Primerjava gibanja reguliranih cen podobnih in inovativnih bioloških zdravil v Republiki Sloveniji do leta 2021

Rožič, Polona (avtor), Locatelli, Igor (mentor), Janžič, Andrej (komentor)

Biološko zdravilo vsebuje učinkovino biološkega izvora. Regulatorne agencije v razvitem svetu so zaradi izjemno strogih zahtev glede varnosti in potencialne imunogenosti bioloških zdravil uvedle novo skupino zdravil, imenovano podobna biološka zdravila. Zaradi zahtevnosti proizvodnje bioloških zdravil so temu primerno tudi cene končnih izdelkov visoke. S prihodom podobnih bioloških zdravil na trg je prišlo do zniževanja cen bioloških zdravil, ustvarjanja večje konkurenčnosti ter posledično boljše dostopnosti in preskrbljenosti trga. V Sloveniji se najvišje dovoljene cene zdravil določa s sistemom zunanje primerjave cen zdravil, uporabljajo pa se le kot izhodišče za nadaljnje oblikovanje cene zdravila. Namen magistrske naloge je ugotoviti, kakšen je trend spreminjanja cen inovativnega biološkega zdravila, potem ko na slovenski trg vstopi prvo njemu podobno biološko zdravilo, in sicer v časovnem obdobju od pojava na slovenskem trgu pa do konca leta 2021. Zdravila, ki smo jih analizirali, smo izbrali s pomočjo seznama zdravil z dovoljenjem za promet po centraliziranem postopku, ki je objavljen na spletni strani Evropske agencije za zdravila. V analizo smo dodali še zdravila z enako učinkovino, ki so pridobila dovoljenje za promet po ostalih postopkih registracije, navedena pa so na seznamu Centralne baze zdravil. Sestavili smo seznam zdravil, ki imajo na slovenskem trgu vsaj dve zdravili z isto učinkovino, od tega je vsaj eno zdravilo podobno biološko zdravilo. Dopolnili smo ga s podatki, pridobljenimi iz Centralne baze zdravil, torej z najvišjimi dovoljenimi cenami, izrednimi višjimi dovoljenimi cenami zdravil ter najvišjimi priznanimi vrednostmi. Zdravila smo razporedili v skupine – vsaka skupina je vsebovala različna zdravila z enako učinkovino. Za vsako od skupin zdravil smo pripravili časovne krivulje cen v odvisnosti od časa ter na krivulji inovativnega biološkega zdravila določili 4 izhodiščne točke: (I) točka ob prihodu prvega inovativnega biološkega zdravila na slovenski trg, (II) točka eno leto pred prihodom prvega podobnega biološkega zdravila na trg, (III) točka eno leto po prihodu prvega podobnega biološkega zdravila na trg ter (IV) točka konec obdobja, ki ga spremljamo. Ugotovili smo, da je pri vseh 13 skupinah zdravil prišlo do znižanja najvišjih dovoljenih cen inovativnega biološkega zdravila po vstopu na slovenski trg. Pri zdravilih, pri katerih smo spremljali gibanje najvišjih dovoljenih cen, se je povprečna najvišja dovoljena cena znižala za kar 45 % (razpon od 68 % do 30 %) od prihoda prvega podobnega biološkega zdravila na slovenski trg do konca obdobja spremljanja. To so bila zdravila z naslednjimi učinkovinami: adalimumab, bevacizumab, epoetin, etanercept, folitropin alfa, infliksimab, rituksimab, teriparatid in trastuzumab. Največji padec najvišje dovoljene cene smo zaznali pri inovativnem biološkem zdravilu Humira z učinkovino adalimumab, najmanjši padec najvišje dovoljene cene pa smo zaznali pri inovativnem biološkem zdravilu GONAL-f z učinkovino folitropin alfa. Pri zdravilih, ki jim je bila po najvišji dovoljeni ceni določena še najvišja priznana vrednost zdravil, pa je bila v obdobju od prve najvišje dovoljene cene pa do konca leta 2021 najvišja priznana vrednost nižja za kar 51 % (razpon od 80 % do 18 %). To so bila zdravila z naslednjimi učinkovinami: enoksaparin, filgrastim, pegfilgrastim in somatropin. Največji padec cene smo zaznali pri inovativnem biološkem zdravilu Neupogen z učinkovino filgrastim, najmanjši padec cene pa smo zaznali pri inovativnem biološkem zdravilu Clexane z učinkovino enoksaparin.

• Jezik: Slovenski jezik
• Ključne besede: Biološka zdravila, podobna biološka zdravila, regulirane cene
• Vrsta gradiva: Magistrsko delo/naloga
• Organizacija: FFA - Fakulteta za farmacijo
• Leto izida: 2022
• PID: 20.500.12556/RUL-143504
• Datum objave v RUL: 23.12.2022

Sekundarni jezik

• Jezik: Angleški jezik
• Naslov: Comparison of regulated price trends of biosimilars and innovative biological medicines in the Republic of Slovenia until 2021

Izvleček

Biological medicinal products contains active substances of biological origin. Regulatory agencies in developed countries have introduced a new class of medicinal products called biosimilars because of the extremely stringent safety and potential immunogenicity requirements for biological medicinal products. Due to the complexity of the production of biological medicines, the prices of finished products are correspondingly high. The prices of biological medicinal products have also decreased with the emergence of biosimilars on the market, leading to greater competitiveness and consequently better market accessibility and supply. The maximum allowed prices of medicinal products in Slovenia are determined by an external reference price of medicinal products, which only serves as a starting point for further pricing of the medicinal product. The aim of our work is to determine the trend of price development of an innovative biological medicinal product after the first biosimilar with the same active substance enters the Slovenian market until the end of 2021. The selection of medicinal products was based on the list of medicinal products for which a marketing authorization was granted under the centralized procedure, which is published on the website of the European Medicines Agency. We added medicinal products with same active substance to the analysis which a marketing authorization was granted under the other procedures, and are listed in Centralna baza zdravil. We selected active substances containing the innovative biological medicinal product and at least one biosimilar. We also supplemented the list with data obtained from the Centralna baza zdravil, including the maximum allowed prices for medicinal products, the exceptionally allowed higher prices for medicinal products, and the highest recognized values. We divided medicinal products into groups – each group contained different medicinal products with the same active substance, it had to contain at least one innovative biological medicinal product and at least one biosimilar. We created time curves of prices as a function of time for groups of medicinal products and determined 4 starting points on the curve of the innovative biological drug: (I) point when the first innovative biological medicinal product enters the Slovenian market, (II) point one year before the first biosimilar enters the market, (III) point one year after the first biosimilar enters the market and (IV) point at the end of the monitoring period. We found that the maximum allowable prices for the first innovative biological medicinal product that entered the Slovenian market were reduced for all 13 groups of medicinal products. We found that the average maximum allowable price decreased by 45 % in the period between the entry of the first biosimilar on the Slovenian market and the end of the monitoring period (range from 68 % to 30 %) for the medicinal products that we monitored the movement of the maximum allowable prices. These were medicinal products with the following active substances: adalimumab, bevacizumab, epoetin, etanercept, follitropin alfa, infliximab, rituximab, teriparatide and trastuzumab. The largest decrease in the maximum allowable price was detected for the innovative biological medicinal product Humira with the active substance adalimumab, and the smallest decrease in the maximum allowable price was detected for the innovative biological medicinal product GONAL-f with the active substance follitropin alfa. The regulated price decreased to 51% in the period from the first maximum allowable price was determined to the end of the monitoring period (range from 80 % to 18 %) for the medicinal products for which the highest recognized values were determined after maximum allowable price. These were medicinal products with the following active substances: enoxaparin, filgrastim, pegfilgrastim and somatropin. The largest decrease in the price was detected for the innovative biological medicinal product Neupogen with the active substance filgrastim, and the smallest decrease in the price was detected for the innovative biological medicinal product Clexane with the active substance enoxaparin.

• Ključne besede: Biological medicinal products, biosimilars, regulated prices