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1.
Medicine (Baltimore) ; 99(2): e18723, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31914087

RESUMO

Effectiveness, efficacy and safety of biosimilar infliximab (CT-P13) in inflammatory bowel disease (IBD) patients has been shown in previous studies. Limited data exist on health-related quality of life (HRQoL) of switching originator to biosimilar infliximab (IFX) in IBD patients. The objective of this study was to evaluate impact of switching originator to biosimilar IFX on HRQoL, disease activity, and health care costs in IBD maintenance treatment.In this single-center prospective observational study, all IBD patients receiving maintenance IFX therapy were switched to biosimilar IFX. HRQoL was measured using the generic 15D health-related quality of life instrument (15D) utility measurement and the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ). Crohn Disease Activity Index (CDAI) or Partial Mayo Score (pMayo), and fecal calprotectin (FC) served for evaluation of disease activity. Data were collected at time of switching and 3 and 12 months after switching. Patients' characteristics, clinical background information and costs were collected from patient records and the hospital's electronic database.Fifty-four patients were included in the analysis. No statistically significant changes were observed in 15D, CDAI, pMayo, and FC during 1-year follow-up. IBDQ scores were higher (P = .018) in Crohn disease 3 months after switching than at time of switching. Costs of biosimilar IFX were one-third of costs of originator one. Total costs related to secondary health care (excluding costs of IFX), were similar before and after the onset of biosimilar IFX.HRQoL and disease activity were after switching from originator to biosimilar IFX comparable, but the costs of biosimilar IFX were only one-third of those of the originator one.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Fármacos Gastrointestinais/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/uso terapêutico , Qualidade de Vida , Adulto , Anticorpos Monoclonais/economia , Medicamentos Biossimilares/economia , Substituição de Medicamentos/economia , Feminino , Fármacos Gastrointestinais/economia , Recursos em Saúde/economia , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Infliximab/economia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Indução de Remissão
2.
BMC Health Serv Res ; 19(1): 827, 2019 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-31718624

RESUMO

BACKGROUND: In 2014 and 2015, biosimilars for the drugs filgrastim, infliximab, and insulin glargine were approved for use in Canada. The introduction of biosimilars in Canada could provide significant cost savings for the Canadian healthcare system over originator biologic drugs, however it is known that the use of biosimilars varies widely across the world. The aim of this study was to estimate the use of biosimilars in Canada and potential cost-savings from their use. METHODS: We performed a retrospective analysis of Canadian drug purchases for filgrastim, infliximab, and insulin glargine from July 2016 to June 2018. This was a cross-sectional study and the time horizon was limited to the study period. As a result, no discounting of effects over time was included. Canadian drugstore and hospital purchases data, obtained from IQVIA™, were used to estimate the costs per unit and unit volume for biosimilars and originator biologic drugs within each province. Potential cost-savings were calculated as a product of the units of reference originator product purchased and the cost difference between the originator biologic and its corresponding biosimilar. RESULTS: The purchase of biosimilars varied by each province in Canada, ranging from a low of 0.1% to a high of 81.6% of purchases. In total, $1,048,663,876 Canadian dollars in savings could have been realized with 100% use of biosimilars over the originator products during this 2 year time period. The potential savings are highest in the province of Ontario ($349 million); however, even in smaller markets (PEI and Newfoundland), $28 million could have potentially been saved. Infliximab accounted for the vast majority of the potential cost-savings, whereas the purchases of the biosimilar filgrastim outpaced that of the originator drug in some provinces. In sensitivity analyses assuming only 80% of originator units would be eligible for use as a biosimilar, $838 million dollars in cost savings over this two-year time period would still have been realized. CONCLUSIONS: The overall use of biosimilar drugs in Canada is low. Policy makers, healthcare providers, and patients need to be informed of potential savings by increased use of biosimilars, particularly in an increasingly costly healthcare system.


Assuntos
Medicamentos Biossimilares/economia , Redução de Custos , Filgrastim/economia , Infliximab/economia , Insulina Glargina/economia , Estudos Transversais , Bases de Dados Factuais , Humanos , Terra Nova e Labrador , Ontário , Estudos Retrospectivos
3.
Expert Rev Pharmacoecon Outcomes Res ; 19(5): 537-549, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31340686

RESUMO

Introduction: Early biological treatment of rheumatoid arthritis (RA) may reverse the autoimmune response in some patients resulting in favorable long-term outcomes. Although the cost-effectiveness of this strategy has been questioned, biosimilar entries warrant the revision of clinical and pharmaco-economic evidence. Areas covered: We conducted a systematic review of randomized controlled trials (RCTs) published up to 24 May 2018 in Pubmed, EMBASE and Cochrane CENTRAL, comparing infliximab with non-biological therapy in patients with RA naïve to methotrexate. We performed meta-analyses for efficacy outcomes at month 6 and years 1 and 2. Six RCTs were identified, involving 1832 patients. At month 6 ACR70 response and remission, and at year 1 ACR20/ACR70 responses and remission were improved significantly with first-line infliximab versus control. The differences were not significant at year 2. We reviewed cost-utility studies, up to 31 October 2018 in PubMed, Cochrane CENTRAL and the CRD HTA databases. Four studies indicated that first-line use of originator infliximab calculated at 2005-2008 prices was not cost-effective. Expert opinion: We demonstrated the efficacy benefits of first-line infliximab therapy up to 1 year in methotrexate-naïve RA. We highlighted the need for standardized reporting of outcomes and conducting cost-effectiveness analyses of first-line biosimilar therapy in RA.


Assuntos
Antirreumáticos/administração & dosagem , Artrite Reumatoide/tratamento farmacológico , Infliximab/administração & dosagem , Antirreumáticos/economia , Artrite Reumatoide/economia , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/economia , Análise Custo-Benefício , Farmacoeconomia , Humanos , Infliximab/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento
4.
Gut ; 68(10): 1774-1780, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31233395

RESUMO

OBJECTIVE: Evaluate the cost-effectiveness of laparoscopic ileocaecal resection compared with infliximab in patients with ileocaecal Crohn's disease failing conventional therapy. DESIGN: A multicentre randomised controlled trial was performed in 29 centres in The Netherlands and the UK. Adult patients with Crohn's disease of the terminal ileum who failed >3 months of conventional immunomodulators or steroids without signs of critical strictures were randomised to laparoscopic ileocaecal resection or infliximab. Outcome measures included quality-adjusted life-years (QALYs) based on the EuroQol (EQ) 5D-3L Questionnaire and the Inflammatory Bowel Disease Questionnaire (IBDQ). Costs were measured from a societal perspective. Analyses were performed according to the intention-to-treat principle. Missing cost and effect data were imputed using multiple imputation. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated to show uncertainty. RESULTS: In total, 143 patients were randomised. Mean Crohn's disease total direct healthcare costs per patient at 1 year were lower in the resection group compared with the infliximab group (mean difference €-8931; 95% CI €-12 087 to €-5097). Total societal costs in the resection group were lower than in the infliximab group, however not statistically significant (mean difference €-5729, 95% CI €-10 606 to €172). The probability of resection being cost-effective compared with infliximab was 0.96 at a willingness to pay (WTP) of €0 per QALY gained and per point improvement in IBDQ Score. This probability increased to 0.98 at a WTP of €20 000/QALY gained and 0.99 at a WTP of €500/point of improvement in IBDQ Score. CONCLUSION: Laparoscopic ileocaecal resection is a cost-effective treatment option compared with infliximab. CLINICAL TRIAL REGISTRATION NUMBER: Dutch Trial Registry NTR1150; EudraCT number 2007-005042-20 (closed on 14 October 2015).


Assuntos
Colectomia/métodos , Doença de Crohn/terapia , Custos de Cuidados de Saúde , Ileíte/terapia , Infliximab/uso terapêutico , Laparoscopia/economia , Adulto , Ceco/cirurgia , Colectomia/economia , Análise Custo-Benefício , Doença de Crohn/economia , Feminino , Seguimentos , Fármacos Gastrointestinais/economia , Fármacos Gastrointestinais/uso terapêutico , Humanos , Ileíte/diagnóstico , Ileíte/economia , Íleo/cirurgia , Infliximab/economia , Masculino , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
5.
BioDrugs ; 33(3): 285-297, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30945207

RESUMO

BACKGROUND: Decentralisation of healthcare budgets and issuance of local guidelines means that the use of biosimilars can vary by region within a particular country, for example between the 21 counties of Sweden. OBJECTIVES: This study aimed to analyse the county-level market dynamics of biosimilar and originator infliximab, which are hospital products, and to examine how local policy measures and practices, in addition to national policy, influenced market dynamics. METHODS: We first conducted a literature review on (biosimilar) policies in Sweden, then analysed market data provided by IQVIA™ on uptake of originator and biosimilar infliximab within the different counties (Q2 2012 to Q4 2017), including discounts from (tender) contracts. Biosimilar market shares were calculated with volume data (measured as defined daily doses [DDDs]). We then discussed our findings in semi-structured interviews with the national pricing and reimbursement agency, key experts within the county councils of Skåne, Västra Götaland, and Stockholm, and an industry representative. RESULTS: Market shares of biosimilar infliximab vary widely between counties (range 18-96% in 2017). The initial uptake of biosimilar infliximab was slow and variable, with abrupt increments in biosimilar market shares coinciding with expiration of contracts for the originator product. Different approaches taken by counties to achieve a low cost per DDD of infliximab were identified, i.e., a rapid switch to the biosimilar (Skåne), a delayed switch to the biosimilar (Stockholm), or no switch to the biosimilar when a favourable price on the originator product could be obtained (Västra Götaland). Quantitative analysis showed that 59% of the variability in biosimilar market shares could be explained by the relative difference in discounted price between the biosimilar and the originator product. In addition, qualitative analysis indicated the presence of key opinion leaders, local guidelines and initiatives, and whose budget it affects as drivers in the decision-making process. CONCLUSIONS: Variations in the market share of biosimilar infliximab between the Swedish counties is largely explained by the discounted price difference between biosimilar and originator product, and counties used different strategies to leverage such biosimilar competition. Additionally, the presence of key opinion leaders, local guidelines and gainsharing arrangements appeared to play a role in infliximab market dynamics in counties.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Infliximab/uso terapêutico , Anticorpos Monoclonais/economia , Medicamentos Biossimilares/economia , Custos e Análise de Custo/economia , Humanos , Infliximab/economia , Suécia
6.
Int J Rheum Dis ; 22(6): 995-1001, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30989813

RESUMO

AIM: We evaluated the effects of anti-tumor necrosis factor (TNF) agents on health economics in ankylosing spondylitis (AS) patients. METHODS: QUality of Life as Outcomes and its VAriation with DIsease States (QUO-VADIS) was a prospective observational study following bio-naïve AS patients (modified New York criteria) newly treated with golimumab (GLM) or infliximab (IFX; originator) in a clinical practice setting over 6 months. We evaluated use of concomitant medications, hospitalizations (in-patient care or acute care) and visits in day care and out-patient settings for the assessment of healthcare resource utilization (HCRU). Work productivity and activity impairment (WPAI) was assessed by the number of work days missed and quantifying absenteeism, presenteeism, work impairment, and activity using the WPAI instrument adapted to spondyloarthritis (WPAI-SpA). RESULTS: Nine hundred and sixty-three patients received ≥1 dose of medication (78%, n = 751 GLM; 22%, n = 221 IFX). Mean age was 42.7 years; 61.4% were male. At baseline, the percentage of patients who reported hospitalizations (in-patient care) was 13.6%, which decreased to 3.1% at 6 months, while out-patient care at baseline was reported by 39.4% of patients, which decreased to 19.0% at 6 months. The percentage of patients receiving acute emergency at baseline reduced from 1.6% to 0.3% at 6 months. The mean (SD) number of days of work missed due to AS, was reduced from 6.3 (31.1) days at baseline to 2.7 (12.3) days at 6 months. CONCLUSION: In patients with AS newly treated with GLM or IFX for 6 months, HCRU was reduced and work productivity and activity increased.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Antirreumáticos/uso terapêutico , Eficiência , Infliximab/uso terapêutico , Espondilite Anquilosante/tratamento farmacológico , Desempenho Profissional , Absenteísmo , Adulto , Anticorpos Monoclonais/economia , Antirreumáticos/economia , Análise Custo-Benefício , Custos de Medicamentos , Feminino , Humanos , Infliximab/economia , Masculino , Presenteísmo , Estudos Prospectivos , Qualidade de Vida , Recuperação de Função Fisiológica , Licença Médica , Espondilite Anquilosante/diagnóstico , Espondilite Anquilosante/economia , Espondilite Anquilosante/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Desempenho Profissional/economia
7.
J Med Econ ; 22(9): 859-868, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31012362

RESUMO

Aims: To evaluate the cost differences between a treatment strategy including tofacitinib (TOFA) vs treatment strategies including adalimumab (ADA), golimumab (GOL), infliximab (IFX), and vedolizumab (VEDO) among all patients with moderate-to-severe ulcerative colitis (UC) (further stratified by patients naïve/exposed to tumor necrosis factor inhibitors [TNFis]). Materials and methods: An Excel-based decision-analytic model was developed to evaluate costs from the perspective of a third-party US payer over 2 years. Efficacy and safety parameters were taken from prescribing information and published trials. All patients started induction therapy on the first treatment in the strategy and continued if efficacy criteria were met and no major adverse event occurred (in which cases they proceeded to the next treatment in the strategy). Results: The cost per member per month (PMPM) of the TOFA->IFX->VEDO->GOL strategy ($1.11) was lower than that of the ADA->IFX->VEDO->GOL strategy ($1.34; Δ = $-0.23) among the TNFi-naïve population (n = 204 patients out of a plan of one million members). Similarly, the use of TOFA before ADA (i.e. TOFA->ADA->IFX-> VEDO) was also associated with lower PMPM costs than the use of ADA before TOFA (i.e. ADA->TOFA->IFX->VEDO): $1.15 vs $1.25 (Δ = $-0.10). Similar, and often larger, differences were observed in both the overall moderate-to-severe population and the TNFi-exposed population. Sensitivity analyses resulted in the same conclusions. Limitations: Our model relied on efficacy data from prescribing information and published trials, which were not head-to-head and slightly differed with respect to methods. Additionally, our model used representative minor and major ADRs (and the associated costs) to represent toxicity management, which was a simplifying assumption. Conclusions: This analysis, the first of its kind to evaluate TOFA vis-à-vis other advanced therapies in the US, suggests the early use of TOFA among both TNFi-naïve and TNFi-failure patients results in lower PMPM costs compared with other treatment alternatives.


Assuntos
Colite Ulcerativa/tratamento farmacológico , Fármacos Gastrointestinais/economia , Fármacos Gastrointestinais/uso terapêutico , Gastos em Saúde/estatística & dados numéricos , Piperidinas/economia , Piperidinas/uso terapêutico , Pirimidinas/economia , Pirimidinas/uso terapêutico , Pirróis/economia , Pirróis/uso terapêutico , Adalimumab/economia , Adalimumab/uso terapêutico , Anticorpos Monoclonais/economia , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados/economia , Anticorpos Monoclonais Humanizados/uso terapêutico , Análise Custo-Benefício , Fármacos Gastrointestinais/efeitos adversos , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Infliximab/economia , Infliximab/uso terapêutico , Modelos Econométricos , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Piperidinas/efeitos adversos , Pirimidinas/efeitos adversos , Pirróis/efeitos adversos , Índice de Gravidade de Doença , Fator de Necrose Tumoral alfa/agonistas , Estados Unidos
8.
Actas Dermosifiliogr ; 110(7): 546-553, 2019 Sep.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-30851873

RESUMO

BACKGROUND AND OBJECTIVES: Psoriasis is a chronic inflammatory skin disease with an estimated prevalence in Spain of 2.3% of the population. Approximately 30% of patients have moderate-to-severe forms. Treatment with biologic agents is proving to be a step forward in the management of the disease, although these treatments are very expensive. The objective of this study was to determine the efficiency, in terms of cost per number needed to treat (NNT), of the biologic drugs available in Spain for the treatment of moderate to severe plaque psoriasis. METHODS: NNT data were obtained from a network meta-analysis that included all randomized clinical trials of biologic drugs sold in Spain. The cost of each treatment was calculated based on the approved dosage for the first year of treatment, as indicated in the Summary of Product Characteristics. These data were used to calculate the cost per NNT of the drugs for various PASI scores (75, 90, and 100). A sensitivity analysis was performed taking into consideration only the PASI-response measurement time (after 10, 12, or 16 weeks, depending on the drug). RESULTS: The order of efficiency, from most to least efficient, in the case of a PASI 75 response was ixekizumab > ustekinumab 45mg > ustekinumab 90mg > secukinumab > infliximab > etanercept > adalimumab. The order for PASI 90 was ixekizumab >secukinumab >ustekinumab 45mg > ustekinumab 90mg > infliximab > adalimumab > etanercept. The order for PASI 100 was ixekizumab > secukinumab > infliximab > ustekinumab 90mg > ustekinumab 45mg > adalimumab > etanercept. The sensitivity analysis showed some changes in the order, depending on the response-assessment period. CONCLUSIONS: The findings show a link between the efficacy of the biologic therapies available in Spain for the treatment of moderate-to-severe plaque psoriasis and their efficiency. Ixekizumab had the lowest cost per NNT for all PASI-response scores (75, 90, and 100) during the first year of treatment.


Assuntos
Custos de Medicamentos , Números Necessários para Tratar , Psoríase/tratamento farmacológico , Adalimumab/administração & dosagem , Adalimumab/economia , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/economia , Etanercepte/administração & dosagem , Etanercepte/economia , Humanos , Infliximab/administração & dosagem , Infliximab/economia , Metanálise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto , Sensibilidade e Especificidade , Índice de Gravidade de Doença , Espanha , Resultado do Tratamento , Ustekinumab/administração & dosagem , Ustekinumab/economia
9.
J Crohns Colitis ; 13(10): 1323-1333, 2019 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-30893421

RESUMO

OBJECTIVES: To examine the cost-effectiveness of continued treatment for patients with moderate-severe Crohn's disease in clinical remission, with a combination of anti-tumour necrosis factor alpha [anti-TNFα] [infliximab] and immunomodulator therapy compared with two different withdrawal strategies: [1] withdrawal of the anti-TNFα therapy; and [2] withdrawal of the immunomodulator therapy, respectively. METHODS: A decision-tree model was constructed mimicking three treatment arms: [1] continued combination therapy with infliximab and immunomodulator; [2] withdrawal of infliximab; or [3] withdrawal of the immunomodulator. Relapses in each arm are managed with treatment intensification and re-institution of the de-escalated drug according to a prespecified algorithm. State-dependent relapse risks, remission probabilities, and quality of life weights were collected from previous published studies. RESULTS: Combination therapy was less costly and more efficient than the withdrawal of the immunomodulator, and more costly and more efficient than withdrawal of infliximab. Whether or not combination therapy is cost-effective, compared with the alternatives, depends primarily on current pharmaceutical prices and the willingness-to-pay per additional quality-adjusted life-year [QALY]. CONCLUSIONS: Combination therapy using a combination of anti-TNFα [infliximab] and an immunomodulator is cost-effective in the treatment of Crohn's disease compared with treatment cycles in which the immunomodulator is withdrawn. Combination treatment is cost-effective compared with treatment cycles in which infliximab is withdrawn, at prices of infliximab below€192/100 mg, given a willingness-to-pay threshold at€49 020 [Sweden] per additional QALY.


Assuntos
Terapia Biológica/economia , Doença de Crohn/economia , Terapia Biológica/métodos , Análise Custo-Benefício , Doença de Crohn/tratamento farmacológico , Árvores de Decisões , Custos de Medicamentos , Quimioterapia Combinada/economia , Custos de Cuidados de Saúde , Humanos , Fatores Imunológicos/administração & dosagem , Fatores Imunológicos/economia , Fatores Imunológicos/uso terapêutico , Infliximab/administração & dosagem , Infliximab/economia , Infliximab/uso terapêutico , Método de Monte Carlo , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida
12.
J Dermatolog Treat ; 30(4): 376-382, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30256686

RESUMO

Background: There is limited evidence regarding biologics dosing patterns and its costs among psoriasis patients in the United Kingdom (UK). Objective: This retrospective study assessed biologics dose increase beyond labelled dose and associated UK pharmacy costs in moderate to severe psoriasis patients. Methods: Adult psoriasis patients on biologic prescription for ≥12 continuous months between January 2010 and March 2015 with their diagnosis recorded in the UK Hospital Treatment Insights Database within one month of such prescription were included. The proportion of patients receiving ≥30% higher the average daily maintenance dose as per the UK product label, and associated 12-month costs were reported. Results: The study included 362 patients, receiving adalimumab (48%), etanercept (17%), ustekinumab (12%), and infliximab (23%). Beyond labelled dose increase was noted in 14% adalimumab, 20% etanercept, 18% ustekinumab and 28% infliximab patients with an associated mean annual extra cost per patient of £7936, £5912, £2422 and £2275, respectively. Conclusion: Dose increase beyond labelled dose of biologics was commonly observed in moderate to severe psoriasis in the UK and resulted in substantial annual incremental pharmacy costs.


Assuntos
Produtos Biológicos/administração & dosagem , Produtos Biológicos/economia , Psoríase/tratamento farmacológico , Adalimumab/administração & dosagem , Adalimumab/economia , Adulto , Custos e Análise de Custo , Bases de Dados Factuais , Etanercepte/administração & dosagem , Etanercepte/economia , Feminino , Humanos , Infliximab/administração & dosagem , Infliximab/economia , Masculino , Pessoa de Meia-Idade , Farmácias/economia , Estudos Retrospectivos , Reino Unido , Ustekinumab/administração & dosagem , Ustekinumab/economia
13.
Dig Liver Dis ; 51(1): 112-119, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30268737

RESUMO

BACKGROUND: Drug de-escalation is considered in Crohn's disease patients in sustained remission on optimized infliximab treatment. AIM: We built a model to evaluate the magnitude of cost savings in patients' disease course with or without drug de-escalation guided by infliximab trough levels. METHODS: We designed 4 virtual cohorts (P1-P4) of 10,000 patients in clinical remission on optimized infliximab treatment followed for 2 years. P1: no drug de-escalation - 10 mg/kg/8 weeks; P2: drug de-escalation from 10 mg/kg/8 weeks to 5 mg/kg/8 weeks according to trough levels; P3: no drug de-escalation - 10 mg/kg/6 weeks; and P4: drug de-escalation from 10 mg/kg/6 weeks to 10 mg/kg/8 weeks according to trough levels. For P2 and P4 cohorts, drug de-escalation was decided if trough levels were ≥7 µg/mL and no de-escalation if trough levels were <7 µg/mL. Only costs related to drug administration were considered. RESULTS: The cost differences when comparing P1 versus P2 and P3 versus P4 were 7.6% and 4.6%, respectively, corresponding to costs savings of €30.5 millions and €20.3 million for 10,000 patients. CONCLUSION: Over a 2-year period, infliximab de-escalation according to trough levels led to cost saving of about 6%, corresponding to around €25.4 million.


Assuntos
Redução de Custos/estatística & dados numéricos , Doença de Crohn/tratamento farmacológico , Fármacos Gastrointestinais/economia , Infliximab/economia , Adulto , Anticorpos Monoclonais , Relação Dose-Resposta a Droga , Feminino , Fármacos Gastrointestinais/administração & dosagem , Fármacos Gastrointestinais/efeitos adversos , Humanos , Infliximab/administração & dosagem , Infliximab/efeitos adversos , Estudos Longitudinais , Masculino , Indução de Remissão
14.
Curr Med Chem ; 26(2): 259-269, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-28393687

RESUMO

Biological drugs revolutionized the treatment of inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. However, not all clinically eligible patients have access to biologicals due to significant costs and budget impact. Biosimilars are highly comparable to their originator product in terms of clinical efficacy and safety. Biosimilars are priced 15-75% lower than their reference product, which makes them a less costly alternative and is expected to offer better patients access to biologicals. The total projected cost savings are significant. If the achieved budget savings were used to cover more biological therapy, several additional IBD patients could be treated. Currently, the main barriers to the increasing uptake of biosimilars are the few incentives of the key stakeholders, while physicians' and patients' skepticism towards biosimilars seems to be changing. Over the coming years, biosimilars are expected to gain a growing importance in the treatment of IBD, contributing to a better access to treatment, improving population-level health gain and sustainability of health systems. This review summarizes the results of the literature on the economic considerations of biosimilars in IBD and the role of biosimilar infliximab in the treatment of IBD.


Assuntos
Anti-Inflamatórios não Esteroides/economia , Medicamentos Biossimilares/economia , Farmacoeconomia , Doenças Inflamatórias Intestinais/economia , Anti-Inflamatórios não Esteroides/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Análise Custo-Benefício , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Doenças Inflamatórias Intestinais/terapia , Infliximab/economia , Infliximab/uso terapêutico
15.
J Manag Care Spec Pharm ; 24(10): 1028-1033, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30247103

RESUMO

BACKGROUND: Infliximab dose rounding is a commonly accepted practice at many institutions to contain costs. Currently, there is limited data on the clinical and financial implications of infliximab dose rounding standardization. OBJECTIVE: To determine whether standardized infliximab dose rounding is comparable with nonstandardized dosing in patients with Crohn's disease or ulcerative colitis in terms of cost and efficiency, using a cost comparison between the 2 dosing methods at an outpatient infusion center attached to a community teaching hospital. METHODS: A retrospective electronic chart review was conducted to identify patients who received infliximab for ulcerative colitis or Crohn's disease over a 6-month period. The primary endpoint was cost comparison between the 2 dosing methods. The secondary outcomes were estimated time taken for order verification, number of order clarifications, increase in dose or frequency of infliximab, number of patients who switched to alternative therapy, and use of medications for adverse drug effects. Descriptive statistics and Fisher's exact test were used for data analysis. RESULTS: 72 patients met the inclusion criteria. Because of patient overlap during the study period, 45 patients (62.5%) were in the standardized rounding arm, and 69 patients (95.8%) were in the nonstandardized rounding arm. One patient in each arm required an increased dose or frequency of infusion (2.2% vs. 1.5%, P = 1.000). Standardized infliximab dose rounding had a theoretical cost savings of at least $104,640 per year (based on our rough annual census of 480 patients) compared with the nonstandardized method that had been used previously. The cost savings can also be translated as $218 per patient per month on average. The mean times to order verification were 10 vs. 12 minutes in the nonstandardized and standardized groups, respectively. Two patients in the nonstandardized group switched to alternative therapy. There was no difference in usage of rescue medications for adverse drug effects. CONCLUSIONS: Standardization of infliximab dose rounding resulted in increased efficiency in the pharmacy workflow by reducing time for order verification. Furthermore, standardized dose rounding resulted in a significant reduction in expenditure for infliximab for the institution. DISCLOSURES: No outside funding supported this research. The authors have nothing to disclose. This research was presented as a poster at the ASHP Midyear Clinical Meeting & Exhibition 2017; December 3-7, 2017; Orlando, FL.


Assuntos
Assistência Ambulatorial/economia , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/economia , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/economia , Doença de Crohn/tratamento farmacológico , Doença de Crohn/economia , Custos de Medicamentos , Custos Hospitalares , Infliximab/administração & dosagem , Infliximab/economia , Ambulatório Hospitalar/economia , Adulto , Colite Ulcerativa/diagnóstico , Redução de Custos , Análise Custo-Benefício , Doença de Crohn/diagnóstico , Cálculos da Dosagem de Medicamento , Feminino , Gastos em Saúde , Hospitais Comunitários/economia , Hospitais de Ensino/economia , Humanos , Masculino , Serviço de Farmácia Hospitalar/economia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Fluxo de Trabalho
17.
J Med Econ ; 21(11): 1102-1109, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30101633

RESUMO

AIMS: Increasing use of biologics has led to interest in treatment components with potential for cost savings. This study was aimed at comparing administration times and associated costs of infliximab and vedolizumab infusions for inflammatory bowel disease (IBD). MATERIALS AND METHODS: This study used claims data from the Symphony Health Integrated Dataverse to identify IBD patients using infliximab or vedolizumab between 20 May 2014 and 29 February 2016. Use of Current Procedural Terminology administration codes was evaluated and costs calculated using the 2016 Center for Medicare and Medicaid Services Physician Fee Schedule. Assessments included infusion times, associated costs, productivity loss using average wage estimates from the United States Bureau of Labor Statistics, and home infusion adoption. RESULTS: A total of 10,051 infliximab and 3114 vedolizumab patients with first-hour claims were identified; 52.0% were female and 64.5% had Crohn's disease. There were 48,377 infliximab first-hour claims (mean 4.8 infusions per patient); 46,462 (96.0%) had a second-hour claim. In comparison, there were 14,717 vedolizumab claims (mean 4.7 infusions per patient), with only 411 (2.8%) second-hour claims, resulting in vedolizumab cost savings of approximately $1.27 million. The difference in second-hour infusions resulted in 46,051 additional hours of productivity loss with infliximab, and lost wages averaging $1.18 million (range $0.68-$1.77 million). LIMITATIONS: Administration costs were inferred as charge costs and not directly assessed. Productivity loss assessed time spent on infusion only, and included a small proportion of patients beyond working age. CONCLUSIONS: Second-hour infusion billing was significantly lower with vedolizumab than with infliximab, corresponding to cost savings and reduced productivity loss.


Assuntos
Anticorpos Monoclonais Humanizados/economia , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/economia , Adulto , Anticorpos Monoclonais Humanizados/administração & dosagem , Eficiência , Feminino , Gastos em Saúde , Serviços de Assistência Domiciliar/economia , Humanos , Infliximab/administração & dosagem , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Modelos Econométricos , Estudos Retrospectivos , Fatores de Tempo , Estados Unidos
18.
BMC Dermatol ; 18(1): 5, 2018 07 11.
Artigo em Inglês | MEDLINE | ID: mdl-29996929

RESUMO

BACKGROUND: Biological therapies (BTs) including infliximab (IFX), adalimumab (ADL), secukinumab (SCK) and ustekinumab (UST) are approved in Japan for the treatment of psoriasis. Although the persistence rates and medical costs of BTs treatment have been investigated in multiple foreign studies in recent years, few such studies have been conducted in Japan and the differences between patients who adhered to treatment and those who did not have not been reported. This study is aimed at investigating the persistence rates and medical costs of BTs in the treatment of psoriasis in Japan, using the real-world data from a large-scale claims database. METHODS: Claims data from the JMDC database (August 2009 to December 2016) were used for this analysis. Patient data were extracted using the ICD10 code for psoriasis and claims records of BT injections. Twelve-month and 24-month persistence rates of BTs were estimated by Kaplan-Meier methodology, and 12-month-medical costs before and after BT initiation were compared between persistent and non-persistent patient groups at 12 months. RESULTS: A total of 205 psoriasis patients treated with BTs (BT-naïve patients: 177) were identified. The 12-month/24-month persistence rates for ADL, IFX, SCK, and UST in BT-naïve patients were 46.8% ± 16.6%/46.8 ± 16.6%, 53.0% ± 14.9%/41.0% ± 15.5%, 55.4%/55.4% (95% CI not available) and 79.4% ± 9.9%/71.9% ± 12.2%, respectively. Statistically significant differences in persistence were found among different BT treatments, and UST was found to have the highest persistence rate. The total medical costs during the 12 months after BT initiation in BT-naïve patients were (in 1000 Japanese Yen): 2218 for ADL, 3409 for IFX, 465 for SCK, 2824 for UST (average: 2828). Compared with the 12-month persistent patient group, the total medical costs in the persistent group was higher (Δ:+ 118), but for some medications such as IFX or UST cost increases were lower for persistent patients. CONCLUSIONS: UST was found to have the highest persistence rate among all BTs for psoriasis treatment in Japan. The 12-month medical costs after BT initiation in the persistent patient group may not have increased as much as in the non-persistent patient group for some medications.


Assuntos
Produtos Biológicos/economia , Produtos Biológicos/uso terapêutico , Terapia Biológica/economia , Custos de Medicamentos/estatística & dados numéricos , Psoríase/tratamento farmacológico , Adalimumab/economia , Adalimumab/uso terapêutico , Anticorpos Monoclonais/economia , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados , Antirreumáticos/economia , Antirreumáticos/uso terapêutico , Terapia Biológica/estatística & dados numéricos , Comorbidade , Bases de Dados Factuais , Fármacos Dermatológicos/economia , Fármacos Dermatológicos/uso terapêutico , Feminino , Humanos , Infliximab/economia , Infliximab/uso terapêutico , Revisão da Utilização de Seguros , Japão/epidemiologia , Masculino , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Psoríase/economia , Psoríase/epidemiologia , Ustekinumab/economia , Ustekinumab/uso terapêutico , Suspensão de Tratamento/economia , Suspensão de Tratamento/estatística & dados numéricos
19.
J Med Econ ; 21(8): 810-820, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29873270

RESUMO

AIMS: Patients with psoriasis often undergo treatment with a sequence of biologic agents because of poor/loss of response to initial therapy. With the availability of newer agents like ixekizumab and secukinumab, there is a need for cost-effectiveness analyses to better reflect current clinical practice. This study aimed to assess the cost-effectiveness of a sequence of biologic therapies containing first-line ixekizumab vs first-line secukinumab in patients with moderate-to-severe plaque psoriasis in the UK. MATERIALS AND METHODS: A Markov model with a lifetime horizon was developed to compare the cost-effectiveness of ixekizumab and secukinumab treatment sequences: ixekizumab → ustekinumab → infliximab → best supportive care (BSC) vs secukinumab → ustekinumab → infliximab → BSC. The model used monthly cycles, and included four health states: trial period, treatment maintenance, BSC, and death. At the end of the trial period, responders transitioned to maintenance therapy; non-responders transitioned to the next biologic in the sequence. An annual discontinuation rate of 20% was assumed for maintenance therapy. RESULTS: The ixekizumab sequence provided cost savings of £898 (£176,203 vs 177,101) [year 2015 values] and gained 0.03 more quality-adjusted life-years (QALYs: 1.45 vs 1.42) vs the secukinumab sequence over the lifetime horizon. Probabilistic sensitivity analysis showed an 89.8% likelihood that the ixekizumab sequence would be cost-effective at a threshold of £20,000 per QALY gained. LIMITATIONS: The analysis used list prices for drugs rather than confidential, preferentially priced Patient Access Scheme costs. In addition, efficacy input data were based on a network meta-analysis, as there were no head-to-head trials comparing ixekizumab and secukinumab. CONCLUSION: First-line treatment with ixekizumab as part of a specific sequential biologic therapy for moderate-to-severe plaque psoriasis in the UK provided slight advantages in cost savings and QALYs gained over a similar treatment sequence initiated with secukinumab. In view of the small magnitude of these differences, factors such as patient preferences (e.g. for number of injections) and long-term safety (e.g. related to time on the market) may also be important for clinical decision-making.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Fatores Biológicos/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Psoríase/tratamento farmacológico , Anticorpos Monoclonais/economia , Anticorpos Monoclonais Humanizados/economia , Fatores Biológicos/economia , Análise Custo-Benefício , Fármacos Dermatológicos/economia , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Infliximab/economia , Infliximab/uso terapêutico , Cadeias de Markov , Anos de Vida Ajustados por Qualidade de Vida , Índice de Gravidade de Doença , Reino Unido , Ustekinumab/economia , Ustekinumab/uso terapêutico
20.
J Eur Acad Dermatol Venereol ; 32(12): 2191-2199, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29729105

RESUMO

BACKGROUND: Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin 17A, has demonstrated strong and sustained efficacy in adults with moderate to severe psoriasis in clinical trials. OBJECTIVE: This analysis compared the cost per responder of secukinumab as first biologic treatment of moderate to severe psoriasis, with adalimumab, infliximab, etanercept and ustekinumab in Germany. METHODS: A 52-week decision-tree model was developed. Response to treatment was assessed based on the likelihood of achieving a predefined Psoriasis Area and Severity Index (PASI) response to separate the cohort into responders (PASI ≥75), partial responders (PASI 50 to 74) and non-responders (PASI <50). Responders at week 16 continued initial treatment, whereas partial responders and non-responders were switched to standard of care, which included methotrexate, cyclosporine, phototherapy and topical corticosteroids. Sustained response was defined as 16-week response maintained at week 52. A German healthcare system perspective was adopted. Clinical efficacy data were obtained from a mixed-treatment comparison; 2016 resource unit costs from national sources; and adverse events and discontinuation rates from the literature. We calculated cost per PASI 90 responder over week 16 and week 52, as well as cost per sustained responder between weeks 16 and 52. RESULTS: Secukinumab had the lowest cost per PASI 90 responder over 16 weeks (€18 026) compared with ustekinumab (€18 080), adalimumab (€23 499), infliximab (€29 599) and etanercept (€34 037). Over 52 weeks, costs per PASI 90 responder ranged from €42 409 (secukinumab) to €70 363 (etanercept). Likewise, secukinumab had the lowest cost per sustained 52-week PASI 90 responder (€22 690) compared with other biologic treatments. Sensitivity analyses, excluding patient copayments, showed similar results. CONCLUSIONS: First biologic treatment with secukinumab for moderate to severe psoriasis is cost-effective, with lowest cost per responder compared with other biologic treatments in Germany.


Assuntos
Anticorpos Monoclonais/economia , Anticorpos Monoclonais/uso terapêutico , Fármacos Dermatológicos/economia , Fármacos Dermatológicos/uso terapêutico , Psoríase/tratamento farmacológico , Adalimumab/economia , Adalimumab/uso terapêutico , Anticorpos Monoclonais Humanizados , Produtos Biológicos/economia , Produtos Biológicos/uso terapêutico , Análise Custo-Benefício , Etanercepte/economia , Etanercepte/uso terapêutico , Alemanha , Humanos , Infliximab/economia , Infliximab/uso terapêutico , Psoríase/economia , Índice de Gravidade de Doença , Resultado do Tratamento , Ustekinumab/economia , Ustekinumab/uso terapêutico
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