Cost Of Adverse Events Associates With the Management of Invasive Mold Disease With Isavuconazole Compared With Voriconazole in Spain
Author(s)
MARIA CARLOTA MOYA, PharmD1, Manuel Galvez, MD1, José Ramón Azanza, MD2, Isabel Izquierdo, MD3, Vicente Merino-Bohórquez, ParmD4, José Tiago Silva, MD5, Carlos Rubio Terrés, MPharmacol, MHE, BSc6, Edward Ivor Broughton, MD7.
1PFIZER SLU, MADRID, Spain, 2Universidad de Navarra, Pamplona, Spain, 3Hospital Universitario Miguel Servet, Zaragoza, Spain, 4Hospital Universitario Virgen Macarena, Sevilla, Spain, 5Hospital Universitario 12 de Octubre, MADRID, Spain, 6HEALTH VALUE, Madrid, Spain, 7Pfizer, New York, NY, USA.
1PFIZER SLU, MADRID, Spain, 2Universidad de Navarra, Pamplona, Spain, 3Hospital Universitario Miguel Servet, Zaragoza, Spain, 4Hospital Universitario Virgen Macarena, Sevilla, Spain, 5Hospital Universitario 12 de Octubre, MADRID, Spain, 6HEALTH VALUE, Madrid, Spain, 7Pfizer, New York, NY, USA.
OBJECTIVES: To analyze the cost of adverse events (AEs) associated with isavuconazole (ISA) vs voriconazole (VORI) in the treatment of invasive fungal infections (IFI) in Spain.
METHODS: A systematic literature review (following PRISMA guidelines) of comparative clinical studies (experimental and observational) of ISA and VORI in patients with IFI was conducted. Published studies (full articles; PubMed or clinicaltrials.gov databases) that systematically captured the frequency of individual AEs observed during treatment were selected. The cost of AEs (€ 2025) was calculated based on their frequency, differentiating between severe and mild-moderate, using ISA or VORI and the cost of management from the Spanish National Healthcare System (NHS) perspective obtained from Spanish sources (published studies and public healthcare prices). A Monte Carlo simulation (1,000 iterations) was performed, to calculate the mean cost (95% CI), and the probability of savings with the best-tolerated treatment compared to the worst-tolerated treatment.
RESULTS: Five studies were initially included, but only one study met the inclusion criteria: the SECURE study, a double-blind randomized clinical trial, which included 257 and 259 patients with invasive aspergillosis treated with ISA and VORI, respectively. The frequency of AEs was taken from the final study report published at www.clinicaltrials.gov, as it included all observed AEs (134 and 149 severe AEs and 227 and 228 mild-to-moderate AEs, respectively). The mean cost per patient of managing AEs was €1,657.47 (95% CI: €1,323.28; €2,002.62) with ISA and €2,148.46 (95% CI: €1,715.27; €2,595.85) with VORI. Therefore, the improved tolerability of ISA vs VORI would result in an average saving per patient of €491 (95% CI: €392-€593), with a 100% probability of saving (savings occurred in all 1,000 analyses performed).
CONCLUSIONS: According to this analysis based on AEs, the improved tolerability of ISA vs VORI would result in significant savings per treated patient.
METHODS: A systematic literature review (following PRISMA guidelines) of comparative clinical studies (experimental and observational) of ISA and VORI in patients with IFI was conducted. Published studies (full articles; PubMed or clinicaltrials.gov databases) that systematically captured the frequency of individual AEs observed during treatment were selected. The cost of AEs (€ 2025) was calculated based on their frequency, differentiating between severe and mild-moderate, using ISA or VORI and the cost of management from the Spanish National Healthcare System (NHS) perspective obtained from Spanish sources (published studies and public healthcare prices). A Monte Carlo simulation (1,000 iterations) was performed, to calculate the mean cost (95% CI), and the probability of savings with the best-tolerated treatment compared to the worst-tolerated treatment.
RESULTS: Five studies were initially included, but only one study met the inclusion criteria: the SECURE study, a double-blind randomized clinical trial, which included 257 and 259 patients with invasive aspergillosis treated with ISA and VORI, respectively. The frequency of AEs was taken from the final study report published at www.clinicaltrials.gov, as it included all observed AEs (134 and 149 severe AEs and 227 and 228 mild-to-moderate AEs, respectively). The mean cost per patient of managing AEs was €1,657.47 (95% CI: €1,323.28; €2,002.62) with ISA and €2,148.46 (95% CI: €1,715.27; €2,595.85) with VORI. Therefore, the improved tolerability of ISA vs VORI would result in an average saving per patient of €491 (95% CI: €392-€593), with a 100% probability of saving (savings occurred in all 1,000 analyses performed).
CONCLUSIONS: According to this analysis based on AEs, the improved tolerability of ISA vs VORI would result in significant savings per treated patient.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE176
Topic
Economic Evaluation
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
Infectious Disease (non-vaccine)