Determination of healthcare resource and cost implications of using alternative sodium valproate formulations in the treatment of epilepsy in children in England: A retrospective database review

Objectives: The aim of this study was to compare the adherence, healthcare resource and cost implications of using Episenta (R) minitablets or Epilim (R) monolithic tablet in the treatment of epilepsy in children in England. Design: This is a retrospective analysis of healthcare administrative databases. Setting: The study analysed data collected from Primary Care (Clinical Practice Research Datalink (CPRD)) and Secondary Care (Hospital Episode Statistics (HES)) in England, UK. Participants: Patients (stratified by age 0-12; 0-17 and 18+ years) with a diagnosis of epilepsy in receipt of a new prescription for Episenta (R) minitablets or Epilim (R) monolithic tablet from January 2012 to October 2017. Limited to those with a minimum of 12 months follow-up. Main outcome measures: Determining the impact of sodium valproate formulation on measures of treatment adherence and healthcare resource usage. Results: There were 793 patients in the dataset: 84 on Episenta (R) minitablets and 709 on Epilim (R) tablets. Measures of medication adherence were not significantly different between the minitablet formulation and the monolithic matrix tablet. However there was a greater annualised incidence rate of epilepsy related primary healthcare contacts in a paediatric population from the tablet formulation compared to those treated with minitablets (95% CI [-1.561,0.0152]) for those aged 0-12 and (95% CI [-1.3234,-0.0058]) for those aged 0-17. This is found despite a lower dose being used in the minitablet cohort (595 mg vs 945 mg for the tablet) for those aged 0-17 which indicates effective therapy at a lower dose using the minitablet compared to the monolithic tablet formulation. Conclusions: Minitablet formulations of sodium valproate (presented as granules in capsules or sachets) can provide better therapeutic outcomes and reduced associated healthcare resource costs compared to monolithic tablets in children and young people with epilepsy. The interpretation of this data is limited by the large difference in sample size between the two groups which needs additional investigation to generate matched data for future comparisons. Further work is required to understand why the Episenta (R) minitablets formulation generated better outcomes in paediatric populations.

Automated summary

This study compared the adherence, healthcare resource, and cost implications of using Episenta (R) minitablets and Epilim (R) monolithic tablet in the treatment of epilepsy in children in England. The results suggest that minitablet formulations may provide better therapeutic outcomes and reduced healthcare resource costs in pediatric populations, particularly for patients aged 0-17. Additional investigation is needed to further understand this difference in outcomes between the two formulations.