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.