Биоподобни лекарствени продукти в ЕС и предизвикателствата при пускането им на пазара // Biosimilar medicinal products in the EU and the challenges in placing them on the market
Зареждане...
Дата
2023
Автори
Бончева, Елка Цанева // Boncheva, Elka Tsaneva
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ISSN на списанието
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Издател
Медицински университет - София // Medical University - Sofia
Резюме
ЦЕЛ И ЗАДАЧИ НА ИЗСЛЕДВАНЕТО
Цел:
Настоящото изследване има за цел да проучи и анализира регулаторните изисквания за пускане на пазара на биоподобни ЛП и как те повлияват достъпа до терапия, както и да направи анализ на влиянието на пускането на пазара на биоподобните ЛП върху разходите за лекарствена терапия, заплатени от НЗОК за лечение на онкохематологични заболявания - фоликуларен лимфом (ФЛ), дифузен В-едроклетъчен лимфом (ДБЕКЛ) и хронична лимфоцитна левкемия (ХЛЛ).
Задачи.
За постигане на поставената цел са определени следните задачи:
1) Определяне на основните регулаторните изисквания, касаещи разрешаването за употреба, принципите на ценообразуване и реимбурсиране, както и пускането на пазара на биоподобните ЛП в ЕС и в България.
За постигането на посочената задача са поставени следните подзадачи:
* Преглед на общата политика на ЕС относно разрешаване за употреба, ценообразуване и реимбурсиране на биоподобните ЛП, както и на актуалните регулаторни изисквания, определящи пускането им на пазара в България;
* Сравнителен анализ на методите на ценообразуване и пускане на пазара на биоподобните ЛП в България и в референтните за България държави.
2) Систематизиран преглед на пазара на биоподобни ЛП в ЕС и в България чрез следните подзадачи:
* Анализ на одобрените и пуснати на пазара биоподобни ЛП в България;
* Анализ на влиянието на пускането на пазара на биоподобните ЛП в референтните държави върху цената на ЛП с INN Rituximab в България за периода 2017 – 2021 г.;
* Ретроспективен анализ на определената в Приложение № 2 на ПЛС референтна стойност за ЛП с INN Rituximab за периода 2017 – 2021 г.
3) Оценка на пускането на пазара на биоподобните ЛП върху разходите на НЗОК чрез:
* Анализ на общите разходи на НЗОК за лекарствена терапия на ФЛ, ДБЕКЛ и ХЛЛ за периода 2018 – 2021 г.;
* Анализ на разходите на НЗОК за лекарствена терапия на ФЛ, ДБЕКЛ и ХЛЛ с
референтния и биоподобните ЛП за периода 2018 – 2021 г.;
* Анализ на пазарния дял на биоподобните ЛП за периода 2018 – 2021 г.
4) Оценка на влиянието на нормативните изисквания върху достъпа до пазара на
биоподобни ЛП.
//
SUMMARY.
The present work examines an issue that is relevant both at the national and European level, given the continuously increasing healthcare costs due to the observed demographic trends of population aging and increasing morbidity on the one hand, and scientific progress in the medical sciences on the other. The elaboration of the present work has shown to what extent the expectation of "reducing costs for medication and increasing patient access to treatment" after the launch of biosimilars is valid for Bulgaria. Analyzing costs for specific diseases in detail and determining their dependence on regulatory requirements in Bulgaria in such an extent after the launch of biosimilars monoclonal antibodies for hospital use has not been conducted. The available so far comparative analyzes of the legislation regarding the market placement of biosimilars in different countries of the region do not provide a clear picture and quantitative dimension of the penetration of biosimilars in oncology from the payer point of view, in this case the NHIF. For this purpose, the main characteristics of biosimilar medicines from their development to their release on the market have been examined and discussed. The subsequent analysis of the legislation identifies the milestones that are key to market access for biosimilars. To the extent that production and market authorization are regulated and controlled at the Community level by the EMA, the focus is on the processes of pricing and effective reimbursement, which prove to be key to the accessibility to the market of biosimilars in the given country. Once providing opportunities for better health is a top priority for all health policymakers, the development of rules on price regulation and the inclusion of biosimilars in the social and health insurance system should ensure a balance between all market players. The analysis of the regulatory requirements in Bulgaria and the reference countries showed that all administrative mechanisms guaranteeing a reduction in the prices of prescription drugs are applied in Bulgaria, namely: external price referencing and its periodic application, normatively determined ratio between the price of the reference and the biosimilar MP, as well as internal price referencing. In addition to this, public procurement for medicines for hospital use is performed at two stages - at the central level through the CPB and at the level of a medical establishment. As far as all the listed mechanisms have been proven to lead to a significant reduction in the value of drug therapy, which in turn determines the saving of funds and their redirection for other therapies or activities, their unjustified combined application in the long term can disrupt the optimal functioning of the health system as a whole. The case study discussed with the entry of biosimilar Rituximab in oncohematology, clearly delineates the trends and factors that determine the actual market penetration of biosimilars in three distinct diseases where different numbers of therapeutic alternatives are available. A decrease in the funds paid by the NHIF for drug therapy with MP with INN Rituximab was also observed when biosimilars with INN Rituximab were included in Annex No. 2 of the PDL. It has been found that reductions in the drug therapy cost and savings are achieved in the absence of a therapeutic alternative. Offsetting the increased costs of the introduction of innovative therapies is achieved with a limited number of therapeutic alternatives on the market, which are gradually displacing drugs with well-established use in medical practice. As the cost-effectiveness and, accordingly, the added health benefits of the individual therapeutic alternatives were not evaluated when considering the costs of drug therapy, it is not correct to categorically talk about savings in the long term. It was also found that, despite the positive impact on drug therapy costs, the possibility of establishing a monopoly position after only one biosimilar MP remains on the market puts patient treatment at risk in the event of a shortage or supply disruption. This would be a problem especially when MP is included not only in main treatment regimens but also in combination with innovative therapies. The presented results can serve as a starting point for a change in the legislation in a direction not only aimed at the financial resources of the healthcare insurance system, but also to place the individual patient and his needs at the center of the healthcare system by guaranteeing accessibility to the necessary therapy. Ensuring sustainable access to drug therapy is a necessity directly related to ensuring the health well-being of the population.