Reimbursed orphan medicines in Bulgaria and the share of biotechnology-derived products

Manova, Manoela and Stoimenova, Assena and Savova, Alexandra and Angelovska, Bistra and Petrova, Guenka (2012) Reimbursed orphan medicines in Bulgaria and the share of biotechnology-derived products. Biotechnology & Biotechnological Equipment, 25 (2). pp. 2418-2423. ISSN 1310-2818

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Abstract

Rare diseases are life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European
Union. Most of the people suffering from rare diseases are actually affected by less frequently occurring diseases affecting one
in 100,000 people or fewer. Almost 80% of the rare diseases have identified genetic origins and lots of them are treated with
biotechnology-derived medicinal products. The aim of our study was to evaluate the access to orphan medicines in Bulgaria
based on the analysis of the Positive Drug List (PDL) and the share of biotechnology-derived products reimbursed for rare
diseases in Bulgaria. Only 21 out of 56 medicines with European orphan designation and European marketing authorisation
are available and funded in Bulgaria. 29% of them are biotechnology-derived. Another 17 (out of 47) orphan medicines with
European marketing authorisation and without prior orphan designations in the EU are reimbursed and 59% of them are
biotechnology-derived. Thus approximately just 37% of the orphan medicines (both with and without prior orphan designation)
are available and funded in Bulgaria. Evidently the centralised marketing authorisation is not supported by the national regulatory
requirements for price setting and inclusion into the PDL, which are necessary for guaranteeing medicines availability on the
national market. The regulators and payers still do not ensure balance between the needs of patients and resources allocation.

Item Type:	Article
Subjects:	Medical and Health Sciences > Health biotechnology
Divisions:	Faculty of Medical Science
Depositing User:	Bistra Angelovska
Date Deposited:	31 Jan 2013 10:03
Last Modified:	25 Apr 2014 09:35
URI:	https://eprints.ugd.edu.mk/id/eprint/1839

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