A813independent reviewers performed the evaluation and a third reviewer or concession resolved any disagreement. The quality of Budget Impact Analyses on Drugs was evaluated according to Principles of Good Practice BIA -ISPOR 2012 Results: Publications were found between 2001 and 2015. More than 70% published since 2010. USA, Spain, Italy and UK together produced more than 50% of the publications. More than 70% did not declare a guideline used (even after the year 2010). The most usually guideline (14%) was the ISPOR (after the year 2009). Even guideline being used the studies did not present all the requirements. More than 30% analysis were just a projection of expenditures. More than 42% did not use reference scenario. More than 30% used smaller horizon time than three years. More than 50% of the study perspective the public system. More than 50% of the analyses were performed by statistical method using a spreadsheet. More than 21% did not do sensitivity analysis. More than 90% did not present model validation. More than 80% of the studies report limitations in the methods. Only 19% of the studies declare no conflicts of interest. ConClusions: The amount of budget impact analysis has increased, but few studies have yet been carried out based on guidelines and registers all the requirements. Many methodological uncertainties were identified and most of the studies recorded conflict of interest. The budget impact analysis still lack acceptable quality.
The associated cost per relapse for G-Clb as first line therapy was significantly lower compared to R-Clb (G-Clb vs. R-Clb= 4815.6 € vs. 6946.1€ ). Sensitivity analyses showed the robustness of the base case results. The PSA demonstrated that the probability of cost effectiveness was 84% for G-Clb compared to R-Clb. ConClusions: G-Clb represents a cost -effective treatment strategy for unfit CLL patients in R.Macedonia.
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