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drotrecogin alfa (Xigris®)


Reference No. 116

Publication date:
31/07/2003


Appraisal information

drotrecogin alfa (Xigris®) powder for solution for infusion


Company: Eli Lilly & Co Ltd
BNF category: Cardiovascular system
NMG meeting date: Not scheduled
AWMSG meeting date: 04/03/2003
   
   
Submission Type: Full Submission
Status: Marketing authorisation withdrawn
Advice No: Not available
Ministerial ratification: 31/07/2003

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

LICENCE WITHDRAWN. AWMSG ADVICE SUPERSEDED BY NICE GUIDANCE (TA84) NICE GUIDANCE ISSUED SEPTEMBER 2004 (Refer to NICE website for full guidance on NICE recommendations, including any specific restrictions on the use of the technology) Drotrecogin alfa (activated) for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care was appraised by the All Wales Medicines Strategy Group at a meeting held on the 4th March 2003. The outcome of the appraisal was to approve the drug for use within NHS Wales with restrictions, which included: • Inclusion and exclusion criteria to be as set out in the PROWESS study. • Welsh Intensive Care Society to agree standards and audit criteria with WMP/AWMSG. • Ability of units to meet the standards set out in the audit and contribute the necessary data sets. The audit criteria were agreed with the Welsh Intensive Care Society in July 2003. All units in Wales that use drotrecogin alfa (activated) are required to complete the data collection forms and collaborate in the Welsh Intensive Care Society audit to be reported to AWMSG in March 2004. The use of drotrecogin alfa (activated) in accordance with the specified criteria has the full support of AWMSG.
Final Appraisal Recommendation (FAR)
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