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Sistematični pregled izhodišč za odločitve o umestitvi zdravil v slovenski zdravstveni sistem v obdobju od 2012 do 2018
Šušteršič, Špela (Author), Kos, Mitja (Mentor) More about this mentor... This link opens in a new window, Marđetko, Nika (Co-mentor)

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Abstract
V Sloveniji razvrščanje zdravil na listo ureja Zakon o zdravstvenem varstvu in zdravstvenem zavarovanju, o samem procesu razvrščanja pa odloča Zavod za zdravstveno zavarovanje Slovenije (ZZZS). Pri postopku umeščanja zdravil v slovenski zdravstveni sistem ZZZS pridobi tudi strokovno mnenje Komisije za razvrščanje zdravil. ZZZS se nato na podlagi Pravilnika o razvrščanju zdravil na listo odloča katera zdravila bodo razvrščena na listo in financirana iz obveznega oziroma dopolnilnega zdravstvenega zavarovanja. Namen magistrskega dela je sistematično pregledati in ovrednotiti postopke razvrščanja zdravil obravnavnih na sejah Komisije za razvrščanje zdravil na listo v obdobju od 2012 do 2018. Izhajali smo iz zapisnikov sej Komisije za razvrščanje zdravil, dostopnih na spletni strani ZZZS. V prvem delu naše raziskave smo pregledali vsa obravnavana zdravila in popisali podatke glede tipa dokumenta, predlagateljev, vrste vlog, vrste zdravil, datumov oddaje vloge/seje/razvrstitve na listo, ATC klasifikacije, terapevtskega področja in vsebine sklepov Komisije. V drugem delu pa smo se osredotočili na merila, ki jih Komisija upošteva pri razvrščanju zdravil in pregledali ocene Komisije glede na posamezna merila. Zanimalo nas je katere ocene so prevladovale, ali so ocene meril konsistentno podane čez posamezna leta in koliko je bilo ocen, ki so bile nejasno opredeljene glede na Pravilnik. Večina dokumentov, ki jih je Komisija obravnavala na sejah med leti 2012 – 2018, so bile vloge (več kot 50 %), med temi je bilo največ vlog za razvrstitev novega zdravila. V 55,7 % so bile to vloge za originalna zdravila in kot drugo skupino z največ vlogami so predstavljale vloge za zdravila sirote (7,8 %). Ugotovili smo, da je bilo na sejah obravnavnih največ zdravil iz skupine L glede na ATC klasifikacijo, glede na terapevtsko področje pa so prevladovala zdravila za zdravljenje pljučnega raka, raka dojk in revmatoidnega artritisa. Zdravila so se največkrat razvrstila na pozitivno listo z omejitvijo predpisovanja, ki je v celoti krita iz obveznega zdravstvenega zavarovanja (P100*) (v 27 %) in na bolnišnično listo zdravil z omejitvijo predpisovanja, katerih cena v priporočenem odmerku presega vrednost 5000 eur na osebo v enem letu (B*) (v 23 %). Pri pregledu končnih sklepov Komisije je bilo pozitivnih sklepov med 72,9 % in 83,3 % (glede na posamezna leta), največ negativnih sklepov pa je Komisija podala leta 2018 (11,0 %), kar si lahko razlagamo s tem, da trenutne cene zdravil presegajo zmožnosti ZZZS ali pa ta zdravila nimajo dovolj podatkov o (večji) učinkovitosti in varnosti glede na že razvrščena zdravila. Pri pregledu ocen Komisije glede na merila za razvrščanje je bilo veliko pomanjkljivih podatkov, največ podatkov je manjkalo pri merilih farmakoekonomskega vidika in v splošnem pri zdravilih obravnavanih leta 2012 in 2013, medtem ko so bile najbolj jasno opredeljene ocene merila »Etični vidik« čez celotno obdobje naše analize. Posledično smo le pri 20 zdravilih dobili celokupne ocene Komisije glede na vsa merila, kar predstavlja 6,5 % vseh zdravil (skupno število zdravil je bilo 309), ki smo jih obravnavali v drugem delu naše analize.

Language:Slovenian
Keywords:Razvrščanje zdravil na listo, Komisija za razvrščanje zdravil, Zavod za zdravstveno zavarovanje Slovenije, Lista zdravil, Merila razvrščanja
Work type:Master's thesis/paper (mb22)
Organization:FFA - Faculty of Pharmacy
Year:2019
Views:112
Downloads:48
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Secondary language

Language:English
Title:A systematic review of decision elements for medicine reimbursement in the Slovenian healthcare system during 2012 to 2018 period
Abstract:
In Slovenia the classification of medicine on the list of medicines is regulated by the Health Care and Health Insurance Act and the Health Insurance Institute of Slovenia (hereinafter referred to as ZZZS) decides on the process itself. In the process of medicine reimbursement ZZZS also acquires expert opinion of the Committee for Classification of Medicines. ZZZS then determines on the basis of the Regulation on the classification of medicine on the list which medicines will be listed and financed by the health insurance and which will not. The purpose of the master's thesis is to systematically review and evaluate the procedures and decision elements for medicine reimbursement, which were discussed at the Committee's meetings during 2012 – 2018 period. The basis of our research were the Committee's meeting reports, available on the website of the Health Insurance Institute of Slovenia (ZZZS). In the first part of our analysis, we reviewed all applications and listed out all the data about the type of documents, promoters, types of applications, types of medicines, dates of submission of application / Committee's meeting / classification on the list, ATC classification, therapeutic area and content of Committee's conclusions. While in the second part of our work we focused on the criteria and decision elements taken into account by the Committee in the medicine reimbursement process, and we observed how clearly the assessments were made for the individual criteria, the estimates prevailing, whether the estimates of criteria were given consistently over each year and how many were unclearly defined. Most of the documents, processed by the Committee during the 2012-2018 meetings, were applications (more than 50 %), among which the highest number of applications were associated with new medicinal products. In 55,7 % these were applications for original medicines and as second group with the highest number of applications were applications for orphan medicinal products (7,8 %). We found that most of the medicines processed at the meetings were from the group L according to the ATC classification, and the predominant therapeutic areas were areas of lung cancer, breast cancer and rheumatoid arthritis. The drugs were most often classified on the positive list with prescription limitations, which is fully covered by compulsory health insurance (P100*) (27 %) and hospital list of medicines with prescription limitations whose price at the recommended dose exceeds 5000 eur per person per year (B*) (23 %). In the review of Committee's final decisions, we found out that the Committee gave a positive decision in 72,9 % - 83,3 % (relative to each year), while the most negative decisions were given in 2018 (11,0 %), which can be explained by the fact that the current prices of medicinal products go beyond the capabilities of ZZZS or that these medicines do not have sufficient data on (better) efficiency and safety compared to already classified medicinal products. In reviewing the criteria for the classification of medicines, there was a lack of data in the Committee's evaluations, so we often had to decide on the estimates based on the content of the Committee's comments. Most of the data were missing for applications evaluated in 2012 and 2013, more specifically for criteria in pharmacoeconomic point of view, while the most clearly assessed criteria over the entire period of our analysis was “Ethical aspect". Consequently, only 20 medicines received clear evaluations for all criteria, which represents 6,5 % of all medicines (total number of medicines was 309), which were included in the second part of our analysis.

Keywords:Medicine reimbursement, Committee for the classification of medicines, Health Insurance Institute of Slovenia, List of medicines, Classification criteria

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