The study, published in Value in Health, the journal of the International Society for Pharmaco-economics and Outcomes Research (ISPOR), covers the agencies of the UK, Germany, France, Italy, Sweden and Netherlands, comparing the policies each uses to integrate real world health data into their assessments.
The study also explored differences in the interpretation of real world data in initial reimbursement schemes, conditional reimbursement schemes and pharmaco-economic analyses.
The biggest inconsistencies among the six agencies were in relative effectiveness assessment of pharmaceuticals, which was variable not only across agencies, but even within a single agency, depending on the context in which the assessment was performed.
The researchers say this variability in the way real world data is evaluated at the national level raises a concern about the impact on clinical practice and policy implementation. If the differences across EU healthcare systems are so pronounced at the assessment level, it remains questionable how well health policies and standards of practice can be harmonised among member states at the execution level.
The report highlights the need for improvements on collaboration and policy alignment on real world data for the future work of HTA agencies.
“The lack of harmonisation of policies on real world data used for relative effectiveness assessments of drugs may present marketing authorisation holders with a multitude of challenging questions when they consider collecting and using real world data for HTA purposes. As a result, they may be discouraged from using real world data for HTA. HTA agencies need to align policies on real world data and provide guidance on practical aspects of its collection and analysis. Recently published position articles and future project proposals by the EUnetHTA may provide a starting point for discussions and a suitable platform for HTA agencies to achieve this.”
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