Background: Few direct head-to-head comparisons have been conducted between drugs for the treatment of diabetic peripheral neuropathic pain (DPNP). Approved or recommended drugs in this indication include duloxetine (DLX), pregabalin (PGB), gabapentin (GBP) and amitriptyline (AMT). We conducted an indirect meta-analysis to compare the efficacy and tolerability of DLX with PGB and GBP in DPNP, using placebo as a common comparator.

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dations is cost-effectiveness information. Currently in Poland there is no specific formal threshold for orphan designations, there is only a general cost-effectiveness threshold that equals 3 x GDP per capita for ICUR/QALY (for CUA) or ICER/LYG (for CEA), which in 2014 is approximately € 26 800. We extracted data on orphan drugs from our database of medical technologies assessments from 2009 to March 2014. Data on the cost-effectiveness (QALY / LYG) were put together with the decision of reimbursement. On the basis of these data the threshold of cost effectiveness in Poland for orphan designations was determined and summarized with the costeffectiveness thresholds current for a given time interval. Determination of the threshold of cost effectiveness for orphan designations, that would be different (higher) than the generally accepted cost-effectiveness threshold (due to high price of orphan drugs to provide value for money is unlikely), is particularly important from an ethical point of view, because of substantial therapeutic meaning of these drugs and/or absence of other treatment options of proven benefit for the disease.