Admission of new oncological drugs to the Slovenian health care system and their accessibility to the patients

  • Mitja Kos
  • Marko Obradović
  • Aleš Mrhar
  • Julijana Zucchiati-Godina
Keywords: oncology, medications, admission, accessibility, healthcare system

Abstract

Background: The aim of the present study is to analyze the admission of anticancer drugs to the Slovenian healthcare system, and to evaluate patients’ accessibility to these medications.

Methods: Admission and accessibility to anticancer drugs was evaluated by analysing: differences in registration time among USA, selected member states of EU, and Slovenia; time from the registration to the first use in Slovenia; differences between the first use in Slovenia and the first use in selected member states of EU and by analysing the market of oncology drugs. The study included drugs of the ATC groups such as Antitumor medications (cytostatics) (ATC = L01) and Endocrine treatment (ATC = L02) that were used in Slovenia for the first time between 1999 to 2005. Registration data for Slovenia and EU was obtained from the registration documention of selected drugs at the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, and the European Agency for the Evaluation of Medicinal Products (EMEA). Registration data for USA was obtained from the registration documention of selected drugs at the Food and Drug Administration (FDA). The information upon the first use of drugs in Slovenia was acquired from the PharMIS system, and the information upon the first use of drugs in selected member states of EU was obtained from the study on patients’ access to oncology drugs by Nils Wilking and Bengt Jönsson, performed from 2005. Data for the market analysis of oncology drugs was obtained from the PharMIS system.

Results: In previous years a delay in registration time between Slovenia and compared states was present for some oncology drugs. Along with the acceptance of Slovenia as a new member state of EU, on 1st May 2004, registration process in Slovenia became a part of the registration system of the European Agency for the Evaluation of Medicinal Products (EMEA). Majority of drugs had a time difference between the registration and the first use shorter than 10 months. Exceptions are drugs which were first used, mostly in a limited amount, before the acquisition of trade permit in Slovenia or through centralized procedure at EMEA such as oxaliplatin, irinotecan, capecitabine, imatinib mesylate. Average difference between the first use in Slovenia and selected member states of EU for the chosen oncology drugs decreased with years. In recent period oncology drugs were more quickly accessed by patients than in the past. The drug market continuously increased from 1999 to 2005, with an average increase of 30 M EUR per year. The largest increase was demonstrated for the antitumor medications and imunomodulators (ATC = L). In 1999 their market amounted to 10 M EUR or 3.9 % of the whole drug market, in 2005 it amounted to 38 M EUR or 8.6 % of the whole drug market. The market of the targeted drugs has been progressively increasing from year 2000 onwards, and amounted to 6 M EUR in 2005, which represents 39 % of the market share of Antitumor medications (cytostatics) (ATC = L01) group or 1.4 % of the market share for all of the drugs. The reason for this progressive increase is attributed to the increased use of mainly three drugs: imatinib mesylate trastuzumab, and rituximab.

Conclusions: The discrepancies in admission and access to newer oncology drugs between Slovenia and other member states of EU are becoming smaller. The market of oncology drugs is increasing significantly faster compared to the whole drug market, mainly due to the new targeted drugs.

Downloads

Download data is not yet available.

References

PharMIS database, MIS Consulting d.o.o.

Zakon o zdravilih. Uradni list RS 2006; 31: 3217–40.

Uredba št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila. Uradni list L 136, 30. 4. 2004: 0001–0033.

Pravilnik o postopku razvrščanja zdravil na liste. Uradni list RS 2001; 106: 11291.

Sklep o kriterijih za razvrščanje zdravil na liste. Uradni list RS 2003; 78: 11647.

Sklep o spremembi in dopolnitvi liste zdravil na podlagi sklepa o kriterijih za razvrščanje zdravil na liste. Uradni list RS 2006; 123: 13093.

Razširjeni strokovni kolegij. Mar 2007. Dosegljivo na: http://www.mz.gov.si/index.php?id=6844

Zdravstveni svet. Mar 2007. Dosegljivo na: http://www.mz.gov.si/index.php?id=6843

Splošni dogovor za pogodbeno leto 2006. ZZZS 2006. Mar 2007. Dosegljivo na: http://www.zzzs.si/ZZZS/info/egradiva.nsf/splosni_dogovor?OpenView

Evropska agencija za vrednotenje zdravil EMEA. Mar 2007. Dosegljivo na: http://www.emea.eu.int

Agencija (ZDA) za hrano in zdravila FDA. Mar 2007. Dosegljivo na: http://www.fda.org

PharMIS database, MIS Consulting d.o.o.

Wilking N, Jönsson B. »A pan-European comparison regarding patient access to cancer drugs.« Karolinska Institutet in collaboration with Stockholm School of Economics Stockholm, Sweden. September 2005. Mar 2007. Dosegljivo na: http://ki.se/content/1/c4/33/52/Cancer_Report.pdf

Rotea W, Saad ED. Targeted Drugs in Oncology: New Names, New Mechanisms, New Paradigm. Am J Health-Syst Pharm 2003; 60: 1233–45.

Register zdravil Republike Slovenije. Ljubljana: Ministrstvo za zdravje, Agencija RS za zdravila in medicinske pripomočke in Inštitut za varovanje zdravja; 2005.

Štrukelj B, Kos J. Biološka zdravila. Od gena do učinkovine. Ljubljana: Slovensko farmacevtsko društvo; 2007.

Zakon o zdravilih. Uradni list RS 2006; 31: 3217–40.

Statistični urad Republike Slovenije. Mar 2007. Dosegljivo na: http://www.stat.si/

Zakon o zdravstvenem varstvu in zdravstvenem zavarovanju (uradno prečiščeno besedilo). Uradni list RS 2004; 20: 2212–26.

How to Cite
1.
Kos M, Obradović M, Mrhar A, Zucchiati-Godina J. Admission of new oncological drugs to the Slovenian health care system and their accessibility to the patients. ZdravVestn [Internet]. 1 [cited 17Jun.2019];76(9). Available from: https://vestnik.szd.si/index.php/ZdravVest/article/view/1804
Section
Professional article

Most read articles by the same author(s)