Drug Policy in Bulgaria

Dimova, Antoniya; Rohova, Maria; Atanasova, Elka; Kawalec, Paweł; Czok, Katarzyna

doi:10.1016/j.vhri.2017.08.001

Cited by 11 publications

(10 citation statements)

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“…Health technology assessment is developing rapidly in Central and Eastern Europe (CEE): e.g. in Bulgaria, Czechia, Hungary and Croatia [1–4]. In Poland, it is compulsory when applying for drug reimbursement [5].…”

Section: Introductionmentioning

confidence: 99%

Valuation of EQ-5D-5L Health States in Poland: the First EQ-VT-Based Study in Central and Eastern Europe

Golicki

Jakubczyk

Graczyk³

et al. 2019

PharmacoEconomics

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ObjectiveCost-utility analyses are becoming increasingly important in Central and Eastern Europe. We aimed to develop a Polish utility tariff for EQ-5D-5L health states.MethodsFace-to-face, computer-assisted interviews were collected in a representative sample. Each respondent followed a standardised protocol to collect ten composite time trade-off and seven discrete choice experiment observations. In the Bayesian approach, several model specifications were compared based on model fit, the usability of the final value set and how they reflect the elicitation procedure (e.g. censoring). A hybrid approach (using composite time trade-off and discrete choice experiment data) was employed in the final set, which was compared with the existing ones: EQ-5D-3L and EQ-5D-5L cross-walk.ResultsData from 1252 respondents (11,480 composite time trade-off valuations and 8764 discrete choice experiment pairs) were collected over the period June to October 2016. The final model accounted for random parameters, error scaling with fat tails, censoring at − 1, unwillingness to trade in time trade-off by the religious people and Cauchy distribution in discrete choice experiments. Pain/discomfort impacts the utility most: the disutility equals 0.575 when at level 5. In the value set, 4.4% of EQ-5D-5L states are worse than dead. The new value set has a comparable range (minimum of − 0.590 compared to − 0.523) and the same ordering of the first three dimensions (pain/discomfort, mobility, self-care) as the EQ-5D-3L value set and the EQ-5D-5L cross-walk value set. Moreover, it is more sensitive to a moderate decline in health.ConclusionsThe new value set supports consistency with past decisions in cost-utility studies, while offering a better assessment of even moderate improvements in health. It could represent an option for Central and Eastern Europe countries lacking their own value sets.Electronic supplementary materialThe online version of this article (10.1007/s40273-019-00811-7) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

Valuation of EQ-5D-5L Health States in Poland: the First EQ-VT-Based Study in Central and Eastern Europe

Golicki

Jakubczyk

Graczyk³

et al. 2019

PharmacoEconomics

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“…In Finland, the national authorities set the ex-factory prices of OTC medicines, and these prices must be the same for all pharmacies and online [ 23 ]. In Bulgaria, the maximum retail prices are subject to registration by the National Council on Prices and Reimbursement of Medicinal Products (NCPRMP), and no other external price reference system is used as explained in Dimova et al [ 24 ]. Finally, the retail maximum prices of OTC medicines in Latvia are set by a process that involves the manufacturer, and the marketing authorization holders (MAH), details about the pricing process can be found in Silins and Szkultecka-Dębek [ 25 ].…”

Section: Resultsmentioning

confidence: 99%

A quantitative classification of OTC medicines regulations in 30 European countries: dispensing restrictions, distribution, pharmacy ownership, and pricing systems

Vila

Buts

Jegers

2023

J of Pharm Policy and Pract

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Background This paper reviews the regulations of over-the-counter (OTC) medicines in 30 European countries with the goal of identifying the regulatory trends and clusters as of May 2022. Methods To that end, we reviewed the regulation that directly or indirectly might have an impact on OTC medicines. The data were gathered from the national legislation, reports from international organizations, and the existent literature. The 12 regulatory items obtained were classified into four categories: price, pharmacy ownership, distribution modes, and dispensing restrictions. In addition, these items were also employed in the cluster analysis. Results Pharmacy ownership is mainly private, and in the majority of countries, OTC medicines are not subject to any pricing system. Almost every country studied allows online selling of OTC medicines, and 16 countries allow non-pharmacy retail to sell OTC medicines as well. The dispensing restrictions applicable in pharmacy retail are similar in the countries studied: they rely on the staff, OTC medicines are placed behind the counter and the doses dispensed tend to be restricted. Concerning non-pharmacy retail, additional dispensing restrictions might be imposed, such as the establishment of buyers’ minimum age, the requirement of a pharmacist to supervise the operations, a regulation on the location in the store, and further restrictions on the package sizes, strength, or pharmaceutical form. The cluster analysis resulted in an initial division between countries that widely allow the sale of OTC medicines in non-pharmacy retail and countries, where pharmacy retail has an OTC monopoly. Based on the regulations, 7 subsequent groups were identified evidencing wide regulatory heterogeneity within the countries studied. Conclusions Our findings point out that OTC medicines are in general not subject to pricing systems, selling is allowed online, and ownership of pharmacies is mostly private. However, regarding dispensing restrictions, pharmacy chains, and establishment restrictions of pharmacies, we found heterogeneity that is also visible in our cluster analysis, since we identified 7 clusters.

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“…18 This macro-costing approach possess some limitations because it focuses only on the pharmacotherapy cost and does not include any other costs, due to their unavailability in the country of such an information at central level. [19][20][21][22][23][24][25][26] The other limitation is the lack of data at patient level, as well number of packages sold for the whole period. This limits some of the calculations.…”

Section: Discussionmentioning

confidence: 99%

Availability and reimbursement of biological products for severe asthma in Bulgaria

2020

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Objectives: This study aims to analyze the reimbursement and cost of biological therapy for severe asthma in Bulgaria during 2014–2019 from the perspective of the National Health Insurance Fund. Methods: It is a retrospective, Marco-costing, top-down study of the expenditures for biological products for severe asthma. The changes in the cost paid by the National Health Insurance Fund per year, per product, and per patient during 2015–2020 were systematized and calculated. The utilization of biologicals was analyzed by calculating the defined daily dose/1000inh/day. Three databases were searched—the European Medicines Agency for the date of marketing authorization of biological products, National Council of Prices and Reimbursement for the date of their respective inclusion in the positive drug list, and National Health Insurance Fund about the number of patients with asthma, reimbursed sum for all asthma patients, and number of packages sold of biological products. Results: At the end of 2019, five international non-proprietary names of biologicals with indication for severe asthma had received European marketing authorization, and three of them were included in the Bulgarian positive drug list—omalizumab, mepolizumab, and benralizumab with a 75% reimbursement. Upon their introduction into the positive drug list, the reimbursed expenditures for asthma therapy started to increase from 27 million in 2014 to 33 million BGN in 2019 (€13.5–€16.5 million). The cost of therapy with biologicals rose from 16% to 24% of all anti-asthmatic medicines budget. The National Health Insurance Fund database reported that between 47,000 and 52,000 of patients with asthma, 466 are on biological therapy. The yearly cost of one asthma patient ranges between 512 and 615 BGN (€258–€307), and the yearly per-patient cost of severe asthma is 16,666 BGN (appr. €8333). Total utilization in defined daily dose/1000inh/day increases from 0.0199 to 0.0383 from 2015 to 2019. Conclusion: The access to biological therapy through the reimbursement system has improved during the last 3 years. The cost of therapy is posing a high burden on the National Health Insurance Fund and on the patients and is expected to increase due to the small number of patients on biological therapy currently in comparison to all reimbursed asthmatics.

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Drug Policy in Bulgaria

Cited by 11 publications

References 0 publications

Valuation of EQ-5D-5L Health States in Poland: the First EQ-VT-Based Study in Central and Eastern Europe

Valuation of EQ-5D-5L Health States in Poland: the First EQ-VT-Based Study in Central and Eastern Europe

A quantitative classification of OTC medicines regulations in 30 European countries: dispensing restrictions, distribution, pharmacy ownership, and pricing systems

Availability and reimbursement of biological products for severe asthma in Bulgaria

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