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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 Christine on
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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
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Permalink Reply by Susan McAdams on
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Thank you, Christine, for your kind words. The whole red tape nightmare between medical insurance, CVS and Pfizer is really logistic. Of course Pfizer wants to get the drug out there. And medical insurance just wants to wash their hands of it completely. It all came down to the people at the CVS Specialty Pharmacy knowing HOW to process the copay card. Once I finally found someone at CVS who knew what to do (it was as simple as obtaining a Pre-Authorization code from Pfizer), the word was spread through a company-wide email and now folks are getting their prescriptions filled.
I feel good about doing my part to help the Alopecia community and I will by staying in this trial for the next three months! After that when the meds run out, I will have to decide what to do. It will all come down to whether I see any results or not and what my doctors in Los Angeles advise me to do.
I wish anyone and everyone who is in one of these trials good luck and good health! And again, anyone is free to email me if you have ANY questions, comments or concerns. We all gotta stick together!
--Susan
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Permalink Reply by leah on
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Hello Susan,
Thank you, thank you! I hope you are feeling less icky side effects now. I appreciate you doing this and sharing. I have too poor of health and low money to do any trials right now. But will pass the word on...thinking good thoughts for you. Curious if be open to share about your bout w/ mercury poisoning; if drs ever thought if treated help with hair loss. Had thought of getting my hair sample tested for toxity before I lost. But didn't and heard fillings are bad.
Best!
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Permalink Reply by Michjo57 on
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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.
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Hi Everyone--
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.
Good Luck!
Susan
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Permalink Reply by Kat on
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Hi Susan. I was going to wait for someone else to bring this up but no one has. I will risk looking uninformed because i guess I am misunderstanding something here. I didn't understand why, if the medication would cost u $2600 out of pocket, and the trial would give u the option of being on it 3 additional months, u would opt out and take the burden of the expense instead. Am i missing something...?
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The doctors running the trial do not have any funds to provide Xeljanz to patients. Nor do the doctors at Yale or Columbia or any other trials that are now popping up. Everyone is taking advantage of the 3-month per CALENDAR year copay card that Pfizer is offering off the Internet. What the doctors at Stanford are now doing (to ammend their original trial) is after 3 months on the drug, if a patient wants to continue, they can choose to dismiss themselves from the trial, yet the doctors said they will provide a necessary PRESCRIPTION for the drug for another 6 months. They are not giving it away--no one is. They are just giving the patient the opportunity to keep on the drug if he/she wants to. Most research is seeing that very little, if any regrowth occurs in 3 months. It really takes 6 months to see changes. For example, I am now 8 weeks on Xeljanz, today, and I see a few vellus hairs on my eyebrows/eyelashes. But I do not want to quit in a month! What would be the point? I have no negative side effects on the drug. Therefore, I am going to ask for a 6-month RX from thebStanford doctors in May when my last scheduled appointment takes place. I will then have my internist in LA monitor my blood monthly while I continue on the Xeljanz.
There are a lot of doctors out there who are finally offering prescriptions to their patients who want to try Xeljanz. Before last January, it was tough to find anyone. But I think the results coming in from these trials throughout the country are showing that few, if any patients are having side effects and that many are having regrowth after several months on the drug. The problem now is no FDA approval yet, so $2,600 out of pocket. You CANNOT get the drug in Canada or another country when using the Pfizer co-pay card. They state specifically you can only use it for Xeljanz obtained in the U.S.
So for anyone reading this, wishing he/she could be in a trial or worrying about the cost--just know you CAN get the drug for 3 Months free with the Pfizer copay card from the Internet. You have to just find a doctor who will prescribe it. It is likely, according to one of the Stanford doctors I spoke to, that Xeljanz WILL get FDA approval for alopecia in the near future--probably sometime in 2016. There has been a lot of pressure to do so, and these trials have been showing great results.
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Thanks for all the info Susan. I am on the drug through my own doctor who prescribed it. My ins pays half and the co-pay card pays the rest. I was worried that I had not seen anything after one month, but you set those worries aside. I realize now it will take a lot longer.
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Starshine,
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?
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Okay. That clarifies a lot, thank u. So...per calendar year means u couldn't, say, apply in October and then again in January to have the opportunity to be on the drug for 6 months concurrently? Also, i do have a family history of arthritis - has anyone here (particularly in Dallas, this would be most helpful to me) had any success with being prescribed Xeljanz by a rheumatologist? Sorry, just have so many curiosities. I have had alopecia since i was 16. Never any big patches til i had surgery 3 years ago. All my hair fell out but i have been taking turmeric (and more recently bovine colostrum, as well) and have vellus hairs over most of my head now. For some reason most of the front has hair but the back is fairly bare except a little patch in the middle. Since ive been taking the turmeric (about 4 or 5 months) i have seen barely but a few more eyebrow hairs.
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Thank you Susan, can I ask what they are monitoring your blood for? Is the drug really hard on the liver? When I first started missing hair in patches (+10 years ago) ago first doctor put me on strong drug for ringworm where I had to do blood test each month, to watch my liver as a side effect was damage...after while realized not ringworm but AA. I will look into trial, but if side effect liver probs may say no. As I have taken lot pain meds for other stuff bad for and my grandma died badly from liver cancer. I appreciate you updating us on your status and all. Great efforts on your part with all the challenges and good CVS helped! Thank You! Hoping works well!!
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Thank you so much for sharing your story and for being a pioneer for a cure.
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