Navigating HTA and Innovation: Oncologists’ Perspectives on Access to Cancer Therapies in Bulgaria
Author(s)
Ralitsa D. Raycheva, MA, MCom, PhD1, Iva Zdravkova-Aneva, MPH2.
1Associate Professor, Medical University Plovdiv, Plovdiv, Bulgaria, 2Social Medicine and Public Health, Medical University Plovdiv, Plovdiv, Bulgaria.
1Associate Professor, Medical University Plovdiv, Plovdiv, Bulgaria, 2Social Medicine and Public Health, Medical University Plovdiv, Plovdiv, Bulgaria.
OBJECTIVES: Since late 2015, Ministerial Order N9 has mandated new medicines to be subject to health technology assessment (HTA) for the Positive Drug List (PDL), which leads to National Health Insurance Fund (NHIF) reimbursement. This framework was strengthened in April 2019 when the Medicinal Products in Human Medicine Act added HTA procedures. This study examined Bulgarian oncologists’ views on how HTA processes affect patient access to innovative oncology therapies (IOTs).
METHODS: A cross-sectional online questionnaire surveyed Bulgarian oncologists. HTA protocols, clinical trial participation, and IOTs access were covered. The survey was distributed from March to May 2025 in five rounds to optimize reach and response.
RESULTS: 115 oncologists participated, 44.7% with medical oncology postgraduate specialties. They were evenly distributed by gender, employed in public healthcare (61.4%) and treated solid tumors for over 10 years (55.3%). Around 70% reported to be well informed about the existing IOTs with 35% estimated that over 50% of patients received such therapy. About 60% said Bulgaria's introduction of IOTs was timely. However, 64% of respondents stated their patients sought therapy abroad due to a lack of IOTs in Bulgaria, yet this is below 5% of their practice. Moreover, 36% agreed their patients have comparable access to other European countries. Most common access barriers were high NHIF budget impact (56.6%), regulatory delays in the HTA procedure and inclusion in the PDL (48.7%), and pharmaceutical company reimbursement application delays (30.1%), which led to 50% of respondents to participate in clinical trials to obtain unavailable drugs. Over one-third projected moderate JCA gains in access, EU timeline alignment, and guideline harmonization.
CONCLUSIONS: Bulgaria has institutionalized HTA to control funded novel treatments, but implementation issues were reported. Transparent HTA procedures, clearer clinical guideline updates, and greater training may assist implement IOTs. Awareness of JCA programs may help align national decisions with European access needs.
METHODS: A cross-sectional online questionnaire surveyed Bulgarian oncologists. HTA protocols, clinical trial participation, and IOTs access were covered. The survey was distributed from March to May 2025 in five rounds to optimize reach and response.
RESULTS: 115 oncologists participated, 44.7% with medical oncology postgraduate specialties. They were evenly distributed by gender, employed in public healthcare (61.4%) and treated solid tumors for over 10 years (55.3%). Around 70% reported to be well informed about the existing IOTs with 35% estimated that over 50% of patients received such therapy. About 60% said Bulgaria's introduction of IOTs was timely. However, 64% of respondents stated their patients sought therapy abroad due to a lack of IOTs in Bulgaria, yet this is below 5% of their practice. Moreover, 36% agreed their patients have comparable access to other European countries. Most common access barriers were high NHIF budget impact (56.6%), regulatory delays in the HTA procedure and inclusion in the PDL (48.7%), and pharmaceutical company reimbursement application delays (30.1%), which led to 50% of respondents to participate in clinical trials to obtain unavailable drugs. Over one-third projected moderate JCA gains in access, EU timeline alignment, and guideline harmonization.
CONCLUSIONS: Bulgaria has institutionalized HTA to control funded novel treatments, but implementation issues were reported. Transparent HTA procedures, clearer clinical guideline updates, and greater training may assist implement IOTs. Awareness of JCA programs may help align national decisions with European access needs.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA243
Topic
Epidemiology & Public Health, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology