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

Abstract

Advanced Treatment Medicinal Products (ATMPs) are innovative treatments aimed at severe diseases. However, patient access varies across European countries. The present research reviews the reimbursement status of the licensed ATMPs in England, Scotland, France, Germany, Italy, Spain, Ireland, Denmark and Sweden and aims to assess the differences in the outcomes of the decisions / recommendations of the different HTA bodies along with their reimbursement status. The Health Technology Assessment (HTA) evaluations and the reimbursement status of all the ATMPs with an active market authorization by March 2026, in the 9 countries in scope were assessed through the official sites of the national HTA bodies. In March 2026, 22 ATMPs held active EU marketing authorizations, with 20 having orphan designation. Only six of them, Yescarta ® , Kymriah ® , Zolgensma ® , Luxturna ® , Tecartus ® and Libmeldy ® —underwent HTA evaluations across the nine countries. AIFA, NICE, and G-BA gave the highest number of positive HTA recommendations for ATMPs, whereas NCPE did not recommend any of the ATMPs reviewed. Of the reviewed ATMPs, Yescarta ® , Kymriah ® , and Luxturna ® were eventually reimbursed in all countries, even if they hadn’t received positive HTA recommendations. Several ATMPs with European marketing authorization had not yet undergone HTA evaluations across the 9 countries. While evaluation gaps for recently approved ATMPs reflect expected administrative timelines, those persisting in Ireland, Denmark, and Sweden suggest deeper structural barriers. Nonetheless, Yescarta ® , Kymriah ® , and Luxturna ® achieved reimbursement across all 9 countries, demonstrating that access is possible even without uniformly positive HTA outcomes.