Developing an evidence-based methodological framework to systematically compare HTA coverage decisions: A mixed...

Area of Science:

• Health economics
• Health services research
• Pharmaceutical policy

Background:

• Health Technology Assessment (HTA) processes often yield divergent coverage recommendations for the same medication across different countries.
• Existing methodological similarities in HTA do not consistently lead to aligned policy outcomes.

Purpose of the Study:

• To develop and pilot a systematic methodological framework to identify the root causes of differing HTA coverage recommendations.
• To enhance understanding of variability in HTA decision-making processes.

Main Methods:

• An exploratory sequential mixed methods research design was employed.
• The framework analyzed HTA stages: evidence appraisal, interpretation, and influence on recommendations.
• Qualitative thematic analysis and correspondence analysis were used on data from England, Scotland, Sweden, and France for two orphan drugs.

Main Results:

• The framework identified 18 distinct evidence uncertainties, with 56% related to commonly appraised evidence and 44% to selectively considered evidence.
• Poor agreement in evidence interpretation (κ=0.183) was linked to stakeholder input, agency-specific risk, and value preferences.
• The framework successfully codified and quantified variability across HTA stages.

Conclusions:

• The developed framework systematically identifies and quantifies reasons for divergent HTA recommendations.
• Its iterative and flexible design ensures transferability across different contexts, medicines, and countries.
• This approach promotes greater transparency and consistency in global HTA decision-making.