OBJECTIVES: To assess the appropriateness of pharmacoeconomics methodologies used in Pricing and Reimbursement (P&R) Applications of innovative therapies in Slovakia.

METHODS: Analyzing recent submissions from local Marketing Authorization Holder representatives (MAH) on presented pharmacoeconomics methodologies from an official Slovak Ministry of Health (MoH) P&R Portal, which is publicly available, and comparing presented methodologies with currently valid legal framework on assessment and appraisal of innovative therapies in Slovakia.

RESULTS: We have analyzed 162 recently (2016-2017) submitted P&R Applications of innovative therapies by MAH. Cost Utility Analysis (CUA), which is compulsary required for innovative therapies by the Law (Act of Drug, #363/2011), was presented in less then 1/3 of all applications (30,25%). The most common methodology used (48,77%) was Cost Minimisation Analysis (CMA), followed by either single CUA or CEA (8,64%). Less then 7% of all applications have used more then ona analysis, out of which CEA+CMA was the most frequent (4,94%). Suprisingly enought, there have been assessed aplications without any analysis presented as well (6,17%). Furthermore, we have analyzed final assessment and appraisal decisions, published during by Expert and Reimbursement Committees. Reasonings for negative assessment was recorded. None of all stakeholders involved (MoH, Health Insurance Companies or Healthcare Surveillance Authority) have been able to challenge the efficiency of health technology assessment and appraisal in terms of simple validation of pharmacoeconomics methodologies used, based on the currently valid legal requirements.

CONCLUSIONS: Existing Drug Policy in Slovakia, inspite of being one of the most transparent across OECD countries, have no formal and/or informal simple validation tools in place to assess at least retroactivly the MAH P&R submissions and to avoid or limit the impact of significantly missleading inputs on pharmacoeconomics methodology used after the successful P&R assessment and appraisal. Such a malpractice in P&R methodology leads to continuous inefficiency in public healthcare spendings.