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ATC codes: A10BK03
Indication
Type 2 diabetes mellitus ICD11 code: 5A11
INN
Empagliflozin
Medicine type
Chemical agent
List type
Core
Formulations
Oral > Solid: 10 mg ; 25 mg
EML status history
First added in 2021
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
Medicines within the same pharmacological class can be used
Patent information
Main patent is active in several jurisdictions. For more information on specific patents and license status for developing countries visit www.MedsPal.org
Expert Committee recommendation
Since SGLT2 inhibitors were last reviewed by the Expert Committee in 2017, new evidence has confirmed the positive effect of SGLT2 inhibitors compared with placebo on all-cause mortality, cardiovascular outcomes (cardiovascular mortality, non-fatal myocardial infarction and hospital admission for unstable angina), renal outcomes (kidney failure, end-stage renal disease and renal death), body weight and HbA1c. Based on this new evidence, the Expert Committee had increased confidence in the cumulative estimates and overall evidence for relevant clinical benefits associated with SGLT2 inhibitors as add-on therapy. The Committee noted that the situation is less clear when comparing SGLT2 inhibitors with GLP-1 RAs, although the SGLT2 inhibitors seem to be the preferred option as they are consistently associated with favourable results for most cardiovascular outcomes and are orally administered in contrast to GLP-1 RAs that need to be injected. The Committee considered that SGLT2 inhibitors are associated with some relevant adverse events such as urogenital infections, Fournier gangrene, osmotic diuresis and euglycemic diabetic ketoacidosis. However, overall, the benefit-to-risk ratio favours SGLT2 inhibitors, particularly in patients with cardiovascular and kidney disease. While prices are substantially higher than for the oral hypoglycaemic agents currently listed on the EML (metformin and sulfonylureas), cost–effectiveness analyses, mainly conducted in high-income countries, suggest favourable incremental cost–effectiveness ratios at usual willingness-to-pay thresholds, given the effect of SGLT2 inhibitors on hard clinical outcomes. The Expert Committee therefore recommended the inclusion of SGLT2 inhibitors on the core list of the EML as a second-line therapy for patients with type 2 diabetes who have not achieved appropriate glycaemic control with metformin or a sulfonylurea. High-quality evidence shows there are clinically beneficial effects in this population, particularly in those at high risk of cardiovascular events and/or diabetic nephropathy, and there is a reasonable safety profile. The Committee recommended listing empagliflozin as the representative of the pharmacological class, with canagliflozin and dapagliflozin as therapeutic alternatives. The Expert Committee also recommended that the Medicines Patent Pool explores how to facilitate affordable access to SGLT2 inhibitors in low- and middle-income countries through public health-oriented licences with the companies holding the patents.