The method appraises the stakeholders value judgments in the Health Technology Assessment (HTA) process, through a new model of research that addresses clinical scenarios to simulate real world HTA dilemmas and support decision making. The scenarios are based on criteria, such as clinical and epidemiological elements, and also, economic, social and ethical factors. The stakeholders decisions can induce strategic impacts in different HTA fields. We agreed to call this model Decision Making Clinical Scenarios (DMCS).
The model of research is based on a cross exploratory research, through a DMCS questionnaire applied to stakeholder respondents. The first survey was composed of four scenarios. The scenarios introduce value judgments, preferences and structuring choices, under specific circumstances. The scenarios are based on trade-offs involving HTA, such as budget impact, sources of funding, patients eligibility, technology characteristics and disease epidemiology. The stakeholders points of view are analyzed, through groups that represent payers, suppliers, developers, researchers, prescribers, regulators, government, patients and society.
The scenarios have been shown to be understandable for all stakeholders groups. When testing the model with hypothetical dilemmas through clinical scenarios, the results are strongly influenced by each presented trade-off. We can observe specific trends and motivations when analyzing the stakeholders groups separately. The results are always evaluated and validated through statistical analysis. A total of 193 stakeholders answered the survey. The majority were male (n = 104; 53.9 percent) and aged between 31 and 40 years (n = 71; 36.8 percent). In scenario 1, almost half of respondents (n = 95; 49.2 percent opted not to incorporate the new drug and in scenario 2, an even higher proportion chose not to incorporate the new drug (n = 112; 58.0 percent). In scenario 3, most have responded to not incorporate the new treatment for any age group (n = 81; 42.0 percent). In scenario 4, 65 percent of respondents opted for the preferential allocation for prevention, rather than treatment (n = 125; 64.8 percent). Overall results showed a conservative trend, considering the presented criteria and trade-offs.
We concluded that most stakeholders are not guided only by the clinical benefit of a decision. They valorize the importance of funding mechanisms and budget control, and consider economic, social, ethical, clinical and epidemiological aspects. This study model seems to be useful to evaluate the trends of decision makers conduct. We understand that the use of clinical scenarios brings the discussion into the enviroment and dynamics of the HTA process, where outcome impacts can be analyzed properly. This model can be explored in further research, using flexible criteria for each desired scenario, through real world situations. This model can be used to evaluate impacts in strategic subjects, as budget allocation, public healthcare policies, and patient-shared decision making.