Therapeutic Group System Set for Introduction in Slovenia; Prescription Drug Market Declines 1.5% in Value During 2011

Therapeutic Groups to Be Introduced from August

With the passing of the Law on the Balancing of Public Finances (ZUJF) by Slovenia's National Assembly, a new system of therapeutic groups is set to be introduced within the Slovenian public healthcare system, based on the reimbursement of the lowest priced medicine within a group of therapeutically comparable medicines, but not necessarily containing the same active pharmaceutical ingredient (API). Although it has been emphasised by the Slovenian Ministry of Health that doctors can prescribe an originator product with no co-payment in situations in which it is justified and can be shown to be advantageous to patients, patient groups and medical professionals are highly critical of the changes. The Institute for Health Insurance of Slovenia (ZZZS) is now due to specify the more exact conditions for determining the composition of the therapeutic groups and their maximum levels of reimbursement in association with the health minister, and according to the law's own terms, the ZZZS is due to complete this within three months of the passing of the ZUJF. Thus, it should be completed by early August. The system will apply to both the positive and intermediate drug reimbursement lists, and the ZZZS is due to have full information concerning the groups available on its website.

Slovenian Health Minister Accuses Pharma Industry of "Exploiting" Patients

Slovenia's health minister, Tomaž Gantar, is reported by Slovenian newspaper Dnevnik as saying doctors will still be able to prescribe the medicines they want to prescribe, and that the purpose of the changes is to save money and therefore make it possible for Slovenian patients to have access to new drugs. Gantar is quoted as saying Slovenia is one of the few remaining countries in which the pharmaceutical industry is able to "exploit" patients, because certain changes have not yet taken place. In particular, the source reports, the system of therapeutic groups is intended to guard against the introduction of new, more expensive medicines that are not significantly better than older ones but are commonly prescribed because of strong marketing and promotion.

Savings Expected in Tens of Millions

The introduction of the system is expected to result in savings amounting to tens of millions of euro (EUR10 million = USD12.4 million). If it is demonstrated that a medicine has special therapeutic properties, however, it can be treated differently from others within the therapeutic group, according to the source. There will be a limited range of prices in comparison with the present situation, in which the disparity in the prices of treatment groups is very large, stretching to well over 100%. According to the director of the pharmaceutical department of the ZZZS, Jurij Fürst, quoted by Dnevnik, it is not likely that patients will have to pay excessively high co-payments for medicines after the system is introduced, because pharmaceutical companies will adapt to the new situation and reduce their prices.

The Slovenian Forum of International Research and Development Pharmaceutical Companies (FIRDPC), which represents the innovative pharmaceutical industry in the country, has expressed its strong opposition to the introduction of therapeutic groups, warning against the grouping together of patent-protected and generic medicines, and also warning of the potential risks for patients, particularly those like the elderly, who often take a number of medicines at the same time.

Slovenian Prescription Drug Market Value Declines

Meanwhile, the ZZZS has published information on the value and volume of the prescription-drug market in 2011, showing that in value terms, it suffered a slight decline of 1.5% year-on-year (y/y), to EUR469.528 million. In volume terms measured in terms of defined daily doses, however, the market grew by 2.9% y/y.

Outlook and Implications

As yet, it is not clear how wide the therapeutic groups will be, and under what circumstances it will be possible for doctors prescribe a more expensive medicine, with these questions due to be answered in the next few months as the appropriate legislation is developed. Until then, there is likely to be a considerable amount of debate and discussion on the nature of the therapeutic groups, with the fairly anti-pharma tone already set by the new health minister. Nevertheless, representatives of the industry are expected to be consulted in the formation of the new system, leaving some room for hope that there will continue to be positive dialogue between the sides.

Recent warnings from the FIRDPC concerning the trend of falling expenditure on drug reimbursement have clearly not had the intended effect (see Slovenia: 12 April 2012: Slovenia's Innovative Pharma Association Warns Against Trend of Declining Drug Expenditure). Slovenia already has a similar system in place for drugs with the same API, and expanding this to therapeutic groups is certainly not unusual in comparison with other European markets. Slovenia has the added problem of the small size of its market and the need to attract and retain pharmaceutical companies' interest in it, however, as it would not be a major problem for most multinationals to withdraw products from Slovenia in terms of the impact on their overall sales.

Looking at the decline in drug reimbursement spending during 2011, it can be seen that the trend is already downward, due in no small part to the reference-pricing system employed with drugs with the same APIs. It seems almost inevitable that spending will decline even further in 2012; by how much depends on the final version of the therapeutic groups and the associated reimbursement system that will be implemented later in the year.