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agalsidase alfa (Replagal®)

Reference No. 11

Publication date:

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
Ratification by Welsh Government: 15/11/2007

Current Progress

Ratification by
Welsh Government

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)