• Article

Evidence-based market access value resource Navigating the hurdles for a biologic obtaining a license in a second indication in key European countries

Market access for an innovative technology, such as a biologic obtaining a license in a second indication, can be complex and time consuming. Reimbursement is critical to rapid adoption of and optimal patient access to a new technology. This study aimed to determine the best approach for communicating value and providing field-based staff with value resources to facilitate dialogue with stakeholders in various scenarios.

We conducted desktop research of published literature, health technology assessment reports, clinical trials data, and third-party websites to identify the critical path and data most valuable to reimbursement decision making in order to prepare a communication resource. We conducted a country-affiliate workshop and qualitative one-on-one interviews with payer decision makers in several key markets to understand funding flow and the most appropriate means of communicating value to external decision makers.

The process and restrictions for biologics may be stricter than for other medications because of perceived high cost. There are multiple appropriate access pathways for various settings of care, all with varying requirements and value drivers. It is critical to understand the needs of external decision makers and provide field-based staff with a consistent yet customizable means of communicating the value of new technologies. All evidence and insights were synthesized into an evidence-based market access value resource for key stakeholder engagement.

The evidence-based market access value resource approach provides a clear, concise, and globally integrated value story that will assist in market access and form the basis of consistent communication regarding value at the national, regional, and local level across external stakeholders (e. g., payer decision makers, physicians, patient advocates). Access for a biologics will be complex; regardless of pathway, decisions regarding reimbursement and adoption of a new technology are diverse and dispersed across and within countries, with varying levels of required evidence.


Hogue, S., Bjoerk, B., Walker, A., Balp, MM., Fernandez, M., Quijano, M., ... Heyes, A. (2014). Evidence-based market access value resource: Navigating the hurdles for a biologic obtaining a license in a second indication in key European countries. Value in Health, 17(7), A431-A432. https://doi.org/10.1016/j.jval.2014.08.1099