ORGANIZATION: The Pharmaceutical Benefits Board in Sweden (LFN). PROBLEM OR ISSUE ADDRESSED: Uncertainty about the cost-effectiveness of reimbursed products. In Sweden, the Pharmaceutical Benefits Board (LFN) was instituted in 2002 with the purpose of contributing to a rational and cost-effective use of pharmaceuticals. The Board’s assignment is to systematically and in accordance with national prioritization guidelines decide which pharmaceuticals should be reimbursed. Societal cost-effectiveness is a key decision parameter. One task of the LFN is to review the subsidy status of all products (~3000 products) that were already in the pharmaceutical benefits when the Board was instituted. Also these products should meet the current requirements for cost-effectiveness. GOALS: These reviews serve two purposes. First and foremost, to inform the Board’s decisions on subsidy status, second, to help other decision makers in Swedish health care to use pharmaceuticals rationally and cost-effectively. To meet both these objectives, the reviews need to meet scientific standards and yet be delivered in a timely fashion. OUTCOMES ITEMS USED IN THE DECISION: The scientific literature is searched for systematic reviews and meta-analyses of effectiveness and efficacy data, evidence on the humanistic burden of disease, as well as for health economic evaluations. If deemed necessary, the LFN may perform additional health economic analyses or modelling. IMPLEMENTATION STRATEGY: The products have been classified into 49 groups (using three-digit ATC codes). A project team consisting of a pharmacist/pharmacologist, a health economist and a legal advisor is assembled for each review group. 3-4 external clinical experts are also attached to the project group. These experts are recruited based on nominations from stakeholders, both from the healthcare system, patient groups and the pharmaceutical industry. Companies marketing a product included in a review are also asked to submit documentation about which studies best support the effectiveness and cost-effectiveness of their product. Before a report is published it is sent out for review by the stakeholders involved. RESULTS: Two reviews have been completed so far (drugs against migraine and acid related problems) and another six are currently in progress. The results from the review of drugs against migraine resulted in one triptan being removed from reimbursement and two manufacturers chose to lower their prices to make their products cost-effective. Based on the review of drugs against acid related problems the Board decided to remove two proton pump inihibitors from reimbursement since they were found not to be cost-effective compared to generic omeprazol. H2-antagonists were removed from reimbursement based on need and solidarity grounds. In addition to decisions to remove individual products from reimbursement, recommendations on cost-effective use of the pharmaceuticals were included in the reports. The impact of such recommendations on clinical practice seems to be quite small according to the sales data. LESSONS LEARNED: Reviewing an entire group of pharmaceuticals is time consuming especially in a small organization. It is however possible to produce reports of a high quality which can be used as a basis for decision making even with comparatively limited resources by using existing systematic reviews and only when necessary performing them within your own organization. Substantial savings and better health outcomes are possible to achieve if cost-effective strategies can be identified.