semaglutide (Rybelsus)

following assessment under the abbreviated process:

semaglutide (Rybelsus®) is accepted for restricted use within NHSScotland.

Indication under review: for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise
• As monotherapy when metformin is considered inappropriate due to intolerance or contraindications
• In combination with other medicinal products for the treatment of diabetes.

SMC restriction: 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.

SMC has previously accepted semaglutide solution for subcutaneous injection (Ozempic) for restricted use (SMC2092). Oral semaglutide (Rybelsus) costs the same per day as subcutaneous semaglutide (Ozempic). Prescribers should note that the effect of switching between oral and subcutaneous semaglutide cannot easily be predicted because of high pharmacokinetic variability of oral semaglutide. Clinical effectiveness should be considered when making switching decisions between formulations.

The company’s submission related only to use in addition to other medicinal products for the treatment of diabetes, therefore SMC cannot recommend semaglutide tablets as monotherapy.