Information intended for healthcare professionals only.
The production of this Guidelines card has been commissioned by MSD. MSD has reviewed this card for technical accuracy and regulatory compliance. The SMC has reviewed this card for technical accuracy and permission request only. The SMC were not involved in the production of this card.
Ertugliflozin (Steglatro®) SMC21021
The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows:
Advice: following a full submission
ertugliflozin (Steglatro®) is accepted for restricted use within NHS Scotland.
Indication under review: in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
- As monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
- In addition to other medicinal products for the treatment of diabetes.
SMC restriction: ertugliflozin is accepted for use as monotherapy and as add-on therapy. When used as monotherapy it is restricted to patients who would otherwise receive a dipeptidyl peptidase-4 inhibitor and in whom a sulphonylurea or pioglitazone is not appropriate.
ertugliflozin was superior to placebo in lowering HbA1c in adults with type 2 diabetes mellitus in phase III studies in monotherapy, dual therapy and triple therapy settings.
About the SMC
The purpose of the SMC is to accept for use those newly licensed medicines that clearly represent good value for money to NHS Scotland. SMC analyses information supplied by the medicine manufacturer on the health benefits of the medicine and justification of its price. As the NHS has limited resources, the SMC works to make sure that those medicines which represent good value for money are accepted for routine use as quickly as possible so that they can benefit patients.
- Scottish Medicines Consortium. ertugliflozin (Steglatro) SMC2102. SMC, January 2019.
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Date of preparation: February 2019