Cost-effectiveness of Prednisolone to Treat Bell Palsy in Children

Abstract

Background and Objectives:Bell’s palsy is the third most frequent diagnosis in children with sudden onset neurological dysfunction. The cost-effectiveness of treating Bell’s palsy with prednisolone in children is unknown. We aimed to assess the cost-effectiveness of prednisolone in treating Bell’s Palsy in children compared with placebo.Methods:This economic evaluation was a prospectively planned secondary analysis of a double-blinded, randomized, placebo-controlled superiority trial (BellPIC) conducted from 2015 to 2020. Time horizon was 6 months since randomization. Children aged 6 months to <18 years who presented within 72 hours of onset of clinician diagnosed Bell’s palsy and who completed the trial were included (N=180). Interventions were oral prednisolone, or taste matched placebo administered for 10 days. Incremental cost-effectiveness ratio comparing prednisolone with placebo was estimated. Costs were considered from a healthcare sector perspective and included Bell’s palsy related medication cost, doctor visits and medical tests. Effectiveness was measured using quality-adjusted life-years (QALYs) based on Child Health Utility 9D. Nonparametric bootstrapping was performed to capture uncertainties. Pre-specified sub-group analysis by age 12-18 years versus <12 years was conducted.Results:The mean cost per patient was A$760 in the prednisolone group and A$693 in the placebo group over the 6-month period (difference A$66, 95% confidence interval [CI]: -A$47, A$179). QALYs over 6-months was 0.45 in the prednisolone group and 0.44 in the placebo group (difference 0.01, 95%CI: -0.01, 0.03). The incremental cost to achieve one additional recovery was estimated to be A$1577 using prednisolone compared with placebo, and cost per additional QALY gained was A$6625 using prednisolone compared with placebo. Given a conventional willingness-to-pay threshold of A$50,000 per QALY gained (equivalent to US$35,000 or £28,000), prednisolone is very likely cost-effective (probability is 83%), . Sub-group analysis suggests that this was primarily driven by the high probability of prednisolone being cost-effective in children aged 12-18 years (probability is 98%) and much less so for those <12 years (probability is 51%).Discussion:This provides new evidence to stakeholders and policy makers when considering whether to make prednisolone available in treating Bell’s palsy in children aged 12-18 years.Trial Registration:Australian New Zealand Clinical Trials Registry ACTRN12615000563561.

Development of algorithms for estimating the Child Health Utility 9D from Caregiver Priorities and Child Health Index of Life with Disabilities

“…The CHU9D is a generic MAUI designed for children and adolescents aged 7–17 [ 20 ]. Xiong et al [ 21 ] reported that the CHU9D can be used for children between the ages of 5 and 18, with parent-report for children aged 5–7 years and self-report for children aged 8–18 years. It consists of nine questions that assess child’s worry, sadness, pain, fatigue, annoyance, schoolwork, sleep, daily routine, and ability to participate in activities.…”

“…Caregivers provide their views on their child over the preceding 24 hours using a 5-level response rating, ranging from 0 (no problems) to 5 (severe problem) [ 22 ]. The CHU9D can be completed by either children themselves or a proxy [ 21 ]. In this study, a proxy-report was used because many non-ambulatory children with CP were unable to complete questionnaires by themselves.…”

Can an Intervention Be Cost-effective Following a Negative Clinical Trial?

“…The article by Xiong, et al, 2 which reports the results of a CEA conducted alongside a randomized, blinded placebo-controlled clinical trial of prednisolone in children with Bell palsy (BellPIC), 3 begs this very question. The BellPIC RCT looked at the outcome of complete clinical recovery at 1, 3, and 6 months and found no difference in recovery rates at any of the end points in the placebo and intervention groups.…”

Pain in children with Bell’s palsy: secondary analysis of a randomised controlled trial

“…As part of a larger body of work to improve the care of children with Bell’s palsy, we recently completed a randomised controlled trial (RCT) of prednisolone for the treatment of Bell’s palsy. The study did not find any benefit of prednisolone in the recovery of complete facial function at 1 month,4 17 as measured using the clinician-administered House-Brackmann Scale (primary outcome). Given the lack of available data on pain in children with Bell’s palsy, the aim of the current study was to describe the prevalence and severity of pain experienced by children with Bell’s palsy over the 6-month period following symptom onset.…”