Historical overview of regulatory framework development on pricing and reimbursement of medicines in Bulgaria.
Expert Rev Pharmacoecon Outcomes Res
; 19(6): 733-742, 2019 Dec.
Article
en En
| MEDLINE
| ID: mdl-30900482
ABSTRACT
Objectives:
The current study aims to analyze, from a historical perspective, the regulatory framework of prices and reimbursement in Bulgaria with emphasis on the introduction of economic evaluation.Methods:
The study explores all regulatory changes during the period 1995-2016 combining the macroeconomic and regulatory analysis on medicines pricing and reimbursement. A roadmap summarizing the current regulatory requirements for the medicinal product entrance on national market and access to public funding was elaborated.Results:
Demographic processes in the country have been negative for the past decade. On the other hand, health care and pharmaceutical expenditures experienced a growth up to 8.6% and 3% of total GDP, respectively. The total pharmaceutical market permanently grew from 309 to 1409 million of Euro. During the last 20 years, the pricing and reimbursement legislation of medicines in Bulgaria was changed extensively.Conclusion:
Pricing policy remains oriented toward the lowest European prices and reimbursement policy impose cost containment measures. Appraisal of the obligatory Health Technology Assessment Dossiers and pharmacoeconomic analysis is in accordance with world recommendations. Main regulatory issues that still remain to be tackled are the slower entrance of medicines on the national market and lower national prices that often lead to parallel import.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
Problema de salud:
1_financiamento_saude
/
1_medicamentos_vacinas_tecnologias
Asunto principal:
Mecanismo de Reembolso
/
Costos de los Medicamentos
/
Economía Farmacéutica
/
Costos y Análisis de Costo
Tipo de estudio:
Health_economic_evaluation
/
Health_technology_assessment
/
Prognostic_studies
Límite:
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
Expert Rev Pharmacoecon Outcomes Res
Asunto de la revista:
FARMACOLOGIA
Año:
2019
Tipo del documento:
Article
País de afiliación:
Bulgaria