This week, the Institute for Clinical and Economic Review (ICER) released a Draft Evidence Report
assessing the clinical effectiveness and value of 2 potential drug therapies to treat individuals with peanut allergy.
ICER is an independent body that analyzes the cost effectiveness of drugs as well as other medical services within the United States. Though it is not government-affiliated, the conclusions drawn from its analyses are becoming increasingly influential
Neither of the 2 products– Viaskin Peanut, developed by DBV Technologies, and AR101, developed by Aimmune Therapeutics, have earned FDA approval as of yet. AR101 is expected to receive a regulatory decision by January 2020, while DBV is expected to submit its application to regulatory bodies later this year.
Prior to the development of these 2 potential therapies, peanut allergies were largely managed by avoidance, though the threat of accidental exposure has always been present, and avoidance is notably, not a treatment. While ICER notes that “these therapies have the potential to improve [the] quality of life [of those with peanut allergy],” it also noted that “There is significant uncertainty about the long-term risks and benefits for both therapies as the placebo-controlled comparisons are only 1 year in length and data from the extension trials are sparse.”
In terms of how the therapies are delivered, the 2 products are very different. AR101 is an oral therapy delivered in escalating doses until the goal dose of 300mg daily is reached. The initial dose escalation and each subsequent increase in dose must be observed by a healthcare professional for a minimum of 12 total visits. The therapy is presently being studied in pediatric patients ages 4 to 17 years.
On the other hand, Viaskin Peanut is a patch that is applied daily to the upper back (rotating the location) that delivers 250mcg of peanut antigen. While the first patch is placed under the supervision of a healthcare professional, the subsequent patches can be applied at home. The patch is worn 6 hours per day for 1 week, and then 12 hours a day for another week, and then 24 hours per day from then on.
As neither product has been approved by regulatory bodies as of yet, ICER conducted its cost-effectiveness analysis using price assumptions based on various analyst models. These models suggest that AR101 will cost between $5000 to $10,000 for the first 6 months of use, and $300 to $400 per month thereafter. Conversely, Viaskin Peanut was estimated to cost more than $6000 for a year’s supply.
Using these estimates as a guide, ICER assumed a cost for AR101 at $350 per month ($6595 for months 1-6 including clinical visits for dose escalation; $4200 per year thereafter). For Viaskin Peanut, ICER assumed a cost of $6400 per year. Over an average lifespan, ICER noted that these costs work out to be $84,000 for AR101, and $56,000 for Viaskin Peanut.
ICER then based its cost-effectiveness calculations on quality-adjusted life-years (QALYs), which elicits a measure of the state of health of a person or group in which the length of life is adjusted to reflect the quality of life. Interestingly, ICER’s analysis found that treatment with AR101 had 0.63 incremental QALYs, while treatment with Viaskin Peanut had 0.22 incremental QALYs when compared to no treatment over one’s lifetime.
“These benefits are due to improved subjective quality of life despite the relative rarity with which serious events occur,” wrote ICER. Though, it conceded that “The ultimate value of these products will be determined by the prices that are set by the manufacturers and their long-term effectiveness.”
DBV Technologies disagreed
with ICER, stating that it believes there are several flaws in the overall methodology that ICER used in its Draft Evidence Report. In December 2018, both DBV Technologies and Aimmune Therapeutics– as well as many other stakeholders–submitted comments
to ICER in regard to the draft scope of the analysis. DBV noted that it “believes it is premature to assess Viaskin Peanut at this time,” due to the “lack of FDA-approved therapeutic options for peanut allergy and associated absence of health state utility and long-term treatment data.”
The draft report is open to public comment
until 5pm ET on May 8, 2019, after which it may revise some assumptions made and will publish its Evidence Report on May 28, 2019. Additionally, ICER plans to hold a meeting to review its assessment of treatments for peanut allergy on June 11, 2019.