Barriers to access to innovative oncology medicines in Bulgaria: a survey of oncology specialists

Background

Timely access to innovative oncology medicinal therapies is essential for equitable cancer care, yet remains a major challenge, particularly in healthcare systems with constrained resources. This study assessed the main barriers to access in Bulgaria and the measures specialists consider most relevant for improvement.

Methods

A cross-sectional survey was conducted among 114 oncology specialists in Bulgaria. A dedicated questionnaire examined perceived barriers, their significance, the proportion of patients affected and potential improvement measures. Multiple-response questions and five-point Likert scales were analysed descriptively.

Results

The most frequently reported barriers were the high budget impact on the National Health Insurance Fund (57.0%; n = 65) and regulatory restrictions and delays in health technology assessment and inclusion in the Positive Drug List (48.2%; n = 55). Delays by pharmaceutical companies were reported by 29.8% (n = 34). Budget impact and regulatory delays were also rated as the most important barriers (median 4.0 for both; IQR 2 and 1). Limited access was reported for <5% of patients by 31.6% of respondents and for >20% by 4.4%. Better access to specialised oncology centres and more local clinical trials were rated highly (60.6% and 56.2%; median 4.0 for both). Support for a dedicated fund for innovative oncology therapies reached 65.8%.

Conclusions

Access to innovative oncology medicines in Bulgaria is constrained mainly by payer budget pressure and reimbursement-related regulatory delays. Faster assessment and listing procedures, better access to specialised centres, more local clinical trials and a dedicated fund with clear criteria could improve timely and equitable access.

Key messages

• Bulgarian specialists identified payer budget pressure and reimbursement delays as the main barriers to patient access to innovative oncology medicines.

• Respondents prioritised specialised oncology centres, more local clinical trials and a dedicated fund with clear criteria to improve access.