Cost-Effectiveness and Budget Impact Analyses of Selective Internal Radiation Therapy versus Atezolizumab Plus Bevacizumab from a German Statutory Health Insurance Perspective.

Purpose: To compare personalized dosimetry with yttrium-90 (90Y)-loaded glass microspheres (SIRT) vs atezolizumab and bevacizumab (A+B) in hepatocellular carcinoma (HCC) treatment in terms of cost-effectiveness and budget impact from a German statutory health insurance (SHI) perspective. Patients and Methods: Cost-effectiveness analysis (CEA) and budget impact analysis (BIA) models were developed in MS Excel. The available key studies (IMbrave150 and DOSISPHERE-01) suggest that both strategies are comparable in terms of progression-free survival and overall survival in HCC, but a difference in severe adverse events (SAE) in favor of SIRT was observed. Accordingly, the CEA model investigates the endpoints "cost per SAE avoided" and "cost per quality-adjusted life year (QALY) gained", whereas the BIA simulates the impact of a stepwise re-allocation of current market share to the option which emerges as more cost-effective from the CEA. Results: The model suite estimated a mean annual total per-patient costs of € 29,984 for SIRT, compared to € 75,725 for A+B. SIRT was associated with a lower number of SAE and a higher number of QALYs compared to A+B. Switching additionally 25% of the eligible patients (≈500) from systemic therapy to SIRT could generate annual savings of approximately € 22.6 million Euros to the SHI. Conclusion: SIRT was identified as dominant treatment strategy. SIRT use not only saves SHI expenditure compared to systemic immunotherapy but also yields extra QALYs. This positions SIRT as the dominant and more cost-effective treatment strategy for patients with HCC. The savings to the SHI system, derived from the BIA conducted, become increasingly significant with rising adoption rates of SIRT.

Informing evidence-based medicine for opioid use disorder using pharmacoeconomic studies.

INTRODUCTION: The health and economic consequences of inadequately treated opioid use disorder (OUD) are substantial. Healthcare systems in the United States (US) and other countries are facing a growing healthcare crisis due to opioids. Although effective medications for OUD exist, relying solely on clinical information is insufficient for addressing the opioid crisis. AREAS COVERED: In this review, the role of pharmacoeconomic studies in informing evidence-based medication treatment for OUD is discussed, with a particular emphasis on the US healthcare system, where the economic burden is significantly higher than the global average. The scope/objective of pharmacoeconomics as a distinct scientific research program is briefly defined, followed by a discussion of existing evidence informed by data from systematic reviews, in addition to a convenience sample of recently published pharmacoeconomic studies and protocols. The review also explores the need for methodological advancements in the field. EXPERT OPINION: Despite the potential of pharmacoeconomic research in shaping evidence-based medicine for OUD, significant challenges limiting its real-world application remain. How to address these challenges are explored, including how to combine cost-effectiveness and budget impact analyses to address the needs of the healthcare system as a whole and specific stakeholders interested in adopting new OUD treatment strategies.

Cost-Effectiveness and Budget Impact Analysis of the Implementation of Differentiated Service Delivery Models for HIV Treatment in Mozambique: a Modelling Study.

INTRODUCTION: In 2018, the Mozambique Ministry of Health launched guidelines for implementing differentiated service delivery models (DSDMs) to optimize HIV service delivery, improve retention in care, and ultimately reduce HIV-associated mortality. The models were fast-track, 3-month antiretrovirals dispensing, community antiretroviral therapy groups, adherence clubs, family approach and three one-stop shop models: adolescent-friendly health services, maternal and child health, and tuberculosis. We conducted a cost-effectiveness analysis and budget impact analysis to compare these models to conventional services. METHODS: We constructed a decision tree model based on the percentage of enrolment in each model and the probability of the outcome (12-month retention in treatment) for each year of the study period-three for the cost-effectiveness analysis (2019-2021) and three for the budget impact analysis (2022-2024). Costs for these analyses were primarily estimated per client-year from the health system perspective. A secondary cost-effectiveness analysis was conducted from the societal perspective. Budget impact analysis costs included antiretrovirals, laboratory tests and service provision interactions. Cost-effectiveness analysis additionally included start-up, training and clients' opportunity costs. Effectiveness was estimated using an uncontrolled interrupted time series analysis comparing the outcome before and after the implementation of the differentiated models. A one-way sensitivity analysis was conducted to identify drivers of uncertainty. RESULTS: After implementation of the DSDMs, there was a mean increase of 14.9 percentage points (95% CI: 12.2, 17.8) in 12-month retention, from 47.6% (95% CI, 44.9-50.2) to 62.5% (95% CI, 60.9-64.1). The mean cost difference comparing DSDMs and conventional care was US$ -6 million (173,391,277 vs. 179,461,668) and -32.5 million (394,705,618 vs. 433,232,289) from the health system and the societal perspective, respectively. Therefore, DSDMs dominated conventional care. Results were most sensitive to conventional care interaction costs in the one-way sensitivity analysis. For a population of 1.5 million, the base-case 3-year financial costs associated with the DSDMs was US$550 million, compared with US$564 million for conventional care. CONCLUSIONS: DSDMs were less expensive and more effective in retaining clients 12 months after antiretroviral therapy initiation and were estimated to save approximately US$14 million for the health system from 2022 to 2024.

[Pharmacoeconomic analysis of anti-angiogenic drugs for diabetic macular edema]. / Farmakoekonomicheskii analiz primeneniya antiangiogennykh preparatov pri diabeticheskom makulyarnom oteke.

Diabetic macular edema (DME) is a degenerative disease of the macular area in diabetes mellitus and can lead to vision loss, disability, and significantly reduced quality of life. Faricimab is the only bispecific antibody for DME therapy that targets two pathogenic pathways (Ang-2 and VEGF-A). PURPOSE: This study comparatively evaluates the clinical and economic feasibility of faricimab and other angiogenesis inhibitors in patients with DME. MATERIAL AND METHODS: This article analyzed literature on the efficacy and safety of intravitreal injections (IVI) of ranibizumab 0.5 mg, aflibercept 2 mg, and faricimab 6 mg. A model of medical care was developed for patients with DME receiving anti-angiogenic therapy. Pharmacoeconomic analysis was performed using cost minimization and budget impact analysis (BIA) methods. Modeling time horizon was 2 years. The research was performed from the perspective of the healthcare system of the Russian Federation. RESULTS: The efficacy and safety of faricimab in a personalized regimen (up to one IVI in 16 weeks) are comparable to those of aflibercept and ranibizumab, administered in various regimens. The use of faricimab is associated with the lowest number of IVIs. Over 2 years, the maximum costs of drug therapy were associated with the use of ranibizumab (about 914 thousand rubles), while the minimum costs were associated with the use of faricimab (614 thousand rubles). The reduction in inpatient care costs with faricimab therapy was 36% compared to aflibercept (216 and 201 thousand rubles in inpatient and day hospitals, respectively) and 82% compared to ranibizumab (486 and 451 thousand rubles in inpatient and day hospitals, respectively). BIA demonstrated that the use of faricimab will reduce the economic burden on the healthcare system by 11.3 billion rubles (9.8%) over 2 years. CONCLUSION: The use of faricimab is a cost-effective approach to treatment of adult patients with DME in Russia.

A Retrospective Budget Impact Analysis of Fidaxomicin Treatment for Clostridioides difficile Infections (CDI) in Germany.

BACKGROUND: Clostridioides difficile is the most common cause of healthcare-associated diarrhea. Research suggests that treating C. difficile infections (CDI) with fidaxomicin (FDX) is more effective than vancomycin (VAN), with potential cost savings. The objective was to calculate the budget impact of FDX treatment compared to VAN from a German payer perspective. RESEARCH DESIGN AND METHODS: The analysis used real-world data of patients discharged from University Hospital Cologne between Jan-01-2018 and Dec-31-2019. We identified recurrent and non-recurrent CDI cases and calculated direct treatment costs based on G-DRG flat rates. To calculate average costs per treatment and the budget impact, recurrence probabilities for VAN and FDX were taken from published evidence (28-day and 90-day scenarios). RESULTS: Totally, 475 cases were analyzed, thereof 421 non-recurrent, causing mean costs of €32,901 per case (95% CI: 27.752-38.050). Thirty-two patients experienced a recurrence within 28 days, yielding mean costs of €10,952 (95% CI: 5.627-16.277) for their additional hospital stay. The resulting budget impact was €1,303 (95% CI: 670 - 1.937) in favor of FDX, ranging from €148.34 to €2,190.30 in scenario analyses. CONCLUSION: The analysis indicates FDX treatment can lead to cost savings compared to VAN. Future research should focus on specific patient groups, such as refractory CDI patients.

Variables affecting new drug prices in South Korea's pricing system.

Objective: The price of pharmaceuticals is important from the economic and industrial perspectives but as well as patients' access to treatment. This study aimed to analyze the variables affecting the prices of new drugs in South Korea's pricing system. Methods: Data on 192 new drugs listed in South Korea from 2012 to 2022 were collected from the official website of the Health Insurance Review and Assessment Service. The independent variables included drugs for severe diseases, alternatives, number of patients, number of advanced 7 countries listed, budget impact, and listing period. The dependent variables included annual treatment cost and the price ratio to the advanced 7 country's average adjusted price. Descriptive statistics of variables, linear correlations between quantitative independent and dependent variables, and associations between independent and dependent variables were analyzed. Results: The mean annual treatment cost and price ratio to the advanced 7 country's average adjusted price were higher for drugs for severe diseases and those with no alternatives. Annual treatment cost and price ratio to the advanced 7 country's average adjusted price were negatively correlated with the number of patients and positively correlated with the number of advanced 7 countries listed. Annual treatment cost was affected by the variables drugs for severe diseases, alternatives, number of patients, number of advanced 7 countries listed, and budget impact. The price ratio to the advanced 7 country's average adjusted price was affected by drugs for severe diseases, alternatives, and the number of patients. Conclusion: This study revealed the effect of different variables on the prices of new drugs in South Korea, allowing for the development of a more effective assessment system to evaluate the prices of new drugs while ensuring profitability for pharmaceutical companies, sustainability of public insurance, and accessibility to drugs by patients.

Cost saving analysis of prediabetes intervention modalities in comparison with inaction using Markov state transition model-A multiregional case study.

BACKGROUND: Prediabetes management is a priority for policymakers globally, to avoid/delay type 2 diabetes (T2D) and reduce severe, costly health consequences. Countries moving from low to middle income are most at risk from the T2D "epidemic" and may find implementing preventative measures challenging; yet prevention has largely been evaluated in developed countries. METHODS: Markov cohort simulations explored costs and benefits of various prediabetes management approaches, expressed as "savings" to the public health care system, for three countries with high prediabetes prevalence and contrasting economic status (Poland, Saudi Arabia, Vietnam). Two scenarios were compared up to 15 y: "inaction" (no prediabetes intervention) and "intervention" with metformin extended release (ER), intensive lifestyle change (ILC), ILC with metformin (ER), or ILC with metformin (ER) "titration." RESULTS: T2D was the highest-cost health state at all time horizons due to resource use, and inaction produced the highest T2D costs, ranging from 9% to 34% of total health care resource costs. All interventions reduced T2D versus inaction, the most effective being ILC + metformin (ER) "titration" (39% reduction at 5 y). Metformin (ER) was the only strategy that produced net saving across the time horizon; however, relative total health care system costs of other interventions vs inaction declined over time up to 15 y. Viet Nam was most sensitive to cost and parameter changes via a one-way sensitivity analysis. CONCLUSIONS: Metformin (ER) and lifestyle interventions for prediabetes offer promise for reducing T2D incidence. Metformin (ER) could reduce T2D patient numbers and health care costs, given concerns regarding adherence in the context of funding/reimbursement challenges for lifestyle interventions.

The Use of Precision Epigenetic Methods for the Diagnosis and Care of Stable Coronary Heart Disease Reduces Healthcare Costs.

INTRODUCTION: The cost of secondary prevention of coronary heart disease (CHD) is continuing to increase, with a substantial portion of this acceleration being driven by the expense of confirmatory diagnostic testing. Conceivably, newly developed precision epigenetic technologies could drive down these costs. However, at the current time, their impact on overall expense for CHD care is poorly understood. We hypothesized that the use of a newly developed, highly sensitive, and specific epigenetic test, PrecisionCHD, could decrease the costs of secondary prevention. METHODS: To test this hypothesis, we constructed a budget impact analysis using a cost calculation model that examined the effects of substituting PrecisionCHD for conventional CHD diagnostic tests on the expenses of the initial evaluation and first year of care of stable CHD using a 1-year time horizon with no discounting. RESULTS: The model projected that for a commercial insurer with one million members, full adoption of PrecisionCHD as the primary method of initial CHD assessment would save approximately $113.6 million dollars in the initial year. CONCLUSION: These analyses support the use of precision epigenetic methods as part of the initial diagnosis and care of stable CHD and can meaningfully reduce cost. Real-world pilots to test the reliability of these analyses are indicated.

Estimating the Allocation of the Economic Value Generated by Utilization of All-Oral Direct-Acting Antivirals for Hepatitis C in the United States, 2015 to 2019.

OBJECTIVES: Between 2013 to 2019, several all-oral direct-acting antivirals (DAAs) were launched with the potential to cure patients with hepatitis C virus (HCV). They generated economic value in terms of the health gains for patients and cost-savings for the US healthcare system. We estimated the share of this value allocated to 4 manufacturers vs society. METHODS: For 2015 to 2019, we estimated the incremental impact of DAAs on HCV health outcomes and costs. We used the Center for Disease Analysis Foundation Polaris Observatory database to estimate utilization. Per-patient projections of lifetime quality-adjusted life-years (QALYs) gained and medical costs avoided were based on a standard 9-state HCV disease-progression model for DAA treatment vs alternatives. Annual QALY gains were valued at $114 000 per QALY. Outcomes and costs were discounted at 3%. Estimated revenues were based on reported sales. RESULTS: An estimated 1 080 000 patients received DAAs: 81.5% would not have received the pre-DAA standard of care. On average, these patients were projected to gain 4.4 QALYs and save $104 400 in lifetime healthcare costs, generating $531.8 billion in value. Those who would have received treatment gained 1.7 QALYs and saved $41 500 in lifetime costs, generating $47.4 billion in economic value. As treatment costs fell nearly 75%, the 4 manufacturers reported $37.4 billion from DAA sales-an allocation of 6.5% of the total value. CONCLUSIONS: The significant majority (∼90%) of the economic value of curing HCV with DAAs were health benefits to patients and net cost-savings to society. DAA manufacturers received a minority share (6.5%) of the aggregate economic value generated.

Health and economic impact of dapagliflozin for type 2 diabetes patients who had or were at risk for atherosclerotic cardiovascular disease in the Italian general practitioners setting: a budget impact analysis.

AIM: In 2022, in Italy, general practitioners (GPs) have been allowed to prescribe SGLT2i in Type 2 Diabetes (T2D) under National Health Service (NHS) reimbursement. In the pivotal clinical trial named DECLARE-TIMI 58, dapagliflozin reduced the risk of hospitalization for heart failure, CV death and kidney disease progression compared to placebo in a population of T2D patients. This study evaluated the health and economic impact of dapagliflozin for T2D patients who had or were at risk for atherosclerotic cardiovascular disease in the Italian GPs setting. METHODS: A budget impact model was developed to assess the health and economic impact of introducing dapagliflozin in GPs setting. The analysis was conducted by adopting the Italian NHS perspective and a 3-year time horizon. The model estimated and compared the health outcomes and direct medical costs associated with a scenario with dapagliflozin and other antidiabetic therapies available for GPs prescription (scenario B) and a scenario where only other antidiabetic therapies are available (scenario A). Rates of occurrence of cardiovascular and renal complications as well as adverse events were captured from DECLARE-TIMI 58 trial and the literature, while cost data were retrieved from the Italian tariff and the literature. One-way sensitivity analyses were conducted to test the impact of model parameters on the budget impact. RESULTS: The model estimated around 442.000 patients eligible for the treatment with dapagliflozin in the GPs setting for each simulated year. The scenario B compared to scenario A was associated with a reduction in the occurrence of cardiovascular and renal complication (-1.83%) over the 3 years simulated. Furthermore, the scenario A allowed for an overall cost saving of 102,692,305€: 14,521,464€ in the first year, 33,007,064€ in the second and 55,163,777€ in the third. The cost of cost of drug acquisition, the probability of cardiovascular events and the percentage of patients potentially eligible to the treatment were the factor with largest impact on the results. CONCLUSIONS: The use of dapagliflozin in GPs setting reduce the number of CVD events, kidney disease progression and healthcare costs in Italy. These data should be considered to optimize the value produced for the T2D patients who had or were at risk for atherosclerotic cardiovascular disease.

Budget impact of the Walk With Ease program for knee osteoarthritis.

Objective: Walk With Ease (WWE) is an effective low-cost walking program. We estimated the budget impact of implementing WWE in persons with knee osteoarthritis (OA) as a measure of affordability that can inform payers' funding decisions. Methods: We estimated changes in two-year healthcare costs with and without WWE. We used the Osteoarthritis Policy (OAPol) Model to estimate per-person medical expenditures. We estimated total and per-member-per-month (PMPM) costs of funding WWE for a hypothetical insurance plan with 75,000 members under two conditions: 1) all individuals aged 45+ with knee OA eligible for WWE, and 2) inactive and insufficiently active individuals aged 45+ with knee OA eligible. In sensitivity analyses, we varied WWE cost and efficacy and considered productivity costs. Results: With eligibility unrestricted by activity level, implementing WWE results in an additional $1,002,408 to the insurance plan over two years ($0.56 PMPM). With eligibility restricted to inactive and insufficiently active individuals, funding WWE results in an additional $571,931 over two years ($0.32 PMPM). In sensitivity analyses, when per-person costs of $10 to $1000 were added with 10-50% decreases in failure rate (enhanced sustainability of WWE benefits), two-year budget impact varied from $242,684 to $6,985,674 with unrestricted eligibility and from -$43,194 (cost-saving) to $4,484,122 with restricted eligibility. Conclusion: Along with the cost-effectiveness of WWE at widely accepted willingness-to-pay thresholds, these results can inform payers in deciding to fund WWE. In the absence of accepted thresholds to define affordability, these results can assist in comparing the affordability of WWE with other behavioral interventions.

A budget impact model and a cost-utility analysis of reducer device (Neovasc) in patients with refractory angina.

Background: Refractory angina (RA) is a chronic condition characterized by the presence of debilitating angina symptoms due to established reversible ischemia in the presence of obstructive coronary artery disease (CAD). Treatments for this condition have undergone major developments in recent decades; however, the treatment for RA remains a challenge for medicine. In this sense, the Coronary Sinus Reducer System (CSRS) stands as the last line of therapy for ineligible patients for revascularization with reversible ischemia. The purpose of this report is to evaluate the potential burden on the National Health Service (NHS) and measure the health effects in terms of both quantity (life years) and quality-of-life aspects related to the reducer. Methods: Two different economic evaluation models were developed as part of the analysis. The budget impact was developed to estimate the potential burden on the NHS from incremental uptake of the use of the reducer in the target population. The utility cost analysis compares and evaluates the quality of life and health resource use and costs between the two alternatives, based on the research of Gallone et al. A deterministic and probabilistic sensitivity analysis was carried out to characterize the uncertainty around the parameters of the model. Results: In the budget impact analysis (BIA), the reducer is shown to be more expensive in the first 2 years of the model, due to the gradual uptake in the market and the cost of the device. Starting from the third year, assuming maintenance of effectiveness, there are savings in terms of resource absorption in direct healthcare costs arising from hospitalizations, emergency department accesses, coronarography, and visits avoided. Conclusion: The BIA and cost-effectiveness model show that the reducer device, despite an increase in resources absorbed in the first years of implementation and use, has the potential to result in increased quality of life in patients with RA. These costs are largely offset in the short term by the improved clinical outcomes achievable leading to savings from the third year onward in the BIA and a dominance ratio in the cost-utility analysis.

Cost-effectiveness and budget impact analysis of screening and preventive interventions for cardiovascular disease in Myanmar: an economic modelling study.

Background: Cardiovascular diseases (CVD) remains a leading cause of mortality in Myanmar. Despite the burden, CVD preventive services receive low government and donor budgets, which has led to poor CVD outcomes. Methods: We conducted a cost-effective analysis and a budget impact analysis on CVD prevention strategies recommended by the WHO. A Markov model was used to analyse the cost and quality-adjusted life year (QALY) from healthcare provider and societal perspectives. We calculated transition probabilities from WHO CVD risk data and obtained treatment effects and costs from secondary sources. Subgroup analysis was performed on different sex and age groups. We framed the budget impact analysis from a healthcare provider perspective to assess the affordability of providing CVD preventive care. Findings: The most cost-effective strategy from the healthcare provider perspective varied. The combination of screening, primary prevention, and secondary prevention (Sc-PP-SP) (incremental cost-effectiveness ratio [ICER]: US$1574/QALY) is most cost-effective at the three times gross domestic product (GDP) per capita threshold, while at one time the GDP per capita threshold, secondary prevention is the most cost-effective strategy (ICER: US$160/QALY). Sc-PP-SP is the most cost-effective strategy from the societal perspective (ICER: US$647/QALY). Among age groups, intervention at age 45 years appeared to be the most cost-effective option for both men and women. The budget impact revealed the Sc-PP-SP would avert 55,000 acute CVD events and 28,000 CVD-related deaths with a cost of US$157 million for the first year of CVD preventive care. Interpretation: A combination of screening, primary prevention, and secondary prevention is cost-effective to reduce CVD-related deaths in Myanmar. This study provides evidence for the government and development partners to increase investment in and support for CVD prevention. These findings not only provide a basis for efficient resource allocation but also underscore the importance of adopting a total cardiovascular risk approach to CVD prevention, in alignment with global health goals. Funding: Pilot grant from Duke Global Health Institute, USA.

Budget impact analyses for treatment of heart failure. A systematic review.

Heart failure (HF) is increasing globally and turning out to be a serious worldwide public health problem with significant morbidity and mortality. This study aims to systemically review the budget impact analysis of heart failure treatments on health care expenditure worldwide. Scientific databases such as PubMed, Web of Science, Scopus, and Google Scholar were searched for budget impact analysis and heart failure treatments, over January 2001 to August 2023. The quality assessment of the selected studies was evaluated through ISPOR practice guideline. Nineteen studies were included in this systematic review. Based on ISPOR recommendations, most studies were performed on a 1-year time horizon and used a government (public health) or health system perspective. Data for selected studies was mainly collected from randomized clinical trials, published literature, pharmaceutical companies, and registry data. Only direct costs were reported in the studies. Sensitivity analyses were stated in almost all studies. However, studies conducted in high-income countries reported sensitivity analyses more elaborately than those performed in low- and middle-income countries. In many published articles related to the budget impact analyses of heart failure treatment, addition of new treatments to the health system's formularies can lead to a reduction in cardiovascular hospitalization rates, re-hospitalization rates, cardiac-associated mortality rates, and an improvement in heart failure class, which can decrease the costs of hospitalizations, specified care visits, primary care visits, and other related treatments.

Use of a Blood Biomarker Test Improves Economic Utility in the Evaluation of Older Patients Presenting with Cognitive Impairment.

More than 16 million Americans living with cognitive impairment warrant a diagnostic evaluation to determine the cause of this disorder. The recent availability of disease-modifying therapies for Alzheimer's disease (AD) is expected to significantly drive demand for such diagnostic testing. Accurate, accessible, and affordable methods are needed. Blood biomarkers (BBMs) offer advantages over usual care amyloid positron emission tomography (PET) and cerebrospinal fluid (CSF) biomarkers in these regards. This study used a budget impact model to assess the economic utility of the PrecivityAD® blood test, a clinically validated BBM test for the evaluation of brain amyloid, a pathological hallmark of AD. The model compared 2 scenarios: (1) baseline testing involving usual care practice, and (2) early use of a BBM test before usual care CSF and PET biomarker use. At a modest 40% adoption rate, the BBM test scenario had comparable sensitivity and specificity to the usual care scenario and showed net savings in the diagnostic work-up of $3.57 million or $0.30 per member per month in a 1 million member population, translating to over $1B when extrapolated to the US population as a whole and representing a 11.4% cost reduction. Savings were driven by reductions in the frequency and need for CSF and PET testing. Additionally, BBM testing was associated with a cost savings of $643 per AD case identified. Use of the PrecivityAD blood test in the clinical care pathway may prevent unnecessary testing, provide cost savings, and reduce the burden on both patients and health plans.

Antivirals to prepare for surges in influenza cases: an economic evaluation of baloxavir marboxil for the Netherlands.

OBJECTIVES: We perform a cost-effectiveness analysis (CEA) and budget impact analysis (BIA) of baloxavir marboxil compared to current care in the Netherlands for patients at risk of influenza-related complications, including patients with comorbidities and the elderly. METHODS: In the CEA, a decision tree model was developed to assess the cost-effectiveness of baloxavir marboxil for a cohort of 52-year-olds from a societal perspective. A lifetime horizon was taken by incorporating the quality-adjusted life expectancy. The BIA included different epidemiological scenarios, estimating different plausible epidemiological scenarios for seasonal influenza considering the whole Dutch population with an increased risk of influenza complications. RESULTS: The base-case ICER was estimated to be €8,300 per QALY. At the willingness-to-pay threshold of €20,000 per QALY, the probability of being cost effective was 58%. The base-case expected budget impact was €5.7 million on average per year, ranging from €1.5 million to €10.5 million based on the severity of the influenza epidemic and vaccine effectiveness. CONCLUSION: In the Netherlands, baloxavir is a cost-effective treatment option for seasonal influenza, with a base-case ICER of €8,300 per QALY for the population aged 60 years and over and patients at high risk of influenza-related complications. For a large part, this ICER is driven by the reduction of the illness duration of influenza and productivity gains in the working population.

Economic value of diastasis repair with the use of mesh compared to no intervention in Italy.

AIM: Rectus abdominal diastasis (RAD) can cause mainly incontinence and lower-back pain. Despite its high incidence, there is no consensus regarding surgical indication. We aimed at comparing RAD repair (minimally invasive technique with mesh implant) with no treatment (standard of care - SOC) through cost-effectiveness and budget impact analyses from both National Healthcare Service (NHS) and societal perspectives in Italy. METHODS: A model was developed including social costs and productivity losses derived by the online administration of a socio-economic questionnaire, including the EuroQol for the assessment of quality of life. Costs for the NHS were based on reimbursement tariffs. RESULTS: Over a lifetime horizon, estimated costs were 64,115€ for SOC and 46,541€ for RAD repair in the societal perspective; QALYs were 19.55 and 25.75 for the two groups, respectively. Considering the NHS perspective, RAD repair showed an additional cost per patient of 5,104€ compared to SOC, leading to an ICUR of 824€. RAD repair may be either cost-saving or cost-effective compared to SOC depending on the perspective considered. Considering a current scenario of 100% SOC, an increased diffusion of RAD repair from 2 to 10% in the next 5 years would lead to an incremental cost of 184,147,624€ for the whole society (87% borne by the NHS) and to incremental 16,155 QALYs. CONCLUSION: In light of the lack of economic evaluations for minimally invasive RAD repair, the present study provides relevant clinical and economic evidence to help improving the decision-making process and allocating scarce resources between competing ends.

Budget impact analysis of a Lifestyle-integrated Functional Exercise (LiFE) program for older people in Germany: a Markov model based on data from the LiFE-is-LiFE trial.

BACKGROUND: Fall prevention is important for healthy ageing, but the economic impact of fall prevention are scarcely investigated. A recent cost-effectiveness analysis compared a group-delivered Lifestyle-integrated Functional Exercise Program (gLiFE) with an individually-delivered program (LiFE) in community-dwelling people (aged ≥ 70 years) at risk of falling. In addition, the current study aimed to analyze the budget impact of LiFE and gLiFE, compared with standard care in Germany. METHODS: A Markov model was developed to reflect falls and associated care needs for community-dwelling persons over 5 years. The intervention effects of LiFE and gLiFE were shown to be equivalent in a non-inferiority trial, although the costs differed. Outpatient, inpatient, and intervention costs were assessed from a payer's perspective. The effect of parameter uncertainty was assessed in sensitivity analyses. RESULTS: The budget impact due to intervention costs was €510 million for LiFE and €186 million for gLiFE. Over five years, health care expenditures were €35,008 million for those receiving standard care, €35,416 million for those receiving LiFE, and €35,091 million for persons receiving gLiFE. Thereby, LiFE and gLiFE could prevent 2700 deaths and 648,000 falls over 5 years. Parameter uncertainties in the risk of falling, uptake of an intervention offer, and in the intervention effects had a major influence; thus cost savings for LiFE and gLiFE compared with standard care could be achieved for individuals with a high risk of falling. CONCLUSIONS: The results revealed that cost savings for LiFE and gLiFE compared with standard care could only be achieved for individuals at high risk of falling, with gLiFE being superior to LiFE. Future research should consider benefits and aspects of fall prevention beyond falls (e.g., physical activity, social aspects, and personal preferences of participants). TRIAL REGISTRATION: The study was preregistered under underclinicaltrials.gov (identifier: NCT03462654) on 12th March 2018; https://clinicaltrials.gov/ct2/show/NCT03462654 .

PEG hydrogel sealant versus fibrin glue in posterior fossa surgery: an economic comparison across five European countries.

Aim: Posterior cranial fossa (PCF) surgery is associated with complications, including cerebrospinal fluid (CSF) leakage. Dural sealants such as polyethylene glycol (PEG)-based hydrogels and fibrin glue can prevent CSF leaks, with evidence suggesting PEG hydrogels may outperform fibrin glue. However, the budget impact of using PEG hydrogels in PCF surgeries in Europe is unclear. Materials & methods: A decision tree was developed based on a previous US model, to assess the budget impact of switching from fibrin glue to PEG hydrogel in PCF surgery across five European countries. Input costs were derived from published sources for the financial year 2022/2023. Health outcomes, including CSF leaks, were considered. Results: The model predicted that using PEG hydrogel instead of fibrin glue in PCF surgery can lead to cost savings in five European countries. Cost savings per patient ranged from EUR 419 to EUR 1279, depending on the country. Sensitivity analysis showed that the incidence of CSF leaks and pseudomeningoceles had a substantial impact on the model's results. Conclusion: PEG hydrogels may be a cost-effective alternative to fibrin glue in PCF surgery. The model predicted that cost savings would be mainly driven by a reduction in the incidence of postoperative CSF leaks, resulting in reduced reliance on lumbar drains, reparative surgery and shortened hospital stays.