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1.
Value Health ; 23(5): 606-615, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32389226

RESUMO

OBJECTIVES: Ensuring access to precision medicine has been an issue because in some European countries, desynchronized reimbursement decision-making occurs between the medicine and the companion diagnostic (CDx). This has resulted in cases in which precision medicine is reimbursed but not the CDx. In overcoming this issue, an alignment of the decision-making process for reimbursement between the 2 entities should be considered. As pharmaceutical reimbursement procedures are meticulously covered in the literature, we set out to systematically map in vitro diagnostic (IVD) reimbursement procedures and identify policies for aligning these procedures with the pharmaceutical reimbursement procedures. METHODS: We selected 8 European countries for this analysis. For each country, we characterized the national benefit basket entailing the IVD medical acts in outpatient care, evaluated the procedure for inclusion, and identified alternative reimbursement practices for CDx. Targeted searches, using publicly accessible sources, were conducted to identify relevant reimbursement policies and laws. RESULTS: We systematically describe the reimbursement process in 8 European countries. Alternative procedures for CDx reimbursement were identified in Belgium and Germany. Alternative policies attributed to the practice of precision medicine were identified in England and Italy. In France, some CDx are included in the "coverage with evidence" development program. Specifically, the health technology assessment agencies of France and England commented on the assessment of companion diagnostics and their clinical utility. CONCLUSION: CDx reimbursement procedures have recently been implemented in some countries. This was seemingly done primarily to ensure access to the precision medicine and only secondary to the value they would provide.


Assuntos
Reembolso de Seguro de Saúde/economia , Medicina de Precisão/economia , Medicina Estatal/economia , Avaliação da Tecnologia Biomédica/economia , Inglaterra , Europa (Continente) , Política de Saúde , Humanos
2.
Value Health ; 23(4): 425-433, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32327159

RESUMO

BACKGROUND: Mounting pressures on the healthcare system, such as budget constraints and new, costly health technologies reaching the market, have pushed payers and manufacturers to engage in managed entry agreements (MEAs) to address uncertainty and facilitate market access. OBJECTIVES: This study was conducted to illustrate the current landscape of MEAs in Europe and to analyze the main hurdles they face in implementation, providing a policy perspective. METHODS: We conducted a health policy analysis based on a literature review and described the emergence, classification, current use, and implementation obstacles of MEAs in Europe. RESULTS: Throughout Europe, uncertainty and high prices of health technologies have pushed stakeholders towards MEAs. Two main types of MEAs were applied heavily, finance-based agreements (FBAs) and performance-based agreements, including individual performance-based agreements and coverage with evidence development (CED). Service-based agreements have not been as heavily considered so far, yet are increasingly used. Many European countries are turning to CEDs to address uncertainty and facilitate market access while negotiating the pricing and reimbursement rates of products. Despite the interest in CEDs, European countries have moved toward FBAs due to the complexities and burdens associated with PBAs. CONCLUSIONS: Ultimately, in Europe, with the exception of Italy, where MEAs have proven to be inefficient, MEAs are predominantly FBAs dedicated to addressing cost containment from payers' perspective and external reference pricing from the manufacturers' perspective. It has been speculated that MEAs will disappear in the medium-term as they are counterproductive for extending patient access and emergence of innovation. To inform value-based decision making and allow early access to innovative medicines, CEDs should be revisited.


Assuntos
Tecnologia Biomédica/economia , Assistência à Saúde/economia , Política de Saúde , Controle de Custos , Indústria Farmacêutica/economia , Europa (Continente) , Humanos , Formulação de Políticas , Avaliação da Tecnologia Biomédica/economia
3.
Value Health ; 23(2): 139-150, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32113617

RESUMO

Healthcare resource allocation decisions made under conditions of uncertainty may turn out to be suboptimal. In a resource constrained system in which there is a fixed budget, these suboptimal decisions will result in health loss. Consequently, there may be value in reducing uncertainty, through the collection of new evidence, to make better resource allocation decisions. This value can be quantified using a value of information (VOI) analysis. This report, from the ISPOR VOI Task Force, introduces VOI analysis, defines key concepts and terminology, and outlines the role of VOI for supporting decision making, including the steps involved in undertaking and interpreting VOI analyses. The report is specifically aimed at those tasked with making decisions about the adoption of healthcare or the funding of healthcare research. The report provides a number of recommendations for good practice when planning, undertaking, or reviewing the results of VOI analyses.


Assuntos
Orçamentos , Tomada de Decisões , Técnicas de Apoio para a Decisão , Custos de Medicamentos , Desenvolvimento de Medicamentos/economia , Alocação de Recursos para a Atenção à Saúde/economia , Pesquisa sobre Serviços de Saúde/economia , Avaliação da Tecnologia Biomédica/economia , Redução de Custos , Análise Custo-Benefício , Humanos , Reembolso de Seguro de Saúde/economia , Modelos Econômicos , Modelos Estatísticos , Formulação de Políticas , Seguro de Saúde Baseado em Valor/economia , Aquisição Baseada em Valor/economia
4.
Value Health ; 23(3): 277-286, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32197720

RESUMO

The allocation of healthcare resources among competing priorities requires an assessment of the expected costs and health effects of investing resources in the activities and of the opportunity cost of the expenditure. To date, much effort has been devoted to assessing the expected costs and health effects, but there remains an important need to also reflect the consequences of uncertainty in resource allocation decisions and the value of further research to reduce uncertainty. Decision making with uncertainty may turn out to be suboptimal, resulting in health loss. Consequently, there may be value in reducing uncertainty, through the collection of new evidence, to better inform resource decisions. This value can be quantified using value of information (VOI) analysis. This report from the ISPOR VOI Task Force describes methods for computing 4 VOI measures: the expected value of perfect information, expected value of partial perfect information (EVPPI), expected value of sample information (EVSI), and expected net benefit of sampling (ENBS). Several methods exist for computing EVPPI and EVSI, and this report provides guidance on selecting the most appropriate method based on the features of the decision problem. The report provides a number of recommendations for good practice when planning, undertaking, or reviewing VOI analyses. The software needed to compute VOI is discussed, and areas for future research are highlighted.


Assuntos
Técnicas de Apoio para a Decisão , Custos de Cuidados de Saúde , Alocação de Recursos para a Atenção à Saúde/economia , Prioridades em Saúde/economia , Necessidades e Demandas de Serviços de Saúde/economia , Modelos Estatísticos , Determinação de Necessidades de Cuidados de Saúde/economia , Avaliação da Tecnologia Biomédica/economia , Consenso , Análise Custo-Benefício , Custos de Cuidados de Saúde/estatística & dados numéricos , Alocação de Recursos para a Atenção à Saúde/estatística & dados numéricos , Prioridades em Saúde/estatística & dados numéricos , Necessidades e Demandas de Serviços de Saúde/estatística & dados numéricos , Humanos , Determinação de Necessidades de Cuidados de Saúde/estatística & dados numéricos , Probabilidade , Avaliação da Tecnologia Biomédica/estatística & dados numéricos , Incerteza
5.
Value Health ; 23(3): 319-327, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32197727

RESUMO

OBJECTIVE: To assess whether using surrogate versus patient-relevant endpoints in pivotal trials of cancer drugs was associated with health technology assessment recommendations in England (National Institute for Health and Care Excellence [NICE]) and Canada (Canadian Agency for Drugs and Technologies in Health [CADTH]). METHODS: Cancer drug approvals from 2012 to 2016 were categorized by demonstrating benefit on overall survival (OS), progression-free survival, disease response, or having no comparator. Approvals were analyzed by benefit category and health technology assessment recommendation. The association between benefit (surrogate vs OS) and recommending a drug was examined using descriptive statistics and linear probability models controlling for unmet need, orphan designation, and cost-effectiveness. RESULTS: Of 42 cancer indications that NICE recommended, 15 (36%) demonstrated OS benefit. Cancer indications with OS benefit were less likely to receive a recommendation from NICE than those without (P = .04). In linear probability models, availability of OS benefit was no longer associated with a recommendation from NICE (P = .32). Cost-effective cancer drugs had a 55.6% (95% CI: 38.9%-72.3%) higher probability of receiving a recommendation from NICE than those that were not. In Canada, 15 of 37 (41%) cancer indications that were recommended showed OS benefit. There was no detectable association between surrogate measures and CADTH recommendations based on descriptive statistics (P = .62) or in linear probability models (P = .73). CONCLUSION: When cost-effectiveness was considered, pivotal trial endpoints were not associated with NICE recommendations. Pivotal trial endpoints, unmet need, orphan status, and cost-effectiveness did not explain CADTH recommendations.


Assuntos
Antineoplásicos/uso terapêutico , Ensaios Clínicos como Assunto , Aprovação de Drogas , Determinação de Ponto Final , Neoplasias/tratamento farmacológico , Projetos de Pesquisa , Avaliação da Tecnologia Biomédica , Antineoplásicos/efeitos adversos , Antineoplásicos/economia , Canadá , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Aprovação de Drogas/economia , Custos de Medicamentos , Humanos , Modelos Econômicos , Neoplasias/economia , Neoplasias/mortalidade , Formulação de Políticas , Intervalo Livre de Progressão , Estudos Retrospectivos , Avaliação da Tecnologia Biomédica/economia , Fatores de Tempo , Reino Unido
6.
Value Health ; 23(2): 171-179, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32113622

RESUMO

OBJECTIVES: Universal healthcare coverage in low- and middle-income countries requires challenging resource allocation decisions. Health technology assessment is one important tool to support such decision making. The International Decision Support Initiative worked with the Ghanaian Ministry of Health to strengthen health technology assessment capacity building, identifying hypertension as a priority topic area for a relevant case study. METHODS: Based on guidance from a national technical working group of researchers and policy makers, an economic evaluation and budget impact analysis were undertaken for the main antihypertensive medicines used for uncomplicated, essential hypertension. The analysis aimed to address specific policy questions relevant to the National Health Insurance Scheme. RESULTS: The evaluation found that first-line management of essential hypertension with diuretics has an incremental cost per disability-adjusted life-year avoided of GH¢ 276 ($179 in 2017, 4% of gross national income per capita) compared with no treatment. Calcium channel blockers were more effective than diuretics but at a higher incremental cost: GH¢ 11 061 per disability-adjusted life-year avoided ($7189 in 2017; 160% of gross national income per capita). Diuretics provide better health outcomes at a lower cost than angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or beta-blockers. Budget impact analysis highlighted the potential for cost saving through enhanced price negotiation and increased use of better-value drugs. We also illustrate how savings could be reinvested to improve population health. CONCLUSIONS: Economic evaluation enabled decision makers to assess hypertension medicines in a Ghanaian context and estimate the impact of using such evidence to change policy. This study contributes to addressing challenges associated with the drive for universal healthcare coverage in the context of constrained budgets.


Assuntos
Anti-Hipertensivos/economia , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Custos de Medicamentos , Hipertensão Essencial/tratamento farmacológico , Hipertensão Essencial/economia , Medicina Baseada em Evidências/economia , Alocação de Recursos para a Atenção à Saúde/economia , Avaliação de Processos e Resultados em Cuidados de Saúde/economia , Formulação de Políticas , Avaliação da Tecnologia Biomédica/economia , Anti-Hipertensivos/efeitos adversos , Orçamentos , Análise Custo-Benefício , Hipertensão Essencial/epidemiologia , Hipertensão Essencial/fisiopatologia , Feminino , Gana/epidemiologia , Nível de Saúde , Humanos , Masculino , Fatores de Tempo , Resultado do Tratamento
7.
Value Health ; 23(2): 191-199, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32113624

RESUMO

BACKGROUND: Changes in the regulatory context enable faster approval of transformative medicines. They also lead to health technology assessment (HTA) agencies having to make decisions with less evidence. In response, HTA agencies have also initiated forms of conditional approval. When the evidence base for a new oncology treatment leaves substantial uncertainty, the new Cancer Drugs Fund allows the National Institute for Heath and Care Excellence to give the manufacturer two options: (1) offer a low price based on conservative assumptions and obtain immediate approval ("stick") or (2) wait until the evidence base has further matured before finalizing a potentially higher agreed price ("twist"). OBJECTIVES: The purpose of this article is to explain how, using the theoretical framework of the expected value of sample information, simulation methods can help inform a manufacturer's decisions when faced with the option to stick or twist. METHODS: We first summarize a general model to help frame the manufacturer's negotiating strategy. We then use a motivating case study, based on a hypothetical immunotherapy, to illustrate how manufacturers can use simulation methods to robustly characterize the uncertainty inherent to further data collection and incorporate this uncertainty within their decision making. RESULTS: Our approach allows us to estimate the commercial value of generating additional data (the difference between the estimated net present value of stick and twist). We test the sensitivity of the results to different assumptions via scenario analyses. CONCLUSIONS: This article shows that simulation methods can be used to help pharmaceutical managers make informed strategic decisions in contexts of uncertainty.


Assuntos
Antineoplásicos Imunológicos/economia , Antineoplásicos Imunológicos/uso terapêutico , Orçamentos , Contratos/economia , Tomada de Decisões , Técnicas de Apoio para a Decisão , Aprovação de Drogas/economia , Custos de Medicamentos , Desenvolvimento de Medicamentos/economia , Negociação , Avaliação da Tecnologia Biomédica/economia , Antineoplásicos Imunológicos/efeitos adversos , Simulação por Computador , Análise Custo-Benefício , Alocação de Recursos para a Atenção à Saúde/economia , Humanos , Modelos Econômicos , Modelos Estatísticos , Formulação de Políticas , Resultado do Tratamento , Incerteza
8.
Expert Rev Med Devices ; 17(4): 277-288, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32167800

RESUMO

Introduction: Health technology assessments (HTA) are tools for policymaking and resource allocation. Early HTAs are increasingly used in design and development of new technologies. Conducting early HTAs is challenging, due to a lack of evidence and significant uncertainties in the technology and the market. A multi-disciplinary approach is considered essential. However, an operational framework that can enable the integration of multi-dimensional evidence into commercialization remains lacking.Areas covered: We developed the Lean and Agile Multi-dimensional Process (LAMP), an early HTA framework, for embedding commercial decision-making in structured evidence generation activities, divided into phases. Diverse evidence in unmet needs, user acceptance, cost-effectiveness, and market competitiveness are being generated in increasing depth. This supports the emergence of design and value propositions that align technology capabilities and clinical and user needs.Expert opinion: We have been applying LAMP to working with medical device and diagnostic industry in the UK. The framework can be adapted to suit different technologies, decision needs, time scales, and resources. LAMP offers a practical solution to the multi-disciplinary approach. Methodologists drive the process by performing evidence generation and synthesis as and by enabling interactions between manufacturers, designers, clinicians, and other key stakeholders.


Assuntos
Tecnologia Biomédica , Avaliação da Tecnologia Biomédica , Tecnologia Biomédica/economia , Tomada de Decisão Clínica , Análise Custo-Benefício , Grupos Focais , Humanos , Avaliação da Tecnologia Biomédica/economia
10.
Value Health ; 23(1): 10-16, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31952664

RESUMO

BACKGROUND: Health technology assessment (HTA) plays an important role in reimbursement decision-making in many countries, but recommendations vary widely throughout jurisdictions, even for the same drug. This variation may be due to differences in the weighing of evidence or differences in the processes or procedures, which are known as HTA practices. OBJECTIVE: To provide insight into the effects of differences in practices on interpretation of intercountry differences in HTA recommendations for conditionally approved drugs. METHODS: HTA recommendations for conditionally approved drugs (N = 27) up until June 2017 from England/Wales, France, Germany, the Netherlands, and Scotland were included. Recommendations and practice characteristics were extracted from these five jurisdictions and this data was validated. The effect of nonsubmissions, resubmissions, and reassessments; cost-effectiveness assessments; and price negotiations on changes in the percentage of negative recommendations and the interpretation of intercountry differences in HTA outcomes were analyzed using Fisher exact tests. RESULTS: The inclusion of cost-effectiveness assessments led to significant increases in the proportion of negative recommendations in England/Wales (from 4% to 50%, P<.01) and Scotland (from 21% to 71%, P<.01). The subsequent inclusion of price negotiations led to significant reductions in the proportion of negative recommendations in England/Wales (from 50% to 14%, P<.01), France (from 31% to 3%, P=.012), and Germany (from 34% to 0%, P<.01). Results indicated that the inclusion of nonsubmissions and resubmissions might affect Scottish negative HTA recommendations (from 7% to 21%), but this effect was not significant. No significant effects were observed in the Netherlands, possibly owing to sample size. CONCLUSION: Variations in HTA practices between international jurisdictions can have a substantial and significant impact on conclusions about recommendations by HTA bodies, as exemplified in this cohort of conditionally approved products. Studies comparing international HTA recommendations should carefully consider possible practice variations between jurisdictions.


Assuntos
Comportamento de Escolha , Custos de Cuidados de Saúde , Alocação de Recursos para a Atenção à Saúde/economia , Política de Saúde/economia , Disparidades em Assistência à Saúde/economia , Padrões de Prática Médica/economia , Avaliação da Tecnologia Biomédica/economia , Tomada de Decisão Clínica , Análise Custo-Benefício , Comparação Transcultural , Tecnologia Culturalmente Apropriada/economia , Assistência à Saúde Culturalmente Competente/economia , Europa (Continente) , Alocação de Recursos para a Atenção à Saúde/organização & administração , Disparidades em Assistência à Saúde/organização & administração , Humanos , Formulação de Políticas , Padrões de Prática Médica/organização & administração , Avaliação da Tecnologia Biomédica/organização & administração
11.
Value Health ; 23(1): 17-24, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31952668

RESUMO

OBJECTIVES: To investigate whether the use of economic evaluation (EE) in healthcare decision making is influenced by the social values and institutional context in a given country. METHODS: We developed and tested a conceptual framework for the 36 Organisation for Economic Co-operation and Development (OECD) countries. The countries were divided into two groups based on the extent of their use of EE in drug reimbursement. The key social values were efficiency, equity, and personal responsibility, measured in an international survey. Countries were classified based on their institutional context in terms of their general welfare paradigm/type of healthcare system and the administrative tradition to which they belong. We performed correlation tests and ran path analysis regression models to test our hypotheses. RESULTS: EE high users included significantly more Beveridge-type systems (50% vs 31%) and fewer Bismarck-type (15% vs 56%). Napoleonic tradition countries seemed to reject personal responsibility in health (r = -0.511, P = .009), whereas Germanic tradition countries embraced it (r = 0.572, P = .003); Anglo-American tradition countries exhibited a significant association with efficiency (r = 0.444, P = .026), whereas Scandinavian tradition countries appeared to reject it as a criterion for rationing in healthcare (r = -0.454, P = .023). No significant direct association was found between social values and use of EE. CONCLUSION: Our exploratory analysis suggests that institutional context and, indirectly, social values may play a role in shaping the use of EE in healthcare decision making. Because of the differences among countries in terms of institutional context, which may in part be influenced by social values, it is unlikely that there will ever be a single, harmonious approach to the use of EE.


Assuntos
Comportamento de Escolha , Custos de Cuidados de Saúde , Alocação de Recursos para a Atenção à Saúde/economia , Política de Saúde/economia , Valores Sociais , Avaliação da Tecnologia Biomédica/economia , Tomada de Decisão Clínica , Alocação de Recursos para a Atenção à Saúde/organização & administração , Humanos , Organização para a Cooperação e Desenvolvimento Econômico , Formulação de Políticas , Avaliação da Tecnologia Biomédica/organização & administração
12.
Value Health ; 23(1): 25-31, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31952669

RESUMO

BACKGROUND: The economic evaluation of healthcare technologies has become in many countries a basic tool for reimbursement, pricing and purchasing decisions. OBJECTIVE: The objective of this article is to examine the institutional, legal, and political factors that have impeded the application of economic evaluation and the criterion of efficiency in the process of pricing and reimbursement of new medicines in Spain. METHODS: Narrative description of the current institutional framework for the use of economic evaluation in pricing and reimbursement in Spain, legal and policy framework in the field of evaluation of new medicines, and stakeholder initiatives and policies related to the use of economic evaluation outside of the pricing and reimbursement process. RESULTS: Spain has an institutional framework created and established over the last years that could have facilitated a formal use of economic evaluation in the process of pricing and reimbursement. Nevertheless, the real use of economic evaluation at the central or regional level is still unknown, although application of the efficiency criterion, linking to cost-effectiveness, has been clearly required by Spanish laws and regulations at the national level. We highlight a certain degree of moral hazard from the central government that is not directly responsible for the budget impact of reimbursement and pricing decisions. There are currently a number of ongoing initiatives in the field of economic evaluation by various agents, but they remain uncoordinated. CONCLUSIONS: Poor governance at the highest level of decision making is the main reason for the lack of interest in economic evaluation. A profound political change, supported by transparency and accountability, is required before the criterion of efficiency can be fully considered in the process of pricing and reimbursement of new medicines in Spain.


Assuntos
Custos de Medicamentos , Alocação de Recursos para a Atenção à Saúde/economia , Política de Saúde/economia , Reembolso de Seguro de Saúde/economia , Avaliação da Tecnologia Biomédica/economia , Análise Custo-Benefício , Regulamentação Governamental , Disparidades em Assistência à Saúde/economia , Humanos , Formulação de Políticas , Política , Espanha , Participação dos Interessados
13.
Value Health ; 23(1): 3-9, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31952670

RESUMO

BACKGROUND: Social scientists have paid increasing attention to health technology assessment (HTA). This paper provides an overview of existing social scientific literature on HTA, with a focus on sociology and political science and their subfields. METHODS: Narrative review of key pieces in English. RESULTS: Three broad themes recur in the emerging social science literature on HTA: the drivers of the establishment and concrete institutional designs of HTA bodies; the effects of institutionalized HTA on pricing and reimbursement systems and the broader society; and the social and political influences on HTA decisions. CONCLUSION: Social scientists bring a focus on institutions and social actors involved in HTA, using primarily small-N research designs and qualitative methods. They provide valuable critical perspectives on HTA, at times challenging its otherwise unquestioned assumptions. However, they often leave aside questions important to the HTA practitioner community, including the role of culture and values. Closer collaboration could be beneficial to tackle new relevant questions pertaining to HTA.


Assuntos
Comportamento de Escolha , Alocação de Recursos para a Atenção à Saúde/economia , Política de Saúde/economia , Política , Ciências Sociais/economia , Valores Sociais , Avaliação da Tecnologia Biomédica/economia , Tomada de Decisão Clínica , Análise Custo-Benefício , Custos de Cuidados de Saúde , Alocação de Recursos para a Atenção à Saúde/organização & administração , Humanos , Formulação de Políticas , Ciências Sociais/organização & administração , Avaliação da Tecnologia Biomédica/organização & administração
14.
Value Health ; 23(1): 32-38, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31952671

RESUMO

BACKGROUND: Some studies in the Netherlands have gauged public views on principles for healthcare priority setting, but they fall short of comprehensively explaining the public disapproval of several recent reimbursement decisions. OBJECTIVE: To obtain insight into citizens' preferences and identify the criteria they would propose for decisions pertaining to the benefits package of basic health insurance. METHODS: Twenty-four Dutch citizens were selected for participation in a Citizen Forum, which involved 3 weekends. Deliberations took place in small groups and in plenary, guided by 2 moderators, on the basis of 8 preselected case studies, which participants later compared and prioritized under the premise that not all treatments can or need to be reimbursed. Participants received opportunities to inform themselves through written brochures and live interactions with 3 experts. RESULTS: The Citizen Forum identified 16 criteria for inclusion or exclusion of treatments in the benefits package; they relate to the condition (2 criteria), treatment (11 criteria), and individual characteristics of those affected by the condition (3 criteria). In most case studies, it was a combination of criteria that determined whether or not participants favored inclusion of the treatment under consideration in the benefits package. Participants differed in their opinion about the relative importance of criteria, and they had difficulty in operationalizing and trading off criteria to provide a recommendation. CONCLUSIONS: Informed citizens are prepared to make and, to a certain extent, capable of making reasoned choices about the reimbursement of health services. They realize that choices are both necessary and possible. Broad public support and understanding for making tough choices regarding the benefits package of basic health insurance is not automatic: it requires an investment.


Assuntos
Custos de Medicamentos , Alocação de Recursos para a Atenção à Saúde/economia , Política de Saúde/economia , Reembolso de Seguro de Saúde/economia , Opinião Pública , Avaliação da Tecnologia Biomédica/economia , Assistência de Saúde Universal , Cobertura Universal do Seguro de Saúde/economia , Análise Custo-Benefício , Regulamentação Governamental , Alocação de Recursos para a Atenção à Saúde/organização & administração , Disparidades em Assistência à Saúde/economia , Humanos , Países Baixos , Preferência do Paciente , Formulação de Políticas , Política , Participação dos Interessados , Avaliação da Tecnologia Biomédica/organização & administração , Cobertura Universal do Seguro de Saúde/organização & administração
15.
Value Health ; 23(1): 39-42, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31952672

RESUMO

India is a diverse land with different cultures, social norms, castes, religions, faiths, languages, politics, and a complex healthcare system. As a step to enhance healthcare, the government of India announced a move toward universal health coverage to increase accessibility and affordability of health-related services. Recently, there has been an introduction of health technology assessment (HTA) in India to help inform evidence-based decision making in cases of limited resources and budgets. Nevertheless, there are challenges related to biased decision making, an unregulated healthcare framework, and the lack of data and capacity that will (directly or indirectly) affect the use of HTA in India. For HTA to be successful in India and in similar low- and middle-income countries, it is important that the decision makers acknowledge these challenges and embrace differences in ideologies, cultures, and politics instead of ignoring them. Drawing lessons from countries with well-developed HTA bodies may help, but these need to be modified for the country-specific context. Ensuring quality and transparency is key to building trust in medical decision making. Improved coordination at all levels of healthcare is vital to ensure the long-term success of HTA in India. This is challenging but achievable by spreading awareness among stakeholders and achieving moderate health-sector regulation that can combat corruption. HTA will prosper in India if it incorporates cultural and institutional diversity, alongside tackling socioeconomic inequalities.


Assuntos
Comportamento de Escolha , Alocação de Recursos para a Atenção à Saúde , Política de Saúde , Avaliação da Tecnologia Biomédica , Assistência de Saúde Universal , Cobertura Universal do Seguro de Saúde , Tomada de Decisão Clínica , Análise Custo-Benefício , Tecnologia Culturalmente Apropriada , Assistência à Saúde Culturalmente Competente , Custos de Cuidados de Saúde , Alocação de Recursos para a Atenção à Saúde/economia , Alocação de Recursos para a Atenção à Saúde/organização & administração , Política de Saúde/economia , Disparidades em Assistência à Saúde/economia , Disparidades em Assistência à Saúde/organização & administração , Humanos , Índia , Formulação de Políticas , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Valores Sociais , Participação dos Interessados , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/organização & administração , Cobertura Universal do Seguro de Saúde/economia , Cobertura Universal do Seguro de Saúde/organização & administração
16.
Value Health ; 23(1): 43-51, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31952673

RESUMO

In April 2019, Japan formally introduced health technology assessment (HTA) and, more specifically, a cost-effectiveness analysis, to inform healthcare decision making, mainly when it comes to the pricing of new technologies. This article provides an overview of this new policy, which was implemented formally after a pilot program. In the fiscal year (FY) 2012, discussions on cost-effectiveness assessments were initiated in Japan. After 7 years of deliberations, a cost-effectiveness assessment was implemented formally in April 2019. In Japan, the cost-effectiveness analysis has been used to inform price adjustments of healthcare technologies, although it has not yet been used for decision making on insurance coverage. Selection criteria were established because not all drugs and medical devices could be evaluated owing to a shortage of experts. Exclusion criteria have also been applied to prevent access restriction. The scope of the evaluation's price adjustment target is limited to part of the product price. If the cost per quality-adjusted life-year (QALY) threshold falls below ¥5 million per QALY, the price adjustment rate changes stepwise according to the cost per QALY. In addition to price reduction, a price-raising scheme has also been implemented for scenarios where products are evaluated to be highly cost-effective and innovative. This article describes the first formally implemented HTA system in Japan. Although it is too early to make any conclusions about its effect, the Japan-specific context makes this system unique. To fully understand the opportunities and challenges of the new system, it is vital that Japan accumulates experience with this system and develops human resources in health economic evaluation.


Assuntos
Custos de Cuidados de Saúde , Alocação de Recursos para a Atenção à Saúde/economia , Política de Saúde/economia , Reembolso de Seguro de Saúde/economia , Avaliação da Tecnologia Biomédica/economia , Análise Custo-Benefício , Regulamentação Governamental , Disparidades em Assistência à Saúde/economia , Humanos , Japão , Formulação de Políticas , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Valores Sociais , Participação dos Interessados
17.
Value Health ; 23(1): 52-60, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31952674

RESUMO

BACKGROUND: Many high cost treatments for advanced melanoma have become available in recent years. National health technology assessment agencies have raised concerns regarding uncertainty in their clinical and cost-effectiveness. OBJECTIVE: The aim of this systematic review is to identify economic evaluations of treatments for advanced melanoma and review model assumptions, outcomes, and quality as preparation for a health technology assessment. METHODS: A search of Embase, MEDLINE, EconLit, and the Cochrane Database was conducted. Only studies using decision-analytic models were included. Two authors independently completed full-text review and data extraction. RESULTS: Fifteen studies were identified. There were major differences in the structural assumptions underpinning the models. There was general agreement in study conclusions, although the predicted costs and quality-adjusted life years for each treatment varied. BRAF monotherapy (vemurafenib, dabrafenib) or BRAF/MEK combination therapy (BRAF monotherapy with cobimetinib or trametinib) has not been shown to be cost-effective in any jurisdiction. PD-1 inhibitors (pembrolizumab, nivolumab) are consistently found to be cost-effective compared with ipilimumab, although their cost-effectiveness compared with chemotherapy is not established. Combination therapy with nivolumab and ipilimumab is unlikely to be cost-effective in any setting. One study including all agents found that none of the new treatments were cost-effective relative to chemotherapy. Publication of the study in a health economics journal is associated with better reporting of and higher-quality assessment than those published in clinical journals. CONCLUSION: Despite differences in model structures and assumptions, the conclusions of most included studies were consistent. Health technology assessment has a key role in maximizing value from high-cost innovative treatments. Consideration should be given to divestment from BRAF/MEK inhibitors and ipilimumab in favor of reimbursement of PD-1 inhibitors.


Assuntos
Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Custos de Medicamentos , Alocação de Recursos para a Atenção à Saúde/economia , Política de Saúde/economia , Melanoma/tratamento farmacológico , Melanoma/economia , Neoplasias Cutâneas/tratamento farmacológico , Neoplasias Cutâneas/economia , Avaliação da Tecnologia Biomédica/economia , Antineoplásicos/efeitos adversos , Análise Custo-Benefício , Humanos , Melanoma/patologia , Modelos Econômicos , Terapia de Alvo Molecular/economia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Neoplasias Cutâneas/patologia , Fatores de Tempo , Resultado do Tratamento
18.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 619-626, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31721598

RESUMO

Introduction: In recent decades, medical devices (MDs) have increasingly become an integral part of patient care. However, when it comes to designing and appraising economic models, researchers typically follow pharmaceutical templates (e.g. CHEERS) to assess their economic viability. This study evaluates the generalizability of four device-specific criteria, as recommended by the recent MedtechHTA project, of learning curve, incremental innovation, dynamic pricing, and organizational impact with a broader group of MDs including diagnostics and implantables. The purpose was to determine the applicability of these criteria to a broader range of MDs.Areas Covered: We determined the extent to which these criteria could be applied to each device type and attempted to identify common themes. We performed a literature search using PubMed and Google of a range of devices to understand the clinical significance, operation, and economic viability.Expert Opinion: Our findings suggest that the four characteristics are not applicable to all device types. Prior evaluation of a device's intrinsic properties (such as longevity and device location) and its FDA risk classification could help to indicate the applicability of the criteria. Documenting this process when assessing the additional four criteria on the CHEERS checklist would improve the transparency of future economic evaluations.


Assuntos
Equipamentos e Provisões/economia , Modelos Econômicos , Avaliação da Tecnologia Biomédica/métodos , Lista de Checagem , Análise Custo-Benefício/métodos , Humanos , Avaliação da Tecnologia Biomédica/economia
19.
Int J Health Policy Manag ; 8(10): 575-582, 2019 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-31657184

RESUMO

BACKGROUND: To assess whether early health economic modeling helps to distinguish those healthcare innovations that are potentially cost-effective from those that are not potentially cost-effective. We will also study what information is retrieved from the health economic models to inform further development, research and implementation decisions. METHODS: We performed secondary analyses on an existing database of 32 health economic modeling assessments of 30 innovations, performed by our group. First, we explored whether the assessments could distinguish innovations with potential cost-effectiveness from innovations without potential cost-effectiveness. Second, we explored which recommendations were made regarding development, implementation and further research of the innovation. RESULTS: Of the 30 innovations, 1 (3%) was an idea that was not yet being developed and 14 (47%) were under development. Eight (27%) innovations had finished development, and another 7 (23%) innovations were on the market. Although all assessments showed that the innovation had the potential to become cost-effective, due to improved patient outcomes, cost savings or both, differences were found in the magnitude of the potential benefits, and the likelihood of reaching this potential. The assessments informed how the innovation could be further developed or positioned to maximize its cost-effectiveness, and informed further research. CONCLUSION: The early health economic assessments provided insight in the potential cost-effectiveness of an innovation in its intended context, and the associated uncertainty. None of the assessments resulted in a firm 'no-go' recommendation, but recommendations could be provided on further research and development in order to maximize value for money.


Assuntos
Análise Custo-Benefício , Modelos Econômicos , Avaliação da Tecnologia Biomédica/economia
20.
Value Health ; 22(8): 878-883, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31426928

RESUMO

Sometimes a government or other payer is called on to fund a new health technology even when the evidence leaves a lot of uncertainty. One option is for the payer to provisionally fund the technology and reduce uncertainty by developing evidence. This is called coverage with evidence development (CED). Only-in-research CED, when the payer funds the technology only for patients who participate in the evidence development, raises the sharpest ethical questions. Is the patient coerced or induced into participating? If so, under what circumstances, if any, is this ethically justified? Building on work by Miller and Pearson, we argue that patients have a right to funding for a technology only when the payer can be confident that the technology provides reasonable value for money. Technologies are candidates for CED precisely because serious questions remain about value for money, and therefore patients have no right to technologies under a CED arrangement. This is why CED induces rather than coerces. The separate question of whether the inducement is ethically justified remains. We argue that CED does pose risks to patients, and the worse these risks are, the harder it is to justify the inducement. Finally, we propose conditions under which the inducement could be ethically justified and means of avoiding inducement altogether. We draw on the Australian context, and so our conclusions apply most directly to comparable contexts, where the payer is a government that provides universal coverage with a regard for cost-effectiveness that is prominent and fairly clearly defined.


Assuntos
Análise Ética , Medicina Estatal/ética , Medicina Estatal/organização & administração , Avaliação da Tecnologia Biomédica/ética , Avaliação da Tecnologia Biomédica/organização & administração , Austrália , Análise Custo-Benefício , Humanos , Medicina Estatal/economia , Avaliação da Tecnologia Biomédica/economia
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