European Joint Clinical Assessment: Revolutionizing HTA in the Netherlands?

OBJECTIVES: Starting Q1 2025, oncology products and ATMPs will require European Union (EU) Joint Clinical Assessments (JCAs). Despite the European effort, national health technology assessment (HTA) bodies will still draw their own conclusions regarding clinical added value of novel treatments. To date, it is uncertain how national HTA bodies, such as Zorginstituut Nederland (ZIN), will incorporate EU JCAs assessments into their own assessments starting in 2025. This study aims to explore the impact of future EU JCAs on national HTA processes in the Netherlands, building upon the EUnetHTA’s (EU JCA pilot 2006-2021) and ZIN’s venetoclax assessment in acute amyloid leukeamia as a case study.

METHODS: A qualitative assessment of EUnetHTA's and ZIN's assessment of venetoclax was conducted, with a comparison of proposed JCA guidelines.

RESULTS: Although the conclusions on venetoclax's added value were similar, there were differences in scope. ZIN relied heavily on EUnetHTA's work: although EUnetHTA considered more comparator treatments and additional outcomes in their assessment than ZIN, ZIN also highlighted outcomes that were not included in the EUnetHTA report. The timelines for reimbursement in the Netherlands were shorter for venetoclax compared to regular ZIN assessments (CHMP positive opinion April 2021; ZIN pakketadvies November 2021; reimbursement decision February 2022).

CONCLUSIONS: Venetoclax in AML is the only treatment that was assessed by both EUnetHTA and ZIN [2016-2021], therefore generalisability of conclusions is limited. There is a potential that the future EU JCA will accelerate patient access, but to date there are many uncertainties for manufacturers. To illustrate, it is unclear how JCA timelines align with the national (economic) assessment, whether the JCA can sufficiently provide the evidence for the clinical benefit analysis and ultimately whether it duplicates or prevents duplication of work at the national level.