Author Topic: IVIG Availability in Sjögren's Syndrome and Polymyositis  (Read 607 times)

vrystaat

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IVIG Availability in Sjögren's Syndrome and Polymyositis
« on: July 02, 2019, 12:57:26 PM »
I have both of these debilitating diseases since 1992.
I have been a patient of elite Universities in Los Angeles, high-end researchers and well-qualified Rheumatologists in California.
I have been tried on Imuran, Cellcept, high dose Prednisone, Methotrexate and IVIG.

Recently the Rheumatology Group in Los Angeles have adversely tightened up the indications and use of IVIG.
They have declined to give it to me two weeks ago, citing recent restrictions on its use due to some reported incidents of thrombosis and mini-strokes. I have neither of these.
My Sjögren's Syndrome and Polymyositis severity have doubled in 2018 and 2019, and I fulfill the Medicare criteria.
So I am suspicious of their motives, particularly the expense of the drug and its shortages. They cite an inconclusive diagnosis of Inclusion Body Myositis in me and Medicare restrictions.
I don't believe them. There is a great shortage of Rheumatologists in the Western States and many practitioners are unskilled, and/or too busy.
I am now stuck in no-mans' land, and am thinking of other ways to get IVIG.
Any thoughts would be helpful.
Best wishes
Sjogrens;Polymyositis;Polyneuropathy;Gastritis;GERD, Autonomic Neuropathy, Neurological complications, Trigeminal Neuralgia,Gamma 3 globulin low;Multiple infections;Brain fog; Ocular problems - blepharitis, scleritiis, dry eye,severe eye pain. Possible Inclusion body Myositis.Currently Endstage

irish

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Re: IVIG Availability in Sjögren's Syndrome and Polymyositis
« Reply #1 on: July 02, 2019, 03:43:31 PM »
I have been on IVIG since 2006 for Myasthebia travis which has been on their list of diseases that can be treated by IVIG and response by IVIG. One generally has to have an approved medical condition to get IVIG in the first place. Over the years there have been times when IVIG has been used on other issues but everyone who is given IVIG has to go through this committee who approves IVIG for that particular use.

I suspect that they rate not using the IVIG for any unusual reason lately. Reason being: there is a real shortage of IVIG products lately. I mean the biggest shortage I have seen in my 12+ years. They ran out of my product for May and had to give me another product which was much more expensive and they let me know they were losing money on me. Thankfully they got my product in for June.

This bad shortage has been coming for months and years. There has been an increase in patients with autoimmune diseases and with other disease issues that are now proving to need IVIG for control. The issue is a shortage of people giving blood for the products. Each IVIG product takes blood from between 2000 and 10,000 people to get all the antibodies etc that area needed. It is an expensive deal. Look up the factories or company centers where they make these products. Total sterile, stainless steel, hugely high tech operation. You can find these pictures on line. Do a search on Boehring IVIG and see if you can find the pictures of their production centers. I hope I spelled it right. They are in Germany I believe.

Now, Because I receive IVIG my infusion center see that I get a small mag called IG Living. I have received it since 2006 about 5 times a year or so. On the back 2-3 pages there is always the List of approved diseases for the IVIG. I will list them now.
Ataxia Teleangiectasis (A-T)                                                 Miltiple Sclerosis (MS)
      Evans Syndrome                                                               Myasthenia Gravis (MG)
Chronic Inflammatory Demyelinating Polyneurolpathy (CIDP)   Myositis
      Guillain-Barre Syndrome (GBS)                                           PANDAS...see below
Idiopathic Thrombocypenic Purpura (ITP)                               Pemphigus and Pemphigoid
      Kawasaki Disease                                                                Peripheral Neuoropathy (PN)
Mitochondrial Disease                                                           Primary Immune Deficiency Disease (PI)
      Multifocal Motor Neuropathy (MMN)                                       Scleroderma
                                                                                           Stiff Person Syndrome (SPS)

PANDAS is : Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus....This is a new disorder that has just been identified in the past few years. Occurs in children and is devastating. IVIG saves them!!!

Will start another section. Irish

irish

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Re: IVIG Availability in Sjögren's Syndrome and Polymyositis
« Reply #2 on: July 02, 2019, 03:56:00 PM »
I was going to run out of words!!! Now, all these listed diseases are the approved diseases for IVIG. Obviously there have been more people getting IVIG but it is because they have had their names submitted to the committee and have been approved. I forget how many people on the committee, but they take their job seriously. The amount of people  wane and ebb depending on the supply of the products.

I had diagnosed Sjogrens when I started in 2006 and I have been on 4 different products and the Sjogrens has had not change. I am loaded with lots of weird things such as pancreatic insufficiency, BAM (this is a diagnosis) Both of these really have done a job on me plus I have a lot more that has gotten worse including neuropathy of everything including possibly the discs in the spinal cord.

However, IVIG has kept my Myasthenia gravis somewhat under control. It has helped my Pemphigoid and my Primary Immune issues under control. The last three diagnoses were helped as a secondary result.

I have have seen a lot of people come on here who have had IVIG and other products and Sjogrens is a bugger. Some people on Rituximab have had some good results. My son has AID and his insurance company is refusing to pay for Rituximab for him. We are in a place where people are being refused the big gun meds by the insurance companies and the IVIG is running short.

I would not be surprised if I would get dropped or have to pay some. MY insurance company has been paying thankfully all these years. I am a retired RN and have tried to keep up with this stuff but I am running out of steam. Do a search on companies producing IVIG products and see if you can find more info. Good luck. Irish

irish

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Re: IVIG Availability in Sjögren's Syndrome and Polymyositis
« Reply #3 on: July 02, 2019, 04:12:35 PM »
Why didn't these 2 posts show up as posted by irish????

irish

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Re: IVIG Availability in Sjögren's Syndrome and Polymyositis
« Reply #4 on: July 02, 2019, 04:13:18 PM »
OK  I must have done something!!!!!?????? Irish

irish

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Re: IVIG Availability in Sjögren's Syndrome and Polymyositis
« Reply #5 on: July 02, 2019, 04:17:37 PM »

there is something not right with this...I lose my name in the right hand column on its page.

Carolina

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Re: IVIG Availability in Sjögren's Syndrome and Polymyositis
« Reply #6 on: July 03, 2019, 04:58:12 AM »
Dear Vrystaat and Irish,

I just had my IVIG infusion yesterday.  I have Primary Immune Deficiency.  A nurse comes to my house and manages the IVIG, and stays with me while I am infusing, which takes about 3 hours.

IVIG is an infusion of the antibody IgG, which is one of the antibodies that my body does not produce in sufficient amounts.

Before I began IVIG in 2013, the amount of IgG in my blood was 388 on a scale of normal IgG of 588 - 1588.

I was sick all of the time, one infection after another.

Now my IgG level is 1020 and I have had only two major infections in 6 years. But if my IVIG infusions stopped, my IgG level would drop again to well below normal.

I have my infusion of 30 grams of Gammunex every four weeks (13 times a year).  Each infusion is billed at $15,000.  Medicare and my medicare supplement pay for all of the costs.  I surely couldn't pay this amount even once a year, on my own!

I will have this infusion of IVG for the rest of my life, because my body does not produce the IgG I need to fight infection.  One infusion of IVIG lasts about 4 weeks, then it is gone from my body.

My IVIG product is one that is in very short supply.  Last Spring the company that supplies my IgG wanted to switch me to another product.  However, my Immunologist would not approve this switch, and I am still on the product I've been on for 6 years.

The key, as I understand it, to approval for IVIG is the ability of the prescribing Immunologist (or other physician) to submit compelling evidence for approval.  The FDA sets the criteria for what conditions can be treated with IVIG.  Irish listed the current conditions that are eligible.  But within each condition there are criteria beyond the diagnosis.
 
To be approved for IVIG for my condition, Primary Immune Deficiency Disease, I had to meet the criteria of 1. deficiency in TWO antibodies (far below the normal range),  I am deficient in IgG and IgM, 2. failure to achieve immunity when given the Pneumovax vaccine, and 3. a compelling history of infection/illness.  If I did not meet all three criteria, I would not have been approved.

While I have been on IVIG, in the past 6 years, my Immune Mediated Neuropathy has progressed to damage more and more parts of my body, my Dryness has increased( I'm now on 20 mg of Pilocarpine a day), and I am severely disabled and wear braces and walk with a walker.

IVIG only gives me relief from constant chronic infections.  It is ironic that my Immune System is both deficient in the antibodies that protect me, and ALSO attacks the organs and systems of my body.  So far I have damage to my moisture producing system, my ears, my lungs, my esophagus, my small intestine, my bladder, the nerves in my legs and feet, and the nerves in all of the skin of my body.

The damage to my lungs, my small intestine, and all of the skin of my body have developed since I started IVIG.  So IVIG does only one thing for me, it adds the antibody to my blood that helps my body fight infections. 

Vrystaat, you indicated that you did have treatment with IVIG at one point.  Why was IVIG discontinued? 

If IVIG treatment was very successful for you, I wonder why the treatment was discontinued.  That must be very frustrating for you.

I have no suggestions for getting approval for IVIG except that of finding the physician that can make a compelling case, within the guidelines currently set for approval of the use of IVIG.

As Irish pointed out, it takes between 2,000 and  10,000 blood donations to make ONE infusion of IVIG.
These donors are highly screened and are compensated for their donations.  Once the donations have been made, it take about 9 months to finally have the IVIG ready for patient use. Obviously each donation of blood has only a tiny amount of IgG, and the rest of the blood donation is used for other medical purposes.

Regards, Elaine
















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vrystaat

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Re: IVIG Availability in Sjögren's Syndrome and Polymyositis
« Reply #7 on: July 03, 2019, 08:46:02 AM »
The Rheumatologists at the University of California (There! I've said it): are not on the ball.
Their peripheral clinics have a constant turnover of Rheumatologists, who can stay for 3 months to about 2 years.
So there is no continuity of care, which of course is demanded in the private practice setting.
So my IVIG infusions got lost in the wash.
I am so concerned about this that I have considered reporting them to the State for malpractice. But I won't, because they are trying their best.
Another comment is that perhaps the Standard of Medicine in the USA is going down. And prices keep going up.
Some of my friends are getting their care in Europe.

Sorry to be so outraged.
Sjogrens;Polymyositis;Polyneuropathy;Gastritis;GERD, Autonomic Neuropathy, Neurological complications, Trigeminal Neuralgia,Gamma 3 globulin low;Multiple infections;Brain fog; Ocular problems - blepharitis, scleritiis, dry eye,severe eye pain. Possible Inclusion body Myositis.Currently Endstage

irish

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Re: IVIG Availability in Sjögren's Syndrome and Polymyositis
« Reply #8 on: July 03, 2019, 10:42:05 AM »
I would advise against reporting any people or entity out of preservation of your own medical care.

I went to the Higher ups and reported a doctor one time at the clinic where I still go. Supposed to be privacy....right. The next time I came into my internist he gave me heck for complaining about that doctor. News travels....I think people should be punished for leaking private info. This was back in 2005.

Another clinic I complained to the nurse manager about the triage nurse as I felt she didn't have the ability to put info together or ask the appropriate questions to get the correct info to the doctor. The next time I came for appt. I got the cold shoulder from all the staff. Am I mad...you bet. Can I afford to lose these caregivers...no way as they are both important in my care and have otherwise done a good job.

The bottom line is people, including doctors, don't always perform up to par at certain times. Pts complaining is a clue that some counseling is needed to encourage the doctor to up his game. None of us are perfect and patients are ill...plus their insurance is what keeps the medical facilities doors open. So I think the medical facilities should just do what is expected of them, listen to the patient and do their best to keep up the good will and listen to the patient plus let the doc know what they need to do to improve.

Now, after saying all that, it comes down to the fact that every clinic and medical facility is short of specialists and don't want to make any doc quit. However, I have seen a couple really bad docs sent on their way and didn't mourn their leaving.

Also, it can come back to haunt us big time if we complain and we could end up losing our doctors. I tread on egg shells for a while after the one episode and it took me a while to get over that. Being a patient is not a bed of roses. I have one quite big facility that treated me pretty badly over the years and I got so I wouldn't put up with it. MY hubby spoke his mind also. That clinic said I did not have autoimmune disease..period and wanted to send me to the psychiatrist.

One year later diagnosed with Bullous Pemphigoid and 1 more year later I was diagnosed with Sjogres with a positive biopsy. Three more years and diagnosed with Myasthenia gravis, Hashimotos and severely low T-cells. That other clinic missed the Myasthenia completely. So, yeah, sometimes we do feel like spouting off a bit!!! Irish
« Last Edit: July 03, 2019, 10:48:54 AM by irish »

irish

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Re: IVIG Availability in Sjögren's Syndrome and Polymyositis
« Reply #9 on: July 03, 2019, 10:53:49 AM »
vrystaat, Have you considered seeing an Immunologist? They can diagnose autoimmune, immune deficiencies and allergies of all kinds.

They are pretty darn smart and have the ability to trouble shoot and understand what is causing what and why. You might find out more important things about your autoimmune issues and yoyo might be able to get your IVIG back. Of course, they are ion short supply and might have to wait for appointment. It is the nature of the beast and going to get worse as no one wants to go to medical school anymore. Good luck. Irish

vrystaat

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Re: IVIG Availability in Sjögren's Syndrome and Polymyositis
« Reply #10 on: July 03, 2019, 05:45:59 PM »
Very good advice.
I am keeping mum.
Sjogrens;Polymyositis;Polyneuropathy;Gastritis;GERD, Autonomic Neuropathy, Neurological complications, Trigeminal Neuralgia,Gamma 3 globulin low;Multiple infections;Brain fog; Ocular problems - blepharitis, scleritiis, dry eye,severe eye pain. Possible Inclusion body Myositis.Currently Endstage