ICER to Examine Benefit, Value of OIT for Food Allergy, Including Commercial Products

With the possible release of 2 innovative therapies for peanut allergies on the horizon, the Institute for Clinical and Economic Review (ICER), a body that performs analyses on the effectiveness and costs of medical treatments, is opening up a review looking at their effectiveness and value.

In addition, ICER will include uncommercialized oral immunotherapy (OIT), a food allergy treatment using available food products and provided by some allergists around the country.

ICER is looking for comment on Viaskin Peanut and AR101, both of which would be commercialized immunotherapies for peanut allergy if approved by the FDA. Viaskin Peanut is an epicutaneous immunotherapy in the form of a skin patch and is under development by DBV Technologies. DBV is also studying the technology for milk and egg allergies, but it is the peanut skin patch that is farthest along in development. AR 101, an engineered peanut capsule, is under development by Aimmune.

In its scoping document, ICER noted the burden of food allergy, which is incurable and outgrown by only a minority of patients. It can also be fatal in rare cases.

The only “treatment” for food allergy is to avoid the allergen, and, in case of a severe allergic reaction, to use epinephrine. But epinephrine is currently in shortage by some manufacturers, and the price of it has drawn scrutiny in the past few years.

The ICER review will evaluate the health and economic outcomes of both commercial therapies in children aged 4 to 17 years. The value framework will include both quantitative and qualitative comparisons across treatments to ensure that all benefits and harms are accounted for, including those not usually captured in clinical trials, such as innovation, public health effects, reduction in disparities, and unmet medical needs.

The cost of food allergy is not just the epinephrine or possible visits to the emergency department. Patients with multiple allergies, for example, have to buy special foods and may lose time from work or school for medical appointments. One 2013 report said the direct and indirect costs of food allergy were estimated at $24.8 billion annually.

ICER noted that only $4.3 billion of that amount came from direct medical costs. The remaining represents costs borne by the families of affected children, including out-of-pocket medical costs, the costs of special foods, and lost caregiver productivity.

However, ICER said the base-case analysis will focus on direct medical care costs only. Other indirect costs, such as lost wages for parents, will be considered in a separate societal perspective analysis.

The key measures of clinical benefit will include:

• Health-related quality of life
• Parental time off work
• Parental anxiety
• Expanded activities for child
• Patient anxiety/depression
• Use of epinephrine
• Angioedema/anaphylaxis
• Emergency department visits
• Hospitalizations
• Death

Not wanting to wait for commercial treatments, some parents of children with severe or multiple food allergies have turned to OIT using a variety of protocols developed by allergists. The ICER review will consider that approach as well in its assessment.

OIT involves mixing an allergenic food into something that the patient would tolerate, like applesauce or a liquid, and increasing the dose in gradually increasing amounts. Depending on the allergist, protocols can vary, because neither of the 2 main medical associations for allergists—the American Academy of Allergy, Asthma, and Immunology, or the American College of Allergy, Asthma, and Immunology—have officially endorsed OIT or come up with a standardized protocol for it.

There are 3 phases to OIT: an initial escalation phase, followed by a dose build-up phase and a maintenance phase.

Desensitization occurs when there is temporary increase in the threshold for reactivity; the person with allergies must keep eating their allergen in order to keep reactions at bay. Sustained unresponsiveness is not known until the allergen is avoided for some time period, and then an oral food challenge is conducted in a medical setting to see if there is a reaction.

After receiving public comment and releasing a revised scoping document, ICER will discuss the issue at a meeting in June 2019.