Evaluation of HTA Frameworks for In Vivo Diagnostics: Assessing Methodological Gaps and Implications for Market Access.

Objectives: This study investigates the evaluation of in vivo diagnostics, particularly molecular imaging (MI) tracers and contrast media (CM), within health technology assessment (HTA) frameworks across 28 countries. The aim is to identify variations in HTA methodologies and highlight gaps in the evaluation of diagnostics, focusing on market access and reimbursement.

Methods: Guidance documents from Ministry of Health, national insurers, and HTA organizations were reviewed to assess roles and methodologies for evaluating In vitro diagnostics (IVDs), pharmaceuticals, and in vivo diagnostics. HTA organizations were grouped into five categories based on assessment processes and legal influence. A mapping methodology created regulatory-to-reimbursement process maps, resulting in two taxonomies. Representative countries from each group were analyzed for evidence requirements for MI tracers and CM. Five published HTA case studies were used to validate findings and evaluate the impact of HTA decisions on coverage and reimbursement.

Results: The study found that IVDs were universally evaluated as medical technologies, while MI tracers and CM were often evaluated as pharmaceuticals, with diagnostic modalities considered separately. HTA frameworks in 11 countries were analyzed, revealing variation in how evidence requirements were defined. Case studies revealed discrepancies in reimbursement decisions despite similar clinical evidence, highlighting inconsistencies in HTA methodologies.

Conclusion: This study identifies gaps in HTA frameworks for evaluating in vivo diagnostics, including reliance on pharmaceutical-centric models, lack of standardization, and inconsistent methodologies across markets. These gaps pose barriers to access and reimbursement for MI tracers and CM, emphasizing the need for methodologies tailored specifically to in vivo diagnostics.