An overall analysis of the ARTSCAN 2 RCT indicates that pre- and post-operative RT are equally effective alternatives for resectable OCC regarding LRC and OS when combinations of surgery of RT are considered (5). The present analysis based on this trial demonstrates that post-operative RT is cost-effective in comparison to pre-operative RT. Arguably, the information will aid to support or refute a specific treatment order of surgery and RT for resectable OCC.
The main finding of this study is that post-operative RT is cost-effective in comparison to pre-operative RT. According to the sensitivity analysis, indirect costs arising from sick-leave and early retirement are primary factors influencing the ICER. The fact that this is revealed despite the minor differences in nominal costs between the treatment regimens reflects the strength of the methodology and indicates the importance of such analyses in addition to mere descriptions of actual cost in assessments of diseases and their associated healthcare measures. Furthermore, differences in costs between pre- and post-operative RT are in keeping with the cost-effectiveness analysis, i.e., a trend for higher costs for the former and lower for the latter, with a statistical significance reached for a 1.24-fold greater direct costs for work-up and treatment for pre-operative RT.
A major strength of the present analysis is that it is based on an RCT, which is a desired design for comparisons of clinical effects and, consequently, for analyses of effectiveness of health care interventions. The patients in an RCT are randomly allocated to a treatment regimen, resulting in estimates of treatment effects that are considered to have high internal validity. This is because patients randomised to different groups will be similar in terms of observed characteristics (i.e., factors affecting the outcome) as well as unobserved characteristics (i.e., factors affecting the outcome but are unknown to the analyst) (7).
There are two previous studies focusing on treatment order of surgery and radiotherapy in head and neck cancer (11, 12), both arguing for post-operative RT, but they do not specifically focus on OCC. Accordingly, this is the first RCT for OCC that can be analysed regarding treatment order when a combination of surgery and RT is considered appropriate. Data from the ARTSCAN 2 RCT are now in press showing a numerical difference in OS (although not statistically significant) in favour of post-operative RT (5). While further data on patient-reported quality-of-life outcome associated with OCC and its treatment will be produced later by the ARTSCAN 2 Study Group, the present analysis compares costs and cost-effectiveness between the treatment regimens. As such the analysis, which is the first of its kind, may be of particular interest to head and neck surgeons/oncologists and health care officials alike, when deciding on how resectable OCC may best be treated from a societal perspective.
There are several studies focusing on societal costs for head and neck cancer, but none exclusively on OCC and the cost-effectiveness of its various treatment options. Furthermore, previous cost studies on head and neck cancer, in general, have key drawbacks. First, they report only direct or indirect costs (13-20). Second, they are “top-down” analyses of registry data, not curated against medical records (18-20). In contrast, the present study assesses costs specifically for OCC including direct medical costs of work-up and treatment from a “bottom-up” perspective and indirect costs (e.g., costs due to sick-leave and early retirement), cleared from costs of co-existing conditions. The advantage of having patient-specific data on both societal costs and outcome is that these can be further used in cost-utility-analyses with a lifetime perspective to determine whether a treatment is justified in terms of health gains for patients with OCC. However, further data on lifetime expectancy, health-related quality of life, palliative care, pharmaceuticals in out-patient care, informal care, and transportation are warranted.
The “bottom-up” analysis of direct costs for OCC and its treatment was of importance to the present analysis and enabled us to clear the data from costs produced by conditions other than, or considered not associated with, OCC. As this detailed level of information was not available for the study population as a whole, we focused on the patient cohort of the Southern Healthcare Region of Sweden. There were no statistically significant differences between this cohort and the remainder of the study population regarding age, gender, and stage distribution. Therefore, the data were extrapolated to the study population as a whole. Furthermore, as the parts of the combined treatment for OCC, i.e., surgery and RT, is executed similarly in Sweden and exclusively by the public health care system, we have no reason to believe that the direct costs retrieved for the Southern Healthcare Region are not representative for Sweden in general. Taken together, our observations arguably represent an accurate assessment of direct and indirect costs associated with resectable oral cancer specified per treatment regimen.