国立保健医療科学院 保健医療経済評価研究センター
Center for Outcomes Research and Economic
Evaluation for Health (C2H), National Institute of
Public Health (NIPH) | URL:http://c2h.niph.go.jp

July 20th, 2023

[C2H2115] Summary of Cost-effectiveness Analysis
Evaluation of Expedium Verse Fenestrated Screw
System
1. Purpose of use
Spine fixation
2. Price of the device
Expedium Verse Fenestrated Screw (EVFS) system has been reimbursed since
March 2022, and the device is priced at JPY 101,000 per screw as of April 2023.
The price was determined using the Similar Efficacy Comparison Method with a
5% premium. The product was designated as an item for the cost-effectivenessevaluation with H2 classification.
3. Scope of Cost-effectiveness Evaluation
The EVFS is a fenestrated spine fixation screw used for spinal fusion. The scopeof the cost-effectiveness evaluation determined at the first session of the Expert
Committee of Cost–Effectiveness Evaluation (ECCEE) is described below.
The target population was osteoporotic patients with reduced bone strength
who undergo multi-intervertebral spinal fusion using spinal fixation screws. The
comparator was a non-fenestrated spine fixation screw with artificial bone.

Targetpopulation

Osteoporotic patients with reduced bone strength who
undergo multi-intervertebral spinal fusion using spinal fixationscrew
Non-fenestrated spine fixation screw + artificial boneComparator(Target technology: Expedium Verse Fenestrated Screw +bone cement)

4. Evaluation of additional benefits
In a previous systematic review and meta-analysis, revision rates after spinal
fusion in osteoporotic patients were significantly lower for fenestrated screws(1.33 (95% CI:0.56%-2.09%)) than for non-fenestrated screws (4.85% (95%CI:2.31%-7.39%)) ((p=0.009)).
Based on these results, the manufacturer concluded that the EVFS system had
additional benefits.
However, the comparators in the previous study were not limited to nonfenestrated screws with artificial bones. As other studies show that using artificial
bone improves spine fixation, it is not appropriate to regard this study as
evidence that matches the scope.
Although the academic group conducted systematic reviews to identify
observational studies and single-arm clinical trials, and considered the possibilityof indirect comparisons, it was not possible to identify evidence that matched thescope.
Therefore, the academic group concluded that the target technology could not
be judged as having an additional benefit.
5. Results of the cost-effectiveness analysis
The manufacturer conducted a cost-minimization analysis regardless of theadditional benefit that the manufacturer claimed, as a cost reduction wasexpected during its analysis. The analysis included medical device and adverse
effect costs, assuming that other costs, such as administration costs, did not
differ between the groups.
In the academic analysis, sincethe medical device price of non-fenestrated
screw, part of the comparator had been revised from JPY 93,500 to JPY 79,100,
it used the renewed price.
The ECCEE accepted the following criteria:
Population
Osteoporotic

Patients with reducedbone strength who undergo multiintervertebral spinal fusion using spinal
fixation screw

Comparator
Non-fenestrated spine
fixation screw +artificial bone

ICER (JPY/QALY)
Costincrease