Table 2.

Heterogeneity of value drivers across Europe; comments received within the questionnaire

Area of Heterogeneity	Examples
Different evidence requirements for European regulatory vs applicable national HTA procedures	• Primary study endpoints to be acceptable for regulatory authorities and HTA bodies • Clinical trial comparators should meet both regulatory and HTA requirements • What is the HTA equivalent to EMA’s accelerated pathways and conditional approvals? • How to align early regulatory and HTA advice procedures? • Regulators are relying on the totality of evidence while HTA bodies usually rely only on Head-to-Head evidence
Different treatment algorithms and national guideline recommendations	• Clinical Treatment Guidelines differ across Europe • Inconsistent definition and relevance of ‘unmet medical need’ within the national HTA procedures
Different methodological standards for national HTAs	• Acceptance of Indirect Treatment Comparisons • Applied Comparative Treatments • Accepted Endpoints • Acceptance of pre-defined hierarchical testing • Lack of a standardized methodological guidance
Different national HTA and reimbursement processes	• Time to market differs across Europe • Early Advice and Early Access Programs differ across Europe • Acceptance of EU HTA outcomes differs across the various EU countries • How to overcome different treatment standards in western vs eastern Europe