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

SMC Update - September 2020

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

Sodium zirconium cyclosilicate (Lokelma®) has been accepted for restricted use, following a resubmission, for use in the treatment of hyperkalaemia in adult patients. The restriction limits use to patients with hyperkalaemia (defined as a serum potassium of >6.0mmol/L) with chronic kidney disease stage 3b to 5 and/or heart failure, who would otherwise need to down-titrate or discontinue their renin-angiotensin-aldosterone system inhibitor (RAASi) therapy to maintain a clinically acceptable serum potassium level. It should be noted the NICE Guidance exists for England and Wales that contains similar restrictions.

Esketamine nasal spray (Spravato®) has been accepted for use in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI), for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

Cannabidiol (Epidyolex®) has been accepted for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome, in conjunction with clobazam, for patients 2 years of age and older. It is noted that this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. As such it would be expected that prescribing would occur in secondary care.

Cannabidiol (Epidyolex®) is accepted for use as adjunctive therapy of seizures associated with Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older. It is noted that this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. As such it would be expected that prescribing would occur in secondary care.

Semaglutide (Rybelsus®) has been accepted for restricted use in the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise. The restrictions limits use to being in addition to other oral anti-diabetic medicines, or as an add-on to basal insulin, as an alternative glucagon-like peptide-1 receptor agonist option.

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