colesevelam hydrochloride (Cholestagel)

In the absence of a submission from the holder of the marketing authorisation

Colesevelam hydrochloride (Cholestagel), is not recommended for use within NHSScotland for the treatment of:

- primary hypercholesterolaemia, co-administered with an HMG-CoA reductase inhibitor (statin), as adjunctive therapy to diet to provide an additive reduction in LDL-cholesterol levels in patients not adequately controlled with a statin alone.

- as monotherapy as adjunctive therapy to diet for reduction of elevated total and LDL- cholesterol in patients with isolated primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.