Review and Horizon Scanning of Advanced Therapy Medicinal Products in Slovenia: Registration, Reimbursement, and Future Pipeline
Author(s)
Klemen Bele, MPharm, Dominik Zadravec, MPharm, Mitja Kos, MParm, PhD.
University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia.
University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia.
OBJECTIVES: To map the landscape of ATMPs in Slovenia by assessing current EU-authorized products, their national registration and reimbursement status, and to perform horizon scanning of emerging ATMPs (next 2 years), identifying gaps in policy and HTA readiness.
METHODS: We conducted a two-phase analysis in October 2024. Phase 1: identification of all ATMPs with EC authorization via EMA CAT reports and EPARs; data extraction included ATMP type (gene, somatic cell, tissue-engineered), orphan status, indication, and ATC code. Slovenian marketing authorizations and reimbursement status were cross-checked via national registers and Health Insurance Institute of Slovenia (ZZZS). Phase 2: horizon scanning of emerging ATMPs was performed via EMA CAT and EMA advice registers, ClinicalTrials.gov, and NIHR MIND listing to collect pipeline products expected to reach authorization within two years. Products were categorized by therapy type and indication, with policy environment assessed for Slovenian HTA and horizon scanning mechanisms.
RESULTS: As of October 2024, Slovenia had reimbursed 2 of 20 EU-authorized ATMPs, both gene therapies for rare diseases. Several ATMPs with orphan status remain without national reimbursement or rely on individual funding decisions. Horizon scanning identified 63 emerging ATMPs, spanning a diverse range of modalities (gene, somatic cell, tissue-engineered) with indications extending into oncology, ophthalmology, and neurology. Slovenia currently lacks a formal HTA-based horizon scanning framework for ATMPs, with ad hoc payer decisions and confidential discount schemes underpinning access.
CONCLUSIONS: Slovenia’s ATMP landscape mirrors EU trends regarding innovation, but lags in systematic HTA horizon scanning and structured reimbursement. Enhanced national frameworks are needed to ensure timely access, budgetary planning, and informed decisions for the upcoming wave of varied ATMPs. Our findings support policy development for early assessment and integration of ATMPs into national health systems.
METHODS: We conducted a two-phase analysis in October 2024. Phase 1: identification of all ATMPs with EC authorization via EMA CAT reports and EPARs; data extraction included ATMP type (gene, somatic cell, tissue-engineered), orphan status, indication, and ATC code. Slovenian marketing authorizations and reimbursement status were cross-checked via national registers and Health Insurance Institute of Slovenia (ZZZS). Phase 2: horizon scanning of emerging ATMPs was performed via EMA CAT and EMA advice registers, ClinicalTrials.gov, and NIHR MIND listing to collect pipeline products expected to reach authorization within two years. Products were categorized by therapy type and indication, with policy environment assessed for Slovenian HTA and horizon scanning mechanisms.
RESULTS: As of October 2024, Slovenia had reimbursed 2 of 20 EU-authorized ATMPs, both gene therapies for rare diseases. Several ATMPs with orphan status remain without national reimbursement or rely on individual funding decisions. Horizon scanning identified 63 emerging ATMPs, spanning a diverse range of modalities (gene, somatic cell, tissue-engineered) with indications extending into oncology, ophthalmology, and neurology. Slovenia currently lacks a formal HTA-based horizon scanning framework for ATMPs, with ad hoc payer decisions and confidential discount schemes underpinning access.
CONCLUSIONS: Slovenia’s ATMP landscape mirrors EU trends regarding innovation, but lags in systematic HTA horizon scanning and structured reimbursement. Enhanced national frameworks are needed to ensure timely access, budgetary planning, and informed decisions for the upcoming wave of varied ATMPs. Our findings support policy development for early assessment and integration of ATMPs into national health systems.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR176
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Approval & Labeling, Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
Genetic, Regenerative & Curative Therapies, Oncology, Personalized & Precision Medicine, Rare & Orphan Diseases