Reimbursed Orphan Medicines in Bulgaria and the Share of Biotechnology-Derived Products

Stoimenova, А.; Manova, Manoela; Savova, Alexandra; Angelovska, Bistra; Petrova, Guenka

doi:10.5504/bbeq.2011.0043

Cited by 5 publications

(6 citation statements)

References 16 publications

(22 reference statements)

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“…Several authors studied the access of Bulgarian patients to orphan medicines (16,22,27). Some of them compared Bulgaria with other countries such as Serbia and Sweden, other analyzed the access to particular orphan medicines for a given period of time.…”

Section: Final Remarksmentioning

confidence: 99%

A Cross-Country Comparison of Reimbursed Orphan Medicines in Bulgaria, Greece and Romania

Kamusheva

Stoimenova

Doneva

et al. 2013

Biotechnology & Biotechnological Equipment

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Section: Final Remarksmentioning

confidence: 99%

A Cross-Country Comparison of Reimbursed Orphan Medicines in Bulgaria, Greece and Romania

Kamusheva

Stoimenova

Doneva

et al. 2013

Biotechnology & Biotechnological Equipment

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“…Even high-income countries developed a special status for funding ultra-orphan medicines with less scrutiny of cost-effectiveness criterion [22]. Evidence suggests that patients have more limitations in accessing orphan medicines in CEE countries [23,24].…”

Section: Objective #2: Equity In Healthmentioning

confidence: 99%

Benefits of investment into modern medicines in Central–Eastern European countries

Inotai¹,

Petrova

Vitezić

et al. 2013

Expert Review of Pharmacoeconomics & Outcomes Research

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Transferability of current evidence and expressing value of innovative pharmaceuticals according to health system objectives Due to the scarcity of healthcare resources, decision-makers often expect monetary benefits--including cost savings or productivity gain--from innovative medicines. Manufacturers try to fulfill this expectation by expressing the benefits of innovative technologies in monetary units citing approaches from the scientific literature. Unfortunately, currently available evidence has limited relevance and transferability in Central-Eastern European (CEE) countries. This study aims to summarize how innovative pharmaceuticals in CEE countries may contribute to WHO-defined health system objectives, including health gain, equity in health, financial protection, responsiveness, equity in finance and financial sustainability. References in this study are also mainly based on international examples; therefore, additional policy research from CEE countries is necessary to validate assumptions. If CEE politicians can rely on credible arguments based on local research evidence, they may improve long-term strategies and policy decisions related to healthcare innovation.

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“…The definitions for rare diseases vary across the regions, but the major classification criterion is associated with the number of affected patients: not more than 5 in 10,000 in the European Union and in Canada and fewer than 200,000 people in the USA (Stoimenova et al, 2011 ; Chicevaliev and Aleksovska, 2016 ; Lacoste, 2018 ). Despite the limited number of individuals affected by a particular rare disease the total number of patients represents a significant percent (Schieppati et al, 2008 ).…”

Section: Introductionmentioning

confidence: 99%

Comparative Analysis of Legislative Requirements About Patients' Access to Biotechnological Drugs for Rare Diseases in Central and Eastern European Countries

et al. 2018

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Objectives: The aim of the study was to compare the access of patients with rare diseases (RDs) to biotechnological drugs in several Central and Eastern European countries (CEECs). We focused on the legislative pricing and reimbursement requirements, availability of biotechnological orphan medicinal products (BOMPs) for RDs, and reimbursement expenditures.Methods: A questionnaire-based survey was conducted among experts from 10 CEECs: Bulgaria, Croatia, Estonia, Greece, Hungary, Poland, Romania, Slovakia, Serbia, and Macedonia. The legal requirements for reimbursement and pricing of BOMPs were collected. All BOMPs and medicines without prior orphan designations were extracted from the European list of orphan medicinal products, 2017. The reimbursement status of these medicinal products in 2017 in the public coverage of the included CEECs as well as the share of their costs in relation to the total public pharmaceutical spending for the period from 2014 to 2016 were defined.Results: Our survey revealed that some differences in the legal requirements for pricing and reimbursement of BOMPs amongst the countries included in the study. All European Union countries have developed and implemented pharmacoeconomic guidelines with or without some specific reimbursement requirements for orphan medicinal products. Cost-effectiveness analysis, cost-utility analysis, Markov models, meta-analysis, and discount levels of costs and results were required only in Bulgaria, Poland and Hungary. The number of reimbursed BOMPs and biotechnological medicinal products for RDs without prior orphan designation was the highest in Hungary (17 and 40, respectively). Patient-based reimbursement schemes were available only in Hungary for 11 out of 17 BOMPs. Poland and Greece have the highest pharmaceutical expenditure of reimbursed BOMPs with are ~214 million and 180 million EUR, respectively in the observed period from 2014 to 2016. High proportion of the pharmaceutical expenditure on the reimbursed biotechnological medicinal products for RDs for the observed period 2014–2016 is presented in Bulgaria and Slovakia.Conclusions: The non-European Union CEECs face a significant delay in the legal implementation of pharmacoeconomic guideline for assessment of BOMPs. The access to BOMPs is similar among the observed CEECs and the countries with the best access are Hungary and Greece. The influence of BOMP expenditures on the budget in the individual countries is significant.

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Reimbursed Orphan Medicines in Bulgaria and the Share of Biotechnology-Derived Products

Cited by 5 publications

References 16 publications

A Cross-Country Comparison of Reimbursed Orphan Medicines in Bulgaria, Greece and Romania

A Cross-Country Comparison of Reimbursed Orphan Medicines in Bulgaria, Greece and Romania

Benefits of investment into modern medicines in Central–Eastern European countries

Comparative Analysis of Legislative Requirements About Patients' Access to Biotechnological Drugs for Rare Diseases in Central and Eastern European Countries

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