Health Technology Assessment (HTA) is a multidisciplinary process that collect information about the medical, economic, organizational, social, legal and ethical issues related to the use of a ...certain health technology in a systematic, transparent, unbiased, manner. Its main purpose is to support health care decision-makers. From the conception of HTA in the 1970s, it has been argued that the ethical domain is a constitutive part of HTA and that value judgments are inherent in the whole process of HTA. Specifically, ethical domain aims at analyzing both the ethical questions that a given technology raises when it is put into use/disinvestment and the ethical issues that the HTA process itself raises. Despite almost 40 years with similar considerations, ethics has not so frequently been part of HTA reports. The paper provides an overview of the ethical domain within the HTA processes and the experience of the Institute of Bioethics and Medical Humanities of the Università Cattolica del Sacro Cuore.
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“HTA is a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, ...unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused, and seek to achieve best value” (EUnetHTA
2007
). Even though the assessment of ethical aspects of a health technology is listed as one of the objectives of a HTA process, in practice, the integration of these dimensions into reports remains limited. The article is focused on four points: 1. the HTA concept; 2. the difficult HTA-ethics relationship; 3. the ethical issues in HTA; 4. the methods for integrating ethical analysis into HTA.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, PRFLJ, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Background: This article describes the lessons learned from an international pilot assessment using the first version of the HTA Core Model® and Guidelines for rapid Relative Effectiveness Assessment ...(REA) of pharmaceuticals based on input from three different perspectives: the assessors, the users (health technology assessment organisations) and the marketing authorisation holder.
Methods: A pilot assessment was performed of pazopanib for the treatment of advanced or metastatic renal cell carcinoma for which 54 individuals from 22 EUnetHTA member organisations from 16 European countries gave their contribution. The work was divided in eight domain teams. Subsequently, results of these domain teams were synthesised in one pilot report. Feedback on the outcomes of the pilot was gathered throughout the project and through structured surveys.
Results: The first version of the assessment was produced in six months and consisted of 55 question and answer pairs, 8 domain reports and a synthesis section that combined the results from the different domains. The organisation of the pilot required intense coordination. Main points of criticism on the assessment were the lengthiness of the document and overlap of information throughout the assessment.
Conclusions: A reduction in the number of authoring organisations and individuals participating is necessary to avoid information overlap and increase efficiency in undertaking the assessment. Involving several organisations (e.g. five) in an in-depth review could still ensure the benefit of broad participation from various countries. The focus of a rapid REA should be on the first four domains of the Model.
This article highlights the importance of teaching “bioethics and human rights†to undergraduate students seeking health care degrees and illustrates how this topic fits well within these programs ...of studies. Historical, cultural, anthropological and practical reasons support teaching these topics as enrichment of medical training. The years after the Second World War showed how bioethics, human rights and medicine are closely intertwined. Moreover the relationship between human rights and bioethics has grown ever closer increasingly involving medicine and health care professionals. The authors observe that medical students have to face a cultural pluralism in bioethics and biolaw and we give students the opportunity to develop their critical thinking and logical argumentation abilities as well as their interest in academic research. Furthermore, the authors – who draw up briefly the experience of the Institute of Bioethics at the Faculty of Medicine and Surgery of the UCSC (Rome) - assert the necessity to help medical students to be respectful of patients in every clinical setting. It is therefore of utmost importance to train students to focus on the ethical dimension of care and to make good ethical decisions even in dilemmatic cases. To achieve this outcome, healthcare professionals should possess an integral vision of their work (technical and humanistic competence) and sharp skills to reflect in depth, avoiding superficiality and negligence. From this perspective, the teaching of “bioethics and human rights†could be very useful.
Purpose
To analyse the evolution of impact on the healthcare expenditure of first and second line treatments for relapsing-remitting multiple sclerosis (RRMS) in Italy.
Methods
An economic model was ...developed in MSTM Excel (2010) and populated with data from three of the main Regions (Lombardy, Lazio, and Sicily) considered representative in Italy for location (North, Centre and South, respectively), population, and care organisation. Input data were retrieved from published sources and validated by a Board* of experts. The analysis considers an average from regional healthcare resource consumption, and national tariffs were used to economically quantify it. A sensitivity analysis was performed varying the market shares of second line treatments (fingolimod and natalizumab).
*I nomi dei membri del Board sono riportati a fine articolo
Results
The results show that the total drug expenditure is €542,279,468 for both first and second line treatments. Among second line treatments, fingolimod showed to be less expensive than natalizumab with an annual mean saving per patient of €4,276 (of which €2,120 for routine management). The sensitivity analysis shows that, increasing the market shares of fingolimod from 59% of the base case to 80%, it is possible to achieve savings for almost €8.5 million/year.
Conclusions
Fingolimod is an affordable therapy for the Italian National Health Service. Moreover, due to a timely use of fingolimod in patients not responding to first line drugs, savings could be around €10 million due to avoided relapses.
Ethical issues are connatural with the medical activity. Moral questions regarding some medical specialities as obstetrics or pre or perinatal medicine are well known. Nevertheless few is known about ...ethical problems perceived as remarkable from physicians and patients in onco-hematology. This is a retrospective monocentric descriptive study. Its purpose is to recognize, in oncohematology, what are the problems perceived as ethically relevant both from physicians and patients. Ethical issues regarding onco-hematologic patients were recognized consulting clinical diary of 100 patients treated in our institution. Patients have casually been selected in the temporal period from January 2004 to June of 2008. Ethical questions were listed in two groups: those perceived as remarkable for the physicians and those for the patients. Median age of the patients was 54.5 years (R 33–86). M/F was 55/45. Sixty-one patients were affected by chronic or indolent hemopathies. Sixty-six patients received 1st line therapy, instead 34 2nd line or superior. Seventy-five patients had primary school instruction, 22 secondary, 3 had got a degree. Eighty patients were assisted by a relative. Twenty-nine patients perceived a problem as ethically relevant (5 compliance to treatments; 5 refusal of treatment; 7 intolerance to hospitalization; 9 scarce trust in caregivers; 3 difficulty to understand the therapeutic plan). In 38 cases physicians perceived a problem as ethically relevant (8 over treatment; 7 type of treatment to adopt; 8 correct timing of therapy; 11 correct use of resources; 4 adequacy of treatment). Physicians perceived these problems mainly about patients requiring 2nd line treatment or further (28 cases out of 38). In 12 cases only patients perceived a problem, in 21 cases only physicians perceived a problem, while in 17 cases a problem was perceived as ethically relevant by physicians and patients simultaneously. In our study, in onco-hematology the main issue perceived by patients as ethically relevant is the scarce trust in caregivers, while for physicians it is the correct use of resources. Physicians perceive an ethical problem mainly considering patient candidate to 2nd line treatment or further. In 24% of cases, a problem perceived as ethically relevant by patients is underestimated by physicians. In this contest the possibility of an ethical consultation within a clinical counselling might create a convergence between physician and patient perspective.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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