| Popis: |
Zavod za zdravstveno zavarovanje Slovenije (ZZZS) je v Sloveniji zadolžen za razvrščanje zdravil na listo zdravil. Na liste se razvrščajo zdravila na recept, bolnišnična in ambulantna zdravila. Razvrščanje poteka na podlagi vlog, ki jih obravnava Komisija za razvrščanje zdravil na listo (Komisija). Namen magistrske naloge je bil raziskati področje umeščanja zdravil v slovenski zdravstveni sistem. Analizirali in vrednotili smo vloge in zdravila, ki jih je Komisija v okviru ZZZS obravnavala v obdobju 2017-2022. Vse podatke smo analizirali z vrtilnimi tabelami v programu Excel. V tem obdobju je bilo obravnavanih 374 vlog, prvič obravnavanih je bilo 291 vlog (v povprečju 49 na leto), od tega je bilo 207 vlog (v povprečju 35 na leto) za razvrščanje zdravil na listo. Največ od teh zdravil (64 %) se je razvrstilo na pozitivni listi (P100* 26,4 % in P70* 14,4 %), na vmesno listo (V* 9,3 %) in na listo za bolnišnična zdravila (B* 13,9 %). Povprečno 5 od 35 obravnavanih zdravil na leto se ni uspelo razvrstiti na liste po prvi obravnavi, le povprečno 0,5 od 35 zdravil na leto pa se tudi po ponovnih obravnavah ni uspelo razvrstiti. V obravnavanem obdobju so se 65 od 88 zdravilom uspešno spremenile omejitve predpisovanja. V tem obdobju je bilo največ prvič obravnavanih zdravil s področja zdravljenja novotvorb (36 %), bolezni prebavil in presnove (12 %), bolezni živčevja (8 %), bolezni krvi in krvotvornih organov (8 %) in sistemskih infekcij (8 %). 82,6 % teh zdravil (povprečno 28,5 na leto) je bilo originatorskih (66,7 % povprečno 23 na leto) in bioloških (15,9 % povprečno 5,5 na leto). Skoraj vsa (99 %) prvič obravnavana zdravila so imela velik do srednje velik javnozdravstveni pomen, pri čemer jih je bilo 74 % (povprečno 36 na leto) vključenih v smernice, le 14 % (povprečno 7 na leto) pa je imelo definirano stopnjo priporočila. 90 % (povprečno 43,9 na leto) prvič obravnavanih zdravil je imelo srednje velik ali velik terapevtski pomen, 93 % (povprečno 45 na leto) pa vpliv na nadomestne izide zdravljenja. Dodatno terapevtsko vrednost je imelo 57 % (povprečno 27,5 na leto) prvič obravnavanih zdravil, le 2 % (povprečno 1 na leto) pa je imelo novo terapevtsko vrednost. Iz farmakoekonomskega vidika smo ugotovili, da 58 % prvič obravnavanih zdravil (povprečno 28 na leto) vpliva na stroške plačnika tako, da jih viša, zato ima 43 % zdravil (v povprečju 20,7 na leto) pomemben finančni učinek. 31 % prvič obravnavanih zdravil (povprečno 14,8 na leto) je bilo namenjenih zdravljenju hudih ali redkih bolezni. Večina zdravil je imelo ceno pod 3000 EUR in večino jih v celoti financira ZZZS, ki lahko letno na novo razvrsti do 30 ne predragih zdravil. 84 % obravnavanih zdravil (povprečno 40,5 na leto) je imelo kot pogoj za razvrstitev določen dogovor o financiranju. The Institute for Health Insurance of Slovenia (ZZZS) is responsible for the uptake of medicines on lists of drugs in Slovenia. Prescription drugs, drugs for hospital and ambulatory use are classified into lists. Classification takes place on the basis of applications, which are considered by the Committee for the Classification of Medicines (Comission) on the list. The purpose of the master's thesis was to investigate the field of uptake of medicines in the Slovenian healthcare system. We analyzed and evaluated the applications and medicines that the Commission considered in the framework of ZZZS in the period 2017 – 2022. All data were analyzed using pivot tables in Excel. During this period, 374 applications were considered, 291 (on average 49 per year) applications were considered for the first time, of which 207 (on average 35 per year) were applications for classifying medicines on the list. Most of these drugs (64%) were classified on the positive list (P100* 26,4 % and P70* 14,4 %), on the intermediate list (V* 9,3 %) and on the list for hospital drugs (B* 13,9 %). An average of 5 out of 35 drugs considered per year failed to be classified on the lists after the first review, and only an average of 0.5 out of 35 drugs per year failed to be classified even after repeated reviews. During the considered period, 65 out of 88 drugs had their prescription restrictions successfully changed. During this period, the majority of drugs discussed for the first time were from the field of treatment of neoplasms (36 %), diseases of the gastrointestinal tract and metabolism (12 %), diseases of the nervous system (8 %), diseases of the blood and blood-forming organs (8 %), and systemic infections (8 %). 82,6% of these drugs (average 28,5 per year) were originator (66,7 average 23 per year) and biological (15,9 % average 5,5 per year). Almost all (99%) first-time drugs were of high to moderate public health importance, with 74% (mean 36 per year) included in guidelines and only 14% (mean 7 per year) having a defined level of recommendation. 90% (average 43.9 per year) of first-time treatments had medium or high therapeutic importance, and 93% (average 45 per year) had an impact on alternative treatment outcomes. 57% (average 27.5 per year) of the drugs treated for the first time had additional therapeutic value, and only 2% (average 1 per year) had new therapeutic value. From a pharmacoeconomic point of view, we found that, in principle, 58% of first-time drugs (average 28 per year) affect the payer's costs by increasing them, and as a result, 43 % of drugs (average of 20.7 per year) have a significant financial impact. 31% of the drugs treated for the first time (an average of 14.8 per year) were intended for the treatment of severe or rare diseases. Most of the medicines had prices below EUR 3000 and most of them are fully financed by ZZZS, which can afford to reclassify 30 not too expensive medicines every year. 84% of the drugs considered (an average of 40.5 per year) had a specific funding agreement as a condition for classification. |
