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2.
Adv Rheumatol ; 61: 14, 2021. tab
Artigo em Inglês | LILACS | ID: biblio-1152743

RESUMO

Abstract Background: The objective of this paper is to analyze the prices of biological drugs in the treatment of Rheumatoid Arthritis (RA) in three Latin American countries (Brazil, Colombia and Mexico), as well as in Spain and the United States of America (US), from the point of market entry of biosimilars. Methods: We analyzed products authorized for commercialization in the last 20 years, in Brazil, Colombia, and Mexico, comparing them to the United States of America (USA) and Spain. For this analysis, we sought the prices and registries of drugs marketed between 1999 and October 1, 2019, in the regulatory agencies' databases. The pricing between countries was based on purchasing power parity (PPP). Results: The US authorized the commercialization of 13 distinct biologicals and four biosimilars in the period. Spain and Brazil marketed 14 biopharmaceuticals for RA, ten original, four biosimilars. Colombia and Mexico have authorized three biosimilars in addition to the ten biological ones. For biological drug prices, the US is the most expensive country. Spain's price behavior seems intermediate when compared to the three LA countries. Brazil has the highest LA prices, followed by Mexico and Colombia, which has the lowest prices. Spain has the lowest values in PPP, compared to LA countries, while the US has the highest prices. Conclusions: The economic effort that LA countries make to access these medicines is much higher than the US and Spain. The use of the PPP ensured a better understanding of the actual access to these inputs in the countries analyzed.(AU)


Assuntos
Artrite Reumatoide/economia , Preço de Medicamento , Produtos Biológicos/economia , Antirreumáticos/economia , Acesso a Medicamentos Essenciais e Tecnologias em Saúde , Espanha , Estados Unidos , Avaliação em Saúde , Brasil , Colômbia , México
6.
JAMA Netw Open ; 3(4): e203969, 2020 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-32338754

RESUMO

Importance: The closure of the Medicare Part D coverage gap from 2010 to 2019 was intended to help decrease out-of-pocket costs for beneficiaries, especially those taking high-cost drugs. However, yearly increases in list prices and the introduction of newer and more expensive drugs may have limited savings for beneficiaries. Objective: To assess the association of closure in the Medicare Part D coverage gap with projected annual out-of-pocket costs from 2010 through 2019 for rheumatoid arthritis (RA) biologics. Design, Setting, and Participants: This cross-sectional analysis used data from the Medicare Formulary and Pricing Files for the first quarter (January 1 to March 31) in each calendar year from 2010 to 2019 for 17 RA biologic drug and strength combinations. Exposures: Medicare Part D plan design and drug price by year. Main Outcomes and Measures: Expected annual out-of-pocket costs for 1 year of treatment. Results: Among the 17 drug and strength combinations assessed, list prices increased each year for every product, with a mean increase of 160% for the 6 drugs available during the entire study period. For the 6 products available during the entire study period, projected mean (SD) annual out-of-pocket costs were 34% (2%) lower in 2011 than in 2010 ($6108 in 2010 to $4026 in 2011) but only 21% (8%) lower in 2019 ($4801) because of yearly increases in list price. All 4 products with higher out-of-pocket costs in 2019 than in the first year available entered the market between 2011 and 2015. For all products studied, the percentage of money spent in the catastrophic phase increased each year and was a mean (SD) of 22% (14%) higher in 2019 than in 2010 or the year first available. Conclusions and Relevance: Although beneficiaries experienced large reductions in out-of-pocket spending from 2010 to 2011, more than half of those savings were lost by 2019 because of annual increases in list prices, even as the coverage gap continued to close in subsequent years.


Assuntos
Artrite Reumatoide/economia , Produtos Biológicos/economia , Medicare Part D/economia , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Estudos Transversais , Custos de Medicamentos , Gastos em Saúde/estatística & dados numéricos , Humanos , Estados Unidos
7.
Internist (Berl) ; 61(5): 522-529, 2020 May.
Artigo em Alemão | MEDLINE | ID: mdl-32333085

RESUMO

BACKGROUND: Biologic therapies are a key component of modern medicine, especially in the treatment of chronic conditions and in particular immune-mediated diseases. Biosimilars are molecularly highly similar variants of biologic therapies approved after patent expiration of the original product. OBJECTIVES: To provide an overview of the emerging role of biosimilars and present data with respect to efficacy and safety. CURRENT DATA: Since the approval of human insulin as the first biologic therapy, over 150 biologic therapeutics have been approved in the European Union (EU). Due to the high cost of development and production, biologic therapies place a heavy burden on healthcare systems and, at costs totaling 13.8 billion Euros annually, comprise one third of the annual drug expenditure in Germany. Biosimilars are highly similar versions of already approved biologic therapies that do not have clinically relevant differences with respect to efficacy, safety and immunogenicity, as far as can currently be ascertained. Through competition with the original product, biosimilars have been able to drive down prices and relieve the healthcare system without changing overall efficacy. The potential savings through biosimilars are estimated to be 500 million Euros in Germany alone. Currently, over 50 biosimilars of 16 different biologic therapies are approved in the EU. CONCLUSIONS: Biosimilars are safe and economical alternatives to biooriginal drugs that can boost access to modern, high-cost therapies and relieve healthcare systems.


Assuntos
Produtos Biológicos/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Aprovação de Drogas , Custos de Medicamentos , Produtos Biológicos/economia , Medicamentos Biossimilares/economia , Alemanha , Humanos
8.
Adv Ther ; 37(5): 2098-2115, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32141018

RESUMO

INTRODUCTION: We compared treatment switch patterns and healthcare costs among biologic-naive patients with psoriatic arthritis (PsA) who initiated apremilast or biologics. METHODS: A 1:2 propensity score match was used to adjust administrative claims data for adults initiating apremilast or biologics from January 1, 2014, to September 30, 2016, for possible selection bias. Patients had at least 12 months of pre- and post-index continuous enrollment in the Optum Clinformatics™ Data Mart database. Outcomes included switch frequency, days to switch, adherence on index treatment, and healthcare costs (total and per patient per month). Switch rate was defined as the proportion of patients who switched to a new treatment after initiation of the index treatment, and days to switch was calculated as the days between initiation of the index treatment and initiation of the new treatment. Adherence was calculated using the proportion of days covered and the medication possession ratio. The t test and chi-square, Kaplan-Meier, and Wilcoxon rank-sum tests were used to evaluate differences between the cohorts. RESULTS: Patient characteristics and switch rates were similar between the matched apremilast (n = 170) and biologic (n = 327) cohorts. After matching, patient characteristics were similar between the matched cohorts. The 12-month switch rates were similar for patients initiating apremilast versus those on biologics (17.7% vs. 25.1%, P = 0.06). This trend was similar at 6 months (7.7% vs. 13.2%, P = 0.07) and 18 months (24.4% vs. 29.3%, P = 0.33). Regardless of treatment switching, 12-month total healthcare costs were lower with apremilast versus biologics (all: $28,423 vs. $41,178, P < 0.0001; switched: $39,803 vs. $51,517, P = 0.0040; did not switch: $25,984 vs. $37,717, P < 0.0001). CONCLUSIONS: Biologic-naive patients with PsA who initiated apremilast had switch rates similar to biologic users and significantly lower healthcare costs, regardless of treatment switching.


Assuntos
Anti-Inflamatórios não Esteroides/economia , Antirreumáticos/economia , Artrite Psoriásica/tratamento farmacológico , Produtos Biológicos/economia , Produtos Biológicos/uso terapêutico , Talidomida/análogos & derivados , Adulto , Idoso , Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Psoriásica/economia , Artrite Psoriásica/epidemiologia , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Talidomida/economia , Talidomida/uso terapêutico , Estados Unidos/epidemiologia
9.
Lancet Gastroenterol Hepatol ; 5(5): 454-464, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32061322

RESUMO

BACKGROUND: Inflammatory bowel disease (IBD) places a significant burden on health-care systems because of its chronicity and need for expensive therapies and surgery. With increasing use of biological therapies, contemporary data on IBD health-care costs are important for those responsible for allocating resources in Europe. To our knowledge, no prospective long-term analysis of the health-care costs of patients with IBD in the era of biologicals has been done in Europe. We aimed to investigate cost profiles of a pan-European, community-based inception cohort during 5 years of follow-up. METHODS: The Epi-IBD cohort is a community-based, prospective inception cohort of unselected patients with IBD diagnosed in 2010 at centres in 20 European countries plus Israel. Incident patients who were diagnosed with IBD according to the Copenhagen Diagnostic Criteria between Jan 1, and Dec 31, 2010, and were aged 15 years or older the time of diagnosis were prospectively included. Data on clinical characteristics and direct costs (investigations and outpatient visits, blood tests, treatments, hospitalisations, and surgeries) were collected prospectively using electronic case-report forms. Patient-level costs incorporated procedures leading to the initial diagnosis of IBD and costs of IBD management during the 5-year follow-up period. Costs incurred by comorbidities and unrelated to IBD were excluded. We grouped direct costs into the following five categories: investigations (including outpatient visits and blood tests), conventional medical treatment, biological therapy, hospitalisation, and surgery. FINDINGS: The study population consisted of 1289 patients with IBD, with 1073 (83%) patients from western Europe and 216 (17%) from eastern Europe. 488 (38%) patients had Crohn's disease, 717 (56%) had ulcerative colitis, and 84 (6%) had IBD unclassified. The mean cost per patient-year during follow-up for patients with IBD was €2609 (SD 7389; median €446 [IQR 164-1849]). The mean cost per patient-year during follow-up was €3542 (8058; median €717 [214-3512]) for patients with Crohn's disease, €2088 (7058; median €408 [133-1161]) for patients with ulcerative colitis, and €1609 (5010; median €415 [92-1228]) for patients with IBD unclassified (p<0·0001). Costs were highest in the first year and then decreased significantly during follow-up. Hospitalisations and diagnostic procedures accounted for more than 50% of costs during the first year. However, in subsequent years there was a steady increase in expenditure on biologicals, which accounted for 73% of costs in Crohn's disease and 48% in ulcerative colitis, in year 5. The mean annual cost per patient-year for biologicals was €866 (SD 3056). The mean yearly costs of biological therapy were higher in patients with Crohn's disease (€1782 [SD 4370]) than in patients with ulcerative colitis (€286 [1427]) or IBD unclassified (€521 [2807]; p<0·0001). INTERPRETATION: Overall direct expenditure on health care decreased over a 5-year follow-up period. This period was characterised by increasing expenditure on biologicals and decreasing expenditure on conventional medical treatments, hospitalisations, and surgeries. In light of the expenditures associated with biological therapy, cost-effective treatment strategies are needed to reduce the economic burden of inflammatory bowel disease. FUNDING: Kirsten og Freddy Johansens Fond and Nordsjællands Hospital Forskningsråd.


Assuntos
Produtos Biológicos/economia , Colite Ulcerativa/economia , Doença de Crohn/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Adulto , Produtos Biológicos/uso terapêutico , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/terapia , Doença de Crohn/diagnóstico , Doença de Crohn/terapia , Técnicas e Procedimentos Diagnósticos/economia , Procedimentos Cirúrgicos do Sistema Digestório/economia , Europa (Continente) , Feminino , Seguimentos , Custos de Cuidados de Saúde/tendências , Hospitalização/economia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
11.
Ann Rheum Dis ; 79(6): 685-699, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31969328

RESUMO

OBJECTIVES: To provide an update of the European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) management recommendations to account for the most recent developments in the field. METHODS: An international task force considered new evidence supporting or contradicting previous recommendations and novel therapies and strategic insights based on two systematic literature searches on efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) since the last update (2016) until 2019. A predefined voting process was applied, current levels of evidence and strengths of recommendation were assigned and participants ultimately voted independently on their level of agreement with each of the items. RESULTS: The task force agreed on 5 overarching principles and 12 recommendations concerning use of conventional synthetic (cs) DMARDs (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GCs); biological (b) DMARDs (tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, sarilumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (the Janus kinase (JAK) inhibitors tofacitinib, baricitinib, filgotinib, upadacitinib). Guidance on monotherapy, combination therapy, treatment strategies (treat-to-target) and tapering on sustained clinical remission is provided. Cost and sequencing of b/tsDMARDs are addressed. Initially, MTX plus GCs and upon insufficient response to this therapy within 3 to 6 months, stratification according to risk factors is recommended. With poor prognostic factors (presence of autoantibodies, high disease activity, early erosions or failure of two csDMARDs), any bDMARD or JAK inhibitor should be added to the csDMARD. If this fails, any other bDMARD (from another or the same class) or tsDMARD is recommended. On sustained remission, DMARDs may be tapered, but not be stopped. Levels of evidence and levels of agreement were mostly high. CONCLUSIONS: These updated EULAR recommendations provide consensus on the management of RA with respect to benefit, safety, preferences and cost.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Sociedades Médicas , Medicamentos Sintéticos/uso terapêutico , Antirreumáticos/economia , Produtos Biológicos/economia , Consenso , Quimioterapia Combinada , Europa (Continente) , Humanos , Inibidores de Janus Quinases/uso terapêutico , Medicamentos Sintéticos/economia , Revisões Sistemáticas como Assunto , Fator de Necrose Tumoral alfa/antagonistas & inibidores
12.
Am J Gastroenterol ; 115(1): 128-137, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31895723

RESUMO

OBJECTIVES: The prevalence of inflammatory bowel disease (IBD) is increasing. The total direct costs of IBD have not been assessed on a population-wide level in the era of biologic therapy. DESIGN: We identified all persons with IBD in Manitoba between 2005 and 2015, with each matched to 10 controls on age, sex, and area of residence. We enumerated all hospitalizations, outpatient visits and prescription medications including biologics, and their associated direct costs. Total and per capita annual IBD-attributable costs and health care utilization (HCU) were determined by taking the difference between the costs/HCU accrued by an IBD case and their controls. Generalized linear modeling was used to evaluate trends in direct costs and Poisson regression for trends in HCU. RESULTS: The number of people with IBD in Manitoba increased from 6,323 to 7,603 between 2005 and 2015. The total per capita annual costs attributable to IBD rose from $3,354 in 2005 to $7,801 in 2015, primarily driven by an increase in per capita annual anti-tumor necrosis factor costs, which rose from $181 in 2005 to $5,270 in 2015. There was a significant decline in inpatient costs for CD ($99 ± 25/yr. P < 0.0001), but not for ulcerative colitis ($8 increase ±$18/yr, P = 0.63). DISCUSSION: The direct health care costs attributable to IBD have more than doubled over the 10 years between 2005 and 2015, driven mostly by increasing expenditures on biological medications. IBD-attributable hospitalization costs have declined modestly over time for persons with CD, although no change was seen for patients with ulcerative colitis.


Assuntos
Produtos Biológicos/economia , Colite Ulcerativa/economia , Doença de Crohn/economia , Custos Diretos de Serviços/estatística & dados numéricos , Custos Diretos de Serviços/tendências , Adulto , Fatores Etários , Idoso , Assistência Ambulatorial/economia , Assistência Ambulatorial/estatística & dados numéricos , Produtos Biológicos/uso terapêutico , Estudos de Casos e Controles , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/epidemiologia , Doença de Crohn/tratamento farmacológico , Doença de Crohn/epidemiologia , Prescrições de Medicamentos/economia , Prescrições de Medicamentos/estatística & dados numéricos , Feminino , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Humanos , Estudos Longitudinais , Masculino , Manitoba/epidemiologia , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Prevalência , Estudos Retrospectivos , Fatores Sexuais
13.
Arthritis Rheumatol ; 72(2): 234-241, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31609057

RESUMO

OBJECTIVE: Billions of public dollars are spent each year on biologic disease-modifying antirheumatic drugs (DMARDs), but the drivers of recent increases in biologic DMARD spending are unclear. This study was undertaken to characterize changes in total spending and unit prices for biologic DMARDs in Medicare and Medicaid programs and quantified the major sources of these spending increases. METHODS: We accessed drug spending data from years 2012-2016, covering all Medicare Part B (fee-for-service), Medicare Part D, and Medicaid enrollees. After calculating 5-year changes in total spending and unit prices for each biologic DMARD as well as in aggregate, we performed standard decomposition analyses to isolate 4 sources of spending growth: drug prices, uptake (number of recipients), treatment intensity (mean number of doses per claim), and treatment duration (annual number of claims per recipient), both excluding and including time-varying rebates. RESULTS: From 2012 to 2016, annual spending on public-payer claims for the 10 biologic DMARDs included in this study more than doubled ($3.8 billion to $8.6 billion), with median drug price increases of 51% in Medicare Part D (mean 54%) and 8% in Medicare Part B (mean 21%). With adjustment for general inflation, unit price increases alone accounted for 57% of the 5-year, $3.0 billion spending increase in Part D, while 37% of the spending increase was from increased uptake. Accounting for time-varying rebates, prices were still responsible for 54% of increased spending. Unit prices and spending were lower under Medicaid than under Medicare Part D, though temporal trends and contributors were similar. CONCLUSION: Postmarket drug price changes alone account for the majority of the recent spending growth in biologic DMARDs. Policy interventions targeting price increases, particularly those under Medicare Part D plans, may help mitigate financial burdens for public payers and biologic DMARD recipients.


Assuntos
Antirreumáticos/economia , Produtos Biológicos/economia , Comércio , Gastos em Saúde , Medicaid/economia , Medicare/economia , Humanos , Estados Unidos
14.
Am J Clin Dermatol ; 21(1): 109-117, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31452091

RESUMO

Elderly patients are a group with a high frequency of psoriasis. Their disease burden has negative impacts on their quality of life. While there is a clear need to treat these patients, there are challenges in doing so. This work seeks to define the challenges that exist in treating elderly Medicare patients, as well as to provide treatment suggestions for providers to follow if they encounter one or more of these challenges. Providers face the following challenges when creating treatment plants for elderly patients with psoriasis: difficulty in obtaining drug coverage through Medicare, increased medical comorbidities, and polypharmacy. Providers aim for regimens that are affordable, safe, and efficacious, but it is not always clear how to achieve this combination, especially in elderly Medicare patients. This work is relevant in that it aims to explain the logistical roadblocks posed by Medicare coverage and provide solutions for commonly encountered issues in the treatment of a disabling and common disease in a high-risk population. Specifically, alternative treatment options to biologics and small-molecule inhibitors are discussed and include topical therapies, phototherapy, methotrexate, acitretin, and cyclosporine and for psoriatic arthritis include corticosteroids and leflunomide. The specific risks and benefits of these therapies in the elderly population are provided, allowing providers to make patient-specific decisions about optimal regimens.


Assuntos
Artrite Psoriásica/tratamento farmacológico , Fármacos Dermatológicos/administração & dosagem , Psoríase/tratamento farmacológico , Idoso , Artrite Psoriásica/economia , Artrite Psoriásica/patologia , Produtos Biológicos/administração & dosagem , Produtos Biológicos/economia , Fármacos Dermatológicos/economia , Humanos , Medicare/economia , Fototerapia/métodos , Psoríase/economia , Psoríase/patologia , Qualidade de Vida , Índice de Gravidade de Doença , Talidomida/administração & dosagem , Talidomida/análogos & derivados , Talidomida/economia , Estados Unidos
15.
J Dermatolog Treat ; 31(4): 370-377, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30924390

RESUMO

Background: Biologics for moderate-to-severe psoriasis are expensive and treatment substitutions may vastly increase cost. Moreover, administration regimens in routine practice may differ from recommended guidelines.Objectives: To evaluate long-term effectiveness, regimen, drug-survival, and efficiency of self-administered biologics in clinical practice.Methods: We performed a 5-year retrospective study in 72 patients (44 ± 14 years old) with moderate-to-severe psoriasis at the University Hospital La Plana (Vila-real, Spain), treated with subcutaneous biologics. We determined the effectiveness (PASI 75 or PASI < 5), and drug-survival using Kaplan-Meier estimates, and analyzed reasons for treatment interruption, drug substitution patterns, and costs.Results: Etanercept was less effective (45%) than ustekinumab (85%) and adalimumab (71%). In 15% of patients, optimal responses were maintained despite dose intervals lengthening. Drug-survival was significantly lower for etanercept than for the other biologics (p < .005). Most adalimumab and etanercept discontinuations were due to adverse events or lack of effectiveness; for ustekinumab the causes were unrelated to drug effects. Ustekinumab was 100% effective as a secondary biologic.Conclusion: Ustekinumab was the safest and most efficient treatment. Etanercept showed the highest treatment failure rate, incurring higher costs. Dosage individualization according to patient needs improves the therapy efficiency, reducing therapeutic failure and derived costs.


Assuntos
Adalimumab/administração & dosagem , Produtos Biológicos/administração & dosagem , Etanercepte/administração & dosagem , Psoríase/tratamento farmacológico , Autoadministração , Ustekinumab/administração & dosagem , Adulto , Produtos Biológicos/economia , Custos de Medicamentos , Substituição de Medicamentos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Espanha
16.
J Med Econ ; 23(1): 80-85, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31294641

RESUMO

Aims: Adalimumab, infliximab, and ustekinumab have been approved for patients with moderate-to-severe Crohn's disease in Japan. This study compared the relative efficacy and cost-effectiveness of adalimumab, infliximab, and ustekinumab in patients with Crohn's disease based on data from randomized controlled trials.Methods: Data were extracted from four phase 3 clinical trials: CHARM, NCT00445432, ACCENT I, and IM-UNITI. A network meta-analysis (NMA) compared 1-year clinical remission rates in patients who responded to treatment during an induction phase. Remission was defined as a Crohn's Disease Activity Index score <150. The number needed to treat (NNT) was defined as the inverse of the risk reduction (compared with placebo) estimated from the NMA among initial responders. Cost per incremental remitter was calculated based on the projected per patient drug cost (2018 Japanese Yen [¥]) and the NNT.Results: Among initial responders, the remission rates were 45.2%, 31.9%, 27.4%, 24.1%, and 15.6% for adalimumab 40 mg every other week (EOW), infliximab 5 mg/kg every 8 weeks, ustekinumab 90 mg every 8 weeks, ustekinumab 90 mg every 12 weeks, and placebo, respectively. The NNT was the lowest for adalimumab 40 mg EOW. Compared with adalimumab, the incremental cost per remitter was numerically higher for infliximab (¥5,375,470) and statistically higher for ustekinumab 90 mg every 8 weeks and ustekinumab 90 mg every 12 weeks (¥42,788,597 and ¥41,495,543, respectively).Limitations: Indirect comparisons are limited by the availability of suitable clinical evidence and there may be residual heterogeneity that could not be adjusted for.Conclusion: Adalimumab was associated with a numerically lower cost per remitter compared with infliximab and a statistically lower cost per remitter compared with ustekinumab in patients with moderate-to-severe Crohn's disease in Japan.


Assuntos
Produtos Biológicos/economia , Produtos Biológicos/uso terapêutico , Doença de Crohn/tratamento farmacológico , Fármacos Gastrointestinais/economia , Fármacos Gastrointestinais/uso terapêutico , Adalimumab/economia , Adalimumab/uso terapêutico , Ensaios Clínicos Fase III como Assunto , Análise Custo-Benefício , Humanos , Infliximab/economia , Infliximab/uso terapêutico , Japão , Metanálise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Índice de Gravidade de Doença , Ustekinumab/economia , Ustekinumab/uso terapêutico
17.
Mar Drugs ; 18(1)2019 Dec 24.
Artigo em Inglês | MEDLINE | ID: mdl-31878264

RESUMO

The aim of this paper is to review the multiplicity of the current uses of marine macroalgae. Seaweeds are already used in many products and for different purposes, from food products to medicine. They are a natural resource that can provide a number of compounds with beneficial bioactivities like antioxidant, anti-inflammatory, anti-aging effects, among others. Despite studies directed in prospecting for their properties and the commodities already marketed, they could, surely, be even more researched and sustainably explored.


Assuntos
Produtos Biológicos/química , Produtos Biológicos/economia , Alga Marinha , Anti-Inflamatórios , Antioxidantes
18.
Curr Oncol ; 26(5): e597-e609, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31708653

RESUMO

Background: Evidence from a retrospective analysis of multiple large phase iii trials suggested that primary tumour location (ptl) in RAS wild-type metastatic colorectal cancer (wtRAS mcrc) might have predictive value with respect to response to drug therapies. Recent studies also show a potential preferential benefit for epidermal growth factor inhibitors (egfris) for left-sided tumours. In the present study, we aimed to determine the incremental cost-effectiveness ratio (icer) for the first-line use of an egfri for patients with left-sided wtRAS mcrc. Methods: We developed a state-transition model to determine the cost effectiveness of alternative treatment strategies in patients with left-sided mcrc:■ Standard of care■ Use of an egfri in first-line therapyThe cohort for the study consisted of patients diagnosed with unresectable wtRAS mcrc with an indication for chemotherapy and previously documented ptl. Model parameters were obtained from the published literature and calibration. The perspective was that of a provincial ministry of health in Canada. We used a 5-year time horizon and an annual discount rate of 1.5%. Results: Selecting patients for first-line egfri treatment based on left-sided location of their colorectal primary tumour was more effective than the standard of care, resulting in an increase in quality-adjusted life-years (qalys) of 0.226 (or 0.644 life-years gained). However, the strategy was also more expensive, costing an average of $60,639 more per patient treated. The resulting icer was $268,094 per qaly. A 35% price reduction in the cost of egfri would be needed to make this strategy cost-effective at a willingness-to-pay threshold (wtp) of $100,000 per qaly. Conclusions: Selective use of an egfri based on ptl was more cost-effective than unselected use of those agents; however, based on traditional wtp thresholds, it was still not cost-effective. While awaiting the elucidation of more precise predictive biomarkers that might improve cost-effectiveness, the price of egfris could be reduced to meet the wtp threshold.


Assuntos
Antineoplásicos/economia , Bevacizumab/economia , Produtos Biológicos/economia , Neoplasias Colorretais/economia , Inibidores de Proteínas Quinases/economia , Antineoplásicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Bevacizumab/uso terapêutico , Produtos Biológicos/uso terapêutico , Camptotecina/análogos & derivados , Camptotecina/economia , Camptotecina/uso terapêutico , Cetuximab/economia , Cetuximab/uso terapêutico , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/genética , Neoplasias Colorretais/patologia , Análise Custo-Benefício , Receptores ErbB/antagonistas & inibidores , Fluoruracila/economia , Fluoruracila/uso terapêutico , Humanos , Leucovorina/economia , Leucovorina/uso terapêutico , Compostos Organoplatínicos/economia , Compostos Organoplatínicos/uso terapêutico , Inibidores de Proteínas Quinases/uso terapêutico , Proteínas ras/genética
19.
J Manag Care Spec Pharm ; 25(12): 1328-1333, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31778614

RESUMO

BACKGROUND: Analysis of salary data for health economics, outcomes research, and market access professionals in biopharmaceutical space plays an important role in hiring talent, benchmarking remuneration, and evaluating income discrepancies. OBJECTIVES: To (a) identify predictors of annual base salary (ABS) for health economics, outcomes research, and market access professionals who participated in the 2017 Global Salary Survey by HealthEconomics.Com and (b) evaluate salary-related gender disparity among survey respondents. METHODS: 501 professionals from the HealthEconomics.Com global subscriber list participated in a survey that assessed salary, bonus, benefits, and job satisfaction in June 2017. Two multivariable regression models identified significant predictors of ABS for U.S. and non-U.S. regions separately. Analysis of variance determined interaction effects between gender, organizational size, job title, and people management responsibilities separately. RESULTS: Of the 501 respondents, 385 were included in the analysis because they reported ABS. Median ABS for male (n = 117) and female (n = 111) U.S.-based respondents was $172,500 and $162,500, respectively. For male (n = 75) and female (n = 65) non-U.S.-based respondents, the median was identical at $92,500. Mean (SD) ABS between male ($180,534 [$77,755]) and female ($165,113 [$64,604]; t [226] = 1.62; P = 0.106) U.S. respondents was not significantly different. Mean (SD) ABS for male ($110,900 [$65,898]) and female ($98,039 [$48,639]; t [138] = 1.30; P = 0.196) non-U.S. respondents was not significantly different, as well. Multivariable regression models for U.S. and non-U.S. respondents accounted for 62.7% and 63.9% of variance in ABS (P < 0.001), respectively. In both models, significantly higher salaries were associated with professionals aged > 40 years; biopharmaceutical employment; having a PhD, PharmD, or MD; and having a job title of president or director (all P < 0.05). CONCLUSIONS: After controlling for covariates, gender was not statistically significantly associated with ABS. Age, organization type, terminal degree, and job title were significant predictors of higher salaries inside and outside of the United States. Additional research should be conducted to increase generalizability of results, which were based on a convenience sample. DISCLOSURES: No funding supported this research. Shah and Peeples are employed by HealthEconomics.Com, which administered the survey used in this study. The authors report no other potential conflicts of interest.


Assuntos
Produtos Biológicos/economia , Indústria Farmacêutica/economia , Emprego/economia , Marketing/economia , Salários e Benefícios/economia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/economia , Inquéritos e Questionários , Adulto Jovem
20.
J Manag Care Spec Pharm ; 25(12): 1366-1376, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31778621

RESUMO

BACKGROUND: As more biologics become available for the treatment of psoriasis (PsO), there is a lack of direct comparisons of health care costs between patients who are treated by different medications, including ixekizumab (IXE), secukinumab (SEC), and adalimumab (ADA). OBJECTIVE: To compare the real-world health care costs of patients with PsO initiating IXE with those of patients initiating either SEC or ADA. METHODS: Patients diagnosed with PsO between July 1, 2015, and May 31, 2018, were identified from the IBM MarketScan commercial and Medicare databases. Two weighted patient sample sets were constructed based on drug claims between March 1, 2016, and May 31, 2018: IXE versus SEC and IXE versus ADA. Within each sample, the first claim of eligible drugs was set as the index date. Patients were aged ≥ 18 years and had ≥ 12 months of continuous eligibility before and after the index date. Patients with other indications for the index drug in the preperiod or with use of the index drug within 90 days before the index date were excluded. Inverse probability of treatment weighting (IPTW) was employed to balance cohorts. All-cause and PsO-related health care costs per member per month (PMPM) incurred during the 12-month follow-up period were assessed. Monthly PsO-related pharmacy costs were adjusted using drug discount rates published by the Institute for Clinical and Economic Review (ICER). Annual index drug costs were estimated by adjusting for medication possession ratio and ICER discount rates. All costs were weighted by IPTW. RESULTS: Two study samples were identified: 357 IXE users were compared with 763 SEC users, and 388 IXE users were separately compared with 2,578 ADA users. Before weighting, IXE users were demographically and clinically similar to SEC users but were older and had worse health status than ADA users. Cohorts were balanced postweighting. After weighting, mean monthly all-cause health care costs were $7,313 and $6,477 (P = 0.002) and mean PsO-related costs were $6,303 and $5,437 (P < 0.001), for IXE and SEC users, respectively. Similarly, mean monthly all-cause health care costs were $6,535 and $5,557 (P = 0.026) and mean PsO-related costs were $5,792 and $4,754 (P = 0.017), for IXE and ADA users, respectively. After applying ICER adjustments, mean monthly PsO-related costs were comparable between groups: $3,637/IXE versus $3,443/SEC (P = 0.132) and $3,320/IXE versus $3,287/ADA (P = 0.907). CONCLUSIONS: After adjusting for drug discount programs (through application of ICER discount rate), this real-world study estimated that average monthly PsO-related costs during the first year of treatment were similar between patients treated with IXE compared with those treated with SEC or ADA. DISCLOSURES: Funding for this study was provided to IBM Watson Health by Eli Lilly and Company. The analysis was conducted independently by IBM Watson Health. Eli Lilly and Company and IBM Watson Health collaborated on study design and interpretation of results. Shi, Lew, and Zimmerman were employed by IBM Watson Health and received funding from Eli Lilly and Company to conduct this study. Zhu, Burge, Malatestinic, Lin, Goldblum, and Murage were employed by Eli Lilly and Company while this study was conducted. Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Akros, Allergan, Almirall, Amgen, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly and Company, FLX Bio, Galderma, Genentech/Roche, GlaxoSmithKline, Janssen, Leo, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Revance, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB Pharma, Valeant, and Vidac, and as a paid speaker for AbbVie, Regeneron, and Sanofi Genzyme. A portion of these results were presented at the 2019 International Society for Pharmacoeconomics and Outcomes Research Annual Meeting; May 18-22, 2019; New Orleans, LA, and the 2019 Academy of Managed Care Pharmacy Annual Meeting; March 25-28, 2019; San Diego, CA.


Assuntos
Adalimumab/economia , Anticorpos Monoclonais Humanizados/economia , Antirreumáticos/economia , Custos de Medicamentos/estatística & dados numéricos , Custos de Cuidados de Saúde/estatística & dados numéricos , Psoríase/economia , Adalimumab/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/ultraestrutura , Antirreumáticos/uso terapêutico , Produtos Biológicos/economia , Produtos Biológicos/uso terapêutico , Feminino , Humanos , Masculino , Medicare/economia , Pessoa de Meia-Idade , Psoríase/tratamento farmacológico , Estudos Retrospectivos , Estados Unidos
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