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Anaphylm (dibutepinephrine)

Type I allergic reactions including anaphylaxis

Also known as AQST-109
Launch
Not announced
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122 sources

Cost-effectiveness analyses and utility weights

Published cost-effectiveness analyses and health-state utility weights that a model of this product could cite, adapt, or compare against, grouped by how each article relates to the product and its indication. Every value is quoted from the article it cites, and section 3 lists the searches that found the articles.

11 cost-effectiveness analyses and 9 studies reporting utility weights · 15 sources

Overview

ItemDetail
Literature searchedTufts Medical Center Cost-Effectiveness Analysis Registry, searched October 21, 2026; the queries are listed in section 3.
Cost-effectiveness analyses11
Studies reporting utility weights9

Cost-effectiveness analyses

Analyses of Anaphylm (dibutepinephrine and AQST-109)

No evidence found.

Treatments for the same indication

Intranasal or sublingual and inhaled epinephrine versus intramuscular epinephrine for severe allergic reactions in peanut allergy, United States: Shaker et al. (2025)

Relevance: Evaluates non-injectable epinephrine, modeled as an approved intranasal form or a sublingual form under development, against intramuscular epinephrine for severe allergic reactions in peanut allergy in the United States; section 4.1 quotes this analysis and reports that no economic model of dibutepinephrine sublingual film has been identified.

“Markov cohort analyses evaluated the cost-effectiveness of noninjectable epinephrine forms.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“The base-case assumed exaggerated anaphylaxis fatality rates (50-fold increase) for using inhaled epinephrine given low certainty evidence in anaphylaxis and deliberately reduced fatality risk for nasal or sublingual forms (10-fold reduction) theorizing higher adherence and early use during an allergic reaction.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“In the base-case scenario, assuming a 10-fold decreased risk in peanut allergy fatality associated with intranasal or sublingual epinephrine treatment for a severe allergic reaction (net monetary benefit [NMB], $2,189,134) vs intramuscular epinephrine use (NMB, $2,189,114), intranasal or sublingual epinephrine was the most cost-effective option (incremental cost-effectiveness ratio [ICER], $83,748/quality-adjusted life-year [QALY]), but only at a marginal annual cost of $4.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Intramuscular epinephrine was cost-effective (ICER, $17,900/QALY) vs inhaled epinephrine (NMB, $2,183,531), although inhaled epinephrine reached cost-effectiveness (willingness to pay [$100,000/QALY]) if associated fatality risk fell below 2.5-fold.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Substituting a single noninjectable form of epinephrine for a second injectable device (in patients prescribed 2 autoinjectors already) would be cost-effective; however, adding a supplemental noninjectable device was not cost-effective, even assuming a 10-fold risk reduction with multiple device carriage (ICER, $858,462).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

Personal epinephrine autoinjectors versus no personal epinephrine in children with peanut allergy, United States: Shaker and Greenhawt (2018a)

Relevance: Estimates the value-based price of epinephrine auto-injectors for children with peanut allergy in the United States as a function of fatality risk, the auto-injector pricing analysis section 4.1 cites.

“In an economic evaluation study using a cost-effectiveness birth cohort model over an extended 80-year time horizon, Markov simulations of children with peanut allergy evaluated cost ceilings for value-based epinephrine prices in peanut allergy.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“All costs were expressed in 2018 US dollars and discounted at 3% per annum.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“Cohorts of children with peanut allergy prescribed epinephrine autoinjectors were compared with those not receiving personal epinephrine prescriptions. Children without epinephrine autoinjectors assumed 10-fold to 100-fold fatality risk increases. Costs were evaluated from a societal perspective.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“Over the time horizon, the cost of anaphylaxis preparedness and treatment in those with personal epinephrine devices was $25 478 (95% CI, $25 399-$25 557) compared with $654 (95% CI, $645-$663) for those without personal epinephrine” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“The value-based price (incremental cost-effectiveness ratio, $100 000 per quality-adjusted life-year) for personal epinephrine based on 10-fold fatality risk difference was $24.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“At a market cost of $715 per twin pack, the autoinjector incremental cost-effectiveness ratio was $2 742 697 per quality-adjusted life-year.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“If a hypothetical fatality risk protection from personal epinephrine was modeled at 100-fold, the value-based price ceiling for a personal autoinjector was $264.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

Universal prescription of two epinephrine autoinjectors versus risk-stratified prescription in peanut allergy, United States and United Kingdom: Shaker et al. (2021a)

Relevance: Evaluates universal prescription of two epinephrine autoinjectors against risk-stratified prescription in peanut allergy from United States and United Kingdom perspectives, addressing the two-device prescribing that the EpiPen and neffy labels in section 2 recommend.

“To evaluate the cost-effectiveness of routinely prescribing all patients 2 EAI devices versus a risk-stratified approach (2 EAIs prescribed only for patients with a risk factor).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Markov models compared universal versus risk-stratified approaches on the basis of either a previous medical history of anaphylaxis (PMH-ana) or anaphylaxis requiring multiple epinephrine doses (multi-epi).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Cohorts of children with peanut allergy were evaluated over an 80-year time horizon from both US and UK societal and health care perspectives.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Cost-effectiveness threshold was $100,000/quality-adjusted life-year (QALY).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“From a US perspective, universal prescription of 2 EAIs to all patients with peanut allergy was not cost-effective in the base case versus risk stratification by PMH-ana.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Universal prescription of 2 EAIs was associated with an incremental cost of $10,696,036/QALY versus the PMH-ana strategy, and $17,514,558/QALY versus the multi-epi strategy.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“From a UK perspective, universally prescribing 2 EAIs was also not cost-effective (incremental cost of $4,132,440/QALY vs PMH-ana and $6,208,227/QALY vs multi-epi) at single device costs more than $18.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

Undesignated school stock epinephrine (supplemental and universal models) versus no school supply for peanut anaphylaxis, United States: Shaker and Greenhawt (2019a)

Relevance: Evaluates undesignated stock epinephrine auto-injector supplies in schools for peanut anaphylaxis in the United States, one of the stock epinephrine settings that section 4.1 summarizes.

“Markov simulations of the Chicago Public Schools system were used over extended time horizons to model 2 school stock epinephrine autoinjector policies to provide access for at-risk students.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“This study compared the following 3 strategies: no school undesignated epinephrine supply, school undesignated supplemental epinephrine supply (supplemental model), and school undesignated universal epinephrine supply (universal model).” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“Costs of school stock epinephrine units available for acquisition by schools were evaluated from a societal perspective.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“Costs and quality-adjusted life-years (QALYs) were discounted equally at 3% per annum.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“Based on Markov simulations of the Chicago Public Schools system (371 382 students), the cost was $107 816 (95% CI, $107 382-$108 250) for no school undesignated epinephrine supply compared with $108 160 (95% CI, $107 725-$108 595) for the supplemental model and $100 397 (95% CI, $99 979-$100 815) for the universal model.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“When comparing supplemental model stock epinephrine to the strategy without undesignated devices, the incremental cost-effectiveness ratio was high at $268 811 per QALY in the base-case simulation.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“The universal model dominated all others and was associated with significant cost savings ($7419 per student at risk who would otherwise be prescribed an individual school epinephrine supply).” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

Supplemental stock epinephrine autoinjectors versus ampule-only medical kits on commercial aircraft for food allergy, United States: Shaker and Greenhawt (2019b)

Relevance: Evaluates stock epinephrine auto-injectors on commercial aircraft, a stock epinephrine setting that section 4.1 summarizes.

“We conducted a Markov model with microsimulation of food-allergic individuals over an 80-year time horizon to evaluate the cost-effectiveness of supplementing airline medical kits with epinephrine autoinjectors (eg, providing autoinjector twin-packs in addition to the epinephrine ampule in the medical kit), versus not doing so, using a per-plane annual value-based cost ceiling of $338 (the value-based ceiling for school stock epinephrine).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“We assumed that autoinjector availability reduced fatality risk by 10%.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Equipping all commercial aircraft with autoinjectors cost $2,470,422/year ($0.08/passenger-at-risk), from a societal perspective and when distributed over all at-risk travelers.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Over the model horizon, the supplemental autoinjector strategy cost $32,329.29 (standard deviation [SD], $4024.32) versus $32,326.70 (SD $4024.29), produced 26.8917 quality-adjusted life-years (QALYs) (SD, 2.9720) versus 26.8915 (SD, 2.9725), with a lower fatality rate (0.00012; SD, 0.01095 vs 0.00015; SD, 0.1225) versus the ampule-only strategy.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“The incremental cost-effectiveness ratio of supplemental airline epinephrine autoinjectors was $10,766/QALY in the base-case analysis.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

Watchful waiting versus immediate emergency department transfer after epinephrine autoinjector use in children with food allergy, Canada: Yin et al. (2025)

Relevance: Evaluates watchful waiting against immediate emergency department transfer after epinephrine auto-injector use for anaphylaxis in Canada, the post-administration management a model of community epinephrine use would include.

“We developed a probabilistic Markov model of individuals starting at age of one year who are at risk of severe food-related allergic reactions requiring epinephrine.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“We evaluated medical costs (in 2022 Canadian dollars) and quality-adjusted life years (QALY) of each strategy over a 20-year horizon.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“In the base case, we assumed a tenfold increase in food allergy fatality for patients under watchful waiting, which we increased to 100- to 1,000-fold in sensitivity analysis.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“The analysis was conducted from the Canadian healthcare system perspective with a 1.5% annual discount rate and a willingness-to-pay (WTP) threshold of $50,000 per QALY.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“Watchful waiting resulted in cost savings of $1,157 per patient” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“an incremental cost per QALY saved of $1,589,854. The incremental cost per death prevented with immediate ED transfer was $12,586,613.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

“Watchful waiting remained cost-effective in all sensitivity and scenario analyses, except under extreme increases in fatality risk of 500-fold and 1,000-fold.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

The same disease in other populations or settings

Universal versus contextual self-injectable epinephrine for patients receiving allergen immunotherapy, United States: Sun et al. (2019)

Relevance: Evaluates universal against contextual prescribing of self-injectable epinephrine to patients receiving allergen immunotherapy in the United States, a population at risk of systemic allergic reactions.

Access: Not open access

Not quoted: The results are reported in the full text, which is closed access.

“An economic evaluation using cohort and microsimulation was performed from both the societal and health care sector perspectives for patients undergoing AIT, assessing a universal requirement to fill SIE prescriptions at the outset of therapy compared with requiring this only after a systemic reaction to immunotherapy (SRIT).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“A universal SIE requirement for AIT is not cost-effective, with the incremental cost-effectiveness ratio for this strategy estimated at $669,327,730 per quality-adjusted life-year (QALY).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“In the microsimulation (n = 10,000), the mean (SD) costs of a universal approach exceeded that of a more context-specific strategy where SIE was only prescribed for patients after an initial SRIT ($19,653.36 [$4296.66] vs $16,232.14 [$5204.32]), and given the effects on rates of AIT discontinuation, the universal approach was less effective (mean [SD], 25.555 [2.285] QALYs) compared with a contextualized approach (mean [SD], 25.579 [2.345] QALYs).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Universal SIE prescription could be cost-effective if it provided a 1000 times protection against AIT fatality at a value-based cost of $24, and the annual AIT fatality rates unrealistically exceed 2.6 per 10,000 patients.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

Preemptive epinephrine before symptoms versus epinephrine for symptoms in children with peanut allergy, United States: Shaker and Greenhawt (2018b)

Relevance: Evaluates preemptive epinephrine for any peanut exposure before symptoms against epinephrine for symptoms in children with peanut allergy in the United States, the timing question that the guideline recommendations in section 2 address.

Access: Not open access

Not quoted: The results are reported in the full text, which is closed access.

“The objective of this study was to assess the health and economic benefits of pre-emptively injecting epinephrine for peanut ingestion in the absence of any symptoms, and to avoid products with peanut precautionary allergen labeling (PAL).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“We used Markov modeling and simulations, assuming a base-case 10-fold fatality risk increase for less conservative management, with sensitivity analysis investigating 100- to 1000-fold increased fatality risk, incorporating risks of accidental exposures, reactions, fatality, and family costs of food allergy.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Based on these assumptions, small reductions in per-patient fatality risk resulted from pre-emptive epinephrine injection without symptoms present (<1 × 10-4 fewer per-patient fatalities), with incremental costs of $1193 per patient, $11,681,501/life year saved, and $110,270,820/death prevented versus waiting for symptoms before use, but this was not cost-effective even assuming 1000-fold risk ($107, 971/quality of life adjusted year) or quality of life (QoL).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Commonly recommended practices of pre-emptive epinephrine injection in the absence of symptoms, or universal avoidance of PAL, were not cost-effective when compared with administering epinephrine on symptom development or allowing PAL consumption.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

AR101 oral immunotherapy and Viaskin Peanut versus peanut avoidance in peanut allergy, United States: ICER (2019)

Relevance: A United States health technology assessment that evaluates peanut oral immunotherapy and epicutaneous immunotherapy against peanut avoidance, the allergen immunotherapy and trigger avoidance strategies section 2 lists for preventing food-induced anaphylaxis.

“The primary aim of this analysis was to estimate the lifetime cost-effectiveness of the two peanut allergy immunotherapies from a US health care sector perspective.” (opens the source at this quote in a new tab)

“Health states and transitions among them are modeled using a Markov model approach” (opens the source at this quote in a new tab)

“All costs and outcomes were discounted at 3% per year.” (opens the source at this quote in a new tab)

“Using the available placeholder price, the total lifetime cost was $72,000 for AR101 versus $6,000 for avoidance alone, and the incremental cost-effectiveness ratio was $88,000.” (opens the source at this quote in a new tab)

“Immunotherapy with AR101 resulted in increased QALYs due to the utility benefit of more patients having peanut desensitization, with 0.75 incremental QALYs versus avoidance alone (Table 4.13).” (opens the source at this quote in a new tab)

“Using the available placeholder price, the total cost was $62,000 for Viaskin Peanut versus $6,000 for avoidance alone, and the incremental cost- effectiveness ratio was $216,000.” (opens the source at this quote in a new tab)

“Immunotherapy with Viaskin Peanut resulted in increased QALYs due to the utility benefit of increased peanut desensitization, with 0.26 incremental QALYs versus avoidance alone (Table 4.14).” (opens the source at this quote in a new tab)

“Annual Cost to Achieve $100,000 per QALY Annual Cost to Achieve $150,000 per QALY AR101 $4,808 $7,248 Viaskin Peanut $3,010 $4,513” (opens the source at this quote in a new tab)

Omalizumab versus no omalizumab for food allergy in infants, United States: Shaker et al. (2024)

Relevance: Evaluates omalizumab against no omalizumab in infants with food allergy in the United States from a societal perspective, a preventive therapy for people who carry epinephrine for food-induced anaphylaxis.

Access: Not open access

Not quoted: The results are reported in the full text, which is closed access.

“We evaluated health and economic outcomes in Markov cohorts of simulated food allergic infants randomized to receive omalizumab using a 15-year horizon.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“Monte Carlo simulation was used (n = 40,000 subjects) to evaluate cost-effectiveness from a societal perspective, incorporating both a family-level and individual-level analysis.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“In the family-level cohort analysis, omalizumab exceeded cost-effectiveness thresholds ($185,183/quality-adjusted life-years [QALY]).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“In a comparison of the omalizumab strategy (OMA) with the non-omalizumab strategy, the cost of OMA exceeded the non-omalizumab strategy ($315,020 vs $136,609) with greater incremental effectiveness (12.668 vs 11.699 QALY).” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“In the individual-level analysis, the cost-effectiveness of OMA was $573,698/QALY.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

“The value-based cost of OMA ranged from $14,166 to $23,791 when it was considered at the individual and family-unit levels.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

Preschool peanut oral immunotherapy versus no immunotherapy in peanut allergy, United States and Canada: Shaker et al. (2021b)

Relevance: Evaluates preschool peanut oral immunotherapy, an allergen immunotherapy that section 2 lists for food-induced anaphylaxis, against no immunotherapy in the United States and Canada from a societal perspective.

Related diseases and analogous treatments

No evidence found.

Utility weights

Utility weights from analyses of Anaphylm (dibutepinephrine and AQST-109)

No evidence found.

Utility weights for the same indication

No evidence found.

Utility weights for the same disease in other populations or settings

Utility weights for moderate and severe allergic reactions, food allergy, and anaphylaxis, peanut allergy: Shaker et al. (2021a)

Relevance: Utilities for moderate and severe allergic reactions in peanut allergy and disutilities for food allergy and for a transient episode of anaphylaxis, from a United States and United Kingdom model of epinephrine autoinjector prescribing.

Access: Not open access

Not quoted: The utility weights are reported in the full text, which is closed access.

Utility weights for peanut allergy, anaphylaxis, and oral immunotherapy, peanut allergy: Shaker et al. (2021b)

Relevance: Utility weights for peanut allergy, anaphylaxis, and oral immunotherapy, from a United States and Canadian model of preschool peanut oral immunotherapy.

Access: Not open access

Not quoted: The utility weights are reported in the full text, which is closed access.

Baseline utility weight, peanut allergy: Shaker et al. (2025)

Relevance: Baseline utility for peanut allergy used in the model of non-injectable against intramuscular epinephrine.

Access: Not open access

Not quoted: The utility weights are reported in the full text, which is closed access.

Disutility for food allergy, peanut allergy in school-age children: Shaker and Greenhawt (2019a)

Relevance: Disutility for food allergy, from a United States model of school stock epinephrine for peanut anaphylaxis.

Utility weights for food allergy and peanut oral immunotherapy, peanut allergy in children: Shaker (2017)

Relevance: Utility weights for food allergy and for peanut allergy on oral immunotherapy in children, from a model of peanut oral immunotherapy.

Access: Not open access

Not quoted: The utility weights are reported in the full text, which is closed access.

Disutility for anaphylaxis, second Tdap vaccine dose: Kamiya et al. (2016)

Relevance: Disutility for an episode of anaphylaxis, from a model of a second Tdap vaccine dose in which anaphylaxis is an adverse event.

Access: Not open access

Not quoted: The utility weights are reported in the full text, which is closed access.

Disutility for anaphylaxis, routine annual influenza vaccination: Kim DeLuca et al. (2023)

Relevance: Disutility for anaphylaxis, from a United States influenza vaccination model in which anaphylaxis is an adverse event.

Access: Full text not retrieved

Not quoted: The utility weights are reported in the full text, which this page does not quote.

Utility weight for hospitalization with anaphylaxis, pneumococcal vaccination in healthy younger adults: Pepper and Owens (2002)

Relevance: Utility for a hospitalization with anaphylaxis, from a vaccination model in which anaphylaxis is an adverse event.

Access: Not open access

Not quoted: The utility weights are reported in the full text, which is closed access.

Utility weights for related diseases and analogous treatments

No evidence found.

Search strategy

DatasetQueryResults
Methodsdibutepinephrine OR Anaphylm OR "AQST-109"0
Ratiosepinephrine OR adrenaline23
Ratiosanaphylaxis OR anaphylactic OR autoinjector OR "auto-injector"24
Ratios"peanut allergy" OR "food allergy" OR "peanut anaphylaxis"34
Ratiosvenom OR hymenoptera OR "insect sting"0
Weightsanaphylaxis OR anaphylactic OR "allergic reaction"50
Methodsepinephrine OR adrenaline OR anaphylaxis21
Ratiosneffy OR "nasal epinephrine" OR "intranasal epinephrine" OR "sublingual epinephrine"2
Weights"food allergy" OR "peanut allergy"36