This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

To summarise the available evidence on activated protein C for severe sepsis.

- Severe sepsis is a systemic inflammatory response to infection involving organ dysfunction. Severe sepsis is a common cause of death and is associated with a 20% to 56% mortality rate.

- Drotrecogin alpha (activated) is a recombinant human activated protein C (rhAPC) approved in the U.S. for the reduction of mortality in adult patients with severe sepsis who have a high risk of death.

- Drotrecogin alpha (activated), when administered to adult patients with clinically-defined severe sepsis, demonstrated a 6.1% absolute reduction (p=0.005) in 28-day all-cause mortality in one published, randomized, double-blind study of 1,690 patients (PROWESS).

- Drotrecogin alpha (activated) is used as an adjunct to standard therapy and is therefore an "add-on" cost.

- Close attention must be paid to proper patient selection for treatment with drotrecogin alpha (activated). Certain individuals, such as those at a greater risk of bleeding, could be harmed from therapy. The benefit or harm in individuals not meeting the trial selection criteria is uncertain.