Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Inibidores de Checkpoint Imunológico/uso terapêutico , Dose Máxima Tolerável , Neoplasias/tratamento farmacológico , Piperazinas/uso terapêutico , Piridinas/uso terapêutico , Pirimidinas/uso terapêutico , Humanos , Estados Unidos , United States Food and Drug AdministrationAssuntos
Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Análise Custo-Benefício , Neoplasias/tratamento farmacológico , Neoplasias/economia , Antineoplásicos/farmacocinética , Custos de Cuidados de Saúde , Humanos , Neoplasias/patologia , Prognóstico , Equivalência Terapêutica , Distribuição TecidualRESUMO
The increasing cost of health care is a major challenge around the world, but particularly in the United States. One reason for increased costs is the rapidly rising cost of oncology drugs. Potential solutions to this problem involve broad changes to health policy. However, an alternative solution is the development of lower-cost off-label treatment regimens, based on pharmacologic rationale, with significant potential economic impact. The pharmacologic and clinical properties of many drugs allow for a variety of different strategies. We describe this approach of interventional pharmacoeconomics and provide multiple individual examples.
Assuntos
Farmacoeconomia/normas , HumanosRESUMO
Cancer care's sustainability is challenged by drug expenditures. In the absence of systemic change, innovation is needed to curtail drug costs. Interventional pharmacoeconomics (IVPE) utilizes clinical research to identify safe, efficacious, cost-conscious dosing regimens to extract maximum value from expensive therapies. Strategies include de-escalation of dosage, treatment duration and administration frequency, and substitution with therapeutic alternatives. In this review, we discuss how IVPE strategies have been successfully used and could be implemented going forward.
Assuntos
Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Custos de Medicamentos , Neoplasias/tratamento farmacológico , Neoplasias/economia , Antineoplásicos/efeitos adversos , Antineoplásicos/farmacocinética , Redução de Custos , Análise Custo-Benefício , Uso de Medicamentos/economia , Farmacoeconomia , Humanos , Indicadores de Qualidade em Assistência à Saúde/economia , Seguro de Saúde Baseado em Valor/economiaAssuntos
Antineoplásicos/economia , Pesquisa Biomédica , Ética Médica , Reforma dos Serviços de Saúde/tendências , Neoplasias/tratamento farmacológico , Responsabilidade Social , Redução de Custos , Medicina Baseada em Evidências , Alocação de Recursos para a Atenção à Saúde , Mau Uso de Serviços de Saúde/prevenção & controle , Humanos , Padrões de Prática Médica/ética , Padrões de Prática Médica/normas , Estados UnidosRESUMO
The Learning Health Community is an emergent global multistakeholder grassroots incipient movement bonded together by a set of consensus Core Values Underlying a National-Scale Person-Centered Continuous Learning Health System developed at the 2012 Learning Health System (LHS) Summit. The Learning Health Community's Second LHS Summit was convened on December 8 to 9, 2016 building upon LHS efforts taking shape in order to achieve consensus on actions that, if taken, will advance LHSs and the LHS vision from what remain appealing concepts to a working reality for improving the health of individuals and populations globally. An iterative half-year collaborative revision process following the Second LHS Summit led to the development of the Learning Health Systems Consensus Action Plan.
Assuntos
Ensaios Clínicos como Assunto , Oncologia , Neoplasias/tratamento farmacológico , Projetos de Pesquisa , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Efeitos Psicossociais da Doença , Análise Custo-Benefício , Gerenciamento Clínico , Custos de Cuidados de Saúde , Humanos , Oncologia/economia , Oncologia/organização & administração , Resultado do TratamentoRESUMO
The promise of emerging science and the challenges confronting today's health care system can both be addressed by fully embracing the IoM's vision of a learning health care system. ASCO's initial foray into realizing this vision for oncology shows great promise.
Assuntos
Atenção à Saúde , Oncologia/educação , Sociedades Médicas , Registros Eletrônicos de Saúde , Humanos , Informática Médica/métodos , Oncologia/tendências , SoftwareAssuntos
Conflito de Interesses , Revelação/normas , National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division , Centros Médicos Acadêmicos , Bases de Dados Factuais , Controle de Formulários e Registros , Indústrias , Publicações Periódicas como Assunto/normas , Médicos , Pesquisadores , Estados UnidosRESUMO
Conflicts of interest in medicine have received significant attention in recent years, through the public and professional media, federal and state governments, and through a 2009 report of the Institute of Medicine on Conflict of Interest in Medical Research, Education and Practice. The Council of Medical Specialty Societies (CMSS) Code for Interactions with Companies was adopted by the CMSS in April 2010. The Code guides specialty societies in the profession of medicine in ethical relationships between societies and the pharmaceutical and medical device industries. The Code serves to protect and promote the independence of specialty societies and their leaders in corporate sponsorships, licensing, advertising, society meetings, exhibits, educational programs, journals, clinical practice guidelines, and research.
Assuntos
Conflito de Interesses , Difusão de Inovações , Setor de Assistência à Saúde/normas , Relações Interinstitucionais , Relações Interprofissionais , Qualidade da Assistência à Saúde/normas , Sociedades Médicas/normas , Códigos de Ética , Conflito de Interesses/economia , Conflito de Interesses/legislação & jurisprudência , Comportamento Cooperativo , Honorários e Preços , Doações , Regulamentação Governamental , Setor de Assistência à Saúde/economia , Setor de Assistência à Saúde/ética , Setor de Assistência à Saúde/legislação & jurisprudência , Política de Saúde , Humanos , Relações Interprofissionais/ética , Padrões de Prática Médica/normas , Qualidade da Assistência à Saúde/economia , Qualidade da Assistência à Saúde/ética , Qualidade da Assistência à Saúde/legislação & jurisprudência , Má Conduta Científica , Sociedades Médicas/economia , Sociedades Médicas/ética , Sociedades Médicas/legislação & jurisprudênciaRESUMO
BACKGROUND: Tamoxifen is standard adjuvant treatment for postmenopausal women with hormone-receptor-positive breast cancer. We assessed the benefit of adding chemotherapy to adjuvant tamoxifen and whether tamoxifen should be given concurrently or after chemotherapy. METHODS: We undertook a phase 3, parallel, randomised trial (SWOG-8814, INT-0100) in postmenopausal women with hormone-receptor-positive, node-positive breast cancer to test two major objectives: whether the primary outcome, disease-free survival, was longer with cyclophosphamide, doxorubicin, and fluorouracil (CAF) given every 4 weeks for six cycles plus 5 years of daily tamoxifen than with tamoxifen alone; and whether disease-free survival was longer with CAF followed by tamoxifen (CAF-T) than with CAF plus concurrent tamoxifen (CAFT). Overall survival and toxicity were predefined, important secondary outcomes for each objective. Patients in this open-label trial were randomly assigned by a computer algorithm in a 2:3:3 ratio (tamoxifen:CAF-T:CAFT) and analysis was by intention to treat of eligible patients. Groups were compared by stratified log-rank tests, followed by Cox regression analyses adjusted for significant prognostic factors. This trial is registered with ClinicalTrials.gov, number NCT00929591. FINDINGS: Of 1558 randomised women, 1477 (95%) were eligible for inclusion in the analysis. After a maximum of 13 years of follow-up (median 8.94 years), 637 women had a disease-free survival event (tamoxifen, 179 events in 361 patients; CAF-T, 216 events in 566 patients; CAFT, 242 events in 550 patients). For the first objective, therapy with the CAF plus tamoxifen groups combined (CAFT or CAF-T) was superior to tamoxifen alone for the primary endpoint of disease-free survival (adjusted Cox regression hazard ratio [HR] 0.76, 95% CI 0.64-0.91; p=0.002) but only marginally for the secondary endpoint of overall survival (HR 0.83, 0.68-1.01; p=0.057). For the second objective, the adjusted HRs favoured CAF-T over CAFT but did not reach significance for disease-free survival (HR 0.84, 0.70-1.01; p=0.061) or overall survival (HR 0.90, 0.73-1.10; p=0.30). Neutropenia, stomatitis, thromboembolism, congestive heart failure, and leukaemia were more frequent in the combined CAF plus tamoxifen groups than in the tamoxifen-alone group. INTERPRETATION: Chemotherapy with CAF plus tamoxifen given sequentially is more effective adjuvant therapy for postmenopausal patients with endocrine-responsive, node-positive breast cancer than is tamoxifen alone. However, it might be possible to identify some subgroups that do not benefit from anthracycline-based chemotherapy despite positive nodes. FUNDING: National Cancer Institute (US National Institutes of Health).