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[PMID]:28746714
[Au] Autor:Cerullo M; Chen SY; Dillhoff M; Schmidt C; Canner JK; Pawlik TM
[Ad] Endereço:Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
[Ti] Título:Association of Hospital Market Concentration With Costs of Complex Hepatopancreaticobiliary Surgery.
[So] Source:JAMA Surg;152(9):e172158, 2017 Sep 20.
[Is] ISSN:2168-6262
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Trade-offs involved with market competition, overall costs to payers and consumers, and quality of care have not been well defined. Less competition within any given market may enable provider-driven increases in charges. Objective: To examine the association between regional hospital market concentration and hospital charges for hepatopancreaticobiliary surgical procedures. Design, Setting, and Participants: This study included all patients undergoing hepatic or pancreatic resection in the Nationwide Inpatient Sample from January 1, 2003, through December 31, 2011. Hospital market concentration was assessed using a variable-radius Herfindahl-Hirschman Index (HHI) in the 2003, 2006, and 2009 Hospital Market Structure files. Data were analyzed from November 19, 2016, through March 2, 2017. Interventions: Hepatic or pancreatic resection. Main Outcomes and Measures: Multivariable mixed-effects log-linear models were constructed to determine the association between HHI and total costs and charges for hepatic or pancreatic resection. Results: Weighted totals of 38 711 patients undergoing pancreatic resection (50.8% men and 49.2% women; median age, 65 years [interquartile range, 55-73 years]) and 52 284 patients undergoing hepatic resection (46.8% men and 53.2% women; median age, 59 years [interquartile range, 49-69 years]) were identified. Higher institutional volume was associated with lower cost of pancreatic resection (-5.4%; 95% CI, -10.0% to -0.5%; P = .03) and higher cost of hepatic resection (13.4%; 95% CI, 8.2% to 18.8%; P < .001). For pancreatic resections, costs were 5.5% higher (95% CI, 0.1% to 11.1%; P = .047) in unconcentrated hospital markets relative to moderately concentrated markets, although overall charges were 8.3% lower (95% CI, -14.0% to -2.3%; P = .008) in highly concentrated markets. For hepatic resections, hospitals in highly concentrated markets had 8.4% lower costs (95% CI, -13.0% to -3.6%; P = .001) compared with those in unconcentrated markets and charges that were 13.4% lower (95% CI, -19.3% to -7.1%; P < .001) compared with moderately concentrated markets and 10.5% lower (95% CI, -16.2% to -4.4%; P = .001) compared with unconcentrated markets. Conclusions and Relevance: Higher market concentration was associated with lower overall charges and lower costs of pancreatic and hepatic surgery. For complex, highly specialized procedures, hospital market consolidation may represent the best value proposition: better quality of care with lower costs.
[Mh] Termos MeSH primário: Procedimentos Cirúrgicos do Sistema Digestório/economia
Preços Hospitalares/estatística & dados numéricos
[Mh] Termos MeSH secundário: Competição Econômica
Hepatectomia/economia
Seres Humanos
Pancreatectomia/economia
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170727
[St] Status:MEDLINE
[do] DOI:10.1001/jamasurg.2017.2158


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[PMID]:29400932
[Au] Autor:Perez K
[Ti] Título:Health Information Plays BIG ROLE in Competitive Strategies of Population Health Analytics.
[So] Source:J AHIMA;88(1):21-3, 2017 Jan.
[Is] ISSN:1060-5487
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Organizações de Assistência Responsáveis/economia
Competição Econômica
Gestão da Informação em Saúde
Medicare/economia
Saúde da População
[Mh] Termos MeSH secundário: Seres Humanos
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:H
[Da] Data de entrada para processamento:180206
[St] Status:MEDLINE


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[PMID]:29443670
[Au] Autor:Dafny LS
[Ad] Endereço:From the Department of General Management, Harvard Business School, Boston, and the Kennedy School of Government, Harvard University, and the National Bureau of Economic Research, Cambridge - all in Massachusetts.
[Ti] Título:Does CVS-Aetna Spell the End of Business as Usual?
[So] Source:N Engl J Med;378(7):593-595, 2018 Feb 15.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Competição Econômica
Seguradoras
Seguro Saúde/organização & administração
Farmácias/organização & administração
[Mh] Termos MeSH secundário: Instituições de Assistência Ambulatorial/organização & administração
Redução de Custos
Assistência à Saúde/economia
Assistência à Saúde/organização & administração
Instituições Associadas de Saúde
Seguro Saúde/economia
Farmácias/economia
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180220
[Lr] Data última revisão:
180220
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180215
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMp1717137


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[PMID]:29361657
[Au] Autor:Steiner DJ; Thomson Reuters Accelus.
[Ti] Título:Pharmaceuticals and Medical Devices: Cost Savings.
[So] Source:Issue Brief Health Policy Track Serv;2017:1-31, 2017 Dec 26.
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Custos de Medicamentos
Indústria Farmacêutica/economia
Farmacoeconomia/organização & administração
Medicamentos sob Prescrição/economia
[Mh] Termos MeSH secundário: Canadá
Comércio/economia
Redução de Custos
Dedutíveis e Cosseguros
Revelação
Aprovação de Drogas
Custos de Medicamentos/legislação & jurisprudência
Medicamentos Genéricos/economia
Competição Econômica
Farmacoeconomia/legislação & jurisprudência
Epinefrina/economia
Seres Humanos
Adesão à Medicação
Conduta do Tratamento Medicamentoso/economia
Medicamentos sem Prescrição/economia
Farmácias/economia
Equivalência Terapêutica
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drugs, Generic); 0 (Nonprescription Drugs); 0 (Prescription Drugs); YKH834O4BH (Epinephrine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180219
[Lr] Data última revisão:
180219
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180124
[St] Status:MEDLINE


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[PMID]:29298119
[Au] Autor:Kiran S; Kulkarni M
[Ad] Endereço:a Council of Scientific and Industrial Research-Unit for Research and Development of Information Products (CSIR-URDIP) , India.
[Ti] Título:Secondary patents in the pharmaceutical industry: missing the wood for the trees?
[So] Source:Expert Opin Ther Pat;28(3):241-250, 2018 Mar.
[Is] ISSN:1744-7674
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: The critics of the Innovator pharmaceutical industry allege that secondary patents are trivial modifications over the primary patent, which extend its term and delay the entry of the generics in the market place. The protagonists regard secondary patents a result of continuous research and development (R&D), which help them introduce and protect new, differentiated products. Areas covered: The areas covered are Product life cycle management (PLCM), Drug approval process, Orange book (OB) listed patents, US patent data. Expert opinion: Our analysis of the patents and products of four innovators viz., AstraZeneca, Takeda, Eisai and Wyeth in the field of proton pump inhibitors (PPI's) and Merck and Pfizer in the field of Statins shows that secondary patents help innovators sustain competition against other innovators in the specific product segment. The number of secondary patents listed in OB per NCE depends on the innovators interest in exploiting the NCE, the success of R & D effort and product lifecycle management strategy in the wake of market competition. Market entry decisions of innovators are strategic rather than a mere fallout of the secondary patents granted. Entry of another innovator is more unpredictable and hurts the first entrant more vis a vis the entry of generics who can enter the market when the patents protecting a product are no more enforceable, and hence more predictable. Generic entry in the field of PPI's shows that the term of the primary patent is not extended by the secondary patents.
[Mh] Termos MeSH primário: Aprovação de Drogas/legislação & jurisprudência
Desenho de Drogas
Indústria Farmacêutica/legislação & jurisprudência
[Mh] Termos MeSH secundário: Aprovação de Drogas/economia
Indústria Farmacêutica/economia
Medicamentos Genéricos/economia
Competição Econômica/legislação & jurisprudência
Seres Humanos
Patentes como Assunto
Pesquisa/economia
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Drugs, Generic)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180215
[Lr] Data última revisão:
180215
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180104
[St] Status:MEDLINE
[do] DOI:10.1080/13543776.2018.1424134


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[PMID]:29231030
[Au] Autor:Levin RP
[Ti] Título:Opportunities and Challenges of a Small Group Practice.
[So] Source:Dent Today;36(6):8, 10, 2017 Jun.
[Is] ISSN:8750-2186
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Prática Odontológica de Grupo/organização & administração
Administração da Prática Odontológica/organização & administração
[Mh] Termos MeSH secundário: Mobilidade Ocupacional
Competição Econômica
Seres Humanos
Investimentos em Saúde
Liderança
Técnicas de Planejamento
Salários e Benefícios
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180115
[Lr] Data última revisão:
180115
[Sb] Subgrupo de revista:D
[Da] Data de entrada para processamento:171213
[St] Status:MEDLINE


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[PMID]:29215232
[Au] Autor:Hall MA; Fronstin P
[Ti] Título:Narrow Provider Networks for Employer Plans.
[So] Source:EBRI Issue Brief;(428):1-17, 2016 12 14.
[Is] ISSN:0887-137X
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Planos de Assistência de Saúde para Empregados/economia
Seguro Saúde/economia
[Mh] Termos MeSH secundário: Adulto
Competição Econômica
Feminino
Trocas de Seguro de Saúde
Acesso aos Serviços de Saúde
Seres Humanos
Masculino
Patient Protection and Affordable Care Act
Pesquisa Qualitativa
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180108
[Lr] Data última revisão:
180108
[Sb] Subgrupo de revista:H
[Da] Data de entrada para processamento:171208
[St] Status:MEDLINE


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[PMID]:29236427
[Au] Autor:Carrier MA
[Ad] Endereço:Rutgers Law School.
[Ti] Título:Sharing, samples, and generics: an antitrust framework.
[So] Source:Cornell Law Rev;103(1):1-64, 2017.
[Is] ISSN:0010-8847
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition. But these regimes can only be effectuated through generic entry. And that entry can take place only if a generic can use a brand's sample to show that its product is equivalent. More than 100 generic firms have complained that they have not been able to access needed samples. One study of 40 drugs subject to restricted access programs found that generics' inability to enter cost more than $5 billion a year. Brand firms have contended that antitrust law does not compel them to deal with their competitors and have highlighted concerns related to safety and product liability in justifying their refusals. This Article rebuts these claims. It highlights the importance of samples in the regulatory regime and the FDA's inability to address the issue. It shows how a sharing requirement in this setting is consistent with Supreme Court caselaw. And it demonstrates that the brands' behavior fails the defendant-friendly "no economic sense" test because the conduct literally makes no sense other than by harming generics. Brands' denial of samples offers a textbook case of monopolization. In the universe of pharmaceutical antitrust behavior, other conduct--such as "pay for delay" settlements between brands and generics and "product hopping" from one drug to a slightly modified version--has received the lion's share of attention. But sample denials are overdue for antitrust scrutiny. This Article fills this gap. Given the failure of Congress and the FDA to remedy the issue, antitrust can play a crucial role in ensuring generic access to samples, affirming a linchpin of the pharmaceutical regime.
[Mh] Termos MeSH primário: Acesso à Informação/legislação & jurisprudência
Leis Antitruste/economia
Aprovação de Drogas/legislação & jurisprudência
Medicamentos Genéricos/economia
Competição Econômica/legislação & jurisprudência
[Mh] Termos MeSH secundário: Custos de Medicamentos
Seres Humanos
Equivalência Terapêutica
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drugs, Generic)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180105
[Lr] Data última revisão:
180105
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:171214
[St] Status:MEDLINE


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[PMID]:28975217
[Au] Autor:Vokinger KN; Kesselheim AS; Avorn J; Sarpatwari A
[Ad] Endereço:The Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
[Ti] Título:Strategies That Delay Market Entry of Generic Drugs.
[So] Source:JAMA Intern Med;177(11):1665-1669, 2017 Nov 01.
[Is] ISSN:2168-6114
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although generic competition helps lower drug prices, manufacturers of brand-name drugs often work to delay the availability of generic versions of their products. Strategies to forestall generic competition include patenting peripheral aspects of a drug or modified formulations that do not add clinical value, paying generic manufacturers to settle lawsuits challenging the validity of patents on brand-name drugs ("reverse payment" settlements), denying generic manufacturers access to drug samples necessary for bioequivalence testing, misusing risk evaluation and mitigation strategies, and filing citizen petitions with the US Food and Drug Administration (FDA). To address such tactics, the federal government can interpret existing patenting standards more strictly and promote certain types of patent challenges to ensure that patents are granted or upheld only for true innovations. Congress can enact pending legislation that would help discourage reverse payment settlements and compel brand-name manufacturers to share drug samples for bioequivalence testing. Finally, the FDA can provide earlier guidance on bioequivalence determinations for complex generic products and adopt the presumption that late-filed citizen petitions should be summarily rejected.
[Mh] Termos MeSH primário: Custos de Medicamentos/estatística & dados numéricos
Indústria Farmacêutica/economia
Medicamentos Genéricos/economia
Patentes como Assunto
[Mh] Termos MeSH secundário: Custos de Medicamentos/legislação & jurisprudência
Indústria Farmacêutica/legislação & jurisprudência
Competição Econômica
Política de Saúde
Seres Humanos
Equivalência Terapêutica
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drugs, Generic)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171113
[Lr] Data última revisão:
171113
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171005
[St] Status:MEDLINE
[do] DOI:10.1001/jamainternmed.2017.4650


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[PMID]:28964446
[Au] Autor:Lexchin J
[Ad] Endereço:School of Health Policy and Management, York University, Toronto, Ontario, Canada. Electronic address: jlexchin@yorku.ca.
[Ti] Título:Market Exclusivity Time for Top Selling Originator Drugs in Canada: A Cohort Study.
[So] Source:Value Health;20(8):1139-1142, 2017 Sep.
[Is] ISSN:1524-4733
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: This study looks at market exclusivity time for the top selling originator drugs in Canada. Total sales for drugs without competition were also calculated. METHODS: A list of the top selling originator drugs by dollar sales from 2009 to 2015 inclusive, except for 2010, was compiled along with their annual sales. Health Canada databases were used to extract the following information: generic name, date of Notice of Compliance (NOC, date of marketing authorization), whether the product was a small molecule drug or a biologic, and date of NOC for a generic or biosimilar. Market exclusivity time was calculated in days for drugs. RESULTS: A total of 121 drugs were identified. There were 96 small molecule drugs (63 with a generic competitor and 33 with no generic competitor) and 25 biologics (none with a biosimilar competitor). The 63 drugs with a competitor had a mean market exclusivity time of 4478 days (12.3 years) (95% CI 4159-4798). The 58 drugs without competition had total annual sales of Can$8.59 billion and were on the market for a median of 5357 days (14.7 years) (interquartile range 3291-6679) as of January 31, 2017. CONCLUSIONS: Top selling originator drugs in Canada have a considerably longer period of market exclusivity than the 8 to 10 years that the research-based pharmaceutical industry claims.
[Mh] Termos MeSH primário: Produtos Biológicos/economia
Comércio/estatística & dados numéricos
Indústria Farmacêutica/economia
Competição Econômica/estatística & dados numéricos
Preparações Farmacêuticas/economia
[Mh] Termos MeSH secundário: Medicamentos Biossimilares/economia
Canadá
Estudos de Coortes
Comércio/economia
Bases de Dados Factuais
Aprovação de Drogas
Medicamentos Genéricos/economia
Seres Humanos
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biological Products); 0 (Biosimilar Pharmaceuticals); 0 (Drugs, Generic); 0 (Pharmaceutical Preparations)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171013
[Lr] Data última revisão:
171013
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171002
[St] Status:MEDLINE



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