljanz for AU (NO insurance will because it is not FDA approved for Alopecia). However, pre-authorization is necessary to begin the trial and then to get the ball rolling with the pharmacy. Before my first trip to Stanford, I had to get my local dermatologist to send a fax to Healthnet telling them I was flying to Stanford to "receive treatment for AU that is not available to me here in Los Angeles." I was told NOT to have my dermatologist state it is a "medical trial." That could delay things. I got the pre-authorization to go do an out-of-network office visit up at Stanford. That was the easy part.
The logistic nightmare came when I then tried to get the drug with Pfizer's co-pay card. I will not go into all the details here or I could write a novel. I will just say that the ONLY pharmacy that is getting the process completed and getting Xeljanz into trial members' hands is the CVS Specialty Compounding Pharmacy. You submit your RX to your local CVS, and they must send it off to this compounding branch (it has a 1-800 number) where they process the prescription. It took three weeks of back and forth between more pre-authorizations needed from Healthnet, faxes from the doctors at Stanford, getting the co-pay card processed, and ultimately getting the drug mailed to me (or your local CVS where you can pick it up). It took a lot of effort, but I not only got the drug, but I paved the way for future trial members by getting a representative at the CVS Specialty Center to send out a company-wide email memo so any representative getting the prescription and co-pay card should now know what to do. I wouldn't bet on it, though. I spoke to many folks on that 1-800 number who had no clue how to get the Pfizer co-pay card processed. HOWEVER, if you are reading this and decide to partake in either the Stanford or Columbia trial, feel free to email me at the address under my name at the end of this post. I am happy to talk you through the step-by-step process required for getting the drug in your hands. I don't want anyone to go through the shit-storm I battled.
So, now I begin the trial in earnest. I took my first pill today. I will continue to post throughout the 6 months that I am on the trial to document my progress (if I have any). Who knows what will come out of this? Maybe nothing. But, I feel very strongly about supporting the Alopecia community by participating in this trial. It is outrageous that there is still no reliable drug available for our disorder, and the FDA must be convinced that JAK Inhibitors such as Xeljanz DO work for some Alopecia patients. Currently, Pfizer is trying to get Xeljanz approved for psoriasis since the case study patient at Yale saw dramatic improvement to not only his RA and AU but severe psoriasis. Pfizer is heavily advertising Xeljanz in the magazines for RA because that is the only condition it is currently FDA approved for. But, I learned that Pfizer lost $114 million last year on Xeljanz because there were simply not enough RA patients willing to switch to this new drug. Pfizer is very invested in Xeljanz as a future cash cow. That is one reason they are providing the $8,000 co-pay coverage for trial members! They are hoping to get their drug FDA approved for more than RA or they will never make money on it. This is a very positive sign for the Alopecia community, I believe. We trial members are the pioneers.
Again, if you are reading this and are interested in the Stanford trial, call Dr. Milene Crispin ASAP at 603-667-1310. When I visited her offices on 01/14, there were about 20 trial members. They will cap the number at 40. I know Dr. Crispin has been bombarded with emails. So don't delay emailing her if you are interested. She will contact you by phone and talk you through the trial conditions and find out if you meet the first qualifications to come to the clinic for the first consultation visit. If you are already in the trial and are trying to get through the red tape to get the drug, email me and we can exchange numbers, and I will talk you through the process.
Wish me luck! My journey is finally under way!
Thank you so much for posting this and your future results, I think a lot of us will be waiting to hear from you on your progress, good or bad, your forging new ground for us all. I'm a bit surprised that you have to go through your insurance for the medication, as I would think that the pharmacutical company would be providing the drug at no cost, you would think they would want this to go forward. Best of luck to you. My fingers are crossed :D
HI Susan, at my last dermatologist appointment we discussed this option. She was a little hesitant after reading the side effects, since I'm pretty healthy and don't take any medications.
I am still very interested in giving it a try though. I have lost most of my hair on my head, eyebrows, eyelashes, legs, arms. Not sure what my diagnosis is because I have been given many. Can you see hair follicles on your head? I don't see mine, so I wonder if that means I would not be a candidate for the Xeljanz.
Sorry for the rely in responding to recent comments, and thank you for so many kind words of encouragement! I am grateful for this forum because it allows everyone to share important information and compare our experiences.
The Stanford Trial is not accepting anymore patients. They are full. What they did (because of so many demands by trial members) is offer to give us the choice to withdraw from the trial after 3 months and then receive a 6-month RX from the doctors to continue the drug--though we would have to pay out of pocket. Dr. Ko at Stanford really predicts that Xeljanz will get FDA approval sometime in 2016 because there are so many alopecia patients getting the drug on their own, now. Plus, the stats from the trials at Stanford, Yale and Columbia are showing very few, if any adverse side effects, and patients are starting to see regrowth. If you DO choose to seek out the drug from a doctor who will prescribe it, be aware that ANYONE can go to the Pifzer website and get the free 3-month co-pay card. You are allowed one co-pay card per calendar year. So, I can get another come January 2016. That at least lessens the burden of the high costs of the meds. It is still expensive to pay approx. $2,600 per/month for the remaining 9 months, but better than nothing. And if the FDA comes through with approval, that will change everything. I have been in touch with a few people who are getting on the drug with their own doctors and not participating in any trial. So this is all taking off in the right direction.
To update my status, I have been on Xeljanz since 02/04/15 (7 weeks). I have experienced no adverse side effects, and my bloodwork is all normal. Right now, I have a nasty little cold, but that was to be expected because two of my daughters had it last week, as well as my best friend. But it is nothing major. Just a cold with a sore throat.
I have yet to see any regrowth except for a few vellus hairs in my eyebrows and maybe a few on my scalp. Upon talking to my Stanford doctor, he said that is not unusual. It takes time for the drug to first calm the immune system down, THEN you have to wait through the natural hair cycle that can be three months. That's why they realize that 3 months on the drug is probably not sufficient. The Stanford doctors have modified their trial, and are offering patients the choice to withdraw after 3 months and then they will be given a 6-month RX to keep rolling with the drug (out of pocket, of course). That is precisely what i plan to do. I came this far, my bloodwork is fine, and i need to see if this drug will work for me.
To update the situation at the Stanford Trial...the doctors are being more responsive and not as aloof as I felt they were earlier. The fact that they are offering the 6-month RX after the 3 months is a good thing. Dr. Ko said, "We are regarding our trial participants as patients first and trial subjects second.' Their goal is to see this drug get FDA approval. Dr. Ko believes it will happen sometime in 2016 because of the huge surge of alopecia patients demanding the drug from their dermatologists. I already know two folks through this forum who are doing just that--they got the RX through their regular doctors, are using the Pfizer co-pay card that can be obtained straight off the internet and will be monitored by their private doctors.
If anyone has been on the drug, please share if you are seeing any legitimate regrowth. I am curious who is benefitting from the drug. I am not giving up hope. I know I have to be patient and not expect much of anything for at least 6 months. I will keep you posted.
If you don't mind me asking, what insurance do you have that is paying for half of the xeljanz? I am being prescribed tomorrow and am under the impression that my insurance will not be paying for any of it (I have United Healthcare). Did you tell your insurance company you had Alopecia?
Thank you so much for sharing your story and for being a pioneer for a cure.