Davies et al. (1), presenting the results of a survey conducted in Europe, showed that health economics assessments do not play an important role in decision-making processes. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) (2) investigated in 2003 the use of economic health information, they evidenced that the main issue affecting the relevance of these studies is that do not explore budgetary impact, in fact the Cost-Effectiveness-Analysis gives as information the cost-effectiveness ratio measurement indicating the value for money from a therapy, but it says nothing about total cost. On the other hand, the decision maker is often more concerned about affordability, which depends on the overall budgetary impact. The local decision maker, waiting on local community, are also interested to the impact that a new strategy have in health and social terms relevant to the population of interest with its particular epidemiological and demographic characteristics, by means a contextualised information. Mauskopf et al. (3) affirm that impact evaluations have to include a classification of the policy-maker’s information needs and a full and detailed breakdown of resource uses, costs and expected results in health terms. This method, described by Mauskopf et al. and defined “cost-consequence analysis”, systematically sets out, and measures the value of, the variables that should be taken into consideration in health intervention decision-making. Objective: The main objective is define the methodology to calculate some indicators of intervention’s effects on a local setting which are useable and useful for local decision-maker process about resource planning and management. In particular this study will evaluate the economic, health and social impact of the introduction in the Veneto region of Italy of new cancer drug, Trastuzumab a recombinant humanised monoclonal antibody that shows a high binding affinity with the Her-2/neu protein and is capable of inhibiting Her-2/neu-mediated malignant transformation of epithelial cells. We explore the indication for early breast cancer treatment, this drug intervention is in addition to standard therapy. Methods: The methodology to calculate the four useful indicator in a perspective of a decision maker is:1)TARGET POPULATION INDICATOR. The first indicator useful for decision-making purposes is the target population, that is, the number of residents who, in accordance with measures the frequency of disease like incidence and with clinical appropriateness criteria, are potential users of the innovative drug in a year. 2) HEALTH INDICATORS. The proportion of subjects saved by the therapy or proportion who receive a benefit from therapy 3) INDICATOR OF ECONOMIC IMPACT. This indicator corresponds to the net incremental cost generated by the use of the new drugs. This impact is measured considering the difference between the costs and the savings generated by the use of the new drug. 4) INDICATOR OF SOCIAL IMPACT. It was assumed that the indicators denotes the number of children saved from losing their mother by the introduction of the project. The statistical method used to work out the health-social-economic indicators will be the Markov model. This model is particularly useful for analysing events that can occur, even repeatedly, in an unspecified moment in time, such as, for example, the onset and development of a tumour. A Markov model is composed of a finite number of exhaustive and mutually exclusive states of health. From a temporal point of view, the analysis is divided into equal intervals defined Markov cycles. Markov models was implemented through cohort simulations or Monte Carlo analyses to produce a sort of trace from which it is possible to observe the movement of the cohort among the different states of health and to estimate the efficacy and overall cost associated with each of them, estimating not only mean, efficacy and cost values, but also some of the characteristics of their distribution, such as standard deviations. Markov models can all be derived from a basic model composed of the following four states of health: (1) presence of tumour; (2) presence of local relapse tumour; (3) metastasis; (4) death. A patient with a localised tumour can remain in this state or move into another state: metastasis or deceased. Death is, by definition, the “state of absorption”, i.e., the state from which, once entered, it is no longer possible to move to other states. Results TARGET POPULATION INDICATOR The new cases each year of breast cancer in Region Veneto are 4209 cases, among which the new cases are in a range of 527 to 751. HEALTH INDICATORS The incremental benefit of Trastuzumab are 32 avoided died in four years. INDICATOR OF SOCIAL IMPACT 14 orphan avoided INDICATOR OF ECONOMIC IMPACT The average cost of a treated patients with Trastuzumab is 60.096 euro (range 40.874 -79.497) instead the average cost for teat a patient with standard therapy is 4644 euro ( range 9.338-33.966). The incremental cost in four years are 28.000.000. Discussion: It is clear that a public policy-maker that is enabled to appreciate clearly all the costs of a health intervention in a population will be far better equipped to negotiate with its own industrial interlocutors (providers) than it would be (or is, in many cases) in the absence of this information. At this purpose is very useful the indicator estimating the net incremental cost. Furthermore as was debate by Ann Barrett, when a institution decide to adopt a new technology, it has to provide extra funding and suggest what cuts should be made to release these extra funds. Only having this indicator it is possible to evaluate this issue.

Utilization of epidemiological data and local cost to make usefulness to decision maker the economic evaluations: a case study in Region Veneto.

BUJA, ALESSANDRA;REBBA, VINCENZO;GRIGOLETTO, FRANCESCO;PERISSINOTTO, EGLE;GREGORI, DARIO
2009

Abstract

Davies et al. (1), presenting the results of a survey conducted in Europe, showed that health economics assessments do not play an important role in decision-making processes. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) (2) investigated in 2003 the use of economic health information, they evidenced that the main issue affecting the relevance of these studies is that do not explore budgetary impact, in fact the Cost-Effectiveness-Analysis gives as information the cost-effectiveness ratio measurement indicating the value for money from a therapy, but it says nothing about total cost. On the other hand, the decision maker is often more concerned about affordability, which depends on the overall budgetary impact. The local decision maker, waiting on local community, are also interested to the impact that a new strategy have in health and social terms relevant to the population of interest with its particular epidemiological and demographic characteristics, by means a contextualised information. Mauskopf et al. (3) affirm that impact evaluations have to include a classification of the policy-maker’s information needs and a full and detailed breakdown of resource uses, costs and expected results in health terms. This method, described by Mauskopf et al. and defined “cost-consequence analysis”, systematically sets out, and measures the value of, the variables that should be taken into consideration in health intervention decision-making. Objective: The main objective is define the methodology to calculate some indicators of intervention’s effects on a local setting which are useable and useful for local decision-maker process about resource planning and management. In particular this study will evaluate the economic, health and social impact of the introduction in the Veneto region of Italy of new cancer drug, Trastuzumab a recombinant humanised monoclonal antibody that shows a high binding affinity with the Her-2/neu protein and is capable of inhibiting Her-2/neu-mediated malignant transformation of epithelial cells. We explore the indication for early breast cancer treatment, this drug intervention is in addition to standard therapy. Methods: The methodology to calculate the four useful indicator in a perspective of a decision maker is:1)TARGET POPULATION INDICATOR. The first indicator useful for decision-making purposes is the target population, that is, the number of residents who, in accordance with measures the frequency of disease like incidence and with clinical appropriateness criteria, are potential users of the innovative drug in a year. 2) HEALTH INDICATORS. The proportion of subjects saved by the therapy or proportion who receive a benefit from therapy 3) INDICATOR OF ECONOMIC IMPACT. This indicator corresponds to the net incremental cost generated by the use of the new drugs. This impact is measured considering the difference between the costs and the savings generated by the use of the new drug. 4) INDICATOR OF SOCIAL IMPACT. It was assumed that the indicators denotes the number of children saved from losing their mother by the introduction of the project. The statistical method used to work out the health-social-economic indicators will be the Markov model. This model is particularly useful for analysing events that can occur, even repeatedly, in an unspecified moment in time, such as, for example, the onset and development of a tumour. A Markov model is composed of a finite number of exhaustive and mutually exclusive states of health. From a temporal point of view, the analysis is divided into equal intervals defined Markov cycles. Markov models was implemented through cohort simulations or Monte Carlo analyses to produce a sort of trace from which it is possible to observe the movement of the cohort among the different states of health and to estimate the efficacy and overall cost associated with each of them, estimating not only mean, efficacy and cost values, but also some of the characteristics of their distribution, such as standard deviations. Markov models can all be derived from a basic model composed of the following four states of health: (1) presence of tumour; (2) presence of local relapse tumour; (3) metastasis; (4) death. A patient with a localised tumour can remain in this state or move into another state: metastasis or deceased. Death is, by definition, the “state of absorption”, i.e., the state from which, once entered, it is no longer possible to move to other states. Results TARGET POPULATION INDICATOR The new cases each year of breast cancer in Region Veneto are 4209 cases, among which the new cases are in a range of 527 to 751. HEALTH INDICATORS The incremental benefit of Trastuzumab are 32 avoided died in four years. INDICATOR OF SOCIAL IMPACT 14 orphan avoided INDICATOR OF ECONOMIC IMPACT The average cost of a treated patients with Trastuzumab is 60.096 euro (range 40.874 -79.497) instead the average cost for teat a patient with standard therapy is 4644 euro ( range 9.338-33.966). The incremental cost in four years are 28.000.000. Discussion: It is clear that a public policy-maker that is enabled to appreciate clearly all the costs of a health intervention in a population will be far better equipped to negotiate with its own industrial interlocutors (providers) than it would be (or is, in many cases) in the absence of this information. At this purpose is very useful the indicator estimating the net incremental cost. Furthermore as was debate by Ann Barrett, when a institution decide to adopt a new technology, it has to provide extra funding and suggest what cuts should be made to release these extra funds. Only having this indicator it is possible to evaluate this issue.
2009
Utilization of epidemiological data and local cost to make usefulness to decision maker the economic evaluations: a case study in Region Veneto.
9788878305014
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