Budget Impact Model Research Articles

Emicizumab prophylaxis for people with hemophilia A: Waste estimation and the Brazilian perspective

Costs of hemophilia A treatment are increasing. Waste of clotting products should be avoided. To estimate the first-year waste of emicizumab prophylaxis for people with hemophilia A and inhibitors (PwHAi) who failed immune tolerance induction (ITI), in Brazil. We evaluated the manufacturer and the Brazilian Ministry of Health (MoH) protocol-recommended regimens in a budget impact model. The loading dose consisted of 3.0 mg/kg/Q1W for 4 weeks, for both recommendations. The manufacturer maintenance regimens comprised 1.5 mg/kg/Q1W, 3.0 mg/kg/Q2W, and 6.0 mg/kg/Q4W. The MoH protocol maintenance regimen encompassed a hybrid Q1W/Q2W administration, depending on the body weight. The Q4W regimen was not recommended by the MoH protocol. Analyses were performed to estimate waste given its expense based on the World Health Organization body weight range (percentiles [P] 15, 50, and 85). The first-year emicizumab waste was estimated individually and for the disclosed PwHAi who failed ITI (n = 114). The highest emicizumab waste was estimated for the lowest body weights and the Q1W regimen. The Q4W regimen resulted in the lowest emicizumab waste, followed by the MoH protocol regimen. The total reconstituted costs estimated for the PwHAi who failed ITI according to the hybrid MoH protocol ranged from US$32,858,777 (P15) to US$47,186,858 (P85), with emicizumab waste ranging from 7.9 % (US$2,594,515) to 3.7 % (US$1,738,750), respectively. Lost resources due to current protocols for emicizumab prophylaxis for PwHAi who failed ITI in Brazil are considerable. Waste was more pronounced due to lower body weight and shorter administration intervals.

The budget impact of alteplase in the treatment of acute ischemic stroke in Egypt.

Stroke is the second leading cause of mortality worldwide. Five percent of all the disability-adjusted life years (DALYs) lost around the world are attributed to stroke. This study aimed to assess the economic burden of acute ischemic stroke (AIS) in Egypt and reveal the benefits of alteplase treatment by measuring the resource use and costs associated with this treatment compared to the standard of care and extrapolate the overall budget impact of alteplase to the local Egyptian setting over a 5-year time horizon from a societal perspective. A budget impact model was developed to estimate the impact of adding alteplase to the current treatment of AIS patients within the Egyptian healthcare setting. The efficacy data for both arms of the model were sourced from a systematic review of the literature. Resource use and cost data were sourced from a retrospective study. Proportions of patients potentially eligible for treatment and the treatment time distributions were estimated from an analysis of the results of this retrospective data collection. A univariate sensitivity analysis was conducted to assess the robustness of the model results. The input parameters varied between plausible extremes based on a review of available evidence. The total annual costs with alteplase treatment [i.e., drug, symptomatic intracerebral hemorrhage (ICH) management, acute hospitalization, and post-hospitalization costs] for the targeted patients from a societal perspective were estimated to be less than the total annual costs without alteplase. This resulted in savings of approximately EGP 37.2 million ($ 1.2 million), EGP 14.2 million ($ 458.06), EGP -33.0 million ($ -1.06 million), EGP -54.0 million ($ -1.74 million), and EGP -89.8 million ($ -2.89 million) for each of the 5 years, respectively. In year 1, more than 2,787 patients (+30.1%) achieved an excellent outcome and <1,204 patients (-22.3%) had a poor outcome when treated with alteplase. The savings in acute hospitalization and post-hospitalization costs offset the increase in drug and ICH management costs in the alteplase group compared to treatment without alteplase. The total cumulative cost savings for alteplase in AIS patients were estimated at EGP -228,146,871 ($ -7,359,576) over 5 years. The budget impact model estimates suggest that from a societal perspective, alteplase is likely to be a cost-saving option for the treatment of AIS in Egypt due to the treatment benefits, resulting in savings in acute hospitalization and annual post-hospitalization costs.

Evaluation of an acute trust Domestic Abuse Coordinator role: Impact findings and a budget impact model.

Domestic Abuse Coordinators (DACs) work strategically across National Health Service (NHS) hospital and other off-site clinical settings to support clinical staff in domestic abuse enquiry and response, and to co-lead the development and implementation of effective clinical policies and procedures for the management of domestic abuse and the support of survivors. Drawing on data from a large NHS acute trust in central London, we analyse the impact of the DAC role in increasing the rate of referrals of high-risk domestic abuse cases, and generate plausible estimates of the budget impact of the DAC role in respect of costs accrued to NHS trusts. Using eight quarters of clinical data and an interrupted time series design, we find that evidence that implementation of a DAC role is linked with an increase in the rate of high-risk referrals of between 18% and 21% per quarter, indicating improved responses to victim-survivors at highest risk of imminent harm. Under a range of reasonable assumptions, initiation of the DAC role is shown to be cost-saving to an employing acute trust. Future work should seek to quantify the direct impacts to survivor health and wellbeing of the implementation of the DAC role.

The economic value of insulin glargine 300 U/mL (Gla-300) in people ≥18 years of age with type 2 diabetes mellitus: a value-based economic model from a U.S. payer perspective

AimsThis study aimed to evaluate the value and affordability of insulin glargine 300 U/mL (Gla-300) in a budget impact model from a United States (U.S.) payer perspective by leveraging recent real-world evidence (RWE) studies and incorporating the recent insulin price caps where applicable.Materials and methodsAn economic model for a hypothetical one million U.S. health-plan population was developed to assess the budgetary impact of therapeutic interchanges in either direction between the two long- and longer-acting basal insulins (BIs) for patients with type 2 diabetes over a three-year model horizon. The utilization of long-acting BIs, longer-acting BIs, biosimilar BIs, and insulin degludec (IDeg-100) were informed by IQVIA data and internal forecasting at Sanofi. The DELIVER-2 and DELIVER-naïve studies provided healthcare resource utilization (HCRU) parameters. In the model base case, 24% of patients switched from long-acting BIs to insulin glargine biosimilars, IDeg-100, and other longer-acting BIs (Gla-300) by projected year 3.ResultsThe base case total costs were $10,145 per patient per year (PPPY) in year 3 for the cumulative population. When all patients switched to Gla-300, the total costs in year 3 were $8,799, reflecting a net savings of -$660 PPPY compared to the budget increase of $686 PPPY in the base case. However, the longer-acting to long-acting BIs reversal scenario demonstrated a budgetary decrease of $676 PPPY over the model horizon. The reduction in incremental PPPY cost of $93 was observed using net drug costs rather than wholesale acquisition costs (WAC).LimitationsThe market shares for years 1–3 were based on expectations supported by the clinicians’ expert opinions and were not obtained from real-world data.ConclusionsThe economic value of increased utilization of Gla-300 was driven by the reduction in HCRU, costs and market shares assumptions. Budgetary reductions were achieved by switching patients from long-acting BIs to Gla-300.

Economic impact of olaparib on maintenance treatment of patients with BRCA-mutation positive, platinum-sensitive relapsing high-grade serous epithelial ovarian cancer in Spain

ObjectiveTo estimate the economic impact of the introduction of olapa- rib in the Spanish National Health System as maintenance monotherapy in patients with BRCA-mutation positive high-grade serous ovarian cancer. Method: A budget impact model was developed from the Spanish NHS perspective and a time horizon of 5 years for four treatment lines. The model included prevalent and incident patients estimated according to Spanish epidemiological data. Patients moved between treatment lines according to the progression-free survival and overall survival curves obtained from the respective clinical trials. Only direct costs (€2017) were considered: pharmacological, administration, adverse effects and genetic tests. The robustness of the model was verified by a univariate sensitivity analysis. ResultsThe use of olaparib meant that, after 5 years, 6% fewer patients progressed to later lines compared to scenario without olaparib, remaining longer in the second line and delaying the initiation of subsequent lines. The total estimated budgetary impact ranged between € 1.6 and € 5.4 million (1-5 years). The economic impact associated to the introduction of olaparib is partially offset by the lower cost of chemotherapy, related adverse events, and palliative care in patients with olaparib than in patients without it. ConclusionsOlaparib as maintenance treatment in patients with BR- CA-mutation positive high-grade serous ovarian cancer increases progression-free survival and delays the use of subsequent chemotherapy, with an budgetary impact for the Spanish National Health System of 5.4 million euros after 5 years.

Budget impact analysis of dexamethasone intravitreal implant for the treatment of diabetic macular oedema

ObjectiveTo assess the economic impact following the inclusion of an intravitreal implant of dexamethasone for the treatment of diabetic macular oedema in a healthcare area in Spain. MethodA 3-year budget impact model was designed to estimate healthcare direct costs for adult patients with diabetic macular oedema from the National Health System perspective. The approved therapies in use (aflibercept/ranibizumab/dexamethasone) were considered. The target population was estimated from published diabetic macular oedema prevalence (6.41%) and incidence (0.82%) for a population of 25,000 adults. Dexamethasone was assumed to be used annually in 20%, 30% and 40% of patients, respectively. Annual total costs included: drug acquisition (based on frequency of injections per every year, considering ex-factory prices with mandatory deduction and split of vials), intravitreal administration, patient monitoring, management of cardiovascular and ocular adverse events (cataracts, increased intraocular pressure, endophthalmitis, vitreous haemorrhage and retinal detachment). Detailed resource consumption reflecting clinical practice was provided from local experts in retina and vitreous. Unitary costs (€, 2016) were obtained from national databases and literature. Sensitivity analyses were performed to assess model robustness. ResultsThe inclusion of intravitreal dexamethasone implant would lead to annual cost savings of €35,030 (–4.2%), €10,743 (–1.8%) and €5,051 (–0.9%), years 1-3 respectively. Total costs were reduced mainly by the fewer annual injections required by dexamethasone. The average annual incremental costs were –€350, –€96 and –€41 per patient. ConclusionsThe inclusion of an intravitreal dexamethasone implant for the treatment of diabetic macular oedema would lead to cost-savings for the considered health area, mainly by reducing the administration costs.

Budget impact of introducing oral semaglutide to the public healthcare benefit package in Saudi Arabia

BackgroundThe Kingdom of Saudi Arabia (KSA) has embarked on a Health Sector Transformation Program as part of the Kingdom’s Vision 2030 initiatives with the facilitation of access to healthcare services for the millions in KSA with diabetes an essential part of the Program. Decision-making tools, such as budget impact models, are required to consider the addition of new medications like oral semaglutide that have multifaceted health benefits and address barriers related to therapeutic inertia to reduce diabetes-related complications.ObjectiveTo determine the financial impact of the introduction of oral semaglutide as a treatment option for people with type 2 diabetes mellitus (T2DM) in KSA.MethodsFrom the public payer’s perspective, the budget impact model estimates the costs before and after the introduction of oral semaglutide over a 5-year time horizon. The budget impact of introducing oral semaglutide (primary comparator) compared with three different classes of diabetes medicines: glucagon-like peptide-1 receptor agonists (GLP-1), sodium-glucose transport protein 2 inhibitors (SGLT 2i) and dipeptidyl peptidase 4 inhibitors (DDP-4i) have been calculated based on the projected market shares. The model includes the cost of care through the incorporation of health outcomes that have an impact on the national payer’s budget in Saudi Riyals (SAR).ResultsThe budget impact over the five-year time horizon indicates a medication cost increase (17,424,788 SAR), and cost offsets which include a difference in diabetes management costs (-3,625,287 SAR), CV complications costs (-810,733 SAR) and weight loss savings of 453,936 SAR. The cumulative total cost difference is 12,427,858 SAR (0.66%).ConclusionThe introduction of oral semaglutide 14 mg as a second-line treatment option after metformin is indicated as budget-neutral to slightly budget-inflating for the public pharmaceutical formulary of KSA. The price difference is offset by positive health outcomes and costs. This conclusion was confirmed through a probabilistic sensitivity analysis.

Inebilizumab for neuromyelitis optica spectrum disorders in Italy: a budget impact model

ABSTRACT Background The Italian National Health Service (INHS) has recently reimbursed the monoclonal antibody inebilizumab as a second line monotherapy after rituximab (RTX) use for neuromyelitis optica spectrum disorders (NMOSD) patients ≥ 18 years anti-aquaporin 4 antibody-immunoglobulin G positive, who experienced a relapse in the last year or cannot receive RTX, if incident patients. Other INHS-reimbursed drugs for NMOSD treatment are satralizumab, eculizumab and, off-label, besides RTX, ocrelizumab, tocilizumab, and immunosuppressants. Research design and methods A 3-year (2023–2025) prevalence-based budget impact model following the INHS viewpoint compared the costs and the NMOSD attacks without (1st scenario) and with inebilizumab (2nd scenario). The epidemiology of NMOSD, and the INHS-funded healthcare resources (drugs and their administration; specialist visits; hospitalizations due to drug-related adverse events and NMOSD attacks) were obtained from the literature. One-way, threshold value and scenario sensitivity analyses investigated the robustness of the baseline findings. Results During 2023–2025 inebilizumab saves the INHS €8,373,125.13 (1st scenario: €176,770,028.63; 2nd scenario: €168,396,903.50) and 12.74 NMOSD attacks (1st scenario: 213.94; 2nd scenario: 201.19). Sensitivity analyses confirmed the robustness of the baseline results. Conclusion Inebilizumab reduces the INHS expenditure for NMOSD drugs. Future research should explore the cost-effectiveness of inebilizumab vs other NMOSD-targeting drugs in Italy.

Budget Impact Analysis of Intensification with iGlarLixi Compared to Alternative Treatment Strategies Among Patients with Type2 Diabetes Mellitus.

The clinical benefits of treating patients with type2 diabetes mellitus (T2DM) with fixed-ratio combination of insulin iGlar (iGlar) plus lixisenatide (iGlarLixi) were demonstrated in clinical trials and real-world evidence studies; however, its cost impact to healthcare payers is unknown. A budget impact model was developed from a United States (US) payer's perspective for a hypothetical healthcare plan of 1million people over a 1-year time horizon. In scenario analysis, patients with uncontrolled glycated hemoglobin (HbA1c) treated with 60units or less of daily insulin (insulin cohort) or oral antidiabetic drugs (OADs) only (OAD cohort) were intensified to iGlarLixi/rapid-acting insulin (RAI)/glucagon-like peptide1 receptor agonists (GLP-1RA) or iGlarLixi/iGlar/GLP-1RA, respectively. Model inputs from real-world data (RWD) included baseline market shares, proportion of patients intensifying to respective treatments, and dosing inputs; unit costs were obtained from published literature. One-way sensitivity analyses assessed the impact of individual parameters. Intensification with iGlarLixi resulted in the lowest incremental per member per month (PMPM) budget impact compared to other intensifying drugs (iGlar, RAI, and GLP-1RA). In the insulin cohort, the incremental PMPM cost for intensification with iGlarLixi ($0.03) was the lowest among intensifying drugs; GLP-1RA ($72.20) and RAI ($4.81). Similarly, the incremental PMPM cost for intensification with iGlarLixi was the lowest ($1.25) in the OAD cohort among intensifying drugs; GLP-1RA ($321.65) and iGlar ($114.82). In scenario analyses, when equal market intensification shares for iGlarLixi and GLP-1RA were explored, the incremental PMPM cost for iGlarLixi ($0.03) remained lower than GLP-1RA ($2.28) and RAI ($10.44) in the insulin cohort. Intensification with iGlarLixi was associated with lower costs compared to other treatment intensifications, as well as overall budget reductions compared to pre-intensification when considering cost savings attributable to reduction in HbA1c; therefore, its inclusion for the treatment of T2DM would represent a budget saving.

A cost-consequences and budget impact analysis of blue light-guided cystoscopy with Hexvix in patients diagnosed with non-muscle-invasive bladder cancer in France

AimsFrench guidelines for the management of non-muscle-invasive bladder cancer recommend that blue-light cystoscopy should be used in patients where the risk of missing residual tumor is highest. Despite evidence for its cost-effectiveness, budgetary concerns have limited uptake in France. The aim of this analysis was to model the cost-consequences of adopting the recommendations in a French urology unit.Materials and methodsA budget impact model was developed in Excel, using a decision tree approach derived from guidelines issued by L’Academie franҫaise d’urologie. Risk profiles were derived from an analysis of studies using white-light cystoscopy; estimates for the impact of blue-light cystoscopy were derived from a published Cochrane Review. Costs were based on published tariff prices from L’Agence Technique de L’Information sur L’Hospitalisation. The model allowed results to be tailored to activity levels and projected blue-light usage in the chosen urology unit.ResultsTwo scenarios were evaluated, based on a 3-year time horizon. Full implementation of all recommendations within a large public hospital was estimated to yield incremental costs of €269 per procedure (∼10% increase overall); a more targeted approach within a smaller private hospital yielded incremental costs of €133 per procedure (5% increase overall).LimitationsThe basis of the model is a change in the time to first recurrence. There are no data available for subsequent recurrences or progression, both of which could have an influence on expenditure. Secondly, recurrence rates for blue-light cystoscopy were not specifically available for each patient group identified in the guidelines: extrapolation of data may have resulted in bias. Finally, the data were derived from clinical trials, which may not be generalisable to real-world clinical practice.ConclusionsThe model has shown that the additional expenditure required to implement blue-light cystoscopy is modest and not disproportionate to the overall cost of care.

Cost-minimization Analysis in Iron-deficiency Anemia Comparing Intravenous Ferric Carboxymaltose to Standard of Care in Pregnant Women in Algeria

Abstract INTRODUCTION: Anemia due to iron deficiency is frequent during pregnancy and increases morbidity and mortality of mothers and infants. The objective of this study was to assess the economic consequences of intravenous ferric carboxymaltose (FCM) in anemic pregnant women in Algeria. METHODS: The economic analysis was a cost-minimization model comparing the strategy for treating pregnant women with intravenous iron sucrose to FCM. The perspective of Algerian health-care providers was adopted to calculate costs savings. Cost related to treatment of iron-deficiency anemia included infusion, iron workup, medical time, iron vials acquisition, and absenteeism. Data were obtained mostly from available scientific literature and public health data and were validated by expert opinion. A budget impact model was also developed for the population of Algerian women needing intravenous iron treatment to evaluate the gross impact on payers’ budget if FCM treatment was prescribed. RESULTS: Treatment of pregnant women with iron-deficiency anemia (mean weight, 65 kg; hemoglobin 7.5 g/dL) needed 7 hospital visits and 14.9 doses for iron sucrose treatment to be compared to 2 hospital visits and 2 doses for FCM treatment. Total cost was Algerian dinar (DZD) 69,222 per patient for iron sucrose and DZD 57,452 for FCM (cost savings per patient: DZD 11,769, i.e., 17%). If all 192,000 pregnant Algerian anemic women eligible for injectable iron treatment received FCM, global cost savings would be DZD 2,259,820,627 per year. CONCLUSION: This economic model suggests that FCM is a cost-saving treatment compared to standard iron sucrose treatment in pregnant women with iron-deficiency anemia in Algeria.

Budget and health impact of switching eligible patients with atrial fibrillation to lower- dose dabigatran

ABSTRACT Objectives: To assess the comparative budget and health impact of lower-dose dabigatran versus reduced doses of apixaban and rivaroxaban in atrial fibrillation (AF) patients eligible for a lower-/reduced-dose due to individual patient characteristics in the Netherlands. Methods: A budget impact model was developed in accordance with ISPOR guidelines. A 3-year-time horizon was considered, and analyses were conducted from a Dutch healthcare payer’s perspective. The model applies published data to local AF-epidemiology, allowing calculations to estimate clinical events (strokes and haemorrhages) and costs. The analyses were based on real-world outcomes from patients with AF receiving a first direct oral anticoagulant (DOAC) prescription for low-dose dabigatran (110 mg) and a reduced dose of apixaban (2.5 mg) or rivaroxaban (15 mg). Two situations of switching treatments from one to another DOAC were modelled: switching from apixaban to dabigatran and from rivaroxaban to dabigatran. Base case results were given as savings per 100 patient-year, per total Dutch population, and events avoided. A univariate sensitivity analysis was conducted to explore the uncertainty around epidemiological and event costs input data. Scenario analyses were performed to estimate the effect of different market shares and potential price reductions due to future patent expiry for the total real-world population from the Netherlands. Results: The 3-years outcomes of switching patients eligible for a lower-/reduced-dose due to individual patient characteristics from apixaban or rivaroxaban to dabigatran resulted in cost savings estimated at €157 or €72 thousand per 100 patient-years, respectively, or €146 million per total Dutch population. Looking into the clinical events, dabigatran reflected the lowest number of mortalities, ischemic strokes, major bleeding, non-major bleeding, and haemorrhagic stroke compared to apixaban and rivaroxaban. The sensitivity analysis consistently reflected cost savings, with the ischeamic stroke events having the biggest impact. Accounting for the Dutch situation, both scenarios showed total savings ranging from €45 to €229 million over 3 years. Conclusions: Switching eligible AF-patients from reduced-dose apixaban or rivaroxaban to lower-dose dabigatran has the potential to reduce healthcare payer’s budget expenditures and provide health gains. Cost savings can potentially be further enhanced by market share adjustments and further price reductions.

Hemoadsorption Using CytoSorb® in Patients with Infective Endocarditis: A German-Based Budget Impact Analysis.

A considerable number of infective endocarditis (IE) patients require cardiac surgery with an increased risk for postoperative sepsis. Intraoperative hemoadsorption may diminish the risk of postoperative hyperinflammation with potential economic implications for intensive care unit (ICU) occupation. The present study aimed to theoretically investigate the budget impact of a reduced length of ICU stay in IE patients treated with intraoperative hemoadsorption in the German healthcare system. Data on ICU occupation were extrapolated from a retrospective study on IE patients treated with hemoadsorption. An Excel-based budget impact model was developed to simulate the patient course over the ICU stay. A base-case scenario without therapy reimbursement and a scenario with full therapy reimbursement were explored. The annual eligible German IE patient population was derived from official German Diagnostic-Related Group (DRG) volume data. One-way deterministic sensitivity analysis and multivariate analysis were performed to evaluate the uncertainty over the model results. The use of intraoperative hemoadsorption resulted in EUR 2298 being saved per patient in the base-case scenario without therapy reimbursement. The savings increased to EUR 3804 per patient in the case of full device-specific reimbursement. Deterministic and probabilistic sensitivity analyses confirmed the robustness of savings, with a probability of savings of 87% and 99% in the base-case and full reimbursement scenario, respectively. Intraoperative hemoadsorption in IE patients might have relevant economic benefits related to reduced ICU stays, resulting in improved resource use. Further evaluations in larger prospective cohorts are warranted.

Management of perioperative iron deficiency anemia as part of patient blood management in France: A budget impact model-based analysis based on real world data.

Patient Blood Management (PBM) is defined as a patient-centered, systematic, evidence-based approach to improve patient outcomes by managing and preserving a patient's own blood, while promoting patient safety and empowerment. As a corollary, it also reduces the utilization of allogeneic blood components. However, demonstrating cost-effectiveness depends on the health insurance system considered. This analysis aims to estimate the one-year budget impact of PBM in four elective surgical areas, from French National Health Insurance and hospital perspectives. A budget impact model was developed to estimate the difference in the cost of care between scenarios with and without PBM. The impact of hematopoiesis optimization (first pillar of PBM) was studied throughout the management of preoperative anemia and iron deficiency in four types of surgeries: orthopedic, cardiac & cardiovascular, vascular & thoracic, and urologic & visceral surgery. Estimation of model's parameters was based on data collected in 10 French hospitals, literature, and on data from the French national medico-administrative database. A total of 980,125 patients were modeled for all four therapeutic areas. Results shows that implementation of a PBM program could generate annual savings up to €1079 M from the French National Health Insurance perspective (€1018 M from the hospital perspective), and the sparing of 181,451 red blood cells units per year. The deterministic sensitivity analysis showed that PBM generates savings for both perspectives in most parameters tested. Implementing PBM programs could result in important savings for the health care system in France.

Projecting the Potential Budget Impact Analysis of Paliperidone Palmitate in Egyptian Adult Patients with Schizophrenia.

Background: Schizophrenia is a serious mental disorder that has greater negative consequences on role functioning than many other severe chronic diseases. Objective: We evaluated the economic impact of long-acting injections of paliperidone palmitate (PP) vs daily oral antipsychotics to treat chronic schizophrenia from a societal perspective over a 2-year period. Methods: A static budget impact model was developed to compare PP with daily oral antipsychotics (risperidone, olanzapine, and aripiprazole) in the treatment of patients with chronic schizophrenia. Our study included treatments used during relapse and hospitalization, validated by an expert panel. The clinical parameters were extracted from the PRIDE trial. Direct medical costs and indirect costs were measured. The unit cost of drug acquisition for all medications was extracted from the public sector. One-way sensitivity analyses were conducted. Results: The target population in our model was estimated to be 142 incident patients. In the first year, the total drug costs in Egyptian pounds (EGP) for PP and oral antipsychotics were £2.7 million and £724 004, respectively, while the total medical costs for PP and oral antipsychotics were £3 million and £5.6 million, respectively. In the second year, the total drug costs for PP and oral antipsychotics were £2.7 million and £724 004, respectively, while the total medical costs for PP and oral antipsychotics were £3 million and £5 million, respectively. The total costs for PP (£11.6 million) over 2 years were less than those of oral antipsychotics without PP (£12.7 million). PP produced an estimated budget savings of £1 046 561 (budget savings per patient per year, £3667). In addition, PP resulted in the avoidance of 18 hospitalizations per year compared with the without-PP arm. Sensitivity analyses showed that the percent of hospitalizations for both oral antipsychotics and PP had the greatest impact on the results. Conclusion: The lower hospitalization rates associated with PP offset the increase in drug costs. PP may potentially be cost-saving compared with the standard of care in chronic schizophrenia in Egyptian representative healthcare settings. Policy makers may consider this approach to improve patient outcomes and budget sustainability.

Lsisi G, Ezzat M, Ramadan M. Projecting the Potential Budget Impact Analysis of Paliperidone Palmitate in Egyptian Adult Patients with Schizophrenia

Background: Schizophrenia is a serious mental disorder that has greater negative consequences on role functioning than many other severe chronic diseases. Objective: We evaluated the economic impact of long-acting injections of paliperidone palmitate (PP) vs daily oral antipsychotics to treat chronic schizophrenia from a societal perspective over a 2-year period. Methods: A static budget impact model was developed to compare PP with daily oral antipsychotics (risperidone, olanzapine, and aripiprazole) in the treatment of patients with chronic schizophrenia. Our study included treatments used during relapse and hospitalization, validated by an expert panel. The clinical parameters were extracted from the PRIDE trial. Direct medical costs and indirect costs were measured. The unit cost of drug acquisition for all medications was extracted from the public sector. One-way sensitivity analyses were conducted. Results: The target population in our model was estimated to be 142 incident patients. In the first year, the total drug costs in Egyptian pounds (EGP) for PP and oral antipsychotics were £2.7 million and £724 004, respectively, while the total medical costs for PP and oral antipsychotics were £3 million and £5.6 million, respectively. In the second year, the total drug costs for PP and oral antipsychotics were £2.7 million and £724 004, respectively, while the total medical costs for PP and oral antipsychotics were £3 million and £5 million, respectively. The total costs for PP (£11.6 million) over 2 years were less than those of oral antipsychotics without PP (£12.7 million). PP produced an estimated budget savings of £1 046 561 (budget savings per patient per year, £3667). In addition, PP resulted in the avoidance of 18 hospitalizations per year compared with the without-PP arm. Sensitivity analyses showed that the percent of hospitalizations for both oral antipsychotics and PP had the greatest impact on the results. Conclusion: The lower hospitalization rates associated with PP offset the increase in drug costs. PP may potentially be cost-saving compared with the standard of care in chronic schizophrenia in Egyptian representative healthcare settings. Policy makers may consider this approach to improve patient outcomes and budget sustainability.

Analysis of heterogeneity of the different health technology assessment reports produced on the transcatheter aortic valve implantation in patients with severe aortic valve stenosis at low surgical risk.

Symptomatic severe aortic stenosis is a congenital or acquired aortic valve disease that occurs when the aortic valve of the heart narrows. It represents the most common valvular disease in adults and generally has a degenerative nature. Transcatheter aortic valve implantation (TAVI), due to its non-invasive approach, has become the standard treatment in patients who are ineligible to surgery or at high surgical risk, and it is also increasingly being performed in patients at intermediate to low surgical risk. The aim is to analyze the heterogeneity and explore the limitations of current health technology assessments (HTAs) on TAVI. For the purpose of this analysis, a review of the literature based on manual research was performed. A population, intervention, comparators, and outcome (PICO) model was used to gather the HTA reports assessing TAVI in the treatment of patients affected by symptomatic severe aortic valve stenosis at low surgical risk. Furthermore, a manual search has been developed to also include assessments from the Haute Autorité de Santé. At the end of the investigation, a certain degree of heterogeneity in the evidence factored and in the recommendations on the technology has emerged. Relative to the clinical domains, the main drivers for the disparity are found in the type of evidence considered and in the use or not of the grading of recommendations, assessment, development, and evaluation (GRADE) methodology to evaluate the quality of the clinical evidence included. Another element concerns the chosen device generation assessed within the evaluation. In order to perform the economic evaluation, a cost-utility analysis and a budget impact model were developed. Despite some elements of heterogeneity, the economic assessments demonstrate a favorable or dominant cost-effectiveness profile for TAVI compared with surgical aortic valve replacement (SAVR). Despite the presence of heterogeneity elements both in clinical and economic domains, HTA agencies reached the same recommendations on the use of TAVI. It emerged the need for a centralized vision on the "strong" domains, which means giving up freedom to local bodies to adapt to their context on the "soft" ones. This approach could have the potential to strengthen the role of HTA in Europe by ensuring faster decision-making and equity of access to health innovations and reduce the heterogeneity in the assessment methods.

Clinical and Economic Assessment of MyDiaCare, Digital Tools Combined With Diabetes Nurse Educator Support, for Managing Diabetes in South Africa: Observational Multicenter, Retrospective Study Associated With a Budget Impact Model.

In South Africa, diabetes prevalence is expected to reach 5.4 million by 2030. In South Africa, diabetes-related complications severely impact not only patient health and quality of life but also the economy. The Diabetes Nurse Educator (DNE) study assessed the benefit of adding the MyDiaCare program to standard of care for managing patients with type 1 and type 2 diabetes in South Africa. An economic study was also performed to estimate the budget impact of adding MyDiaCare to standard of care for patients with type 2 diabetes older than 19 years treated in the South African private health care sector. The real-world DNE study was designed as an observational, retrospective, multicenter, single-group study. Eligible patients were older than 18 years and had at least 6 months of participation in the MyDiaCare program. The MyDiaCare program combines a patient mobile app and a health care professional platform with face-to-face visits with a DNE. The benefit of MyDiaCare was assessed by the changes in glycated hemoglobin (HbA1c) levels, the proportion of patients achieving clinical and biological targets, adherence to care plans, and satisfaction after 6 months of participating in the MyDiaCare program. A budget impact model was performed using data from the DNE study and another South African cohort of the DISCOVERY study to estimate the economic impact of MyDiaCare. Between November 25, 2019, and June 30, 2020, a total of 117 patients (8 with type 1 diabetes and 109 with type 2 diabetes) were enrolled in 2 centers. After 6 months of MyDiaCare, a clinically relevant decrease in mean HbA1c levels of 0.6% from 7.8% to 7.2% was observed. Furthermore, 54% (43/79) of patients reached or maintained their HbA1c targets at 6 months. Most patients achieved their targets for blood pressure (53/79, 67% for systolic and 70/79, 89% for diastolic blood pressure) and lipid parameters (49/71, 69% for low-density-lipoprotein [LDL] cholesterol, 41/71, 58% for high-density-lipoprotein [HDL] cholesterol, and 59/71, 83% for total cholesterol), but fewer patients achieved their targets for triglycerides (32/70, 46%), waist circumference (12/68, 18%), and body weight (13/76, 17%). The mean overall adherence to the MyDiaCare care plan was 93%. Most patients (87/117, 74%) were satisfied with the MyDiaCare program. The net budget impact per patient with type 2 diabetes, older than 19 years, treated in the private sector using MyDiaCare was estimated to be approximately South African Rands (ZAR) 71,023 (US $4089) during the first year of introducing MyDiaCare. The results of using MyDiaCare program, which combines digital tools for patients and health care professionals with DNE support, suggest that it may be a clinically effective and cost-saving solution for diabetes management in the South African private health care sector.

Vaccinating the German Population Aged 60 Years and Over with a Quadrivalent High-Dose Inactivated Influenza Vaccine Compared to Standard-Dose Vaccines: A Transmission and Budget Impact Model.

In Germany, influenza vaccination is mainly advised for persons aged 60 years and over and individuals with health risks. Since 2021, an inactivated, quadrivalent high-dose influenza vaccine (IIV4-HD) has been recommended for persons aged 60 years and over. The aim of this study was to calculate the impact of vaccinating the German population aged 60 years and over with IIV4-HD compared to standard-dose influenza vaccines (IIV4-SD) with regard to health outcomes and costs. An age-stratified deterministic compartment model was built to simulate the course of influenza infection for the German population in the season 2019/20. Probabilities for health outcomes and cost data were searched from the literature and were used to compare the influenza-related health and economic effects for different scenarios. Perspectives were those of the statutory health insurance and the society. Deterministic sensitivity analyses were conducted. From the statutory health insurance perspective, vaccinating the German population aged 60 years and over with IIV4-HD would have prevented 277,026 infections (-1.1%) with an increase of overall direct costs of €224 million (+40.1%) compared with IIV4-SD. A separate analysis showed that increased vaccination of 75% (World Health Organization recommendation for older age groups) in persons aged 60 years and over using IIV4-SD only would prevent 1,289,648 infections (-5.1%) and would save costs from a statutory health insurance perspective of €103 million (-13.2%) compared with IIV4-HD at actual vaccination rates. The modeling approach offers important insights into the epidemiological and budgetary impact of different vaccination scenarios. Achieving a higher vaccination coverage with IIV4-SD in persons aged 60 years and over would result in lower costs and fewer influenza infections compared with the scenario with IIV4-HD and actual vaccination rates.

Budget Impact Analysis of Ferric Derisomaltose for the Treatment of Iron-Deficiency in Malaysia

Introduction: Untreated iron deficiency (ID) can lead to severe anaemia, requiring blood transfusion, or increased mortality risk. Globally intravenous (IV) iron is increasingly recognised as a recommended option for patients. This study aims to evaluate the budget impact associated with introducing a new intravenous (IV) iron, ferric derisomaltose (Monofer® [IIM]) as one of the treatment options for the management of ID in the Ministry of Health Malaysia (MOHM) setting. Methods: A 5-year budget impact model was developed from 2020 to 2024 for patients with ID that require a high iron dose (≥500 mg), using the perspective of MOHM. The model was built with four external medical specialists, each with experience and deep knowledge of ID management, to support estimations on the future development of iron use in Malaysia. Results: Compared to the current market mix with the existing IV iron products (i.e., iron sucrose and iron dextran), a cost-saving of MYR 53,910 could be achieved with the introduction of IIM in 2020. The uptake of IIM into MOHM over five years is estimated to lead to an overall budget saving of MYR 11,837,524 over a 5-year time horizon. Conclusion: The use of IIM in place of the current IV iron products in MOHM resulted in a significant cost saving by reducing the number of visits required to achieve the targeted iron dose and the shorter IV infusion time with IIM.