We clarify basic terms and explain what has an effect on the price of medication

Medicines are one of the most regulated areas and are subject to strict control every step of the way - from the process of research and development all the way to their sales and use. Of course the prices of prescription medicines, which are funded by public means, are strictly regulated, a number of institutions are involved and a long list of legislation is applied. 

In Slovenia prices of medicines are subject of the Medicinal Products Act and are the domain of  Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). Public funding of medicines is defined in the Healthcare and Health Insurance Act and is the domain of Health Insurance Institute of Slovenia (ZZZS). Additional control over innovative prescription medicines' prices is guaranteed through Rules on determining the prices of medicinal products for human use and Rules of Reimbursement. 

Maximum Allowed Price (MAP) 

As most other countries do Slovenia also has a comparative model in place to determine the prices of medicinal products. This model considers medicinal products prices in Germany, Austria and France. The law determines that a MAP for an individual medicine must be the same as the lowest price for the same medicine in any of those three countries. MAPs are under strict control and JAZMP checks them regularly twice a year. Austria, Germany and France each in their own way consider medicinal products prices in other countries as well and relevant clinical contributions and values of the medicine. So MAPs in Slovenia are indirectly influenced by prices in other European countries, too.  

Agreed price

Strictly regulated MAPs are, however, not the final prices for medicines in Slovenia. Suppliers, payers and buyers can negotiate about the prices which are lower than MAPs and so ZZZS and pharmaceutical industry can arrange discounts. The agreed price is therefore usually lower than the lowest price for that medicine in Austria, Germany and France. An in-depth analysis by Quintiles IMS (NYSE) company showed that additional discounts to MAPs in Slovenia average more than 20 percent. 

Highest Recognised Value (HRV)

In addition to MAP and agreed price a Highest Recognised Value (HRV) needs to be explained to fully understand this subject. HRV is the price standard set by ZZZS for each medicine which is funded from mandatory health insurance either fully or in part depending on its classification. HRVs are adjusted every two months by ZZZS's management board or by the Director General of ZZZS if so authorised by the Management Board. ZZZS sets HRVs for therapeutic and interchangeable medicinal products. If the sales price of a medicine is higher than its HRV then one must pay for the difference between them.

Therapeutic groups of medicinal products are defined by ZZZS at their own initiative. One such group includes innovative medicines with the same therapeutic indication with or without an approved generic alternative. An HRV for a therapeutic group equals the lowest price of a comparable dose of the medicine which has the best cost to effectiveness ratio within the therapeutic group. All doses of at least one medicine from a therapeutic group are fully covered by medical insurance. 

Interchangeable medicinal products groups are comprised of innovative medicines with expired patent protection and with existing approved generic alternatives. One such group is defined by a number of parameters (active substance, ATC mark, strength and comparable form of medicine) and comprised of at least two medicines with a proprietary name regarding the work code. HRV for medicinal products from this group is set by the price of a comparable dose of the cheapest medicine in the group.