‘Order from chaos’, an unsound foundation for decisions in health care?: Non-adherence to disease-specific guidelines for pharmacoeconomic studies in rheumatoid arthritis
Amr Ahmed Mahmoud Abdelkader Makady, .
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Objectives: Biologic drugs used in treatment of rheumatoid arthritis (RA) increase economic burden of RA on health care systems. Thus, pharmacoeconomic (PE) studies of treatment options in RA are valuable for decision-makers in the health care sector. Previous literature has demonstrated the presence of wide variations in PE study outcomes and methodology. This study aimed to firstly examine whether major variations still exist in PE study outcomes and methodology for RA treatment, and secondly, assess whether PE studies in RA treatment options adhered to RA disease-specific guidelines presented by OMERACT-ILAC. Methods: A literature review was conducted for PE studies evaluating TNF-α inhibitors use in RA. Four different databases (e.g. Embase, NIHR-EED) were searched for PE studies that focussed on Adalimumab between October 2003 and May 2013. Methodological quality of included studies was checked using the CHEC-checklist. Data extraction forms were used to retrieve information such as study outcomes (QALY’s, costs, ICER’s) and modelling methods and parameters (e.g. time horizon, sources for costs and effectiveness data). Finally, information retrieved from all studies was compared to recommendations proposed by the OMERACT-ILAR guideline of 2002. Results: Ten studies were identified that met all inclusion criteria and were consequently included in our analysis. All studies met at least 12 of the 19 items of the CHEC checklist for quality and 4 studies met all 19 items. Study outcomes varied considerably in QALY’s calculated, costs and ICER’s. Patient subtypes investigated, modelling methods, sources for cost and effectiveness data also varied significantly. Only 1 of the 12 recommendations presented in the OMERACT-ILAR guideline was unanimously implemented in all 10 studies of our review. Only 1 study was found to contain all elements of guideline recommendations, albeit with some limitations Conclusions: Considerable variations still exist in outcomes and methodologies for PE studies of Adalimumab in the treatment of RA. Adherence to disease-specific guidelines for the conduct of PE studies in RA is very low. Development of strict disease-specific guidelines in RA and subsequent adoption by re-imbursement agencies is vital to ensure comparability and validity of PE study outcomes during decision-making in the health care setting.