SIR-Spheres® Y-90 resin microspheres in chemotherapy refractory or intolerant patients with metastatic colorectal cancer:

Selective internal radiation therapy is a form of intra-arterial brachytherapy used to treat primary liver cancer and liver metastases. This article aims to provide an overview of the clinical, economic, organizational legal, social and ethical impact of selective internal radiation therapy using SIR-Spheres Y-90 resin microspheres in the treatment of patients with unresectable, liver-dominant metastatic colorectal cancer who are refractory to or intolerant of chemotherapy. A systematic literature review was performed by querying PubMed, Scopus, EBSCO, CRD and GIN. Two reviewers blindly screened the records retrieved against predefined inclusion/exclusion criteria. The selected studies where summarized following a simplified version of the EuNetHTA Core Model® 2.1. The studies included evaluated selective internal radiation therapy in first-line or further-line treatment and showed a good safety and tolerability profile and significant improvement in efficacy expressed as time to liver progression, progression-free survival and overall survival. Selective internal radiation therapy should be provided in specialized centres and administered by a multidisciplinary team. A hub-and-spoke network could be a viable option to guarantee access to this technology across jurisdictions. The lack of a specific diagnosis-related group tariff accounting for the cost of the device could be seen as the major obstacle to a fair diffusion of this technology. The economic evaluations currently available show the cost-effectiveness of this technology in the population under study. Selective internal radiation therapy using SIR-Spheres Y-90 resin microspheres appears to be a clinically effective and cost-effective option in the treatment of metastatic colorectal cancer patients who are chemotherapy refractory or chemotherapy intolerant

Why teach “Bioethics and Human Rights” to healthcare professions undergraduates?

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

Allogeneic versus Autologous: ethical issues in umbilical cord blood use

OBJECTIVE. To analyse some ethical issues involved in umbilical cord blood (UCB) collection, storage and use. MATERIALS AND METHODS. Ethical issues were addressed in the light of the wellknown fundamental ethical principles for biomedicine: beneficence/non maleficence, respect for autonomy and justice. Specific issues that have been debated concerning the clinical utility of autologous use compared with allogeneic use for transplantation, the validity of informed consent, especially in private UCB banking, and finally the controversial question of private UCB banking for-profit compared to public UCB banking non-profit. RESULTS. Our ethical analysis has highlighted that the allogeneic UCB use for transplantation, compared to autologous UCB use, seems to fulfil the principle of beneficence/non maleficence as it provides “logistic” and clinical benefits and it decreases risks; the acquisition of informed consent requires some counselling, particularly for autologous collection; finally, public UCB banking seems to fulfil the criteria for justice more than private ones. CONCLUSION. Present and future therapeutic UCB possibilities for treating a wide variety of diseases need to increase the number of UCB units available. For this purpose, a “gift” culture and a “solidarity chain” between donors and recipients are requested. Moreover, in recent years, a further and emerging model of bank seems usable, i.e. “hybrid” banking

Allogeneic versus Autologous: ethical issues in umbilical cord blood use

OBJECTIVE. To analyse some ethical issues involved in umbilical cord blood (UCB) collection, storage and use. MATERIALS AND METHODS. Ethical issues were addressed in the light of the wellknown fundamental ethical principles for biomedicine: beneficence/non maleficence, respect for autonomy and justice. Specific issues that have been debated concerning the clinical utility of autologous use compared with allogeneic use for transplantation, the validity of informed consent, especially in private UCB banking, and finally the controversial question of private UCB banking for-profit compared to public UCB banking non-profit. RESULTS. Our ethical analysis has highlighted that the allogeneic UCB use for transplantation, compared to autologous UCB use, seems to fulfil the principle of beneficence/non maleficence as it provides “logistic” and clinical benefits and it decreases risks; the acquisition of informed consent requires some counselling, particularly for autologous collection; finally, public UCB banking seems to fulfil the criteria for justice more than private ones. CONCLUSION. Present and future therapeutic UCB possibilities for treating a wide variety of diseases need to increase the number of UCB units available. For this purpose, a “gift” culture and a “solidarity chain” between donors and recipients are requested. Moreover, in recent years, a further and emerging model of bank seems usable, i.e. “hybrid” banking

health technology assessment processes for nanotechnologies the ethical domain

The ethical assessment of the use of technologies is generally considered a component of the health technology assessment (HTA) processes. HTA is a multidisciplinary process that summarizes information about medical, economic, organizational, ethical, psychological, social and legal issues related to the implementation of a certain health technology in health care system and its main purpose is to inform policymaking. Unlike the other technologies nanotechnologies pose different risks and, therefore, new bioethical implications should be assessed. So, the ethical assessment of nanotechnologies within the HTA processes could be more problematic. The article intends to debate this complexity

A cost-minimization analysis of a preventive testing strategy for relatives of patients with BRCA mutated ovarian cancer

Purpose: This study aims to estimate the cost-minimization strategy of a preventive testing strategy destined to relatives of patients with BRCA mutated cancer versus a no test strategy in Italia. Methods: A BRCA testing pathway was designed by a panel of experts based on the MSTM Excel (2010) tool; the analysis was carried out considering the perspective of the Italian National Health Service. Two alternatives were considered: 1) preventive BRCA testing for relatives of patients affected by ovarian cancer carrying a BRCA1/BRCA2 mutation; 2) no test. Cost and effectiveness data, derived from literature and published sources validated by a Board of experts, were discounted using a discount factor equal to 3%. Probabilistic sensitivity analysis was performed. Results: Considering an average cost of therapy for breast and ovarian cancer major of €90,000.00 per case, the economic impact related to the preventive testing strategy are equal to –€17,814,767.25. The sensitivity analysis confirms these results in the totality of the simulations performed. Conclusions: Preventive genetic testing in relatives of patients affected by ovarian cancer is cost-effective and represents a sustainable cost for the National Healthcare System in Italia, also in the light of its reference values

New opportunities in Haemophilia treatment: Efmoroctocog Alfa for patients with Haemophilia A

Recently new opportunities are emerging for improving the way patients with Haemophilia A are treated. Among these opportunities, efmoroctocog alfa is a first-in-class recombinant factor VIII-Fc fusion protein (rFVIIIFc) produced by recombinant DNA technology with an extended half-life compared with conventional FVIII preparations. The available evidence coming from an Italian HTA report indicates that efmoroctocog alfa provides an effective alternative to conventional FVIII preparations (including standard rFVIIIs) for the management of Haemophilia A. Moreover, by reducing the frequency of injections required, it has the potential to reduce treatment burden, and hence improve adherence to prophylaxis and patient Quality-of-Life.&nbsp

Health technology assessment of pathogen reduction technologies applied to plasma for clinical use

Although existing clinical evidence shows that the transfusion of blood components is becoming increasingly safe, the risk of transmission of known and unknown pathogens, new pathogens or re-emerging pathogens still persists. Pathogen reduction technologies may offer a new approach to increase blood safety. The study is the output of collaboration between the Italian National Blood Centre and the Post-Graduate School of Health Economics and Management, Catholic University of the Sacred Heart, Rome, Italy. A large, multidisciplinary team was created and divided into six groups, each of which addressed one or more HTA domains.Plasma treated with amotosalen + UV light, riboflavin + UV light, methylene blue or a solvent/detergent process was compared to fresh-frozen plasma with regards to current use, technical features, effectiveness, safety, economic and organisational impact, and ethical, social and legal implications. The available evidence is not sufficient to state which of the techniques compared is superior in terms of efficacy, safety and cost-effectiveness. Evidence on efficacy is only available for the solvent/detergent method, which proved to be non-inferior to untreated fresh-frozen plasma in the treatment of a wide range of congenital and acquired bleeding disorders. With regards to safety, the solvent/detergent technique apparently has the most favourable risk-benefit profile. Further research is needed to provide a comprehensive overview of the cost-effectiveness profile of the different pathogen-reduction techniques. The wide heterogeneity of results and the lack of comparative evidence are reasons why more comparative studies need to be performed

REVEALING AND ACKNOWLEDGING VALUE JUDGMENTS IN HEALTH TECHNOLOGY ASSESSMENT

Background: Although value issues are increasingly addressed in health technology assessment (HTA) reports, HTA is still seen as a scientific endeavor and sometimes contrasted with value judgments, which are considered arbitrary and unscientific. This article aims at illustrating how numerous value judgments are at play in the HTA process, and why it is important to acknowledge and address value judgments. Methods: A panel of experts involved in HTA, including ethicists, scrutinized the HTA process with regard to implicit value judgments. It was analyzed whether these value judgments undermine the accountability of HTA results. The final results were obtained after several rounds of deliberation. Results: Value judgments are identified before the assessment when identifying and selecting health technologies to assess, and as part of assessment. They are at play in the processes of deciding on how to select, frame, present, summarize or synthesize information in systematic reviews. Also, in economic analysis, value judgments are ubiquitous. Addressing the ethical, legal, and social issues of a given health technology involves moral, legal, and social value judgments by definition. So do the appraisal and the decision-making process. Conclusions: HTA by and large is a process of value judgments. However, the preponderance of value judgments does not render HTA biased or flawed. On the contrary they are basic elements of the HTA process. Acknowledging and explicitly addressing value judgments may improve the accountability of HT

Ethical analysis in HTA of complex health interventions

Background: In the field of health technology assessment (HTA), there are several approaches that can be used for ethical analysis. However, there is a scarcity of literature that critically evaluates and compares the strength and weaknesses of these approaches when they are applied in practice. In this paper, we analyse the applicability of some selected approaches for addressing ethical issues in HTA in the field of complex health interventions. Complex health interventions have been the focus of methodological attention in HTA. However, the potential methodological challenges for ethical analysis are as yet unknown. Methods: Six of the most frequently described and applied ethical approaches in HTA were critically assessed against a set of five characteristics of complex health interventions: multiple and changing perspectives, indeterminate phenomena, uncertain causality, unpredictable outcomes, and ethical complexity. The assessments are based on literature and the authors’ experiences of developing, applying and assessing the approaches. Results: The Interactive, participatory HTA approach is by its nature and flexibility, applicable across most complexity characteristics. Wide Reflective Equilibrium is also flexible and its openness to different perspectives makes it better suited for complex health interventions than more rigid conventional approaches, such as Principlism and Casuistry. Approaches developed for HTA purposes are fairly applicable for complex health interventions, which one could expect because they include various ethical perspectives, such as the HTA Core Model® and the Socratic approach. Conclusion: This study shows how the applicability for addressing ethical issues in HTA of complex health interventions differs between the selected ethical approaches. Knowledge about these differences may be helpful when choosing and applying an approach for ethical analyses in HTA. We believe that the study contributes to increasing awareness and interest of the ethical aspects of complex health interventions in general