Dataset Information

Association of Fatality Risk With Value-Based Drug Pricing of Epinephrine Autoinjectors for Children With Peanut Allergy: A Cost-effectiveness Analysis.

ABSTRACT: Importance:The high cost of self-injectable epinephrine autoinjectors may represent a barrier to community anaphylaxis management. Value-based pricing can provide a benchmark for rational epinephrine autoinjector costs. Objective:To define value-based pricing of community epinephrine autoinjectors. Design, Setting, and Participants: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. Simulation inputs included all-cause age-adjusted mortality (2013 US life tables), 2013 published food allergy fatality rates, 2017 rates of autoinjector device carriage, and 2016 published market costs of self-injectable epinephrine. All costs were expressed in 2018 US dollars and discounted at 3% per annum. Exposures: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. Main Outcomes and Measures:Fatality risk, quality-adjusted life-years, and incremental cost-effectiveness ratio. Results:A total of 100?000 simulated infants with peanut allergy entered each strategy, with two-thirds of the group receiving annual personal epinephrine prescriptions and using those devices appropriately when indicated. 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, resulting in an average food allergy fatality of 0.00056 (95% CI, 0.000414-0.000706) per patient prescribed self-injectable epinephrine and 0.00148 (95% CI, 0.001242-0.001718) in those not prescribed self-injectable epinephrine. 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. At a market cost of $715 per twin pack, the autoinjector incremental cost-effectiveness ratio was $2?742?697 per quality-adjusted life-year. 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. Conclusions and Relevance:In a simulation of children with peanut allergy, a value-based epinephrine cost has a ceiling of $24 for a personal autoinjector, even at an exaggerated fatality risk.

SUBMITTER: Shaker M

PROVIDER: S-EPMC6324395 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Association of Fatality Risk With Value-Based Drug Pricing of Epinephrine Autoinjectors for Children With Peanut Allergy: A Cost-effectiveness Analysis.

Shaker Marcus M Greenhawt Matthew M

JAMA network open 20181102 7

<h4>Importance</h4>The high cost of self-injectable epinephrine autoinjectors may represent a barrier to community anaphylaxis management. Value-based pricing can provide a benchmark for rational epinephrine autoinjector costs.<h4>Objective</h4>To define value-based pricing of community epinephrine autoinjectors.<h4>Design, setting, and participants</h4>In an economic evaluation study using a cost-effectiveness birth cohort model over an extended 80-year time horizon, Markov simulations of child ...[more]

PMID: 30646369

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Project description:ObjectiveTo compared the cost-effectiveness of coadministration of a probiotic adjuvant with peanut oral immunotherapy (PPOIT) with placebo (no treatment) in children with peanut allergy.DesignProspectively planned cost-effectiveness analysis alongside a randomised control trial.SettingThe Royal Children's Hospital, Melbourne, Australia.Participants56 children with peanut allergy aged 1-10 years at recruitment.InterventionA daily dose of probiotic Lactobacillus rhamnosus CGMCC 1.3724 (NCC4007) and peanut oral immunotherapy administered for 1.5 years.Main outcomes measuresCosts were considered from a healthcare system perspective and included costs of treatment delivery and adverse events. Effectiveness outcomes included rate of sustained unresponsiveness (SU) and quality-adjusted life years (QALYs). The cost-effectiveness of PPOIT versus placebo was analysed using patient-level data. Time horizon was 10 years from commencement of PPOIT treatment, comprising 1.5 years of treatment (actual data), 4 years of post-treatment follow-up (actual data), and 4.5 years of extrapolation thereafter (modelling).ResultsHealthcare cost per patient over 10 years was higher for PPOIT compared with placebo ($A9355 vs $A1031, p<0.001). Over half of the per patient healthcare cost (53%) in the PPOIT group was attributable to treatment delivery, while the remaining cost was attributable to adverse events. Both measures of effectiveness were superior in the PPOIT group: the average SU rate over 10 years was 54% for PPOIT versus 6% for placebo (p<0.001); QALYs over 10 years were 9.05 for PPOIT versus 8.63 for placebo (p<0.001). Overall, cost per year of SU achieved was $A1694 (range $A1678, $A1709) for PPOIT compared with placebo, and cost per additional QALY gained was $A19 386 (range $A19 024, $A19 774).ConclusionsCost per QALY gained using PPOIT compared with no treatment is approximately $A20 000 (£10 000) and is well below the conventional value judgement threshold of $A50 000 (£25 000) per QALY gained, thus deemed good value for money ($A1= £0.5 approximately).Trial registration numberAustralian New Zealand Clinical Trials Registry ACTRN12608000594325; Post-results.

Project description:Importance:Children experiencing anaphylaxis at school may lack access to a personal epinephrine device, prompting recent legislation permitting undesignated (eg, non-student specific) stock epinephrine autoinjector units at school. However, epinephrine device costs vary, and the cost-effectiveness of undesignated school stock epinephrine is uncharacterized to date. Objective:To define value-based strategies for undesignated school stock epinephrine programs. Design, Setting, and Participants: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. The dates of the data used in the analysis were September 2017 to June 2018 (the 2017-2018 school year). Main Outcomes and Measures: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). The base-case model assumed a 10-fold reduced fatality risk with having undesignated stock epinephrine units available vs not having undesignated stock epinephrine units available. Costs of school stock epinephrine units available for acquisition by schools were evaluated from a societal perspective. Quality-adjusted life-years (QALYs) and total epinephrine acquisition expenses were calculated. Results: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. Undesignated stock epinephrine improved outcomes, with 26.869 (95% CI, 26.841-26.897) QALYs accrued as the model concluded compared with 26.867 (95% CI, 26.839-26.896) QALYs for the strategy without undesignated stock epinephrine. 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. However, the cost of the supplemental model fell below $100 000 per QALY when the annual undesignated epinephrine acquisition costs did not exceed $338 per school (compared with stock epinephrine unavailability). 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). Conclusions and Relevance:Undesignated school stock epinephrine is cost-effective at device acquisition costs not exceeding $338 per school per year, although a universal model vs a supplemental model is associated with superior health and economic outcomes.

Project description:The role of cost-effectiveness analysis (CEA) in incentivizing innovation is controversial. Critics of CEA argue that its use for pricing purposes disregards the 'value of innovation' reflected in new drug development, whereas supporters of CEA highlight that the value of innovation is already accounted for. Our objective in this article is to outline the limitations of the conventional CEA approach, while proposing an alternative method of evaluation that captures the value of innovation more accurately. The adoption of a new drug benefits present and future patients (with cost implications) for as long as the drug is part of clinical practice. Incidence patients and off-patent prices are identified as two key missing features preventing the conventional CEA approach from capturing 1) benefit to future patients and 2) future savings from off-patent prices. The proposed CEA approach incorporates these two features to derive the total lifetime value of an innovative drug (i.e., the value of innovation). The conventional CEA approach tends to underestimate the value of innovative drugs by disregarding the benefit to future patients and savings from off-patent prices. As a result, innovative drugs are underpriced, only allowing manufacturers to capture approximately 15% of the total value of innovation during the patent protection period. In addition to including the incidence population and off-patent price, the alternative approach proposes pricing new drugs by first negotiating the share of value of innovation to be appropriated by the manufacturer (>15%?) and payer (<85%?), in order to then identify the drug price that satisfies this condition. We argue for a modification to the conventional CEA approach that integrates the total lifetime value of innovative drugs into CEA, by taking into account off-patent pricing and future patients. The proposed approach derives a price that allows manufacturers to capture an agreed share of this value, thereby incentivizing innovation, while supporting health-care systems to pursue dynamic allocative efficiency. However, the long-term sustainability of health-care systems must be assessed before this proposal is adopted by policy makers.

Project description:ImportanceEarly peanut introduction reduces the risk of developing peanut allergy, especially in high-risk infants. Current US recommendations endorse screening but are not cost-effective relative to other international strategies.ObjectiveTo identify scenarios in which current early peanut introduction guidelines would be cost-effective.Design, setting, and participantsThis simulation/cohort economic evaluation used microsimulations and cohort analyses in a Markov model to evaluate the cost-effectiveness of early peanut introduction with and without peanut skin prick test (SPT) screening in high-risk infants during an 80-year horizon from a societal perspective. Data were analyzed from April to May 2019.ExposuresHigh-risk infants with early-onset eczema and/or egg allergy underwent early peanut introduction with and without peanut SPT screening (100?000 infants per treatment strategy) using a dichotomous 8-mm SPT cutoff value (stipulated in the current US guideline).Main outcomes and measuresCost, quality-adjusted life-years (QALYs), net monetary benefit, peanut allergic reactions, severe allergic reactions, and deaths due to peanut allergy.ResultsIn the simulated cohort of 200 000 infants and using the base case during the model horizon, a no-screening approach had lower mean (SD) costs ($13?449 [$38?163] vs $15?279 [$38?995]) and higher mean (SD) gain in QALYs (29.25 [3.28] vs 29.23 [3.30]) vs screening but resulted in more allergic reactions (mean [SD], 1.07 [3.15] vs 1.01 [3.02]), severe allergic reactions (mean [SD], 0.53 [1.66] vs 0.52 [1.62]), and anaphylaxis involving cardiorespiratory compromise (mean [SD], 0.50 [1.59] vs 0.49 [1.47]) per individual. In deterministic SPT sensitivity analyses at base-case sensitivity and specificity rates, screening could be cost-effective at a high disutility rate (the negative effect of a food allergic reaction) (76-148 days of life traded) for an at-home vs in-clinic reaction in combination with high baseline peanut allergy prevalence among infants at high risk for peanut allergy and not yet exposed to peanuts. If an equivalent rate and disutility of accidental and index anaphylaxis was assumed and the 8-mm SPT cutoff had 0.85 sensitivity and 0.98 specificity, screening was cost-effective at a peanut allergy prevalence of 36%.Conclusions and relevanceThe results of this study suggest that the current screening approach to early peanut introduction could be cost-effective at a particular health utility for an in-clinic reaction, SPT sensitivity and specificity, and high baseline peanut allergy prevalence among high-risk infants. However, such conditions are unlikely to be plausible to realistically achieve. Further research is needed to define the health state utility associated with reaction location.

Dataset Information

Association of Fatality Risk With Value-Based Drug Pricing of Epinephrine Autoinjectors for Children With Peanut Allergy: A Cost-effectiveness Analysis.

Publications

Association of Fatality Risk With Value-Based Drug Pricing of Epinephrine Autoinjectors for Children With Peanut Allergy: A Cost-effectiveness Analysis.

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