Price determinants and pricing policies concerning potentially innovative health technologies: a scoping review

Background: Policymakers face challenges in developing pricing policies for potentially innovative healthcare technologies (pIHTs) that balance limited budgets, access, and incentives for innovation. This study aimed to map existing evidence and identify knowledge gaps regarding price determinants and pricing policies for pIHTs and their effect on access and sustainability. Methods: We conducted a scoping Review of scientific and grey literature in English published between 2014 and September 2023 with pre-specified inclusion and exclusion criteria to identify stakeholder-informed price determinants, pricing policies applied by European Economic Area (EEA) or Organisation for Economic Cooperation and Development (OECD) member states, and their access-related impacts. Literature databases and various stakeholder organisation websites were searched. Further records were included through snowballing and manual addition. Results: 135 Records were included. Stakeholder views on price determinants were available from 15 records and predominantly involved value-based determinants. Pricing policies in EEA/OECD member states are heterogeneous and often feature a mix of policy interventions and implementation methods. External price referencing (EPR), while yielding short-term affordability improvements, is associated with price inequities and launch strategies impairing patient access. Policies combining pricing methods and considering a pIHT’s value have more positive access-related impact but may face feasibility and implementation challenges. Two records mentioned medical device pricing; none featured environmental aspects. Conclusion: While EPR is commonly applied across Europe, value-informed pricing in connection with health technology assessment is more favoured regarding pIHT access in the literature. Knowledge gaps concern medical device pricing, stakeholder views on price determinants, and the implementation of environmental aspects in pIHT pricing.