Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study)

Abstract

ObjectiveTo evaluate the cost–utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study.DesignA cost–utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial.SettingHospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect.Participants180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91).InterventionsOral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days.Main outcome measuresQuality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost–utility was expressed in incremental cost-effectiveness ratio (ICER).ResultsMean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; −3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%.ConclusionsAmoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.Trial registration numberClinicalTrials.gov NCT02323412.

Cost-Effectiveness of Vaccination of Older Adults with an MF59®-Adjuvanted Quadrivalent Influenza Vaccine Compared to Standard-Dose and High-Dose Vaccines in Denmark, Norway, and Sweden

“…There are no official willingness to pay thresholds in Denmark, Norway, and Sweden. We identified economic evaluations in these countries that use different thresholds ranging from EUR 22,000 to EUR 55,000 per QALY [118][119][120]. To allow easy interpretation of the model results and enable a comparison between the three countries, we adopted a commonly referenced threshold in Europe (~EUR 30,000/QALY) [28,121].…”

Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial

“…Although LBP is not a serious condition with high morbidity, it is nevertheless common and can cause many years of living with disability, productivity loss and reduced quality of life. 2 The threshold of 275,000 NOK is used in other Norwegian LBP studies, 37,38 but there is a possibility that considering just the health care costs could lead to lower priority of this group of patients, as the loss of productivity contributed to most of the societal costs both in earlier studies and in our study.…”

The area ratio of Modic changes has predictive value for postoperative surgical site infection in lumbar spine surgery: a retrospective study

“…Due to the controversy over the duration of antibiotic use, combined with the results of this study, it is recommended that to use antibiotics to reduce the area ratio below the cut-off value (24.62%) before surgery. At the same time, it is necessary to consider the financial burden of the patient and the side effects of the drug [ 32 ].…”