Top 20 Orphan Drugs Availability, Pricing and Reimbursement In Slovakia: 2005-2012 Review.

RESULT S We considered orphan drugs list defined by Cote and Keating (2012) that globally exceeded 1 billion $ sales in 2008 and compared same molecules’ availability in Slovakia. Several orphan drugs are among best selling 20 orphan drugs in Slovakia, with highest sale of 95 million EUR (Bevacizumab, 2005-2012) compared to lowest sale of 19 million EUR (Tacrolimus, 2005-2012). It took from one year (e.g. Imatinib) to 19 years (e.g. Glatiramer acetate) to be launched in Slovakia after orphan designation confirmation. Top 20 orphan drugs had average DOT value 472 EUR compared to total pharma market DOT average value 0,43 EUR. From selected orphan drugs 60% had full (100%) reimbursement status and 40% were fully covered by hospital budgets. Only 4 of them were launched in Slovakia since 2005 (included), 16 of them were launched from 1990 till 2004. Prices, according to official Ministry of Health Price List, ranged from 330 EUR to 5800 EUR (ex-factory, one package, 2012). OBJECTIVES Orphan drugs are highly priced and top 20 orphan drugs create almost 2,5% of total drug expenditure in Slovakia. We conducted 8 years review of government and literature sources to provide insight into pricing, reimbursement and availability situation surrounding top 20 orphan drugs in Slovakia from the health care payer perspective.