Spring Intro 2023

23/03/2023

HTA differs from Regulatory

• Multi-disciplinary: ‘medical, social, ethical and economic issues’ • Applied to many technologies, not just drugs • Focus is on policy and decision making, not hypotheses testing • Concerned not just with introduction, but diffusion and appropriate use of (new) technology • Context and health system dependent: ‘what is the impact on MY population?’ • Greater emphasis on summarising all available evidence: systematic reviews and meta-analyses • Endpoints must be clinically relevant (surrogate endpoints not so valued) • relative differences • Values the innovation of the drug (e.g. new mechanism of action) Assessment Appraisal Scoping

The Organisation for Professionals in Regulatory Affairs

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HTA differs from Regulatory Regulatory Dossier

Reimbursement Dossier

SmPC

SmPC

Quality Module

Non-clinical data

In vitro data; PK/PD

Clinical data

Clinical data

Network meta-analyses & indirect comparisons

Real World Evidence

Real World Evidence

Cost-effectiveness

Budget Impact

The Organisation for Professionals in Regulatory Affairs

12

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