Anaphylm (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.