BRIDGING EU AND NATIONAL HTA - BULGARIAN ONCOLOGISTS’ PERCEPTIONS OF THE JOINT CLINICAL ASSESSMENT
Author(s)
Iva Zdravkova-Aneva, MPH1, Rositsa Dimova, MD, MPH2, Ralitsa D. Raycheva, MA, MCom, PhD1;
1Medical University Plovdiv, Social Medicine and Public Health, Plovdiv, Bulgaria, 2Medical University Plovdiv, Department of Health Management and Health Economics, Plovdiv, Bulgaria
1Medical University Plovdiv, Social Medicine and Public Health, Plovdiv, Bulgaria, 2Medical University Plovdiv, Department of Health Management and Health Economics, 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. The 2019 legislative updates strengthened Bulgaria's HTA framework, coinciding with the EU’s introduction of the Joint Clinical Assessment (JCA). This study examined Bulgarian oncologists’ perceptions of how HTA and the forthcoming JCA may influence 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%). Awareness of the JCA was limited, with 71.1% indicating unfamiliarity. Regarding anticipated outcomes of JCA implementation, nearly half of respondents expected only a moderate likelihood of improvements - 46.5% for faster or enhanced access and 44.7% for greater transparency and predictability - while approximately one-third considered these benefits highly likely (28.9% and 29.8%, respectively). Expectations for reduced administrative burden were also predominantly moderate (52.6%). At the same time, many oncologists believed the JCA’s influence may remain constrained at the national level, with 59.6% indicating that access would be minimally affected due to continued national responsibility for pricing and reimbursement. Moreover, 51.8% perceived a moderate likelihood of no substantial overall impact on access.
CONCLUSIONS: Although JCA is viewed as a potentially positive harmonizing mechanism, Bulgarian oncologists express cautious optimism. Limited familiarity with JCA and expectations of only modest gains highlight the need for targeted communication, increased institutional preparedness, and clearer alignment between EU-level assessments and national reimbursement pathways to meaningfully enhance access to innovative oncology therapies.
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%). Awareness of the JCA was limited, with 71.1% indicating unfamiliarity. Regarding anticipated outcomes of JCA implementation, nearly half of respondents expected only a moderate likelihood of improvements - 46.5% for faster or enhanced access and 44.7% for greater transparency and predictability - while approximately one-third considered these benefits highly likely (28.9% and 29.8%, respectively). Expectations for reduced administrative burden were also predominantly moderate (52.6%). At the same time, many oncologists believed the JCA’s influence may remain constrained at the national level, with 59.6% indicating that access would be minimally affected due to continued national responsibility for pricing and reimbursement. Moreover, 51.8% perceived a moderate likelihood of no substantial overall impact on access.
CONCLUSIONS: Although JCA is viewed as a potentially positive harmonizing mechanism, Bulgarian oncologists express cautious optimism. Limited familiarity with JCA and expectations of only modest gains highlight the need for targeted communication, increased institutional preparedness, and clearer alignment between EU-level assessments and national reimbursement pathways to meaningfully enhance access to innovative oncology therapies.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR11
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
SDC: Oncology