Recent Developments in European Voluntary Cross-Border Collaborations in Joint HTA, Drug Pricing, Procurement, and Readiness for EU HTA Implementation

Author(s)

Skowron R1, Grioui N2, Koćwin A3, Dimassi M2, Cork D4, Remuzat C5, Francois C5
1Putnam, Newcastle Upon Tyne, NT, UK, 2Putnam, Tunis, Tunis, Tunisia, 3Putnam, Kraków, MA, Poland, 4Putnam, Newcastle upon Tyne, NT, UK, 5Putnam, Paris, Île-de-France, France

OBJECTIVES: Over the past decade, several European countries have pooled resources to conduct joint health technology assessment (HTA) or drug pricing/procurement to ultimately improve access to medicines and secure affordable prices. This research explores recent developments in European voluntary cross-border HTA and drug pricing/procurement initiatives from 2023 onwards, and their readiness for upcoming European Union (EU) HTA implementation in 2025.

METHODS: A comprehensive literature review was conducted using publicly available resources, including the World Health Organization website, national health authorities’ websites, PubMed, and grey literature.

RESULTS: Few well-established cross-border initiatives remain active: BeNeLuxA (established in 2015), Nordic Pharmaceutical Forum (NLF, established in 2015), and the Joint Nordic HTA-Bodies (JNHB), formerly FINOSE (established in 2018). BeNeLuxA successfully completed joint price negotiations for atidarsagene autotemcel in 2024 and is currently conducting joint HTA of another high-price gene therapy. JNHB, which was strengthened by Iceland's entry in 2024, has updated its guidance and submission documents to improve transparency of methods and processes and has started collaboration with the NLF, allowing a product assessed through JNHB to undergo joint Nordic price negotiations. Most countries involved in these collaborations participated in EUnetHTA21 and contributed to EU HTA regulation development, acknowledging the role these collaborations may play in supporting its implementation at national level.

CONCLUSIONS: Established cross-border cooperations like JNHB and BeNeLuxA are poised to maintain their work post-EU HTA regulation implementation. Given the tight timelines and anticipated challenges for national implementation of EU HTA, these collaborations are expected to streamline and accelerate local processes through PICO alignment and/or integration of joint clinical assessment reports for national decision-making. Furthermore, the growing interest in voluntary cooperation on HTA within EU and European Commission’s ambitions to reinforce cross-country collaborations supporting pricing and reimbursement policies underscore the evolving landscape of cross-border collaborations.

Conference/Value in Health Info

2024-11, ISPOR Europe 2024, Barcelona, Spain

Value in Health, Volume 27, Issue 12, S2 (December 2024)

Code

HPR103

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes, Procurement Systems, Reimbursement & Access Policy

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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