The entry of the biological medicinal products (BMPs) in the clinical practice more than 10 years ago raised complex regulatory issues as well as significant pharmacoeconomic concerns, because the costs of treatment is higher than the costs of the conventional products. The “data exclusivity” of BMPs expired and biosimilar medicinal products (BSMPs) are available on the market. The market share of BSMPs is expected to increase gradually and lead to cost reductions of biological treatment. Aim: To analyze the availability, affordability and drug utilization of BSMPs containing monoclonal antibodies in Bulgaria. Materials and methods: Retrospective study of the public data from EMA, National Council on Prices and Reimbursement and National Health Insurance Fund for 2015–2019. Descriptive statistical analysis was performed. Results and Discussion: On the ЕU level, BSMPs with Marketing Authorization are Adalimumab, Infliximab, Rituximab, Bevacizumab and Trastuzumab. In the Bulgarian Positive Drug List, there are 12 BSMPs with the same INN, excluding Bevacizumab. The total cost of BMPs is 691 673 158 BGN – the share of BSMPs is 34 139 639 BGN (4.7%). The access of BSMPs in Bulgaria is still very limited. BSMPs are available with the lower price, but the reference products are the preferred treatment. The reason for this could be the lack of national standards for the switching/interchangeability of BMPs with BSMPs, and the prescribers distrust of the so-called replacement therapies and aggressive drug promotion to the healthcare professionals are also of great importance.
Abstract:Over the recent years, there has been an alarming increase in the market penetration of the so-called "counterfeit" medicinal products in the European Union and worldwide. These products usually contain substandard (lower quality) or false ingredients, do not contain the necessary ingredients, or contain substances or active pharmaceutical ingredients, which are wrongly or incorrectly dosed. Bulgarian experience has shown that the counterfeit medicinal products enter the market not only through illegal channels, but are also distributed in and/or through lawful channels and distribution chains of medicinal products manufacturers (importers), wholesalers and retailers (pharmacies and drugstores). A special phenomenon is the distance selling of medicinal products, including on-line marketing (internet trade)-perhaps the riskiest way the counterfeit medicinal products reach the patients. Counterfeit medicinal products are one of the most significant threats to human health and their market penetration can lead to loss of confidence in the drug distribution systems and in the public health system as a whole.
Целта е да се анализират нежеланите лекарствени реакции (НЛР) при българска популация пациенти с възпалителни ставни заболявания, които отговарят на изискванията да провеждат лечение с биологични лекарствени продукти (БЛП). Описва се едноцентрово, обсервационно, открито, проспективно, неинтервенционално, фармакоепидемиологично проучване на клинични серии от слу- чаи на НЛР при българска популация пациенти с ревматоиден артрит (РА), анкилозиращ спондилит (AС) и псориатичен артрит (ПсА) на лечение с БЛП през периода март 2015 г.–октомври 2016 г. Проучването е осъществено по протокол и след подписано информирано съгласие. Пациентите про- веждат лечение със: etanercept, adalimumab, golimumab, certolizumab pegol, rituximab. Задължително ус- ловие е да няма предхождащо лечение с БЛП. Статистическите анализи са направени с пакет SPSS версия 16.0. Скринирани са 53 пациенти, 5 не отговарят на включващите критерии; 47 включени, от тях 5 отпадат в хода на проучването, анализирани 42. Разпределение по заболявания: РА – 40,5% (n = 17), ПсА – 19% (n = 8), АС – 40,5% (n = 17). Жени – 52% (n = 22), мъже – 48% (n = 20). При 76% от пациентите лечението е с adalimumab и etanercept. При 17% от пациентите (n = 7) биологичното лечение е спряно поради изява на сериозни НЛР, при 3 от тях – с 3-та степен на тежест, при 4 – с 4 степен. Най-голям относителен дял заемат НЛР със степен на тежест 1 и 2, като с 1 степен са 63%. Общият брой на съобщените и потвърдени НЛР е 160. От тях 3 НЛР отговарят на дефиници- ята за SUSAR; неочаквани – 30; подозирани – 127. Общата честота на НЛР в цялото проспективно проучване се измерва на 3,80 НЛР/пациент, като най-висок е този дял при АС – 4,35 НЛР/пациент. Установява се много висока честота на НЛР, несъответно по-висока в сравнение с предрегистра- ционните данни за анализираните БЛП. Най-честата причина за преустановяване на биологичната терапия при болните с възпалителни ставни заболявания е изявата на НЛР.
Aim: To analyze drug utilization and rational drug use in treatment of essential arterial hypertension in Bulgaria by using quantitative and qualitative parameters at national level. To assess generic penetration as a part of rational drug use. Materials and methods: Design: retrospective study of publicly accessible data from registries of National health insurance fund for the period January–December 2017. The analyses are in accordance with ATC/DDD methodology of WHO. The data was processed via descriptive statistical methods. Results: The analyzed population includes 185 671 patients with essential arterial hypertension—13.33% of all hypertensive patients. The expenses for 2017 are 9 796 940.12 BGN (Bulgarian leva; 1 Euro=1.95,585 BGN). The expense per patient per year is 52.76 BGN, monthly expense is 4.40 BGN and daily expense is 0.14 BGN. The sum of 9 796 940.12 BGN is divided into two groups—expenses for monoproducts 65.88% and expenses for combined products 34.12%. Blockbusters are INNs lercanidipine and nebivolol. The total expenses for uncomplicated essential arterial hypertension are 1.22% of the total expenses. With this resource, 1.6 DDD/Patient/Day is provided. Discussion: In Bulgarian therapeutic practice, the most prescribed products are beta-blockers nebivolol and bisoprolol, calcium antagonist lercanidipine, and centrally acting antiadrenergic agents rilmenidine and moxonidine. Sartanes are represented mainly by valsartan. In all section analyses, the considerable use of lercanidipine is evident. Reference (original) medicinal products are mainly prescribed, while the market share of generic products, both in terms of costs and DDD, is significantly lower. Obtained results are inconsistent with European recommendation, while lack of national pharmacotherapeutic guideline poses a serious challenge.
BackgroundThe role of the endothelium as an active player rather than a passive victim of inflammation has received considerable interest in systemic vasculitis 1. Local vascular inflammation can have distant effects on the systemic vascular system, leading to widespread endothelial cell dysfunction 2. Damage to endothelial cells and developed vascular endothelial dysfunction are crucial events during the pathogenesis of vasculitis. The mechanisms that drive such endothelial dysfunction are unclear but factors such as adhesion molecules, chemokines, inflammatory cells, and different cytokines may play a role. One of the adaptive responses to this injury is the migration of hemopoetic stem cells from the bone marrow to sites of endothelial injury under the control of serum cytokines and growth factors3.ObjectivesThe objectives of the study were to examine some serum markers of inflammation (adhesion molecules – sICAM-1, sPECAM; cytokines - IL-10, IL-8, TNFα) and activated T helpers and hemopoetic stem cells in patients with active vasculitis and healthy controls.MethodsWe performed a longitudinal study of 32 patients with vasculitis and 30 healthy age-matched controls. The group of vasculitis consisted of 18 patients with ANCA negative vasculitis, developed in the course of systemic connective tissue disease and 14 patients with ANCA-associated vasculitis. The vasculitis subtype was classified using the Chapel Hill Consensus Conference (CHCC) criteria and/or the American College of Rheumatology (ACR) classification criteria. Serum levels of sICAM-1, sPECAM, IL-10, IL-8, TNFα were measured by sandwich enzyme-linked immunosorbent assay (ELISA). For the detection of activated T helpers (CD3+CD4+CD69) and hemopoetic CD45+CD34+ stem cells we used flow cytometry. Statistical analyses were performed with SPSS 19.0, it was used unpaired and paired two sample Students's t-test.ResultsLevels of sPECAM and IL-8 were significantly higher in patients with vasculitis than in healthy controls (p=0.028, respectively p=0.002). We also found statistically significant increased percentage of CD3+CD4+CD69+ T helper cells in patients (p<0.001). No significant difference was found between both groups for TNFα, IL-10 and sICAM levels. The percentage of CD45+CD34+ hemopoetic stem cells was higher in healthy controls than in patients, as the difference was no significantly (p>0.05).ConclusionsWe have demonstrated changes in some biomarkers of inflammation in patients with active vasculitis. The study of different biomarkers provides an opportunity to investigate the pathogenesis of vascular inflammation, which could be used for clinical monitoring of vasculitis.ReferencesBacon P. Endothelial cell dysfunction in systemic vasculitis: new developments and therapeutic prospects. Curr Opin Rheum 2005, 17: 49-55.Buckley C. Endothelail cells, fibroblast and vasculitis. Rheumatology 2005, 44: 860-863.Clarke L et al. Endothelail injury and repair in systemic vasculitis of the young. Arth Rheum 2010, 62: 1770-1780.Disclosure of InterestNone declared
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