- Prescribing Advice for GPs - https://www.prescriber.org.uk -

SMC Update - August 2014

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Colestilan (BindRen®) has been rejected for the treatment of hyperphosphataemia in adult patients with chronic kidney disease (CKD) stage 5 receiving haemodialysis or peritoneal dialysis. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.

Dapagliflozin and Metformin (Xigduo®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

The restriction limits use to patients where a combination of dapagliflozin and metformin is an appropriate choice of therapy.

Lubiprostone (Amitiza®) has been rejected for the treatment of chronic idiopathic constipation and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g. educational measures, physical activity) are inappropriate. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.

Olodaterol solution for inhalation (Striverdi Respimat®) has been rejected for use as a maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.

Racecadotril (Hidrasec®) has been rejected for complementary symptomatic treatment of acute diarrhoea in infants older than three months and in children, together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.

Umeclidinium / Vilanterol (Anoro®) has been rejected for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.