ICER deems unapproved Aimmune, DBV peanut allergy drugs unaffordable, sparking backlash

Two small companies, Aimmune Therapeutics and DBV Technologies, are racing to break into what analysts expect will be a billion-dollar market for drugs to treat peanut allergies. But neither of their experimental treatments, Aimmune’s AR101 and DBV’s Viaskin, has been approved by the FDA, nor have the companies said anything about pricing plans. That didn���t stop the Institute for Clinical and Economic Review (ICER) from issuing a dreaded “affordability alert” on the drugs, however. The report, released earlier this week, blasted both drugs for being unaffordable based on analysts’ estimates that AR101 could cost $4,200 a year and Viaskin $6,500. AR101 and Viaskin were designed to build an immune tolerance to peanuts in children with the allergy. With the help of an independent appraisal committee, ICER determined that there wasn’t enough evidence to prove that either drug offers a health benefit over simply avoiding peanuts. In order to avoid crossing ICER’s acceptable annual healthcare budget threshold of $819 million, Aimmune would need to capture 41% of eligible patients and DBV 71%, ICER concluded. David Rind, M.D., ICER’s chief medical officer, acknowledged in a statement that the drugs have been proven to desensitize patients to the peanut allergy, but that they also raise the risk of “increased allergic reactions” and use of epinephrine—the shot kids and parents carry around to stop life-threatening reactions. “Caregivers and patients must remain vigilant about avoiding peanuts even while on desensitization therapy, and future clinical trials will need to demonstrate whether long-term benefits of these approaches outweigh their short-term risks,” Rind said.