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OBJECTIVES: This study estimated the cost of prophylaxis with activated prothrombin complex concentrate (aPCC) and recombinant activated factor VIIa (rFVIIa) in surgical patients with haemophilia A and inhibitors in Spain. METHODS: A decision-analytic model was developed to estimate the cost to the Spanish National Health System of providing haemostatic coverage in this haemophilia population, with age distribution and average weight derived from the literature, and the annual number of surgeries (0.33 per patient) from local data. Drug costs were calculated from official ex-factory prices with a 7.5% mandatory deduction and recommended dosing regimens. RESULTS: The estimated average costs per patient were 10 100.73 (aPCC) and 14 265.89 (rFVIIa) for dental extraction, 24 043.88 (aPCC) and 62 301.08 (rFVIIa) for minor surgery and 126 595.81 (aPCC) and 347 731.09 (rFVIIa) for major surgery. Assuming an estimated 23 annual surgeries in this population (N = 69), distributed as 19% dental extraction, 50% minor surgery and 31% major surgery, the total annual cost of prophylaxis was 1 209 682.35 with aPCC and 3 221 929.28 with rFVIIa. CONCLUSIONS: aPCC costs were 62.5% lower than rFVIIa. Assuming potential clinical equivalence, aPCC is a potentially cost-saving option for surgical patients with haemophilia A and inhibitors.
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Inibidores dos Fatores de Coagulação Sanguínea/sangue , Custos de Medicamentos , Fator VIIa/administração & dosagem , Hemofilia A/complicações , Hemorragia/etiologia , Hemorragia/prevenção & controle , Isoanticorpos/sangue , Tomada de Decisão Clínica , Análise Custo-Benefício , Gerenciamento Clínico , Fator VIIa/imunologia , Pesquisas sobre Atenção à Saúde , Hemofilia A/tratamento farmacológico , Hemofilia A/epidemiologia , Hemofilia A/cirurgia , Hemorragia/epidemiologia , Humanos , Isoanticorpos/imunologia , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/imunologia , Espanha/epidemiologia , Procedimentos Cirúrgicos Operatórios/efeitos adversosRESUMO
INTRODUCTION: Chronic hepatitis B (CHB) is associated with high burden and healthcare costs. Virologic response achieved with antivirals is associated with progression avoidance. This study aimed to estimate the efficiency and clinical impact of antiviral strategies in CHB patients. MATERIAL AND METHODS: A Markov model estimated lifetime complications and direct costs in both, HBeAg-positive and HBeAg-negative cohorts. Strategy 1 (71% of treated population) and strategy 2 (100%), both based on pegylated interferon (peg-IFN) followed by oral tenofovir or entecavir, were compared to no treatment. Progression was based on HBV-DNA levels. Rescue therapy with oral antivirals was applied for peg-IFN failure. Disease costs (C, 2014) and utilities were obtained from literature. RESULTS: Compared to natural history, strategy 1 increased QALY (3.98 in HBeAg-positive, 2.16 in -negative cohort). With strategy 2, survival was up to 5.60 (HBeAg-positive) and 3.05 QALY (in HBeAg-negative). The model predicted avoidance of 128 and 86 carcinomas in HBeAg-positive and -negative patients with strategy 1, and up to 181 and 121 in HBeAg-positive and -negative for strategy 2. Total cost increased up to C102,841 (strategy 1) and C105,408 (strategy 2) in HBeAg-positive, and C85,858 and C93,754 in HBeAg-negative. A C1,581/QALY gained ratio was estimated versus the natural history for both strategies. In conclusion, increasing antiviral coverage would be efficient, reducing complications.
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Antivirais/economia , Antivirais/uso terapêutico , Custos de Medicamentos , Antígenos E da Hepatite B/sangue , Vírus da Hepatite B/efeitos dos fármacos , Hepatite B Crônica/tratamento farmacológico , Hepatite B Crônica/economia , Antivirais/efeitos adversos , Biomarcadores/sangue , Simulação por Computador , Análise Custo-Benefício , DNA Viral/sangue , Progressão da Doença , Farmacorresistência Viral , Substituição de Medicamentos/economia , Quimioterapia Combinada , Guanina/análogos & derivados , Guanina/economia , Guanina/uso terapêutico , Vírus da Hepatite B/genética , Vírus da Hepatite B/imunologia , Hepatite B Crônica/sangue , Hepatite B Crônica/virologia , Humanos , Interferon-alfa/economia , Interferon-alfa/uso terapêutico , Cadeias de Markov , Modelos Econômicos , Polietilenoglicóis/economia , Polietilenoglicóis/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida , Proteínas Recombinantes/economia , Proteínas Recombinantes/uso terapêutico , Tenofovir/economia , Tenofovir/uso terapêutico , Fatores de Tempo , Resultado do Tratamento , Carga ViralRESUMO
INTRODUCTION: The effectiveness of a screening strategy for the detection of a hepatitis B virus (HBV) infection followed by prophylaxis in order to prevent HBV reactivation was assessed in patients with hematologic neoplasms. MATERIAL AND METHODS: A decision tree was developed to compare the cost and effectiveness (prevented reactivations) over an 18 month period of a screening strategy prior to chemotherapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) with a non-screening approach. HBsAg+ (hepatitis B surface antigen) and/or anti-HBc+ (antibodies to hepatitis B core antigen) and HBV-DNA+ patients received oral antiviral prophylaxis with tenofovir disoproxil (245 mg once daily) from chemotherapy baseline until one year after chemotherapy completion. Non-screened patients received tenofovir in case of a reactivation. Model probabilities were obtained from the literature. The total cost (, 2015) included: antiviral prophylaxis, R-CHOP, screening tests (HBsAg, anti-HBc, HBV-DNA) and liver function tests. Drug therapy costs were estimated using ex-factory prices with mandatory deductions. The incremental cost-effectiveness ratio (ICER) was calculated in order to assess the cost-effectiveness of this intervention in terms of cost per reactivation averted versus no screening. RESULTS: In a hypothetical cohort of 1,000 patients, screening prevented 7.36 reactivations when compared to the non-screening approach (14.9 versus 22.3). Total cost/patient (including 8,282 for R-CHOP) was 8,584 for the screening strategy and 8,449 for the non-screening approach. The ICER for screening versus non-screening was 18,376/prevented reactivation. CONCLUSION: HBV screening followed by oral antiviral prophylaxis yielded more health benefits than non-screening, reducing HBV reactivation in patients with hematologic neoplasms on chemotherapy.
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Neoplasias Hematológicas/complicações , Vírus da Hepatite B/imunologia , Hepatite B/economia , Hepatite B/prevenção & controle , Anticorpos Monoclonais Murinos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Estudos de Coortes , Análise Custo-Benefício , Ciclofosfamida/uso terapêutico , Árvores de Decisões , Doxorrubicina/uso terapêutico , Neoplasias Hematológicas/tratamento farmacológico , Neoplasias Hematológicas/economia , Hepatite B/diagnóstico , Humanos , Prednisona/uso terapêutico , Prevalência , Rituximab , Vincristina/uso terapêuticoRESUMO
AIMS: Cost-effectiveness analysis of sofosbuvir combined with peginterferon alpha-2a and ribavirin (SOF/Peg-IFN/RBV) in early versus advanced fibrosis in previously untreated patients with chronic hepatitis C genotype 1 (CHC-GT1), from the perspective of the Spanish National Health System (NHS). METHODS: A Markov model was developed to compare lifetime costs and outcomes (life years gained [LYGs] and quality-adjusted life years [QALYs]) of 2 treatment strategies: SOF/Peg-IFN/RBV administered during early fibrosis (mild-moderate fibrosis; F2-F3) or advanced fibrosis (cirrhosis; F4). Efficacy (sustained virologic response), annual transition probabilities, disease management costs and utilities were obtained from the literature. Costs and outcomes were discounted annually at 3%. Direct costs were considered, expressed in Euros (, 2014). Probabilistic sensitivity analysis (PSA) was also performed. RESULTS: SOF/Peg-IFN/RBV therapy at F2-F3 was more effective (19.12 LYGs and 14.14 QALYs) compared to F4. In a cohort of 1,000 patients, SOF/Peg-IFN/RBV prevented 66 cases of decompensated cirrhosis, 60 hepatocellular carcinomas and 4 liver transplantations compared with therapy in advanced fibrosis. The total lifetime cost of early therapy (43,263) was less than the cost of treatment in the advanced stage (49,018). Early therapy was a dominant strategy, more effective and less costly in all simulations. In the PSA analysis, administration of SOF/PEG-IFN/RBV at F2-F3 was dominant in all simulations. CONCLUSIONS: Starting SOF/Peg-IFN/RBV therapy at F2-F3, compared with therapy at F4, reduced the incidence of liver disease complications and was associated with cost savings for the Spanish NHS in CHC-GT1 patients.
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Antivirais/economia , Hepatite C Crônica/tratamento farmacológico , Interferon-alfa/economia , Polietilenoglicóis/economia , Ribavirina/economia , Sofosbuvir/economia , Antivirais/administração & dosagem , Antivirais/uso terapêutico , Simulação por Computador , Análise Custo-Benefício , Custos de Medicamentos/estatística & dados numéricos , Quimioterapia Combinada , Gastos em Saúde/estatística & dados numéricos , Hepatite C Crônica/complicações , Humanos , Interferon-alfa/administração & dosagem , Interferon-alfa/uso terapêutico , Cirrose Hepática/tratamento farmacológico , Cirrose Hepática/etiologia , Cirrose Hepática/prevenção & controle , Cadeias de Markov , Modelos Econômicos , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/economia , Proteínas Recombinantes/uso terapêutico , Ribavirina/administração & dosagem , Ribavirina/uso terapêutico , Sofosbuvir/administração & dosagem , Sofosbuvir/uso terapêutico , EspanhaRESUMO
BACKGROUND: A comparative study was performed to evaluate the effectiveness and costs of a fibrin sealant (Tissucol Duo [known as Tisseel in the United States], Baxter International, Deerfield, Illinois) to improve postoperative outcomes in patients with spinal cord injury undergoing surgical treatment for pressure ulcers (PrUs). METHODS: Between January and June 2011, 27 patients underwent surgical treatment for PrUs with the direct application of Tissucol Duo sprayed before closure. The costs and outcomes obtained in this cohort were compared with those obtained in a previous retrospective study where 71 patients underwent conventional surgery. RESULTS: Lower rates of hematoma-seroma were observed in the study group (3.7% vs 33.8%; P < .05). Drain removal occurred earlier (10 vs 15 days; P < .05), and the average drain volume was also lower (155 vs 360 mL; P < .05) for this group. The mean length of hospital stay was significantly lower in the study group and was the main contributing factor to the overall costs. CONCLUSIONS: The application of Tissucol Duo during surgical treatment of PrUs in patients with spinal cord injury has been shown to be effective in reducing postoperative complications and in shortening the duration of the hospital stay with a consequent savings in costs.
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Adesivo Tecidual de Fibrina/economia , Adesivo Tecidual de Fibrina/uso terapêutico , Úlcera por Pressão/cirurgia , Traumatismos da Medula Espinal/complicações , Adesivos Teciduais/economia , Adesivos Teciduais/uso terapêutico , Estudos de Coortes , Custos e Análise de Custo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Úlcera por Pressão/economia , Úlcera por Pressão/etiologiaRESUMO
The objective was to estimate the annual interaction management cost of agonist opioid treatment (AOT) for opioid-dependent (OD) patients with buprenorphine-naloxone (Suboxone®) (B/N) or methadone associated with concomitant treatments for infectious (HIV) or psychiatric comorbidities. A costs analysis model was developed to calculate the associated cost of AOT and interaction management. The AOT cost included pharmaceutical costs, drug preparation, distribution and dispensing, based on intake regimen (healthcare center or take-home) and type and frequency of dispensing (healthcare center or pharmacy), and medical visits. The cost of methadone also included single-dose bottles, monthly costs of custody at pharmacy, urine toxicology drug screenings and nursing visits. Potential interactions between AOT and concomitant treatments (antivirals, antibacterials/antifungals, antipsychotics, anxiolytics, antidepressant and anticonvulsants), were identified to determine the additional use of healthcare resources for each interaction management. The annual cost per patient of AOT was 1,525.97 for B/N and 1,467.29 for methadone. The average annual cost per patient of interaction management was 257.07 (infectious comorbidities), 114.03 (psychiatric comorbidities) and 185.55 (double comorbidity) with methadone and 7.90 with B/N in psychiatric comorbidities. Total annual costs of B/N were 1,525.97, 1,533.87 and 1,533.87 compared to 1,724.35, 1,581.32 and 1,652.84 for methadone per patient with infectious, psychiatric or double comorbidity respectively.Compared to methadone, the total cost per patient with OD was lower with B/N (47.45-198.38 per year). This is due to the differences in interaction management costs associated with the concomitant treatment of infectious and/or psychiatric comorbidities.
El objetivo fue estimar en pacientes con dependencia a opiáceos (DO), el coste anual del manejo de interacciones del tratamiento sustitutivo con buprenorfina/naloxona (Suboxone®) (B/N) o metadona, asociado con tratamientos concomitantes por comorbilidades infecciosas (VIH) o psiquiátricas. Se realizó un análisis de costes (, 2013), del tratamiento sustitutivo y del manejo de interacciones. El coste del tratamiento de B/N incluyó costes farmacológicos, elaboración, distribución y dispensación, en función del régimen de administración (centro asistencial o domiciliaria) y del tipo y frecuencia de dispensación (centro asistencial o farmacia), y visitas al especialista para prescripción. El coste de tratamiento con metadona incluyó, además, frascos monodosis, coste de custodia en farmacia, determinación en orina y visitas a enfermería. Se identificaron las interacciones para determinar los recursos sanitarios adicionales consumidos por la administración conjunta del tratamiento sustitutivo y concomitante (antirretrovirales, bactericidas/antifúngicos, antipsicóticos, ansiolíticos, antidepresivos y anticonvulsivos). El coste anual/paciente estimado del tratamiento sustitutivo fue de 1.525,97 (B/N) y 1.467,29 (metadona). El coste promedio anual/paciente estimado del manejo de interacciones fue de 257,07 (infecciosas), 114,03 (psiquiátricas) y 185,55 (ambas) con metadona, y de 7,90 con B/N por comorbilidades psiquiátricas. El coste total anual/paciente estimado de B/N fue 1.525,97, 1.533,87 y 1.533,87 comparado con 1.724,35, 1.581,32 y 1.652,84 de metadona, en pacientes que presentan comorbilidad infecciosa, psiquiátrica o ambas, respectivamente. Comparado con metadona, el coste total por paciente con DO de B/N fue menor (47,45-198,38 anuales) derivado de la diferencia del coste por manejo de interacciones del tratamiento concomitante de las comorbilidades infecciosas y/o psiquiátricas.
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Analgésicos Opioides/economia , Analgésicos Opioides/uso terapêutico , Buprenorfina/economia , Buprenorfina/uso terapêutico , Custos de Cuidados de Saúde , Infecções/complicações , Infecções/tratamento farmacológico , Transtornos Mentais/complicações , Transtornos Mentais/tratamento farmacológico , Metadona/economia , Metadona/uso terapêutico , Naloxona/economia , Naloxona/uso terapêutico , Antagonistas de Entorpecentes/economia , Antagonistas de Entorpecentes/uso terapêutico , Tratamento de Substituição de Opiáceos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/economia , Interações Medicamentosas , HumanosRESUMO
BACKGROUND: Surgical bleeding can be associated with an increased risk of morbidity and mortality across all surgical areas. Thus, numerous products have been developed to achieve haemostasis. A flowable haemostatic matrix such as Floseal® can quickly and reliably stop bleeding across the full spectrum of bleeding scenarios. The aim of this study was to systematically review clinical and economic evidence regarding the use of Floseal® in surgical procedures. METHODS: An extensive literature search was conducted in PubMed, EMBASE, and the Cochrane Library over the period spanning 2003-2013 to identify publications related to Floseal® use in all types of surgical procedures. Case reports and case series studies were excluded. RESULTS: A total of 27 papers met the selection criteria and were analysed. In the studies, blood loss and the time to achieve haemostasis were the most reported outcomes used to assess the efficacy of Floseal®. The majority of published studies (64%) examined the use of Floseal® compared with conventional methods (such as electrocautery or suturing). The remaining 36% of the studies evaluated the use of Floseal® compared with other haemostatic agents, such as Surgicel®, Gelfoam®, and Hemostase®. FloSeal® has been demonstrated to be an efficacious method in surgical procedures to reduce the time to achieve haemostasis, the frequency of intra- and postoperative bleeding, and the length of hospital stay, among other primary outcomes, resulting in less consumption of health resources. CONCLUSIONS: The majority of the selected studies confirmed that Floseal® showed improvements over other haemostatic agents in achieving haemostasis and reducing blood loss.
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Perda Sanguínea Cirúrgica/prevenção & controle , Esponja de Gelatina Absorvível/uso terapêutico , Hemostasia Cirúrgica/métodos , Hemostáticos/uso terapêutico , Redução de Custos , Esponja de Gelatina Absorvível/economia , Hemostáticos/economia , HumanosRESUMO
PURPOSE: To estimate the cost-effectiveness of axi-cel vs. salvage immunochemotherapy followed by high-dose chemotherapy and autologous stem-cell transplantation (HDT+ASCT) for responders to second-line treatment for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). METHODS: A partitioned survival mixture-cure model comprising three health states was used to estimate the costs, life years gained (LYG), and quality-adjusted life years (QALYs) accumulated over a lifetime horizon. Overall survival, event-free survival, and time to the next treatment with axi-cel and HDT+ASCT were derived from the ZUMA-7 study. The total costs (EUR, 2022) included drug acquisition and administration, ASCT, subsequent treatment, disease and adverse event management, and palliative care. The unitary costs were derived from local databases and the literature. A 3% discount rate was applied to the costs and outcomes. RESULTS: Compared with HDT+ASCT, axi-cel provided higher LYG per patient (10.00 vs. 8.28 LYG/patient) and greater QALYs gained per patient (7.85 vs. 6.04 QALY/patient). The lifetime total costs were 343,581 EUR/patient with axi-cel vs. 257,994 EUR/patient with IQT+ASCT. The incremental cost-effectiveness ratio of axi-cel vs. HDT+ASCT was 49,627 EUR/LYG, and the incremental cost-utility ratio was 47,309 EUR/QALY. Sensitivity analyses confirmed the robustness of the model. CONCLUSION: Axi-cel is a potentially cost-effective alternative to HDT+ASCT for the treatment of R/R DLBCL in Spain.
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BACKGROUND: Desmoid tumours (DTs) or deep fibromatosis are benign soft-tissue tumours, sometimes locally aggressive, requiring intervention on some cases. Surgery has been the gold standard, but new less invasive techniques such as percutaneous cryoablation have proved their effectiveness, reducing health resources and complications. The study aimed to compare the total cost of percutaneous cryoablation and conventional surgery for patients with extra-abdominal and/or abdominal wall DTs, candidates for local ablative treatment in Spain. METHODS: A cost-analysis model was developed. An expert panel provided data about resource consumption for the percutaneous cryoablation technique and validated the epidemiology used for target population estimation. Unitary resources cost ( 2022) derived from local cost databases. A retrospective analysis of 54 surgical cases in 3 Spanish hospitals was performed to estimate the cost of conventional surgery based on the cost of the Diagnosis-Related group (DRG) codes identified on this patient sample, weighted by each DRG proportion. The total cost for each alternative included intervention cost and complications cost, considering debridement required in 4.5% of cases with percutaneous cryoablation and minor surgery for surgical site infection in 18.0% for conventional surgery. RESULTS: The total cost for percutaneous cryoablation ( 5774.78/patient-year) was lower than the total cost for conventional surgery ( 6780.98/patient-year), yielding cost savings up to 80,002 in 1 year for the entire cohort of 80 patients with DTs eligible for intervention estimated in Spain. One-way sensitivity analyses confirmed the results' robustness. CONCLUSION: Percutaneous cryoablation versus conventional surgery would yield cost savings for the management of DT patients in Spain. CRITICAL RELEVANCE STATEMENT: This manuscript provides insight into the economic impact derived from the savings related to the use of percutaneous cryoablation for desmoid-type tumours from the perspective of the Spanish National Healthcare System, providing useful information for the health decision-making process. KEY POINTS: ⢠Desmoid tumours are locally aggressive and may require local therapy. ⢠Percutaneous cryoablation procedure is less invasive than the conventional surgery. ⢠Cost comparison shows savings associated to percutaneous cryoablation use.
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BACKGROUND: Several surgical treatments are available for managing lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH). Water vapor thermal therapy (WVTT) is a new minimally invasive therapy. This study estimates the budget impact of introducing WVTT for LUTS/BPH into the Spanish health care system. METHODS: A model simulated the evolution of men over 45 years of age with moderate-severe LUTS/BPH after surgical treatment, over a 4-year time horizon, from the Spanish public health care service´s perspective. The technologies in scope included those most used in Spain: WVTT, transurethral resection (TURP), photoselective laser vapourization (PVP) and holmium laser enucleation (HoLEP). Transition probabilities, adverse events and costs were identified from the scientific literature and validated by a panel of experts. Sensitivity analyses were performed by varying the most uncertain parameters. RESULTS: Per intervention, WVTT resulted in savings of 3,317, 1,933 and 2,661 compared to TURP, PVP and HoLEP. Over a 4-year time horizon, when performed in 10% of the cohort of 109,603 Spanish males with LUTS/BPH, WVTT saved 28,770,125 against the scenario without WVTT availability. CONCLUSIONS: WVTT could reduce the cost of managing LUTS/BPH, increase the quality of health care and reduce the length of procedure and hospital stay.
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Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Masculino , Humanos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Vapor , Sintomas do Trato Urinário Inferior/terapia , Sintomas do Trato Urinário Inferior/complicações , Orçamentos , Atenção à Saúde , Resultado do TratamentoRESUMO
A cost analysis of thiopurine treatment was carried out in 257 patients, with 153 preemptively genotyped for TPMT and 104 retrospectively genotyped in a Spanish setting. The healthcare cost was significantly higher in patients retrospectively genotyped compared to those who were preemptively genotyped (p < 0.001). TPMT intermediate metabolizers (IMs) (n = 23) showed a 3.3-fold higher healthcare cost when compared to normal metabolizers (NMs) (p < 0.001). The healthcare cost in patients with a TPMT IM phenotype whose physician adhered to the genotype-informed recommendation was similar than the cost in TPMT NMs and was significantly lower than IMs whose physician did not adhere to the therapeutic recommendation (3.8-fold, p = 0.016). Myelotoxicity occurrence was significantly lower in patients preemptively vs. retrospectively genotyped (2.0% and 21.2%, respectively, p < 0.001). Patients who developed myelotoxicity showed a significantly higher healthcare cost than those who did not (4.10-fold, p < 0.001). Overall, 87% of patients whose dose was not adjusted despite being TPMT IMs suffered myelotoxicity, while only one of the eight patients (13%) whose dose was adjusted suffered myelotoxicity (p < 0.001). In conclusion, TPMT preemptive genotyping and physician adherence to genotype-informed therapeutic recommendations prevents myelotoxicity and significantly reduces the healthcare cost, and it is therefore essential for the sustainability of the Spanish healthcare system.
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OBJECTIVE: To assess the economic impact of introducing biosimilars of bevacizumab for the management of cancer patients receiving systemic bevacizumab in the National Health System (SNHS) of Spain. METHODS: A 3-year budget impact analysis model was adapted to estimate the cost of introducing biosimilars of bevacizumab in the SNHS for the adult population who were candidates to receive treatment with bevacizumab. Values for the estimation of the population were obtained from the literature and were validated by an expert panel. In this analysis only pharmaceutical costs (, year 2021) obtained from official databases were considered. A sensitivity analysis was performed to examine the robustness of the model. RESULTS: The introduction of bevacizumab biosimilars would generate an annual cost saving of 11 558 268 (-5.1%) for the first year with a penetration share of biosimilars from 30.0%, 29 126 373 (-8.5%) for the second year with a share of 50.0% and 52 361 778 (-13.6%) for the third year with a share of 80.0%. The total pharmaceutical costs of the scenario without biosimilars are 227 033 352 for the first year, 342 663 209 for the second year and 385 013 076 for the third year. In contrast, the pharmaceutical costs of the scenario with bevacizumab biosimilars are 215 475 084, 313 536 836 and 332 651 297 for years 1, 2 and 3, respectively. CONCLUSIONS: The introduction of biosimilars in the Spanish Health System would generate saving costs in the pharmacological budget to boost biological drugs from the first year.
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Medicamentos Biossimilares , Neoplasias , Humanos , Adulto , Bevacizumab/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Espanha/epidemiologia , Preparações Farmacêuticas , Neoplasias/tratamento farmacológico , Neoplasias/epidemiologiaRESUMO
INTRODUCTION: The assessment of liver fibrosis is crucial for taking therapeutic decisions in patients infected with HIV/AIDS coinfected with HCV, because it allows the prognosis of the disease and the prioritization of hepatitis C treatment in these patients. METHODS: A discrete events model simulation (DEMS) and a Markov model have been developed to represent the evolution of liver fibrosis to cirrhosis in patients coinfected with HIV/HVC. The model evaluated two alternatives for the diagnosis and monitoring of these patients, transient elastography performed annually and liver biopsy performed every seven years. The models have been developed under Health Care System perspective and only considered direct medical costs (disease treatment and health state costs). One-way sensitivity analyses were carried out to assess the impact of parameters with higher uncertainty. A discount rate of 3% was applied. RESULTS: Base case analysis shows that the diagnosis and monitoring of patients with transient elastography is a dominant strategy compared with to liver biopsy, resulting in greater life expectancy at lower cost. The sensitivity analysis performed confirmed the robustness of these results. CONCLUSION: Transient elastography has proved to be a dominant strategy compared to liver biopsy in the diagnosis and monitoring of liver fibrosis in patients coinfected with HIV/HCV in Spain.
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Simulação por Computador , Técnicas de Imagem por Elasticidade/economia , Infecções por HIV/complicações , Hepatite C/complicações , Cirrose Hepática/diagnóstico , Modelos Biológicos , Modelos Econômicos , Adolescente , Adulto , Idade de Início , Idoso , Idoso de 80 Anos ou mais , Biópsia/economia , Criança , Pré-Escolar , Análise Custo-Benefício , Custos e Análise de Custo , Progressão da Doença , Feminino , Infecções por HIV/epidemiologia , Gastos em Saúde , Humanos , Fígado/diagnóstico por imagem , Fígado/patologia , Cirrose Hepática/economia , Cirrose Hepática/etiologia , Cirrose Hepática/patologia , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Prognóstico , Sensibilidade e Especificidade , Fatores de Tempo , Adulto JovemRESUMO
OBJECTIVE: This study aimed to assess the potential epidemiological and economic impact of rapid initiation of human immunodeficiency virus (HIV) treatment with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) on HIV transmission compared with the current initiation observed in clinical practice in Spain. METHODS: A transmission model was adapted to estimate the cumulative HIV infection incidence and potential cost savings based on the number of HIV infections prevented among men who have sex with men, heterosexual males and females, and people who inject drugs (PWID) over a 20-year time horizon. The analysis compared rapid antiretroviral therapy (ART) initiation with B/F/TAF (9 days from diagnosis until treatment initiation) versus current ART initiation practice (with an average of 35 days from diagnosis to treatment). People living with HIV were distributed according to their treatment status. Risk for transmission was assigned to undiagnosed, diagnosed in care and not receiving ART, and receiving ART but virally unsuppressed, which was estimated by sexual contact, needles and syringes shared among PWID, state of HIV infection, and ART use. RESULTS: In the base-case analysis, rapid ART initiation with B/F/TAF is expected to prevent 992 new HIV infections over the next 20 years compared with current ART initiation practices. Considering the lifetime costs of treating HIV infection, the reduction in HIV incidence could result in potential cost savings of 323 million. CONCLUSIONS: These results suggest that rapid ART initiation with B/F/TAF in newly diagnosed patients with HIV is a high-value strategy for the Spanish National Health System and society, reducing HIV incidence and thereby reducing future related direct and indirect costs of care.
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OBJECTIVES: To evaluate the potential epidemiologic and economic impact of applying an HIV screening protocol in hospital emergency departments (ED) and compare it to current clinical practice in Spain. MATERIAL AND METHODS: We estimated the cumulative incidence of human immunodeficiency virus (HIV) infections and associated costs in Spain for a 20-year time horizon based on a model comprised of various health states with different risks for HIV transmission. The impact of current clinical practices in Spain, in which there is no established protocol for HIV screening, was compared to the potential impact of applying a targeted screening protocol in persons who come to the ED with certain conditions suggestive of HIV infection (diagnosis of a sexually transmitted infection, mononucleosis, herpes zoster infection, community-acquired pneumonia; practice of chemsex, and need for postexposure prophylaxis). RESULTS: Screening all persons with a condition suggestive of HIV infection in hospital EDs would require an investment of 20 million over 20 years, but it would prevent 13 615 new infections (reducing the incidence by 20.6%, down from 66 265 to 52 650 cases) in comparison with the current diagnostic approaches. Such a reduction in the incidence of HIV infection would potentially save 4411 million over 20 years, giving a return of 224 per euro invested. CONCLUSION: A protocol for targeted screening of persons in circumstances suggestive of risk for HIV infection in Spain would increase diagnoses, avert new infections, and generate savings in comparison with screening practices currently in effect.
OBJETIVO: El objetivo del análisis fue evaluar el impacto epidemiológico y económico de protocolizar el cribado dirigido del virus de la inmunodeficiencia humana (VIH) en los servicios de urgencias hospitalarios (SUH) comparado con la actual práctica clínica en España. METODO: Mediante un modelo formado por varios estados de salud con diferentes riesgos de transmisión se estimó la incidencia acumulada de infecciones por VIH y los costes asociados, en 20 años, en España. El análisis comparó la protocolización del cribado dirigido a personas que presentan alguna condición indicadora (CI) de infección por VIH (diagnóstico de enfermedad de transmisión sexual, síndrome mononucleósido, herpes zóster, neumonía adquirida en la comunidad, práctica del chemsex y profilaxis postexposición) que acuden a los SUH frente a la actual práctica clínica en España en la que el cribado del VIH no está protocolizado. RESULTADOS: El cribado dirigido a personas con alguna CI de VIH en los servicios de urgencias requeriría una inversión de 20 millones de euros en 20 años, pero evitaría 13.615 nuevas infecciones (de 66.265 a 52.650 casos; 20,6%) comparado con la actual estrategia de diagnóstico. La reducción de la incidencia de VIH supondría unos ahorros potenciales de 4.411 millones de euros en 2 décadas, con un retorno económico de 224 por euro invertido. CONCLUSIONES: Protocolizar el cribado dirigido a personas con alguna CI de VIH en los SUH en España podría incrementar el diagnóstico, evitar nuevas infecciones de VIH y generar ahorros versus el cribado no protocolizado realizado en la práctica clínica actual.
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Infecções por HIV , Serviço Hospitalar de Emergência , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Humanos , Programas de Rastreamento , Espanha/epidemiologiaRESUMO
Primary immunodeficiency diseases (PID), which are comprised of over 400 genetic disorders, occur when a component of the immune system is diminished or dysfunctional. Patients with PID who require immunoglobulin (IG) replacement therapy receive intravenous IG (IVIG) or subcutaneous IG (SCIG), each of which provides equivalent efficacy. We developed a cost-minimization model to evaluate costs of IVIG versus SCIG from the Spanish National Healthcare System perspective. The base case modeled the annual cost per patient of IVIG and SCIG for the mean doses (per current expert clinical practice) over 1 year in terms of direct (drug and administration) and indirect (lost productivity for adults and parents/guardians of pediatric patients) costs. It was assumed that all IVIG infusions were administered in a day hospital, and 95% of SCIG infusions were administered at home. Drug costs were calculated from ex-factory prices obtained from local databases minus the mandatory deduction. Costs were valued on 2018 euros. The annual modeled costs were 4,266 lower for patients with PID who received SCIG (total 14,466) compared with those who received IVIG (total 18,732). The two largest contributors were differences in annual IG costs as a function of dosage (- 1,927) and hospital administration costs (- 2,688). However, SCIG incurred training costs for home administration (695). Sensitivity analyses for two dose-rounding scenarios were consistent with the base case. Our model suggests that SCIG may be a cost-saving alternative to IVIG for patients with PID in Spain.
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Síndromes de Imunodeficiência , Doenças da Imunodeficiência Primária , Adulto , Criança , Custos Hospitalares , Humanos , Imunoglobulinas Intravenosas/uso terapêutico , Síndromes de Imunodeficiência/tratamento farmacológico , EspanhaRESUMO
OBJECTIVE: To assess the incremental cost-utility ratio (ICUR) of gemtuzumab ozogamicin (GO) + standard of care (SOC) vs SOC alone for treatment of patients with de novo AML from a Spanish Health Service perspective. METHODS: A cohort state-transition model, with 12 health-states, was used to estimate the lifetime accumulated cost and benefits in terms of quality-adjusted-life-years (QALYs) in AML patients with favourable, intermediate, and unknown cytogenetic profiles. Patient profile was defined based on the ALFA-0701 trial. Therapeutic regimens were defined by 5 haematologists. SOC was assumed to be idarubicin and cytarabine, the combination most used in Spain. QALYs were estimated by applying utilities for the time spent by the cohort in each health-state and utility decrements associated with adverse events (AE). Total cost (,2020) included drug-acquisition, hematologic stem-cell transplantation, disease management, AE management and end-of-life costs. Unit costs were derived from local databases. All parameters were validated by haematologist. Costs and outcomes were discounted (3%/year). RESULTS: Higher cost/patient (177,618 vs 151,434) and greater QALYs (5,70 vs 4,62) were obtained with GO+SOC vs SOC. The ICUR was 24,203/QALY gained. CONCLUSION: This simulation suggests that GO + SOC could be a cost-effective option for treatment of patients with de novo AML in first line.
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INTRODUCTION: FreeStyle Libre® 2 system is a sensor-based flash-monitoring system that measures interstitial fluid glucose. The study aimed to compare cost of FreeStyle Libre 2 system and self-monitoring of blood glucose (SMBG) in the type 2 diabetes mellitus (T2DM) population from the Spanish Health System perspective. METHODS: On the basis of data collected from a literature review, the cost of glucose monitoring was modelled for patients with T2DM on a basal-bolus insulin regimen. The cost estimate included annual consumption for glucose monitoring (strips, lancets and sensors) and severe hypoglycaemic events (SHE) management. A published rate of SHE (2.5 episodes/patient-year) was considered. A reduction of SHE (- 48.8%) associated with FreeStyle Libre 2 system, derived from the REPLACE trial, was applied. Hospital attendance for 20.5% of SHEs (with subsequent hospitalization in 16.0%) was applied. Consumption of strips and lancets was set at 6/day for SMBG (derived from national monitoring recommendations), and 0.2/day for FreeStyle Libre 2 system users, with 26 FreeStyle Libre 2 sensors/year. Unitary costs (, year 2020 excluding VAT) were derived from literature (0.28/strip; 0.09/lancet; 3.09/daily FM sensor; 3804/hospitalized SHE; 1794/hospital-attended non-admitted SHE; 389/community-attended SHE). RESULTS: Costs were 2700 and 2120/year/patient using SMBG or FreeStyle Libre 2 system, respectively. For 1000 patients with T2DM using basal-bolus insulin, 1220 SHEs/year (with 48 hospitalizations) could be prevented and FreeSytle Libre 2 system could generate cost savings of up to 580,953/year versus SMBG (- 21.5%). CONCLUSION: FreeStyle Libre 2 system is a potential cost-saving strategy in patients with T2DM in Spain on a basal-bolus insulin regimen.
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BACKGROUND: Orphan drugs are indicated for the treatment of rare diseases which, in the EU, are defined as those with a prevalence of <5 per 10000 inhabitants. Characteristically, these diseases negatively affect health-related quality of life and may be life threatening. The EU has passed legislation to encourage pharmaceutical companies to invest in research programmes into rare diseases, with the aim of developing new, safe and effective orphan drugs. OBJECTIVES: To describe the status of orphan drugs in five countries in the EU (France, Germany, the UK, Italy and Spain), estimate the mean annual cost per patient and indication of these orphan drugs, and determine the associated cost of these drugs in comparison with overall spending on drugs in each country (year 2007 values). METHODS: The analysis was limited solely to costs of orphan drugs with sales data available for 2007. The mean annual cost per patient was estimated using recommended regimens for maintenance dose and duration from the summary of product characteristics. Likewise, the ratio between annual costs per patient for treatment of each disease and its prevalence was calculated. Sales data were available for at least one of the countries studied for 38 of the 44 orphan drugs authorized by the European Medicines Agency. Only 21 products had data available for all five countries studied. RESULTS: Germany was the country with access to the largest number of orphan drugs (36), followed by the UK (34), Spain (28), France (27) and Italy (25). The mean annual cost per patient and indication of the 38 orphan drugs on the market ranged widely from 331 to 337,501. It appears that orphan drugs indicated to treat diseases with a prevalence of <2 per 10000 inhabitants have higher annual per-patient costs than those indicated to treat diseases with a higher prevalence. The percentage of total drug spending accounted for by orphan drugs in 2007 was 1.7% in France, 2.1% in Germany, 1.0% in the UK, 1.5% in Italy and 2.0% in Spain, with an average overall percentage of 1.7% for these five countries. CONCLUSIONS: In 2007, spending on orphan drugs in five European countries was acceptable in terms of the percentage of these countries' overall drug expenditure. Mean annual costs per patient of orphan drugs varied widely, with costs being related to the prevalence of the disease for which the product is indicated.
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Produção de Droga sem Interesse Comercial/economia , Honorários por Prescrição de Medicamentos , Doenças Raras/tratamento farmacológico , França , Alemanha , Humanos , Itália , Espanha , Reino UnidoRESUMO
OBJECTIVE: The aim of this study was to assess the efficiency of exenatide 2 mg/week compared with other glucagon-like peptide-1 (GLP-1) receptor agonists (dulaglutide 1.5 mg/week, liraglutide 1.2 mg/day, liraglutide 1.8 mg/day and lixisenatide 20 µg/day) in adult patients with type 2 diabetes mellitus (T2DM) not adequately controlled on metformin alone from the perspective of the Spanish National Health System (NHS). METHODS: Quality-adjusted life-years (QALYs) gained and total costs of each assessed drug combined with metformin (2 g/day) were estimated over a 40-year time horizon using the Cardiff Diabetes Model (based on UK Prospective Diabetes Study [UKPDS] 68 equations), which simulates disease progression considering the T2DM-related micro- and macrovascular complications, hypoglycaemia, nausea, body mass index (BMI) changes and treatment discontinuation due to adverse effects (AEs). Drug efficacy derived from an indirect comparison performed in a network meta-analysis. Patient characteristics were obtained from the literature. The baseline utility value (0.80) was derived from the PANORAMA study, applying utility decrements to micro- and macrovascular complications, hypoglycaemia episodes and changes in BMI. Treatment discontinuation due to AEs or poorly controlled diabetes (HbA1c > 7.5%) involved switching to second-line (basal insulin) or third-line (basal-bolus insulin) treatment. Total cost (, 2018) included the costs of drug acquisition, hypoglycaemia, weight gain, micro- and macrovascular complications, nausea and treatment discontinuation due to AEs. An annual discount rate of 3% was applied to costs and outcomes. Deterministic and probabilistic sensitivity analyses (SA) were performed. RESULTS: In base-case, exenatide 2 mg/week resulted in more QALYs (8.26) than dulaglutide 1.5 mg/week (8.19 QALYs), liraglutide 1.2 mg/day (8.10 QALYs), liraglutide 1.8 mg/day (8.20 QALYs) and lixisenatide 20 µg/day (8.13 QALYs). Total cost/patient was 20,423.27 (exenatide 2 mg/week), 22,611.94 (dulaglutide 1.5 mg/week), 21,065.97 (liraglutide 1.2 mg/day), 24,865.69 (liraglutide 1.8 mg/day) and 21,334.58 (lixisenatide 20 µg/day). Deterministic SA confirmed the robustness of the model. In the probabilistic SA, 95-99% of the 1000 Monte Carlo iterations performed were under a hypothetical willingness-to-pay threshold of 20,000/QALY gained. CONCLUSIONS: Exenatide 2 mg/week would be a dominant strategy (more effective and less costly) versus the other GLP-1 receptor agonists assessed for the treatment of T2DM patients who are not adequately controlled on metformin alone.