Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems)

Hutton, John; McGrath, Clare; Frybourg, Jean-Marc; Tremblay, Mike; Bramley-Harker, Edward; Henshall, Christopher

doi:10.1017/s0266462306050781

Cited by 80 publications

(84 citation statements)

References 9 publications

(5 reference statements)

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“…Table 3 provides an overview of decisions by country, decision-making institution, and outcome. Spanish health authorities (23), the UK National Institute of Health and Clinical Excellence (NICE) (12), the German Federal Joint Committee (FJC) (10), and the Irish Health Service Executive (9) were most frequent. Although acceptance rates varied across institutions, half the decisions resulted in unrestricted coverage.…”

Section: Sensitivity Analysesmentioning

confidence: 99%

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Link between Process and Appraisal in Coverage Decisions

2013

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Background. To achieve fair-coverage decision making, both material criteria and criteria of procedural justice have been proposed. The relationship between these is still unclear. Objective. To analyze hypotheses underlying the assumption that more assessment, transparency, and participation have a positive impact on the reasonableness of coverage decisions. Methods. We developed a structural equation model in which the process components were considered latent constructs and operationalized by a set of observable indicators. The dependent variable ''reasonableness'' was defined by the relevance of clinical, economic, and other ethical criteria in technology appraisal (as opposed to appraisal based on stakeholder lobbying). We conducted an Internet survey among conference participants familiar with coverage decisions of third-party payers in industrialized countries between 2006 and 2011. Partial least squares path modeling (PLS-PM) was used, which allows analyzing small sample sizes without distributional assumptions. Data on 97 coverage decisions from 15 countries and 40 experts

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Section: Sensitivity Analysesmentioning

confidence: 99%

“…2,4,9 Given the complexity of decision processes, a large number of further process elements can be included in the analysis, as has been done by Hutton and others. 10 Given the time constraints of respondents, surveys have to restrict the assessed items to a small number that can be justified theoretically and surveyed empirically.…”

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confidence: 99%

Link between Process and Appraisal in Coverage Decisions

2013

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“…HTA programs evaluate the value of new therapies and technologies to patients by considering the following (Hutton et al, 2006): Is the new treatment effective? Although surrogate end points such as response rate may be sufficient evidence of efficacy for regulatory agencies (eg, rise in hemoglobin after administration of erythropoietin stimulating agent), HTAs generally demand more direct evidence of benefit (eg, improved quality of life measured by a validated instrument, or improved survival).…”

Section: Health Technology Assessment (Hta) Programsmentioning

confidence: 99%

Science and Affordability of Cancer Drugs and Radiotherapy in the World - Win-Win Scenarios

Elzawawy¹

2012

Advances in Cancer Management

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“…En los últimos años, varios países -de la Unión Europea y otros-han adoptado medidas tendentes a incorporar la evaluación económica en el conjunto de herramientas que guían las estrategias de adopción y difusión de las innovaciones sanitarias [14][15][16][17] . Muchos de ellos hacen también estudios de impacto presupuestario que -aunque el análisis de las reglas de decisión basadas en el coste de oportunidad escapan al alcance y objetivo de este texto-no deben ser interpretados tanto como un conflicto entre las reglas de eficiencia y las presupuestarias, sino precisamente como forma de tener en cuenta el coste de oportunidad para los aseguradores 18 .…”

Section: Innovaciones Regulatorias En El Sistema Comparadounclassified

De la utilidad de los medicamentos al valor terapéutico añadido y a la relación coste-efectividad incremental

Puig‐Junoy¹,

Peiró²

2009

Rev. Esp. Salud Publica

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RESUMENDesde la perspectiva social los conceptos de utilidad terapéutica y grado de innovación de los nuevos medicamentos deben ser referidos al valor social añadido por los mismos en relación a las alternativas de tratamiento disponibles y los costes añadidos que comporten, esto es, a su relación coste-efectividad incremental. Los elementos analíticos que destacan en esta aproximación son: 1) las dimensiones del valor social del medicamento, que van más allá de las medidas de resultado convencionales para incorporar también medidas de calidad de vida relacionada con la salud, comodidad de los pacientes y sus familias, consumo de recursos sanitarios evitado y pérdi-das productivas evitadas; 2) el carácter relativo o incremental de este valor, que debe cuantificarse frente a las alternativas preexistentes, no frente a placebo, y en condiciones de uso real; y 3) el gasto incremental que conlleve la administración del nuevo medicamento. El enfoque de la relación coste-efectividad incremental es el adecuado para las decisiones de cobertura de un determinado tratamiento por las aseguradoras públicas, del precio que se está dispuesto a pagar por él y de las situaciones clínicas y grupos de pacientes en los que se recomienda. El análisis coste-efectividad incremental y el establecimiento de un umbral indicativo del coste máximo que se está dispuesto a pagar por "año de vida ajustada por calidad" ganado son los elementos esenciales de esta aproximación, que no exige fijar el precio de los nuevos medicamentos en el umbral de la disponibilidad a pagar.Palabras clave: Farmacoeconomía. Coste-efectividad. Evaluación de medicamentos. Coste de los medicamentos. Aseguramiento sanitario. ABSTRACT From the Therapeutic Utility to the Added Therapeutic Value and the Incremental Cost-Effectiveness RatioFrom the social perspective, the concepts of therapeutic utility and degree of innovation of new drugs should be referred to their social added value in relation to the available treatment alternatives and the added costs that they imply; that is, to their incremental cost-effectiveness ratio. The analytic elements highlighting this approach are: 1) the dimensions of the social value of the medication that should go beyond the conventional outcomes measures to also incorporate measures of health related quality of life, patient and family comfort and convenience, healthcare consumption avoided and productive losses avoided; 2) the relative or incremental character of this value that should be quantified in front of previous alternatives -not versus placeboand under conditions of real use; and 3) the incremental costs that bears the administration of the new medication. The incremental cost-effectiveness ratio is the appropriate approach for decisions about coverage of a treatment by the public insurer, the price that he is willing to pay for the drug, and the clinical situations and patient groups in which it is recommended. The incremental costeffectiveness analysis and the use of an indicative threshold of the maximum cost that the ...

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Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems)

Cited by 80 publications

References 9 publications

Link between Process and Appraisal in Coverage Decisions

Link between Process and Appraisal in Coverage Decisions

Science and Affordability of Cancer Drugs and Radiotherapy in the World - Win-Win Scenarios

De la utilidad de los medicamentos al valor terapéutico añadido y a la relación coste-efectividad incremental

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