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2021 has been a record year for marketing authorisations for high-cost, high-value therapies, and it is becoming increasingly important to ensure sustainable funding and early access to these innovative therapies in areas of high-unmet need. Existing structures in some European member states are not currently optimised for the assessment of high-cost, high-value technologies and therefore, new approaches to assess, value and procure these therapies are needed.

Cross border collaboration can be used to pool expertise, minimise risk and increase countries’ purchasing power. This research reviews the different cross-border collaboration initiatives that aim to support the pricing and access of innovative products in Europe.

We identified a positive trend in market access collaborations over the past five years, with initiatives that consist of several smaller countries more commonly arising in Europe. This approach supports therapies to enter specialised market areas and promotes patient access in smaller healthcare markets where pricing and access would otherwise be challenging.

A significant time lag between initiation of a collaboration and the first agreement is common across initiatives. BeNeLuxA began in 2015 and it was three years before the collaborations first output in 2018 (joint HTA assessment), followed by the first successful pricing negotiation of Zolgensma, in 2021. This delay, along with a recent rise in actionable outputs, and the prioritisation of market access for innovative, high-cost therapies is likely to result in the increased need for joint pooling of expertise and purchasing power.

The case study highlighting the EU joint procurement of COVID-19 vaccines, demonstrates the success of an advanced purchase agreement. This agreement was coordinated by one central governing body (the European Commission), to enable equitable early patient access to vaccines with conditional marketing authorisation, irrespective of the size of the market, the healthcare systems’ budget, or the volume of patients in each market.

The success of future EU joint assessment and procurement processes will require alignment of processes and priorities between either a small number of ‘equal’ participating countries or in the presence of one central governing body.

Lightning Heath can support you through the life cycle of your innovative pipeline. Contact us to discuss how we can partner with you for your market access strategy.

Article published 30 November 2021.