Gibanje cen izbranih onkoloških zdravil na slovenskem trgu med letoma 2006 in 2017

Žgajnar, Damjan (avtor), Locatelli, Igor (mentor), Janžič, Andrej (komentor)

Rak je zelo razširjena bolezen z visokimi stroški zdravljenja in velikim številom smrti. Samo v letu 2014 je bilo v Evropi zaradi raka skoraj 1,3 milijona smrti, zaradi česar se je ta bolezen uvrstila na drugo mesto po smrtnosti. Poleg smrtnosti je tudi incidenca raka zelo visoka. Posledično so stroški zdravljenja primerno visoki in se višajo. V letu 1995 so bili stroški zdravljenja raka v Evropi 35,7 milijarde EUR, do leta 2014 pa so se povzpeli že na 83,2 milijarde EUR. Od tega je bilo za onkološka zdravila porabljeno 19,1 milijarde EUR. Namen našega dela je opisati in analizirati gibanja cen tistih onkoloških zdravil, ki imajo na slovenskem trgu dve ali več zdravil z isto učinkovino v časovnem obdobju med letoma 2006 in 2017. Izbranim zdravilom bomo analizirali trende gibanj cen ter poskušalo najti razloge za spremembe cen. Za izbor zdravil smo najprej uporabili zbirko registriranih zdravil po centraliziranem postopku, ki jo vodi EMA. Izbrali smo onkološka zdravila, ki so bila prisotna na slovenskem trgu ob koncu leta 2017. Temu izboru zdravil smo nato iz centralne baze zdravil (CBZ) dodali še druga onkološka zdravila, ki so prisotna na slovenskem trgu in so bila registrirana po decentraliziranem postopku, nacionalnem postopku, medsebojnem prepoznavanju ali pa so na trgu kot nujna neregistrirana zdravila. Primerjali smo tako najvišje dovoljene cene (NDC) zdravil, kot tudi trende dejanskih cen zdravil. Podatke o NDC smo dobili iz CBZ-ja. Poleg primerjave cen smo analizirali razloge za spremembo cen, ki smo jih razdelili v pet skupin; prihod (dodatnega) generičnega zdravila, prihod novega zdravila, odkrita nova indikacija ali razširitev že znane, pojav novega neželenega učinka in drugo. Ugotovili smo, da trendi dejanskih cen sledijo trendom NDC, zato smo primarno opisovali gibanja NDC. V izbranem časovnem obdobju je bilo 124 sprememb NDC pri 56 zdravilih od skupno 71 zdravil. Dvema zdraviloma se je NDC dvignila, 54 zdravilom se je NDC znižala, pri drugih je ostala nespremenjena. Najpogostejši razlog za spremembo NDC je prihod novih originalnih zdravil s 44 spremembami. Sledi prihod novih generičnih zdravil z 32 spremembami. Ugotovili smo tudi, da so se relativno gledano NDC bolj spreminjale originalnim kot generičnim zdravilom.

• Jezik: Slovenski jezik
• Ključne besede: Onkološka zdravila, trend gibanja cen, originalna zdravila, generična zdravila, biološko podobna zdravila, Slovenija
• Vrsta gradiva: Magistrsko delo/naloga
• Organizacija: FFA - Fakulteta za farmacijo
• Leto izida: 2019
• PID: 20.500.12556/RUL-106597
• Datum objave v RUL: 07.03.2019

Sekundarni jezik

• Jezik: Angleški jezik
• Naslov: Trends in prices of selected oncology medicines on the Slovenian market between 2006 and 2017

Izvleček

Cancer is widespread disease with high costs of treatment and a large number of deaths. Only in 2014, cancer deaths accounted for almost 1.3 million deaths in Europe, making the disease ranked second in terms of mortality. Beside mortality, the incidence of cancer is very high; consequently treatment costs are also high and rising. In 1995, the costs of cancer treatment in Europe were EUR 35.7 billion and by 2014, the reached as high as EUR 83.2 billion. Of this, EUR 19.1 billion were spent on cancer medicines. The purpose of our work is to describe and analyse the trends in prices of those oncology medicines, which have two or more medicines with the same active ingredient in the Slovenian market during the period between 2006 and 2017. We will analyse price trends and try to find reasons for price changes. For the selection of medicines, we first used a collection of registered medicines under a centralized procedure led by EMA. We only used medicines that were on Slovenian market at the end of 2017. Then, from Centralna baza zdravil (CBZ), we added other oncological medicines that are present on the Slovenian market and were registered in a decentralized procedure, a national procedure, mutual recognition, or are on the market as urgent unregistered medicinal products. We compared both the maximum allowed prices (NDCs), as well as the trends of actual prices of medicines. NDCs were obtained from CBZ. The reasons for the changes of NDCs were marked in pictures and divided into five groups; the arrival of (additional) generic, the arrival of a new medicine, discovered new indication or extension of already known, the occurrence of a new adverse effect and other. We have found that trends of actual prices follow the trends of NDCs and we have therefore described the movements of NDCs. Within the selected time period, 124 changes of NDCs in 56 from a total of 71 medicines occurred. NDCs for two medicines increased, for 54 medicines NDCs dropped, while the others remained unchanged. The most common reason for changing NDCs is the arrival of new original medicines with 44 changes. This is followed by the arrival of new generics with 32 changes. We also found that, relative to the values of NDCs, the changes in original medicines changed more than in generics.

• Ključne besede: Oncology medicines, price trends, original medicines, generic medicines, biologically similar medicines, Slovenia