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My Stanford trial experience, part 2 (Xeljanz)
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!
--Susan
Replies to This Discussion
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Permalink Reply by asp2014 on
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Hey Julie, hope all's well. After reading your comment I was a bit confused and was hoping you could clarify. You mentioned that since being on xeljanz you were able to grow "some vellus hairs on [your] head" but then you go on to say that you "have no vellus hairs on [your] head yet". Do you mean terminal?
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Permalink Reply by leah on
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Thanks, hope feeling good and no ill effects too! Both Susan, Starshine, and Julie! =)
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Permalink Reply by Juliet on
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Thank you so much for sharing this with us, Susan!! Hoping for the absolute best outcome and looking forward to hear updates on your progress!!!
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Permalink Reply by Susan McAdams on
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Hi All--
Sorry to be out of the loop for awhile. Tending to my eldest daughter graduating high school and all the mother/daughter head-butting that goes with it. Can finally breathe a little.
I finished the 3-month trial at Stanford University and am flying up again on Tuesday to fill out paperwork and take photos and such to close out my participation. I opted to continue on with the Xeljanz, as many trial patients have chosen to do as well. After 3 completed months on the drug (same amounts since the start--5mg twice daily), I have a lot of vellus hair regrowth all over my scalp, in my eyebrows, and I have some eyelashes again! I'm sitting at the beach as I write this and noticed for the first time in a year hair growing on my legs! Photos below.
Yes, these are all vellus hairs--no terminal hairs, yet. My dermatologist in LA said to not expect anything significant for at least 6 months. But at least something's going on, AND no negative side effects. The only negative, now, is having to pay out of pocket for the drug through December until I can get a new 3-month co-pay card from Pfizer. The doctors at Stanford are predicting Xeljanz will get FDA approval next year sometime because of the positive results of the Yale, Stanford and Columbia trials with no major side effects. Let's hope that is the case. $2,600 per month is no walk in the park!
Anyway, would like to hear from others who have been on the drug at least 3 months. One of you said your eyebrows grew completely back with terminal hairs. Hurray! Any other good news out there?
I think I'm going to go buy some mascara--something I haven't done in a year!
--Susan - Attachments:
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Eyebrows and eyelashes coming back!
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Awwww! This makes me want to cry from happiness for u! I miss my eyelashes so much. I take MSM which thus far is the only thing that has grown SOME eyebrow hair back for me. But otherwise so far all i have are my bottom lashes that never totally went away..
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The consistent message from both my doctors in the Stanford Trial and my dermatologist in Los Angeles is BE PATIENT. It is actually unusual to see terminal hair regrowth before 6 months. We all know the normal hair cycle alone is three months long. So you cannot expect those extreme results we all saw from Dr. King's patient last year. He is a very fortunate outlier! It certainly sucks that we only get 3 months of drug coverage per year, so for many, $2,600 per month is not feasible. Let's hope for FDA approval soon so that everyone may have access to Xeljanz if they so wish. I am now glad I jumped through all these hoops and spent a good deal of my own money flying up to Stanford if it means it will expedite FDA approval of the drug!
Anyway, be patient, everyone, if you can. And please share your progress!
--Susan
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Okay--
Just finished up my official participation in the 3-month Stanford Trial today. I am up here in SF about to head back to the airport. My doctor here said since I am one of the only trial patients opting to stay on the Xeljanz and thus pay out of pocket, he is going to keep monitoring me every 3 months. I will remain on the same drug protocol as before--5mg twice daily--until we see enough hair regrowth that we can discuss altering the dosage (and then see where that goes). Until September, though--status quo!
I learned some new info about the hair regrowth I am seeing on my scalp, eyebrows, lashes and most recently legs. I thought these were superficial "vellus" hairs because of their white, fine color. My eyelashes are actually more blonde than white. My doctor examined that these are NOT vellus hairs--this is the start of the hair cycle. The hair comes in white and fine, and eventually darkens and thickens. Like baby hair. Vellus hairs (like the fine fuzz you see on your face) do not grow beyond that status. This is really good news! And what's even better is one month ago at my last appointment, I had emerging fine scalp hair, but not over my whole scalp. Some areas were still bare. One month later, virtually every part of my scalp is showing signs of regrowth. The former bare patches now show very small, fine white hair starting to grow in. Now it's the waiting game to see how much this hair thickens and darkens. My doctor said at this progression, there is no reason to think it won't do just that. Maybe by December, I'll be rocking the Chalize Theron "Mad Max" look. I just may be able to pull it off!
Below are a couple scalp photos. Hard to see in the poor lighting, but you get the idea. NOT vellus hairs! Woot!
--Susan - Attachments:
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