- A prominent drug pricing watchdog claims there isn't enough evidence to conclude patients with peanut allergies would benefit more from treatment than simply avoiding the food.
- ICER, or the Institute for Clinical and Economic Review, evaluated three such treatments in a report released Wednesday. They were DBV Technologies' Viaskin Peanut, expected to be resubmitted to U.S. regulators in the third quarter; Aimmune Therapeutics' AR101, which faces an advisory committee meeting in September; and non-commercialized oral immunotherapy.
- The aim of each treatment is to desensitize patients so, in the event they come in contact with peanuts, they are less likely to experience anaphylaxis. But ICER contends that DBV and Aimmune haven't shown their drugs can provide this effect long-term — or, even more broadly, offer quality of life improvements. Aimmune called the report "biased" and said it doesn't take into account the full breadth of data supporting AR101.
ICER reports typically center around new drugs, and in particular whether they improve patient lives enough to warrant the cost burden they place on healthcare systems.
With peanut allergies, there are currently no Food and Drug Administration-approved treatments. Sometimes patients are given small amounts of peanut flour as an off-label, oral immunotherapy to build up their tolerance. However, stakeholders seem to agree there need to be better management tools.
Aimmune and DBV argue their respective treatments are superior options compared to the oral immunotherapies in use, or to peanut avoidance. ICER, however, isn't so convinced.
In its report, ICER highlighted how peanut allergy patients will still have to avoid the food in many cases even with desensitization. The organization also noted the increased allergic reactions and use of epinephrine seen in clinical trials of AR101 and Viaskin Peanut.
Aimmune's key trial was set up as a "food challenge" study, in which participants were given a dose of peanut protein after desensitization treatment with AR101. Only one allergic reaction in the treatment group was graded "severe."
Based on surrogate outcomes from clinical trials, ICER found AR101 more effective than Viaskin Peanut, but also a source of more adverse effects.
ICER ultimately concluded the fair value-based price benchmark would be $4,800 to $7,200 per year for AR101 and $3,000 to $4,500 per year for Viaskin Peanut. Using annual list price expectations from analysts ($4,200 for AR101 and $6,500 for Viaskin Peanut), ICER foresees 41% of eligible patients could be treated with AR101 and 71% treated with Viaskin Peannut without exceeding the organization's budget impact threshold.
"From the onset, we have believed that ICER’s attempt to assess the value of AR101 was premature, based too heavily on theoretical discussions rather than real-world insight, and omitted valuable patient perspective," Aimmune CEO Jayson Dallas said in a statement.
"Critical data from our Phase 3 trial program continues to emerge, specifically new patient-reported quality-of-life data that were excluded from the analysis," he added.
Aimmune's AR101 fetched positive Phase 3 data for AR101 in early 2018. Yet its road to market stalled due to the government shutdown earlier this year. A meeting with the FDA’s Allergenic Products Advisory Committee scheduled for Sept. 13 serves as one of the drug's last and biggest hurdles, as experts are expected to hone in on its efficacy and safety.
On an earnings call in May, Aimmune leadership forecasted that roughly 1,300 allergists, who collectively treat around 70% of patients aged 4 to 17 with peanut allergies, are gearing up to prescribe AR101. The company also estimates that around 200 to 300 of those allergists are already familiar with either oral immunotherapy, AR101 (from taking part in clinical trials), or both.
DBV may have a harder time making a case for Viaskin Peanut, since the patch failed in late-stage testing.
Though DBV was able to work out a submission package with the FDA, the company disclosed in December that it had pulled its Biologics Licensing Application because regulators said it lacked "sufficient detail regarding data on manufacturing procedures and quality controls."