Anaphylm

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.

No budget impact model for dibutepinephrine sublingual film has been published, and the inputs a payer would need to build one are only partly available. No average sales price or wholesale acquisition cost has been announced, and Aquestive Therapeutics describes payer and pricing research as still under way, with copay assistance, coverage navigation and product fulfillment services planned for launch.

The market inputs that are available are the size of the United States epinephrine market and the population that uses it. The company projects about 7.5 million total prescriptions and about $2.03 billion in market value by 2029, and reports 32 to 40 million people in the United States at chronic risk of a severe systemic Type I reaction. ARS Pharmaceuticals reports approximately 20 million people diagnosed with severe Type I allergic reactions, approximately 6.5 million prescribed an epinephrine auto-injector, and approximately 3.2 million who filled such a prescription in 2023. Survey data cited by Aquestive indicate that 52 percent of people with prior anaphylaxis never received an auto-injector prescription and that 60 percent of those prescribed one did not have it available.

The comparator acquisition costs a budget impact model would use are published. In the September 2026 national average drug acquisition cost file, the authorized generic epinephrine 0.3 mg auto-injector is priced at $141.13969 per unit, the Auvi-Q 0.3 mg auto-injector at $309.37573 per unit, and epinephrine nasal spray 2 mg at $359.54780 per unit; the EpiPen 0.3 mg two-pack was last listed at $289.96000 per unit in the November 2025 file. Because these are per-unit values and people at risk are advised to carry two doses, an annual course is generally twice these amounts. The intranasal comparator carries a $199 cash price and a $0 or $25 copay program, which sets the out-of-pocket benchmark a sublingual film would be compared against.

Published cost-effectiveness analyses of epinephrine delivery show that results turn on device acquisition cost and on carriage and use rather than on route of administration. A non-injectable form was most cost-effective in one analysis only at a marginal annual cost of $4 above intramuscular epinephrine, and a supplemental non-injectable device added to two auto-injectors was not cost-effective. A budget impact model for dibutepinephrine would therefore be most sensitive to its price relative to the generic auto-injector and to the share of prescriptions it converts rather than adds.