Budgetary Impact Analysis of Levetiracetam use for Focal Epilepsy Patients’ Treatment with or without Secondary Generalization from the Brazilian Public Health System Perspective

Abstract

Objectives: The Brazilian Clinical Protocol and Therapeutic Guideline (PCDT) for epilepsy treatment includes twelve different anti-epileptic drugs (AEDs). Currently, levetiracetam (LEV) is not an option on the PCDT. Our objective was to evaluate the potential budgetary impact of LEV use as monotherapy treatment of focal seizures (partial-onset) with or without second generalization in patients over 16 years old in case of adoption by the National Public Health System. MethOds: A budget impact model was developed covering a 5-year period. Patient population and yearly incidence rates applied in the model were extracted from the Brazilian Unified Health System (SUS) database, the DATASUS. Two hypothetical scenarios were compared based on expert opinion and the current clinical guidelines: levetiracetam monotherapy versus valproic acid monotherapy, both as first line treatments. Subsequent treatment lines were the same in both scenarios: 2nd line-carbamazepine monotherapy; 3rd line-topiramate monotherapy; 4th line-lamotrigine adjuvant; 5th linegabapentin adjuvant; 6th line-surgery. It was assumed that levetiracetam would fully replace valproic acid monotherapy. Yearly drug acquisition of all AEDs and surgery costs were considered in local currency; Reais. Results: 54,532 patients were predicted to receive their first AED (valproic acid or LEV monotherapy) in year 1. Total costs without LEV was R$57,212,820 in the first year increasing to R$87,445,861 in year 5. In contrast, switching first-line treatment to LEV was predicted to cost R$49,479,363 (year 1) and R$81,477,840 (year 5), respectively, attributable to the lower acquisition cost. cOnclusiOns: The introduction of LEV as a new therapeutic option for epilepsy patients with focal seizures with or without second generalization is anticipated to be associated with cost savings of R$5,968,021 in year 5 and cumulative cost savings of R$24.348.756 over 5 years for the Brazilian public health system. UCB-Pharma sponsored.Objectives: To perform a cost-utility (CUA) and budget impact analysis (BIA) of oral dimethyl fumarate (DMF) in the Brazil's Unified Health System (SUS). MethOds: A Markov model was developed to simulate costs and outcomes of relapsing-remitting multiple sclerosis (RRMS) patients. Mutually exclusive health states were based on the Expanded Disability Status Scale (EDSS) score. Patients were initially distributed through EDSS states from 0-5 and could progress and/or relapse on yearly cycles. Treatment sequences were set in accordance with current local guidelines, starting with first-line interferon-beta 1a 22 mcg, 44 mcg or 30 mcg (IFN22, IFN44, IFN30), interferon-beta 1b 300 mcg (IFN300), glatiramer acetate (GLA) or DMF followed by second-line therapies natalizumab (NTZ) or fingolimod (FIN). Costs were obtained from SUS reimbursement lists and efficacy, safety/discontinuation parameters from a published literature systematic review. Results were expressed as incremental cost-utility ratios (ICUR). BIA was based on drug acquisition costs. Eligible po...