Peanut allergy treatments from sparring drugmakers — Aimmune and DBV Technologies — are incrementantally beneficial, but their long-term cost-effectiveness will be determined by the price at which they are eventually marketed, ICER said in a draft report published on Tuesday, which concluded using assumed prices that the latter’s product, Viaskin Peanut, was far less of an improvement over peanut avoidance, compared to AR101.
Akin to NICE in the UK, ICER is an independent body that analyzes the cost-effectiveness of drugs and other medical services in the United States. Unlike NICE, though, ICER is not government-affiliated, but its determinations are increasingly becoming influential with payers.
For now, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Aimmune’s AR101 and DBV’s Viaskin Peanut are set to be the pioneering peanut allergy treatments approved by the FDA, but there is “significant uncertainty about the long-term risks and benefits” for both therapies, as each has been studied in placebo-controlled one-year clinical trials, ICER said, noting that data from the extension trials are sparse.
An FDA approval decision for AR101 is expected in January 2020, while DBV is expected to submit its marketing application later in 2019. The so far untapped market is expected to grow to $4.5 billion in 2027 globally, according to GlobalData.
Aimmune $AIMT effectively leapfrogged DBV $DBVT when the latter rescinded an application to market Viaskin Peanut patch last last year in response to FDA concerns about the state of manufacturing and quality control data submitted.
Since neither therapy has been approved yet, ICER conducted its analyses using price assumptions, based on analyst models, which project AR101 will cost between $5,000 and $10,000 for the first six months of use, and $300 to $400 per month after and that Viaskin Peanut will cost more than $6,000 for a year’s supply.
Based on these estimates, ICER assumed a placeholder cost for AR101 at $350 per month ($6,595 for months 1-6 including clinical visits for dose escalation; $4,200 per year thereafter). For Viaskin Peanut, the institute assumed a placeholder cost of $6,500 per year. That works out to AR101 costing $84,000 over a lifetime, and Viaskin Peanut costing $56,000 over a lifetimes, ICER said.
“Relative to our AR101 pricing assumptions based on our conversations with Aimmune, we had conservatively assumed the lower end of the company’s communicated pricing range of $5,000 for the up-dosing phase and $5,000 per year thereafter ($415/month) – so $7,500 for the first year. All-in, the first year costs ICER uses for its analysis are higher by about 16%,” Stifel’s Derek Archila wrote in a note.
For Viaskin Peanut, ICER’s assumed annual cost of therapy is 20% higher than Stifel’s $5,000 assumption, he added.
ICER based its cost-effectiveness calculations on quality-adjusted life-years (QALYs), a measure of the state of health of a person or group in which the benefits — in terms of length of life — are adjusted to reflect the quality of life.
Treatment with AR101 resulted in 0.63 incremental QALYs, while treatment with Viaskin Peanut came up relatively short, resulting in 0.22 incremental QALYs — when compared to no immunotherapy treatment over a lifetime, ICER’s analysis suggested.
“These benefits are due to improved subjective quality of life despite the relative rarity with which serious events occur. The ultimate value of these products will be determined by the prices that are set by the manufacturers and their long-term effectiveness,” ICER concluded.
While informative, the report is not conclusive, partly because a one year timeframe may not reflect the entire benefit of a therapy that provides increasing efficacy over time such as AR101 or Viaskin peanut, and no quality of life data (good or bad) was factored into this analysis, Archila said.
ICER did acknowledge that one of the limitations of its analysis is that it assumed the utility of the two peanut allergy therapies on the basis of existing data on food allergies, but not specifically the peanut allergy patient population, due to “the paucity of preference-weighted health-related quality of life estimates in food allergy patients and their caregivers.”
ICER’s assessment is “premature” and the institutes framework does not take into account the burden caregivers carry, in terms of making therapeutic decisions or making out-of-pocket costs for treatment, a DBV spokesperson wrote in an email to Endpoints News.
“We disagree with ICER on many aspects of its overall methodology, as well as the timing of this report. Because the ICER model relies on health economic measurements…for which there are no published data/evidence for peanut-allergic patients [as there are no approved FDA-approved treatments], we believe the draft report findings were driven by inaccurate clinical outcomes and cost inputs…We believe the lack of FDA-approved therapeutic options for peanut allergy and associated absence of health state utility and long-term treatment data, combined with patient heterogeneity, precludes an accurate and reliable cost effectiveness assessment, including by ICER.”
Endpoints has also contacted Aimmune for comment.
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