National Health System Perspective Research Articles

EE656 A Cost-Utility Analysis of Avacopan for the Treatment of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis, a Rare Disease, in Spain

Antineutrophil cytoplasmic antibody-associated vasculitis (AAV) is a rare, heterogeneous, life-threatening, autoimmune condition. This study aimed to evaluate the cost-utility of avacopan in combination with rituximab or cyclophosphamide compared with glucocorticoids (GC) and cyclophosphamide or rituximab for the treatment of severe, active AAV from the Spanish National Health System perspective.

Economic impact of the first pass effect in mechanical thrombectomy for acute ischaemic stroke treatment in Spain: a cost-effectiveness analysis from the national health system perspective

ObjectiveThe mechanical thrombectomy (MT) benefit is related to the degree of reperfusion achieved. First pass effect (FPE) is defined as complete/near revascularisation of the large-vessel occlusion (modified Thrombolysis in Cerebral...

How real can we get in generating real world evidence? Exploring the opportunities of routinely collected administrative data for evaluation of medical devices.

Real-world data are considered a potentially valuable source of evidence for assessing medical technologies in clinical practice, but their widespread use is hampered by numerous challenges. Using the case of coronary stents in Italy, we investigate the potential of administrative databases for estimating costs and health outcomes associated with the use of medical devices in real world conditions. An administrative dataset was created ad hoc by merging hospital records from patients admitted between 2013 and 2019 for stent implantations with ambulatory records, pharmaceutical use data and vital statistics. Health outcomes were multifold: all-cause and cardiac mortality and myocardial infarction, within 30days, 1, 2, 5years. Costs were estimated from the National Health System perspective. We used multivariable Cox models and propensity score (PS) methods (PS matching; stratification on PS; inverse probability of treatment weighting using PS; PS adjustment). 257,907 coronary stents were implanted in 113,912 patients. For all health outcomes and follow-up times, and across all methods, patients receiving drug-eluting stents (DES) presented lower risk. For all-cause mortality, the DES patient advantage over bare-metal stent (BMS) patients declined over time but remained significant even at 5years. For myocardial infarction, results remained quite stable. The DES group presented lower cumulative total costs (ranging from 3264 to 2363 Euros less depending on methods). Our results confirm the consolidated evidence of the benefits of DES compared to BMS. The consistency of results across methods suggests internal validity of the study, while highlighting strengths and limitations of each depending on research context. Administrative data yield great potential to perform comparative effectiveness and cost-effectiveness analysis of medical devices provided certain conditions are met.

Analysis of the Budget Impact of Fractional Exhaled Nitric Oxide Monitoring in the Management of Childhood Asthma: The Colombian National Health System Perspective.

Fractional exhaled nitric oxide (FeNO) testing is a simple, noninvasive approach to assessing airway inflammation with minimal discomfort that provides results within a few minutes. For policy makers, the economic impact of this technology is the main concern, especially in developing countries. We evaluated the budget impact of asthma management using FeNO monitoring in patients aged between 4 and 18 years in Colombia. A budget impact analysis was performed to evaluate the potential cost of FeNO monitoring. The analysis was based on a 5-year time horizon and performed from the perspective of the Colombian National Health System. The incremental budget impact was calculated by subtracting the cost of the new treatment, in which FeNO is reimbursed, from the cost of conventional treatment without FeNO (management based on clinical symptoms [with or without spirometry/peak flow] or asthma guidelines [or both] for asthma-related cases). Univariate 1-way sensitivity analyses were performed. In the base case analysis the 5-year costs associated with FeNO and non-FeNO were estimated to be €469 904 130 and €480 485 149, respectively, indicating savings for the Colombian National Health System of €10 581 019 if FeNO is adopted for the routine management of patients with persistent asthma. This result proved to be robust in the univariate 1-way sensitivity analysis. FeNO monitoring generated cost savings in emergency settings for infants with persistent asthma. This evidence can be used by decision makers in Colombia to improve clinical practice guidelines and should be replicated to validate the results in other middle-income countries.

A New Methodology to Estimate Drug Cost Avoidance in Clinical Trials: Development and Application.

BackgroundOncology clinical trials can lead to relevant financial savings in drug acquisition for healthcare providers. Considerable methodological heterogeneity is observed among previous studies estimating these savings.MethodsWe developed a methodology to estimate the economic benefit obtained from the enrollment of patients into clinical trials through the analysis of drug cost avoidance. We designed a decision algorithm to determine if a clinical trial is associated with drug cost avoidance. This algorithm is based on five scenarios according to the availability or not of standard treatment, the presence or absence of a control arm (placebo or active treatment), and the provider of the medication. We considered as reference the cost of the standard treatment that the patient would have received in routine clinical practice. We standardized drug doses and treatment durations according to the literature. Costs were considered from a National Health System perspective. We applied this methodology at a single, research-active University Hospital in 2019. A cost avoidance analysis per trial and patient was carried out on cancer patients.ResultsWe analyzed 140 trials in which 198 patients were recruited. Drug cost avoidance was found in 120 trials (85.7%). The estimated total drug cost avoidance amounted to over €3,200,000. Melanoma and genitourinary tumors were the tumor types associated with the highest cost avoidance. The average drug cost avoidance per patient was €16,245.ConclusionWe describe a standardized method to estimate drug cost avoidance in clinical trials. We have applied it to all ongoing oncology clinical trials in our center. This methodology could be valuable for other centers to analyze the potential saving of clinical trials.

Cost-effectiveness of Olaparib plus Bevacizumab versus Bevacizumab in the maintenance of patients with HRD+ advanced ovarian cancer after response to first-line platinum-based chemotherapy in Spain.

e17591 Background: Olaparib, a poly (ADP-ribose) polymerase inhibitor (PARPi), monotherapy as first-line maintenance treatment has shown to be cost-effective in ovarian cancer (OC) patients with BRCA mutations in Spain. Regardless of BRCA status, patients with homologous recombination deficiency positive (HRD+) also benefit from PARPi following first-line platinum-based therapy. PAOLA-1 trial confirmed that adding Olaparib to bevacizumab (BEV) significantly increased progression-free survival (PFS) in OC patients. The aim of this study was to assess the cost-effectiveness of Olaparib plus BEV versus BEV monotherapy for the maintenance treatment of HRD+ advanced OC patients after response to first-line platinum-based therapy plus BEV from Spanish National Health System perspective. Methods: A lifetime partitioned survival model with monthly cycles and four health states (PFS, first progression, second progression, and death) was developed. Long-term survival defined as 60 months was included in the mixed survival model as a landmark to extrapolate PFS from the PAOLA-1 trial. Weibull distribution was selected as the most accurate survival model for PFS extrapolation. Time to second progression, and overall survival (OS) were extrapolated using parametric survival models. Mortality was obtained from the OS and adjusted by Spanish mortality rates. Health state utilities and adverse event (AE) frequencies were obtained from PAOLA-1. An expert panel validated data and assumptions. Direct costs including drug acquisition and administration, follow-up, subsequent therapies, AE, and end-of-life were obtained from local sources. A 3% annual discount rate was applied to costs and outcomes. The incremental cost-effectiveness ratio (ICER) was calculated as cost per quality-adjusted life-years (QALYs) gained. One-way and probabilistic sensitivity analyses (PSA) were performed to assess the robustness of the model. Results: Base-case analysis of Olaparib plus BEV compared with BEV showed an ICER of €24,371 per QALY gained. Discount rates applied to outcomes and the cost of Olaparib generated the most significant changes in the ICER. PSA demonstrated that Olaparib plus BEV had a 49.5% and 90.3% probability of being cost-effective versus BEV at a willingness-to-pay of €25,000 and €60,000 per QALY gained, respectively. Conclusions: Olaparib plus BEV is a cost-effective maintenance therapy compared with BEV for patients with HRD+ advanced OC in Spain.[Table: see text]

Primary care-based follow-up for prostate and kidney cancer survivors: a retrospective monocentric study.

New follow-up models of care are needed to ensure long-term comprehensive care for cancer survivors. We investigated the impact of a general practitioner (GP)-led follow-up program for prostate cancer (PCa) and renal cell cancer (RCC) survivors. This retrospective monocentric study compared standard urologist-led follow-up to experimental GP-led follow-up within a nurse-led network for PCa and RCC survivors. To assess the safe continuity of follow-up, the number of patients lost to follow-up (LFU) was collected. A microcosting analysis from the French national health system perspective was conducted to describe incremental costs associated with experimental follow-up. A satisfaction survey was conducted to determine participating patient's and GP's satisfaction scores, ranging from 0 to 4 and 0 to 5, respectively. Among the 1274 patients included, 92/753 (12.2%) were LFU during standard follow-up vs 0/521 (0%) during experimental follow-up (p < 0.001). In the latter, the median management delay of suspected recurrence for PCa and RCC survivors was 20 [12-27] and 16 [10.5-31.25] days, and the mean incremental cost on a per-patient basis was 34.68 ± 105.87€ and 64.24 ± 93.55€, respectively. Patient and GP mean satisfaction scores were 3.6/4 and 3.9/5, respectively. The GP-led follow-up of PCa and RCC survivors within a nurse-led network seems to provide safe continuity of follow-up and seems not to be associated with major incremental costs. The surveys indicated high level of patient's satisfaction and encouraging results regarding GP's satisfaction. Randomized clinical trials are needed to confirm these findings and promote larger implementation of this type of follow-up care.

Real-world cost-effectiveness analysis of NOACs versus VKA for stroke prevention in Spain.

AimsA Markov model was adapted to assess the real-world cost-effectiveness of rivaroxaban, dabigatran and apixaban. Each of these non-vitamin K antagonist oral anticoagulants was compared with vitamin K antagonist for stroke prevention in patients with non-valvular atrial fibrillation in Spain.MethodsAll inputs were derived from real-world studies: baseline patient characteristics, clinical event rates, as well as persistence rates for the vitamin K antagonist treatment option. A meta-analysis of real-world studies provided treatment effect and persistence data for rivaroxaban, dabigatran and apixaban, each compared with vitamin K antagonist therapy. The model considered 3-month cycles over a lifetime horizon. The model outcomes included different costs, quality-adjusted life years and life-years gained. Sensitivity analyses were performed to test the robustness of the model.ResultsWhen compared with vitamin K antagonist, rivaroxaban incurred incremental costs of €77 and resulted in incremental quality-adjusted life years of 0.08. The incremental cost per quality-adjusted life year was €952. For the same comparison, the incremental cost per quality-adjusted life year for dabigatran was €4,612. Finally, compared with vitamin K antagonist, the incremental cost per quality-adjusted life year for apixaban was €32,015. The sensitivity analyses confirmed the robustness of the base case results. The probabilities to be cost-effective versus vitamin K antagonist were 94%, 86% and 35%, respectively, for rivaroxaban, dabigatran and apixaban, considering a willingness-to-pay threshold of €22,000 per quality-adjusted life year gained, based on a cost-effectiveness study of the Spanish National Health System.ConclusionThese results suggest that rivaroxaban and dabigatran are cost-effective versus vitamin K antagonist for stroke prevention in non-valvular atrial fibrillation, from the Spanish National Health System perspective.

Cost-Effectiveness Analysis of Fracture Liaison Services Compared with Standard of Care in the Secondary Prevention of Fragility Fractures in Spain.

PurposeTo assess the cost-effectiveness of a Fracture Liaison Service (FLS) compared with standard care for the secondary prevention of fragility fractures in Spain.MethodsPatients with osteoporosis and an initial fragility fracture who were candidates to initiate osteoporosis treatment (mean age 65 years, 90.7% female) were included in the model. Disease progression was simulated with a Markov model through seven health states (with and without osteoporosis treatment, subsequent hip, vertebral, forearm and humerus fracture, and death). A time horizon of 10 years and a 6-month duration per cycle was set. Clinical, economic, and quality of life parameters were estimated from the literature and Spanish clinical practice. Resource use and treatment patterns were validated by an expert panel. The Spanish National Health System (SNS) perspective was adopted, taking direct costs (€; 2020) into account. Effectiveness was measured in life-years gained (LYG) and quality-adjusted life years gained (QALYs). A discount rate of 3% was applied to costs and outcomes. The uncertainty of the parameters was assessed using deterministic, scenario and probabilistic sensitivity analyses (1000 iterations).ResultsSetting up a FLS for the secondary prevention of fragility fractures in Spain would provide better osteoporosis treatment initiation and persistence. This would reduce subsequent fragility fractures, disutilities and deaths. FLS would have greater clinical benefits (0.008 and 0.082 LYG and QALY gained per patient, respectively) and higher costs (€563.69 per patient) compared with standard care, leading to an incremental cost-utility ratio of €6855.23 per QALY gained over the 10 years horizon. The sensitivity analyses showed limited dispersion of the base case results, corroborating their robustness.ConclusionFrom the SNS perspective and considering Spanish willingness-to-pay thresholds, the introduction of FLS for the secondary prevention of fragility fractures would be a cost-effective strategy.

Cost-effectiveness analysis of dapagliflozin for the treatment of type 2 diabetes mellitus in Spain: results of the DECLARE-TIMI 58 study

BackgroundThe objective of this study was to carry out a cost-effectiveness analysis of dapagliflozin, as an add-on therapy to standard of care (SoC), for the treatment of type 2 diabetes mellitus (T2DM) in Spain, based on the results of the DECLARE-TIMI 58 trial.MethodsA discrete event simulation model (Cardiff T2DM) based on the data observed in the DECLARE-TIMI 58 trial was adapted to the Spanish setting to estimate the costs and health outcomes of treatment with dapagliflozin in patients with T2DM who had or were at risk of atherosclerotic cardiovascular disease. Macrovascular events (hospitalization for heart failure, myocardial infarction, stroke, and unstable angina), end-stage renal disease and cardiovascular and non-cardiovascular mortality were modeled according to the survival equations of the DECLARE-TIMI 58 study. Microvascular events (blindness and ulcers) were estimated based on the risk equations of the UK Prospective Diabetes Study. The analysis was conducted from the Spanish National Health System perspective and the time horizon was 30 years. The results were evaluated in terms of cost per quality-adjusted life year (QALY) gained. Only direct health costs were included, and a 3% discount rate was applied to costs and health outcomes. Univariate and probabilistic sensitivity analyses (PSA) were made to assess the robustness of the results.ResultsIn the main analysis, dapagliflozin was a dominant therapeutic option compared with placebo, with greater effectiveness (0.08 QALYs) and lower associated total costs per patient (€ -2,921). The univariate sensitivity analysis and the PSA confirmed the robustness of the results. The PSA showed the probability that dapagliflozin was a dominant alternative compared with placebo was 84.2% and that it was cost-effective of 92.1%, under a willingness-to-pay of € 20,000/QALY gained. ConclusionsThe analysis of data from the DECLARE-TIMI 58 trial shows that dapagliflozin would be a cost-effective option in Spain for the treatment of adult patients with T2DM, as an add-on therapy to SoC, compared with placebo.

Cost-Effectiveness Analysis of Axicabtagene Ciloleucel vs. Tisagenlecleucel for the Management of Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Spain.

Simple SummaryCAR T therapies axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) have been approved in Spain for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), given their favourable outcomes for overall survival and progression-free survival. However, the cost of these treatments must be weighed within the context of the Spanish health system. In this study, we assessed the cost-effectiveness and cost-utility of axi-cel vs. tisa-cel from the Spanish National Health System perspective. Using commonly applied willingness-to-pay thresholds in Spain, our analysis shows that axi-cel is highly cost-effective when compared to tisa-cel in R/R DLBCL. These results could be used to support decision-making criteria for axi-cel financing.The study aimed to assess the cost-effectiveness of axicabtagene ciloleucel (axi-cel) vs. tisagenlecleucel (tisa-cel) for the treatment of relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after ≥2 lines of systemic therapy in Spain. A lifetime partitioned survival mixture cure model, which comprises pre-progression, post-progression, and death health states, was used to estimate the accumulated costs and outcomes in terms of life years gained (LYG) and quality-adjusted life years (QALY). A matching-adjusted indirect comparison was used to reweight patient-level data from ZUMA-1, the pivotal clinical trial for axi-cel, to aggregate-level data from the pivotal tisa-cel trial, JULIET. The analysis was performed from the National Health System perspective, thus only direct costs were included. Sensitivity analyses (SA) were performed. Axi-cel yielded 2.74 incremental LYG and 2.31 additional QALY gained per patient compared to tisa-cel. Total incremental lifetime costs for axi-cel versus tisa-cel were €30,135/patient. The incremental cost-effectiveness ratio of axi-cel versus tisa-cel resulted in €10,999/LYG and the incremental cost-utility ratio in €13,049/QALY gained. SA proved robustness of the results. Considering the frequently assumed willingness-to-pay thresholds in Spain (€22,000/QALY and €60,000/QALY), axi-cel is a cost-effective treatment vs. tisa-cel for adult patients with R/R DLBCL in Spain.

POSC392 Economic Impact of Multiple Sclerosis from Hospital and Social Security System Perspective in Italy

Multiple Sclerosis (MS) is a disease of the brain and spinal cord associating with a high economic burden. The objective of this study was to estimate the socio-economic burden of MS in Italy from National Health System (NHS) and Social Security System perspective.

Budget Impact Analysis of Hypertonic Saline Inhalations for Infant Bronchiolitis: The Colombian National Health System Perspective

ObjectivesNebulized 3% hypertonic solution (HS) is associated with lower total cost and higher quality-adjusted life-years. Nevertheless, the expected budget impact of this drug had not been explicitly estimated. The aim of this study was to evaluate the budget impact of 3% HS in the treatment of acute bronchiolitis in Colombia. MethodsA budget impact analysis was performed to evaluate the potential financial impact of the use of 3% HS. The analysis considered a 4-year time horizon and a Colombian national health system perspective. The incremental budget impact was calculated by subtracting the cost of the new treatment, in which 3 % HS (added to humidified oxygen) was reimbursed, from the cost of the conventional treatment without 3 % HS (only humidified oxygen or adrenaline nebulization). Univariate 1-way sensitivity analyses were performed. ResultsIn the base-case analysis, the 4-year costs associated with HS and non-3% HS were estimated to be $47 792 230 and $53 312 832, respectively, indicating savings for Colombian national health system equal to $5 520 602 if HS is adopted for the routine management of patients with acute bronchiolitis. This result was robust in univariate 1-way sensitivity analysis. ConclusionHS was cost saving in emergency settings for treating infants with acute bronchiolitis. This evidence can be used by decision makers in Colombia to improve clinical practice guidelines and should be replicated to validate their results in other middle-income countries.

Cost-effectiveness analysis of Vaborem in Carbapenem-resistant Enterobacterales (CRE) -Klebsiella pneumoniae infections in Italy

BackgroundVaborem is a fixed dose combination of vaborbactam and meropenem with potent activity against target Carbapenem-resistant Enterobacterales (CRE) pathogens, optimally developed for Klebsiella pneumoniae carbapenemase (KPC). The study aims to evaluate the cost-effectiveness of Vaborem versus best available therapy (BAT) for the treatment of patients with CRE-KPC associated infections in the Italian setting.MethodsA cost-effectiveness analysis was conducted based on a decision tree model that simulates the clinical pathway followed by physicians treating patients with a confirmed CRE-KPC infection in a 5-year time horizon. The Italian National Health System perspective was adopted with a 3% discount rate. The clinical inputs were mostly sourced from the phase 3, randomised, clinical trial (TANGO II). Unit costs were retrieved from the Italian official drug pricing list and legislation, while patient resource use was validated by a national expert. Model outcomes included life years (LYs) and quality adjusted life years (QALYs) gained, incremental costs, incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR). Deterministic and probabilistic sensitivity analyses were also performed.ResultsVaborem is expected to decrease the burden associated with treatment failure and reduce the need for chronic renal replacement therapy while costs related to drug acquisition and long-term care (due to higher survival) may increase. Treatment with Vaborem versus BAT leads to a gain of 0.475 LYs, 0.384 QALYs, and incremental costs of €3549, resulting in an ICER and ICUR of €7473/LY and €9246/QALY, respectively. Sensitivity analyses proved the robustness of the model and also revealed that the probability of Vaborem being cost-effective reaches 90% when willingness to pay is €15,850/QALY.ConclusionsIn the Italian setting, the introduction of Vaborem will lead to a substantial increase in the quality of life together with a minimal cost impact, therefore Vaborem is expected to be a cost-effective strategy compared to BAT.

A cost-consequence analysis of the preferential use of secukinumab versus adalimumab for the treatment of psoriatic arthritis

ObjectivesTo assess the efficiency of secukinumab compared to adalimumab as first biologic treatment for psoriatic arthritis (PsA) from the Spanish National Health System (SNHS) perspective. MethodsA cost-consequence analysis of the cost and clinical response of two treatment strategies was conducted over a 2-year time horizon. A hypothetical cohort of 10 patients with PsA initiated treatment with secukinumab 150mg (cohort A) or adalimumab 40mg (cohort B), respectively. Patients achieving clinical response (ACR20/50/70) at week 24 continued the initial treatment, while patients with inadequate response switched to secukinumab 300mg. Pharmacological costs were calculated based on SmPC (notified ex-factory price). The lowest cost of adalimumab biosimilar was considered. Data on clinical response were extracted from the two matching-adjusted indirect comparison (MAIC) published comparing secukinumab vs adalimumab. Results were expressed as the cost difference between the two cohorts (€, 2019) and were calculated for each clinical response criteria (ACR20/50/70) and for each MAIC. Sensitivity analysis assessed the impact of potential discounts on the cost of adalimumab while maintaining the cost of secukinumab unchanged. ResultsDepending on the MAIC used, the cost of initiating biologic treatment for PsA with secukinumab 150mg was 18–33% lower than the one estimated for adalimumab 40mg, for ACR20, 18–28% for ACR50, and 16–23% for ACR70 response rate. Sensitivity analysis showed that it would be necessary a discount of 40–60%, 40–65% and 50–75% over the adalimumab cost to compensate for the differences in efficacy observed for ACR20/50/70, respectively, depending on the MAIC used. ConclusionIn patients with PsA, secukinumab could be considered a more efficient first-line biologic treatment compared to adalimumab, from the SNHS perspective.

A real-world economic analysis of biologic therapies for moderate-to-severe plaque psoriasis in Italy: results of the CANOVA observational longitudinal study

BackgroundPsoriasis is a chronic immune-mediated inflammatory skin disease which can also involve joints. It is often associated with burdensome comorbidities which negatively impact prognosis and quality of life (QoL). Biologic agents have been shown to be effective in controlling disease progression, but their use is associated with higher costs compared with traditional systemic treatments. The economic analysis of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: an obserVAtional longitudinal study of real-life clinical practice) study aims to assess the costs and cost-effectiveness of biologics in a real-world context in Italy.MethodsThe annualised overall direct costs of moderate-to-severe plaque psoriasis management, the annualised cost of biologic drugs and the cost per responder in the Italian National Health System perspective were assessed. More specifically, the cost per response and cost per sustained response of the most prescribed biologic therapies for the treatment of moderate-to-severe plaque psoriasis within the CANOVA study were assessed using the Psoriasis Area Severity Index (PASI) at several score levels (75, 90 and 100%).ResultsThe most frequently used biologic therapies for plaque psoriasis were secukinumab, ustekinumab, adalimumab originator, and ixekizumab. Cost of biologics was the driver of expenditure, accounting for about 98% of total costs. Adalimumab originator was the biologic with the lowest cost per responder ratio (range: €7848 - €31,378), followed by secukinumab (range: €9015 - €33,419). Ustekinumab (range: €11,689 – €39,280) and ixekizumab (range: €11,092 – €34,289) ranked respectively third and fourth, in terms of cost-effectiveness ratio. As concerns the cost per sustained response analysis, secukinumab showed the lowest value observed (€21,375) over the other options, because of its high response rate (86% vs. 60–80%), which was achieved early in time.ConclusionBiologic therapy is a valuable asset for the treatment of moderate-to-severe plaque psoriasis. Concomitant assessment of treatment costs against the expected therapeutic response over time can provide physicians and payers additional insights which can complement the traditional risk-benefit profile assessment and drive treatment decisions.

Health and economic impact of the correct diagnosis of transthyretin cardiac amyloidosis in Spain

Objective: To estimate the health and economic impact of the reduction in mortality and cardiovascular hospitalisations, associated with correct diagnosis of cardiac transthyretin amyloidosis (ATTR-CM), from the Spanish National Health System (NHS) perspective. Methods: A costs and effects analysis were performed (probabilistic Markov model) with time horizons between 1 and 15 years, comparing the correct diagnosis of ATTR-CM versus the non-diagnosis. Transition probabilities were obtained from the ATTR-ACT study (placebo arm) and from the literature. Costs and healthcare resources were obtained from Spanish sources (€ 2019) and from a panel of Spanish clinical experts. Results: After 1, 5, 10 and 15 years, the diagnosis of ATTR-CM would generate a gain of 0.031 (95%CI 0.025; 0.038); 0.387 (95%CI 0.329; 0.435); 0.754 (95%CI 0.678; 0.781) and 0.944 (95%CI 0.905; 0.983) life years per patient, respectively, with savings of € 212 (95%CI € -632; 633), € 2,289 (95%CI € 2,250; 2,517), € 2,859 (95%CI € 2,584; 3,149) and € 2,906 (95%CI € 2,669; 3,450) per patient, respectively, versus the non-diagnosis. Conclusions: Just by correctly diagnosing ATTR-CM, years of life would be gained, cardiovascular hospitalisations would be avoided, and savings would be generated for the NHS, compared to the non-diagnosis of the disease.

Brentuximab vedotin in adult patients with HL CD30+ at high risk of relapse or progression following ASCT: a cost-analysis in Italy

Abstract&#x0D; Introduction: In Hodgkin Lymphoma (HL), the early administration of brentuximab vedotin (BV) represents a highly effective treatment to consolidate patients after autologous stem cell transplantation (ASCT). For this indication, the Summary of Product Characteristics (SPC) reports a lower medical resource utilization in BV vs. placebo. This study aimed at assessing costs accrued by using BV in consolidation after ASCT and compare them with the resource consumption associated with the main options today used in Italy for HL.&#x0D; Methods and results: A cost-analysis based on patients at high risk of relapse (HL CD30+-HR) after ASCT was developed by collecting data about health care consumption (drugs and monitoring). The model is described by two arms, "A," where BV is used as consolidation therapy after ASCT, and "B", where patients are treated only at the time of relapse. A 3-year time horizon and the Italian National Health System perspective were adopted. All data inputs for the analysis were sourced from the available literature and official list prices. The simulation was integrated by sensitivity analysis. The introduction of BV as consolidation therapy would allow savings in terms of drug acquisition and resource consumption. Over a 3-year time frame, the Consolidation arm’s overall expenditure was 137,059€ vs. 225,418€ in the Non-consolidation arm. Early after the ASCT, BV administration guarantees a long period free from relapses (5-year PFS is not reached), thus reducing the clinical and economic burden of the subsequent therapies needed to treat further relapses.&#x0D; Conclusions: The present pharmacoeconomic analysis shows that the introduction of BV as consolidation therapy after ASCT represents a sustainable expenditure for the National Healthcare System (NHS) and a cost-saving paradigm when compared with the drug mainly used for treating the relapses.

Clinical and economic benefit of 32 years of antiretroviral treatment for people living with HIV in Spain: Has it been an efficient intervention?

IntroductionAlthough antiretroviral therapy (ART) for HIV/AIDS was introduced in 1987, improvement in disease progression and reduction in mortality at a population level was not observed until 1996, with the combination of three or more drugs. The objective was to estimate the clinical and economic benefit of ART in Spain in the 32-year period between 1987 and 2018. MethodsA cost-benefit analysis was performed, using a second-order Monte Carlo simulation, from the societal (base case) and the National Health System (NHS) perspectives. New cases of HIV, AIDS and related deaths were obtained from the SINIVIH and UNAIDS registries, with population projections without ART using triple exponential smoothing. Expenditure on ART was obtained from the National AIDS Plan reports and market studies. ResultsThe NHS invested 6185 million euros in 32 years. In that period, 323,651 AIDS-related deaths, 500,129 AIDS cases and 161,417 HIV cases were averted, with total savings of 41,997 million euros. The net benefit (net savings) is estimated at 35,812 million euros (societal) and 1032 million euros (NHS). For every euro invested in ART, a return on investment of € 6.79 and € 1.16 was obtained, respectively. ConclusionsThe use of ART over 32 years prevented a large number of deaths and cases of AIDS and HIV, providing significant economic savings for the NHS. ART is an efficient intervention for the NHS.

Beneficio clínico y económico de 32 años de tratamiento antirretroviral de personas que viven con VIH en España: ¿ha sido una intervención eficiente?

Although antiretroviral therapy (ART) for HIV / AIDS was introduced in 1987, improvement in disease progression and reduction in mortality at a population level was not observed until 1996, with the combination of three or more drugs. The objective was to estimate the clinical and economic benefit of ART in Spain in the 32-year period between 1987 and 2018. A cost-benefit analysis was performed, using a second-order Monte Carlo simulation, from the societal (base case) and the National Health System (NHS) perspectives. New cases of HIV, AIDS and related deaths were obtained from the SINIVIH and UNAIDS registries, with population projections without ART using triple exponential smoothing. Expenditure on ART was obtained from the National AIDS Plan reports and market studies. The NHS invested 6,185 million euros in 32 years. In that period, 323,651 AIDS-related deaths, 500,129 AIDS cases and 161,417 HIV cases were averted, with total savings of 41,997 million euros. The net benefit (net savings) is estimated at 35,812 million euros (societal) and 1,032 million euros (NHS). For every euro invested in ART, a return on investment of € 6.79 and € 1.16 was obtained, respectively. The use of ART over 32 years prevented a large number of deaths and cases of AIDS and HIV, providing significant economic savings for the NHS. ART is an efficient intervention for the NHS.