Bulgarian NCPRMP pharmacoeconomic / HTA assessment framework
This is the official method used in Bulgaria to assess the price, reimbursement eligibility, and health technology value of new medicines. It helps decide which drugs the national health system will fund, based on their clinical benefit and cost.
At a glance
Use when
Assessing the reimbursement eligibility and pricing of new medicinal products in Bulgaria, particularly those with new INNs requiring HTA review.
Avoid when
Conducting detailed cost-utility analyses requiring QALYs if local thresholds are undefined, or when robust financial impact monitoring is required due to current system gaps.
Inputs
Clinical trial data, pharmacoeconomic analyses, cost-effectiveness ratios, budget impact models, comparative efficacy data, regulatory approval status (e.g., EMA), and therapeutic added value assessments.
Outputs
Reimbursement decisions, pricing determinations, HTA recommendations for new medicinal products, lists of approved INNs for public funding.
How it works
The framework is implemented by the National Council on Prices and Reimbursement of Medicinal Products (NCPRMP), established in 2013 to evaluate and approve reimbursement for medicinal products with new international nonproprietary names (INNs). In 2015, HTA functions were transferred to the National Centre for Public Health and Analyses. The process involves pharmacoeconomic evaluation, clinical assessment, and alignment with EU regulations, though formal monitoring and financial reporting mechanisms remain underdeveloped.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Organisational aspects
- Categories
- AppraisalContext & ImplementationCost-effectiveness ModellingReporting Standards & Best Practice
- Assumptions
- That clinical and economic evidence submitted is valid and comparable; that alignment with EU regulations ensures methodological soundness; and that the introduction of dedicated bodies improves transparency and objectivity in decision-making.
- Strengths
- Establishment of dedicated, independent bodies for pricing and reimbursement; compliance with EU regulatory standards; systematic evaluation of new INNs; growing institutional capacity for HTA.
- Limitations
- Lack of formal mechanisms for monitoring and reporting financial impacts annually; limited transparency in decision criteria; absence of comprehensive post-approval evaluation and financial tracking.
- Also known as
- NCPRMP framework, Bulgarian HTA framework, National Council on Prices and Reimbursement of Medicinal Products assessment method
Questions this answers
- › Is a new medicine eligible for reimbursement in Bulgaria?
- › What is the appropriate price for a medicinal product based on its clinical value and cost-effectiveness?
- › How does the medicine compare to existing treatments in terms of clinical benefit and economic impact?
- › Which new INNs have been approved for public funding in recent years?
- › How is HTA integrated into national pharmaceutical policy and decision-making?
- › Are pricing and reimbursement decisions aligned with EU standards?
References & sources
Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.