OBJECTIVE: To assess the cost effectiveness of the addition of @entity4181 to @entity1487 plus @entity7305 in @entity1 with @entity694 from the perspective of the German Social Health Insurance. STUDY DESIGN AND METHODS: @entity1 with International Union Against @entity5 (Union International Contre @entity5 ; UICC) @entity694 enrolled in an open-label randomised clinical trial in Germany (Forschungsgruppe Onkologie Gastrointestinaler Tumoren-1 [FOGT-1]) received either @entity1487 plus @entity7305 (A, standard) or @entity1487 plus @entity7305 and @entity4181 (B) for 12 months as adjuvant chemotherapy after curative intended surgery. Outcome measures for economic evaluation were disease-free life-years gained (df-LYG) and overall life-years gained (LYG) derived from the respective Kaplan-Meier survival curves. Direct medical costs from the perspective of the German Social Health Insurance were estimated retrospectively (2000 values) and incremental cost-effectiveness ratios (ICERs) were calculated. A Markov model was used to project the trial results beyond 5 years for the @entity1 ' remaining life expectancy. RESULTS: Adding @entity4181 to the @entity1487 / @entity7305 regimen results in an increase in time to progression and survival in @entity1 with locally advanced @entity694 . Within the trial period of 5 years ICERs (B versus A) were 33,008 @entity7634 per df-LYG and 51,225 @entity7634 per LYG (costs and effects discounted at 5%). The Markov model yielded ICERs of 11,176 @entity7634 per df-LYG and 11,020 @entity7634 per LYG (costs and effects discounted at 5%). The model was robust for variations of key variables in the sensitivity analysis. CONCLUSIONS: Results of this cost-effectiveness analysis suggest that the addition of @entity4181 offers clinical benefits at additional costs which are likely to be acceptable for decision makers in the long term. Cost-effectiveness ratios calculated within the clinical trial period were just above 50,000 @entity7634 /LYG. Because treatment benefits, i.e. prolonged survival, are sustained beyond 5 years whereas incremental costs are mainly incurred in the first year, results of the Markov model yielded cost-effectiveness ratios that compare more favourably with other published ICERs.

Cost effectiveness of adding @entity4181 to @entity1487 plus @entity7305 as adjuvant chemotherapy in @entity1 with XXXX in Germany.

@entity4181 :: ('MESH:D002955', 'Chemical') :: ['folinic acid'] @entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer'] @entity7305 :: ('MESH:D007978', 'Chemical') :: ['levamisole'] @entity7634 :: ('9319', 'Species') :: ['Euro'] @entity694 :: ('MESH:D003110', 'Disease') :: ['II/T(4) or UICC III colon cancer', 'colon cancer'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['fluorouracil']
@entity694 :: (MESH:D003110,Disease) :: ['colon cancer']
