Primerjava porabe originalnih in generičnih zdravil in izdatkov zanje v Sloveniji od 2010 do 2017

Marčič, Maja (author), Locatelli, Igor (mentor), Janžič, Andrej (comentor)

Originalna zdravila so praviloma zdravila z novo zdravilno učinkovino. Za njih mora predlagatelj izvesti tako neklinične kot klinične študije, oziroma mora za pridobitev dovoljenja za promet z zdravilom imeti popolno dokumentacijo. Generična zdravila vsebujejo že znano zdravilno učinkovino in se po učinkovitosti, kakovosti in varnosti ne razlikujejo od originalnega zdravila. Raziskovali ter primerjali smo količinsko porabo in izdatke za originalna in generična zdravila v Sloveniji od leta 2010 do 2017. Za osnovo smo uporabili agregirana ZZZS poročila o porabi zdravil na recept, ki smo jim dodali podatke o porabi in izdatkih za draga bolnišnična zdravila. Zdravila smo klasificirali kot originalna oziroma generična glede na opredelitev JAZMP pri določitvi najvišje dovoljene cene za zdravilo. Analize smo izvajali glede na produktno prezentacijo zdravila, ki je opredeljena z nacionalnim identifikatorjem, glede na njihova lastniška imena in tudi glede na vsebovane zdravilne učinkovine. Primerjali smo tudi porabo in izdatke v posameznih letih, oziroma trende v izdajanju zdravil. Rezultati so pokazali, da je bilo v celotnem raziskovanem obdobju v breme obveznega zdravstvenega zavarovanja izdanih 50 % originalnih zdravil (glede na število različnih zdravil), 40 % generičnih, 1 % biološko podobnih zdravil, ostalo pa so drugi izdelki, kot so magistralna zdravila, galenski izdelki, medicinski pripomočki, živila in neopredeljena zdravila. V letu 2017 je največ lastniških imen zdravil izdanih iz skupine zdravil z delovanjem na živčevje (podoben delež originalnih in generičnih zdravil), zdravil za bolezni srca in ožilja (podoben delež originalnih in generičnih zdravil) in zdravil z delovanjem na novotvorbe in imunomodulatorje (prevladujejo originalna zdravila), ki skupaj predstavljajo približno polovico med vsemi ATC skupinami. Celotni izdatki ambulantno izdanih zdravil za originalna zdravila po letu 2014 naraščajo, za generična zdravila se v celotnem obdobju ne spreminjajo veliko. V 2017 je vrednost izdatkov za vsa zdravila več kot 350 milijonov evrov, od tega 69 milijonov za draga bolnišnična zdravila. Originalna zdravila predstavljajo 85 % vrednosti izdatkov. Število izdanih škatlic vseh zdravil je leta 2017 približno 38 milijonov in za razliko od izdatkov, originalna zdravila predstavljajo manjši, 48 % delež. Zaključimo, da je za originalna zdravila delež izdatkov leta 2017 skoraj 1x večji (85 %) od deleža njihove porabe v škatlicah (48 %), torej se jih porabi malo manj kot generičnih zdravil, stroškovno pa so bistveno dražja.

• Language: Slovenian
• Keywords: Originalna zdravila, generična zdravila, izdatki za zdravila, poraba zdravil, trendi v izdatkih in porabi zdravil, Slovenija
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2019
• PID: 20.500.12556/RUL-107972
• Publication date in RUL: 11.06.2019

Secondary language

• Language: English
• Title: Comparison of consumption and expenditures for originator and generic medicines in Slovenia between 2010 and 2017

Abstract

The original (brand-name) medicines are most often products with a new active ingredient, for which the applicant must do clinical and non clinical studies to obtain a marketing authorisation and have full documentation. Generic drugs contain an already known active substance and have the same efficacy, quality and safety as the original drug. We explored and compared the consumption and expenditure of original and generic medicines in Slovenia from 2010 to 2017. Data on consumption and expenditure were drawn from the aggregated ZZZS database on drug use, we also added data on consumption and expenditure for costly hospital medicines. We classified medicinal products as original or generic according to the definition of the JAZMP in determining the maximum allowed price of medicines. Analyses were made according to national drug codes, brand names and active substance contained. The results showed that to the burden of compulsory health insurance throughout the analysed period, 50 % of all prescribed drugs based on national drug codes were original, 40 % generic, 1 % of biosimilars, the rest were medical devices, galenical products, food supplements, vaccines. In 2017 the majority of medicines were issued from a group of medicinal products with a function on the nervous system (similar ratio of original and generic medicines), medicines for cardiovascular diseases (similar ratio of original and generic medicines) and antineoplastic and immunomodulating agents (dominated by original medicines); together they represent about half of all ATC groups. The total expenditure for original medicinines is increasing after 2014, for generic medicines the expenditure does not change much throughout the period. In 2017 the value of expenditure for all medicinal products is more than EUR 350 million, 69 million of this amount are for costly hospital medicines. Original medicines represent 85% of total expenditure. The number of issued drug boxes in 2017 is more than 38 million and unlike expenditure, the original medicines represent a smaller 48% share. We conclude that for original medicines, the expenditure in 2017 is almost 1x larger (85%) than their consumption in boxes (48%), which means they are consumed less than generic drugs and much more expensive.

• Keywords: Original medicines, generic medicines, expenditure, consumption, trends in expenditure and consumption of medicines, Slovenia