| Aims: 1.To gauge the burden of epilepsy in Guangzhou and to evaluate the outpatient chronic disease policy.2.To summarize the available evidence and assess the clinical effectiveness and safety of Levetiracetam as adjunctive treatment in children with focal-onset epilepsy And to evaluate the cost effectiveness of standard antiepileptic drug therapy plus leveriracetam compared with standard therapy in treating children with focal-onset seizures.Methods: 1.Economic burden analysis of epilepsy in Guangzhou: Collected the visiting data of all medical insured patients diagnosed as epilepsy in the medical insurance database of Guangzhou from April 2013 to December 2016,Descriptive analysis was used to analyze the basic information of disease burden of epilepsy,expenditure pattern and the distribution of hospitals in patients with epilepsy in Guangzhou.Using Stata 14.0 software,t test and multiple linear stepwise regressions were used to analyze the effect of age,sex,type of medical insurance,medical organization grade on the medical expenses.2.Systematic review: Databases Pub Med(Medline),Web of Science,the Cochrane Central Register of Controlled Trials,and the US NIH Clinical Trials Registry(www.clinicaltrials.gov)were searched for prospective clinical trials that included children with focal-onset seizures who received Levetiracertam.We included randomized controlled trials(RCTs)or controlled cohort studies that compared Levetiracetam and ST,as well as self-controlled studies regarding adjunctive Levetiracetam in children with FOS.A pooled analysis would be performed for prospective self-controlled clinical trials and a Meta-analysis for controlled studies.Overall response rate(ORR)and 95% confidence intervals(CIs)were used to describe outcomes(effectiveness and safety)in self-controlled studies.Mantel-Haenszel risk ratios(RRs)with 95% CIs were used to describe outcomes in controlled studies.The Meta-analysis was performed using Stata 14.3.Cost-effectiveness analysis: The treatment pathway of a hypothetical cohort of 1000 patients over 10 years was simulated using a combination of decision tree and Markov model from the perspective of the Chinese healthcare payer.Using three times of Gross Domestic Product(GDP)per capita per year in 2017 of RMB178090 as the threshold for willingness-to-pay(WTP),all cost and effectivenss were discounted to the year of 2018 at a discounting rate 3%.Results: 1.During the period of April 2013 to December 2016,there are a total of 18477 patients with epilepsy insured by Guangzhou Medical Insurance.There are 12665 medical insurance for urban workers,5812 Medical insurance for urban and rural residents and a total of 220794 hospital visits.Most of the hospitals are tertiary hospitals.The total cost of medical treatment is 152950800 yuan.Hospitalization expenses accounted for 65.7%.The annual medical expenses,the number of visits,the number of visits per person and the per capita cost of the patients with epilepsy in Guangzhou was on rise for past four years.In 2016,the annual medical expenses for patients with epilepsy in guangzhou increased to 53016800 yuan,the number of visits was 101326.76 per capita,the annual per capita self-payment was 2307 yuan and the co-payment rate was 44.1%.The disease burden of medical insurance for non-working urban residents was higher than that of employees.Outpatient chronic disease method is the main way of seeing a doctor.The disease burden of children with seizures was more heavy with Lower reimbursement level.The cost and length of hospitalization of patients covered by outpatient chronic disease policy were significantly lower than that of patients without.2.Eighteen articles involving 1131 pediatric patients were identified.For effectiveness assessment,add-on LEV was more effective than ST group.The pooled RRs and 95% CIs for the 50% responder rate,seizure freedom rate were 1.98(1.49-2.63),5.12(2.09-12.51)between LEV group and ST group respectively.The ORRs and 95% CIs were 56.0%(52.0%-60.0%)and 14.0%(9%-19%)for LEV group respectively.For safety assessment,add-on LEV was fairly tolerated.The pooled RRs and 95% CIs of at least one ADR-related TEAE rate,the ADR-related withdrawal rate and at least one TEAEs were 1.45(1.13-1.86),0.91(0.42-1.98)and 1.03(0.94-1.13)respectively.The ORRs and 95% CIs were 47.6%(40.1%-55.1%),74.0%(94.0%-94.0%),5.9%(3.6%-8.3%).The TEAEs significantly associated with LEV were somnolence and hostility.3.Over a 10-year period,standard antiepileptic drug therapy plus Levetiracetam led to a n increase of 0.56 quality-adjusted life-years(QALYs)and a cost dectease of 70956.55 yaun per patient compared with standard therapy alone.The incremental cost-effectiveness ratio(ICER)for Levetiracetam add-on was was 126708.3 yuan per QALY per year.-.The ICER values not exceeded the predefined WTP(three times of GDP per capita per year),showing that LEV group was more cost-effective than ST group for children with focal-onset seizures.The results of one-way sensitivity analysis showed that the time horizon had the greatest impact on ICER,showing that add-on Levetiracetam in children with focal-onset seizures in short-term was less cost-effective.According to the probability sensitivity analysis,there was a probability of 91.5% for LEV group being more cost-effective than ST group with a WTP of 178980.For cities or provinces with a GDP per capita per year less than 39992,there was a probability of less than 50% for LEV group being more cost-effective than ST group for children with focal-onset seizures.Conclusion: The average annual medical expenses and self-payment of patients with epilepsy in Guangzhou medical insurance are within the affordable range.It is suggested that we should improve the reimbursement of medical insurance for patients with medical insurance appropriately,especially junveniles with epilepsy.In children with focal epilepsy,add-on Levetiracetam can significantly reduce seizure frequency and fairly toleratedt between LEV group and ST group.As WTP was predefined as three times of GDP per capita per year,LEV group showed a probability of 91.5% being more cost-effective than ST group for children with focal-onset seizures. |
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