OBJECTIVES: To assess the impact of an International Reference Pricing (IRP) on Access to Standard Therapy of COPD in Slovakia.

METHODS: Analyzing 2014-2017 data on utilization of selected COPD standard therapy drugs (ATC R03AL, DDDs, quarterly) from an official and independent sources (IMS SellIn, National Centre for Health Informatics and State Institute for Drug Control) in order to assess the impact of IRP and calculate the possible bias of parallel trade on access to therapy in Slovakia.

RESULTS: An aggressive Drug Policy has been implemented since 2011 (Law 363/2011), creating an opportunity for significant cost reduction in public resources for pharmaceuticals in Slovakia. However, our analysis of data has shown, that the more strict the policy, in terms of IRP, the higher is the demand for "channel management" / parallel trade from low price to high price countries, both on the level of the wholesalers as well as the Public Pharmacies. Our findings on ATC R03AL has shown significant differences (DDDs recorded) in originally independent sources of drug utilization. Moreover, we have identified even suspected malpractice in prescribing and reimbursing selected drugs to Slovak patients, due to parallel trade business driven demand. The findings has confirmed our original hypothesis, that an aggressive IRP Drug Policy leads in midterm towards decrease in access for national population.

CONCLUSIONS: IRP, originally perceived as an effective and efficient tool for cost containment strategies across EU, has reached its optimal potential. Further pressure on ex-factory prices in low and middle income European countries (e.g. Slovakia) generates the possible source of drugs shortage on national level in mid-term, and thus represents the high long-term risk for the healthcare outcomes, in terms of chronically treated patient compliance and adherence to therapy, due to the lack of physical availability of standard therapy drugs on the Slovak market.