The Norwegian Knowledge Centre for the Health Services (NOKC) has considered evidence submitted from a producer / supplier of medical equipment. The issue was whether it would be advisable to use the serum marker S100B in the diagnosis of minor head injuries instead of CT, based on evaluation of efficacy, safety and cost effectiveness.

Roche Diagnostics submitted evidence and made reasonable changes in the intended use. Estimates of diagnostic accuracy shows that the ability of S100B to discover head injuries is likely to be slightly less than 100% compared with CT. This means that there may be patients with head injuries not detected by measurement of S100B.

Submitted documentation for evaluation of cost-effectiveness is a cost-minimization analysis. The analysis assumes that clinical outcomes for the patients would be the same irrespective of being diagnosed using CT or the new alternative, S100B and selected CT. NOKC believes a switch from evaluation with CT to S100B analysis may lead to organizational changes for example reallocation of personnel. This is not considered in the submission.

NOKC concludes that S100B compared with CT for patients with minor head injury does not necessarily give identical results. Therefore, the results of the submitted documentation, a cost-minimization, will not fully be able to answer the question of RHA Forum (Regional Health Authorities Forum for the commissioning of HTAs).