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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 Nancy on
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Hi Susan,
Please keep up the updates! I am not too far from Stanford and contacted the Dr via the number you supplied and am hoping to hear back from them. Meanwhile, I really appreciate you going on this journey on behalf of all of us throughout the hi's and lows! GOOD LUCK!!!
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Permalink Reply by Susan McAdams on
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Thanks! By the way, those symptoms I was having the other day have gone. I'm fine today. It was probably something I picked up from one of my kids.
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Susan...
Good luck on the trial. I live in Los Angeles as well. Re: the co-pay card.I I went to a RiteAd pharmacy here and after applying for the co-pay card, called my pharmacist. She did have some initial issues... but after about 20 minutes on the phone on the Xeljanz help line she straighten everything out.
I appreciate all the info on the this trial... but one thing needs to be clear... you DO NOT need pre-authorization from your insurance company to get the drug from the co-pay card. You actually HAVE to be declined from your primary insurance. Once the card is activated, your pharmacy should enter your ID and Group number on the co-pay card as if it was your primary insurance. There is a lot of confusion out there about this...but I just felt I needed to chime in on that.
My one concern about all these 'company wide letters' is that Pfizer might realize that all of us alopecians are getting this med and shut the program down. So It's my feeling that, as much as we can fly under the radar while trials are done and Columbia, etc. to get it FDA approved the better off we'll be. Just my opinion. I more than anyone want this to be approved. I just finished my first week on the drug and I feel great and am looking forward to seeing progress.
Good luck all!!!
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First of all, thank you for sharing and also reassuring me that some women might get chosen to participate since thus far u are the first one i have seen mention your participation. Secondly, i was wondering if u can discuss in any detail how u feel on the medication. I know u do not believe the little bug u caught had anything to do with the medication, but it did pique my interest as to any changes u might be feeling INTERNALLY while on the medication. I submitted my dna for research just over a year ago and am awaiting trials to come to Houston. I consider myself fairly low energy, have lots of tension in my neck and shoulders generally and sometimes a dull pain near my colon area. Have u experienced any additional energy or any less tension in areas where u have normally found it prevalent? I know it may be too early to discuss or maybe these things in particular have not crossed your mind. I am just curious and would love to hear your thoughts if u are so inclined or have noticed any differences in these regards..
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Thank you, Aimee. Does insurance cover costs (outside of co-pay) to get this checked out or are the tests expensive? I was going to have my GP run a CT scan, but she informed me that WITH insurance it would still be $650, which I don't currently have. After you started taking meds for colitis, did you notice improvements in your energy levels? Was it measurable? I am sorry for all the questions, but after having seen a derm for almost 2 years that shot me in the head with steroids and collected a check from me, I am a little paranoid with my trust levels. Thanks for reading.
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Yes, no alopecia or Crohn's in my family either, tho we do have arthritis and my grandmother died of Leukemia. I also always had strep throat when I was little and once even had scarlet fever (holy 1800's, what?) Thank you for the info. I am assuming diagnosing the segmental colitis did nothing for the alopecia, but I am glad you were able to do something to improve your health in SOME capacity. :)
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I will gladly share all of my health experiences, and if anyone wants to discuss them more in depth, feel free to email me privately. I don't have any of the digestive symptoms described below, but on a hunch, I did have extensive lab work done to test for food sensitivities. Low and behold, I learned that I have a high sensitivity to gluten and cow dairy, though I have eaten wheat milk products my whole life with no noticeable problems. I am now going gluten-free, and I limit my dairy to goat or sheep's milk products (but in moderation). If I were to ignore these sensitivities, I predict it will lead to inflammation in the gut, which may further exasperate my immune system. My goal is to calm my immune system the hell down so it doesn't combat the Xeljanz or lead to other autoimmune disorders.
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Hi All--
So tomorrow (3/5/15) I fly back up to Stanford for my second clinic visit--after being on the Xeljanz for one full month. I have not seen any regrowth anywhere, but would not expect to in one month's time. The natural hair cycle alone is a 3-month minimum period.
Which brings me to some thoughts I have been having after talking with several of my doctors (of different specialities) here in Los Angeles. Everyone seems to agree that only 3 months on the drug for the trial should yield little-to-no positive effects. And even if some regrowth DOES begin, how cruel to then be cut off from the drug right when I start to see results! The consensus is that a minimum of 6 months on Xeljanz is necessary to observe any possible benefits.
What I first did not understand is WHY the Stanford doctors are conducting a trial where patients are only on the drug for 3 months. I do not think that is the case at Yale or Columbia. I think (though could be mistaken) they are for 6 months. What I have also learned is that ANYONE can just go to the Pfizer website and download a 3-month copay card. Then it is up to that person to find a doctor to prescribe the drug. There are many who will. Please don't get me wrong, here. I am not promoting irresponsible use of Xeljanz! What I am saying is if you can find a doctor in your area who is willing to prescribe it for you and then carefully monitor you with bloodwork and regular appointments, you will be receiving nothing different than the Stanford trial.
I suspect the Stanford doctors started this very loose trial because they knew they could get that 3-month copay card for anyone who joined the trial (with no expense to them). Once I got the card, I was totally on my own to secure to drug. The Stanford doctors had NO idea that the key to getting it was calling Pfizer to get a "Pre Authorization" code that CVS could plug into heir computers to override the expected insurance rejection. I only learned of this code by accident--getting randomly connected to someone at CVS who knew what to do. I emailed back and forth with the Stanford doctors for over 3 weeks in total frustration before that lucky CVS call, and though they explained they understood my frustration, it appeared they were annoyed with me for "hassling" them when they had other patients in the regular clinic to focus on. I was not even allowed to contact Dr. Ko who was the doctor I saw for the initial clinic visit. The phone number he gave me is NO LONGER in service, so I couldn't even leave him a voice mail! Dr. Crispin, who handled all the pre-trial phone calls was my only contact, and she told me NOT to attempt to disturb Dr. Ko because he had a full schedule! Is this how a trial should be run--especially when some patients, such as myself, are flying up to Stanford, entirely at our own costs? All this has given me much food for thought.
With that said, I will stay in the trial for the 3 months I am on the drug (till early May). After my May clinic visit, I hope to then find a way to stay on the drug through a doctor in Los Angeles--provided my bloodwork still looks good. I do not think this Stanford trial is as serious as the ones on the east coast, so I am not going to jump through hoops to support them when they barely have assisted me so far.
Just to update--I am experiencing no side effects from the drug. My bloodwork tomorrow will show if anything internal is a problem. I don't have any regrowth at this time (I have only been in an AU state for six months, so I am not one with this condition for years). But I don't expect to see anything positive for at least 3 months just because of the natural hair cycle.
ALSO--if ANYONE has found a doctor willing to prescribe Xeljanz for AA or AU, PLEASE pass that info onto me! I am willing to pay out of pocket to stay on the drug for awhile.
Best,
Susan
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Hello Susan,
I am actually being prescribed Xeljanz tomorrow. Have been greatly anticipating this appointment as I went AT within 2 months time. I am following with Dr. Lindsey Bordone at Columbia University Department of Dermatology in NYC. She is accepting patients.
Katie
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Thanks for posting this. I am in the Columbia University trial, it is six months on the drug and then six months off. Like you, it is a 5mg pill two times per day. Fortunately Columbia covers the cost of the drug for the duration of the trial.
I am in week three and just started to notice what appears to be some regrowth on the top of my head (I have about 85% hair loss on my head and 85% on body, including no lashes or eyebrows).
No side effects to date that I can tell. I am cautiously optimistic thus far!
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Good luck in the Columbia trial, and keep us posted on your progress!
Susan
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