Economic consequences of mandatory price re-registration for medicines from the high-cost nosology program

The Government Decree, approved in December 2019, required registration certificates holders of reference drugs, included in the essential drug list (EDL), submit applications for mandatory price re-registration. Drugs included in the high-cost nosology list (high-cost list) must be included in the EDL.Objective: to assess the budget impact of price re-registration for high-cost list drugs.Material and methods. The comparing economic analysis of high-cost nosology program before and after price re-registration based on the Government Decree N 1683 (effective from 16.12.2019). 125 reference stock keeping units (SKUs), included in the high-cost list, were evaluated.Results. The analysis showed, that after re-registration the prices of 66 SKUs will remain the same. The prices of 43 reference SKUs will be reduced after setting a single maximum selling price («equalization»). Prices for 16 SKUs will be reduced due to lower registered prices in the reference countries. Considering the contracts executed in 20192020, the budget of the high-cost program is up to 74.430 billion rubles, and after re-registration it will be equal to 64.162 billion rubles, so the savings will amount 10.267 billion (13.8 %). The main drivers of re-registration prices savings are: Advagraf (1.175 billion rubles), Elizaria (2.083 billion rubles) and Revlimid (2.247 billion rubles). Separately, we analyzed the consequences ofprices re-registration in the V-thgroup ofhigh-cost list, which are provided topatients with malignant neoplasms of lymphoid, hematopoietic and related tissues. It was calculated, that in 2019 the contracts for V-th group of high-cost list were signed for 19.217 billion rubles, and after the price re-registration for the purchase of the same number of drugs 16.762 billion rubles will be spent, so the savings from the price re-registration will amount to 2.455 billion rubles (12.8 %), among which 2.247 billion rubles will be provided by price re-registration of Revlimid.Conclusions. The pricing policy implemented in the Russian Federation is aimed at increasing the availability of highly effective medical care to the population of the Russian Federation and significantly reduces the burden on the budget of the healthcare system

Фармакоэкономика спастических форм детского церебрального паралича

Cerebral palsy (CP) is one of the most widespread and socially significant neurological diseases that affect both various aspects of physical and psychoverbal development of children since birth and stages of their personal development and adaptation in society. Over the last years there has been an increase in the number of children with disabilities in Russia, and it should be noted that CP ranks first among neurological disabilities in children. Given the lifetime course of this disease, CP acquires a huge medical and socioeconomic relevance. In particular, it is necessary to use the most efficient medical technologies (from the point of view of both efficacy, safety and costs). Pharmacoeconomic analysis is the most suitable tool for solving these tasks. However, when performing pharmacoeconomic analysis in the field of cerebral palsy, as well as in any other disease area, it is obligatory to take into account certain peculiarities at the planning and implementation stages. The authors of the article have identified specific features of pharmacoeconomic analysis methods based on assessment of health technologies related to cerebral palsy.Детский церебральный паралич (ДЦП) - одно из наиболее распространённых и социально-значимых неврологических заболеваний, влияющих как на различные аспекты физического и психического развития детей с самого рождения, так и на этапы их личностного становления и дальнейшей адаптации в социуме. В последние годы в Российской Федерации отмечается рост детской неврологической инвалидности, первое место в ее структуре занимает детский церебральный паралич. Учитывая пожизненное течение данного заболевания, оно приобретает огромное как медицинское, так и социальноэкономическое значение. В частности, необходимо использовать наиболее рациональные (как с точки зрения эффективности и безопасности, так и с точки зрения затрат) для сложившихся условий технологии здравоохранения. Наиболее подходящим для решения этих задач инструментом является фармакоэкономический анализ. При этом проведение данного вида исследований в области ДЦП, равно как и в любой другой нозологии, сопряжено с необходимостью учета определённых особенностей на этапах планирования и реализации исследования. В данной статье авторами были выделены особенности методики проведения фармакоэкономического анализа в рамках оценки технологий здравоохранения в области ДЦП

Pharmacoeconomics of spastic cerebral palsy

Cerebral palsy (CP) is one of the most widespread and socially significant neurological diseases that affect both various aspects of physical and psychoverbal development of children since birth and stages of their personal development and adaptation in society. Over the last years there has been an increase in the number of children with disabilities in Russia, and it should be noted that CP ranks first among neurological disabilities in children. Given the lifetime course of this disease, CP acquires a huge medical and socioeconomic relevance. In particular, it is necessary to use the most efficient medical technologies (from the point of view of both efficacy, safety and costs). Pharmacoeconomic analysis is the most suitable tool for solving these tasks. However, when performing pharmacoeconomic analysis in the field of cerebral palsy, as well as in any other disease area, it is obligatory to take into account certain peculiarities at the planning and implementation stages. The authors of the article have identified specific features of pharmacoeconomic analysis methods based on assessment of health technologies related to cerebral palsy

МЕТОДОЛОГИЧЕСКИЕ ОСНОВЫ ИСПОЛЬЗОВАНИЯ МЕТОДА «СТАНДАРТНЫХ РИСКОВ» ПРИ ОЦЕНКЕ КАЧЕСТВА ЖИЗНИ В ФАРМАКОЭКОНОМИЧЕСКИХ ИССЛЕДОВАНИЯХ

Utility assessment is one of the most important stages of pharmacoeconomic analysis. Most of utility researches are conducted using standard gamble method which is considered the classic instrument of health state utilities assessment. This article presents a methodology of conducting researches using standard gamble. The problems and features of the interpretation of the results are covered, examples of research using props, as well as computer programs that calculate the values of the utility automatically are described.Оценка полезности является одним из важнейших этапов фармакоэкономического анализа. Большая часть исследований полезности проводится с использованием метода «стандартных рисков», считающегося классическим видом оценки полезности состояний здоровья. Данная статья представляет основу методологии проведения исследования с использованием метода «стандартных рисков». Раскрыты проблемы и особенности интерпретации полученных результатов, представлены примеры исследования с использованием наглядных пособий, а также компьютерных программ, рассчитывающих значения полезности в автоматическом режиме