Coste-Efectividad

Cost-effectiveness of HA-1A monoclonal antibody for gram-negative sepsis. Economic assessment of a new therapeutic agent.




Abstract


OBJECTIVE:

To assess the cost-effectiveness of the HA-1A monoclonal antibody for the treatment of gram-negative bacteremia.


DESIGN:

Cost-effectiveness analysis of a randomized, double-blind, placebo-controlled trial using clinical efficacydata reported in the medical literature.


SETTING:

Hospitalized patients with sepsis.


PATIENTS:

543 patients with sepsis and suspected gram-negative infection. Patients enrolled in the study met strict criteria for sepsis, including fever or hypothermia (less than 35.6 degrees C or greater than 38.3 degrees C), tachycardia (greater than 90 beats per minute), tachypnea (greater than 20breaths per minute), and hypotension or two of six signs of systemic toxicity.


INTERVENTION:

HA-1A vs placebo in addition to usual care.


MAIN OUTCOME MEASURES:

We determined the range of possible cost-effectiveness ratios for HA-1A therapy, using modeling techniques when clinical or economic variables were unknown. We subjected the model to rigorous sensitivity analysis. Wecalculated the incremental cost of care and years of life saved for patients with sepsis and modeled two different treatment strategies: treat all patients with sepsis or test and then treat only patients with positive test results. $24,100 per year of life saved based on the treat strategy and $14,900 based on the test strategy. In sensitivity analysis the ratios ranged from $5200 to $110,200 per yearof life gained. Annual costs of care for these two strategies are $1.3 billion for the test strategy and $2.3 billion for the treat strategy.


CONCLUSION:

Economic assessment of new technologies early in their development can be used to guide their efficient clinical introduction.
















An investigational antiendotoxin antibody (HA-1A) has recently been shown to bean effective treatment for patients with gram-negative sepsis, a syndrome associated with substancial mortality. This agent is given in addition to usual care including antibiotic theraphy and supportive measures, and is reported to have no major side effects

Based on the resulsts of the recently reported HA-1A study, it may be indicated in the treatment of the approximately 400 000 patientswho develop sepsis annually in the unit states. The agent is not effective for sepsis with gram-positive bacteria or for nonbacteremie gram-negative infections. Still if physicians were to follow the treatment criteria suggested by the investigators, 36% of patients with sepsis would be expected to benefit from therapy



The economic implications of this new therapeutic option have yet to beestablished. The HA-1A monoclonal antibody, like other pharmaceuticals developed though genetic engineering research, is expected to be costly when approved and marketed. While the final US price for this agent has yet to be determined, it recently was approved in the Netherlands ant a price of 3750 per dose.



Under proposed medicare regulations, an economic evaluation of this technologywould be required before the health care financing administration would approve funding for this new clinical service. While the final guidelines describing this new funding requirement have not been released, we are interested in applying this principle to the evaluation of HA-1A monoclonal antibody as therapy for patients with gram negative bacteremia.



Economic analyses early in the life of aproduct often are limited by the lack of firm data about the actual clinical use of firm data about the actual clinical use of agents outside the confines of randomized clinical trials, by the tendency nor to collect economic data in trial and by the wide confidence intervals reported for effect estimates based on the relatively small sample sizes found in prospective trials. In response to...