Health technology assessment of biotechnology medicines with focus on hospital pharmacy

International Journal of Biotech Trends and Technology (IJBTT)
© 2020 by IJBTT Journal
Volume - 10 Issue - 2                          
Year of Publication : 2020
Authors : Svetla Georgieva, PhD
DOI :  10.14445/22490183/IJBTT-V10I2P603


MLA Style:Svetla Georgieva, PhD"Health technology assessment of biotechnology medicines with focus on hospital pharmacy" International Journal of Biotech Trends and Technology 10.2 (2020): 16-19.

APA Style:Svetla Georgieva, PhD(2020). Health technology assessment of biotechnology medicines with focus on hospital pharmacy. International Journal of Biotech Trends and Technology, 10(2), 16-19.


The study aims to present a general overview of the process of HTA for biotechnology medicines in Bulgaria with special emphasis on hospital practice. It is a regulatory and desktop analysis. We studied the current regulation for HTA of new medicines in Bulgaria for special requirements towards biotechnology medicines for hospital use. A review of the scientific literature on the topic was also undertaken for articles from Bulgarian authors in the field. HTA in the Bulgarian regulatory practice was introduced in 2015 with changes in the Drug Law. The law necessitated that the National Pricing and Reimbursement Council had to perform a HTA of new medicines for the purposes of their inclusion into the Positive Drug List. Our study identified 30 articles, and out of them 17 meeting the inclusion criteria. Those studies could be separated in three therapeutic areas – diabetes, oncology, rare diseases therapy. In the above mentioned areas, newly introduced biotechnology medicines prevail and part of them are originator, others are generic medicines. The process of HTA did not differ between synthetic or biotechnology medicines in Bulgaria. Listing and inclusion into the positive drug list is separated between medicines for ambulatory and hospital settings. Hospital pharmacies should develop rules for internal evaluation of the new technologies from the point of view of the hospital budget.


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health technology assessment, biotechnology medicines, hospital practice, hospital pharmacy