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immunotherapy

Allergy Shots Fired: Oldest and Still-Most-Effective Treatment in Danger

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By Dr. Paul Ehrlich

Wither the allergy shot? This oldest and best-proven allergy therapy is under pressure from some of the same forces that have put medicine out of reach for many patients even as more people are covered by health insurance. You won’t find me declaiming against the ACA.

allergy serumA few weeks ago, our guest writer Dr. Robert Y. Lin (like me a former president of the New York Allergy and Asthma Society) warned about proposed new rules that allergen extracts be made available in standardized concentrations and pre-measured vials that must be discarded after 30 days to guard against contamination instead of letting us use open vials at our discretion, sharing particular extracts among patients who have the same allergies and adjusting doses for individual patients. The current system is a very efficient use of resources both for providing individualized medicine, which is supposed to be encouraged, and maximizing the use of still-potent drugs.

A new policy to make efficient and effective treatment more wasteful and lucrative for manufacturers comes at a time when over-prescription and waste are under attack elsewhere in pharmaceutical land. Oversized prescriptions of opioids for iffy pain complaints are blamed for the proliferation of prescription drug addiction and an overdose epidemic. Doctors will now be encouraged to write for as little as three days to keep pills from ending up on the street. Cancer drugs have their own oversupply problems, although fueling a black market is not among them. Researchers at Sloan-Kettering estimate that $3-billion in chemo goes down the toilet annually. “Drug companies are quietly making billions forcing little old ladies to buy enough medicine to treat football players, and regulators have completely missed it,” said Dr. Peter B. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering and a co-author of the study. “If we’re ever going to start saving money in health care, this is an obvious place to cut.”

So why is the United States Pharmacopeia and The National Formulary (USP–NF) pushing allergists in the other direction? Who makes money from forcing people to buy more stuff than they need and throw the surplus away? I’ll tell you: not the allergist. We are trained to customize the dosing and our safety record is stellar. Our mistakes come from occasionally computing the wrong dose, not infecting patients, and are covered by the observation period after the injection.

But that’s not why I am writing this. I am responding to a fascinating piece I came across while catching up on my allergy literature. A September article in the Annals of Allergy, Asthma & Immunology called “Non-adherence to subcutaneous allergen immunotherapy: inadequate health insurance coverage is the leading cause.”*

The authors studied 555 patients with allergic rhinitis and/or asthma who quit their shots before they were done. In descending order, of the 75% who gave a reason, they were: “requirement of copayment for allergy injections and/or payment for allergen extract by their health insurer (40%); inconvenience of travel (15%); change of residence (8%); concurrent health problems (5%); patient-perceived ineffectiveness (4%); patient-perceived lack of need to continue immunotherapy (2%); adverse effects from injection (local reaction 1%; systemic allergic reaction 0.5%); and trial of alternative medicine (0.1%).“

The long-term payoff from allergy shots has been well established. A 2013 study of Florida patients of health care costs over an 18-month period showed significant savings starting within three months of initiating therapy. For the full 18 months, the saving was 38% compared to controls, $6,637 for patients receiving immunotherapy vs $10,644 both for kids and adults. This is just one such study. When you add in the savings from emergency asthma hospitalizations, school and work absences, and greater productivity at both, the savings become much higher.

Shots get a bad name with patients because their doctors seem to regard them as a cash cow for 3-5 years. This is both bad medicine and bad business. In my practice, when people come in asking for shots I put them through the ringer educating them on the realities of treatment, and I would even if it were free to the patient. I don’t want them to start and stop or find excuses not to take the subway or not go out because it’s too cold or too wet. By raising the bar and getting patient buy-in, my compliance rate is about 90%, compared to less than 25% in the universal health care environment of the Netherlands, where this has been studied, and even lower for sub-lingual immunotherapy.

We also require that patients come in for regular follow-up visits, instead of farming out the injections to primary care doctors on autopilot, as often happens. (A retiring doctor once “bequeathed” a patient to my practice who had been on a sub-therapeutic dose for 50 years.) Office visits allow us to evaluate whether the treatment is working, adjust concentrations—sometimes up and sometimes down—and even to respond to patient questions about whether they really might be better off just on over-the-counter medication. These visits are even more important for those who also have asthma.

Regardless, cost should not be an object when you look at the big picture. I.e. there ought to be a way to discount the cost of actual treatment based on the savings as a whole. But it’s hard for individuals to make the investment in tomorrow’s benefits in today’s money. As a structural matter, the insurance industry ought to paying for the future today. This is precisely what the authors recommend:

“If health insurers cover the cost of subcutaneous allergen immunotherapy fully, it will clearly allow for better use of this treatment option. This will not only improve quality of the life of the patient and lessen the direct and indirect costs related to the disease but also will be economical to the health care system.”

 

*Lead author, Ravi Vaswani, I’m pleased to note, is affiliated with the NYU School of Medicine where I am on the faculty, although he is not an MD.

Allovate—New Company Says You Can Brush Your Way to Allergy Desensitization

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By Henry Ehrlich

Allovate
Allovate

For more than a hundred years, allergists have been trying to cure patients by exposing them to small amounts of their allergens and escalating the doses to allow them to tolerate the offending substance. This process has been approached using injections (sub-cutaneous immunotherapy, or SCIT), ingestion (oral immunotherapy—aka OIT), under the tongue (sub-lingual immunotherapy, or SLIT), and more recently, in the form of a patch worn on the skin (epicutaneous immunotherapy—EPIT).

Now a new horse is entering the race—Oral Mucosal Immunotherapy (OMIT), which, like SLIT, has an evocative word as an acronym. One version of OMIT, for respiratory allergies, goes by the brand name Allerdent, suggesting how this new product is introduced to the body in a familiar way—in the form of toothpaste. It is the brainchild of William R. Reisacher, MD, FACS, FAAOA Associate Professor, Department of Otolaryngology–Head and Neck Surgery, Weill Cornell Medical College/New York-Presbyterian Hospital. The idea is a happy juncture of physiology and human behavior.

It is also very timely because allergists are facing new rules that may make theirola cells meat-and-potatoes offering of allergy shots more expensive to the practice and to patients, and early case studies testing the efficacy of OMIT for allergic rhinitis, described in an article by Reisacher and two co-authors, are very encouraging.1 They cite a 2013 World Allergy Organization position paper touting the potential of the mucosal tissue of the oral vestibule and gingiva for enhancing immunotherapy based on the density of oral Langerhans cells (oLC). In my quick and inevitably superficial scan of the literature. I saw these cells described as the “masters of tolerance”2 and as the “sentinels” of the mucosa. They “alter… the immune system not only to pathogen entry but also of tolerance to self antigen and commensal microbes. Oral mucosal Langerhans cells are capable of engaging and internalizing a wide variety of pathogens.”3

Most of the articles I looked at discuss these cells in conjunction with SLIT. However, Reisacher et al suggest that the high density in cheek and gums compared to the low density under the tongue “might explain the suggested decrease in efficacy when multiple antigens are placed in a SLIT vial.”

As for the behavioral part of the equation, almost all of us brush our teeth, including our small children. Compliance being a problem with all the new allergy therapies, including SLIT, OIT, and Chinese herbal medicine, suggests that combining the task of dosing with something you have to do anyway would be an advantage. I learned about this a long time ago when I worked for a bank at the dawn of the automated teller machine. They learned that customers who liked using a teller wouldn’t be coerced into using an ATM. It was only when ATMs started showing up in convenience stores, gas stations, and supermarkets that people realized they could eliminate special trips to the bank and save time. The long-term compliance issues with SLIT and SCIT are well studied, and as Larry has written, completion rates are abysmal.

Allovate Therapeutics, a New York City-based start-up company, is developing Allerdent, a platform for respiratory allergies. A second New York company, Intrommune Therapeutics, is developing OMIT for food allergies. OMIT is only one of Dr. Reisacher’s many ideas. Another one under development is a novel diagnostic that works by sampling epithelial cells from the mouth and nasal turbinates. Immunovent is developing this test, which goes by the name LAMB-Dx.

I was introduced to the company by Danya Glabau, who came on as as Director of Medical Affairs in June 2015 while writing a doctoral thesis on the patient experience of food allergies and food allergy activism. After being in close contact throughout her research, she invited me to meet two of her new colleagues over lunch, Erick Berglund, Allovate’s Chief Executive Officer, and PhD in biochemistry, who has extensive background in research, and Michael Nelson, Chief Financial Officer, who is also a lawyer. (Full disclosure: they paid for the meal.)

Being unfamiliar with the development of a new technology at this stage and the building of a new company, I decided to reach out to them and ask a couple of questions geared to their specific roles in the new company. I hope at some point to follow up with Dr. Reisacher.

Thanks, gentlemen, for taking some time with our readers.

AAC: You mentioned over lunch that Allovate is a “virtual” company, which I inferred means not integrated vertically or horizontally, so you must collaborate with others to do a lot of the work. Can you describe what you meant in a bit of detail, how you choose your collaborators, and the kinds of tasks that they do?

Erick: As a start-up company in a city with very high real estate expenses, we’ve built a lean, smart, flexible core team who work together daily in our Harlem office. They cover the essentials of running the company. We also work with a number of allergy researchers and experts in areas like the law, accounting, and manufacturing. They help us plan and carry out longer-term projects. Ultimately, the benefits of being in the vibrant, rapidly expanding biotech community in New York – the networking, the proximity to smart people in the city’s multiple medical schools – outweighs the challenge of finding the right office space.

AAC: Can you describe the funding and regulatory challenges that lie ahead?

Michael: Biotechnology has always been a high risk, high reward field. It has paid off in many high-need areas, like cancer immunotherapy. Allergy immunotherapy is just getting started as a major part of the biotechnology sector. At Allovate, our early study data and the robust knowledge that scientists already have about allergy immunotherapy makes Allerdent less risky than many new technologies out there.

With respiratory allergies, one big challenge is that doctors in different parts of the world have treated allergies in different ways. Another is that different allergies are prevalent in different regions. Safety regulations for respiratory allergies have substantial regional variations. One big consideration for Allovate is to make sure that Allerdent changes the paradigm for allergy treatment while respecting some of the “facts of life” of treating allergies in different regions and countries of the world.

The situation is a little bit different with food allergies. Treating food allergies is very delicate because of the risk of anaphylaxis. Regulators, doctors, and patients all expect – and deserve – a high level of safety. Companies that do research in the area put many layers of safeguards in place to protect current and future users, from optimizing the dose, to making sure the length, number, and size of studies tell the company and the FDA everything there is to know about a new treatment, to planning extensive physician education on how to safely use the product.

AAC: The cases in Dr. Reisacher’s article in the International Journal of Pharmaceutical Compounding are about allergic rhinitis, and Allerdent seems to be very effective. However, many of our readers are also food allergy parents, and they are interested in the prospects for that. Can you describe any of the special challenges for moving into food?

Erick: Allovate is licensing the OMIT technology to Intrommune Therapeutics, a separate company, to develop the OMIT platform for FDA-approved food allergy treatments. As food allergy parents know, food allergies are a complicated disease that needs to be managed very carefully. Intrommune has assembled a team of staff and advisors with deep clinical research experience with food allergy. They will be developing several safe and effective products for food allergies.

The safety piece is really important, since food allergy is a complicated condition that can be very serious and disproportionately affects children. Intrommune is designing the best studies possible to ensure not only that the technology works, but that it works without causing additional stress due to side effects, something that has been seen in research on other food allergy immunotherapy technologies. The company’s current plan is to start clinical trials in late 2016 in the US and to have OMIT FDA approved and widely available for food allergies starting in 2020.

AAC: Two new forms of food allergy immunotherapy, Viaskin™ and ARA101™, seem to be moving very rapidly. I can understand that the regulators are anxious to green-light new therapies since there is no conventional treatment and the therapeutic agents are familiar. Do you sense that this is a favorable environment to pursue the OMIT platform?

Michael: There is a huge unmet need for treatments for food allergies – 15 million people in the US alone could benefit from safe, effective new options. We get feedback all the time from researchers and food allergy parents about the clear potential they see for OMIT to make a difference in the lives of millions.

There are a number of other companies developing new treatments in the food allergy space, and everyone is working hard to get to the day when food allergies become a treatable condition. Recently completed research has helped to clarify some best practices for studies in the field. Everyone is hoping this will smooth the way to making new, FDA-approved treatments widely available.

The need is there, the interest is there, and the science is now coming along as well. We’re excited that Intrommune Therapeutics is developing our OMIT technology for the treatment of food allergy. We hope to see OMIT become a big player in this area.

1 William Reisacher, MD, FACS, FAAOA, Shara Rudner, RPh, FIACP, FACA, Viktoriya Kotik International Journal of Pharmaceutical Compounding
Vol. 18 No. 4 | July | August | 2014
2 Langerhans Cells and Their Role in Oral Mucosal Diseases
Juhi Upadhyay, Ram B Upadhyay, Pankaj Agrawal, Shweta Jaitley, and Rhitu Shekhar
N Am J Med Sci. 2013 Sep; 5(9): 505–514.
3 Immune mechanisms of sublingual immunotherapy: Are oral Langerhans cells the masters of tolerance? Mark Larché Journal of Allergy and Clinical Immunology September 2010 Volume 126, Issue 3, Pages 646–647

Should Your Child Receive Allergy Shots?

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By Dr. Harold Nelson

Allergy shots, or immunotherapy as it is called among allergists, is a form of treatment that has been shown to be effective for treating allergic rhinitis, also known as hay fever, and allergic asthma. Unlike the pills and sprays that are used to treat allergic rhinitis and asthma, allergy shots involve a commitment usually of 3 to 5 years, with the full benefit coming only to those who complete the course of treatment. Therefore, the decision to begin allergy shots is one that should be made only after considering its advantages and disadvantages.

The basic principle is that we begin with smaller amounts of the allergen and begin to recondition the immune system to stop producing IgE antibodies, which result in allergic symptoms, and produce benign IgG antibodies instead. The serum must be high enough in allergens initially to stimulate an immune response–in spite of claims homeopathic levels just won’t do—and that is why such treatments should be done with medical supervision. Gradually, the dosages are increased.

If your child has nasal allergies, particularly those that recur at certain times each year, many studies have shown that the improvement in symptoms with allergy shots is greater than that with antihistamines or nasal sprays. Furthermore, after a course of 3-4 years of shots, it is possible to stop the treatment with few or no symptoms for a number of years. Results have been shown to persist when patients were reexamined 10 years after stopping the shots. Improvement may persist for a lifetime, but studies have not been conducted to examine that duration of effect. It is not only the nasal symptoms that are improved by allergy shots; studies have shown that the likelihood of the child going on to develop asthma are also reduced by more than 50 percent. The disadvantage of allergy shots for seasonal nasal allergies is that the treatment continues throughout the year and involves visits to the doctor’s office on a weekly basis for several months, followed by less frequent visits for 3-4 years. Thus, if the response to antihistamine pills and nasal sprays is satisfactory and the season is short (one or two months) the added benefit of allergy shots may not outweigh the inconvenience involved. On the other hand, the allergy shots are the only treatment offering the possibility of a cure, whereas antihistamines and nasal sprays may be required for many decades. Immunotherapy is also very cost effective—with overall cost declining steeply after that, versus the perpetual costs of antihistamines and other medications. However, the real payoff is in improved quality of life, and better performance at school.

Asthma has an even greater potential for interfering with a normal lifestyle and resulting in serious illness. However, not all asthma is caused by allergies and therefore the response of asthma to allergy shots will depend on the contribution of allergy to the symptoms in each individual case. This can only be determined by a careful history taken by a person with special interest in allergic diseases and by performing testing to detect sensitivity to environmental exposures. If it is determined that allergies contribute significantly to a child’s asthma, and if the asthma requires daily medication or interferes with normal activities, most allergists would recommend allergy shots to the offending exposures. A problem with allergy shots, in addition to the inconvenience of the visits to the doctor’s office to receive the shot, is that some patients will have reactions to the injections that can vary from hives, to breathing difficulties, to collapse and even death. Fortunately the very severe reactions are largely limited to patients with asthma that is not well controlled. That means, however, that if your child has asthma and begins allergy shots, it is very important that he/she be very faithful in taking their prescribed medication to ensure that the asthma remains well controlled while they are receiving the allergy shots.

Should your child receive allergy shots? Clearly this is an important decision and one that should be discussed on an individual basis with your allergists.

Dr. Harold Nelson is board certified in Asthma and Immunology and Internal Medicine. He graduated from Harvard College and Emory University Medical School, and trained in Allergy and Immunology at the University of Michigan. He spent 30 years in the United States Army and is currently Professor of Medicine at National Jewish Medical and Research Center in Denver.

Health Care System Fixes

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Dr. Larry Chiaramonte

The American health care system has been on an unsustainable course. While most of the debate has concentrated on big fixes, there clearly exist in every specialty individual “fixes” that could collectively save the country as a whole, and millions of individual patients, a great deal of financial and personal misery. An example of this was the Op-Ed piece in the New York Times by Richard J. Ablin, the man who discovered prostate-specific antigen, an enzyme made by the prostate, which became the basis for a test administered to 30 million American men at a direct cost of $3 billion. But this is just the tip of the iceberg, because it results in billions more in unwarranted treatment and the medical consequences, such as impotence and urinary disruptions, affecting 47 men for every one whose life is saved.

In the field of allergy, the same law of large numbers also applies. The American Academy of Allergy and Immunology estimates that expert care for moderate and severe asthma can reduce hospitalizations for asthma by an average of 77% and can reduce emergency room visits for asthma by an average of 53% and save as much as $1.3 billion in annual direct costs for hospital and emergency care costs.

They estimate that current patterns of care for asthma accounts for: 5,000 deaths per year–1 death per 2,400 asthmatics per year; hospitalization 500,000 per year–4 admissions per 100 asthmatics; emergency care –1,500,000 per year: 12 ER visits per 100 asthmatics, plus millions of school and work absences, and limitation of function. (more…)

What does this mean to the individual child with moderate or severe asthma? Referral to a specialist, “might be accompanied by an increase in medication costs of 6-24%, but expert care would be expected to save approximately $1.3 billion [$1.8 billion today] in direct costs for hospitalization and ER visits (the reduction expected if patients at risk were referred for expert care).”

Or take immunotherapy, which is only available from specialists: “Immunotherapy can be expected to reduce the need for medications for allergic rhinitis or asthma, or both, by more than 50%. Current total direct costs for immunotherapy at Emory University in 1996 average approximately $800 for the first year [$1083 now] and $170 for the next 2 to 4 years [$236 now]. After 3 to 5 years, immunotherapy usually is halted. Clearly, the costs of immunotherapy are soon balanced by large reductions in costs for medication.”

The late Senator Everett Dirksen used to say of the federal budget, “a billion here and a billion there—pretty soon you’re talking about real money.”

The point is this—we have billions and billions of dollars of waste in our health care system because we let it operate on automatic pilot, and still it adds up to the 37tth best health are in the world.

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