Which kind of ethical issues in HTA processes? Results and considerations from the application of ethics expertise in HTA processes in Italy

Background: The ethics domain is intrinsic to HTA processes even if the practical experiences are still limited. Objectives: The contribution deals with the kinds of the ethical issues recognized within HTA processes where bioethicists of the Institute of Bioethics of the Università Cattolica (Rome, Italy) were involved. Methods: The overall HTA processes performed from 2007 to 2011 are seven. The technologies assessed were the following: three pharmaceuticals (Lapatinib, Lucentis, Dabigatran etexilate), two antipneumococcal vaccines (Synflorix, Prevenar 13), one diagnostic procedures (PECT and SPECT scanning for early diagnosis of minimally cognitive impairment), one surgical tool (Ultrasound harmonic scalpel in surgery). EUnetHta Core models were utilized for research questions, and the “triangular model” as ethics approach. Results: The ethical issues assessed regarded: 1. Effectiveness/safety of the technologies, particularly the need for patients’ strata to optimize the benefit from the utilization of new pharmaceuticals(often very expensive for a National Health Service); 2. respect for patient’s dignity, integrity, autonomy, values, as well healthcare professionals, and the benefit/harms for other stakeholders; 4. distributive justice issues, with reference to National/Regional Healthcare Service coverage for the technology, its Regional supply; the fairness of the availability of the technology. Discussion: Today, the available HTA tools for ethics analysis (e.g.: EUnetHTA Core Model), can consent a good recognition of specific issues related to healthcare technologies assessment, even considering the different ethical approaches (e.g.: casuistry, utilitarianism, etc. Still, an important open space for further methodological implements/reflections about ethical domain integration and practical running in HTA processes remains. Implications for the health system/professionals/patients/society: Because health technologies embody a variety of social and political aspects for individual and people, technologies cannot be assessed only through the (also necessary) narrow lens of costeffectiveness analysis. Health decision-making processes need to be informed by the values that prevail in a given society.