RESUMEN
Importance: Among patients with rheumatoid arthritis (RA) who had an inadequate response to methotrexate, a treatment sequence initiated with biosimilar disease-modifying antirheumatic drugs (DMARDs) provides better clinical efficacy compared with conventional synthetic DMARDs recommended by current treatment guidelines; but its cost-effectiveness evidence remains unclear. Objective: To evaluate the cost-effectiveness of the treatment sequence initiated with biosimilar DMARDs after failure with methotrexate vs leflunomide and inform formulary listing decisions. Design, Setting, and Participants: This economic evaluation's cost-effectiveness analysis was performed at a Hong Kong public institution using the Markov disease transition model to simulate the lifetime disease progression and cost for patients with RA, using monetary value in 2022. Scenario and sensitivity analyses were performed to test the internal validity of the modeling conclusion. Participants included patients diagnosed with RA from 2000 to 2021 who were retrieved retrospectively from local electronic medical records to generate model input parameters. Statistical analysis was performed from January 2023 to March 2024. Interventions: The model assesses 3 competing treatment sequences initiated with biosimilar infliximab (CT-P13), biosimilar adalimumab (ABP-501), and leflunomide; all used in combination with methotrexate. Main Outcomes and Measures: Lifetime health care cost and quality-adjusted life-years (QALYs) of the simulated cohort. Results: In total, 25â¯099 patients with RA were identified (mean [SD] age, 56 [17] years; 19â¯469 [72.7%] women). In the base-case analysis, the lifetime health care cost and QALYs for the treatment sequence initiated with leflunomide were US $154â¯632 and 14.82 QALYs, respectively; for biosimilar infliximab, they were US $152â¯326 and 15.35 QALYs, respectively; and for biosimilar adalimumab, they were US $145â¯419 and 15.55 QALYs, respectively. Both biosimilar sequences presented lower costs and greater QALYs than the leflunomide sequence. In the deterministic sensitivity analysis, the incremental cost-effectiveness ratio (US$/QALY) comparing biosimilar infliximab sequence vs leflunomide sequence and biosimilar adalimumab sequence vs leflunomide sequence ranged from -15â¯797 to -8615 and -9088 to 10â¯238, respectively, all below the predefined willingness-to-pay threshold (US $48â¯555/QALY gain). In the probabilistic sensitivity analysis, the probability of treatment sequence initiated with leflunomide, biosimilar infliximab, and biosmilar adalimumab being cost-effective out of 10â¯000 iterations was 0%, 9%, and 91%, respectively. Conclusions and Relevance: In this economic evaluation study, the treatment sequences initiated with biosimilar DMARDs were cost-effective compared with the treatment sequence initiated with leflunomide in managing patients with RA who experienced failure with the initial methotrexate treatment. These results suggest the need to update clinical treatment guidelines for initiating biosimilars immediately after the failure of methotrexate for patients with RA.
Asunto(s)
Antirreumáticos , Artritis Reumatoide , Biosimilares Farmacéuticos , Análisis Costo-Beneficio , Leflunamida , Humanos , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/economía , Leflunamida/uso terapéutico , Leflunamida/economía , Biosimilares Farmacéuticos/uso terapéutico , Biosimilares Farmacéuticos/economía , Antirreumáticos/uso terapéutico , Antirreumáticos/economía , Femenino , Masculino , Persona de Mediana Edad , Infliximab/uso terapéutico , Infliximab/economía , Adulto , Hong Kong , Estudios Retrospectivos , Años de Vida Ajustados por Calidad de Vida , Adalimumab/uso terapéutico , Adalimumab/economía , AncianoRESUMEN
OBJECTIVE: To evaluate the impact of the entry of biosimilars on the pricing of eight biologic products in 57 countries and regions. METHODS: We utilized an interrupted time series design and IQVIA MIDAS® data to analyze the annual sales data of eight biologic products (adalimumab, bevacizumab, epoetin, etanercept, filgrastim, infliximab, pegfilgrastim, and trastuzumab) across 57 countries and regions from January 1, 2012, to December 31, 2019. We examined the immediate and long-term changes in biologics ex-manufacturer pricing following the entry of biosimilars to the market. RESULTS: Following the entry of biosimilars, the average price per dose of biologic product was immediately reduced by $438 for trastuzumab, $112 for infliximab, and $110 for bevacizumab. The persistent effect of biosimilars' market entry led to further reductions in price per dose every year: by $49 for adalimumab, $290 for filgrastim, $21 for infliximab, and $189 for trastuzumab. Similarly, we analyzed the impact of biosimilars on four biologics' prices in the US, where the prices of three biologics significantly decreased every year, with filgrastim, pegfilgrastim, and infliximab decreasing by $955, $753, and $104, respectively. CONCLUSIONS: The introduction of biosimilars has significantly reduced the prices of biologics both globally and in the US. These findings not only demonstrate the economic benefits of increasing biosimilar utilization, but also emphasize the importance of biosimilars in controlling healthcare costs. Policies should aim to expand the availability of biosimilars to counteract the exponential growth of medical spending caused by the use of biologics.
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Biosimilares Farmacéuticos , Infliximab , Biosimilares Farmacéuticos/economía , Biosimilares Farmacéuticos/uso terapéutico , Humanos , Infliximab/economía , Infliximab/uso terapéutico , Filgrastim/economía , Filgrastim/uso terapéutico , Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Costos de los Medicamentos , Adalimumab/economía , Adalimumab/uso terapéutico , Etanercept/economía , Etanercept/uso terapéutico , Trastuzumab/economía , Trastuzumab/uso terapéutico , Costos y Análisis de Costo , PolietilenglicolesAsunto(s)
Análisis Costo-Beneficio , Enfermedad de Crohn , Fármacos Gastrointestinales , Infliximab , Humanos , Infliximab/economía , Infliximab/uso terapéutico , Enfermedad de Crohn/tratamiento farmacológico , Enfermedad de Crohn/economía , Niño , Fármacos Gastrointestinales/uso terapéutico , Fármacos Gastrointestinales/economía , Anticuerpos Monoclonales/economía , Anticuerpos Monoclonales/uso terapéuticoAsunto(s)
Análisis Costo-Beneficio , Enfermedad de Crohn , Fármacos Gastrointestinales , Infliximab , Humanos , Enfermedad de Crohn/tratamiento farmacológico , Enfermedad de Crohn/economía , Infliximab/economía , Infliximab/uso terapéutico , Niño , Fármacos Gastrointestinales/economía , Fármacos Gastrointestinales/uso terapéuticoRESUMEN
BACKGROUND: The rise of biologic agents has been a major breakthrough in treating immune-mediated inflammatory diseases (IMIDs). However, their high cost underscores the need for strategies to optimize treatment efficiency. Biosimilars offer cost-effective alternatives to biologics. This study aimed to assess biosimilar drug availability's impact on biologic therapy access for IMIDs. RESEARCH DESIGN AND METHODS: A retrospective observational study in 15 Spanish hospitals analyzed IMID patients (arthropathies, inflammatory bowel disease and psoriasis) initiating biologic therapy with originator or biosimilar drugs (infliximab, etanercept, adalimumab). Time to availability and initiation of biologic therapy were assessed. RESULTS: 267 patients were included, with 58.4% starting on biosimilars. The mean time to availability of the biologic drugs in the hospitals was 15.9 ± 6.7 months, (20.0 ± 12.4 for originator and 11.8 ± 5.2 for biosimilars). Mean time to biologic treatment was 7.7 ± 9.0 years (8.6 ± 8.9 for originators and 7.0 ± 9.0 for biosimilars). Showing statistically significant differences among conditions. CONCLUSION: The emergence of biosimilar drugs has enhanced market competition and accelerated their adoption into hospitals' therapeutic regimens over original reference drugs. This has significantly improved access to biologic therapy for patients with IMIDs, evidenced by a notable 1.6-year reduction in access time for biosimilar drugs.
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Biosimilares Farmacéuticos , Humanos , Biosimilares Farmacéuticos/uso terapéutico , Biosimilares Farmacéuticos/economía , Estudios Retrospectivos , Femenino , Masculino , Persona de Mediana Edad , Adulto , Terapia Biológica , Accesibilidad a los Servicios de Salud , España , Enfermedades del Sistema Inmune/tratamiento farmacológico , Anciano , Infliximab/uso terapéutico , Infliximab/economíaRESUMEN
BACKGROUND: Data on cost-effectiveness of first-line infliximab in paediatric patients with Crohn's disease are limited. Since biologics are increasingly prescribed and accompanied by high costs, this knowledge gap needs to be addressed. AIM: To investigate the cost-effectiveness of first-line infliximab compared to conventional treatment in children with moderate-to-severe Crohn's disease. METHODS: We included patients from the Top-down Infliximab Study in Kids with Crohn's disease randomised controlled trial. Children with newly diagnosed moderate-to-severe Crohn's disease were treated with azathioprine maintenance and either five induction infliximab (biosimilar) infusions or conventional induction treatment (exclusive enteral nutrition or corticosteroids). Direct healthcare consumption and costs were obtained per patient until week 104. This included data on outpatient hospital visits, hospital admissions, drug costs, endoscopies and surgeries. The primary health outcome was the odds ratio of being in clinical remission (weighted paediatric Crohn's disease activity index<12.5) during 104 weeks. RESULTS: We included 89 patients (44 in the first-line infliximab group and 45 in the conventional treatment group). Mean direct healthcare costs per patient were 36,784 for first-line infliximab treatment and 36,874 for conventional treatment over 2 years (p = 0.981). The odds ratio of first-line infliximab versus conventional treatment to be in clinical remission over 104 weeks was 1.56 (95%CI 1.03-2.35, p = 0.036). CONCLUSIONS: First-line infliximab treatment resulted in higher odds of being in clinical remission without being more expensive, making it the dominant strategy over conventional treatment in the first 2 years after diagnosis in children with moderate-to-severe Crohn's disease. TRIAL REGISTRATION NUMBER: NCT02517684.
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Biosimilares Farmacéuticos , Análisis Costo-Beneficio , Enfermedad de Crohn , Fármacos Gastrointestinales , Infliximab , Humanos , Enfermedad de Crohn/tratamiento farmacológico , Enfermedad de Crohn/economía , Infliximab/economía , Infliximab/uso terapéutico , Masculino , Femenino , Niño , Adolescente , Fármacos Gastrointestinales/economía , Fármacos Gastrointestinales/uso terapéutico , Biosimilares Farmacéuticos/economía , Biosimilares Farmacéuticos/uso terapéutico , Resultado del Tratamiento , Azatioprina/uso terapéutico , Azatioprina/economía , Inmunosupresores/economía , Inmunosupresores/uso terapéutico , Corticoesteroides/uso terapéutico , Corticoesteroides/economía , Corticoesteroides/administración & dosificación , Costos de la Atención en Salud/estadística & datos numéricosRESUMEN
BACKGROUND: Patients with Crohn's disease (CD) who lose response to biologics experience reduced quality of life (QoL) and costly hospitalizations. Precision-guided dosing (PGD) provides a comprehensive pharmacokinetic (PK) profile that allows for biologic dosing to be personalized. We analyzed the cost-effectiveness of infliximab (IFX) PGD relative to two other dose intensification strategies (DIS). METHODS: We developed a hybrid (Markov and decision tree) model of patients with CD who had a clinical response to IFX induction. The analysis had a US payer perspective, a base case time horizon of 5 years, and a 4-week cycle length. There were three IFX dosing comparators: PGD; dose intensification based on symptoms, inflammatory markers, and trough IFX concentration (DIS1); and dose intensification based on symptoms alone (DIS2). Patients that failed IFX initiated ustekinumab, followed by vedolizumab, and conventional therapy. Transition probabilities for IFX were estimated from real-world clinical PK data and interventional clinical trial patient-level data. All other transition probabilities were derived from published randomized clinical trials and cost-effectiveness analyses. Utility values were sourced from previous health technology assessments. Direct costs included biologic acquisition and infusion, surgeries and procedures, conventional therapy, and lab testing. The primary outcomes were incremental cost-effectiveness ratios (ICERs). The robustness of results was assessed via one-way sensitivity, scenario, and probabilistic sensitivity analyses (PSA). RESULTS: PGD was the cost-effective IFX dosing strategy with an ICER of 122,932 $ per quality-adjusted life year (QALY) relative to DIS1 and dominating DIS2. PGD had the lowest percentage (1.1%) of patients requiring a new biologic through 5 years (8.9% and 74.4% for DIS1 and DIS2, respectively). One-way sensitivity analysis demonstrated that the cost-effectiveness of PGD was most sensitive to the time between IFX doses. PSA demonstrated that joint parameter uncertainty had moderate impact on some results. CONCLUSIONS: PGD provides clinical and QoL benefits by maintaining remission and avoiding IFX failure; it is the most cost-effective under conservative assumptions.
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Análisis Costo-Beneficio , Enfermedad de Crohn , Fármacos Gastrointestinales , Infliximab , Humanos , Infliximab/administración & dosificación , Infliximab/economía , Infliximab/uso terapéutico , Enfermedad de Crohn/tratamiento farmacológico , Adulto , Fármacos Gastrointestinales/administración & dosificación , Fármacos Gastrointestinales/economía , Fármacos Gastrointestinales/uso terapéutico , Años de Vida Ajustados por Calidad de Vida , Árboles de Decisión , Cadenas de Markov , Relación Dosis-Respuesta a Droga , Calidad de Vida , Medicina de PrecisiónRESUMEN
BACKGROUND: Biologic drugs are highly effective for inflammatory bowel disease (IBD) management but are key drivers of costs of care especially when administered intravenously (i.v.). Availability of subcutaneous (SC) formulations has increased convenience for patients and improved access to care, but at the cost of revenue to health services. AIMS: To evaluate the economic impact of transitioning a tertiary centre IBD cohort from i.v. to SC biologic administration and assess the implications for key stakeholders. METHODS: A retrospective analysis of all patients who received i.v. infliximab or vedolizumab in the outpatient infusion centre of a tertiary IBD centre between July 2019 and June 2021 was undertaken. Data were collated from electronic medical records, pharmacy dispensing systems and the hospital business intelligence unit. An economic analysis and theoretical financial/capacity impact analysis of a transition to an SC model were estimated under two scenarios using a random 10% and 30% of the patient cohort. RESULTS: Transitioning our IBD cohort from i.v. to SC administration would result in a loss to our health service of AU$2 732 123.75, composed of AU$1 463 003.75 in Weighted Inlier Equivalent Separation (WIES) and AU$1 269 120 in drug procurement revenue. However, it would ease capacity in the infusion centre by up to 5256 h. CONCLUSIONS: Transitioning patients to SC administration results in improved access to infusion centres and substantial savings to state governments; however, switching results in a loss of i.v. biologic-generated WIES to health services. Alternative funding models are required to achieve sustainability in IBD care and reduce reliance on i.v. biologic-generated income.
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Anticuerpos Monoclonales Humanizados , Fármacos Gastrointestinales , Accesibilidad a los Servicios de Salud , Enfermedades Inflamatorias del Intestino , Infliximab , Humanos , Estudios Retrospectivos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Enfermedades Inflamatorias del Intestino/economía , Infliximab/economía , Infliximab/administración & dosificación , Infliximab/uso terapéutico , Fármacos Gastrointestinales/economía , Fármacos Gastrointestinales/administración & dosificación , Fármacos Gastrointestinales/uso terapéutico , Masculino , Femenino , Anticuerpos Monoclonales Humanizados/economía , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/administración & dosificación , Adulto , Accesibilidad a los Servicios de Salud/economía , Persona de Mediana Edad , Inyecciones Subcutáneas , Administración Intravenosa , Infusiones IntravenosasAsunto(s)
Biosimilares Farmacéuticos , Biosimilares Farmacéuticos/economía , Biosimilares Farmacéuticos/uso terapéutico , Europa (Continente) , Humanos , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Infliximab/economía , Infliximab/uso terapéutico , Costos de los Medicamentos , Adalimumab/uso terapéutico , Adalimumab/economíaRESUMEN
INTRODUCTION: Rheumatoid arthritis (RA) is a chronic progressive inflammatory disease that causes joint destruction. The condition imposes a significant economic burden on patients and societies. The present study is aimed at evaluating the cost-effectiveness of Infliximab, Adalimumab, and Etanercept in treating rheumatoid arthritis in Iran. METHODS: This is a cost-effectiveness study of economic evaluation in which the Markov model was used. The study was carried out on 154 patients with rheumatoid arthritis in Fars province taking Infliximab, Adalimumab, and Etanercept. The patients were selected through sampling. In this study, the cost data were collected from a community perspective, and the outcomes were the mean reductions in DAS-28 and QALY. The cost data collection form and the EQ-5D questionnaire were also used to collect the required data. The results were presented in the form of an incremental cost-effectiveness ratio, and the sensitivity analysis was used to measure the robustness of the study results. The TreeAge Pro and Excel softwares were used to analyze the collected data. RESULTS: The results showed that the mean costs and the QALY rates in the Infliximab, Adalimumab, and Etanercept arms were $ 79,518.33 and 12.34, $ 91,695.59 and 13.25, and $ 87,440.92 and 11.79, respectively. The one-way sensitivity analysis confirmed the robustness of the results. In addition, the results of the probabilistic sensitivity analysis (PSA) indicated that on the cost-effectiveness acceptability curve, Infliximab was in the acceptance area and below the threshold in 77% of simulations. The scatter plot was in the mentioned area in 81% and 91% of simulations compared with Adalimumab and Etanercept, respectively, implying lower costs and higher effectiveness than the other two alternatives. Therefore, the strategy was more cost-effective. CONCLUSION: According to the results of this study, Infliximab was more cost-effective than the other two medications. Therefore, it is recommended that physicians use this medication as the priority in treating rheumatoid arthritis. It is also suggested that health policymakers consider the present study results in preparing treatment guidelines for RA.
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Adalimumab/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Productos Biológicos/uso terapéutico , Etanercept/uso terapéutico , Infliximab/uso terapéutico , Adalimumab/economía , Antiinflamatorios no Esteroideos/economía , Antiinflamatorios no Esteroideos/uso terapéutico , Antirreumáticos/economía , Antirreumáticos/uso terapéutico , Artritis Reumatoide/economía , Productos Biológicos/economía , Análisis Costo-Beneficio , Estudios Transversales , Etanercept/economía , Femenino , Humanos , Infliximab/economía , Irán , Masculino , Años de Vida Ajustados por Calidad de Vida , Inhibidores del Factor de Necrosis Tumoral/economía , Inhibidores del Factor de Necrosis Tumoral/uso terapéuticoRESUMEN
BACKGROUND: We aimed to examine the uptake of infliximab and etanercept biosimilars in patients with rheumatoid arthritis (RA) and its economic implication for healthcare expenditure. METHODS: Using Korean Health Insurance Review and Assessment Service National Patient Samples, we extracted RA patients who used biologic disease modifying anti-rheumatic drugs (bDMARDs) between 2009 and 2018. Descriptive statistics were used to explain the basic features of the data. We calculated the proportion of users of each bDMARD among total patients with bDMARDs half-yearly. We assessed changes in the utilization proportions of bDMARDs including 4 tumor necrosis factor inhibitors (TNFis) and 2 non-TNFis, which have been approved for RA in Korea: etanercept, infliximab, adalimumab, golimumab, tocilizumab, and abatacept, and analyzed the changes in market share of biosimilars among the bDMARDs after their introduction. Overall trends of medical costs for each bDMARD were presented over the 10-year period. RESULTS: Since the introduction of the biosimilar TNFis in 2012, the proportion of their use among bDMARDs steadily increased to 15.8% in 2018. While there has been a gradual increase in the use of biosimilar TNFis, the use of the corresponding originators has been decreasing. The introduction of biosimilar TNFis has resulted in a decrease in the medical costs of patients using either originator or biosimilar TNFis. CONCLUSION: In Korea, the proportional use of biosimilar TNFis has gradually increased since their introduction. The availability of less expensive biosimilar TNFis seems to have brought about a decrease in the medical costs of users of the originators.
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Antirreumáticos/economía , Artritis Reumatoide/tratamiento farmacológico , Biosimilares Farmacéuticos/economía , Biosimilares Farmacéuticos/uso terapéutico , Costos de la Atención en Salud/estadística & datos numéricos , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Antirreumáticos/uso terapéutico , Artritis Reumatoide/economía , Etanercept/economía , Etanercept/uso terapéutico , Humanos , Infliximab/economía , Infliximab/uso terapéutico , República de Corea , Resultado del Tratamiento , Inhibidores del Factor de Necrosis Tumoral/economíaRESUMEN
The biosimilar concept is now well established. Clinical data accumulated pre- and post-approval have supported biosimilar uptake, in turn stimulating competition in the biologics market and increasing patient access to biologics. Following technological advances, other innovative biologics, such as "biobetters" or "value-added medicines," are now reaching the market. These innovative biologics differ from the reference product by offering additional clinical or non-clinical benefits. We discuss these innovative biologics with reference to CT-P13, initially available as an intravenous (IV) biosimilar of reference infliximab. A subcutaneous (SC) formulation, CT-P13 SC, has now been developed. Relative to CT-P13 IV, CT-P13 SC offers clinical benefits in terms of pharmacokinetics, with comparable efficacy, safety, and immunogenicity, as well as increased convenience for patients and reduced demands on healthcare system resources. As was once the case for biosimilars, nomenclature and regulatory pathways for innovative biologics require clarification to support their uptake and ultimately benefit patients.
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Anticuerpos Monoclonales/administración & dosificación , Biosimilares Farmacéuticos/administración & dosificación , Desarrollo de Medicamentos , Infliximab/administración & dosificación , Administración Intravenosa , Animales , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales/economía , Anticuerpos Monoclonales/farmacocinética , Biosimilares Farmacéuticos/efectos adversos , Biosimilares Farmacéuticos/economía , Biosimilares Farmacéuticos/farmacocinética , Análisis Costo-Beneficio , Difusión de Innovaciones , Composición de Medicamentos , Costos de los Medicamentos , Desarrollo de Medicamentos/economía , Humanos , Infliximab/efectos adversos , Infliximab/economía , Infliximab/farmacocinética , Inyecciones SubcutáneasRESUMEN
In 2018, TNFα inhibitors were the highest cost drug class for Canadian public drug programs. In 2019, two Canadian provinces announced mandatory nonmedical switching policies in an attempt to reduce their costs by increasing biosimilar uptake. The national impact of similar policies across Canada is unknown. We conducted a cross-sectional analysis of monthly publicly funded prescription claims for infliximab, etanercept, and adalimumab between June 2015 and December 2019. We reported the market share of biosimilars for infliximab and etanercept in 2019 for each province and estimated the cost savings that public payers could have realized in 2019 if mandatory switching policies had been implemented across Canada, including a sensitivity analysis, which assumed that governments receive a 25% rebate on all biologics. Provincial drug programs spent CAD $991.84 million on infliximab, etanercept, and adalimumab in 2019, and, when biosimilars were available, they constituted only 15.5% of national utilization of these drugs. In British Columbia, the implementation of a mandatory switching policy for patients with rheumatic conditions increased the biosimilar market share of infliximab and etanercept by 299% (from 19.7% to 78.5%). If applied nationwide to all three biologics for all indications, we estimate such policies could lead to annual savings of between CAD $179.71 million and CAD $425.64 million nationally. The overall market share of biosimilars remains low in all provinces where mandatory switching policies have not been introduced. The cost implications of successfully increasing biosimilar uptake would be substantial, particularly as more biosimilars reach the Canadian market.
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Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Biosimilares Farmacéuticos/economía , Biosimilares Farmacéuticos/uso terapéutico , Costos de los Medicamentos , Sustitución de Medicamentos/economía , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Enfermedades Reumáticas/tratamiento farmacológico , Inhibidores del Factor de Necrosis Tumoral/economía , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Adalimumab/economía , Adalimumab/uso terapéutico , Productos Biológicos/efectos adversos , Biosimilares Farmacéuticos/efectos adversos , Canadá , Ahorro de Costo , Análisis Costo-Beneficio , Estudios Transversales , Etanercept/economía , Etanercept/uso terapéutico , Humanos , Enfermedades Inflamatorias del Intestino/economía , Infliximab/economía , Infliximab/uso terapéutico , Formulación de Políticas , Salud Pública/economía , Enfermedades Reumáticas/economía , Factores de Tiempo , Inhibidores del Factor de Necrosis Tumoral/efectos adversosRESUMEN
BACKGROUND AND OBJECTIVES: In 10% to 20% of cases, Kawasaki disease is refractory to intravenous immunoglobulin (IVIg), an expensive medication under a national shortage. Data suggest that infliximab is a viable alternative to a second dose of IVIg, with similar efficacy and safety. We compared the cost of a second IVIg dose to that of infliximab in the treatment of refractory Kawasaki disease (rKD). METHODS: A decision analysis model was used to compare rKD treatments: a second dose of IVIg at 2 g/kg versus infliximab at 10 mg/kg. Infliximab monitoring times were 24, 36, and 48 hours. Direct hospital costs beginning at rKD diagnosis were estimated by using 2016-2017 Truven MarketScan data. Redbook was used for drug costs. Calculations were applied to 3 hypothetical cohorts of 100 patients aged 2 (12.5 kg), 4 (16 kg), and 8 years (25.5 kg). Indirect costs included parental missed workdays. RESULTS: The total direct cost for children receiving IVIg was $1 677 801, $1 791 652, and $2 100 675 for the 2-, 4-, and 8-year-old cohorts. The direct cost of infliximab with 24 hours of monitoring was $853 042, $899 096, and $1 024 101, respectively. A 20% bidirectional sensitivity analysis revealed stability of our model, with overall cost savings with use of infliximab. With monitoring 48 hours after infliximab treatment, 20% changes in length of stay (LOS) tipped the balance for the 2- and 4-year-old cohorts. Overall, IVIg and infliximab LOS had the most influence on our model. CONCLUSIONS: Infliximab has potential to yield shorter LOS and significant cost savings in the treatment of rKD. Infliximab treatment, followed by 24 hours of monitoring, nearly halved hospital costs, regardless of age.
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Inmunoglobulinas Intravenosas , Infliximab , Síndrome Mucocutáneo Linfonodular , Niño , Preescolar , Costos y Análisis de Costo , Humanos , Inmunoglobulinas Intravenosas/economía , Inmunoglobulinas Intravenosas/uso terapéutico , Infliximab/economía , Infliximab/uso terapéutico , Tiempo de Internación , Síndrome Mucocutáneo Linfonodular/tratamiento farmacológico , Síndrome Mucocutáneo Linfonodular/economíaRESUMEN
BACKGROUND AND AIMS: Anti-tumour necrosis factor alpha [anti-TNF] treatment accounts for 31% of health care expenditures associated with ulcerative colitis [UC]. Withdrawal of anti-TNF in patients with UC in remission may decrease side effects and infections, while promoting cost containment. Approximately 36% of patients relapse within 12-24 months of anti-TNF withdrawal, but reintroduction of treatment is successful in 80% of patients. We aimed to evaluate the cost-effectiveness of continuation versus withdrawal of anti-TNF in patients with UC in remission. METHODS: We developed a Markov model comparing cost-effectiveness of anti-TNF continuation versus withdrawal, from a health care provider perspective. Transition probabilities were calculated from literature, or estimated by an expert panel of 11 gastroenterologists. Deterministic and probabilistic sensitivity analyses were performed to account for assumptions and uncertainty. The cost-effectiveness threshold was set at an incremental cost-effectiveness ratio of 80,000 per quality-adjusted life-year [QALY]. RESULTS: At 5 years, anti-TNF withdrawal was less costly [-10,781 per patient], but also slightly less effective [-0.04 QALY per patient] than continued treatment. Continuation of anti-TNF compared with withdrawal costs 300,390/QALY, exceeding the cost-effectiveness threshold. Continued therapy would become cost-effective if the relapse rate following anti-TNF withdrawal was ≥43% higher, or if adalimumab or infliximab [biosimilar] prices fell below 87/40 mg and 66/100 mg, respectively. CONCLUSIONS: Continuation of anti-TNF in UC patients in remission is not cost-effective compared with withdrawal. A stop-and-reintroduction strategy is cost-saving but is slightly less effective than continued therapy. This strategy could be improved by identifying patients at increased risk of relapse.
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Anticuerpos Monoclonales/economía , Biosimilares Farmacéuticos/economía , Colitis Ulcerosa/tratamiento farmacológico , Análisis Costo-Beneficio , Fármacos Gastrointestinales/economía , Infliximab/economía , Inhibidores de Proteínas Quinasas/economía , Adalimumab/administración & dosificación , Adalimumab/economía , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/economía , Biosimilares Farmacéuticos/administración & dosificación , Fármacos Gastrointestinales/administración & dosificación , Humanos , Infliximab/administración & dosificación , Cadenas de Markov , Piperidinas/administración & dosificación , Piperidinas/economía , Inhibidores de Proteínas Quinasas/administración & dosificación , Pirimidinas/administración & dosificación , Pirimidinas/economía , Años de Vida Ajustados por Calidad de Vida , Recurrencia , Inducción de Remisión , Ustekinumab/administración & dosificación , Ustekinumab/economíaRESUMEN
Over the past 2 decades, biological therapy with monoclonal antibodies targeting tumor necrosis factor-α has become a cornerstone of treatment of patients with inflammatory bowel disease. Although clinically effective, the biological therapies remain expensive, and their availability and utilization have been at times limited due to their high costs. Biosimilars are biological products similar to but not identical to the original biological agent or "reference biologic," also called "originator biologic." It is hoped that the use of biosimilars might enable these agents to become more available and, thus, decrease further expenditures related to the use of the original reference agents such as infliximab and adalimumab. In this study, we review the currently available evidence and shortcomings of these data supporting the use of biosimilars for the treatment of patients with inflammatory bowel disease, including their efficacy and safety as related to initiating therapy with biosimilar agents or switching between reference and biosimilar biologic agents.
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Biosimilares Farmacéuticos/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Adalimumab/economía , Adalimumab/uso terapéutico , Biosimilares Farmacéuticos/economía , Costos de los Medicamentos , Sustitución de Medicamentos , Gastos en Salud , Accesibilidad a los Servicios de Salud , Humanos , Infliximab/economía , Infliximab/uso terapéuticoRESUMEN
OBJECTIVE: To examine whether non-medical switching of patients with inflammatory bowel disease (IBD) from originator infliximab to a biosimilar (CT-P13, Inflectra) is safe and clinically non-inferior to continued treatment with originator infliximab. DESIGN: Prospective, open label, multicentre, parallel cohort, non-inferiority study in seven Australian hospitals over 48 weeks, May 2017 - October 2019. PARTICIPANTS: Adults (18 years or older) with IBD receiving maintenance originator infliximab (Remicade) who had been in steroid-free clinical remission for at least 12 weeks. INTERVENTION: Managed program for switching patients in four hospitals from originator to biosimilar infliximab (CT-P13); patients in three other hospitals continued to receive originator infliximab (control). MAIN OUTCOME MEASURES: Clinical disease worsening requiring infliximab dose escalation or change in therapy. RESULTS: The switch group included 204 patients, the control group 141 patients with IBD. Ten patients in the control group (7%) and 16 patients switched to CT-P13 (8%) experienced clinical deterioration; the adjusted risk difference (control v switch group) was -1.1 percentage points (95% CI, -6.1 to 8.2 percentage points), within our pre-specified non-inferiority margin of 15 percentage points. Serious adverse events leading to infliximab discontinuation were infrequent in both the switch (six, 3%) and control (six, 4%) groups. CONCLUSION: Switching patients with IBD from originator to biosimilar infliximab is safe and non-inferior to continuing treatment with originator infliximab. Moreover, the introduction of biosimilar infliximab, by increasing market competition, has resulted in substantial cost savings for the Pharmaceutical Benefits Scheme.
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Biosimilares Farmacéuticos/uso terapéutico , Fármacos Gastrointestinales/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Infliximab/uso terapéutico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Australia , Biosimilares Farmacéuticos/efectos adversos , Biosimilares Farmacéuticos/economía , Costos de los Medicamentos , Sustitución de Medicamentos , Femenino , Fármacos Gastrointestinales/efectos adversos , Fármacos Gastrointestinales/economía , Humanos , Infliximab/efectos adversos , Infliximab/economía , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Adulto JovenRESUMEN
INTRODUCTION: Medications are major cost drivers in the treatment of patients with inflammatory bowel disease. Recent analyses suggest that there is no added efficacy in continuing nor harm in stopping 5-aminosalicylate (ASA) therapy in patients with inflammatory bowel disease escalated to biological therapies or tofacitinib. We assessed the cost-effectiveness of discontinuing 5-ASA therapy in patients with ulcerative colitis on biological therapies or tofacitinib, compared with continuing 5-ASA therapy. METHODS: We performed a cost-effectiveness analysis of 5-ASA with biologic therapy and tofacitinib compared with the same treatment without 5-ASA. Our primary outcome was to determine whether biologic/tofacitinib monotherapy was cost-effective compared with biologic/tofacitinib and 5-ASA combination therapy using the incremental cost-effectiveness ratio at a willingness to pay of $50,000/quality-adjusted life year. Owing to the uncertainty surrounding outcome probabilities, probabilistic sensitivity analyses with 10,000 simulations were also performed. We conducted a sensitivity analysis comparing biologic/tofacitinib and 5-ASA therapy compared with biologic/tofacitinib monotherapy, whereby vedolizumab was the first biologic used, followed by infliximab and finally tofacitinib. RESULTS: Our model shows that biologic/tofacitinib monotherapy dominates (cheaper and more effective) combination therapy of biologics/tofacitinib with 5-ASA. Probabilistic sensitivity analyses simulations resulted in biologic/tofacitinib monotherapy dominating 100% of the scenarios, with mean cost savings of $24,483.01 over 2 years. When vedolizumab was the first-line therapy in the sensitivity analysis, biologic/tofacitinib monotherapy continued to dominate the combination of 5-ASA and biologic/tofacitinib therapy. DISCUSSION: This analysis in patients with ulcerative colitis who require treatment with biologics or tofacitinib demonstrates that continuing 5-ASA therapy is not a cost-effective strategy. Discontinuation of 5-ASA therapy in these patients is safe and less expensive and should be recommended.
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Antiinflamatorios no Esteroideos/uso terapéutico , Colitis Ulcerosa/tratamiento farmacológico , Fármacos Gastrointestinales/uso terapéutico , Mesalamina/uso terapéutico , Piperidinas/uso terapéutico , Inhibidores de Proteínas Quinasas/uso terapéutico , Pirimidinas/uso terapéutico , Antiinflamatorios no Esteroideos/economía , Anticuerpos Monoclonales Humanizados/economía , Anticuerpos Monoclonales Humanizados/uso terapéutico , Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Colitis Ulcerosa/economía , Colitis Ulcerosa/fisiopatología , Análisis Costo-Beneficio , Deprescripciones , Quimioterapia Combinada , Fármacos Gastrointestinales/economía , Humanos , Infliximab/economía , Infliximab/uso terapéutico , Cadenas de Markov , Mesalamina/economía , Piperidinas/economía , Inhibidores de Proteínas Quinasas/economía , Pirimidinas/economía , Años de Vida Ajustados por Calidad de VidaRESUMEN
OBJECTIVE: To review patients who were treated at Tokai University Hospital with biologic agents for psoriasis vulgaris and psoriatic arthritis and analyze the biological retention rate, reasons for switching biologics, and investigate possible clinical prognostic factor which may affect whether a patient preferred one biologic to another. METHODS: Clinical courses of 63 patients who received biologic agents between Sep of 2010 to June of 2019 were investigated. Biological retention rate of each biologic agents, reasons of switching to another biologic agent, and prognostic factors, if any, between switched and non-switched patients were examined. RESULTS: The biological retention rate of ustekinumab (UST) was significantly longer than that of infliximab (IFX) or adalimumab (ADA). The major reason of switching was due to secondary loss of efficacy. Patients being treated with UST were more likely to switch to another biologic when they exhibited nail lesions. CONCLUSION: These results suggested that biological retention rate of UST was superior than that of IFX or ADA. Furthermore, with patients administered UST, nail symptom suggested possible clinical prognostic factor for switching to other biologic agents.
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Adalimumab/uso terapéutico , Factores Biológicos/uso terapéutico , Razonamiento Clínico , Sustitución de Medicamentos , Infliximab/uso terapéutico , Psoriasis/tratamiento farmacológico , Ustekinumab/uso terapéutico , Adalimumab/efectos adversos , Adalimumab/economía , Adulto , Artritis Psoriásica/tratamiento farmacológico , Factores Biológicos/efectos adversos , Factores Biológicos/economía , Femenino , Humanos , Infliximab/efectos adversos , Infliximab/economía , Masculino , Persona de Mediana Edad , Enfermedades de la Uña/etiología , Pronóstico , Prurito/etiología , Estudios Retrospectivos , Resultado del Tratamiento , Ustekinumab/efectos adversos , Ustekinumab/economíaRESUMEN
OBJECTIVE: Despite the biological drugs, the treatment of moderate to severe ulcerative colitis is still a challenge, particularly in resource-limited settings. The aim of this study was to assess the efficiency of biological drugs and tofacitinib for moderate to severe ulcerative colitis in the Spanish context. METHODS: A Markov model was built to simulate the progression of moderate to severe ulcerative colitis in a cohort of patients. The model used a time horizon of 10 years. The perspective chosen was the National Health Service, with a discount rate of 3%, and a threshold of 30,000/quality adjusted life-year (QALY). It carried out a one-way sensitivity analysis and probabilistic sensitivity analysis. RESULTS: The comparison of infliximab with adalimumab and golimumab estimated an incremental cost-effectiveness ratio (ICER) of 43,928.07/QALY and 31,340.69/QALY, with a difference of - 0.43 and - 0.82 QALY, respectively. Vedolizumab vs infliximab achieved an ICER of 122,890.19/QALY with a gain of 0.46 QALY. The comparison of infliximab with tofacitinib yielded an estimated ICER of 270,503.19/QALY, with a slight gain in QALY (0.16). The one-way sensitivity analysis showed a robust study. CONCLUSION: For a threshold of 30,000/QALY, adalimumab was the most cost-effective treatment versus infliximab for moderate to severe ulcerative colitis in Spain.