Cost-Effectiveness Study of the Use of Fibrinogen Concentrate (Clottafact®) in Patients with Major Bleeding and Trauma Requiring Surgery in Mexican Public Health Institutions

OBJECTIVES:

This study conducts an economic evaluation of the cost-effectiveness of human fibrinogen concentrate (Clottafact®) + blood products versus the national standard treatment (use of blood products only) for the treatment of patients with severe bleeding due to trauma (with low levels of human fibrinogen and usually requiring surgery) within the Mexican public health institutions.

METHODS:

First, we used a decision tree to model the percentage of control of coagulopathies by each of the treatment options: blood products + human fibrinogen concentrate or standard treatment (use of blood products only). We then used the probability of death associated with each final stage of the decision tree: controlled or uncontrolled bleeding by treatment alternative. In each treatment branch, all direct medical costs associated with the patients were considered. Finally, we performed a probabilistic analysis to explore the robustness of our assessment under different conditions of uncertainty.

RESULTS:

We found that the use of human fibrinogen + blood products is a dominant strategy over the use of blood products alone, associated with a total cost of MXN 560,712 and 0.094 deaths for each severe acute trauma event, versus MXN 582,433 and 0.17 deaths for the standard treatment. Then, the incremental savings with human fibrinogen + blood products was MXN 21,721, while the average number of deaths averted was 0.076 per event.

CONCLUSIONS:

The use of human fibrinogen concentrate (Clottafact®) is associated with both savings to the Mexican public health institutions and a significant reduction in deaths associated with severe bleeding during surgery. The human fibrinogen concentrate is able to provide a benefit to a specific group of patients where there is currently an unmet need.