OBJECTIVES: Several health economic guidelines recommend the adoption of a broader societal perspective. In the Czech Republic, a novel approach to the HTA process for orphan drugs has been legally implemented since 2022, adding both governmental and societal perspectives to the standard healthcare payer’s perspective. The objective of this guideline is to establish a standardized framework for incorporating the societal perspective, ensuring consistent principles are applied in health economic analyses.

METHODS: We suggested four conditions that set the basic framework for the health economic analysis from the societal perspective: 1) The analysis from the societal perspective is distinct from the payer’s perspective analysis; 2) The assessment focuses on the patient and the caregiver(s); 3) The societal impact associated with the intervention is expressed in terms of loss of productivity; 4) The opportunity cost associated with loss of productivity is preferentially calculated.

RESULTS: Based on four conditions, five technical principles were established to guide the analyses. 1) Productivity changes due to disease and premature death are measured separately; 2) Productivity changes should be linked to the health economic models; 3) Monetization of productivity changes is calculated using the human capital approach; 4) Cost valuation uses a top-down method – derivation of inputs from macroeconomic data (considering the labor/capital share); 5) Consistent data sources are identified to calculate productivity in the general population.

CONCLUSIONS: Ensuring a consistent methodological approach and interpretation of outputs is crucial for meaningful comparison of results within groups of drugs (vertically), across different diagnoses (horizontally), and over time. Incorporating the governmental and societal perspective brings additional relevant information into the decision-making process. Because of its clarity and applicability, this methodological guideline could be adopted across countries, providing a standardized approach to ensure consistent and comparable results in healthcare decision-making.