BULEVIRTIDE FOR CHRONIC HEPATITIS DELTA IN ROMANIA: A REAL-WORLD-DATA-DRIVEN COST-UTILITY AND BUDGET IMPACT ANALYSIS...
Author(s)
Adina Turcu-Stiolica, PhD1, Speranta Iacob, PhD2, Bogdan Silviu Ungureanu, PhD1, Mihaela Ghioca, PhD3, Mirela Chitul, PhD Student3, Anca Trifan, PhD4, Laura Huiban, PhD4, Daniela Larisa Sandulescu, PhD1, Dan Ionut Gheonea, PhD1, Corina Radu, PhD5, Corina Pop, PhD2, Liana Gheorghe, PhD2.
1University of Medicine and Pharmacy of Craiova, Craiova, Romania, 2„Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania, 3Fundeni Clinical Institute, Bucharest, Romania, 4„Grigore T. Popa” University of Medicine and Pharmacy, Iasi, Romania, 5„Iuliu Hatieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania.
1University of Medicine and Pharmacy of Craiova, Craiova, Romania, 2„Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania, 3Fundeni Clinical Institute, Bucharest, Romania, 4„Grigore T. Popa” University of Medicine and Pharmacy, Iasi, Romania, 5„Iuliu Hatieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania.
OBJECTIVES: To assess the cost-utility and 5-year budget impact of bulevirtide (BLV) compared with Best Supportive Care (BSC) for the treatment of chronic hepatitis Delta (HDV) in Romania, from the perspective of the Romanian public payer (National Health Insurance House), using real-world local clinical data.
METHODS: A Markov cohort state-transition model was adapted to the Romanian healthcare setting, simulating liver disease progression through health states based on the METAVIR scoring system (F0-F4, decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, post-transplant, and liver-related death). Cycle length was set at one year, with a lifetime horizon for the cost-utility analysis and a 5-year horizon for the budget impact analysis. Costs (2024/2025 RON) and outcomes were discounted at 3% annually. Baseline distribution, demographics, and virologic/biochemical response rates were derived from a retrospective cohort of 175 Romanian HDV patients treated with BLV. Deterministic and probabilistic sensitivity analyses were performed.
RESULTS: BLV produced an incremental gain of 3.36 discounted life-years (LYs) and 3.08 quality-adjusted life-years per patient versus BSC (10.52 vs 7.16 LYs; 8.13 vs 5.05 QALYs). Treatment averted over 1,180 decompensated cirrhosis cases, more than 800 hepatocellular carcinomas, and 87 liver transplants. ICERs were 843,091 RON/LY and 918,829 RON/QALY. It should be noted that the drug cost considered in the model reflects the public price and does not account for the confidential agreement or mandatory clawback local tax. PSA showed 100% of iterations in the North-East quadrant, confirming consistent clinical benefit. The BIA demonstrated a negligible PMPM impact, rising from 0.002 to 0.024 RON over 5 years.
CONCLUSIONS: BLV acts as a disease-modifying therapy, substantially extending survival and preserving quality of life in Romanian HDV patients. Although upfront public costs might be considered significant, the impact on the National Health Insurance Fund remains minimal due to disease rarity and severity, supporting reimbursement to address a critical unmet medical need.
METHODS: A Markov cohort state-transition model was adapted to the Romanian healthcare setting, simulating liver disease progression through health states based on the METAVIR scoring system (F0-F4, decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, post-transplant, and liver-related death). Cycle length was set at one year, with a lifetime horizon for the cost-utility analysis and a 5-year horizon for the budget impact analysis. Costs (2024/2025 RON) and outcomes were discounted at 3% annually. Baseline distribution, demographics, and virologic/biochemical response rates were derived from a retrospective cohort of 175 Romanian HDV patients treated with BLV. Deterministic and probabilistic sensitivity analyses were performed.
RESULTS: BLV produced an incremental gain of 3.36 discounted life-years (LYs) and 3.08 quality-adjusted life-years per patient versus BSC (10.52 vs 7.16 LYs; 8.13 vs 5.05 QALYs). Treatment averted over 1,180 decompensated cirrhosis cases, more than 800 hepatocellular carcinomas, and 87 liver transplants. ICERs were 843,091 RON/LY and 918,829 RON/QALY. It should be noted that the drug cost considered in the model reflects the public price and does not account for the confidential agreement or mandatory clawback local tax. PSA showed 100% of iterations in the North-East quadrant, confirming consistent clinical benefit. The BIA demonstrated a negligible PMPM impact, rising from 0.002 to 0.024 RON over 5 years.
CONCLUSIONS: BLV acts as a disease-modifying therapy, substantially extending survival and preserving quality of life in Romanian HDV patients. Although upfront public costs might be considered significant, the impact on the National Health Insurance Fund remains minimal due to disease rarity and severity, supporting reimbursement to address a critical unmet medical need.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
HTA30
Topic
Health Technology Assessment
Disease
SDC: Gastrointestinal Disorders