[Cost-effectiveness of drotrecogin alpha [activated] in the treatment of severe sepsis in Spain].
BACKGROUND
The PROWESS clinical trial has shown that treatment with drotrecogin alpha (activated) in patients with severe sepsis is associated with a reduction in the absolute risk of death compared with standard treatment. The aim of the present study was to assess the cost-effectiveness of drotrecogin alpha (activated) versus that of standard care in the treatment of severe sepsis in Spain.


METHODS
A decision analysis model was drawn up to compare costs to hospital discharge and the long-term efficacy of drotrecogin alpha (activated) versus those of standard care in the treatment of severe sepsis in Spain from the perspective of the health care payer. Most of the information for creating the model was obtained from the PROWESS clinical trial. A two-fold baseline analysis was performed: a) for all patients included in the PROWESS clinical trial and b) for the patients with two or more organ failures. The major variables for clinical assessment were the reduction in mortality and years of life gained (YLG). Cost-effectiveness was expressed as cost per YLG. A sensitivity analysis was applied using 3% and 5% discount rates for YLG and by modifying the patterns of health care, intensive care unit costs, and life expectancy by initial co-morbidity and therapeutic efficacy of drotrecogin alpha (activated).


RESULTS
Treatment with drotrecogin alfa (activated) was associated with a 6.0% drop in the absolute risk of death (p = 0.005) when all of the patients from the PROWESS trial were included and with a 7.3% reduction (p = 0.005) when the analysis was restricted to patients with two or more organ failures. The cost-effectiveness of drotrecogin alfa (activated) was 13,550 euros per YLG with respect to standard care after analysing all of the patients and 9,800 euros per YLG in the group of patients with two or more organ failures. In the sensitivity analysis, the results ranged from 7,322 to 16,493 euros per YLG. The factors with the greatest impact on the results were the change in the efficacy of drotrecogin alfa (activated), adjustment of survival by initial co-morbidity and the application of discount rates to YLG.


CONCLUSIONS
Treatment with drotrecogin alfa (activated) presents a favorable cost-effectiveness ratio compared with other health care interventions commonly used in Spain.
Departamento de Investigación Clínica, Lilly España.
José A
JA
Sacristán
Luis
L
Prieto
Teresa
T
Huete
Antonio
A
Artigas
Xavier
X
Badia
Christopher
C
Chinn
Peter
P
Hudson
D000890:Anti-Infective Agents / Q000191:economics* / Q000627:therapeutic use; D015897:Comorbidity; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D016527:Drug Costs; D017052:Hospital Mortality; D006801:Humans; D008017:Life Expectancy; D009102:Multiple Organ Failure / Q000209:etiology / Q000401:mortality; D011486:Protein C / Q000191:economics* / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000191:economics* / Q000627:therapeutic use; D012680:Sensitivity and Specificity; D018805:Sepsis / Q000150:complications / Q000188:drug therapy / Q000191:economics* / Q000401:mortality; D013030:Spain / Q000453:epidemiology; D016019:Survival Analysis
D000890:Anti-Infective Agents; D011486:Protein C; D011994:Recombinant Proteins; C421124:drotrecogin alfa activated