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Dostopnost do imunoonkoloških zdravil v izbranih evropskih državah
ID Kelher, Rok (Author), ID Kos, Mitja (Mentor) More about this mentor... This link opens in a new window, ID Locatelli, Igor (Comentor)

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Abstract
Imunoonkološka zdravila predstavljajo nov inovativen način zdravljenja, ki dinamično modulira in stimulira imunski sistem, tako da napade rakave celice. Takšen način zdravljenja se je izkazal kot učinkovit pri podaljšanju časa preživetja bolnikov. Njihova glavna slabost so visoke cene, kar predstavlja izziv umeščanja v zdravstveni sistem in s tem njihovo dostopnost do bolnikov. Namen naše naloge je ovrednotiti dostopnost bolnikov do registriranih imunoonkoloških zdravil v Sloveniji in izbranih evropskih državah med januarjem 2008 in decembrom 2019. Med izbrane države smo vključili Združeno kraljestvo, Nemčijo, Francijo, Avstrijo, Italijo, Madžarsko, Bolgarijo, Romunijo, Poljsko in Češko. Dostopnost smo ovrednotili s številom zdravil, kakšen je bil čas od njihove registracije pri EMA do njihove prve uporabe, kakšna je bila njihova poraba v prvem letu po dostopu na trg ter kakšni so bili izdatki za ta zdravila. Podatkovna baza o zdravilih, registriranih po centralnem postopku in njihovih indikacij je bila osnovana na podlagi podatkov pridobljenih s spletne strani EMA. Podatke o prodaji in porabi smo pridobili v podatkovni bazi MIDAS Quantum Monthly Sales Data, IQVIA. V širši nabor smo izbrali vsa onkološka biološka zdravila, v ožji pa izključno imunoonkološka, na katera smo se osredotočili. Ugotovili smo, da obstajajo velike razlike med samimi državami, kar izhaja iz različnih sistemov umeščanja zdravil in same kupne moči države. Največ imunoonkoloških zdravil v uporabi smo našli v Nemčiji s 16, Združenem kraljestvu 16 in Avstriji s 15 zdravili. Slovenija jih ima na voljo 11. Bolgarija jih ima najmanj, 7 zdravil. Te države imajo tudi najhitrejši čas do prve porabe v mediani, kot smo opazili pri Združenem kraljestvu 1 mesec, Nemčiji 2 meseca in Avstriji 2 meseca. Slovenija je imela opaženo mediano 9,5 mesecev. Najdaljšo vrednost mediane je imela Bolgarija, 23 mesecev. Z izjemo Združenega kraljestva je bila poraba zdravil največja v zahodnoevropskih državah. Francija je imela v prvem letu po dostopu porabo 0,770 standardne enote na novo obolelega, Avstrija 0,701 standardne enote ter Nemčija 0,444 enote. Slovenija je imela v primerjavi veliko porabo z 0,383 standardne enote. Najnižjo porabo smo zasledili v Romuniji z 0,05 standardne enote. Največjo prodajo na debelo v letu 2018 smo zasledili v Avstriji s 3820 EUR na novo obolelega, v Franciji s 1921 EUR, Nemčiji s 1908 EUR. Najnižjo prodajo je imela Poljska s 418 EUR. Slovenija je imela vrednost prodaje na debelo 844 EUR na novo obolelega. Relativno razmerje prodaje na standardno enoto je bilo največje v Avstriji z 1,38 v primerjavi z Nemčijo, 1,35 za Češko in 1,31 za Poljsko. Najmanjše razmerje je imela Slovenija z 0,8. Slovenija po času do prve porabe imunoonkoloških zdravil sodi bližje k vzhodnoevropskim državam, po porabi zdravil in sredstev pa sodi k zahodnoevropskim državam.

Language:Slovenian
Keywords:Ključne besede: imunoterapija, imunoonkologija, dostop do zdravil
Work type:Master's thesis/paper
Organization:FFA - Faculty of Pharmacy
Year:2021
PID:20.500.12556/RUL-127274 This link opens in a new window
Publication date in RUL:01.06.2021
Views:1128
Downloads:178
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Secondary language

Language:English
Title:Access to immuno-oncology medicines in selected European countries
Abstract:
Immuno-oncological medicines have emerged as a new innovative way of treatment, which modulates and stimulates patient's own immune system to target cancer cells. This kind of treatment has been proven to effectively prolong patient's survival time. The main drawback of immune-oncological medicines is their high price tag. This presents a major challenge to established health systems and consequently patient access. The aim of this study is to evaluate patient access to registered immune-oncological medicines in Slovenia and other selected European countries between January 2008 and December 2019. The following countries were included, United Kingdom, France, Austria, Germany, Italy, Hungary, Czech Republic, Bulgaria, Poland and Romania. Patient access was assessed by number of medicines available for use in each country, time difference from EMA authorisation to first available use, consumption of medicines in the first year from their first available use and their value of sale. Selected medicines and their indications were based on data available on EMA website, their sales value and consumption data were obtained in MIDAS Quantum Monthly Sales Data database, IQVIA. The selected medicines were studied in two groups. The larger group included all types of oncological-biological medicines, the smaller included exclusively immuno-oncological medicines, which were the primary focus of this study. The results revealed significant differences that exist between different European countries, which stem from various reimbursement and health system policies along with financial opportunities of selected countries. The highest number of immuno-oncological medicines in continuous use were detected in Germany with 16 medicines, United Kingdom also 16 and Austria with 15. Slovenia has 11 medicines available. Bulgaria on the other hand has only 7 medicines. These western European countries also had the fastest enabling median time to continuous use. United Kingdom with 1 month, Germany with 2 months, Austria with also 2 months. Slovenia in comparison had an observed median of 9,5 months. The longest median was observed in Bulgaria with 23 months. Excluding United Kingdom, the highest consumption of medicines and expenditure was also observed in these countries, including Slovenia. The highest medicine consumption in the first 12 months after first continuous use was observed in France with 0,779 standard units per each new cancer case, followed by Austria with 0,701 standard units and Germany with 0,444 units. Slovenia in comparison had high consumption with 0,383 standard units. The lowest consumption was observed in Romania with 0,05 standard units. The largest wholesale value was observed in Austria with 3820 EUR per each new cancer case, France with 1921 EUR and Germany with 1908 EUR. The lowest was observed in Poland with 418 EUR. Slovenia had a value of 844 EUR per each new cancer case. The relative value of standard units, with reference to Germany (in EUR) was highest in Austria with 1,38; 1,35 in Czech Republic and 1,31 in Poland. Slovenia in comparison to selected European countries has the median time to first use comparable to Eastern European countries, however, consumption and expenditure were closer to Western European countries.

Keywords:Key words: immune-oncology, immunotherapy, patient access to medicines

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