Slovenian MoH Puts Forward Series of Pharmaceutical Cost-Containment Measures

The Slovenian ministry of health (MoH) has put forward a series of pharmaceutical cost-containment measures in response to what it perceives as excessive increases in expenditure on the reimbursement of pharmaceuticals provided under the country's national health system, reports Slovenian medical news provider Kemofarmacija. At this stage, the proposals are only in draft form, and their final contents will not be revealed until the MoH has discussed them with all the relevant stakeholders, including representatives of the pharmaceutical industry.

Main Cost-Containment Measures Proposed:

• The extension of the existing system of mutually interchangeable medicines with the same active pharmaceutical ingredient (API). Slovenia has a system of mutually interchangeable medicinal products in place, under which medicines with the same API are grouped together and at least one product is priced at a level that is no higher than the maximum declared value as defined by the Slovenian health insurance institute, the ZZZS, meaning that this product is available with any co-payment (see Slovenia: 30 April 2010: May Expansion of Mutually Exchangeable Products List to Save Slovenian National Health Insurer US$15 mil. per Year).
• The establishment of more stringent criteria for inclusion in the "extraordinary maximum higher price" system. Slovenia's MoH operates a system of "extraordinary maximum higher prices", which allows for prices of drugs to be established at higher prices in exceptional circumstances. This system has come under scrutiny recently, and according to Gregor Makuc of the Slovenian Forum for Research-Based Pharmaceutical Companies, quoted by Slovenian newspaper Poslovni Dnevnik, it is open to abuse (see Slovenia: 22 April 2010: Slovenian Drug Agency Responds to Criticism on Excessive Drug Prices).
• The issuing of cheaper medicines from groups of mutually interchangeable products. No additional co-payment would be charged to patients for the cheapest product in a group of mutually interchangeable products that is recognised to have the highest value.
• Introduction of a system of therapeutically equivalent medicinal products. This is along the line of "therapeutic groups", meaning that groups of medicinal products with comparable effects would be established, which would include medicines with different APIs. The MoH expects that this would yield savings mainly in the case of off-patent originator drugs, which would be grouped together with much cheaper generics, and the latter would be available to patients with little or no co-payment. Savings from this would be used to increase reimbursement for expensive biological drugs.
• Introduction of a system of prescription by API. This has been under debate in Slovenia for some time (see Slovenia: 23 June 2010: Introduction of Prescription by INN in Slovenia Planned for Autumn 2010).
• Establishment of a list of emergency, unregistered drugs imported into Slovenia, and the centralisation of the procurement of these drugs. Purchasing would take place annually, and not as at present, with each hospital purchasing these drugs at different times during the year. This would make it possible for the Slovenian drug agency to keep a closer watch on spending on these drugs.
• Introduction of an electronic prescription system. This is already underway as part of the e-Health system being introduced in Slovenia.
• Public procurement of hospital drugs. It is proposed that the system of procurement for hospital drugs should be unified, unlike at present, with each hospital deciding its own terms in each tender.
• Restrictions on visits by medical representatives. Under this proposal, the MoH would monitor the activities of pharmaceutical company representatives more closely, and visits by representatives to public-sector healthcare workers during working hours would be prohibited. Another proposal relates to greater supervision of the donations made by pharmaceutical companies to healthcare professionals.

Savings Used to Increase Reimbursement of Expensive Biological Drugs

According to Dr Martin Mozina of the University Clinic Centre in Ljubljana, a member of the Scientific Committees of the European Medicines Agency, quoted by Slovenian newspaper Poslovni Dnevnik, the money saved by the introduction of some or all of these measures will be used to increase the amount of funds available to reimburse expensive, biological drugs, the use of which has been on the rise in Slovenia during recent years. The same source reports that in the general agreement for healthcare in Slovenia for 2010, an extra 17 million euro (US$20.7 million euro) will be available for the reimbursement of new, innovative biological drugs in Slovenia.

Outlook and Implications

Expenditure on pharmaceutical reimbursement by the ZZZS during 2009 increased by only 3.2% year-on-year to 317.7 million euro, with the greater funding of treatment with expensive biological drugs being the cause of the increase (see Slovenia: 9 February 2010: State Expenditure on Pharmaceuticals in Slovenia Increases 3.2% Y/Y in 2009). In order to be able to maintain growth in the funding of these drugs, the Slovenian MoH is seeking cost efficiencies on other drugs.

In the context of the present wave of cost-containment measures being introduced in many other European countries, and considering the continued economic difficulties being experienced in Slovenia, it is unsurprising that the country's government is looking at introducing such policies. With prescription by API expected to be introduced in the country during the latter part of the year, it is possible that the other measures agreed on following discussions with stakeholders will also be introduced at that time.

Many of the policies that have been put forward are similar to those introduced by neighbouring countries and other countries in the region. For example, measures to enforce stricter monitoring and restrict the activities of pharmaceutical company representatives have recently been introduced in neighbouring Croatia, having been in place in Hungary since 2007. Also, the introduction of a system of therapeutically equivalent groups of medicines, which has been in place in the Netherlands for some years, has recently been mooted in Romania as well. This shows the influence that countries in the region have on each other, indicating that there are likely to be more such measures proposed and introduced by other countries in the region over the coming months.