OBJECTIVES: The EU HTA Regulation stipulates that member states (MS) will give due consideration to Joint Clinical Assessment (JCA) reports in national HTAs of medicinal products. MS must provide information on how the JCA has been considered in their national process within 2 years of the application date, which for oncology products and advanced therapeutic medicinal products (ATMPs) is 12 January 2025. However, there may be significant heterogeneity in processes across the EU, complicating implementation for various stakeholders. This research aimed to explore differences between national reimbursement and access pathways of the 27 EU MS, specifically for oncology and ATMPs.

METHODS: Based on secondary research, the access pathways were classified based on criteria around the role of HTA and where it fits into the process. The key criteria that were considered are how countries are currently assessing oncology therapies/ATMPs, how they are planning for implementation in 2025 and what differences there are between MS.

RESULTS: Two thirds of the MS (19 out of 27 MS) currently have an HTA process in place for inpatient oncology products/ATMPs. In these countries, the HTA impacts both pricing and reimbursement in the majority (12/19) of cases. The HTA criteria included medical-therapeutic evaluations in 15 MS and economic evaluations in 16 MS. Generally, 13 MS publish their national HTAs of inpatient pharmaceuticals. Limited information was identified on implementation plans for the majority of MS.

CONCLUSIONS: As an update to a mapping that was done by EUnetHTA WP7 in 2018, our analysis shows that large differences in processes between EU MS persist. These differences are likely to impact the national implementation of JCA across MS, as well as the time, effort and resource use invested by all stakeholders.