The extent of additional benefit granted will in turn influence the reimbursement price.
Categorisation of outcome Proof/indication/hint/no proof of (lack of) (additional) benefit (or harm).
Otherwise, proof of additional benefit is not considered to have been provided due to an incomplete dossier (§9 par. 3 G-BA VerfO; § 35a par. 1 SGB V).
This is usually done if no reliable conclusions regarding the extent of additional benefit can be drawn from the submitted data [8].
The following categories define the magnitude of additional benefit: (1) major, (2) considerable, (3) minor, (4) non-quantifiable, (5) no additional benefit, or (6) less benefit.
Following the results of this study (and those findings that match other work), it may be that, in selected cases (and perhaps revision), reconstruction of the ALL can be found to be of additional benefit to intra-articular ACL reconstruction.
While NICE makes a recommendation regarding reimbursement based on the (combined) appraisal of clinical and cost-effectiveness, G-BA/IQWiG quantify the additional benefit and its results certainty (e.g. proof, indication, or hint of additional benefit).
In particular, the G-BA considers itself not bound by decisions made by the licensing authorities regarding appropriate comparator and patient-relevant endpoints [13], two areas of special relevance in the determination of additional benefit.
The volumetric information contained within CBCT images can also be of additional benefit after a patient's treatment to determine the dose the patient actually received (Hatton et al. 2011).
The degree of additional benefit in terms of cure or longer disease-free survival will be estimated from the available literature, and the costs of the procedure and treatment of any complications calculated.
They might be a bit outside the ideal target price range of most, since I often get asked what's the best option at $100, but the extra $100 gets you a lot of additional benefit with the T10i over any comparable option.
