OBJECTIVES

: Cross-border collaboration for the evaluation and procurement of medicines can be undertaken to pool expertise, minimise risk and increase bargaining power. This has become increasingly important in Europe to improve affordability and access to innovative therapies in areas of high-unmet need. This research aims to understand the rationale for collaboration across borders, outcomes of joint initiatives (and associated implications) and key success factors.

METHODS

: A comprehensive review of cross-country collaborations was conducted with a focus on HTA, pricing, procurement, and patient management. Established collaboration models were prioritised including the Valetta Declaration, BeNeLuxA initiative, Nordic Pharmaceutical Forum, and FiNoSe. EU COVID-19 pricing and procurement agreements and cross-border healthcare initiatives in response to the pandemic were also reviewed.

RESULTS

: Successful collaborations occur primarily at the HTA level to pool expertise for evaluation of high-cost, high-value therapies (e.g., Zolgensma by BeNeLuxA and Zynteglo by FiNoSe), however to date influence on access and reimbursement has been minimal. Furthermore, cross border collaboration for price negotiations have had limited success. Successful implementation requires alignment regarding processes and priorities between countries and active engagement from both payers and manufacturers; in this context smaller initiatives with fewer countries are more likely to achieve cross-market consensus.

CONCLUSIONS

: Collaborations are occurring more frequently to support evaluation of high-cost, high-value therapies and to provide a solution for emergency medical care where capacity in individual countries or regions is limited. With an increasing number of innovative therapies in late-stage clinical development, and support for voluntary member state collaborations at the European level, such initiatives are likely to increase in future to pool resources and address shared health priorities across markets. Increased collaboration may lead to further consolidation of evaluation frameworks for high-cost, high-value therapies, including the associated management of clinical and financial uncertainty (e.g., recently introduced EU joint HTA).