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agalsidase alfa (Replagal®)


Reference No. 11

Publication date:
20/11/2007


Appraisal information

agalsidase alfa (Replagal®) 1 mg/ml concentrate for solution for infusion


Company: Shire Human Genetic Therapies
BNF category: Nutrition and blood
NMG meeting date: 12/09/2007
AWMSG meeting date: 18/10/2007
   
   
Submission Type: Full Submission
Status: Recommended
Advice No: 1107
Ministerial ratification: 15/11/2007

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

Agalsidase alfa (Replagal®) should be recommended for use within NHS Wales as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease. Patients receiving agalsidase alfa (Replagal®) will be entered into the Fabry Outcomes Survey. AWMSG urge the manufacturers of agalsidase alfa and agalsidase beta to develop a combined outcomes database. Treatment will be administered under the supervision of a physician experienced in the management of Fabry disease or other inherited metabolic diseases. Treatment will be administered according to agreed guidelines at appropriate designated centres. AWMSG will review this and other enzyme replacement therapies within three years.
Final Appraisal Recommendation (FAR)
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