OBJECTIVES: The EU HTA regulation is adamant that while clinical assessment is being harmonised at EU level, access and pricing remains under the remit of each individual Member State (MS). However, given the EU HTAR goal of accelerating patient access across MS, it is reasonable to assume that early availability of the JCA report may lead to earlier submissions and accelerated price negotiations in historically ‘later’ MS. As differences between MS willingness and ability to pay for new health technologies will remain, the change in timelines for price visibility will have international reference pricing (IRP) implications. This research aimed to simulate the impact of EU HTAR on IRP.

METHODS: Hypothetical scenarios were simulated for an illustrative drug undergoing JCA and compared to a ‘typical’ historical launch sequence. Prior launches were evaluated to create assumptions on average relative list (ex-manufacturer) prices in each MS, normalised to the German pre-AMNOG price. Historical launch sequence was aligned to the EFPIA Patients W.A.I.T. Indicator 2023 Survey. An IRP tool, which leverages all known formal and informal inbound and outbound rules, was then used to model the impact of referencing scenarios on price erosion over 5 years post-EMA approval.

RESULTS: Analysis suggests that if launch in all EU MS is accelerated to within 18 months of EMA approval, average price erosion over 5 years is significantly increased and the differential between highest and lowest prices is widened. Key findings include the high impact of prices in Central & Eastern EU (CEE) markets being made available earlier.

CONCLUSIONS: Acceleration of price-setting in all EU MS due to EU HTAR has the potential to erode drug prices via IRP faster than seen historically. While this has access benefits, health technology developers must ensure new IRP scenarios are incorporated into strategic planning and post-JCA evolution of local pricing processes is closely monitored.