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Monitoring a high-cost drug in critical care units
Critical Care volume 10, Article number: P389 (2006)
Recombinant human activated protein C (APC) (Drotrecogin-alfa activated) was licensed for the treatment of severe sepsis following the large randomised controlled trial, PROWESS . Subgroup analysis of PROWESS and the subsequent ADDRESS  study have shown that only the sickest patients (at least two organ failures or APACHE II score >25) benefit from APC. Treatment is associated with an increased risk of serious bleeding, and so the use of APC is contraindicated in patients at high risk for this complication. The cost of using APC is high, both financially and in terms of possible adverse effects, thus appropriate patient selection is crucial. Upon European Licensing in 2002, the South East London Critical Care Network (SELCCN) successfully bid for funding to use APC on the understanding that the hospital Trusts would provide regular usage reports.
To collect post-licence surveillance data of APC use in severe sepsis across a network of six ICUs (SELCCN). To certify adherence to agreed prescribing guidelines, and to monitor outcome (mortality), adverse events and financial data, thus ensuring best clinical practice and continued funding.
Guidelines for APC were agreed by the SELCCN. A reporting tool and supporting database reflecting these guidelines was designed and implemented to prospectively collect clinical and financial data. The collated data were reported monthly and progress was discussed at local and network meetings.
Data were collected and analysed for 249 patients from November 2002 to June 2005. A total of 87% of patients met the agreed criteria for APC with an average expenditure of €7658 ± €3451 per patient. During treatment, 30 haemorrhagic events were cited with four reported as serious. Of those receiving APC, 126 (51%) where discharged home, 85 (34%) died in the ICU and nine (4%) died as post-ICU patients. Forty per cent of patients with ≥ 4 organs in failure at the time of APC administration were discharged home. Funding was retrieved in at least one site for all patients who received APC.
These results demonstrate that it is possible to develop and ensure excellent adherence to consensus guidelines for the use of a high-cost, life-saving drug. A simple reporting tool allowed easy monitoring of selection criteria, patient outcome, and adverse events across the critical care network. The data show favourable patient outcome especially in those with ≥ 4 organs in failure (40% surviving) when compared with the average survival (19.4%) of a similar group of patients as measured in 91 ICUs throughout the UK . This process of ongoing monitoring of essential data, including cost, ensured a continuous funding stream for this effective therapy and is the first report of such a process in critical illness.
Bernard GR, Vincent JL, Laterre PF, Prowess Study Group, et al.: Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001, 344: 6997-709. 10.1056/NEJM200103083441001
Abraham E, Laterre PF, Garg R, ADDRESS Study Group, et al.: Drotrecogin alfa (activated) for adults with severe sepsis and low risk of death. N Engl J Med 2005, 353: 1332-1341. 10.1056/NEJMoa050935
Green C, Dinnes J, Takeda A, et al.: Clinical effectiveness and cost-effectiveness of drotrecogin alfa (activated) (Xigris®) for the treatment of severe sepsis in adults: a systematic review and economic evaluation. Health Technol Assess 2005, 9: 1-126. iii-iv
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Yassin, S., Wells, H., Batra, R. et al. Monitoring a high-cost drug in critical care units. Crit Care 10, P389 (2006). https://doi.org/10.1186/cc4736
- Severe Sepsis
- Critical Care Unit
- Large Randomise Control Trial
- Reporting Tool
- Haemorrhagic Event