BIOMARKER DIAGNOSTICS IN PROSTATE CANCER: SOCIAL BURDEN AND ECONOMIC ASPECTS OF ACCESS TO PERSONALIZED TREATMENT
Author(s)
Zornitsa Mitkova1, Beatris Yordanova, PhD student2, Manoela Manova, PhD3.
1Associate Professor, Medical University - Sofia, Bulgaria, Sofia, Bulgaria, 2Faculty of pharmacy, Medical University of Sofia, Sofia, Bulgaria, 3Faculty of pharmacy, Medical University, Sofia, Bulgaria.
1Associate Professor, Medical University - Sofia, Bulgaria, Sofia, Bulgaria, 2Faculty of pharmacy, Medical University of Sofia, Sofia, Bulgaria, 3Faculty of pharmacy, Medical University, Sofia, Bulgaria.
OBJECTIVES: To assess the financial burden associated with BRCA testing and access to therapy from a societal perspective in Bulgaria
METHODS: A cost of illness study using a micro-costing approach was conducted based on the Bulgarian Pharmacotherapeutic Guideline in Medical Oncology, the Positive Drug List, the regulatory framework, and publicly available prices of genetic testing. Costs associated with standard therapeutic alternatives and therapies requiring prior biomarker testing were analysed in patients with metastatic castration-resistant prostate cancer (mCRPC). The publicly available price of a next-generation sequencing (NGS) panel for hereditary prostate cancer, including BRCA1/2, was used.
RESULTS: In patients with mCRPC, treatment with Niraparib/Abiraterone acetate is only approved when BRCA1/2 mutations are confirmed. The National Health Insurance Fund (NHIF) reimburses treatment of €5,583.97 but does not cover the genetic test required to determine biomarker status, which costs €613.55. The testing fee is 43.6% of the average monthly gross salary (€ 1,407) and 111.6% of the average monthly pension (€ 550). If biomarker testing is not performed, the monthly treatment costs may include Apalutamide/ADT (€2,825.61), Enzalutamide/ADT (€2,611.33), and Talazoparib/Enzalutamide (€4,627.27), which are fully reimbursed. The lack of information regarding biomarker status is associated with higher healthcare expenditures from the NHIF perspective. This is due to the need for management of complications and hospitalizations. The hospitalization costs are € 347.88 or €1,325.27-3,423.61 depending on the patient's individual characteristics and clinical pathway. Out-of-pocket expenditures also increased as a result of spending on food supplements, alternative therapies, and transportation costs.
CONCLUSIONS: The inclusion of biomarker diagnostics into publicly funded healthcare services could improve access to personalized medicine and support a more efficient use of healthcare resources in the treatment of patients with mCRPC.
METHODS: A cost of illness study using a micro-costing approach was conducted based on the Bulgarian Pharmacotherapeutic Guideline in Medical Oncology, the Positive Drug List, the regulatory framework, and publicly available prices of genetic testing. Costs associated with standard therapeutic alternatives and therapies requiring prior biomarker testing were analysed in patients with metastatic castration-resistant prostate cancer (mCRPC). The publicly available price of a next-generation sequencing (NGS) panel for hereditary prostate cancer, including BRCA1/2, was used.
RESULTS: In patients with mCRPC, treatment with Niraparib/Abiraterone acetate is only approved when BRCA1/2 mutations are confirmed. The National Health Insurance Fund (NHIF) reimburses treatment of €5,583.97 but does not cover the genetic test required to determine biomarker status, which costs €613.55. The testing fee is 43.6% of the average monthly gross salary (€ 1,407) and 111.6% of the average monthly pension (€ 550). If biomarker testing is not performed, the monthly treatment costs may include Apalutamide/ADT (€2,825.61), Enzalutamide/ADT (€2,611.33), and Talazoparib/Enzalutamide (€4,627.27), which are fully reimbursed. The lack of information regarding biomarker status is associated with higher healthcare expenditures from the NHIF perspective. This is due to the need for management of complications and hospitalizations. The hospitalization costs are € 347.88 or €1,325.27-3,423.61 depending on the patient's individual characteristics and clinical pathway. Out-of-pocket expenditures also increased as a result of spending on food supplements, alternative therapies, and transportation costs.
CONCLUSIONS: The inclusion of biomarker diagnostics into publicly funded healthcare services could improve access to personalized medicine and support a more efficient use of healthcare resources in the treatment of patients with mCRPC.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE550
Topic
Economic Evaluation, Health Service Delivery & Process of Care
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
Oncology, Personalized & Precision Medicine