Table 3.

Potential value drivers of ODs in CEE countries

Disease-related factors	Treatment-related factors	Economic factors	Societal factors
• Prevalence (rarity) of disease • Severity of disease • Identifiability of the patients of treatment • Loss of QALYs without treatment • Unmet medical need (i.e., availability of treatment alternatives) • Clinical heterogeneity of the disease (i.e., subgroup of patients)	• Evidence of treatment efficacy or effectiveness • Capacity to benefit from the treatment (i.e., magnitude of benefit) • Treatment is curative or delays progression or alleviates symptoms (e.g., palliative care) • Safety profile of treatment • Innovative profile of treatment • Manufacturing complexity	• Cost-effectiveness • Budget impact • Number of indications • Potential for off-label use	• Societal impact of treatment (i.e., indirect costs on families and caregivers) • Equity in access to treatment • Legal considerations (i.e., patent status)