By Henry Ehrlich
A recent Tweet by our friend and sometimes contributor, Australian allergist Dr. John Weiner caught my attention: I for one am shocked. IVIG has always been free to the patient in Australia for this indication. All costs are shared by Fed/State gov.*
It referred to a press reports about a deposition in which former Aetna Medical Director, Dr. Jay Ken Iinuma testified that “he never looked at patients’ records when deciding whether to approve or deny care.” This deposition was part of a lawsuit brought by Gillen Washington, a 23-year-old with common variable immune deficiency (CVID). Aetna denied him coverage for an infusion of intravenous immunoglobulin (IVIG) four years ago.
Forbes reported, “In this particular case, Iinuma admitted that he had minimal if any knowledge of the medical condition, common variable immune deficiency (CVID), that Washington suffered from. He was also not clear about what the most effective drug would be to treat the patients’s condition, the symptoms of CVID, or even the consequences of the abrupt discontinuation of therapy for the condition.”
Insurance denials are dog-bites-man stories these days—different dog, different man, but we’ve heard it all before and it’s always outrageous. What interested me about this particular incident was IVIG itself. I’m guessing that most people have never heard of it. Fortunately, we have a little piece archived on this website that throws a little light on this obscure drug from 2012, an account of a talk by Dr. Mark Ballow, long-time friend and mentor of Dr. Ehrlich, and former president of the AAAAI. At the risk of being self-referential, I’m going to recycle myself.
“Dr. Ballow was talking about intravenous immune globulin (IVIG), a highly refined form of the substance familiar to allergic people everywhere as IgG, which we at aac.com call IgG(ood), to distinguish it from the allergic antibody IgE(vil). IVIG was originally injected into the muscles for immune disorders, but since the 1980s, intravenous injections have proven to be very effective at boosting platelet counts and reducing inflammation. This holds promise for a large number of off-label uses, i.e. conditions for which it is not now approved, including breakthrough treatment for things like allergies, auto-immune disorders like MS, and even Alzheimer’s Disease.
“As Mark said in an article* on the subject (and repeated in his talk), ‘In fact, the IgG molecule is the single most important naturally occurring specific immune component capable of modulating the immune system.’”
“Exciting though the data was, however, it was also an object lesson in why medical breakthroughs take so long to make it into clinical use and why they are so expensive. Seventy percent of IVIG applications are off-label, so gaining approval for new ones will require a good deal of extremely expensive testing and red tape. Also the basic molecule will require further refinement to work well with the alphabet soup of receptor cells involved in various conditions. But the biggest cost barrier lies in manufacturing enough of the stuff to go around. IVIG can now only be created by refining human blood plasma, and it has to be plasma with the right properties. The arithmetic is daunting. It costs $50-70 per gram. An effective dose is two grams PER KILO of body weight per month. The great hope, Dr. Ballow says, is that it can be bio-engineered to bring that cost way down. Only then will we find out whether this stuff is as promising as it sounds.”
*My reply to Dr. Weiner was “Welcome to US health care, John @AllergyNet”