Abstract
PURPOSE: To investigate the use of the WHO EML as a tool with which to evaluate the evidence base for the medicines on the national insurance coverage list of the Croatian Institute of Health Insurance (CIHI). METHODS: Medicines from 9 ATC categories with highest expenditures from 2012 CIHI Basic List (n = 509) were compared with 2011 WHO EML for adults (n = 359). For medicines with specific indication listed only in CIHI Basic List we assessed whether there was evidence in Cochrane Database of Systematic Reviews questioning their efficacy and safety. RESULTS: The two lists shared 188 medicines (52.4% of WHO EML and 32.0% of CIHI list). CIHI Basic List had 254 medicines and 33 combinations of these medicines which were not on the WHO EML, plus 14 medicines rejected and 20 deleted from WHO EML by its Evaluation Committee. For deleted medicines, we could obtain data that showed 2,965,378 prescriptions issued to 617,684 insured patients, and the cost of approximately € 41.2 million for 2012 and the first half of 2013, when the CIHI Basic List was in effect. For CIHI List-only medicines with a specific indication (n = 164 or 57.1% of the analyzed set), fewer benefits or more serious side-effects than other medicines were found for 17 (10.4%) and not enough evidence for recommendations for specific indication for 21 (12.8%) medicines in Cochrane systematic reviews. CONCLUSIONS: National health care policy should use high-quality evidence in deciding on adding new medicines and reassessing those already present on national medicines lists, in order to rationalize expenditures and ensure wider and better access to medicines. The WHO EML and recommendations from its Evaluation Committee may be useful tools in this quality assurance process.