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Table 2 Heterogeneity of value drivers across Europe; comments received within the questionnaire

From: How can a joint European health technology assessment provide an ‘additional benefit’ over the current standard of national assessments?

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