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1.
Value Health ; 22(5): 518-526, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31104729

RESUMO

BACKGROUND: Health inequalities can be partially addressed through the range of treatments funded by health systems. Nevertheless, although health technology assessment agencies assess the overall balance of health benefits and costs, no quantitative assessment of health inequality impact is consistently undertaken. OBJECTIVES: To assess the inequality impact of technologies recommended under the NICE single technology appraisal process from 2012 to 2014 using an aggregate distributional cost-effectiveness framework. METHODS: Data on health benefits, costs, and patient populations were extracted from the NICE website. Benefits for each technology were distributed to social groups using the observed socioeconomic distribution of hospital utilization for the targeted disease. Inequality measures and estimates of cost-effectiveness were compared using the health inequality impact plane and combined using social welfare indices. RESULTS: Twenty-seven interventions were evaluated. Fourteen interventions were estimated to increase population health and reduce health inequality, 8 to reduce population health and increase health inequality, and 5 to increase health and increase health inequality. Among the latter 5, social welfare analysis, using inequality aversion parameters reflecting high concern for inequality, indicated that the health gain outweighs the negative health inequality impact. CONCLUSIONS: The methods proposed offer a way of estimating the health inequality impacts of new health technologies. The methods do not allow for differences in technology-specific utilization and health benefits, but require less resources and data than conducting full distributional cost-effectiveness analysis. They can provide useful quantitative information to help policy makers consider how far new technologies are likely to reduce or increase health inequalities.


Assuntos
Análise Custo-Benefício , Equidade em Saúde , Disparidades nos Níveis de Saúde , Medicina Estatal/economia , Avaliação da Tecnologia Biomédica/economia , Humanos , Anos de Vida Ajustados por Qualidade de Vida , Reino Unido
2.
Value Health ; 22(5): 575-579, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31104737

RESUMO

Economic models are used in health technology assessments (HTAs) to evaluate the cost-effectiveness of competing medical technologies and inform the efficient use of healthcare resources. Historically, these models have been developed with specialized commercial software (such as TreeAge) or more commonly with spreadsheet software (almost always Microsoft Excel). Although these tools may be sufficient for relatively simple analyses, they put unnecessary constraints on the analysis that may ultimately limit its credibility and relevance. In contrast, modern programming languages such as R, Python, Matlab, and Julia facilitate the development of models that are (i) clinically realistic, (ii) capable of quantifying decision uncertainty, (iii) transparent and reproducible, and (iv) reusable and adaptable. An HTA environment that encourages use of modern software can therefore help ensure that coverage and pricing decisions confer greatest possible benefit and capture all scientific uncertainty, thus enabling correct prioritization of future research.


Assuntos
Análise Custo-Benefício/métodos , Modelos Econômicos , Software , Avaliação da Tecnologia Biomédica/economia , Tomada de Decisões , Humanos
3.
Value Health ; 22(5): 593-600, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31104740

RESUMO

BACKGROUND: Oncology treatments have changed from chemotherapies to targeted therapies and more recently immuno-oncology. This has posed special challenges in the field of health technology assessment (HTA): capturing quality of life (QOL) associated with toxicity due to chemotherapy, crossover upon progression in targeted therapy trials, and survival extrapolation for immuno-oncology drugs. OBJECTIVES: To showcase 20 years of Value in Health (ViH) publications in oncology. METHODS: A review was undertaken of oncology articles published in ViH from May 1998 to August 2018. Full-length articles published in ViH with the keywords "oncology," "cancer," "h(a)ematology," and "malignancy" were included for review. Conference abstracts were excluded. RESULTS: Four major themes were identified: (1) QOL and the development of multiple functional assessment of cancer therapy tools and mapping instruments; (2) analysis of clinical evidence using indirect comparisons, network analyses, and adjustment for crossovers; (3) modeling, Markov models, partitioned survival models, and extrapolation methods; and (4) financial implications and how to deal with uncertainty, introduction of conditional reimbursement, managed entry, and risk share agreements. DISCUSSION: This review article highlights the important role ViH has played in disseminating HTA research in oncology. A few key issues loom on the horizon: precision medicine, further development and practical application of new QOL measures, methods for translating clinical evidence, and exploration of modeling techniques. For a better understanding of the complex interplay between access and financial risk management, ViH will no doubt continue to promote pioneering research in HTA and oncology.


Assuntos
Análise Custo-Benefício , Oncologia/métodos , Qualidade de Vida , Avaliação da Tecnologia Biomédica , Humanos , Imunoterapia , Neoplasias , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/métodos
4.
Value Health ; 22(4): 385-390, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30975388

RESUMO

OBJECTIVES: Reimbursement systems are evolving and endeavor to balance access and affordability. One such evolution in Ireland is the compulsory rapid review (RR) process, the outcome from which is a recommendation for a health technology assessment (HTA) or no HTA. For drugs that avoid an HTA, evaluation times are shorter, lengthy price negotiations are avoided, and access is faster. In the absence of formal decision-making criteria around the requirement of an HTA, this study examines the factors influencing the outcome of the RR process in Ireland. METHODS: A database was developed combining data from publicly available sources for drug evaluations conducted by the National Centre for PharmacoEconomics (NCPE) (January 2010-June 2017, n = 296). Because Irish cost data were not publicly available for all drugs, cost data from the Scottish Medicines Consortium were employed as a proxy. Employing logistic regressions, the factors influencing the RR outcome are revealed. RESULTS: After an RR, an HTA was recommended for 55% of drugs. The regression results revealed therapeutic area (endocrine, musculoskeletal, and neoplasm), first-in-class and orphan disease increased the probability of an HTA. Furthermore, when proxy costs were included, results revealed that every €1000 increase in annual drug costs per patient increased the probability of an HTA being required by 1% and that an HTA was more likely than no HTA when annual drug costs exceeded €15 000. CONCLUSION: Given the current focus on access and affordability, this study identifies the factors influencing the requirement of an HTA in Ireland.


Assuntos
Aprovação de Drogas/economia , Custos de Medicamentos , Acesso aos Serviços de Saúde/economia , Avaliação de Processos e Resultados (Cuidados de Saúde)/economia , Avaliação da Tecnologia Biomédica/economia , Redução de Custos , Análise Custo-Benefício , Bases de Dados Factuais , Aprovação de Drogas/métodos , Humanos , Irlanda , Produção de Droga sem Interesse Comercial/economia , Avaliação de Processos e Resultados (Cuidados de Saúde)/métodos , Mecanismo de Reembolso/economia , Avaliação da Tecnologia Biomédica/métodos , Fatores de Tempo , Fluxo de Trabalho
5.
Value Health ; 22(4): 399-407, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30975390

RESUMO

BACKGROUND: Conditional financing (CF) of hospital drugs was implemented in the Netherlands as a form of managed entry agreements between 2006 and 2012. CF was a 4-year process comprising 3 stages: initial health technology assessment of the drug (T = 0), conduct of outcomes research studies, and reassessment of the drug (T = 4). OBJECTIVES: To analyze stakeholder experiences in implementing CF in practice. METHODS: Public and private stakeholders were approached for participation in stakeholder interviews through standardized email invitations. An interview guide was developed to guide discussions that covered the following topics: perceived aims of CF, functioning of CF, impact of CF, and conclusions and future perspectives. Extensive summaries were generated for each interview and subsequently used for directed content analysis. RESULTS: Thirty stakeholders were interviewed. Differences emerged among the stakeholders on the perceived aims of CF. Conversely, there was some agreement among stakeholders on the shortcomings in the functioning of CF, the positive impact of CF on the Dutch healthcare setting, and improvement points for CF. CONCLUSIONS: Despite stakeholders' belief that CF either did not meet its aims or only partially did so, there was agreement on the need for new policy to address the same aims of CF in the future. Nevertheless, stakeholders diverged on whether CF should be improved on the basis of learnings identified and reintroduced into practice or replaced with new policy schemes.


Assuntos
Aprovação de Drogas/economia , Custos de Medicamentos , Administração Financeira de Hospitais/economia , Gastos em Saúde , Custos Hospitalares , Participação dos Interessados , Avaliação da Tecnologia Biomédica/economia , Orçamentos , Aprovação de Drogas/legislação & jurisprudência , Custos de Medicamentos/legislação & jurisprudência , Administração Financeira de Hospitais/legislação & jurisprudência , Gastos em Saúde/legislação & jurisprudência , Política de Saúde/economia , Custos Hospitalares/legislação & jurisprudência , Humanos , Entrevistas como Assunto , Países Baixos , Formulação de Políticas , Avaliação de Programas e Projetos de Saúde , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
6.
Int J Technol Assess Health Care ; 35(1): 50-55, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30732667

RESUMO

OBJECTIVES: Procurement's important role in healthcare decision making has encouraged criticism and calls for greater collaboration with health technology assessment (HTA), and necessitates detailed analysis of how procurement approaches the decision task. METHODS: We reviewed tender documents that solicit medical technologies for patient care in Canada, focusing on request for proposal (RFP) tenders that assess quality and cost, supplemented by a census of all tender types. We extracted data to assess (i) use of group purchasing organizations (GPOs) as buyers, (ii) evaluation criteria and rubrics, and (iii) contract terms, as indicators of supplier type and market conditions. RESULTS: GPOs were dominant buyers for RFPs (54/97) and all tender types (120/226), and RFPs were the most common tender (92/226), with few price-only tenders (11/226). Evaluation criteria for quality were technical, including clinical or material specifications, as well as vendor experience and qualifications; "total cost" was frequently referenced (83/97), but inconsistently used. The most common (47/97) evaluative rubric was summed scores, or summed scores after excluding those below a mandatory minimum (22/97), with majority weight (64.1 percent, 62.9 percent) assigned to quality criteria. Where specified, expected contract lengths with successful suppliers were high (mean, 3.93 years; average renewal, 2.14 years), and most buyers (37/42) expected to award to a single supplier. CONCLUSIONS: Procurement's evaluative approach is distinctive. While aiming to go beyond price in the acquisition of most medical technologies, it adopts a narrow approach to assessing quality and costs, but also attends to factors little considered by HTA, suggesting opportunities for mutual lesson learning.


Assuntos
Proposta de Concorrência/organização & administração , Custos e Análise de Custo/normas , Tomada de Decisões , Avaliação da Tecnologia Biomédica/organização & administração , Canadá , Proposta de Concorrência/normas , Controle de Custos/organização & administração , Compras em Grupo/organização & administração , Humanos , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/normas
7.
Value Health ; 22(2): 254-262, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30711072

RESUMO

OBJECTIVES: To examine economic evaluation studies of stem cell therapies (SCTs) in neurological disorders and to provide an overview of the quality of the economic evidence available on this topic. METHODS: The review examined studies that performed an economic evaluation of the use of stem cells in adult patients with neurological diseases and that were published in English during the period 2007 to 2017. Data analyzed and reported included study population, disease indication, main analytical approaches for the economic analysis and perspective, key assumptions made or tested in sensitivity analyses, cost outcomes, estimates of incremental cost effectiveness, and approaches to quantifying decision uncertainty. RESULTS: A total of three studies reporting on the findings of the economic evaluation of the use of SCT in stroke, Parkinson disease, and secondary progressive multiple sclerosis, respectively, were identified. All three studies conducted a cost-utility analysis using decision-analytic models and reported an incremental cost per quality-adjusted life-years gained (incremental cost-effectiveness ratio) versus standard care. These studies reported meaningful cost savings in stroke, Parkinson disease, and secondary progressive multiple sclerosis in the base-case scenarios. CONCLUSIONS: Despite significant progress in clinical research in the use of SCT in neurological diseases, economic evaluation of these therapies is still at a nascent stage. Given the early stage of research inputs (clinical and cost outcomes data) into the models per se, further research is urgently needed to enable meaningful assessment of the cost effectiveness of these advanced therapies and to ensure sustainable access for population groups most likely to benefit in clinical practice.


Assuntos
Análise Custo-Benefício/métodos , Doenças do Sistema Nervoso/economia , Doenças do Sistema Nervoso/terapia , Transplante de Células-Tronco/economia , Humanos , Doenças do Sistema Nervoso/epidemiologia , Transplante de Células-Tronco/métodos , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/métodos
8.
Value Health ; 22(1): 13-20, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30661627

RESUMO

The systematic use of evidence to inform healthcare decisions, particularly health technology assessment (HTA), has gained increased recognition. HTA has become a standard policy tool for informing decision makers who must manage the entry and use of pharmaceuticals, medical devices, and other technologies (including complex interventions) within health systems, for example, through reimbursement and pricing. Despite increasing attention to HTA activities, there has been no attempt to comprehensively synthesize good practices or emerging good practices to support population-based decision-making in recent years. After the identification of some good practices through the release of the ISPOR Guidelines Index in 2013, the ISPOR HTA Council identified a need to more thoroughly review existing guidance. The purpose of this effort was to create a basis for capacity building, education, and improved consistency in approaches to HTA-informed decision-making. Our findings suggest that although many good practices have been developed in areas of assessment and some other key aspects of defining HTA processes, there are also many areas where good practices are lacking. This includes good practices in defining the organizational aspects of HTA, the use of deliberative processes, and measuring the impact of HTA. The extent to which these good practices are used and applied by HTA bodies is beyond the scope of this report, but may be of interest to future researchers.


Assuntos
Benchmarking/normas , Formulação de Políticas , Avaliação da Tecnologia Biomédica/normas , Benchmarking/economia , Benchmarking/métodos , Consenso , Medicina Baseada em Evidências/normas , Humanos , Participação dos Interessados , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/métodos
9.
Value Health ; 22(1): 85-91, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30661638

RESUMO

BACKGROUND: Adjusted indirect comparisons (anchored via a common comparator) are an integral part of health technology assessment. These methods are challenged when differences between studies exist, including inclusion/exclusion criteria, outcome definitions, patient characteristics, as well as ensuring the choice of a common comparator. OBJECTIVES: Matching-adjusted indirect comparison (MAIC) can address these challenges, but the appropriate application of MAICs is uncertain. Examples include whether to match between individual-level data and aggregate-level data studies separately for treatment arms or to combine the arms, which matching algorithm should be used, and whether to include the control treatment outcome and/or covariates present in individual-level data. RESULTS: Results from seven matching approaches applied to a continuous outcome in six simulated scenarios demonstrated that when no effect modifiers were present, the matching methods were equivalent to the unmatched Bucher approach. When effect modifiers were present, matching methods (regardless of approach) outperformed the Bucher method. Matching on arms separately produced more precise estimates compared with matching on total moments, and for certain scenarios, matching including the control treatment outcome did not produce the expected effect size. The entropy balancing approach was used to determine whether there were any notable advantages over the method proposed by Signorovitch et al. When unmeasured effect modifiers were present, no approach was able to estimate the true treatment effect. CONCLUSIONS: Compared with the Bucher approach (no matching), the MAICs examined demonstrated more accurate estimates, but further research is required to understand these methods across an array of situations.


Assuntos
Custos de Cuidados de Saúde , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/métodos , Algoritmos , Simulação por Computador , Análise Custo-Benefício , Determinação de Ponto Final/economia , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Reprodutibilidade dos Testes , Resultado do Tratamento
10.
Value Health ; 22(1): 99-103, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30661640

RESUMO

BACKGROUND: It is an unresolved issue as to whether cost-benefit analysis (CBA) or cost-effectiveness analysis (CEA) is the preferable analytical toolkit for use in health technology assessment (HTA). The distinction between the two and an expressed preference for CEA go back at least to 1980 in the USA and, most recently, a Harvard-based group has been reappraising the case for CBA. OBJECTIVES: This article seeks to answer the question: would the use of cost-benefit analysis rather than the more usual cost-effectiveness analysis be an improvement, specifically in appraising health and health-related investments in low and middle-income countries (LMICs) as they transition to Universal Health Coverage?. METHODS/RESULTS: A selective literature review charts the welfare economics (welfarism and extra-welfarism) roots of both approaches. The principal distinguishing feature of the two is the monetary valuation of health outcomes under CBA compared with the use of health constructs such as the Quality-Adjusted Life-Year (QALY) or Disability-Adjusted Life-Year (DALY) under CEA. The former enables direct comparison of the outcomes of health investments with the monetized outcomes of other investments, while the CEA approach facilitates direct comparisons with other health investments. Seven challenges in using CBA in developing countries arise, including ethical issues in outcome valuation, practical challenges in the acquisition of data, intrinsic bias in data on values, and some of the practical issues of implementation for either CBA or CEA. CONCLUSIONS: We conclude with a list of nine issues that both CBA and CEA need to settle if they are to be useful in LMICs. For the immediate future we judge CBA to be the less practicable.


Assuntos
Custos de Cuidados de Saúde , Investimentos em Saúde , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Avaliação da Tecnologia Biomédica/economia , Cobertura Universal do Seguro de Saúde/economia , Análise Custo-Benefício , Avaliação da Deficiência , Gastos em Saúde , Indicadores Básicos de Saúde , Humanos , Modelos Econômicos , Opinião Pública , Seguridade Social
11.
Value Health ; 21(9): 1033-1042, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30224106

RESUMO

BACKGROUND: Clinical use of next-generation sequencing (NGS) tests has been increasing, but few studies have examined their economic value. Several studies have noted that there are methodological challenges to conducting economic evaluations of NGS tests. OBJECTIVE: Our objective was to examine key methodological challenges for conducting economic evaluations of NGS tests, prioritize these challenges for future research, and identify how studies have attempted solutions to address these challenges. METHODS: We identified challenges for economic evaluations of NGS tests using prior literature and expert judgment of the co-authors. We used a modified Delphi assessment to prioritize challenges, based on importance and probability of resolution. Using a structured literature review and article extraction we then assessed whether published economic evaluations had addressed these challenges. RESULTS: We identified 11 challenges for conducting economic evaluations of NGS tests. The experts identified three challenges as the top priorities for future research: complex model structure, timeframe, and type of analysis and comparators used. Of the 15 published studies included in our literature review, four studies described specific solutions relevant to five of the 11 identified challenges. CONCLUSIONS: Major methodological challenges to economic evaluations of NGS tests remain to be addressed. Our results can be used to guide future research and inform decision-makers on how to prioritize research on the economic assessment of NGS tests.


Assuntos
Sequenciamento de Nucleotídeos em Larga Escala/economia , Sequenciamento de Nucleotídeos em Larga Escala/normas , Avaliação da Tecnologia Biomédica/métodos , Análise Custo-Benefício , Técnica Delfos , Sequenciamento de Nucleotídeos em Larga Escala/tendências , Humanos , Avaliação da Tecnologia Biomédica/economia
12.
BMC Health Serv Res ; 18(1): 393, 2018 05 31.
Artigo em Inglês | MEDLINE | ID: mdl-29855313

RESUMO

BACKGROUND: One of the functions of the reformed Cancer Drugs Fund in England is as a managed access fund, providing conditional funding for cancer drugs where there is uncertainty in the economic case, and where that uncertainty can be addressed by data collection during two years' use in the NHS. Our study characterises likely sources of such uncertainty, through a review of recent NICE Technology Appraisals. METHODS: Discussions of uncertainty in NICE Appraisal Committees were extracted from published Single Technology Appraisals of cancer drugs, 2014-2016, and categorised inductively. The location of the comments within the structured Appraisal document was used as a proxy for the degree of concern shown by the Committee. RESULTS: Twenty-nine appraisals were analysed, of which 23 (79%) were recommended for funding. Six main sources of uncertainty were identified. Immaturity of survival data, and issues relating to comparators, were common sources of uncertainty regardless of degree of concern. Uncertainties relating to quality of life, and the patient population in the trial, were discussed frequently but rarely occurred in the more uncertain appraisals. Concerns with trial design, and cost uncertainty, were less common, but a high proportion contributed to the most uncertain appraisals. Funding decisions were not driven by uncertainty in the evidence base, but by the expected cost per QALY relative to acceptance thresholds, and the resultant level of uncertainty in the decision. CONCLUSIONS: The reformed CDF is an improvement on its predecessor. However the main types of uncertainty seen in recent cancer appraisals will not readily be resolved solely by 2 years' RWD collection in the reformed CDF; where there are no ongoing trials to provide longer-term data, randomised trials rather than RWD may be needed to fully resolve questions of relative efficacy. Other types of uncertainty, and concerns with generalisability, may be more amenable to the RWD approach, and it is these that we expect to be the focus of data collection arrangements in the reformed CDF.


Assuntos
Antineoplásicos/economia , Neoplasias/economia , Incerteza , Comitês Consultivos , Antineoplásicos/uso terapêutico , Ensaios Clínicos como Assunto/economia , Análise Custo-Benefício , Aprovação de Drogas/economia , Custos de Medicamentos , Inglaterra , Administração Financeira , Humanos , Neoplasias/tratamento farmacológico , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Tamanho da Amostra , Avaliação da Tecnologia Biomédica/economia
13.
Value Health ; 21(5): 561-568, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29753353

RESUMO

BACKGROUND: The Diabetes-Depression Care-Management Adoption Trial is a translational study of safety-net primary care predominantly Hispanic/Latino patients with type 2 diabetes in collaboration with the Los Angeles County Department of Health Services. OBJECTIVES: To evaluate the cost-effectiveness of an information and communication technology (ICT)-facilitated depression care management program. METHODS: Cost-effectiveness of the ICT-facilitated care (TC) delivery model was evaluated relative to a usual care (UC) and a supported care (SC) model. TC added automated low-intensity periodic depression assessment calls to patients. Patient-reported outcomes included the 12-Item Short Form Health Survey converted into quality-adjusted life-years (QALYs) and the 9-Item Patient Health Questionnaire-calculated depression-free days (DFDs). Costs and outcomes data were collected over a 24-month period (-6 to 0 months baseline, 0 to 18 months study intervention). RESULTS: A sample of 1406 patients (484 in UC, 480 in SC, and 442 in TC) was enrolled in the nonrandomized trial. TC had a significant improvement in DFDs (17.3; P = 0.011) and significantly greater 12-Item Short Form Health Survey utility improvement (2.1%; P = 0.031) compared with UC. Medical costs were statistically significantly lower for TC (-$2328; P = 0.001) relative to UC but not significantly lower than for SC. TC had more than a 50% probability of being cost-effective relative to SC at willingness-to-pay thresholds of more than $50,000/QALY. CONCLUSIONS: An ICT-facilitated depression care (TC) delivery model improved QALYs, DFDs, and medical costs. It was cost-effective compared with SC and dominant compared with UC.


Assuntos
Análise Custo-Benefício , Depressão/terapia , Diabetes Mellitus Tipo 2/terapia , Atenção Primária à Saúde/economia , Provedores de Redes de Segurança/economia , Avaliação da Tecnologia Biomédica/economia , Depressão/etnologia , Diabetes Mellitus Tipo 2/etnologia , Feminino , Hispano-Americanos/estatística & dados numéricos , Humanos , Los Angeles , Masculino , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida
14.
Ont Health Technol Assess Ser ; 18(3): 1-60, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29844845

RESUMO

Background: Urinary incontinence is involuntary leakage of urine and can affect people of all ages. Incidence rises as people age, often because of reduced mobility or conditions affecting the nervous system, such as dementia and stroke. Urinary incontinence can be a distressing condition and can harm a person's physical, financial, social, and emotional well-being. People with urinary incontinence are susceptible to skin irritation, pressure sores, and urinary tract infections. Urinary incontinence is also associated with an increased risk of falls in older adults.This health technology assessment examined the effectiveness of, budget impact of, and patient values and preferences about electronic monitoring systems to assess urinary incontinence for residents of long-term care homes or geriatric hospital inpatients with complex conditions. Methods: A clinical evidence review of the published clinical literature was conducted to June 9, 2017. Critical appraisal of the clinical evidence included assessment of risk of bias and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria to reflect the certainty of the evidence.We calculated the funding required for an electronic urinary incontinence monitoring system in the first year of implementation (when facilities would buy the systems) and in subsequent years.We interviewed six people with urinary incontinence and two caregivers, who described ways urinary incontinence affected daily life. Results: We included one observational study in the clinical review. Most of the 31 participants in the observational study were female (78%) and required high levels of care, primarily because of cognitive impairment. The quality of evidence for all outcomes was very low owing to potential risk of bias and indirectness. We are consequently uncertain about how electronic monitoring systems affect management of urinary incontinence.For patients living in long-term care homes who are eligible for the technology, we estimated that an electronic monitoring system to assess urinary incontinence would cost $6.4 million in the first year of implementation and $1.6 million in subsequent years.Patients said urinary incontinence reduced their independence and social life and adversely affected their quality of life. Incontinence made them embarrassed and reduced their self-esteem. Several respondents mentioned how expensive supplies to manage incontinence were. Conclusions: The effectiveness of using the electronic monitoring system to assess urinary incontinence is uncertain because of the very low quality of the evidence. Introducing electronic monitoring systems would result in incremental costs, and there would be savings only if the systems substantially reduced incontinence.


Assuntos
Avaliação Geriátrica/métodos , Avaliação da Tecnologia Biomédica , Incontinência Urinária/diagnóstico , Idoso , Análise Custo-Benefício , Custos de Cuidados de Saúde , Humanos , Assistência de Longa Duração/estatística & dados numéricos , Preferência do Paciente , Satisfação do Paciente , Qualidade de Vida , Avaliação da Tecnologia Biomédica/economia
15.
Value Health ; 21(4): 386-393, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29680093

RESUMO

BACKGROUND: Patient engagement is a transformative strategy for improving value assessment. US value framework developers have increased engagement activities, but more needs to be learned about how to best achieve meaningful patient engagement in value assessment. The objective was to glean good practices in patient engagement emerging from patient community experiences, to be used in value assessment. METHODS: The National Health Council Value Workgroup conducted a survey and held a focus group with its member advocacy organizations to gather experiences with value framework developers and views on emerging good practices. RESULTS: Ten of 13 organizations completed the survey; reporting 13 interactions with four framework developers. Most rated experiences as "good" to "very good." Emerging good practices included (1) engage early; (2) engage a range of patients; (3) leverage patient-provided information, data resources, and outreach mechanisms; (4) be transparent; and (5) appreciate and accommodate resource constraints. Twelve of 13 organizations participated in the focus group, and this produced 30 emerging good practices in four areas: (1) timing; (2) methodology and data; (3) partnering; and (4) characterizing engagement. DISCUSSION: Patient engagement was limited in early development of value frameworks but has increased in the past few years. Patient groups report positive experiences that can serve as emerging good practices. These groups also reported experienced challenges in their interactions and recommended good practices to mitigate those challenges. CONCLUSIONS/RECOMMENDATIONS: The growing pool of patient engagement experiences can be translated into good practices to advance a patient-centered, value-driven health care ecosystem. Lessons learned from these early experiences can help establish recommend emerging good practices that can eventually result in best practices and standards in the field.


Assuntos
Custos de Cuidados de Saúde , Participação do Paciente/economia , Medidas de Resultados Relatados pelo Paciente , Melhoria de Qualidade/economia , Indicadores de Qualidade em Assistência à Saúde/economia , Avaliação da Tecnologia Biomédica/economia , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Grupos Focais , Humanos , Modelos Econômicos , Participação dos Interessados , Inquéritos e Questionários , Avaliação da Tecnologia Biomédica/métodos
16.
Value Health ; 21(4): 394-397, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29680094

RESUMO

The potential for multi-criteria decision analysis (MCDA) to support health technology assessment (HTA) has been much discussed, and various HTA agencies are piloting or applying MCDA. Alongside these developments, good practice guidelines for the application of MCDA in health care have been developed. An assessment of current applications of MCDA to HTA in light of good practice guidelines reveals, however, that many have methodologic flaws that undermine their usefulness. Three challenges are considered: the use of additive models, a lack of connection between criteria scales and weights, and the use of MCDA in economic evaluation. More attention needs to be paid to MCDA good practice by researchers, journal editors, and decision makers and further methodologic developments are required if MCDA is to achieve its potential to support HTA.


Assuntos
Técnicas de Apoio para a Decisão , Avaliação da Tecnologia Biomédica/métodos , Análise Custo-Benefício , Fidelidade a Diretrizes , Custos de Cuidados de Saúde , Humanos , Modelos Econômicos , Medidas de Resultados Relatados pelo Paciente , Guias de Prática Clínica como Assunto , Participação dos Interessados , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/normas
17.
Value Health ; 21(3): 341-350, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29566842

RESUMO

BACKGROUND: The National Institute for Health and Care Excellence has recently proposed that company submissions with a base-case incremental cost-effectiveness ratio (ICER) of less than £10,000/quality-adjusted life-year (QALY) might be eligible for a "fast-track" appraisal. OBJECTIVES: To explore outcomes relating to previously conducted single-technology appraisals (STAs) with base-case ICERs of less than £10,000/QALY. METHODS: All STAs with published guidance from 2009 to 2016 were included; those with company base-case ICERs of less than £10,000/QALY were identified and analyzed. A secondary analysis was also conducted for those with a company base-case ICER of £10,000 to £15,000/QALY. Relevant data were extracted and presented in a narrative and in tables. RESULTS: In total, 15% (26 of 171) of STAs included a company submission with a base-case ICER of less than £10,000/QALY. Of these, 73% (19 of 26) were given positive recommendations after the first Appraisal Committee (AC) meeting, whereas 27% (7 of 26) were initially given a Minded No before receiving a positive recommendation in the final appraisal determination, albeit with restricted recommendations for three technologies. Five STAs had company base-case ICERs of £10,000 to £15,000/QALY and all received a positive recommendation after the first AC meeting. CONCLUSIONS: Most previous STAs with a company base-case ICER of £10,000 or even £15,000/QALY received a positive recommendation after the first AC meeting, but a number of them proved more complicated and required detailed appraisal, which influenced the final recommendation. This finding might have implications for the proposed fast-track process of the National Institute for Health and Care Excellence.


Assuntos
Análise Custo-Benefício/métodos , Prática Clínica Baseada em Evidências/economia , Programas Nacionais de Saúde/economia , Anos de Vida Ajustados por Qualidade de Vida , Avaliação da Tecnologia Biomédica/economia , Prática Clínica Baseada em Evidências/métodos , Humanos , Avaliação da Tecnologia Biomédica/métodos , Reino Unido/epidemiologia
18.
Value Health ; 21(2): 146-154, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29477392

RESUMO

The fifth section of our Special Task Force report identifies and discusses two aggregation issues: 1) aggregation of cost and benefit information across individuals to a population level for benefit plan decision making and 2) combining multiple elements of value into a single value metric for individuals. First, we argue that additional elements could be included in measures of value, but such elements have not generally been included in measures of quality-adjusted life-years. For example, we describe a recently developed extended cost-effectiveness analysis (ECEA) that provides a good example of how to use a broader concept of utility. ECEA adds two features-measures of financial risk protection and income distributional consequences. We then discuss a further option for expanding this approach-augmented CEA, which can introduce many value measures. Neither of these approaches, however, provide a comprehensive measure of value. To resolve this issue, we review a technique called multicriteria decision analysis that can provide a comprehensive measure of value. We then discuss budget-setting and prioritization using multicriteria decision analysis, issues not yet fully resolved. Next, we discuss deliberative processes, which represent another important approach for population- or plan-level decisions used by many health technology assessment bodies. These use quantitative information on CEA and other elements, but the group decisions are reached by a deliberative voting process. Finally, we briefly discuss the use of stated preference methods for developing "hedonic" value frameworks, and conclude with some recommendations in this area.


Assuntos
Orçamentos , Análise Custo-Benefício/métodos , Tomada de Decisões , Assistência à Saúde/economia , Gastos em Saúde , Avaliação de Resultados (Cuidados de Saúde)/métodos , Avaliação da Tecnologia Biomédica/economia , Comitês Consultivos , Política de Saúde , Prioridades em Saúde , Humanos , Anos de Vida Ajustados por Qualidade de Vida , Estados Unidos
19.
Value Health ; 21(2): 155-160, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29477393

RESUMO

The sixth section of our Special Task Force (STF) report reviews and comments on recent US-oriented value assessment frameworks, specifically those published by the American College of Cardiology/American Heart Association, the Institute for Clinical and Economic Research, the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the Memorial Sloan Kettering Cancer Center. We review published commentaries that address the validity, reliability, and conceptual underpinnings of these frameworks. We find common themes of critique regarding the strengths and limitations across frameworks. Particular shortcomings of some frameworks pose greater threats to their face validity and utility compared with others. The most significant limitations include lack of clear perspective (e.g., patient vs. health plan) and poor transparency in accounting for costs and benefits. We then review how each framework adheres to core STF recommendations, with particular emphasis on whether the framework can be used to support coverage decisions by health insurers, and whether it adheres to core principles of cost-effectiveness analysis. The Institute for Clinical and Economic Research framework most closely adheres to core STF recommendations. Others have significant limitations that vary widely from framework to framework. We also review how the frameworks follow STF recommendations for addressing potentially relevant issues beyond cost-effectiveness analysis - for example, equity in resource allocation and patient heterogeneity. Finally, we review whether and how each framework uses value thresholds and addresses affordability concerns. We conclude with suggestions for further research, particularly in the areas of testing the measurement and use of novel elements of value and deliberative processes.


Assuntos
Análise Custo-Benefício/métodos , Tomada de Decisões , Assistência à Saúde/economia , Gastos em Saúde , Seguro Saúde/economia , Avaliação de Resultados (Cuidados de Saúde)/métodos , Avaliação da Tecnologia Biomédica/economia , Comitês Consultivos , Farmacoeconomia , Política de Saúde , Humanos , Sociedades Médicas , Estados Unidos
20.
Value Health ; 21(2): 161-165, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29477394

RESUMO

This summary section first lists key points from each of the six sections of the report, followed by six key recommendations. The Special Task Force chose to take a health economics approach to the question of whether a health plan should cover and reimburse a specific technology, beginning with the view that the conventional cost-per-quality-adjusted life-year metric has both strengths as a starting point and recognized limitations. This report calls for the development of a more comprehensive economic evaluation that could include novel elements of value (e.g., insurance value and equity) as part of either an "augmented" cost-effectiveness analysis or a multicriteria decision analysis. Given an aggregation of elements to a measure of value, consistent use of a cost-effectiveness threshold can help ensure the maximization of health gain and well-being for a given budget. These decisions can benefit from the use of deliberative processes. The six recommendations are to: 1) be explicit about decision context and perspective in value assessment frameworks; 2) base health plan coverage and reimbursement decisions on an evaluation of the incremental costs and benefits of health care technologies as is provided by cost-effectiveness analysis; 3) develop value thresholds to serve as one important input to help guide coverage and reimbursement decisions; 4) manage budget constraints and affordability on the basis of cost-effectiveness principles; 5) test and consider using structured deliberative processes for health plan coverage and reimbursement decisions; and 6) explore and test novel elements of benefit to improve value measures that reflect the perspectives of both plan members and patients.


Assuntos
Análise Custo-Benefício/métodos , Tomada de Decisões , Assistência à Saúde/economia , Gastos em Saúde , Seguro Saúde/economia , Avaliação de Resultados (Cuidados de Saúde)/métodos , Avaliação da Tecnologia Biomédica/economia , Comitês Consultivos , Farmacoeconomia , Política de Saúde , Humanos , Estados Unidos
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