Health technology assessments (HTAs) are crucial for market access and reimbursement of diagnostic innovations, yet current frameworks often fail to reflect the true value of in vivo diagnostics—such as molecular imaging (MI) tracers and contrast media (CM). These technologies are frequently assessed using methodologies designed for pharmaceuticals, resulting in inconsistent evaluations and delayed patient access across global markets.
The NAVLIN P&MA Consulting team at EVERSANA (Shivani Shah and Chad Gibson), in collaboration with GE HealthCare (Dr. Ricardo De la Fuente and Hermilo Cabra Gomez), systematically reviewed HTA frameworks across 28 countries to identify key methodological gaps impacting access for in vivo diagnostics. Using global policy documents, case studies, and novel taxonomies (MSPFE and CIAX), the team mapped how HTA agencies evaluate MI and CM and how these assessments influence reimbursement decisions.
The analysis revealed significant variation in evidence requirements, the lack of diagnostic-specific evaluation criteria, and a general reliance on pharmaceutical-centric models. For example, the same FDG-PET diagnostic was reimbursed in some countries but rejected in others despite identical evidence packages.
This study highlights the urgent need for diagnostic-tailored HTA frameworks, harmonized standards across markets, and the inclusion of methodologies such as linked evidence modeling to better capture the real-world value of diagnostic tools. By highlighting these global inconsistencies, the study equips manufacturers with critical insights to navigate diverse HTA environments and strengthens the call for more fit-for-purpose, diagnostics-specific policy frameworks.
For a deeper understanding, access the Value in Health article here.
Author
Shivani Shah is Senior Consultant at EVERSANA and has around 6 years of experience working as consultant in pharmaceutical and life-science industry. Prior to joining EVERSANA, she has worked at one of the top…