Evicenter
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Anaphylm (dibutepinephrine)

Type I allergic reactions including anaphylaxis

Also known as AQST-109
Regulatory submission
NDA resubmitted September 2026
Launch
Not announced
Last updated
121 sources

Economic information and modeling report

Modeling overview

10 evidence topics · 10 sources

Summary: published economic evidence for epinephrine delivery in anaphylaxis

No published economic model, cost-effectiveness analysis, or health technology assessment of dibutepinephrine sublingual film has been identified, and no price for the product has been announced. Aquestive Therapeutics describes payer and pricing research as under way ahead of a possible launch.

The published economic evidence for epinephrine delivery in anaphylaxis consists of decision-analytic models of auto-injector prescribing, of undesignated stock epinephrine in schools, camps and aircraft, and of non-injectable epinephrine. In a birth-cohort Markov model of children with peanut allergy, the value-based price of a personal auto-injector at a threshold of $100,000 per quality-adjusted life-year was $24 under a 10-fold fatality risk difference and $264 under a 100-fold difference; at the 2016 market cost of $715 per twin pack the incremental cost-effectiveness ratio was $2,742,697 per quality-adjusted life-year. A companion model of the Chicago Public Schools system found that a supplemental undesignated stock epinephrine strategy fell below $100,000 per quality-adjusted life-year only when annual acquisition cost did not exceed $338 per school, while a universal supply model dominated the alternatives. A model of US summer camps found stock epinephrine to be the least expensive and most effective strategy. A model of commercial aircraft reported an incremental cost-effectiveness ratio of $10,766 per quality-adjusted life-year for supplemental stock auto-injectors. A risk-stratification model found that prescribing two auto-injectors to every patient with peanut allergy was not cost-effective in the United States unless the cost of a single device fell below $80.

Two analyses address non-injectable delivery. A 2025 Markov analysis that modelled an approved intranasal form and a sublingual form under development reported that intranasal or sublingual epinephrine was the most cost-effective option, with an incremental cost-effectiveness ratio of $83,748 per quality-adjusted life-year, but only at a marginal annual cost of $4, and that adding a non-injectable device to an existing pair of auto-injectors was not cost-effective at an incremental cost-effectiveness ratio of $858,462. A 2026 United Kingdom analysis of nasal adrenaline spray reported dominance over adrenaline auto-injectors, with 0.26 additional quality-adjusted life-years at a cost 681 pounds lower, driven by assumed higher carriage and greater likelihood of use. A 2013 United Kingdom health technology assessment of specialist services and adrenaline injectors found specialist services with injectors cost-effective at a threshold of 20,000 pounds per quality-adjusted life-year.

Across these analyses the results are governed by device acquisition cost and by assumptions about carriage and use rather than by pharmacological differences, so a non-injectable product priced at parity with current devices would be cost-effective only if it increases carriage or timely administration. None of these analyses evaluates dibutepinephrine.