Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up :

• When low back pain becomes chronic, surgery is sometimes performed. The gold standard today is lumbar fusion (FUS), using a variety of procedures. Total disc replacement (TDR) aimed at motion preservation is increasing in popularity. This randomized controlled health economic study assesses the cost-effectiveness of TDR (Charité/Prodisc/Maverick) compared with instrumented FUS (posterior lumbar fusion (PLF)/posterior lumbar interbody fusion (PLIF). Social and healthcare perspectives after two years are reported. In all, 152 patients were randomized to either TDR (n=80) or FUS (n=72). Cost to society, (total mean cost/patient, Swedish kronor=SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for FUS SEK 685,919 (422,903) (ns). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (43,055- -1,202). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over two years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the “non-difference” in treatment outcome, which is why cost/QALY could not be defined. Using cost-effectiveness probabilistic analysis, the net benefit with CI) was found to be SEK 91,359 (-73,643 – 249,114) (ns). Conclusion: It is not possible to state whether TDR or FUS is more cost-effective after two years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time.

Nyckelord

Disc prosthesis; Lumbar fusion; Cost-effectiveness; Cost-utility; Health economic evaluation

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