National Health System Perspective Research Articles

Evaluation of the clinical and economic value of sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic hepatitis C in Spain during the last 5 years

ObjectiveDirect-acting antivirals for the treatment of hepatitis C virus (HCV) represented a paradigm shift. In 2017, sofosbuvir/velpatasvir (SOF/VEL-Epclusa®) was approved, which showed a high cure rate in all patient, contributing to HCV elimination. The analysis aimed to quantify the clinical and economic value of SOF/VEL in HCV chronic patients since its approval in Spain. MethodsAn economic evaluation was elaborated adapting a Markov model that simulated the lifetime disease progression in of all HCV chronic patients treated with SOF/VEL (30,488 patients) since its launch (5-years), compared to previous therapies. Patients entered the model and were distributed between the fibrosis states (F0-to-F4) in treated and untreated. All patients (100%) were treated with SOF/VEL regardless of their fibrosis, and 49% with previous therapies in ≥F2. The average sustained viral response (SVR) rates 98.9% SOF/VEL versus 61.0% previous therapies. All parameters for the analysis were obtained from real-life data and literature. Only direct healthcare costs associated with disease management were included. The SOF/VEL value was measured as the number of hepatic complications avoided and their associated cost, and hepatic mortality compared to previous therapies. National Health System perspective and a 3% discount rate was applied. ResultsSOF/VEL decreased the number of liver complications, avoiding 92% decompensated cirrhosis, 80% hepatocellular carcinomas, and 87% liver transplants, as well as 85% liver-related mortality. Their cost associated was reduced, amounting to savings of 197M€. ConclusionSOF/VEL adds relevant value to the HCV treatment, reducing the clinical and economic disease burden and contributing to HCV elimination in Spain.

Cost-Effectiveness Analysis of Abrocitinib Compared with Other Systemic Treatments for Severe Atopic Dermatitis in Spain.

Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by itchy, painful, and dry skin. Despite the great number of available therapies, economic evaluations are still needed to provide evidence on their cost efficiency. This research aimed to evaluate the cost effectiveness of the Janus kinase (JAK) inhibitor abrocitinib (200mg) compared with dupilumab (300mg), tralokinumab (300mg), baricitinib (2 and 4mg), and upadacitinib (15 and 30mg) for the treatment of patients with severe AD from the Spanish National Health System (NHS) perspective. A hybrid model consisting of a decision tree linked to a Markov model was developed to estimate costs, quality-adjusted life-years (QALYs), total years in response and incremental cost-per-QALY gained (willingness-to-pay [WTP] threshold: €25,000/QALY). Adults with severe AD entered the decision tree and response (75% reduction in baseline Eczema Area and Severity Index score, EASI-75) was considered at 16 and 52 weeks. After this time, patients entered the Markov model (remainder of the 10-year time horizon), which consisted of three health states: maintenance with active therapy, subsequent treatment, or death. All costs were presented in 2022 euros (€). Additionally, cost per number-needed-to-treat (NNT) was calculated for abrocitinib and dupilumab based on a head-to-head post-hoc analysis. Abrocitinib 200mg was dominant (i.e., lower incremental costs and higher incremental benefit) compared with all studied alternatives (dupilumab 300mg, tralokinumab 300mg, baricitinib 2 and 4mg, upadacitinib 15 and 30mg) with a QALYs gain of 0.49, 0.60, 0.64, 0.43, 0.45, and 0.08, respectively, and per-person costs savings of €22,097, €24,140, €14,825, €7,116, €12,805, and €45,189, respectively. Considering the WTP threshold, abrocitinib was dominant or cost effective compared with all alternatives for most simulations. Additionally, abrocitinib was dominant compared with all alternatives when evaluating the cost effectiveness over a 5-year time horizon. NNT showed that abrocitinib was dominant versus dupilumab. The results of the study show that abrocitinib is a cost-effective therapy compared with other JAK inhibitors and biological therapies from the Spanish NHS perspective.

The economic burden of pediatric growth hormone deficiency in Italy: a cost of illness study.

Growth hormone deficiency (GHD) is a rare condition with a worldwide prevalence of 1 patient in 4000 to 10,000 live births, placing a significant economic burden on healthcare systems. The aim of this study is to generate evidence on the economic burden of children and adolescents with GHD treated with rhGH and their parents in Italy. A cost of illness analysis, adopting the prevalence approach, has been developed, producing evidence on the total annual cost sustained by the Italian National Health System (NHS) and by the society. The study is based on original data collected from a survey conducted among Italian children and adolescents with GHD and their parents. 143 children/adolescents with GHD and their parents participated to the survey, conducted from May to October 2021. Patients had a mean age of 12.2 years (SD: 3.1) and were mostly males (68.5%). The average direct healthcare cost sustained by the NHS was € 8,497.2 per patient/year; adding the out-of-pocket expenses (co-payments and expenses for private healthcare service), the total expense was € 8,568.6. The indirect costs, assessed with the human capital approach, were € 847.9 per patient/year. The total of direct and indirect cost is € 9,345.1 from the NHS perspective, and € 9,416.5 from a social perspective. The total cost incurred by the Italian NHS for children with GHD (range: 5,708-8,354) was estimated in € 48.5-71.0 million, corresponding to 0.04-0.06% of the total Italian public health expense in the year 2020. The total annual cost for GHD children is close to € 10,000, and is mainly due to the cost of rhGH treatment. This cost is almost entirely sustained by the NHS, with negligible out-of-pocket expenses. The economic burden on the Italian NHS for the health care of established GHD children is fourfold higher than the prevalence of the disease in the overall Italian population.

Economic evidence supports the cost savings of sputum eosinophil counts to guide the treatment of pediatrics patients with persistent asthma: implications for clinical practice guidelines in middle-income countries

Background Tailoring asthma interventions based on biomarkers could substantially impact the high cost associated with asthma morbidity. For policymakers, the main concern is the economic impact of adopting this technology, especially in developing countries. This study evaluates the budget impact of asthma management using sputum eosinophil counts in Colombia patients between 4 and 18 years of age. Methods A budget impact analysis was performed to evaluate the potential financial impact of sputum eosinophil counts (EO). The study considered a 5-year time horizon and the Colombian National Health System perspective. The incremental budget impact was calculated by subtracting the cost of the new treatment, in which EO is reimbursed, from the cost of the conventional therapy without EO (management based on clinical symptoms (with or without spirometry/peak flow) or asthma guidelines (or both), for asthma-related). Univariate one-way sensitivity analyses were performed. Results In the base-case analysis, the 5-year costs associated with EO and no-EO were estimated to be US$ 532.865.915 and US$ 540.765.560, respectively, indicating savings for Colombian National Health equal to US$ 7.899.645, if EO is adopted for the routine management of patients with persistent asthma. This result was robust in univariate sensitivity one-way analysis. Conclusion EO was cost-saving in guiding the treatment of patients between 4 and 18 years of age with persistent asthma. Decision-makers in our country can use this evidence to improve clinical practice guidelines, and it should be replicated to validate their results in other middle-income countries.

Effectiveness, safety and costs of the FreeStyle Libre glucose monitoring system for children and adolescents with type 1 diabetes in Spain: a prospective, uncontrolled, pre-post study

ObjectivesThis study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain.DesignProspective, multicentre...

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.

Economic evaluation and budgetary burden of mepolizumab in severe refractory eosinophilic asthma

ObjectiveMepolizumab is indicated as an additional treatment of severe refractory eosinophilic asthma. The observed differences in population subgroups according to plasma eosinophil count, the existence of patients with high levels of immunoglobulin E who are candidates of omalizumab and mepolizumab, as well as mepolizumab's economic impact, lead to make efficient economic studies for clinical decision making. The aim was to analyze mepolizumab's cost-efficacy and budget impact. MethodCost comparison and the use of mepolizumab's budgetary impact was performed, from the Spanish National Health System's perspective. Among the assessed alternatives, inhaled systemic corticosteroids, plus long acting beta agonist (β2) and/or oral systemic corticosteroids in patients with non immunoglobulin E-mediated severe allergic asthma, and said treatment along with omalizumab in patients with immunoglobulin E mediated eosinophilic allergic asthma were included. Its efficacy was evaluated through avoided clinically relevant exacerbations. The direct costs associated with exacerbation were assessed. ResultsMepolizumab's long run average incremental cost regarding omalizumab's is 797 euros per patient a year. Considering omalizumab's alternative discounted price, including mepolizumab for patients with immunoglobulin E mediated eosinophilic allergic asthma would increase public spending from 2.3 to 4.6 million euros. Given omalizumab's notified price, the gradual introduction of mepolizumab in the Spanish National Health System would save 3.6 million euros in three years. For non immunoglobulin E-mediated severe asthma patients, the avoided cost/exacerbation by introducing mepolizumab is 15,085 euros, assuming a gradual market penetration of mepolizumab. In patients with ≥ 500 eosinophils/µL, this cost decreases to 7,767 euros per avoided exacerbation with a budgetary impact of 183.2 million euros in three years with a progressive penetration of mepolizumab. ConclusionsThe cost comparison between mepolizumab and omalizumab in immunoglobulin E mediated eosinophilic asthma patients suggests a use of the lower cost drug, promoting price competition. Additionally, prioritizing its use among non immunoglobulin E-mediated severe refractory eosinophilic asthma patients and ≥ 500 eosinophils/µL plasma level patients, would improve its efficiency as well as reducing its budgetary impact.

Analysis of the costs associated with the follow-up of HIV patients discontinuing antiretroviral treatment due to lack of effectiveness or unacceptable toxicity in Spain

ObjectiveTo assess the use of resources and the costs associated with following up patients infected with the human immunodeficiency virus after discontinuation of an antiretroviral treatment and initiation of a new one due to a lack of effectiveness or unacceptable toxicity, as compared to the costs involved in the routine follow-up of patients on antiretroviral treatment, from the Spanish National Health System perspective. MethodThe use of resources (clinical tests, medical visits, and hospital pharmacy visits) associated with following three profiles of patients infected with the human immunodeficiency virus (stable ones, those discontinuing an existing antiretroviral treatment and being switched to a new one due to a lack of effectiveness, and those discontinuing an existing antiretroviral treatment and being switched to a new one due to unacceptable toxicity) was identified, based on clinical practice guidelines and the findings of a multidisciplinary expert panel (n = 5). The experts agreed on the main adverse events leading to discontinuation, classifying them into gastrointestinal, renal, osseous, musculoskeletal, dermatological, hepatic, lipid profile-related, neuropsychiatric and sexual alterations. Unit costs were identified from official healthcare costs databases. The cost (€, 2020) of following up each patient profile was estimated, excluding the cost of the antiretroviral treatment itself, with a time horizon of two years. ResultsThe per-patient cost of following up stable patients over two years was estimated at €4,148 (tests: €2,293; visits: €1,855). Patient follow-up after discontinuation of an existing antiretroviral treatment and initiation of a different one due to a lack of effectiveness was estimated at €5,434 (tests: €2,777; visits: €2,657). The cost of follow-up after discontinuation of an existing regimen and initiation of a new one due to unacceptable toxicity varied according to the adverse event prompting the switch, ranging from €4,690 for lipid profile dysregulation, to €5,304, for musculoskeletal alterations. In this patient profile, the cost of tests ranged from €2,403 to €3,017, and that of visits from €2,287 to €2,842. ConclusionsThe cost associated with following up of patients infected with the human immunodeficiency virus after discontinuation of an existing antiretroviral regimen and initiation of a new one is higher than that of routine follow-up, without taking the cost of drugs into account. The treatment discontinuation rate is a relevant factor when selecting the most appropriate therapy for each patient.

Cabotegravir and Rilpivirine Long-Acting Antiretroviral Therapy Administered Every 2Months is Cost-Effective for the Treatment of HIV-1 in Spain.

Current antiretroviral therapies (ARTs) have improved outcomes for people living with HIV. However, the requirement to adhere to lifelong daily oral dosing may be challenging for some people living with HIV, leading to suboptimal adherence and therefore reduced treatment effectiveness. Treatment with long-acting (LA) ART may improve adherence and health-related quality of life. The objective of this study was to evaluate the cost-effectiveness of cabotegravir + rilpivirine (CAB+RPV) LA administered every 2months (Q2M) compared with current ART administered as daily oral single-tablet regimens (STRs) from a Spanish National Healthcare System perspective. A hybrid decision-tree and Markov state-transition model was used with pooled data from three phaseIII/IIIb trials (FLAIR, ATLAS, and ATLAS-2M) over a lifetime horizon, with health states defined by viral load and CD4+ cell count. Direct costs (in €) were taken from Spanish public sources from 2021 and several deterministic and probabilistic analyses were carried out. An annual 3% discount rate was applied to both costs and utilities. Over the lifetime horizon, CAB+RPV LA Q2M was associated with an additional 0.27 quality-adjusted life years (QALYs) and slightly greater lifetime costs (€4003) versus daily oral ART, leading to an incremental cost-effectiveness ratio of €15,003/QALY, below the commonly accepted €30,000/QALY willingness-to-pay threshold in Spain. All scenario analyses showed consistent results, and the probabilistic sensitivity analysis showed cost-effectiveness compared with daily oral STRs in 62.4% of simulations, being dominant in 0.3%. From the Spanish National Health System perspective, CAB+RPV LA Q2M is a cost-effective alternative compared with the current options of daily oral STR regimens for HIV treatment. ATLAS, NCT02951052; ATLAS-2M, NCT03299049; FLAIR, NCT02938520.

Cost-effectiveness analysis of dyevert™ Power XT in patients with chronic kidney disease undergoing percutaneous coronary intervention procedures in Spain.

To assess the efficiency of Dyevert™ Power XT compared to the standard clinical practice when used for percutaneous coronary interventions (PCI). A Markov model was developed to estimate, over 3-month cycles and a lifetime time horizon, the cumulative costs and health outcomes (life years gained [LYG] and quality-adjusted life years [QALY]) in a hypothetical cohort of 1,000 patients with chronic kidney disease (CKD) 3b-4 and an average age of 72 years.The incidence of contrast-induced acute kidney injury for these patients is 18.89% in routine practice and 7.78% with Dyevert. QALYs were estimated by applying utilities by health state. Transitions between states and utilities were obtained from the literature. Overall all-cause and state-specific mortality were considered. The total cost (€2,022) estimated with the National Health System perspective included cost of the procedure and of CKD management. The parameters were validated by a panel of experts. A discount rate (3% per year) was applied to costs and outcomes. The use of Dyevert yielded more health benefits (34.60 LYG and 5.69 QALYs) compared to the current standard practice (33.11 LYG and 5.38 QALYs). Lifetime cost accumulated at the end of the simulation resulted €30,211/patient with Dyevert and €33,895/patient with current standard clinical practice. The use of Dyevert™ Power XT resulted dominant option, due to its higher effectiveness and lower cost as compared to standard clinical practice and, therefore, a preferred option in patients with CKD stages 3b-4 undergoing PCI in Spain.

Cost savings and clinical outcomes in cancer patients enrolled in clinical trials from a national public health system perspective.

e18813 Background: Clinical research has led to great advances that have an impact on improving the survival and quality of life of cancer patients and should be part of the standard of care. However, there is no clear evidence on whether participation in clinical trials (CTs) is cost-efficient for the national health system. For this reason, in the present study I have tried to analyse the direct impact of participation in CTs in terms of improvement in clinical results and costs. Particularly, I have looked into CT subjects diagnosed with metastatic renal cell carcinoma (mRCC) or G1-G2 metastatic neuroendocrine tumors (mNET). In addition, the potential influence of different prognostic and demographic factors on these variables has also been evaluated. Methods: Retrospectively, clinical data of the patients related to their baseline characteristics and the efficacy of the different lines of treatment they had received for their tumor were collected, as well as the direct healthcare costs derived from the clinical approach of all patients diagnosed with mRCC or mNET and clinically followed by the Ramón y Cajal University Hospital Medical Oncology Service, in Madrid, Spain, between January 2010 and February 2017. Subsequently, a comparative statistical analysis was performed of the results obtained in patients included in a clinical trial versus those who never participated in one but instead received therapy according to the standard of care (SOC). Results: Of the 104 patients (65 mRCC and 39 mNET) who were eventually included, 39 participated in a clinical trial. Overall, the 39 CT patients presented a higher overall survival (OS) than SOC patients (52 vs. 15 months. HR: 0.41; 95% CI: [0.23; 0.71]; p < 0.01), a finding that carried through in all subgroups, including age, sex and prognostic factors. Regarding healthcare costs, patients who participated in CT yielded a mean annual savings of €46,109.56 per patient (p < 0.01) compared to patients treated according to SOC, mainly due to pharmacological savings (€27,406.42). Furthermore, the savings were generalized in all subgroups regardless of age, sex and prognostic factors. Additionally, CT patients required 75.81% fewer hospitalisations (p < 0.01) with a lower associated mean cost (p = 0.02), and the mean annual cost corresponding to the use of the Emergency Service was lower (p < 0.01). Finally, the unadjusted incremental cost-effectiveness ratio (ICER) was -€14,970.64 per year of life gained (YLG) and the adjusted ICER was -€42,656.11 per life saved. Conclusions: From the national health system perspective, the participation of patients in CTs is related to an improvement in OS and savings in clinical costs in patients diagnosed with mRCC and mNET. In short, the participation of cancer patients in CTs represents a cost-efficient therapeutic option.

Insertable cardiac monitors in high-risk post-infarction patients: a cost-effectiveness analysis

Abstract Funding Acknowledgements Type of funding sources: None. Background The randomised SMART-MI trial demonstrated that telemonitoring with insertable cardiac monitors (ICMs) for post-acute myocardial infarction patients with cardiac autonomic dysfunction and a left ventricular ejection fraction between 35-50% is highly effective in detecting serious arrhythmic events (SAE) compared to standard of care (SoC). In SMART-MI, SAE were also predictive of subsequent major adverse cardiac and cerebrovascular events (MACCE) which might be prevented by preemptive interventions. It is unknown whether such a monitoring strategy would be cost-effective. Purpose To evaluate the cost-effectiveness of ICM-based telemonitoring compared to SoC among a UK post-acute myocardial infarction population. Methods We created a Markov model to conduct a cost-effectiveness analysis comparing ICMs to SoC for the SMART-MI population. For the analyses, we hypothesized that the SAE-triggered interventions could prevent clinical complications with certain probabilities. A UK National Health System (NHS) perspective was employed with costs and health-related benefits discounted at 3.5%. We employed 6-months Markov cycles and calculated the model over a lifetime horizon. Patient characteristics and detection probabilities were based on the SMART-MI diagnostic study. UK-specific costs and risk-adjusted parameters were used to model the cardiovascular and cerebrovascular pathways. Scenario, deterministic and probabilistic sensitivity analyses were conducted to control for uncertainty. Results The base-case scenario found an incremental cost-effectiveness ratio (ICER) of the ICM to be £7,812.92 per QALY gained compared to SoC. There were 0.0646 less ischaemic strokes events per patient and 0.0168 less syncope events per patient in the ICM arm compared to SoC. Results were robust to sensitivity analysis. Conclusion Under the assumptions of the study, ICMs were a cost-effective diagnostic tool for detecting arrhythmias compared to SoC, preventing stroke and syncope events in post-acute myocardial infarction patients in the UK.

A Cross-Indication Budget Impact Model of Secukinumab for the Treatment of Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis in Italy.

Recent developments improved outcomes in patients with autoimmune diseases. Biologics were approved as first-line treatment in selected naïve patients with plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Among them, secukinumab was most recently approved for treatment of active nr-axSpA in adults. In this work, we assessed the budget impact of new secukinumab treatment options in the Italian market. A cross-indication budget impact model was designed to estimate the effects of adding secukinumab in the Italian market from the National Health System perspective over a 3-year period. The model included all adults with PsO, PsA, AS and nr-axSpA, treated with biologics or biosimilars. It compared costs between two scenarios, secukinumab availability or absence, for the four diseases combined and taken individually. A sensitivity analyses was conducted. There were 68,121 adult patients treated with biologics in 2021 and 68,341 in 2023. The budget impact analysis (BIA) on all indications showed a cost reduction of €33.7million (-1.5%) over 3 years with the introduction of secukinumab. PsA patients had the highest saving (-€34.9million), followed by PsO patients (-€7.8million). Cost saving in PsO patients was balanced by increased budget reported in AS patients (+€8.0million). In nr-axSpA patients, secukinumab reported no significant budget increase (+1.0%). This BIA accounted for the new indication of secukinumab in nr-axSpA patients, reporting no significant changes in the required budget and adding an effective treatment option. Considering all indications, secukinumab is a sustainable treatment option.

The Value of Tucatinib in Metastatic HER2-Positive Breast Cancer Patients: An Italian Cost-Effectiveness Analysis

This study was aimed at estimating the appropriate price of tucatinib plus trastuzumab and capecitabine (TXC), as third-line treatment, in HER2+ breast cancer (BC) patients from the Italian National Health System (NHS) perspective. A partitioned survival model with three mutually exclusive health states (i.e., progression-free survival (PFS), progressive disease (PD), and death) was used to estimate the price of tucatinib vs trastuzumab emtansine (TDM-1), considering a willingness to pay (WTP) of 60,000 EUR. Data from the HER2CLIMB trial, the Italian population, and the literature were used as input. The model also estimated the total costs and the life-years (LY) of TXC and TDM1. Deterministic and probabilistic (PSA) sensitivity analyses were conducted to evaluate the robustness of the model. In the base case scenario, the appropriate price of tucatinib was 4828.44 EUR per cycle. The TXC resulted in +0.28 LYs and +16,628 EUR compared with TDM-1. Results were mainly sensitive to therapy intensity variation. In PSA analysis, TXC resulted cost-effective in 53% of the simulations. Assuming a WTP ranging 20,000-80,000 EUR, the tucatinib price ranged from 4090.60 to 5197.41 EUR. This study estimated the appropriate price for tucatinib according to different WTP in order to help healthcare decision makers to better understand the treatment value.

Coste-efectividad de la vacunación universal infantil frente a la hepatitis A en España: un enfoque dinámico

ObjectiveTo evaluate the cost-effectiveness of infant universal vaccination against hepatitis A in Spain. MethodUsing a dynamic model and decision tree model, a cost-effectiveness analysis was performed to compare three vaccination strategies against hepatitis A: non-vaccination strategy versus universal childhood vaccination of hepatitis A with one or two doses. The perspective of the study was that of the National Health System (NHS) and a lifetime horizon was considered. Both costs and effects were discounted at 3% per year. Health outcomes were measured in terms of quality adjusted life years (QALY) and the cost-effectiveness measure used was the incremental cost-effectiveness ratio (ICER). In addition, deterministic sensitivity analysis by scenarios was performed. ResultsIn the particular case of Spain, with low endemicity for hepatitis A, the difference in health outcomes between vaccination strategies (with 1 or 2 doses) and non-vaccination are practically non-existent, terms of QALY. In addition, the ICER obtained is high, exceeding the limits of willingness to pay from Spain (€22,000–25,000/QALY). The deterministic sensitivity analysis showed that the results are sensitive to the variations of the key parameters, although in no case the vaccination strategies are cost-effective. ConclusionsUniversal infant vaccination strategy against hepatitis A would not be a cost-effective option from the NHS perspective in Spain.

PP33 Molecular Markers For The Detection Of Clinically Significant Prostate Cancer

IntroductionIt is estimated that approximately 1.1 million cases of prostate cancer (PCa) are diagnosed in the world every year. In general, PCa is a slow-onset cancer and less than 10 percent of cases are detected in the metastatic phase. In order to identify patients at risk of suffering from clinically significant prostate cancer (csPCa), as well as to avoid unnecessary biopsies, overdiagnosis and overtreatment, a variety of molecular biomarker detection tests have been developed.MethodsWe undertook a systematic review with meta-analyses on the effectiveness of diagnostic tests based on biomarkers in blood or urine samples for the identification of men at risk of csPCa. A cost-effectiveness analysis was conducted using a decision tree model for the short term and a Markov model for the long term, both from the social and the National Health System perspectives. The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis.ResultsSixty-five studies were included with a total of 34,287 participants. The diagnostic tests analyzed were: PHI, Progensa® PCA3, SelectMDx, MyProstateScore, 4Kscore®, TMPRSS2: ERG, Stockholm3, ExoDx Prostate IntelliScore and Proclarix®. All studies included biopsy as comparator. The sensitivity and specificity of diagnostic tests depended on the test itself and the threshold chosen, and ranged from 42 percent to 99 percent and from 13 percent to 87 percent, respectively. In the cost-effectiveness analysis, the alternative that includes the biomarker, specifically the SelectMDx, led to higher QALYs and healthcare costs with an estimated incremental cost-effectiveness ratio (ICER) of 6,640.21 EUR per QALY. The sensitivity analyses confirmed that the results were robust.ConclusionsBiomarker testing to select men at risk of csPCa who should undergo prostate biopsy can be a cost-effective strategy depending on its cost per determination and its sensitivity/specificity. The analyses carried out indicate that the SelectMDx biomarker is cost-effective at a cost of EUR 375 per determination.

EE509 Burden of Disease in Low-Risk Myelodysplastic Syndromes in Spain

Myelodysplastic syndromes (MDS) are a group of hematological malignancies characterized by cytopenias and an increased risk of progression to acute myeloid leukemia (AML). Red blood cell transfusions constitute the main supportive care for patients with MDS after failure of Erythropoiesis-stimulating agents. The aim was to assess the disease burden in low-risk MDS (LR-MDS) patients from the Spanish National Health System (NHS) perspective.

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.