Intravenous and Subcutaneous Immunoglobulin Prescribing Guidance

Introduction

Normal human immunoglobulin is manufactured from human plasma and contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. It is usually prepared from pooled plasma from not fewer than 1000 donors. Adequate doses can restore abnormally low immunoglobulin G levels to the normal range and thus help against infections. The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.

Indications for use are numerous with critical need as well as the effectiveness of treatment variable; it is life saving for some patients for whom no alternative treatment exists while others do have clinically effective, and often more cost effective, alternatives available.

There have been global and in particular, UK supply issues with Immunoglobulin preparations, on a background of increased demand. Due to this and questions regarding cost effectiveness in some indications, intravenous Immunoglobulins (IVIg) and subcutaneous immunoglobulins (SCIg) are subject to a national Demand Management Plan.

Policy Details