Biosimilar market access considerations

Exploring biosimilar market access considerations across the EU


Objective – The purpose of this study was to understand the EU member states’ local market access needs in relation to biosimilars, in order to identify and understand the key criteria which drive payer decision making.

Methods – The research incorporated insights gathered through a targeted secondary literature review across 15 EU markets, which identified relevant recent biosimilar publications and country-specific biosimilar policy documentation. Supplementary payer research across the EU was also conducted to address any evidence gaps in payer decision-making

Results – Based on this research, four broad, distinct payer archetypes were identified: hospital formulary; retail pharmacy; regional access and single-country tender. The different payer needs for each payer archetype could be described using five categories: stakeholder roles; decision drivers; tactics that allow decision drivers to be leveraged; pricing and market access launch challenges; and critical success factors.

The research also highlighted differences in the access requirements of stakeholders at a national and regional level across the EU. For example, single-country tenders, price is the main driver for decision making whereas in hospital formulary markets, in addition to price as a priority driver, specialists are a key stakeholder, with clinical data as an important driver. Multiple stakeholders are involved in retail pharmacy markets, where treatment is initiated by a hospital specialist but continued within primary care. For Regional access markets price is a driver but as many tenders are not a ‘winner takes all approach’ other product value attributes, such as device design, are also taken into account.

Conclusions – Although payers welcome biosimilars, differences in their assessments and access requirements mean that pharmaceutical companies need to adapt their access approaches to individual stakeholder needs to support positive access decisions. The use of payer archetypes, such as those developed during the course of this project, can help in the development of effective local market access strategies.

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