Presentation (CTI)

OBJECTIVES: To estimate the three-year budget impact of introducing ravulizumab for adult patients with anti-acetylcholine receptor antibody-positive (AChR+) refractory/poorly controlled generalised myasthenia gravis (gMG) from an Ecuadorian National Health System perspective, with indirect (productivity) costs added to reflect a partial societal view.
METHODS: A static budget impact model compared two scenarios over 2026-2028: a current scenario (standard of care: pyridostigmine, prednisone, azathioprine, intravenous immunoglobulin [IVIG], rituximab) versus progressive ravulizumab uptake (market shares 13%/59%/62% in years 1-3). Costs covered drug acquisition, medical procedures, adverse events, healthcare resource utilisation (HCRU), and productivity losses, sourced from Ecuador's medicine price ceilings (STFP), the National Health System tariff, and IESS statistics. The eligible population was derived by applying gMG prevalence, AChR+, treated-symptomatic, and refractory fractions to national projections. A 71% reduction in hospitalizations/exacerbations was applied from the CHAMPION-MG program.
RESULTS: Annual cost per patient was USD 227,289 for ravulizumab versus USD 203,752 for the standard of care. Although acquisition was higher with ravulizumab (USD 216,326 vs 165,897), it incurred lower HCRU (USD 10,513 vs 36,384), adverse-event (USD 0 vs 399), and productivity (USD 283 vs 977) costs. The incremental budget impact rose from USD 94,149 (+1.5%) in year 1 to USD 470,747 (+7.2%) in year 3, for a cumulative three-year impact of USD 1,012,105. By category, the year-3 acquisition increase (+USD 1,008,592) was partly offset by savings in HCRU (-USD 517,405), adverse events (-USD 7,988), and productivity (-USD 13,875).
CONCLUSIONS: Adopting ravulizumab for AChR+ refractory/poorly controlled gMG would generate a moderate, progressive net budget increase for the Ecuadorian health system, driven by acquisition costs but substantially offset by reductions in hospitalisations, adverse events, and productivity losses indicative of better disease control. In a resource-constrained setting, these downstream and indirect offsets are relevant to coverage decisions on high-cost complement inhibitors for rare diseases.