Everyone,
I've been working hard the past 3 weeks to follow the guidelines by so many of you who are fighting the good fight and winning. I've eliminated dairy, gluten, soy and as much fiber as I can at this point.
My doctor has prescribed entocort. My insurance is refusing to pay for it. They say the reason they refuse that (and its generic equivalent) is that it has not been approved by the FDA for treatment of MC. I was told only two studies were done on the drug and the FDA has not approved it as treatment for MC.
I think this is my crap insurance not wanting to fork over the money for this drug more than it is anything else.
My doctor is fighting them hammer and tong on this one, and has asked me to write the insurance company a letter of dispute and grievance (I doubt it will help but am willing to do what I can).
If you were writing the insurance company on a refusal for a drug you knew helped so many people what would you say?
I really do covet your help and guidance in this
~Karen
Insurance refusing Entocort, says not FDA approved
Moderators: Rosie, Stanz, Jean, CAMary, moremuscle, JFR, Dee, xet, Peggy, Matthew, Gabes-Apg, grannyh, Gloria, Mars, starfire, Polly, Joefnh
I can't see why Entocort shouldn't be approved for use with MC. In fact, it's the only evidence based treatment. I think I've read all there is to read about MC, and I would use the two overview articles from renown serials below to enlighten them. The chapters about treatment contains referrals to substantial evidence of the efficiency of Entocort/budesonide.
1. http://www.sciencedirect.com/science/ar ... via%3Dihub
2. http://www.ncbi.nlm.nih.gov/pubmed/22704658
The FDA approvement procedures I know nothing about, though. But I doubt they could be so slow that Entocort isn't approved yet.
--Tor
1. http://www.sciencedirect.com/science/ar ... via%3Dihub
2. http://www.ncbi.nlm.nih.gov/pubmed/22704658
The FDA approvement procedures I know nothing about, though. But I doubt they could be so slow that Entocort isn't approved yet.
--Tor
Life's hard and then you die
-
humbird753
- Rockhopper Penguin
- Posts: 1014
- Joined: Mon Nov 28, 2011 4:44 pm
- Location: Wisconsin
Karen - I'm surprised insurance wont cover it. Entocort was the only prescription drug they offered me.
Your response here is great, Tor.
Good luck, Karen.
Paula
Your response here is great, Tor.
Good luck, Karen.
Paula
Paula
"You'll never know how strong you are until being strong is the only choice you have."
"Life is not about waiting for the storm to pass... It's learning to dance in the rain."
"You'll never know how strong you are until being strong is the only choice you have."
"Life is not about waiting for the storm to pass... It's learning to dance in the rain."
Hi Karen,
That is a pathetic attempt to evade their responsibilities. Whether or not Entocort is approved by the FDA for treating MC is irrelevant, as long as it is FDA-approved for any use. And it is certainly approved for treating Crohn's disease and UC. The FDA regulations allow doctors to prescribe any FDA-approved medication for any off-label use that they see fit.
So if your doctor prescribed Entocort to treat your MC, then that is a legal and legitimate prescription, and your insurance company cannot deny it on the frivolous claim that you mentioned.
In your letter, point out what I have posted here about the legality of physicians to prescribe FDA-approved drugs for off-label use. Your unscrupulous insurance company probably thinks that all their patients are too naive to know that. Shame on them for trying to cheat their clients.
Tex
That is a pathetic attempt to evade their responsibilities. Whether or not Entocort is approved by the FDA for treating MC is irrelevant, as long as it is FDA-approved for any use. And it is certainly approved for treating Crohn's disease and UC. The FDA regulations allow doctors to prescribe any FDA-approved medication for any off-label use that they see fit.
So if your doctor prescribed Entocort to treat your MC, then that is a legal and legitimate prescription, and your insurance company cannot deny it on the frivolous claim that you mentioned.
In your letter, point out what I have posted here about the legality of physicians to prescribe FDA-approved drugs for off-label use. Your unscrupulous insurance company probably thinks that all their patients are too naive to know that. Shame on them for trying to cheat their clients.
Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
Tor,
Entocort isn't approved by the FDA for treating MC because the manufacturer has never petitioned the FDA for approval for that use. Approval for another disease costs many millions of dollars, and pharmaceutical companies are not willing to spend the money for what they consider to be a "rare" disease that might result in limited sales volume.
Drug companies are only interested in profits, not patient care.
Tex
Entocort isn't approved by the FDA for treating MC because the manufacturer has never petitioned the FDA for approval for that use. Approval for another disease costs many millions of dollars, and pharmaceutical companies are not willing to spend the money for what they consider to be a "rare" disease that might result in limited sales volume.
Drug companies are only interested in profits, not patient care.
Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
Karen,
You might be interested in this quote from pages 39–40 of my book (Microscopic Colitis, published in August, 2012):
You might be interested in this quote from pages 39–40 of my book (Microscopic Colitis, published in August, 2012):
Note the sentence that I've highlighted in red. And the following sentence from that quote is the reason why microscopic colitis is not listed on the label for indicated uses of Entocort EC.There are no FDA approved drugs labeled to treat MC
As of the date of this writing, there are no FDA-approved medications that are labeled to treat microscopic colitis. Consequently, as they have been required to do since the disease was first described, if doctors are to prescribe a medication to treat MC, they are forced to prescribe an existing FDA-approved drug, for off-label use. Off-label use can be described as the practice of prescribing pharmaceuticals for an unapproved indication, or in an unapproved age group, or at an unapproved dosage rate, or by means of an unapproved form of administration.
In the United States, the Food and Drug Administration Center for Drug Evaluation and Research oversees application requests for the approval of new drugs, and in consideration of the data from clinical trials and other information from the manufacturer, the agency determines the safety and suitability of a drug for the specific indications listed in the application for approval before granting approval of the drug. Representatives from the manufacturer and the FDA agree on specific language that will appear on the label, describing ingredients, dosage, methods of administration and any other important information and disclaimers that will appear on the product label.
Since the FDA does not have the legal authority to regulate the practice of medicine, a physician may prescribe a drug for off-label use without FDA approval. While it’s legal for a physician to prescribe a drug for an off-label use, it is not legal for a pharmaceutical company to promote a drug for an off-label use. It would appear that it would behoove pharmaceutical companies to seek labeling approval of their products for any and all possible uses. Unfortunately, though, the research trials and documentation requirements leading up to the FDA approval process tend to be so expensive, that unless the additional market potential is huge, the cost of such additional labeling flexibility can be difficult for the manufacturer to recover.
For decades, ever since its first description, microscopic colitis has mostly been viewed by the medical community as a rare disease, so it’s not particularly surprising that to date at least, no pharmaceutical company has been willing to ante up the money required to obtain FDA approval for any drugs specifically labeled to treat it. Therefore, at present, off-label use is the only option available if the benefits of a prescription drug are desired for the treatment of microscopic colitis.
TexWhile it’s legal for a physician to prescribe a drug for an off-label use, it is not legal for a pharmaceutical company to promote a drug for an off-label use.
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
Karen,
You're most welcome. And sure, you can post it here. We'll be happy to try to help in any way we can.
As far as I can tell, insurance companies are by far the biggest obstacle to health in this country, and I have a hunch that most physicians would agree with me, because they are the ones who have to put up with all that BS and jump through all the hoops on a daily basis as part of their work. All the red tape imposed by insurance companies amounts to a huge drain on physicians' time, and a waste of their resources, and that results in added costs for everyone except the insurance companies.
Tex
You're most welcome. And sure, you can post it here. We'll be happy to try to help in any way we can.
As far as I can tell, insurance companies are by far the biggest obstacle to health in this country, and I have a hunch that most physicians would agree with me, because they are the ones who have to put up with all that BS and jump through all the hoops on a daily basis as part of their work. All the red tape imposed by insurance companies amounts to a huge drain on physicians' time, and a waste of their resources, and that results in added costs for everyone except the insurance companies.
Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
Using what you all so graciously helped me with, and after speaking with my doctor, here is the plan.tex wrote:Karen,
You're most welcome. And sure, you can post it here. We'll be happy to try to help in any way we can.
As far as I can tell, insurance companies are by far the biggest obstacle to health in this country, and I have a hunch that most physicians would agree with me, because they are the ones who have to put up with all that BS and jump through all the hoops on a daily basis as part of their work. All the red tape imposed by insurance companies amounts to a huge drain on physicians' time, and a waste of their resources, and that results in added costs for everyone except the insurance companies.
Tex
1. My place of employment (a university, I am the Executive Assistant to the University President)...write the HR Department and let them know what is going on as this is our RENEWAL year for a 2 year commitment to whatever insurance entity they decide to go with. My letter is in part me with great portions that you have shared as well...and for that I am forever grateful. This letter has already gone out and been replied to. Our HR department will contact our benefits broker, as well as my crappy insurance (HAP Health Alliance Plan...what a crock that is) and look into this. Not only did I send the email below, but I also sent them copies of the documentation that you so wonderfully shared. I've filled out the HIPPA information and we'll see what happens.
LETTER TO HR:
I wanted to share with you some difficulties I am having with HAP insurance.
I have a disease that is very rare. It is called Microscopic Colitis and is an inflammatory bowel disease.
I see a specialist in these diseases at the University of Michigan Gastroenterology Clinic. Last year I was hospitalized with sever dehydration due to this disease, and am constantly ill due to what it has done to my body. I'm ready, willing, and more importantly, able to have relief from this illness.
There is one drug that has been shown to be very effective in the treatment of this disease. This drug is called Budesonide.
My specialist called in this drug for my use. HAP denied it. She called in the generic. HAP denied it. She called in another alternative. HAP denied it. She called in an antibiotic to treat the bacterial overgrowth due to this disease. HAP denied it. I have actually had my physician's insurance specialist (a woman they had to hire to fight insurance companies to pay for patients meds through their grievance process) state that this is one of the worst insurances they deal with for patient care when it comes to medications. HAP only cares about the bottom line. Profit.
I called yesterday to speak to the people at HAP, as they are not returning my physician's emails or calls. My doctor and her office help send "received receipts" so they know that HAP sees her email, they just are not responding. That's actually shameful on their part. In my conversation with them I was told that their pharmacy specialist states that the reason they are not covering these drugs is because they were not FDA approved for the treatment of Microscopic Colitis.
Here's the problem. Microscopic colitis falls into the category of inflammatory bowel disease. These drugs are FDA approved for the treatment of all the "typical and well-known" diseases that fall into the inflammatory bowel disease category, such as crohns and ulcerative colitis. The drug is FDA approved. The only reason it has not been specifically FDA approved for Microscopic Colitis is that the disease is rare and the manufacturer has not petitioned the FDA for approval as it costs millions of dollars for the approval process and this disease is RARE. Pharmaceutical companies are not willing to spend the money for a rare disease that might result in limited sales volume.
HAP is using this fact as a pathetic attempt to evade their responsibility. Whether or nor Budesonide is approved by the FDA for treating Microscopic Colitis is irrelevant, as long as it is FDA-approved for any use. FDA regulations allow doctors to prescribe any FDA-approved medication for any off-label use that they see fit. Again...this is pretty unscrupulous on HAP's part, and I'm sure they think their consumers are too naive to know this. In my case this is utterly untrue.
I am sending you this because I know you are dealing with them now on negotiations for the next two years poor service. Many staff and faculty are complaining that this insurance is a let-down as far as they are concerned. As *PROFESSORS NAME REMOVED FOR PRIVACY* was saying to several of us the other day...when you are in a GROUP insurance, all members of the group agree to pay the premiums with the understanding that some members will need a lot of services, while the majority will need little. The theory behind that is that we all agree to this when we enter into a group insurance. But when that insurance then begins cutting the quality of care, be that in the drugs they refuse that will not only return quality of life, but also cure disease, then we have an issue. It is wrong. HAP is doing just that. Our office was aghast to learn that it doesn't even cover pre-natal vitamins!
Should you care to share this information with them, as I plan to (I would prefer my doctor, myself, and my employer benefits speicialist have a united front in this case), there is superfluous documentation on the effectiveness of Budesonide in the treatment of Microscopic Colitis. Below are links to many substantive reviews, and the chapters about treatment contain referrals to substantial evidence of the efficiency of budesonide in the treating of Microscopic Colitis.
I know I've overloaded you with information, but this is important to me. It is my life.
1. http://www.sciencedirect.com/science/ar ... via%3Dihub
2. http://www.ncbi.nlm.nih.gov/pubmed/22704658
and from the book, Microscopic Colitis, published in August, 2012 by: Wayne Persky
There are no FDA approved drugs labeled to treat MC
As of the date of this writing, there are no FDA-approved medications that are labeled to treat microscopic colitis. Consequently, as they have been required to do since the disease was first described, if doctors are to prescribe a medication to treat MC, they are forced to prescribe an existing FDA-approved drug, for off-label use. Off-label use can be described as the practice of prescribing pharmaceuticals for an unapproved indication, or in an unapproved age group, or at an unapproved dosage rate, or by means of an unapproved form of administration.
In the United States, the Food and Drug Administration Center for Drug Evaluation and Research oversees application requests for the approval of new drugs, and in consideration of the data from clinical trials and other information from the manufacturer, the agency determines the safety and suitability of a drug for the specific indications listed in the application for approval before granting approval of the drug. Representatives from the manufacturer and the FDA agree on specific language that will appear on the label, describing ingredients, dosage, methods of administration and any other important information and disclaimers that will appear on the product label.
Since the FDA does not have the legal authority to regulate the practice of medicine, a physician may prescribe a drug for off-label use without FDA approval. While it’s legal for a physician to prescribe a drug for an off-label use, it is not legal for a pharmaceutical company to promote a drug for an off-label use. It would appear that it would behoove pharmaceutical companies to seek labeling approval of their products for any and all possible uses. Unfortunately, though, the research trials and documentation requirements leading up to the FDA approval process tend to be so expensive, that unless the additional market potential is huge, the cost of such additional labeling flexibility can be difficult for the manufacturer to recover.
For decades, ever since its first description, microscopic colitis has mostly been viewed by the medical community as a rare disease, so it’s not particularly surprising that to date at least, no pharmaceutical company has been willing to ante up the money required to obtain FDA approval for any drugs specifically labeled to treat it. Therefore, at present, off-label use is the only option available if the benefits of a prescription drug are desired for the treatment of microscopic colitis.
Again, it is a shameful fact that HAP knows this works, but refuses it on these grounds. Their reasoning on the benefits of this drug is faulty as it is based on money, and not facts.
~Karen
2. I will write a letter tomorrow (huge event at work today so I have no spare time or breaks to compose it today) to HAP, and send them quite a healthy stack of printouts of the information you have shared.
3. Since I keep an attorney on retainer (my fiance is one) that will be my next step, a letter from him.
and
4. My doctor is going to lean heavily on them.
I'll post the letter to HAP once I have a draft for your help if you are willing to make it as concise and hard-hitting as possible.
Thank you again!
Karen, who knows if someone in Human Resources got MC....that drug would be covered! *nodding big time here*
-
Sheila
- Rockhopper Penguin
- Posts: 1150
- Joined: Wed May 18, 2011 5:10 am
- Location: Palm Beach Gardens, Fl
Congratulations! Great letter and hit them where it hurts, in the pocketbook. In the meantime, you can send your scrip for budesinide to a Canadian pharmacy and pay relatively little. I had to do that because my crap insurance asked for a $600.00 co-pay for generic Entocort, budesinide.
Keep fighting,
Sheila W
Keep fighting,
Sheila W
To get something you never had, you have to do something you never did.
A person who never made a mistake never tried something new. Einstein
A person who never made a mistake never tried something new. Einstein
I am going to attack this insurance issue on many fronts.
I have contacted my HR department here at the university and as I am the President's assistant they are listening to a little more, it seems (which is actually a sad commentary if you think about it).
They are also contacting our insurance broker to bring this up with the insurance company as we are in negotiations with them for the next two year's poor service.
I received my denial paperwork and the information on how to protest this denial, and here is ITEM One in my packet of preparedness :)
It is my medical history, and I don't mind sharing it, because if SOMETHING in this format and packet can help one more of us sock it to the insurance company (fingers crossed and prayer bones dusted that I win this thing)...then I hope others can use it.
Here is part One...MEDICAL HISTORY, which I will back up with medical records from all the years, drugs, and colonoscopies I have had.
October 6, 2015
HAP
ATTN Manager of Appeal and Grievance Department
Detroit, MI 48202
I am writing to appeal the refusal by HAP Insurance to cover the drug Entocort (budesonide) for the treatment of my Microscopic Colitis.
First I would like to tell you a bit of my bowel history, as it pertains to this diagnosis, my symptoms and treatments I have tried in the past.
[picture inserted here] I want you to also know about me and how this impacts my daily life. To that end, I am sharing a photo of myself with my granddaughter. I’m not just a statistic, I’m not just an insurance policy holder, or number in the long lists of case numbers you look at daily. I am a person of value and worth who has seen her life get progressively harder due to disease. I know you are aware of all the above, but I’d like to put a face to this letter of dispute and to pause and think what the seeming revenue-driven decisions are doing to me and my family.
My first indication that something was wrong with me began in my 20’s. I began having intense abdominal pain and severe watery diarrhea. I thought it may be something I was eating, put myself on a bland diet and eventually found my way to my general practitioner who put me on dicyclomine in an effort to stop the urgency. He then told me to stop “bulking,” which he described was drinking liquid with a meal, and see if that helped. It did not. He then directed me to continue on the bland diet and ordered a sigmoidoscopy, after which he declared me an IBS patient and told me to take fiber and work around the disorder.
In my 30’s my symptoms, and their impact, became worse. Cramping that would wake me in the night, along with ribbon stools and persistent diarrhea. I was next seen at the University of Michigan Gastroenterology Clinic where I had a colonoscopy and was again told IBS, told to continue to limit bulking when eating, and learned quickly the humiliation of stopping along highways and roadsides, as there were countless times couldn’t make it to where I needed to be in time. The University of Michigan doctors suggested I experiment with a lactose free diet, which I did for 4 to 5 months with no significant improvement. They also had me continue with Bentyl (dicyclomine), and added Imodium. Imodium did stop the diarrhea and in my case it caused constipation that required me using enemas to go at all when I took it.
In my 40’s I began being seen at the Huron Gastroenterology Associates out of St. Joseph Hospital in Ypsilanti, MI. The doctors there recognized my ailment and tried a number of treatments. I tried Amitriptyline a couple of times but only for a short period of time as it made me dizzy, had trouble driving and made me feel generally unwell. They then wanted to try Cholestyramine, a drug I was told would bind the bile salts and hopefully make that diarrhea stop. It didn’t work and also had the effect of bloating me and causing a distended abdomen and pain. They next tried Lomotil (Diphenoxylate/Atropine) which did help hold back the diarrhea, but only served to cause constipation with watery, explosive diarrhea behind that. My abdomen hurt all the time.
These doctors did try their best, and I had many colonoscopies in my time with them. I ended up with a combo of lomotil/bentyl and learned to rearrange my days so that I could have a somewhat productive life with what they also deemed as IBS.
When I say, learning to rearrange my days that would mean no eating at work without a bathroom within a short distance. That would mean going out to the movies, not eating, and THEN heading to dinner if we ate within a few miles of our home. If we were going out for a longer evening, I’d have to take a regimen of preventative doses of Lomotil prior to leaving and then know that the next day, I’d end up with a torn rectum, passing the constipation that was being pressured from behind from the diarrhea just behind it. It was miserable. On several occasions I literally had to have my husband pull over on a busy highway, run down the embankment or into the wooded areas nearby and relieve myself as there was no stopping it! I learned to travel with toilet paper and to check my modesty at the door when going out.
In my 50’s the diarrhea has now become a constant. It is water. No form. Just water. Gushing water. I liken it to (for those of you reviewing this and have had a colonoscopy) the water that comes out when you prep for a colonoscopy. I bleed all the time rectally because I am constantly going to the bathroom. I’ve tried various barrier applications, even using water in a squirt bottle to try and rush water on those sore tissues as I go, but the fact remains, I’m sore. On top of that I have anal lichen sclerosis. Not a great combination.
Last year I had two trips to the emergency room, one leaving me hospitalized with severe dehydration due to this disease.
I work Monday – Friday. I love my job and am excellent at it. I am also in the bathroom from 8-12 times per day in a working day. That’s even with the use of Lomotil, Pepto Bismol and Bentyl. I am fortunate that a bathroom is near my office door. There are days I’d much rather stay home as I feel so bad, but I cannot. I must work. My abdomen distends, nausea ensues, and daily, within 5 minutes of eating anything, I am in the bathroom with diarrhea. This has become my life’s reality.
I miss my grandchildren’s soccer games. Seeing their grandmother up and running to the port a john up to 5-6 times per game isn’t a proud moment for them or me.
I cannot sleep at night. I am sometimes awoken 5-6 times a night with cramping, bloating and diarrhea.
It’s a pretty sad quality of life. My life revolves around diarrhea. My life revolves around the pain and discomfort that comes with diarrhea.
In the past couple of months I found my way again to the University of Michigan Gastroenterology Clinic and am under the care of Dr. ------------. She’s a good doctor. Skilled and knowledgeable. FINALLY, when I went in, someone listened wholeheartedly. She saw how sick I was. At that point I was going to the bathroom up to 15-20 times per day. I was weary. Nauseated. Sore. She suggested a colonoscopy again. I’ve had so many and had even thought to say “no” as all I’d hear is more IBS.
But not so with Dr. ---------. She heard and had the knowledge of a rare condition called Microscopic Colitis. This disease means you produce massive amounts of water diarrhea. I went in for the colonscopy and she did the necessary things via biopsy and this is when we found what had been going on all these years. Lymphocytic Colitis which is part of the Microscopic Colitis family. Microscopic Colitis is part of the Inflammatory Bowel Disease family.
Dr. -----------, being a specialist and with the knowledge of what would work best for me (as well as what hasn’t in past treatments) suggested we try a low dose steroid which had long term effects in not treating the symptoms of Microscopic Colitis, but dealing with the disease itself. She told me that this drug is and has been the drug of choice for treating Microscopic Colitis. It was called Entocort (Budesonide).
Dr. -------- called the drug in to my pharmacy where we were informed that HAP would not cover the drug. She called in a generic. We were also told they would not cover that! She also tried to call in an antibiotic to treat the bacterial overgrowth I had due to this disease, and was told they would not cover that either!
So there is the background information on my health and how we got to this point. A point where I was finally able to see a light at the end of the tunnel, only to have HAP promptly snuff it out in what can only be described as a near-sighted, revenue-driven decision.
*******************
I have not sent this yet, if there are any corrections you see that need to be completed, please feel free to help a sister out!
I'll next post section 2 which is a discussion of Budesonide for the treatment of MC.
I have contacted my HR department here at the university and as I am the President's assistant they are listening to a little more, it seems (which is actually a sad commentary if you think about it).
They are also contacting our insurance broker to bring this up with the insurance company as we are in negotiations with them for the next two year's poor service.
I received my denial paperwork and the information on how to protest this denial, and here is ITEM One in my packet of preparedness :)
It is my medical history, and I don't mind sharing it, because if SOMETHING in this format and packet can help one more of us sock it to the insurance company (fingers crossed and prayer bones dusted that I win this thing)...then I hope others can use it.
Here is part One...MEDICAL HISTORY, which I will back up with medical records from all the years, drugs, and colonoscopies I have had.
October 6, 2015
HAP
ATTN Manager of Appeal and Grievance Department
Detroit, MI 48202
I am writing to appeal the refusal by HAP Insurance to cover the drug Entocort (budesonide) for the treatment of my Microscopic Colitis.
First I would like to tell you a bit of my bowel history, as it pertains to this diagnosis, my symptoms and treatments I have tried in the past.
[picture inserted here] I want you to also know about me and how this impacts my daily life. To that end, I am sharing a photo of myself with my granddaughter. I’m not just a statistic, I’m not just an insurance policy holder, or number in the long lists of case numbers you look at daily. I am a person of value and worth who has seen her life get progressively harder due to disease. I know you are aware of all the above, but I’d like to put a face to this letter of dispute and to pause and think what the seeming revenue-driven decisions are doing to me and my family.
My first indication that something was wrong with me began in my 20’s. I began having intense abdominal pain and severe watery diarrhea. I thought it may be something I was eating, put myself on a bland diet and eventually found my way to my general practitioner who put me on dicyclomine in an effort to stop the urgency. He then told me to stop “bulking,” which he described was drinking liquid with a meal, and see if that helped. It did not. He then directed me to continue on the bland diet and ordered a sigmoidoscopy, after which he declared me an IBS patient and told me to take fiber and work around the disorder.
In my 30’s my symptoms, and their impact, became worse. Cramping that would wake me in the night, along with ribbon stools and persistent diarrhea. I was next seen at the University of Michigan Gastroenterology Clinic where I had a colonoscopy and was again told IBS, told to continue to limit bulking when eating, and learned quickly the humiliation of stopping along highways and roadsides, as there were countless times couldn’t make it to where I needed to be in time. The University of Michigan doctors suggested I experiment with a lactose free diet, which I did for 4 to 5 months with no significant improvement. They also had me continue with Bentyl (dicyclomine), and added Imodium. Imodium did stop the diarrhea and in my case it caused constipation that required me using enemas to go at all when I took it.
In my 40’s I began being seen at the Huron Gastroenterology Associates out of St. Joseph Hospital in Ypsilanti, MI. The doctors there recognized my ailment and tried a number of treatments. I tried Amitriptyline a couple of times but only for a short period of time as it made me dizzy, had trouble driving and made me feel generally unwell. They then wanted to try Cholestyramine, a drug I was told would bind the bile salts and hopefully make that diarrhea stop. It didn’t work and also had the effect of bloating me and causing a distended abdomen and pain. They next tried Lomotil (Diphenoxylate/Atropine) which did help hold back the diarrhea, but only served to cause constipation with watery, explosive diarrhea behind that. My abdomen hurt all the time.
These doctors did try their best, and I had many colonoscopies in my time with them. I ended up with a combo of lomotil/bentyl and learned to rearrange my days so that I could have a somewhat productive life with what they also deemed as IBS.
When I say, learning to rearrange my days that would mean no eating at work without a bathroom within a short distance. That would mean going out to the movies, not eating, and THEN heading to dinner if we ate within a few miles of our home. If we were going out for a longer evening, I’d have to take a regimen of preventative doses of Lomotil prior to leaving and then know that the next day, I’d end up with a torn rectum, passing the constipation that was being pressured from behind from the diarrhea just behind it. It was miserable. On several occasions I literally had to have my husband pull over on a busy highway, run down the embankment or into the wooded areas nearby and relieve myself as there was no stopping it! I learned to travel with toilet paper and to check my modesty at the door when going out.
In my 50’s the diarrhea has now become a constant. It is water. No form. Just water. Gushing water. I liken it to (for those of you reviewing this and have had a colonoscopy) the water that comes out when you prep for a colonoscopy. I bleed all the time rectally because I am constantly going to the bathroom. I’ve tried various barrier applications, even using water in a squirt bottle to try and rush water on those sore tissues as I go, but the fact remains, I’m sore. On top of that I have anal lichen sclerosis. Not a great combination.
Last year I had two trips to the emergency room, one leaving me hospitalized with severe dehydration due to this disease.
I work Monday – Friday. I love my job and am excellent at it. I am also in the bathroom from 8-12 times per day in a working day. That’s even with the use of Lomotil, Pepto Bismol and Bentyl. I am fortunate that a bathroom is near my office door. There are days I’d much rather stay home as I feel so bad, but I cannot. I must work. My abdomen distends, nausea ensues, and daily, within 5 minutes of eating anything, I am in the bathroom with diarrhea. This has become my life’s reality.
I miss my grandchildren’s soccer games. Seeing their grandmother up and running to the port a john up to 5-6 times per game isn’t a proud moment for them or me.
I cannot sleep at night. I am sometimes awoken 5-6 times a night with cramping, bloating and diarrhea.
It’s a pretty sad quality of life. My life revolves around diarrhea. My life revolves around the pain and discomfort that comes with diarrhea.
In the past couple of months I found my way again to the University of Michigan Gastroenterology Clinic and am under the care of Dr. ------------. She’s a good doctor. Skilled and knowledgeable. FINALLY, when I went in, someone listened wholeheartedly. She saw how sick I was. At that point I was going to the bathroom up to 15-20 times per day. I was weary. Nauseated. Sore. She suggested a colonoscopy again. I’ve had so many and had even thought to say “no” as all I’d hear is more IBS.
But not so with Dr. ---------. She heard and had the knowledge of a rare condition called Microscopic Colitis. This disease means you produce massive amounts of water diarrhea. I went in for the colonscopy and she did the necessary things via biopsy and this is when we found what had been going on all these years. Lymphocytic Colitis which is part of the Microscopic Colitis family. Microscopic Colitis is part of the Inflammatory Bowel Disease family.
Dr. -----------, being a specialist and with the knowledge of what would work best for me (as well as what hasn’t in past treatments) suggested we try a low dose steroid which had long term effects in not treating the symptoms of Microscopic Colitis, but dealing with the disease itself. She told me that this drug is and has been the drug of choice for treating Microscopic Colitis. It was called Entocort (Budesonide).
Dr. -------- called the drug in to my pharmacy where we were informed that HAP would not cover the drug. She called in a generic. We were also told they would not cover that! She also tried to call in an antibiotic to treat the bacterial overgrowth I had due to this disease, and was told they would not cover that either!
So there is the background information on my health and how we got to this point. A point where I was finally able to see a light at the end of the tunnel, only to have HAP promptly snuff it out in what can only be described as a near-sighted, revenue-driven decision.
*******************
I have not sent this yet, if there are any corrections you see that need to be completed, please feel free to help a sister out!
I'll next post section 2 which is a discussion of Budesonide for the treatment of MC.
Section two
My US Congressman has contacted me and will also be receiving all of the enclosures and things I am sharing here. My fiance is an attorney who works with a group of attorneys and they will also help if need be. If I don't win this appeal it will not be from lack of trying! *nods*
Section two is in support of Budesonide for the treatment of MC.
I will be enclosing the articles shared with me here, as well as other articles I have found (got to love university databases) that I have found on lymphocytic colitis and budesonide, from all over the world.
******************************
This document is to discuss with you several things.
1. This disease is and has been treated quite successfully with budesonide
2. There is research and much documentation to that effect
3. This treatment is used world-wide in the treatment of Microscopic Colitis
4. This treatment has been prescribed by a professional in the Gastroenterology field
5. It has been approved by the FDA for the treatment of other Inflammatory Bowel Diseases such as crohns and ulcerative colitis
There is one drug that has been shown to be very effective in the treatment of this disease. Budesonide. This drug not only treats the symptoms, but also the disease itself.
My specialist, Dr. ---------- of the University of Michigan, a board certified expert in her field, has prescribed this drug for my use. HAP denied it. She called in the generic. HAP denied that as well. She then called in an antibiotic to treat the bacterial overgrowth due to this disease. HAP denied it.
I called to speak to the people at HAP, as they are not returning my physician's emails. My doctor, and her office staff, send "receive receipts" with their messages, so they know that HAP sees her emails. However, HAP has, to this point, not responded other than the recently received letter (I received, I assume she does as well). That’s shameful and negligent behavior for an insurance company. In my conversation with HAP I was told that their pharmacy specialist states that the reason they are not covering this drug is because budesonide is not FDA approved for the treatment of Microscopic Colitis.
Here's the problem. Microscopic colitis is considered a RARE disease that falls into the category of inflammatory bowel disease. These drugs are FDA approved for the treatment of all the "typical and well-known” diseases that fall into the inflammatory bowel disease category, such as crohns and ulcerative colitis. This drug is FDA approved. The only reason it has not been specifically FDA approved for Microscopic Colitis is that the disease is considered rare and the manufacturer has not petitioned the FDA for specific approval due to costs for the approval process and the limited returns from such a rare disorder.
I feel HAP is using this claim as a sad attempt to evade their patient responsibility. Whether or not Budesonide is approved by the FDA for treating Microscopic Colitis is irrelevant, as long as it is FDA-approved for any use. FDA regulations allow doctors to prescribe any FDA-approved medication for any off-label use that they see fit. In this case, it isn’t even off-label as it is used and approved for other Inflammatory Bowel diseases.
This is pretty unscrupulous behavior on HAP's part. Perhaps you are used to dealing with consumers that are too naive to know this. In my case this is utterly untrue.
Enclosed you will find a vast array of documentation on the effectiveness of Budesonide in the treatment of Microscopic Colitis. Below are links to many substantive reviews, and the chapters about treatment contain referrals to substantial evidence of the efficiency of budesonide in the treating of Microscopic Colitis.
This is just the tip of the iceberg when it comes to sending documentation of this disease and the effective use of budesonide in the treatment of Microscopic Colitis. I could send superfluous amounts of studies from all over the world explaining the benefits for long-term help on this drug. I could send reams and reams of paper to show you the studies, but the truth of the matter is - it works! I believe that through this documentation a reasonable person would see that it is an inflammatory bowel disease, it is helped a great deal through the use of budesonide, and it does have FDA approval.
Something is very wrong there if an informed patient can find this much information on this disease and the effective treatment of it, and your medical staff lacks this knowledge.
1. http://www.sciencedirect.com/science/ar ... via%3Dihub
2. http://www.ncbi.nlm.nih.gov/pubmed/22704658
Below is more evidence from the book, Microscopic Colitis, published in August, 2012 by: Wayne Persky
There are no FDA approved drugs labeled to treat MC
As of the date of this writing, there are no FDA-approved medications that are labeled to treat microscopic colitis. Consequently, as they have been required to do since the disease was first described, if doctors are to prescribe a medication to treat MC, they are forced to prescribe an existing FDA-approved drug, for off-label use. Off-label use can be described as the practice of prescribing pharmaceuticals for an unapproved indication, or in an unapproved age group, or at an unapproved dosage rate, or by means of an unapproved form of administration.
In the United States, the Food and Drug Administration Center for Drug Evaluation and Research oversees application requests for the approval of new drugs, and in consideration of the data from clinical trials and other information from the manufacturer, the agency determines the safety and suitability of a drug for the specific indications listed in the application for approval before granting approval of the drug. Representatives from the manufacturer and the FDA agree on specific language that will appear on the label, describing ingredients, dosage, methods of administration and any other important information and disclaimers that will appear on the product label.
Since the FDA does not have the legal authority to regulate the practice of medicine, a physician may prescribe a drug for off-label use without FDA approval. While it’s legal for a physician to prescribe a drug for an off-label use, it is not legal for a pharmaceutical company to promote a drug for an off-label use. It would appear that it would behoove pharmaceutical companies to seek labeling approval of their products for any and all possible uses. Unfortunately, though, the research trials and documentation requirements leading up to the FDA approval process tend to be so expensive, that unless the additional market potential is huge, the cost of such additional labeling flexibility can be difficult for the manufacturer to recover.
For decades, ever since its first description, microscopic colitis has mostly been viewed by the medical community as a rare disease, so it’s not particularly surprising that to date at least, no pharmaceutical company has been willing to ante up the money required to obtain FDA approval for any drugs specifically labeled to treat it. Therefore, at present, off-label use is the only option available if the benefits of a prescription drug are desired for the treatment of microscopic colitis.
I have taken the time to highlight the word budesonide in each article/study/write-up on budesonide and its effective treatment of Microscopic Colitis to make it easier for your reference.
I feel that if it is a shameful fact that HAP knows this drug works, but refuses to let it be prescribed because, it is not FDA approved for the treatment of Microscopic Colitis specifically, although it is approved for the treatment of Inflammatory Bowel disease of which Microscopic Colitis is a member of the spectrum, that is just wrong. The reasoning of HAP seems to be more based on the company’s P&L and less on patient care and well-being.
I ask you to reconsider your decision not to allow a drug you know will work, especially when faced with the fact that I’ve tried all the other things listed for years to no avail. In fact, the symptoms are getting worse. In the meantime I have gone gluten, dairy and soy free in an effort to do all I can to help myself toward feeling better.
All I need now is your help as well.
If after reading all the literature I am sending, you still feel that you cannot approve the drug, I will at that time have to consider the other options listed in your letter to me dated September 29, 2015.
I am sure an attorney, as well as my congressman, can review it, and after consulting educated and licensed physicians and researchers who specialize in this type of illness, come to an educated opinion using an objective mind. The kind of opinion not driven by the bottom line and shortsightedness.
In discussing this with a group of colleagues at the university one professor said to me, “Karen, this is shameful, we all join a group insurance with the understanding that we will all pay, the university will pay. Some of us will use the insurance a great deal, others not a lot, but we all know this going in. For an insurance to tell you that they get to decide that a promising drug will not help you is a disservice to all we that pay into it in good faith.” He’s right.
I look forward to a productive working relationship and your consideration of all of the items enclosed. I am awaiting medical records from my time with Blue Cross to share pharmaceutical history and can forward that when it arrives.
My US Congressman has contacted me and will also be receiving all of the enclosures and things I am sharing here. My fiance is an attorney who works with a group of attorneys and they will also help if need be. If I don't win this appeal it will not be from lack of trying! *nods*
Section two is in support of Budesonide for the treatment of MC.
I will be enclosing the articles shared with me here, as well as other articles I have found (got to love university databases) that I have found on lymphocytic colitis and budesonide, from all over the world.
******************************
This document is to discuss with you several things.
1. This disease is and has been treated quite successfully with budesonide
2. There is research and much documentation to that effect
3. This treatment is used world-wide in the treatment of Microscopic Colitis
4. This treatment has been prescribed by a professional in the Gastroenterology field
5. It has been approved by the FDA for the treatment of other Inflammatory Bowel Diseases such as crohns and ulcerative colitis
There is one drug that has been shown to be very effective in the treatment of this disease. Budesonide. This drug not only treats the symptoms, but also the disease itself.
My specialist, Dr. ---------- of the University of Michigan, a board certified expert in her field, has prescribed this drug for my use. HAP denied it. She called in the generic. HAP denied that as well. She then called in an antibiotic to treat the bacterial overgrowth due to this disease. HAP denied it.
I called to speak to the people at HAP, as they are not returning my physician's emails. My doctor, and her office staff, send "receive receipts" with their messages, so they know that HAP sees her emails. However, HAP has, to this point, not responded other than the recently received letter (I received, I assume she does as well). That’s shameful and negligent behavior for an insurance company. In my conversation with HAP I was told that their pharmacy specialist states that the reason they are not covering this drug is because budesonide is not FDA approved for the treatment of Microscopic Colitis.
Here's the problem. Microscopic colitis is considered a RARE disease that falls into the category of inflammatory bowel disease. These drugs are FDA approved for the treatment of all the "typical and well-known” diseases that fall into the inflammatory bowel disease category, such as crohns and ulcerative colitis. This drug is FDA approved. The only reason it has not been specifically FDA approved for Microscopic Colitis is that the disease is considered rare and the manufacturer has not petitioned the FDA for specific approval due to costs for the approval process and the limited returns from such a rare disorder.
I feel HAP is using this claim as a sad attempt to evade their patient responsibility. Whether or not Budesonide is approved by the FDA for treating Microscopic Colitis is irrelevant, as long as it is FDA-approved for any use. FDA regulations allow doctors to prescribe any FDA-approved medication for any off-label use that they see fit. In this case, it isn’t even off-label as it is used and approved for other Inflammatory Bowel diseases.
This is pretty unscrupulous behavior on HAP's part. Perhaps you are used to dealing with consumers that are too naive to know this. In my case this is utterly untrue.
Enclosed you will find a vast array of documentation on the effectiveness of Budesonide in the treatment of Microscopic Colitis. Below are links to many substantive reviews, and the chapters about treatment contain referrals to substantial evidence of the efficiency of budesonide in the treating of Microscopic Colitis.
This is just the tip of the iceberg when it comes to sending documentation of this disease and the effective use of budesonide in the treatment of Microscopic Colitis. I could send superfluous amounts of studies from all over the world explaining the benefits for long-term help on this drug. I could send reams and reams of paper to show you the studies, but the truth of the matter is - it works! I believe that through this documentation a reasonable person would see that it is an inflammatory bowel disease, it is helped a great deal through the use of budesonide, and it does have FDA approval.
Something is very wrong there if an informed patient can find this much information on this disease and the effective treatment of it, and your medical staff lacks this knowledge.
1. http://www.sciencedirect.com/science/ar ... via%3Dihub
2. http://www.ncbi.nlm.nih.gov/pubmed/22704658
Below is more evidence from the book, Microscopic Colitis, published in August, 2012 by: Wayne Persky
There are no FDA approved drugs labeled to treat MC
As of the date of this writing, there are no FDA-approved medications that are labeled to treat microscopic colitis. Consequently, as they have been required to do since the disease was first described, if doctors are to prescribe a medication to treat MC, they are forced to prescribe an existing FDA-approved drug, for off-label use. Off-label use can be described as the practice of prescribing pharmaceuticals for an unapproved indication, or in an unapproved age group, or at an unapproved dosage rate, or by means of an unapproved form of administration.
In the United States, the Food and Drug Administration Center for Drug Evaluation and Research oversees application requests for the approval of new drugs, and in consideration of the data from clinical trials and other information from the manufacturer, the agency determines the safety and suitability of a drug for the specific indications listed in the application for approval before granting approval of the drug. Representatives from the manufacturer and the FDA agree on specific language that will appear on the label, describing ingredients, dosage, methods of administration and any other important information and disclaimers that will appear on the product label.
Since the FDA does not have the legal authority to regulate the practice of medicine, a physician may prescribe a drug for off-label use without FDA approval. While it’s legal for a physician to prescribe a drug for an off-label use, it is not legal for a pharmaceutical company to promote a drug for an off-label use. It would appear that it would behoove pharmaceutical companies to seek labeling approval of their products for any and all possible uses. Unfortunately, though, the research trials and documentation requirements leading up to the FDA approval process tend to be so expensive, that unless the additional market potential is huge, the cost of such additional labeling flexibility can be difficult for the manufacturer to recover.
For decades, ever since its first description, microscopic colitis has mostly been viewed by the medical community as a rare disease, so it’s not particularly surprising that to date at least, no pharmaceutical company has been willing to ante up the money required to obtain FDA approval for any drugs specifically labeled to treat it. Therefore, at present, off-label use is the only option available if the benefits of a prescription drug are desired for the treatment of microscopic colitis.
I have taken the time to highlight the word budesonide in each article/study/write-up on budesonide and its effective treatment of Microscopic Colitis to make it easier for your reference.
I feel that if it is a shameful fact that HAP knows this drug works, but refuses to let it be prescribed because, it is not FDA approved for the treatment of Microscopic Colitis specifically, although it is approved for the treatment of Inflammatory Bowel disease of which Microscopic Colitis is a member of the spectrum, that is just wrong. The reasoning of HAP seems to be more based on the company’s P&L and less on patient care and well-being.
I ask you to reconsider your decision not to allow a drug you know will work, especially when faced with the fact that I’ve tried all the other things listed for years to no avail. In fact, the symptoms are getting worse. In the meantime I have gone gluten, dairy and soy free in an effort to do all I can to help myself toward feeling better.
All I need now is your help as well.
If after reading all the literature I am sending, you still feel that you cannot approve the drug, I will at that time have to consider the other options listed in your letter to me dated September 29, 2015.
I am sure an attorney, as well as my congressman, can review it, and after consulting educated and licensed physicians and researchers who specialize in this type of illness, come to an educated opinion using an objective mind. The kind of opinion not driven by the bottom line and shortsightedness.
In discussing this with a group of colleagues at the university one professor said to me, “Karen, this is shameful, we all join a group insurance with the understanding that we will all pay, the university will pay. Some of us will use the insurance a great deal, others not a lot, but we all know this going in. For an insurance to tell you that they get to decide that a promising drug will not help you is a disservice to all we that pay into it in good faith.” He’s right.
I look forward to a productive working relationship and your consideration of all of the items enclosed. I am awaiting medical records from my time with Blue Cross to share pharmaceutical history and can forward that when it arrives.
-
Sheila
- Rockhopper Penguin
- Posts: 1150
- Joined: Wed May 18, 2011 5:10 am
- Location: Palm Beach Gardens, Fl
Perfect letter, Karen. I'm so sorry it has taken so long for you to be diagnosed.
You're correct, insurance companies don't think of their insureds as human beings. I personally know several horrible stories of inhumane treatment of very sick people by insurance companies. It is wrong and because insurance companies are so powerful and have so many of our elected representatives in their pockets, it won't change anytime soon.
Good luck and please let us know what happens.
Sheila W
You're correct, insurance companies don't think of their insureds as human beings. I personally know several horrible stories of inhumane treatment of very sick people by insurance companies. It is wrong and because insurance companies are so powerful and have so many of our elected representatives in their pockets, it won't change anytime soon.
Good luck and please let us know what happens.
Sheila W
To get something you never had, you have to do something you never did.
A person who never made a mistake never tried something new. Einstein
A person who never made a mistake never tried something new. Einstein
Thank you, Sheila.Sheila wrote:Perfect letter, Karen. I'm so sorry it has taken so long for you to be diagnosed.
You're correct, insurance companies don't think of their insureds as human beings. I personally know several horrible stories of inhumane treatment of very sick people by insurance companies. It is wrong and because insurance companies are so powerful and have so many of our elected representatives in their pockets, it won't change anytime soon.
Good luck and please let us know what happens.
Sheila W
I'm a fighter. When I got here and read all about diet and what things most cut out to help, I was on it right away. I'll tell you this, my bloating is down to a 2 month pregnancy size from a 6 months! I credit that to diet change. It could also be the half a bottle of pepto I feel I guzzle a day too, but who knows. Maybe both.
Fingers crossed that the documentation and letters do it!