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Aim To estimate the fiscal burden for taxpayers in Sweden associated with type 2 diabetes (T2D) attributed to diabetes-related complications in patients failing to meet HbA1c targets. Material and Methods We developed a public economic framework to assess how changes in diabetes-related complications influenced projected tax contributions and government disability payments for people with T2D. The analysis applied accepted disease-modelling practices to estimate different rates of diabetes-related complications based on an HbA1c of 6.9% (52 mmol/mol) and of 6.0% (42 mmol/mol). We adjusted the employment activity rates for those experiencing T2D-related events, applying age-specific earnings to estimate lifetime tax losses. Furthermore, the likelihood of receiving payments for health-related employment inactivity was estimated. Direct healthcare costs are excluded from this analysis. Results The estimated per person earnings loss for immediate and delayed HbA1c control was Swedish krona (SEK) 42 299 and SEK 44 157, respectively, over 10 years. The lost employment activity of people with T2D translates to lost tax revenues of SEK 23 265 and SEK 24 287 for immediate and delayed control, respectively. The estimated difference in disability payments was SEK 538. Combining the tax revenue loss and excess disability payments defines the broader fiscal costs, where we observe combined fiscal losses that favour immediate and sustained control by SEK 1560 over 10 years. Conclusions We show that conducting fiscal analysis of diabetes interventions offers an enriched perspective capturing a range of costs that fall on government in relation to lost tax revenue and disability payments. Tax-financed health systems may benefit from broadening the consideration of costs and benefits when evaluating new interventions and treatment practices.

Clinician's choice of hypoallergenic formulas in the first-line management of cow's milk protein allergy (CMPA) should be informed by evidence on clinical efficacy and cost-effectiveness.We compare the cost-effectiveness of amino acid-based formula (AAF), extensively hydrolyzed casein formula with Lactobacillus rhamnosus Gorbach Goldin (EHCF+LGG), extensively hydrolyzed whey formula (EHWF), and rice hydrolyzed formula (RHF) in non-breastfed children in France.Immunotolerance and atopic manifestations' prevalence were based on a prospective non-randomized study with a 36-month follow-up. Resource utilization was sourced from a survey of French clinicians, and unit costs were based on national data. Costs and health consequences were discounted at 2.5% annually. Results were reported using the Collective and French National Health Insurance perspectives.Children receiving EHCF+LGG were predicted to require less healthcare resources, given their reduced prevalence of CMPA symptoms at 3 years. In the base case, EHCF+LGG led to savings of at least €674 per child compared to AAF, EHWF, and RHF at 3 years, from both perspectives. Nutrition had the highest economic burden in CMPA, driven by hypoallergenic formulas and dietetic replacements costs. Results were robust to one-way and probabilistic sensitivity analyses.EHCF+LGG was associated with more symptom-free time, higher immune tolerance, and lower costs.

Background: Cow’s milk protein allergy (CMPA) is the most common food allergy in early childhood. In most children CMPA resolves by age 5 or 6; however, if not treated correctly can provoke nutritional deficiency resulting in poor growth. Management consists of excluding cow’s milk from the diet, with hypoallergenic formulas (or non-dairy alternatives) being introduced to meet nutritional requirements.Objectives: To compare the cost-effectiveness of hypoallergenic formulas in reducing allergic manifestations and promoting immune tolerance in infants with immunoglobulin E (IgE)-mediated symptoms of CMPA.Methods: A trial-based decision analytic cohort model was developed to simulate the occurrence of urticaria, eczema, asthma, rhinoconjunctivitis, or being symptom-free in infants with CMPA in the United Kingdom. Amino acid-based formula (AAF), extensively hydrolysed casein formula containing Lactobacillus rhamnosus Gorbach Goldin (EHCF+LGG), extensively hydrolysed whey formula (EHWF), and soy formula (SF) were compared using the National Health Service (NHS) perspective, 3-year time horizon and 3.5% discount rate for cost and health consequences. Hypoallergenic formulas comparative efficacy was sourced from a prospective cohort study. Resources required to manage allergic symptoms were sourced from published literature, validated by a UK clinician, and applied to UK cost resources. Results were reported as cost per additional child free from allergic manifestations at 3 years and cost per additional immune tolerant child at 3 years.Results: In the base case, infants receiving EHCF+LGG were associated with lower NHS resource use and improved CMPA tolerance. Over the 3-year treatment period, savings of £119, £476, and £1094 were achieved with EHCF+LGG compared to SF, EHWF and AAF, respectively. Infant formula accounted for the largest proportion of resource consumption averaging 44% for all comparators, with a minimum of 31% for SF and a maximum of 53% for AAF over 3 years. General practitioners’ visits constituted the second highest cost component, approximately 17% of total costs across comparators. The results were robust to deterministic and probabilistic sensitivity analyses.Conclusions: Compared to AAF, SF, and EHWF hypoallergenic formulas, EHCF+LGG was the most cost-effective, associated with lower total costs and contributing to a higher proportion of children being symptom-free and developing immune tolerance 3-years after diagnosis.

Background Acute hepatic porphyria (AHP) is a rare, debilitating disease characterized by potentially life-threatening attacks often resulting in chronic symptoms that negatively impact daily functioning and quality of life. Symptoms of AHP prevent many individuals from working and achieving lifetime work averages. The aim of this study was to apply a public economic framework to evaluate AHP in Belgium, taking into consideration a broad range of costs that are relevant to government in relation to social benefit payments and lifetime taxes paid. Methodology A public economic framework was developed exploring lifetime costs for government attributed to an individual with AHP and recurrent attacks in Belgium. Work-activity and lifetime direct taxes paid, indirect consumption taxes and requirements for public benefits were estimated based on established clinical pathways for AHP and compared to the general population (GP). The model includes AHP-related healthcare costs and non-AHP healthcare costs for the GP. Results Lifetime earnings are reduced in an individual with AHP by €347,802 per person (p.p.), translating to reduced lifetime taxes paid of €183,187 for an AHP individual compared to the GP. We estimate increased lifetime disability benefit support of €247,242 for an AHP individual compared to GP. Lifetime healthcare costs for a person with AHP were estimated to be €3,030,316 due to frequent hospitalisations associated with porphyria attacks compared to the GP. The lifetime costs for a person with 12 attacks per annum factoring in transfers, taxes and healthcare costs are estimated to be €3,460,745 p.p. Eliminating AHP attacks after 10 years of active disease, thus, enabling a person to return to work increases lifetime earnings by €224,575 p.p. Increased work activity in such individuals would generate an estimated €118,284 p.p. over their lifetime. The elimination of AHP attacks could also lead to reductions in disability payments of €179,184 p.p. and healthcare cost savings of €1,511,027 p.p. Conclusions Due to severe disability resulting from constant attacks, AHP patients with recurrent attacks incur significant public costs. Lifetime taxes paid are reduced as these attacks occur during peak earning and working years. In those patients, reducing AHP attacks can confer significant fiscal benefits for government, including reduced healthcare costs, reduced disability payments and improved tax revenue.

Limited resources and high treatment costs are arguments often used in many public health systems in low- and middle-income countries to justify providing limited treatments for people with infertility. In this analysis, we apply a government public economic perspective to evaluate public subsidy for in-vitro fertilization (IVF) in South Africa. A fiscal model was developed that considered lifetime direct and indirect taxes paid and government transfers received by a child conceived by IVF. The model was constructed from public data sources and was adjusted for mortality, age-specific educational costs, participation in the informal economy, proportions of persons receiving social grants, and health costs. Based on current proportions of individuals receiving social grants and average payments, including education and health costs, we estimate each citizen will receive ZAR513,165 (USD35,587) in transfers over their lifetime. Based on inflated age-specific earnings, we estimate lifetime direct and indirect taxes paid per citizen of ZAR452,869 (USD31,405) and ZAR494,521 (USD34,294), respectively, which also includes adjustments for the proportions of persons participating in the informal economy. The lifetime net tax after deducting transfers was estimated to be ZAR434,225 (USD31,112) per person. Based on the average IVF investment cost needed to achieve one live birth, the fiscal return on investment (ROI) for the South African Government is 5.64. Varying the discount rate from 4% to 7%, the ROI ranged from 9.54 to 1.53, respectively. Positive economic benefits can emanate from public financing of IVF. The fiscal analytic framework described here can be a useful approach for health services to evaluate future public economic benefits.

Introduction Postoperative anastomotic leaks remain a common and serious complication of colorectal surgeries and are a major cause of mortality and morbidity of these procedures. Anastomotic leaks (AL) have been extensively studied; however, there has been no significant reduction in their prevalence over time. In addition, there is a significant economic burden from AL attributed to the need for repeat surgery, radiologic intervention and lengthened hospital stay. We conducted a comparative cost analysis of patients undergoing colorectal surgery with anastomosis, with the application of fibrin sealant (FS) to the sutured anastomosis versus not treating the sutured anastomosis with FS. Methods The deterministic decision-tree model was populated with clinical data including operating room time, hospitalization days, occurrence of AL, need for revision surgery, blood products and radiologic interventions to treat the AL in lower colorectal surgery. A systematic literature review was conducted to identify appropriate studies with these variables. Results The average cost per case treated lower colorectal surgery with fibrin sealant glue 10 mL Tisseel® and those not treated with a fibrin sealant after suturing the anastomoses was €3233 and €4130, respectively, for resource expenses paid by the healthcare system. This would suggest potential savings of €897 per surgery, achieved through the application of FS to the sutured anastomosis for preventing AL following colorectal surgery. Conclusion Application of FS to the sutured anastomosis in lower colorectal surgery resulted in a decrease in post-operative AL, and cost savings based on a reduction in hospitalization days, a reduction needing: revision surgery, radiologic intervention and blood products to treat AL.

Background: The economics of rotavirus gastroenteritis in infants

Goran Medic,1,2 Nikos Kotsopoulos,3 Mark P Connolly,2,3 Jennifer Lavelle,4 Vincent Norlock,4 Manish Wadhwa,4 Belinda A Mohr,5 Wayne M Derkac4 1Chief Medical Office, Philips Healthcare, Eindhoven, Netherlands; 2Department of Pharmacy, University of Groningen, Groningen, Netherlands; 3Global Market Access Solutions LLC, Charlotte, NC, USA; 4BioTelemetry, Inc., A Philips Company, Malvern, PA, USA; 5Chief Medical Office, Philips, Cambridge, MA, USACorrespondence: Goran MedicChief Medical Office, Philips Healthcare, High Tech Campus 37-3.009, Eindhoven, 5656 AG, NetherlandsTel +31-61-819-3782Email goran.medic@philips.comPurpose: The aim of this study was to compare costs and outcomes of mobile cardiac outpatient telemetry (MCOT) patch followed by implantable loop recorder (ILR) compared to ILR alone in cryptogenic stroke patients from the US health-care payors’ perspective.Patients and Methods: A quantitative decision tree cost-minimization simulation model was developed. Eligible patients were 18 years of age or older and were diagnosed with having a cryptogenic stroke, without previously documented atrial fibrillation (AF). All patients were assigned first to one then to the alternative monitoring strategies. Following AF detection, patients were initiated on oral anticoagulants (OAC). The model assessed direct costs for one year attributed to MCOT patch followed by ILR or ILR alone using a monitoring duration of 30 days post-cryptogenic stroke.Results: In the base case modeling, the MCOT patch arm detected 4.6 more patients with AFs compared to the ILR alone arm in a cohort of 1000 patients (209 vs 45 patients with detected AFs, respectively). Using MCOT patch followed by ILR in half of the patients initially undiagnosed with AF leads to significant cost savings of US$4,083,214 compared to ILR alone in a cohort of 1000 patients. Cost per patient with detected AF was significantly lower in the MCOT patch arm $29,598 vs $228,507 in the ILR only arm.Conclusion: An initial strategy of 30-day electrocardiogram (ECG) monitoring with MCOT patch in diagnosis of AF in cryptogenic stroke patients realizes significant cost-savings compared to proceeding directly to ILR only. Almost 8 times lower costs were achieved with improved detection rates and reduction of secondary stroke risk due to new anticoagulant use in subjects with MCOT patch detected AF. These results strengthen emerging recommendations for prolonged ECG monitoring in secondary stroke prevention.Keywords: ambulatory cardiac monitoring, Holter, atrial fibrillation, electrocardiography, economic evaluation, secondary prevention

Background: Individuals experiencing osteoarthritis (OA) pain can pose significant costs for governments due to reduced work activity in these individuals and increasing reliance on public support benefits. In this analysis we capture the broader economic impact of OA pain by applying a government perspective, public economic framework to assess controlled and uncontrolled pain. Methods: We used a Markov model to compare labour market participation in people with uncontrolled OA hip or knee pain compared to a cohort with controlled OA pain. The likelihood of employment, long-term sickness, disability, and early retirement in those with controlled pain used publicly available UK data. The relative effect of uncontrolled OA pain on fiscal outcomes is drawn from peer reviewed publications reporting reduced work activity and reliance on public benefits for people with uncontrolled OA pain. Lost tax revenue was derived using UK tax rates and national insurance contributions applied to annual earnings. Social benefit rules were applied to calculate government financial support to individuals. Health-care costs were calculated based on estimates from an UK observational study. The base case analysis compared the projected lost tax revenue and transfer payments for a 50-year-old cohort with severe OA pain, retiring at age 65. Results: For a 50-year-old individual with moderate uncontrolled OA pain with 15-years remaining work expectancy, the model estimated a £62 383 reduction in employment earnings, a £24 307 reduction in tax contributions and a need for £16 034 in government benefits, compared to a person with controlled OA pain. In people with severe uncontrolled OA pain incremental foregone earnings were estimated to be £126 384, £44 925 were not paid through taxation and £25 829 were received in public benefits, compared to the controlled pain cohort. Health-care costs represented 13% and 12% of all OA-related fiscal cost in the moderate uncontrolled OA pain and severe uncontrolled OA pain comparison, respectively. Conclusions: For governments, maintaining an active workforce is paramount to maintaining economic growth and reducing spending on government programs. The approach described here can be used to augment cost-effectiveness models to inform a range of stakeholders of benefits attributed to controlled OA pain.

Background Acute hepatic porphyria (AHP) is a rare, debilitating disease characterized by potentially life-threatening attacks often resulting in chronic symptoms that negatively impact daily functioning and quality of life. Symptoms of AHP prevent many individuals from working and achieving lifetime work averages. The aim of this study was to apply a public economic framework to evaluate AHP in Belgium, taking into consideration a broad range of costs that are relevant to government in relation to social benefit payments and lifetime taxes paid. Methodology A public economic framework was developed exploring lifetime costs for government attributed to an individual with AHP in Belgium. Work-activity and lifetime direct taxes paid, indirect consumption taxes and requirements for public benefits were estimated based on established clinical pathways for AHP and compared to the general population (GP). The model includes AHP-related healthcare costs and non-AHP healthcare costs for the GP. Results Lifetime earnings are reduced in an individual with AHP by €347,802 per person (p.p.), translating to reduced lifetime taxes paid of €183,187 for an AHP individual compared to the GP. We estimate increased lifetime disability benefit support of €247,242 for an AHP individual compared to GP. Lifetime healthcare costs for a person with AHP were estimated to be €3,030,316 due to frequent hospitalisations associated with porphyria attacks compared to the GP. The lifetime costs for a person with 12 attacks per annum factoring in transfers, taxes and healthcare costs are estimated to be €3,460,745 p.p. Eliminating AHP attacks after 10 years of active disease, thus, enabling a person to return to work increases lifetime earnings by €224,575. Increased work activity in this cohort would generate an estimated €118,284 p.p. over their lifetime. The elimination of AHP attacks could also lead to reductions in disability payments of €179,184 p.p. and healthcare cost savings of €1,511,027. Conclusions Due to severe disability resulting from constant attacks, AHP patients incur significant public costs. Lifetime taxes paid are reduced as these attacks occur during peak earning and working years. Reducing AHP attacks can confer significant fiscal benefits for government, including reduced healthcare costs, reduced disability payments and improved tax revenue.

Background Assessing the societal perspective in economic evaluations of new interventions requires estimates of indirect non-medical costs caused by the disease. Different methods exist for measuring the labor input function as a surrogate for these costs. They rarely specify the effect of health on labor and who gains and who loses money. Social accounting matrix (SAM) is an established framework that evaluates public policies with multiple perspectives that could help. Objectives We evaluated the use of a modified SAM to assess money flows between different economic agents resulting in economic transactions following policy changes of medical interventions. Methods We compared conventional methods of measuring indirect non-medical costs related to rotavirus vaccination in the Netherlands with a modified SAM framework. To compare the outcome of each method, we calculated returns on investment (ROI) as the net amount of money per euro invested in the vaccine. One-way and probabilistic sensitivity analyses were carried out for each method, focusing on critical variables with the largest impact on indirect cost estimates. Results The ROI was higher for the modified SAM (1.33) than for the conventional methods assessing income calculations (range - 0.178 to 1.22). Probabilistic sensitivity analyses showed wide distributions in the ROI estimates, with variation in the variable impact on the indirect cost results per method selected. Conclusions In contrast to conventional methods, the SAM approach provides detailed and comprehensive assessments of the impact of new interventions on the indirect non-medical costs and the financial interactions between agents, disclosing useful information for different stakeholders.

Background: Following cardiovascular events, individuals often make choices about their working life that pose fiscal costs for the government in relation to lost tax revenue, increasing disability or early retirement. We evaluate the fiscal consequences for the Australian Government in atherosclerotic cardiovascular disease (ASCVD) patients with low-density lipoprotein >3.3 mmol/L after the maximum tolerated doses of a statin or when contraindicated or intolerant to statins, compared to evolocumab added to the standard of care. Methods: The natural history of patients with ASCVD was evaluated using a multi-state Markov cohort model comparing evolocumab with current treatment practices. Published rates for the likelihood of being disabled and retiring prematurely in patients experiencing stroke or myocardial infarction were modeled. Reported government costs for annual disability payments and lost tax revenues from the nationally representative STINMOD + data set were used to estimate the fiscal consequences associated with attributable ASCVD events. Results: The incremental tax gain associated with evolocumab in someone aged 40, 50 or 60 results in additional tax revenues of Aus$15,716, Aus$9,810 and Aus$4,217, respectively. Cost-savings attributed to disability payments of Aus$3,483, Aus$2,495 and Aus$4,619 were observed in those aged 40, 50 and 60, respectively. The ratio of evolocumab to fiscal benefits indicates that up to 52% of evolocumab costs are offset by future lifetime taxes paid and reduced social benefits payments in those treated aged 40. The ratio of fiscal benefits to costs in treating those aged 50 and 60 were 37% and 31%, respectively. Conclusions: Applying a cross-sectorial government perspective budget impact assessment improves our understanding of fiscal changes attributed to ASCVD based on changes in premature mortality and work activity and how this influences lifetime tax contributions and public benefits. The main cost driver observed was associated with reduced ASCVD events that enabled people to remain productive and paying taxes.

Infectious diseases can impose considerable mortality and morbidity for children and adult populations resulting in both short- and long-term fiscal costs for government. Traditionally, healthcare costs are the dominant consideration in economic evaluations of vaccines, which likely ignores many costs that fall on governments in relation to vaccine-preventable conditions. In recent years, fiscal health modeling has been proposed as a complementary approach to cost-effectiveness analysis for considering the broader consequences for governments attributed to vaccines. Fiscal modeling evaluates public health investments attributed to treatments or preventive interventions in the case of vaccination, and how these investments influence government public accounts. This involves translating morbidity and mortality outcomes that can lead to disability, associated costs, early retirement due to poor health, and death, which can result in lost tax revenue for government attributed to reduced lifetime productivity. To assess fiscal consequences of public health programs, discounted cash flow analysis can be used to translate how changes in morbidity and mortality influence transfer payments and changes in lifetime taxes paid based on initial health program investments. The aim of this review is to describe the fiscal health modeling framework in the context of vaccines and demonstrate key features of this approach and the role that public economic assessment of vaccines can make in understanding the broader economic consequences of investing in vaccination programs. In this review, we describe the theoretical foundations for fiscal modeling, the aims of fiscal model, the analytical outputs, and discuss the relevance of this framework for evaluating the economics of vaccines.

Background and aims: The economic consequences of multiple sclerosis (MS) are broader than those observed within the health system. The progressive nature suggests that people will not be able to live a normal productive life and will gradually require public benefits to maintain living standards. This study investigates the public economic impact of MS and how investments in disease-modifying therapies (DMTs) influence the lifetime costs to government attributed to changes in lifetime tax revenue and disability benefits based on improved health status linked to delayed disease progression. Methods: Disease progression rates from previous MS Markov cohort models were applied to interferon beta-1a, peginterferon beta-1a, dimethyl fumarate, and natalizumab using a public economic framework. The established relationship between expanded disability status scale and work-force participation, annual earnings, and disability rates for each DMT were applied. Subsequently, we assessed the effect of DMTs on discounted governmental costs consisting of health service costs, social insurance and disability costs, and changes in lifetime tax revenues. Results: Fiscal benefits attributed to informal care and community services savings for interferon beta-1a, peginterferon beta-1a, dimethyl fumarate, and natalizumab were SEK340,387, SEK486,837, SEK257,330, and SEK958,852 compared to placebo, respectively. Tax revenue gains linked to changes in lifetime productivity for interferon beta-1a, peginterferon beta-1a, dimethyl fumarate, and natalizumab were estimated to be SEK27,474, SEK39,659, SEK21,661, and SEK75,809, with combined fiscal benefits of cost savings and tax revenue increases of SEK410,039, SEK596,592, SEK326,939, and SEK1,208,023, respectively. Conclusion: The analysis described here illustrates the broader public economic benefits for government attributed to changes in disease status. The lifetime social insurance transfer costs were highest in non-treated patients, and lower social insurance costs were demonstrated with DMTs. These findings suggest that focusing cost-effectiveness analysis only on health costs will likely underestimate the value of DMTs.

Toxoplasmosis causes substantial morbidity and mortality in the United States (US). Clinical manifestations to toxoplasmosis vary and there is limited information on incidence or treatment patterns in the US. Treatment pathways for pyrimethamine-based regimens and trimethoprim-sulfamethoxazole (TMP-SMX) for toxoplasmosis hospitalizations were investigated using the Vizient Health Systems inpatient and outpatient data. Between January 1st, 2011 and December 31st, 2017, 10,273 hospital visits from 4,736 unique patients received a primary or secondary ICD-9/ICD-10 diagnosis for toxoplasmosis. The projected annual hospital visits with a diagnosis of toxoplasmosis was 68,821, corresponding to a total annual incidence of 9,832 comprising ocular toxoplasmosis of 2,169, toxoplasmic encephalitis of 1,399, unspecified toxoplasmosis of 4,368, congenital toxoplasmosis of 381, multisystemic toxoplasmosis of 69 and other toxoplasmosis of 1,446. Only 16.3% of the study population received treatment with pyrimethamine-based regimens or TMP-SMX. Pyrimethamine-based regimens were used significantly more often than TMP-SMX in toxoplasmic encephalitis (88.7% vs 79.6%, p = 0.01), other toxoplasmosis (85.0% vs 79.2%, p = 0.04), and unspecified toxoplasmosis (87.6% vs 77.9%, p = 0.03) in hospitals with 300 beds or more. A significantly higher percentage of visits with TMP-SMX as first-line treatment switched to pyrimethamine-based regimens compared to visits initiated on pyrimethamine-based treatments (26.7% vs 4.1%, p

This report provides recommendations for budget holders and decision makers in high-, middle, and low-income countries requiring economic analyses of new vaccination programs to allocate scarce resources given budget constraints. ISPOR's Economic Evaluation of Vaccines Designed to Prevent Infectious Disease: Good Practices Task Force wrote guidelines for three analytic methods and solicited comments on them from external reviewers. Cost-effectiveness analyses use decision-analytic models to estimate cumulative changes in resource use, costs, and changes in quality- or disability-adjusted life-years attributable to changes in disease outcomes. Constrained optimization modeling uses a mathematical objective function to be optimized (e.g. disease cases avoided) for a target population for a set of interventions including vaccination programs within established constraints. Fiscal health modeling estimates changes in net present value of government revenues and expenditures attributable to changes in disease outcomes. The task force recommends that those designing economic analyses for new vaccination programs take into account the decision maker's policy objectives and country-specific decision context when estimating: uptake rate in the target population; vaccination program's impact on disease cases in the population over time using a dynamic transmission epidemiologic model; vaccination program implementation and operating costs; and the changes in costs and health outcomes of the target disease(s). The three approaches to economic analysis are complementary and can be used alone or together to estimate a vaccination program's economic value for national, regional, or subregional decision makers in high-, middle-, and low-income countries.

Inguinal hernias of the abdominal wall are common accounting for 75% of all hernia defects. They can be treated with laparoscopic surgery using a transabdominal preperitoneal (TAPP) approach. However, in surgery there is some contention on how to conclude the hernia repair, as there are alternatives of using fibrin sealant (FS) or tack screws for fixation of a mesh implant over the defect in the abdominal wall. In this study, we evaluate the economic consequences of using FS vs. tacks for mesh fixation in TAPP inguinal hernia repair for the UK from a hospital perspective.The model was populated with clinical inputs (theater time, hospitalization days, occurrence of seroma, and neuralgia) from a previously conducted study comparing FS and tack screws in patients who had undergone TAPP hernia repair, and cost inputs from official government sources. One-way sensitivity analyses were also conducted to evaluate key drivers of cost analyses.The average cost per case treated with FS 2 mL Tisseel® and tack screws (ProTackUsing FS resulted in cost savings in hospitals based on reduced time to complete surgery, hospitalization time post-op, and lower adverse outcomes. Indirect cost savings were also found in favor of FS when comparing the two alternatives from a societal perspective, as patients were able to return to work more promptly in the FS group versus the tack screws group.

We evaluate the broader public economic consequences of investments in smoking cessation that change lifetime productivity, which can influence future government tax revenue and social transfer costs and health care spending. The analysis applies a government perspective framework for assessing the intergenerational relationships between morbidity and mortality and lifetime tax revenue and social transfers received. Applying smoking prevalence in Thailand, a cohort model was developed for smoker and former smokers to estimate impact on lifetime direct taxes and tobacco taxes paid. Age-specific earnings for males and wage appropriate tax rates were applied to estimate net taxes for smokers and former smokers. Introducing smoking cessation leads to lifetime public economic benefits of THB13 998 to THB43 356 per person depending on the age of introducing smoking cessation. Factoring in the costs of smoking cessation therapy, an average return on investment of 1.35 was obtained indicating fiscal surplus generated for government from the combined effect of increased tax revenues and of averting smoking-attributable health care costs.

Background and aims: Smoking gives rise to many cross-sectorial public costs and benefits for government. Costs arise from increased healthcare spending and work-related social benefits, while smoking itself provides significant revenue for government from tobacco taxes. To better understand the public economic impact of smoking and smoking cessation therapies, this study developed a government perspective framework for assessing smoking-attributable morbidity and mortality and associated public costs. This framework includes changes in lifetime tax revenue and health costs, as well as changes in tobacco tax revenue, from fewer smokers.Methods: A modified generational accounting framework was developed to assess relationships between smoking-attributable morbidity and mortality and public economic consequences of smoking, including lifetime tax revenue gains/losses, government social transfers, and health spending. Based on the current prevalence of smoking in South Korean males, a cohort model was developed for smokers, former-smokers, and never-smokers. The model simulated the lifetime discounted fiscal transfers for different age cohorts in 5 year age bands, and the return on investment (ROI) from smoking cessation therapy.Results: Former smokers are estimated to generate higher lifetime earnings and direct tax revenues and lower lifetime healthcare costs due to the reduction of smoking-attributable mortality and morbidity compared to smokers, even after accounting for reduced tobacco taxes paid. Based on the costs of public investments in varenicline, this study estimated a ROI from 1.4-1.7, depending on treatment age, with higher ROI in younger cohorts, with an average ROI of 1.6 for those aged less than 65.Conclusions: This analysis suggests that reductions in smoking can generate positive public economic benefits for government, even after accounting for lost tobacco tax revenues. The results described here are likely applicable to countries having similar underlying smoking prevalence, comparable taxation rates, and social benefit protection provided to individuals with smoking-related conditions.

The pharmacokinetics of a novel locally applied ibuprofen topical patch was evaluated. Healthy subjects (n = 28) were administered a 200-mg ibuprofen patch every 24 hours for 5 days, and steady-state pharmacokinetics was determined. The amount of ibuprofen remaining in the patch following each patch removal was also assessed. The maximum steady-state drug concentration and area under the concentration curve from time 0 on day 5 (t = 0) to the 24-hours sample on day 6 were 514 ng/mL (95% CI 439 to 603 ng/mL) and 9.78 kg·h/mL (95% CI 8.43 to 11.4 kg·h/mL), respectively. Maximum ibuprofen concentration on day 5 occurred at 20 hours post-patch application. No evidence of drug accumulation was observed, and steady state was achieved between days 2 and 5. Ibuprofen levels attenuated rapidly to baseline within 24 hours after treatment discontinuation. The amount of ibuprofen remaining in the patch was high (≥80%). Treatment-emergent adverse events were generally mild, with the most prevalent being headache (n = 6; 21.4%). Only 4 TEAEs were considered related to the ibuprofen patch: paresthesia (n = 1), headache (n = 2), and pruritic rash (n = 1). The study found that the systematic absorption of ibuprofen from a 200-mg patch was low and that the levels of ibuprofen leaving the patch over a 24-hour period are consistent with levels required for therapeutic relief as shown in other studies.

Background: Ibuprofen is used for the treatment of non-serious pain. This study assessed the efficacy and safety of a new ibuprofen plaster for the treatment of pain associated with acute sports impact injuries/contusions.Methods: In this randomised, double-blind, multi-centre, placebo controlled, parallel group study, adults (n = 130; 18-58 years of age) diagnosed with acute sports-related blunt soft tissue injury/contusion were randomized to receive either ibuprofen 200 mg plaster or placebo plaster. Plasters were administered once daily for five consecutive days. The primary assessment was area under the visual analogue scale (VAS) of pain on movement (POM) over 0 to three days (VAS AUC(0-3d)). Other endpoints included algometry AUC from 0 to three days (AUC(0-3d)) and 0 to five days (AUC(0-5d)), to evaluate improvement of sensitivity at the injured site, and patient and investigator global assessment of efficacy. Safety was monitored throughout the study.Results: The ibuprofen plaster resulted in superior reduction in AUC(0-3d) compared with placebo; the Least Squares (LS) mean difference was 662.82 mm*h in favour of the ibuprofen 200mg plaster (P = 0.0011). The greater improvement in VAS AUC of POM was also observed after 12 h, 24 h, and five days of therapy. Tenderness also significantly improved with the ibuprofen plaster compared with placebo; LS mean difference in algometry/tenderness AUC(0-3d) was 1.87 N/cm(2)*d and AUC(0-5d) was 1.87 N/cm(2)*d (P valuesConclusions: The results of this study indicate 200 mg plaster is effective and safe for the treatment of pain due to acute sports-related traumatic blunt soft tissue injury/contusion in adults.

Objectives: To assess the irritation and contact sensitization potential of a 200 mg ibuprofen medicated plaster.Methods: This double-blind, phase-1 placebo controlled study had two phases; the induction phase to evaluate the irritant potential of continuous application of the plaster, and the challenge phase to assess contact sensitivity (allergy). The cumulative irritancy potential was evaluated using an adaptation of the Shelanski method. Healthy adults (18 years of age) (N = 210) were treated simultaneously with one ibuprofen medicated and one placebo plaster applied in a randomized fashion to either the left or right side of the lower back. During the induction phase, plasters were applied on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 and the final plaster removed on Day 22. At each scheduled visit plasters and applications sites were assessed for degree of adhesion and skin irritation (score of 1 = no irritation to 7 = strong reaction spreading beyond test sites), respectively. The challenge phase followed a two-week washout period. A plaster was applied on Day 36 for 48 h and assessment occurred on Days 38, 39, and 40.Results: The mean cumulative irritation score during the induction phase was lower for the ibuprofen medicated plaster than the placebo plaster (0.32 vs. 1.23, respectively). Three (1.4%) subjects experience a dermal reaction of grade >= 3 for the ibuprofen medicated plaster compared with 27 (12.7%) for the placebo plaster. Following challenge with ibuprofen or placebo plasters, 12 subjects (6.2%) with the ibuprofen medicated plaster and four (2.2%) with the placebo plaster had skin reaction of assessment grade higher than the induction phase. One subject for the ibuprofen and two for the placebo plaster had reactions with grade >2. No subjects showed an increase in sensitization on Day 39 or 40 compared with Day 38.Conclusions: The findings indicate that the both the irritancy and contact sensitization of the ibuprofen medicated plaster is acceptable.

Background: Hepatitis C (HCV) infection causes substantial direct health costs, but also impacts broader societal and governmental costs, such as tax revenue and social protection benefits. This study investigated the broader fiscal costs and benefits of curative interventions for chronic Hepatitis C (CHC) that allow individuals to avoid long-term HCV attributed health conditions.Methods: A prospective cohort model, assessing the long-term fiscal consequences of policy decisions, was developed for HCV infected individuals, following the generational accounting analytic framework that combines age-specific lifetime gross taxes paid and governmental transfers received (i.e. healthcare and social support costs). The analysis assessed the burden of a theoretical cohort of untreated HCV infected patients with the alternative of treating these patients with a highly efficacious curative intervention (ledipasvir/sofosbuvir [LDV/SOF]). It also compared treating patients at all fibrosis stages (Stages F0-F4) compared to late treatment (Stage F4).Results: Based on projected lifetime work activity and taxes paid, the treated cohort paid an additional 5,900 pound per patient compared to the untreated cohort. Lifetime government disability costs of 97,555 pound and 125,359 pound per patient for treated cohort vs no treatment cohort were estimated, respectively. Lifetime direct healthcare costs in the treated cohort were 32,235 pound, compared to non-treated cohort of 26,424 pound, with an incremental healthcare costs increase of 5,901 pound per patient. The benefit cost ratio (BCR) of total government benefits and savings relative to government treatment costs (including LDV/SOF) ranged from 1.8-5.6. Treating patients early resulted in 77% less disability costs, 43% lower healthcare costs, and 33% higher tax revenue.Conclusion: The ability to cure Hepatitis C offers considerable fiscal benefits beyond direct medical costs and savings attributed to reduced disability costs, public allowances, and improved tax revenue. Changes in parameters, such as productivity, wage growth, and tax rates, can influence the conclusions described here.

Background: Alzheimer’s Disease is the most common cause of dementia, affecting memory, thinking and behavior. Symptoms eventually grow severe enough to interfere with daily tasks. AD is predicted to increase healthcare spending and costs associated with formal and informal caregiving. The aim of this study was to identify and quantify the contribution of the different cost components associated with AD.Methods: A structured literature review was conducted to identify studies reporting the economic burden of Alzheimer`s Disease beyond the healthcare setting. The search was conducted in Medline, Embase and EconLit and limited to studies published in the last 10 years. For each identified cost component, frequency weighted mean costs were calculated across countries to estimate the percentage contribution of each component by care setting and disease severity. Results obtained by each costing approach were also compared.Results: For community-dwelling adults, the percentage of healthcare, social care and indirect costs to total costs were 13.9%, 17.4% and 68.7%, respectively. The percentage of costs varied by disease severity with 26.0% and 10.4% of costs spent on healthcare for mild and severe disease, respectively. The proportion of total spending on indirect costs changed from 60.7% to 72.5% as disease progressed. For those in residential care, the contribution of each cost component was similar between moderate and severe disease. Social care accounted on average for 85.9% of total costs.Conclusion: The contribution of healthcare costs to the overall burden was not negligible; but was generally exceeded by social and informal care costs.

To investigate the efficacy and safety of a recently developed ibuprofen medicated plaster in the treatment of acute sports impact injuries/contusions.In this double-blind, multi-center, placebo-controlled, parallel group, phase 3 study (EudraCT Number: 2012-003257-2) patients (n = 132; ages 18 to 60 years) diagnosed with acute sports-related traumatic blunt soft tissue injury/contusion to the upper or lower limbs were randomized to receive either ibuprofen 200 mg plaster (n = 64) or placebo plaster (n = 68). Plasters were administered once daily for five consecutive days. The primary assessment was the area under the curve (AUC) of the visual analogue scale (VAS) of pain on movement (POM) over 0 to 72 h (VASThe ibuprofen medicated plaster was associated with a reduction in pain on movement (POM) based on lower VAS AUCThe results of this study indicate that ibuprofen medicated plaster results in rapid and clinically relevant reduction of pain in patients suffering from blunt musculoskeletal injuries or recurrent pain. The ibuprofen medicated plaster was well tolerated.

Governments have an enormous economic and political stake in the health of their populations. Population health is not only fundamental to economic growth but also affects short-term and long-term government expenditure on health care, disability, and other social programs and influences direct and indirect tax receipts. Fiscal transfers between citizen and state are mostly ignored in conventional welfare economics analyses based on the hypothesis that there are no winners or losers through transference of wealth. However, from the government perspective, this position is flawed, as disability costs and lost taxes attributed to poor health and reduced productive output represent real costs that pose budgetary and growth implications. To address the value of health and health care investments for government, we have developed a fiscal health analytic framework that captures how changes in morbidity and mortality influence tax revenue and transfer costs (e.g., disability, allowances, ongoing health costs). The framework can be used to evaluate the marginal impact of discrete investments or a mix of interventions in health care to inform governmental budgetary consequences. In this context, the framework can be considered as a fiscal budget impact and/or cost benefit analysis model that accounts for how morbidity and mortality linked to specific programs represent both ongoing costs and tax revenue for government. Mathematical models identical to those used in cost-effectiveness analyses can be employed in fiscal analysis to reflect how disease progression influences public accounts (e.g., tax revenue and transfers).

A recent systematic literature and meta-analysis reported relative efficacy of trimethoprim-sulfamethoxazole (TMP-SMX) for the treatment of toxoplasmic encephalitis (TE) in HIV-infected adults. Here, we estimated relapse rates during secondary prophylaxis with TMP-SMX, and further explored differences in relapse rates prior to introduction of highly active antiretroviral therapy (HAART) and the widespread adoption of HAART. A systematic search of PubMed, Embase, and Cochrane Central Register of Controlled Trials yielded 707 studies whereby 663 were excluded after abstract screening, and 38 were excluded after full review leaving 6 studies for extraction. We performed double data extraction with a third-party adjudicator. Study designs varied with only one randomized study, four prospective cohorts and one retrospective cohort. Relapse rates were transformed using the Freeman-Tukey method and pooled using both fixed-effect and random-effects meta-analysis models. The TMP-SMX relapse rate was 16.4% (95% CI = 6.2% to 30.3%) based on random-effects models. When the disaggregated pre-HAART studies (n = 4) were included, the relapse rate was 14.9% (random effects; 95% CI = 3.7% to 31.9%). Analysis of two post-HAART studies indicated a relapse rate of 19.2% (random effects; 95% CI = 2.8% to 45.6%). Comparing the relapse rates between pre- and post-HAART studies were contrary to what might be expected based on known benefits of HAART therapy in this population. Nevertheless, cautious interpretation is necessary considering the heterogeneity of the included studies and a limited number of subjects receiving TMP-SMX reported in the post-HAART era. Revisión por pares

Background Osteoporosis and attributable fractures are disruptive health events that can cause short and long-term cost consequences for families, health service and government. In this fracture-based scenario analysis we evaluate the broader public economic consequences for the Korean government based on fractures that can occur at 3 different ages. Methods We developed a public economic modelling framework based on population averages in Korea for earnings, direct taxes, indirect taxes, disability payments, retirement, pension payments, and osteoporosis health costs. Applying a scenario analysis, we estimated the cumulative average per person fiscal consequences of osteoporotic fractures occurring at different ages 55, 65, and 75 compared to average non-fracture individuals of comparable ages to estimate resulting costs for government in relation to lost tax revenue, disability payments, pension costs, and healthcare costs. All costs are calculated between the ages of 50 to 80 in Korean Won (KRW) and discounted at 0.5%. Results From the scenarios explored, fractures occurring at age 55 are most costly for government with increased disability and pension payments of KRW 26,048,400 and KRW 41,094,206 per person, respectively, compared to the non-fracture population. A fracture can result in reduction in lifetime direct and indirect taxes resulting in KRW 53,648,886 lost tax revenue per person for government compared to general population. Conclusions The fiscal consequences of osteoporotic fractures for government vary depending on the age at which they occur. Fiscal benefits for government are greater when fractures are prevented early due to the potential to prevent early retirement and keeping people in the labor force to the degree that is observed in non-fracture population.

Background A wide range of rare diseases can have fiscal impacts on government finances that extend beyond expected healthcare costs. Conditions preventing people from achieving national lifetime work averages will influence lifetime taxes paid and increase the likelihood of dependence on public income support. Consequently, interventions that influence projected lifetime work activity, morbidity and mortality can have positive and negative fiscal consequences for government. The aim of this study was to apply a public economic framework to a rare disease that takes into consideration a broad range of costs that are relevant to government in relation to transfers received and taxes paid. As a case study we constructed a simulation model to calculate the fiscal life course of an individual with hereditary transthyretin-mediated (hATTR) amyloidosis in The Netherlands. In this lethal disease different progressive disease scenarios occur, including polyneuropathy and/or cardiomyopathy. Results Due to progressive disability, health care resource use, and early death, hATTR amyloidosis with polyneuropathy receives more transfers from government compared to the general population. In a scenario where a patient is diagnoses with hATTR at age 45, an individual pays €180,812 less in lifetime taxes and receives incrementally €111,695 in transfers from the government, compared to a person without hATTR. Patients suffering from cardiomyopathy die after median 4 years. The health costs of this scenario are therefore lower than that of the other polyneuropathy-based scenarios. Conclusions The fiscal analysis illustrates how health conditions influence not only health costs, but also the cross-sectorial public economic burden attributed to lost tax revenues and public disability allowances. Due to the progressive nature of hATTR amyloidosis used in this study, public costs including disability increase as the disease progresses with reduced lifetime taxes paid. The results indicate that halting disease progression early in the disease course would generate fiscal benefits beyond health benefits for patients. This analysis highlights the fiscal consequences of diseases and the need for broader perspectives applied to evaluate health conditions. Conventional cost-effectiveness framework used by many health technology assessment agencies have well-documented limitations in the field of rare diseases and fiscal modeling should be a complementary approach to consider.

Toxoplasmosis, a disease with diverse clinical manifestations, caused by infection with the Apicomplexan parasite, Toxoplasma gondii (T. gondii), is a major source of morbidity and mortality in the United States. Although toxoplasmosis prevalence and mortality have declined over the past two decades, the CDC considers this disease a neglected parasitic infection requiring public health action. Here, we overview the literature to bring attention to the prevalence of the disease in the United States, and high economic burden associated with the disease. The conclusions to be drawn are clear: there is low awareness and underestimation of the disease burden amongst healthcare professionals; a high economic burden associated with the disease; relapse rates to treatment represent additional mortality and morbidity and further costs for the healthcare system; and better treatments are necessary to combat this public health threat.