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1.
Health Econ ; 29(5): 537-539, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32239621
2.
Lancet ; 395(10228): 986-997, 2020 03 21.
Artigo em Inglês | MEDLINE | ID: mdl-32199486

RESUMO

Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment options at the time of regulatory approval in Europe and the USA. Even when active-comparator trials exist, they might not produce meaningful data to inform decisions in clinical practice and health policy. The uncertainty associated with the paucity of well designed active-comparator trials has been compounded by legal and regulatory changes in Europe and the USA that have created a complex mix of expedited programmes aimed at facilitating faster access to new drugs. Comparative evidence generation is even sparser for medical devices. Some have argued that the current process for regulatory approval needs to generate more evidence that is useful for patients, clinicians, and payers in health-care systems. We propose a set of five key principles relevant to the European Medicines Agency, European medical device regulatory agencies, US Food and Drug Administration, as well as payers, that we believe will provide the necessary incentives for pharmaceutical and device companies to generate comparative data on drugs and devices and assure timely availability of evidence that is useful for decision making. First, labelling should routinely inform patients and clinicians whether comparative data exist on new products. Second, regulators should be more selective in their use of programmes that facilitate drug and device approvals on the basis of incomplete benefit and harm data. Third, regulators should encourage the conduct of randomised trials with active comparators. Fourth, regulators should use prospectively designed network meta-analyses based on existing and future randomised trials. Last, payers should use their policy levers and negotiating power to incentivise the generation of comparative evidence on new and existing drugs and devices, for example, by explicitly considering proven added benefit in pricing and payment decisions.


Assuntos
Aprovação de Equipamentos/normas , Aprovação de Drogas/métodos , Segurança de Equipamentos , Segurança , Biomarcadores Farmacológicos/análise , Tolerância a Medicamentos , Medicina Baseada em Evidências , Humanos , Estados Unidos , United States Food and Drug Administration
3.
Hum Gene Ther ; 30(6): 753-761, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30700149

RESUMO

Seventy-five percent of patients with beta thalassemia (ß-thalassemia) do not have human leukocyte antigen-matched siblings and until recently had no access to a curative treatment. Gene therapy is a promising treatment that can be proposed to these patients. This study estimates its cost and efficacy. In a monocentric retrospective study and cost-efficacy analysis, this study compared the two-year outcomes and costs of patients with ß-thalassemia treated by gene therapy and hematopoietic stem-cell transplantation (HSCT). Grade III and grade IV complications, hospitalizations, and length of stay were extracted from the hospital discharge data. Costs were estimated from hospital accounting information and national cost studies. A total of seven patients with ß-thalassemia treated between 2009 and 2016 were included, of whom four received gene therapy. Patients treated by gene therapy were older and had fewer complications and hospital admissions. Infectious complications were three times more frequent for patients treated with HSCT than for gene therapy. Average costs were €608,086 for patients treated by gene therapy and €215,571 for HSCT. The total cost of the vector was 48% of the total cost of gene therapy. Gene therapy as a curative alternative for patients lacking human leukocyte antigen-matched donors was costlier but resulted in fewer complications than HSCT.

4.
Int J Technol Assess Health Care ; 34(5): 481-497, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30296954

RESUMO

OBJECTIVES: The aim of this study is to review evidence on the cost-effectiveness of exercise-based interventions in the treatment of chronic conditions a decade after the publication of Roine et al. in 2009 (Roine E, Roine RP, Räsänen P, et al. Int J Technol Assess Health Care. 2009;25:427-454). METHODS: We carried out a review of published articles in PUBMED and JSTOR between January 1, 2008, and December 31, 2016. Full economic evaluations of exercise programs targeting patients with a chronic condition were eligible for inclusion. Data on program, design, and economic characteristics were extracted using a predefined extraction form. The quality of the economic evaluations was appraised using the adjusted Consensus Health Economic Criteria List. RESULTS: A total of 426 articles were identified and thirty-seven studies were selected. Eleven studies dealt with musculoskeletal and rheumatologic disorders, ten with cardiovascular diseases, six with neurological disorders, three with mental illnesses, three with cancers, and four with diabetes, respiratory diseases, or pelvic organ prolapse. In total, 60 percent of exercise programs were dominant or cost-effective. For musculoskeletal and rheumatologic disorders, 72 percent of programs were dominant or cost-effective while this was the case for 57 percent of programs for cardiovascular diseases using a nonsurgical comparator. CONCLUSIONS: There is clear evidence in favor of exercise-based programs for the treatment of musculoskeletal and rheumatologic disorders and, to a lesser extent, for the treatment of cardiovascular diseases. More research is needed to evaluate the cost-effectiveness of physical activity in the treatment of neurological disorders, mental illnesses, cancers, respiratory diseases, and diabetes/obesity.


Assuntos
Doenças Cardiovasculares/terapia , Análise Custo-Benefício , Exercício Físico , Humanos
5.
Pharmacoeconomics ; 32(9): 825-39, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24862533

RESUMO

When evaluating new drugs or treatments eligible for reimbursement, health technology assessment (HTA) agencies are repeatedly faced with cost-effectiveness analyses that evidence lack of adequate data and modeling biases. The case of type 2 diabetes illustrates this difficulty. In spite of its high disease burden, type 2 diabetes is poorly documented through existing cost-effectiveness analyses. We support this statement by an exhaustive literature review that enables us to precisely pinpoint the limitations of models used for the assessment of newly marketed (and expensive) drugs. We find that models are mostly restricted to surrogate endpoints and based on non-inferiority clinical trial data; they also show biases in the choice of comparators and inclusion criteria. Such limitations undermine the scope and applicability of HTA practice guidelines based on cost-effectiveness evidence. Nevertheless, cost-effectiveness models remain an opportunity to better inform decision makers and to reduce the uncertainty surrounding their decisions. HTA agencies are best placed to provide incentives for companies to improve the quality of the cost-effectiveness studies submitted for pricing and reimbursement decisions. One such incentive is to include stages of discussion between the company and the health authority during the evaluation process.


Assuntos
Viés , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/economia , Modelos Biológicos , Avaliação da Tecnologia Biomédica , Análise Custo-Benefício , França , Humanos , Guias de Prática Clínica como Assunto
6.
Therapie ; 68(4): 253-63, 2013.
Artigo em Inglês, Francês | MEDLINE | ID: mdl-23981264

RESUMO

The participants in round table 6 of the Giens Workshops 2012 drafted recommendations based on the collective interpretation of important elements of the decree concerning the medico-economic evaluation of health products published a few days earlier (02 October 2012). The medico-economic evaluation (MEE), becomes an additional determinant for fixing the prices of health products by the Health products economic committee (Comité économique des produits de santé, CEPS) via the hierarchisation of treatment strategies, and thus modifies the market access conditions. Limiting the analysis to medicinal products and medical devices for which a major, important or moderate improvement in the medical service rendered (ASMR) or of the expected service (ASA) has been requested and presenting a significant budget impact on the Social Security expenses, excludes health products with ASMR or ASA with a lower level requested which often create complex price fixing problems and often have a major budget impact. This latter concept remains to be defined in detail. The MEE envisaged for the first registration must include the need to confirm or refute the initial hypotheses especially concerning the actual position in the therapeutic strategy at the time of renewal of the registration. For the first registration, the conventional reference to European prices guaranteeing a minimum price to innovative medicinal products, the medico-economic models submitted by the industry to the French Drug Authority (Haute autorité de santé, HAS) must be used to guide the compilation of new data to be requested at the time of the registration renewal and to negotiate the level of the discounts in the framework of a price-volume agreement, if applicable. The MEE will allow comparing the result of the analysis to the model hypothesis at the time of the renewal of the registration, which may contribute to the renegotiation (either up or down) of the price of health goods. The costs related to obtaining new data must be controlled. In order for the MEE to allow confirming the relationship between the price requested and the benefit expected, the group privileges the definition of reference values with an indicative and non-normative value, likely to evolve with time rather than a threshold. Concerning the evaluation procedure: the time to market access must not be lengthened; while the possibility of regular meetings between the industry and the HAS is recommended to avoid methodological divergences. A transitory period should allow the implementation of the entire evaluation procedure which must also take into account the specificities of health products registered before the 3 October 2013.


Assuntos
Custos de Cuidados de Saúde , Legislação Médica , Garantia da Qualidade dos Cuidados de Saúde , Previdência Social/economia , Tecnologia Biomédica/economia , Tecnologia Biomédica/instrumentação , Tecnologia Biomédica/legislação & jurisprudência , Interpretação Estatística de Dados , França , Custos de Cuidados de Saúde/normas , Humanos , Legislação de Dispositivos Médicos , Garantia da Qualidade dos Cuidados de Saúde/economia , Garantia da Qualidade dos Cuidados de Saúde/legislação & jurisprudência , Garantia da Qualidade dos Cuidados de Saúde/métodos , Projetos de Pesquisa , Previdência Social/legislação & jurisprudência , Previdência Social/organização & administração
9.
Issue Brief (Commonw Fund) ; 58: 1-9, 2009 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-19639712

RESUMO

The French National Authority for Health (Haute Autorité de Santé, or HAS) was established to assist France's public institutions in optimizing the basket of reimbursable goods and services and to help health care professionals continuously improve their clinical practice by defining best-care standards and identifying relevant tools and methods. HAS carries out single technology assessment (STA) and multiple technology assessment (MTA), assessing both the intrinsic benefit of the new technology and its effectiveness compared with that of existing technologies. A new treatment may not be covered unless it provides either improved benefit or lower cost, and STA is mandatory before a new drug, device, or medical procedure can be added to the benefit list for sickness funds. While HAS recommendations are advisory, the decision-making bodies (the Ministry of Health or the union of sickness funds) accept its findings in most cases.


Assuntos
Comitês Consultivos/organização & administração , Medicina Baseada em Evidências/organização & administração , Reembolso de Seguro de Saúde/economia , Garantia da Qualidade dos Cuidados de Saúde/organização & administração , Avaliação da Tecnologia Biomédica/organização & administração , Conflito de Interesses , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Difusão de Inovações , França , Política de Saúde , Humanos , Cobertura do Seguro/economia , Medicina Estatal/organização & administração
10.
Milbank Q ; 87(2): 339-67, 2009 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-19523121

RESUMO

CONTEXT: The discussion about improving the efficiency, quality, and long-term sustainability of the U.S. health care system is increasingly focusing on the need to provide better evidence for decision making through comparative effectiveness research (CER). In recent years, several other countries have established agencies to evaluate health technologies and broader management strategies to inform health care policy decisions. This article reviews experiences from Britain, France, Australia, and Germany. METHODS: This article draws on the experience of senior technical and administrative staff in setting up and running the CER entities studied. Besides reviewing the agencies' websites, legal framework documents, and informal interviews with key stakeholders, this analysis was informed by a workshop bringing together U.S. and international experts. FINDINGS: This article builds a matrix of features identified from the international models studied that offer insights into near-term decisions about the location, design, and function of a U.S.-based CER entity. While each country has developed a CER capacity unique to its health system, elements such as the inclusiveness of relevant stakeholders, transparency in operation, independence of the central government and other interests, and adaptability to a changing environment are prerequisites for these entities' successful operation. CONCLUSIONS: While the CER entities evolved separately and have different responsibilities, they have adopted a set of core structural, technical, and procedural principles, including mechanisms for engaging with stakeholders, governance and oversight arrangements, and explicit methodologies for analyzing evidence, to ensure a high-quality product that is relevant to their system.


Assuntos
Tomada de Decisões Gerenciais , Difusão de Inovações , Medicina Baseada em Evidências/organização & administração , Pesquisa sobre Serviços de Saúde/organização & administração , Atenção Primária à Saúde/organização & administração , Garantia da Qualidade dos Cuidados de Saúde/organização & administração , Austrália , Eficiência Organizacional , Medicina Baseada em Evidências/economia , França , Alemanha , Política de Saúde , Pesquisa sobre Serviços de Saúde/economia , Humanos , Comunicação Interdisciplinar , Programas Nacionais de Saúde/organização & administração , Atenção Primária à Saúde/economia , Reino Unido , Estados Unidos
11.
Health Econ ; 15(1): 49-64, 2006 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-16167322

RESUMO

Do Primary Care Physicians (PCPs) react strategically to financial incentives and if so how? To address this question, we follow a quasi-natural experiment in Quebec, using a panel system technique. In so doing, we both correct for underestimation biases in earlier time series findings and generate new results on the issue of complementarity/substitution between consultations with varying levels of technicality. Under both techniques, we show that PCPs are sensitive to the enforcement and subsequent temporary removals of expenditure caps and more generally, to changes in consultations' relative prices over time. These results support the existence of a discretionary power over the choice of consultation, PCPs increasing strategically the number of the more technical (and therefore more lucrative) consultations when pressed to defend their income. This finding for primary care parallels the now well-established DRG creep in hospitals. The panel system approach offers a better account of the complexity surrounding PCPs' decision-making process. In particular, it successfully addresses issues of physician heterogeneity, jointness between consultations and temporal breaks and generates robust estimates of PCPs volume and quality reactions to regulatory changes.


Assuntos
Medicina de Família e Comunidade/economia , Médicos de Família/economia , Padrões de Prática Médica/economia , Atenção Primária à Saúde/economia , Reembolso de Incentivo , Orçamentos , Current Procedural Terminology , Tomada de Decisões , Grupos Diagnósticos Relacionados , Medicina de Família e Comunidade/estatística & dados numéricos , Necessidades e Demandas de Serviços de Saúde , Humanos , Modelos Econométricos , Análise Multivariada , Programas Nacionais de Saúde/economia , Médicos de Família/psicologia , Padrões de Prática Médica/estatística & dados numéricos , Atenção Primária à Saúde/estatística & dados numéricos , Quebeque , Encaminhamento e Consulta/economia , Encaminhamento e Consulta/estatística & dados numéricos
12.
J Health Polit Policy Law ; 30(1-2): 97-119, 2005.
Artigo em Inglês | MEDLINE | ID: mdl-15943389

RESUMO

In this article, we assess the recent performance of the French state at containing costs in health care using political science concepts such as path dependency and incentives, which are central to an economic approach. The article focuses on institutional capacities and cultural immobilism and attempts to lay bare the tensions at play in seizing (or not) opportunities for structural change. In particular, we attempt to delineate what constitutes real change in this policy arena (big reforms versus the accumulation of many small policy movements) and to understand the variables at play in the coming together of conjunctures that provide for the big, as well as the underlying structures that allow the accumulation of the small. Except in cases of favorable conjuncture, the analysis bodes very ill for nonincremental reform and, indeed, for significant change over the long term.


Assuntos
Reforma dos Serviços de Saúde/tendências , Programas Nacionais de Saúde/organização & administração , Formulação de Políticas , Política , Controle de Custos , França , Reforma dos Serviços de Saúde/organização & administração , Gastos em Saúde , Acesso aos Serviços de Saúde/tendências , Administração Hospitalar/tendências , Humanos , Cultura Organizacional , Inovação Organizacional , Sociologia Médica/tendências
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