OBJECTIVES: To determine similarities in requirements and timeline alignment in health technology assessment (HTA) submissions across Europe. Current country differences challenge harmonization and parallel scientific advice with regulatory bodies.
METHODS: Submission guidance from HTA bodies in the UK (England and Wales; Scotland), France, Germany, The Netherlands, Belgium, Denmark, Finland, Norway, Sweden, Poland and Portugal were reviewed. Evidence requirements (e.g., therapeutic benefit, patient benefit, economic evaluations) and timelines for submissions were identified and compared.
RESULTS: Requirements of assessment of therapeutic benefit, patient benefit, systematic literature reviews and dossier submissions were consistent across countries. Economic assessment criteria vary across countries. The UK, France, Norway, and Germany recommend a payer perspective and others recommend some form of a societal perspective (Poland, Denmark, Finland, Sweden, and the Netherlands). Differences in preferences for economic perspective drive further differences in economic analyses recommended by HTA bodies. Most HTA bodies suggest cost-utility analysis (CUA) but some a cost-effectiveness analysis (CEA), adding complexity to the development of global economic models and country adaptations. All countries recommend a budget impact model and the Nordics propose a cost calculation. In terms of health-related quality of life evaluation, all countries recommend both generic and disease-specific measures. There is a high degree of variability in mean time from submission to reimbursement across countries. Most countries report an expected mean of 180 days from submission to reimbursement; however, in practice this can extend in some countries to approximately one year (360-400 days). Exceptions include the Netherlands and Denmark, which report an expected 90 days from submission to reimbursement and Germany is the outlier with 12-month free pricing from the time of submission.
CONCLUSIONS: Despite several similar requirements for HTA submissions to multiple countries, harmonization is challenged by differences in both economic evaluations and submission to reimbursement timelines.
