The Institute for Clinical and Economic Review issued an “affordability alert” for Aimmune’s AR101 and DBV’s Viaskin.

The market for drugs designed to treat peanut allergies is expected to reach a billion dollars. Two drugs in development –– AR101 from Aimmune Therapeutics and Viaskin from DBV Technologies –– aim to build an immune tolerance to peanuts in children with the allergy.

Even though neither treatment has received approval from the U.S. Food and Drug Administration (FDA), and the companies have not issued any statements about their intended pricing strategies, analysts are estimating annual costs for the two to approach $4,200 and $6,500, respectively.

In response to those estimates, the Institute for Clinical and Economic Review (ICER) has issued an “affordability alert” for both. ICER determined there was insufficient evidence to indicate that the drugs provided a greater benefit that simply avoiding peanuts.

According to ICER’s chief medical officer David Rind, the drugs desensitize patients to peanut allergy, but also raise the risk of increased allergic reactions and the use of rescue epinephrine. In addition, avoidance of peanuts is still recommended, even when taking the drugs.

Aimmune issued a statement saying: “The resulting final report is biased against immunotherapy, generally, and fails to specifically capture the full value of AR101.” DBV responded that ICER’s methodology was flawed, partly because it relied on a Lancet study on oral immunotherapy that did not include DBV’s treatment. They also pointed out that there are limited data available on the real benefits children might enjoy once the treatments are available. Even patient advocate groups were unhappy with the ICER report, indicating that the agency’s review was conducted prematurely.

The FDA is expected to issue an approval decision on AR101 by January 2020. DBV withdrew its application for Viaskin after the FDA indicated that the company provided inadequate data and is working on a revised submission.