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1.
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
2.
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
3.
J Manag Care Spec Pharm ; 25(8): 879-887, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31347977

RESUMO

BACKGROUND: Disease-modifying antirheumatic drugs (DMARDs) are recommended as the standard of care for patients with rheumatoid arthritis (RA) due to their ability to reduce pain and disability; however, DMARD use is low in some subgroups of the RA population. OBJECTIVE: To identify characteristics associated with DMARD use in the overall cohort of patients with RA and newly diagnosed RA patients. METHODS: This retrospective observational study used claims from a large national health plan. Use of DMARDs was measured according to the Healthcare Effectiveness Data and Information Set (HEDIS) as the proportion of patients with RA receiving DMARDs. Following HEDIS measure technical specifications, we identified patients aged 18-89 years with continuous enrollment during 2014 (measurement year) with ≥ 2 claims for RA outpatient visits and/or discharges on different dates between January and November 2014. Additionally, we identified a subset of patients newly diagnosed with RA in 2014 based on absence of any claims for RA or DMARDs in 2013. Descriptive analyses and bivariate associations were used to compare demographic and clinical characteristics of patients with RA with or without DMARD use in 2014. Health care resource utilization (HCRU) and costs were compared in 2014 for patients enrolled in Medicare Advantage Prescription Drug (MAPD) plans during both 2014 and 2015. Regression models were used to evaluate patient and provider characteristics associated with DMARD use in 2014 and the effect on HCRU and costs. RESULTS: Among the 33,880 patients identified with RA in 2014, most patients received a DMARD (75.2%); 29.4% of patients newly diagnosed with RA had been treated with DMARDs in 2014. Patients with DMARD use, on average, were younger (aged 67 years ± 10.7 vs. 69 years ± 10.7) and healthier (Deyo-Charlson Comorbidity Index [DCCI] 2.4 ± 1.9 vs. 2.6 ± 2.1) and included a greater proportion of women (75.9% vs. 71.0%) than those with no DMARD use (P < 0.0001). Use of DMARDs (P < 0.0001) was associated with 14.5% fewer hospitalizations and 18.0% fewer emergency department visits. Although total costs increased by 15.0% with use of DMARDs, when the cost of DMARDs was excluded, the total cost decreased by 13.7% (P < 0.0001). Female gender (32.2%), higher claims-based index for RA severity score (47.0%), higher RxRisk-V score (26.7%), visit to a rheumatologist (34.3%), and use of glucocorticoids (17.7%) increased the odds of DMARD use (P < 0.0001). Use of certain classes of medication, such as nonsteroidal anti-inflammatory drugs (12.3%), opioids (19.5%), antidepressants (20.0%), muscle relaxants (12.5%), and anticonvulsants (15.5%), were associated with lower use of DMARDs (P < 0.0001). CONCLUSIONS: We found significant differences in demographic and clinical characteristics between patients with and without DMARD use, which can potentially inform treatment decisions regarding DMARD use as deemed necessary by the provider. Future research should investigate the reasons for lack of treatment. DISCLOSURES: This study was supported by funding from Eli Lilly to Humana as a collaborative research project involving employees of both companies. Boytsov, Saverno, Zhang, and Gaich are employees of Eli Lilly. Nair, Bhattacharya, Abbott, and Dixon are employees of Humana, which received funding from Eli Lilly to complete this research.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Idoso , Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/economia , Artrite Reumatoide/economia , Produtos Biológicos/economia , Produtos Biológicos/uso terapêutico , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Aceitação pelo Paciente de Cuidados de Saúde , Medicamentos sob Prescrição/economia , Medicamentos sob Prescrição/uso terapêutico , Estudos Retrospectivos
5.
J Eur Acad Dermatol Venereol ; 33(7): 1214-1223, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31037770

RESUMO

BACKGROUND: Treatment persistence is becoming a useful measure to evaluate long-term effectiveness and safety of biological therapies in real-world settings. OBJECTIVE: The main objective of this study was to explore the scientific opinion of a panel of dermatologists and hospital pharmacists to reach a consensus about the impact, causes, and best strategies and interventions that might be associated with improved drug persistence in patients with psoriasis in Spain. METHODS: This research was conducted using a modified Delphi method organized in two rounds and involving a panel of 90 dermatologists and 34 hospital pharmacists. A questionnaire of 70 items was developed. The items proposed to reach a consensus included topics such as definitions and measures in the treatment of psoriasis, analysis of treatment persistence, factors that may influence treatment persistence, impact of treatment persistence and economic cost of treatment. RESULTS: Dermatologists reached a consensus on 77.1% of the items proposed, and hospital pharmacists reached a consensus on 71.4%. Both groups agreed that it is important to use standardized measures in the evaluation of treatment maintenance over time. Dermatologists agreed that treatment survival, persistence and retention are synonymous, but hospital pharmacists considered only treatment persistence as a valid term. In addition, panelists agreed that drug persistence is an indicator of success in the treatment of psoriasis that may be influenced by a drug's effectiveness and safety profile, as well as by patient satisfaction. They agreed that the different causes of treatment discontinuation should be considered in Kaplan-Meier analysis of treatment persistence. Moreover, treatment persistence was agreed to decrease the cost of therapy. CONCLUSION: This Delphi consensus highlights the different perspectives of dermatologists and hospital pharmacists regarding the interpretation of treatment persistence, and the challenge of harmonizing the results obtained.


Assuntos
Produtos Biológicos/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Dermatologistas , Adesão à Medicação , Farmacêuticos , Psoríase/tratamento farmacológico , Produtos Biológicos/efeitos adversos , Produtos Biológicos/economia , Consenso , Técnica Delfos , Fármacos Dermatológicos/efeitos adversos , Fármacos Dermatológicos/economia , Humanos , Estimativa de Kaplan-Meier , Satisfação do Paciente , Psoríase/economia , Índice de Gravidade de Doença , Espanha , Terminologia como Assunto , Resultado do Tratamento
6.
J Manag Care Spec Pharm ; 25(5): 510-514, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31039065

RESUMO

DISCLOSURES: Funding for this summary was contributed by the Laura and John Arnold Foundation, Blue Shield of California, and California Health Care Foundation to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, AHIP, Anthem, Blue Shield of California, CVS Caremark, Express Scripts, Harvard Pilgrim Health Care, Cambia Health Solutions, United Healthcare, Kaiser Permanente, Premera Blue Cross, AstraZeneca, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck, National Pharmaceutical Council, Prime Therapeutics, Sanofi, Spark Therapeutics, Health Care Service Corporation, Editas, Alnylam, Regeneron, Mallinkrodt, Biogen, HealthPartners, and Novartis. Synnott, Kumar, Adair, Rind, and Pearson are employees of ICER, which provided grants to the University of California, San Francisco, and the University of Colorado to perform work for these analyses. Tice and Walsh are employed by the University of California, San Francisco, and Campbell and Whittington are employed by the University of Colorado.


Assuntos
Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Glucocorticoides/uso terapêutico , Administração por Inalação , Adulto , Fatores Etários , Antiasmáticos/economia , Asma/diagnóstico , Asma/economia , Produtos Biológicos/economia , Criança , Análise Custo-Benefício , Aprovação de Drogas , Quimioterapia Combinada/economia , Quimioterapia Combinada/métodos , Glucocorticoides/economia , Política de Saúde , Humanos , Modelos Econômicos , Índice de Gravidade de Doença , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration , Adulto Jovem
7.
J Manag Care Spec Pharm ; 25(5): 514-516, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31039068

RESUMO

DISCLOSURES: No outside funding supported the writing of this article. Mendez is president and CEO of the Asthma and Allergy Foundation of America, which receives greater than 25% of its funding to produce educational materials and for patient research through grants from pharmaceutical companies, including AstraZeneca, Genentech, GSK, Sanofi/Regeneron, and Teva.


Assuntos
Antiasmáticos/economia , Asma/tratamento farmacológico , Análise Custo-Benefício/métodos , Interpretação Estatística de Dados , Modelos Econômicos , Antiasmáticos/uso terapêutico , Asma/economia , Asma/mortalidade , Produtos Biológicos/economia , Produtos Biológicos/uso terapêutico , Conjuntos de Dados como Assunto , Glucocorticoides/economia , Glucocorticoides/uso terapêutico , Humanos , Revisão da Utilização de Seguros , Medidas de Resultados Relatados pelo Paciente , Resultado do Tratamento , Estados Unidos
9.
J Dermatol ; 46(6): 478-481, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30942911

RESUMO

Compared with topical corticosteroids, topical combined active vitamin D3 /corticosteroids and especially biologics are more expensive despite their marked efficacy in the treatment of psoriasis. The aim of the present study is to evaluate total costs as well as costs versus efficacy of various psoriasis treatments under the current Japanese health-care insurance system. A prospective study was performed from the database of a single clinic located in Hokkaido Prefecture. Cost and quality of life of psoriatic patients were evaluated in a prospective manner during a total of 12 months from March 2017 until June 2018. Quality-adjusted life year (QALY) of biologics was the highest among all treatments. Among the topical treatments, the cost versus efficacy of combined active vitamin D3 /corticosteroid was lowest (¥10 557/1 Psoriasis Area and Severity Index). Furthermore, incremental cost-effectiveness ratio (ICER) of combined active vitamin D3 /corticosteroid was ¥1 024 031/QALY when compared with topical corticosteroid treatment alone. The topical combined active vitamin D3 /corticosteroid treatment showed the best cost-efficacy in terms of medical economic burden.


Assuntos
Efeitos Psicossociais da Doença , Análise Custo-Benefício/estatística & dados numéricos , Fármacos Dermatológicos/economia , Psoríase/tratamento farmacológico , Administração Tópica , Adulto , Idoso , Instituições de Assistência Ambulatorial/economia , Instituições de Assistência Ambulatorial/estatística & dados numéricos , Produtos Biológicos/economia , Produtos Biológicos/uso terapêutico , Colecalciferol/economia , Colecalciferol/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Combinação de Medicamentos , Custos de Medicamentos/estatística & dados numéricos , Feminino , Glucocorticoides/economia , Glucocorticoides/uso terapêutico , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Psoríase/diagnóstico , Psoríase/economia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Índice de Gravidade de Doença , Resultado do Tratamento , Adulto Jovem
10.
J Dermatol ; 46(6): 466-477, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30985030

RESUMO

Psoriasis is a chronic autoimmune disease affecting skin which may also manifest in nails and joints. Several biologic treatments have been approved in Japan for psoriasis. Each biologic has a different profile for efficacy and safety, including different dosing regimens and co-payment considerations which may complicate treatment decisions made by patients and physicians during short consultations. Elucidating patient preference is expected to contribute to shared decision-making between patients and physicians to optimize treatment satisfaction and outcomes. However, the number of studies investigating this in Japan is very limited. The study used a discrete choice experiment methodology to elicit patient preferences for hypothetical options in an experimental framework. Participants were asked to choose their preferred treatment option from two hypothetical choices, defined by different levels of six attributes (i.e. early onset of efficacy, long-term efficacy, sustained efficacy after drug withdrawal, dosing convenience, co-payment and risk of serious infection). The survey included 16 treatment choice scenarios and was completed by 395 participants. Across all participants, the attribute regarded as most important was sustained efficacy after drug withdrawal, followed by dosing convenience, co-payment, long-term efficacy, early onset of efficacy and risk of serious infection. The study found that patients prefer treatments which have durable efficacy and lower treatment burden characterized as fewer injection frequency and lower co-payment. These results may be helpful to understand patient preference for biologic treatments used for psoriasis in Japan and contribute to shared decision-making between patients and physicians to improve patient satisfaction and treatment outcomes.


Assuntos
Produtos Biológicos/uso terapêutico , Tomada de Decisões , Preferência do Paciente/estatística & dados numéricos , Psoríase/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Produtos Biológicos/economia , Esquema de Medicação , Honorários Farmacêuticos/estatística & dados numéricos , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Preferência do Paciente/economia , Projetos Piloto , Psoríase/diagnóstico , Psoríase/economia , Índice de Gravidade de Doença , Inquéritos e Questionários/estatística & dados numéricos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
11.
Healthc Policy ; 14(3): 10-18, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-31017862

RESUMO

Introduction: Biologics are currently protected from competition by eight years of data protection. The renegotiated North American Free Trade Agreement (NAFTA) increases data protection from 8 to 10 years. This study investigates the effect of such an extension on drug spending in Canada. Methods: A list of currently available biologics eligible for data protection along with their 2017 sales was compiled. Two years were added to the current expiration date of data protection to see if it exceeded patent protection, and any theoretical change in spending due to delayed competition was calculated. The number of biologics approved after January 1, 1995, that have competition and the time until competition started was analyzed. Theoretical competition due to increased data protection for biologics where data protection has already expired was examined. Results: Depending on how much of the market is captured by biologic competitors and how strong the patents are, lost savings from data protection extension could range from $0 to $305.8 million. One biologic competitor currently on the market could theoretically have been affected by an increase in data protection. Increased data protection would have had minor effects on products that have already lost data protection. Discussion: The potential impact on drug expenditures of a two-year extension in data protection is highly variable. Possible increases in spending on biologics strengthen the rationale for a national pharmacare plan where monopsony buying power would help to control drug prices overall and offset increased spending on biologics.


Assuntos
Produtos Biológicos/economia , Segurança Computacional/legislação & jurisprudência , Custos de Medicamentos/estatística & dados numéricos , Canadá , Humanos , Cooperação Internacional/legislação & jurisprudência
12.
J Dermatol ; 46(5): 389-398, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30861182

RESUMO

Biologics are efficacious for treating psoriasis vulgaris (PsV) and psoriatic arthritis (PsA), but sometimes must be terminated or changed for various reasons including ineffectiveness or adverse events. To find the optimal choice of biologics for treating psoriasis, we analyzed the real-world data on drug survival and the reason for terminating or switching biologics. Medical records from patients with PsV or PsA, who visited the Department of Dermatology, Fukuoka University Hospital from 2010 to 2017, were analyzed. Two hundred and eleven patients received biologics, and 147 patients (69.7%) were treated with only one biologic, while 64 patients (30.3%) were switched to different products. Frequently used biologics in PsV were ustekinumab (UST), infliximab and adalimumab when calculated by patient-year. Tumor necrosis factor inhibitor (TNFi) use decreased while UST and interleukin (IL)-17 inhibitors increased in newly introduced patients. UST showed the highest survival rate as a first-line drug, but the advantage was lost in the second reagent's group. The major reasons for terminating/switching biologics were as follows: primary ineffectiveness (26.4%), secondary loss of efficacy (36.5%), patient's preference, including referral to nearby hospital, or stopped visiting (22.6%), side-effects (7.7%), comorbidities (3.4%) and economic burden (2.4%). In PsA patients, TNFi are more frequently employed than in PsV patients, although switching to UST or IL-17 inhibitors showed an increasing trend. Biologic reagents were changed mostly because of primary or secondary loss of efficacy, which affected drug survival. Further research is needed to find the optimal choice of biologics with larger samples at multiple facilities.


Assuntos
Artrite Psoriásica/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Substituição de Medicamentos/estatística & dados numéricos , Sistema de Registros/estatística & dados numéricos , Adulto , Idoso , Artrite Psoriásica/economia , Artrite Psoriásica/patologia , Produtos Biológicos/economia , Produtos Biológicos/farmacologia , Custos de Medicamentos/estatística & dados numéricos , Resistência a Medicamentos , Substituição de Medicamentos/economia , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Preferência do Paciente/estatística & dados numéricos , Estudos Retrospectivos , Resultado do Tratamento
13.
Mar Drugs ; 17(3)2019 Feb 27.
Artigo em Inglês | MEDLINE | ID: mdl-30818811

RESUMO

The objective of this report was to investigate the isolation and recovery of different biocompounds and bioproducts from wastes (skins and heads) that were obtained from five species discarded by fishing fleets (megrim, hake, boarfish, grenadier, and Atlantic horse mackerel). Based on chemical treatments, enzymatic hydrolysis, and bacterial fermentation, we have isolated and produced gelatinous solutions, oils that are rich in omega-3, fish protein hydrolysates (FPHs) with antioxidant and antihypertensive activities, and peptones. FPHs showed degrees of hydrolysis higher than 13%, with soluble protein concentrations greater than 27 g/L and in vitro digestibilities superior to 90%. Additionally, amino acids compositions were always valuable and bioactivities were, in some cases, remarkable. Peptones that were obtained from FPHs of skin and the heads were demonstrated to be a viable alternative to expensive commercial ones indicated for the production of biomass, lactic acid, and pediocin SA-1 from Pediococcus acidilactici.


Assuntos
Produtos Biológicos/isolamento & purificação , Ácidos Graxos Ômega-3/isolamento & purificação , Peixes , Peptonas/isolamento & purificação , Hidrolisados de Proteína/isolamento & purificação , Animais , Anti-Hipertensivos/economia , Anti-Hipertensivos/isolamento & purificação , Anti-Hipertensivos/farmacologia , Antioxidantes/economia , Antioxidantes/isolamento & purificação , Antioxidantes/farmacologia , Bactérias/metabolismo , Produtos Biológicos/economia , Produtos Biológicos/farmacologia , Ácidos Graxos Ômega-3/economia , Ácidos Graxos Ômega-3/farmacologia , Fermentação , Pesqueiros/economia , Cabeça , Hidrólise , Peptonas/economia , Peptonas/farmacologia , Hidrolisados de Proteína/economia , Hidrolisados de Proteína/farmacologia , Pele/química , Espanha
14.
Ann Allergy Asthma Immunol ; 122(4): 367-372, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30703438

RESUMO

OBJECTIVE: To evaluate relevant studies and documents that address the cost-effectiveness and comparative effectiveness of biologics current approved by the US Food and Drug Administration for the treatment of asthma. DATA SOURCES: Publications currently available on biologics, the Global Initiative for Asthma pocket book on difficult-to-treat asthma in adolescents and adults, and the recent Institute for Clinical and Economic Review on biologic therapies for the treatment of asthma. STUDY SELECTIONS: Priority was placed on studies that speak to the cost-effectiveness and comparative effectiveness of biologic therapies published from 2016 to 2019. RESULTS: Current pricing for all biologics exceeds measures of cost-effectiveness. To meet available measures indicating cost-effectiveness, prices would have to be reduced by a minimum of approximately 60%. The effect of biologics on exacerbations is similar but should be interpreted in the context of comparable patient phenotypes. The effect on quality of life is deemed modest based on the available study designs. CONCLUSION: To maximize cost-effectiveness of the biologics, emphasis should be placed on identifying predictors of response, focusing on those patients receiving oral corticosteroid therapy, and assessing the effect of treatment for decisions that relate to continuation. Multidisciplinary stakeholder efforts are needed to ensure responsible application of biologic therapy.


Assuntos
Antiasmáticos/economia , Asma/economia , Produtos Biológicos/economia , Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Asma/epidemiologia , Produtos Biológicos/uso terapêutico , Análise Custo-Benefício , Humanos , Estados Unidos/epidemiologia
15.
Expert Rev Gastroenterol Hepatol ; 13(2): 143-155, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30791783

RESUMO

INTRODUCTION: The patent expiration of some biologics used in chronic conditions such as inflammatory bowel disease (IBD) has led to the development of biosimilar monoclonal antibodies. The tailored regulatory approval route for biosimilar development ensures that approved biosimilars show similarity to their originators in terms of efficacy and safety, and avoids unnecessary repetition of clinical trials carried out with the originator product. However, some patients may still have concerns about using biosimilars and it is the responsibility of healthcare professionals (HCPs) to alleviate these concerns. Areas covered: This review highlights clinical and real-world evidence supporting efficacy and safety of biosimilars in patients with IBD. Moreover, based on international surveys, potential patient concerns are highlighted, along with possible actions HCPs can take to address these concerns. Expert commentary: The rising use of biosimilars in IBD is expected to have a positive impact on the availability of biologics and healthcare costs. Several biosimilars have been approved for use and more are likely to come to the market in the future; however, transitioning patients to biosimilars could pose an unexpected challenge without the help and support of HCPs.


Assuntos
Atitude do Pessoal de Saúde , Produtos Biológicos/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Comunicação em Saúde , Conhecimentos, Atitudes e Prática em Saúde , Doenças Inflamatórias Intestinais/tratamento farmacológico , Relações Profissional-Paciente , Produtos Biológicos/efeitos adversos , Produtos Biológicos/economia , Medicamentos Biossimilares/efeitos adversos , Medicamentos Biossimilares/economia , Redução de Custos , Análise Custo-Benefício , Custos de Medicamentos , Humanos , Doenças Inflamatórias Intestinais/economia , Doenças Inflamatórias Intestinais/imunologia , Doenças Inflamatórias Intestinais/psicologia , Segurança do Paciente , Medição de Risco , Fatores de Risco , Resultado do Tratamento
16.
J Med Econ ; 22(4): 365-371, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30652520

RESUMO

OBJECTIVE: This study compared real-world treatment patterns and healthcare costs among biologic-naive psoriasis patients initiating apremilast or biologics. METHODS: A retrospective cohort study was conducted using the Optum Clinformatics™ claims database. Patients with psoriasis were selected if they had initiated apremilast or biologics between January 1, 2014, and December 31, 2015; had 12 months of pre-index and post-index continuous enrollment in the database; and were biologic-naive. The index date was defined as the date of the first claim for apremilast or biologic, and occurred between January 1, 2014, and December 31, 2015. Treatment persistence was defined as continuous treatment without a > 60-day gap in therapy (discontinuation) or a switch to a different psoriasis treatment during the 12-month post-index period. Adherence was defined as a medication possession ratio (MPR) of ≥ 80% while persistent on the index treatment. Persistence-based MPR was defined as the number of days with the medication on hand measured during the patients' period of treatment persistence divided by the duration of the period of treatment persistence. Because patients were not randomized, apremilast patients were propensity score matched up to 1:2 to biologic patients to adjust for possible selection bias. Treatment persistence/adherence and all-cause healthcare costs were evaluated. Cost differences were determined using Wilcoxon rank-sum tests. RESULTS: In all, 343 biologic-naive patients initiating apremilast were matched to 680 biologic-naive patients initiating biologics. After matching, patient characteristics were similar between cohorts. Twelve-month treatment persistence was similar for biologic-naive patients initiating apremilast vs biologics (32.1% vs 33.2%; p = 0.7079). While persistent on therapy up to 12 months, per-patient per-month (PPPM) total healthcare costs were significantly lower among biologic-naive cohorts initiating apremilast vs biologics ($2,214 vs $5,184; p < 0.0001). Likewise, PPPM costs while persistent on therapy were significantly lower among patients initiating apremilast vs biologics, whether they switched treatments ($2,475 vs $4,422; p < 0.0001), remained persistent ($2,279 vs $3,883; p < 0.0001), or discontinued but did not switch treatments ($2,104 vs $6,294; p < 0.0001). LIMITATIONS: Data were limited to individuals with United Healthcare commercial and Medicare Advantage insurance plans, and may not be generalizable to psoriasis patients with other insurance or without health insurance coverage. CONCLUSION: Biologic-naive patients with similar patient characteristics receiving apremilast vs biologics had significantly lower PPPM costs, even when they switched to biologics during the 12-month post-index period. These results may be useful to payers and providers seeking to optimize psoriasis care while reducing healthcare costs.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Produtos Biológicos/uso terapêutico , Inibidores da Fosfodiesterase 4/uso terapêutico , Psoríase/tratamento farmacológico , Talidomida/análogos & derivados , Adulto , Idoso , Anti-Inflamatórios não Esteroides/administração & dosagem , Anti-Inflamatórios não Esteroides/economia , Produtos Biológicos/administração & dosagem , Produtos Biológicos/economia , Feminino , Gastos em Saúde , Humanos , Revisão da Utilização de Seguros , Masculino , Pessoa de Meia-Idade , Inibidores da Fosfodiesterase 4/economia , Pontuação de Propensão , Estudos Retrospectivos , Talidomida/administração & dosagem , Talidomida/economia , Talidomida/uso terapêutico
17.
JAMA Dermatol ; 155(1): 22-28, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-30477000

RESUMO

Importance: A phase 2 trial comparing talimogene laherparepvec plus ipilimumab vs ipilimumab monotherapy in patients with advanced unresectable melanoma found no differential benefit in progression-free survival (PFS) but noted objective response rates (ORRs) of 38.8% (38 of 98 patients) vs 18.0% (18 of 100 patients), respectively. Objective: To perform an economic evaluation of talimogene laherparepvec plus ipilimumab combination therapy vs ipilimumab monotherapy. Design, Setting, and Participants: For PFS, cost-effectiveness and cost-utility analyses using a 2-state Markov model (PFS vs progression or death) was performed. For ORRs, cost-effectiveness analysis of the incremental cost of 1 additional patient achieving objective response was performed. In this setting based on a US payer perspective (2017 US dollars), participants were patients with advanced unresectable melanoma. Main Outcomes and Measures: The PFS life-years and PFS quality-adjusted life-years were determined, and the associated incremental cost-effectiveness ratios (ICERs) and incremental cost-utility ratios (ICURs) were estimated. Also estimated was the ICER per 1 additional patient (out of 100 treated patients) achieving objective response. Base-case analyses were validated by sensitivity analyses. Results: In PFS analyses, the cost of talimogene laherparepvec plus ipilimumab ($494 983) exceeded the cost of ipilimumab monotherapy ($132 950) by $362 033. The ICER was $2 129 606 per PFS life-years, and the ICUR was $2 262 706 per PFS quality-adjusted life-year gained. Probabilistic sensitivity analyses yielded an ICER of $1 481 208 per PFS life-year gained and an ICUR of $1 683 191 per PFS quality-adjusted life-year gained. In 1-way sensitivity analyses, the PFS hazard ratio and the utility of response were the most influential parameters. Talimogene laherparepvec plus ipilimumab has a 50% likelihood of being cost-effective at a willingness-to-pay threshold of $1 683 191 per PFS quality-adjusted life-year gained. In ORR analyses, talimogene laherparepvec plus ipilimumab ($474 904) vs ipilimumab alone ($132 810), a $342 094 difference, yielded an ICER of $1 629 019 per additional patient achieving objective response. In subgroup analyses by disease stage and BRAFV600E mutation status, ICERs ranged from $1 069 044 to $17 104 700 per 1 additional patient achieving objective response. Conclusions and Relevance: The cost to gain 1 additional progression-free quality-adjusted life-year, 1 additional progression-free life-year, or to have 1 additional patient attain objective response is about $1.6 million. This amount may be beyond what payers typically are willing to pay. Combination therapy of talimogene laherparepvec plus ipilimumab does not offer an economically beneficial treatment option relative to ipilimumab monotherapy at the population level. This should not preclude treatment for individual patients for whom this regimen may be indicated.


Assuntos
Produtos Biológicos/administração & dosagem , Custos de Medicamentos , Ipilimumab/administração & dosagem , Melanoma/tratamento farmacológico , Estadiamento de Neoplasias , Neoplasias Cutâneas/tratamento farmacológico , Pele/patologia , Antineoplásicos Imunológicos/administração & dosagem , Antineoplásicos Imunológicos/economia , Produtos Biológicos/economia , Análise Custo-Benefício , Intervalo Livre de Doença , Relação Dose-Resposta a Droga , Quimioterapia Combinada , Herpesvirus Humano 1 , Humanos , Injeções Intravenosas , Ipilimumab/economia , Melanoma/diagnóstico , Melanoma/economia , Neoplasias Cutâneas/diagnóstico , Neoplasias Cutâneas/economia , Resultado do Tratamento , Estados Unidos
19.
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
20.
Rheumatol Int ; 39(3): 417-429, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30413925

RESUMO

Our aim was to appraise publications from Bulgaria, to assess their global impact, and to describe features and challenges unique to the rheumatology practice in Bulgaria characterized by stringent cost constraints. The Scopus database was queried on 25th July 2018 and data on the number of published documents, their Hirsch-indices and citations number were extracted. Published Bulgarian guidelines for the management of rheumatic diseases and the presented data on Bulgarian Rheumatology Society were identified based on prior knowledge of the authors. From all the identified 1082 document the most extensively researched areas were rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), osteoporosis, and osteoarthritis (OA). For the last five years (from Jan 2013 to 25th July 2018) the number of publications was 293. We found that Bulgaria's international scientific collaboration in the field of rheumatology is focused on a handful of countries mainly from Europe. Although Bulgarian rheumatologists have access to costly biologic agents for treating their patients with rheumatic diseases, their funding may not be granted according to the current recommendations of European League against Rheumatism (EULAR) and national guidelines for the management of rheumatic diseases. Although the western world clearly dominates the production of scientific publications in rheumatology, Bulgarian rheumatology may present another perspective for diagnosis and management of patients with rheumatic diseases in a cost-stringent environment. Nevertheless, both rheumatology science and practice in Bulgaria still have a long way to go to take its deserved place among the other European countries.


Assuntos
Produtos Biológicos/uso terapêutico , Pesquisa Biomédica , Acesso aos Serviços de Saúde , Doenças Reumáticas/tratamento farmacológico , Reumatologia , Artrite Reumatoide , Produtos Biológicos/economia , Bulgária , Controle de Custos , Custos de Medicamentos , Custos de Cuidados de Saúde , Humanos , Lúpus Eritematoso Sistêmico , Osteoartrite , Osteoporose , Editoração
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