With the ever-rising concerns over the costs of various prescription medications, a report from consumer pharmaceutical watchdog group Institute for Clinical and Economic Review released a report questioning the potential pricing of two yet-to-be-approved peanut allergy treatments.
With the ever-rising concerns over the costs of various prescription medications, a report from consumer pharmaceutical watchdog group Institute for Clinical and Economic Review (ICER) released a report questioning the potential pricing of two yet-to-be-approved peanut allergy treatments.
In March, the U.S. Food and Drug Administration accepted the Biologics License Application of Aimmune Therapeutics’s lead peanut allergy candidate, AR101. Aimmune’s product could be approved as a potential treatment to reduce the risk of anaphylaxis following accidental exposure to peanut. AR101 has been granted both Breakthrough Therapy Designation, as well as Fast Track Designation by the FDA. The company filed the BLA based on Phase III data that showed its peanut allergy therapy was effective in more than 67 percent of juvenile patients.
France-based DBV Technologies is aiming its Viaskin technology at multiple food allergies, such as milk and peanuts. In February, the company shared a post hoc analysis of its Phase III PEPITES study that showed 62.6 percent of patients who received Viaskin Peanut showed an increase in their eliciting dose at 12 months of treatment in comparison to placebo.
Aimmune is farther along in the chance of bringing its AR101 peanut allergy treatment to market than DBV, The FDA could make a decision on AR101 by January 2020. A decision for DBV could come later in the year but is currently not known.
Neither company has publicly disclosed any potential pricing for its life-saving product. However, ICER’s report pegged potential costs for DBV’s Viaskin Peanut treatment at $6.500 per year. AR101 would have a more complicated pricing structure due to dose escalation over the first year of treatment. But, ICER speculated that Aimmune’s drug would have a cost of about $8,700 for the first year and then $4,200 per year thereafter.
In its report, ICER said it estimated the total placeholder cost of AR101 to be” $84,000 over a lifetime, and an incremental cost-effectiveness ratio of $109,000. The estimated lifetime cost for Viaskin Peanut was $56,000, and its incremental cost-effectiveness ratio to be $259,000.” To be more cost effective and meet a quality-adjusted life year threshold of $100,000 set by ICRE, the prices of both medications should be less expensive than the company’s predictions. For AR101, the cost should be $3,500 and Viaskin Peanut should be about $2,500.
ICER noted that both AR101 and Viaskin Peanut are predicted to produce an incremental benefit for people with peanut allergy relative to standard care. The benefits, ICER said in its report, are due to improved subjective quality of life “despite the relative rarity with which serious events occur.” ICER added that quality of life data was not included in its cost analysis.
“The ultimate value of these products will be determined by the prices that are set by the manufacturers and their long-term effectiveness,” ICER said.
Shares of Aimmune was down less than 1 percent and DBV’s stock was up less than 1 percent after ICER’s report was released.
