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August 22, 2026Discover Health SystemsOpen Access

Variation in Health Technology Assessment recommendations and reimbursement of Advanced Therapy Medicinal Products across nine european countries

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Authors

PGParaskevi M. GeorgiouKAKostas P. Athanasakis

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Overview

Comparative policy review reveals wide disparities in health technology assessments for advanced therapies, highlighting reimbursement barriers across European healthcare systems.

Key Points

  • To evaluate differences in Health Technology Assessment (HTA) recommendations and national reimbursement decisions for Advanced Therapy Medicinal Products (ATMPs) across nine European countries.
  • Reviewed regulatory and HTA records from national HTA agency portals across nine countries: England, Scotland, France, Germany, Italy, Spain, Ireland, Denmark, and Sweden.
  • Assessed all 22 ATMPs holding active European Union marketing authorizations as of March 2026.
  • Among 22 authorized ATMPs (20 carrying orphan designation), only six underwent HTA evaluations across all nine countries: Yescarta, Kymriah, Zolgensma, Luxturna, Tecartus, and Libmeldy.
  • AIFA (Italy), NICE (England), and G-BA (Germany) issued the highest number of positive HTA recommendations, whereas Ireland's NCPE issued no positive recommendations.
  • Yescarta, Kymriah, and Luxturna attained national reimbursement across all nine countries, demonstrating that patient access is achieved even without universally positive HTA outcomes.

Cite This Study

Georgiou et al. (2026) studied this question.

synapsesocial.com/papers/6a895ffeca7ade938187efbfhttps://doi.org/10.1007/s44250-026-00416-w
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