Abstract
The orphan drugs development is related to the progress of personalized medicine. The relationship between them is based on a treatment tailored to personalized patient needs. Personalized medicine is defined as “providing the right patient with the right drug, at the right dose and at the right time”, while the orphan drug is defined as “intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United States” and no more than 10,000 people for the European Union. The main goal of the article is to study the approved orphan drugs in Bulgaria, determining how many of them are reimbursed by the NHIF and are cost-effective
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