From Sofia to Skopje: Collaborative Insights on HTA Requirements in Republic of Bulgaria and Republic of North Macedonia

OBJECTIVES: The abstract aims to compare the Health Technology Assessment (HTA) requirements in the Republic of Bulgaria and the Republic of North Macedonia, shedding light on the similarities and differences in their approaches.

METHODS: A comparative analysis was conducted, examining the HTA frameworks, regulatory structures, and key considerations in Bulgaria and North Macedonia. Relevant official guidelines, regulations, and standards issued by governmental bodies overseeing HTA processes were reviewed. The results were consulted with key stakeholders, including government officials, healthcare professionals, and legal experts.

RESULTS: Bulgaria and North Macedonia use similar HTA methodologies, relying on systematic literature reviews and data from clinical trials and observational studies, with informal willingness-to-pay thresholds guiding reimbursement decisions. Both have governmental structures for evaluations, and North Macedonia uniquely has a separate Managed Entry Agreements (MEA) committee. Prescription drug prices in both countries are regulated based on reference prices from other European countries. Bulgaria uses the lowest prices from 10 EU countries, while North Macedonia references four countries (Slovenia, Croatia, Serbia, and Bulgaria). Bulgaria requires at least one positive HTA assessment from the UK, France, Germany, or Sweden for reimbursement, a requirement not present in North Macedonia. Health technologies are included in the Positive Drug List (PDL) once a year in Bulgaria and twice a year in North Macedonia, with reimbursement status maintained for three years in Bulgaria and two years in North Macedonia. Reimbursement decisions are made by a subcommittee report in Bulgaria and by the support of a scorecard in North Macedonia.

CONCLUSIONS: Bulgaria and North Macedonia’s HTA processes show methodological similarities while regulatory differences are present. Recognizing these distinctions is key for effective healthcare resource allocation and evidence-based decision-making. Collaboration has helped adopt best practices, optimizing patient outcomes. This approach should improve Macedonia’s access to cost-effective drug treatments.