Insulin glargin / Lixisenatid (2) – Suliqua®
Diabetes mellitus type 2, combination with metformin and with SGLT-2 inhibitors
Characteristics
| Start date | 15.04.2020 – Marketing authorisation: 09.03.2020 |
|---|---|
| Resolution | 15.10.2020 |
| INN | Insulin glargin/Lixisenatid |
| Brand name | Suliqua® |
| Pharm. company | Sanofi-Aventis Deutschland GmbH |
| G-BA Procedure ID | D-539 |
| ATC code | A10AE54 Insulins and analogues for injection, long-acting (A10AE) |
| ICD-10 codes (AIS) | E11.01Type 2 diabetes mellitus with hyperosmolarity with coma, E11.11Type 2 diabetes mellitus with ketoacidosis with coma, E11.20, E11.21Type 2 diabetes mellitus with intercapillary glomerulosclerosis, E11.30, E11.31Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema, E11.40Type 2 diabetes mellitus with diabetic neuropathy, unspecified, E11.41Type 2 diabetes mellitus with diabetic mononeuropathy, E11.50, E11.51Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene, E11.60, E11.61Type 2 diabetes mellitus with diabetic neuropathic arthropathy, E11.72, E11.73, E11.74, E11.75, E11.80, E11.81, E11.90, E11.91, E12.01, E12.11, E12.20, E12.21, E12.30, E12.31, E12.40, E12.41, E12.50, E12.51, E12.60, E12.61, E12.72, E12.73, E12.74, E12.75, E12.80, E12.81, E12.90, E12.91, E13.01Other specified diabetes mellitus with hyperosmolarity with coma, E13.11Other specified diabetes mellitus with ketoacidosis with coma, E13.20, E13.21Other specified diabetes mellitus with intercapillary glomerulosclerosis, E13.30, E13.31Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema, E13.40Other specified diabetes mellitus with diabetic neuropathy, unspecified, E13.41Other specified diabetes mellitus with diabetic mononeuropathy, E13.50, E13.51Other specified diabetes mellitus with diabetic peripheral angiopathy without gangrene, E13.60, E13.61Other specified diabetes mellitus with diabetic neuropathic arthropathy, E13.72, E13.73, E13.74, E13.75, E13.80, E13.81, E13.90, E13.91, E14.01, E14.11, E14.20, E14.21, E14.30, E14.31, E14.40, E14.41, E14.50, E14.51, E14.60, E14.61, E14.72, E14.73, E14.74, E14.75, E14.80, E14.81, E14.90, E14.91 Show more >> |
| Alpha-ID codes (AIS) | I110911Diabetic foot syndrome, I110976Diabetes mellitus with eye complications, I110978Diabetes mellitus with neurological complications, I111029Diabetes mellitus with complication, I111031Diabetes mellitus with vascular complication, I111458Secondary diabetes mellitus, I111462Diabetic derailment, I111702Diabetes mellitus type 2b with nephropathy, I111707Diabetes mellitus type 2b with complications, I115660Type 2 diabetes mellitus with diabetic foot syndrome, I119462Type 2 diabetes mellitus in conjunction with malnutrition (malnutrition), I127364Insulin resistance syndrome, type A, I127626Wolfram syndrome, I2202Diabetes mellitus without complications, I25564Diabetes mellitus with coma, I31391Diabetes mellitus with multiple complications, I97452Diabetes mellitus with hypoglycemia, I98004Diabetes mellitus with ketoacidosis, I98511Hypoglycemic coma in diabetes mellitus, I99009Type 2 diabetes mellitus with coma, I99030Type 2 diabetes mellitus with peripheral vascular complication, I99034Type 2 diabetes mellitus with multiple complications, I99037Diet-treated type 2 diabetes mellitus without complications, I99064Hypoglycemic coma in type 2 diabetes mellitus, I99192Type 2 diabetes mellitus with ketoacidosis, I99238Diabetes mellitus type 2 with hypoglycemia |
| DDD | 40 U P |
| Therapeutic area | Metabolic diseases Diabetes mellitus (DM type 1-2) |
| Reason for procedure | New therapeutic indication |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
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Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.
This decision refers to the new combination therapy consisting of insulin glargine / lixisenatid + metformin + SGLT-2 inhibitors. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with type 2 diabetes mellitus who are not adequately controlled by treatment with at least two blood glucose-lowering medicines (other than insulin) | - Human insulin + metformin or – human insulin + empagliflozin or – human insulin + liraglutide or – Human insulin if the specific combination partners are intolerable or contraindicated according to the summary of product characteristics (SmPC) or are not sufficiently effective due to advanced type 2 diabetes mellitus Empagliflozin or liraglutide only for patients with manifest cardiovascular disease who are receiving other medication for the treatment of cardiovascular risk factors, in particular antihypertensives, anticoagulants and/or lipid-lowering agents |
| b) | Adult patients with type 2 diabetes mellitus who are not adequately controlled by treatment with insulin (with or without another blood glucose-lowering drug) | - The optimisation of the human insulin regime (+ metformin or empagliflozin or liraglutide, if applicable). Empagliflozin or liraglutide only for patients with manifest cardiovascular disease who are receiving other medication to treat cardiovascular risk factors, especially antihypertensives, anticoagulants and/or lipid-lowering agents |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Patient eligibility |
- Clinical trials
- The G-BA has reached its decision on whether an additional benefit of insulin glargine/lixisenatide can be established compared with the appropriate comparator therapy, based on the dossier submitted by the pharmaceutical manufacturer, the dossier assessment prepared by the IQWiG, and the statements presented during the written and oral consultation procedures.
a) Adult patients with type 2 diabetes mellitus whose condition is not adequately controlled by treatment with at least two blood glucose-lowering medicinal products (excluding insulin)
- An additional benefit is not proven.
b) Adult patients with type 2 diabetes mellitus whose condition is not adequately controlled by treatment with insulin (with or without another blood glucose-lowering medicinal product)
- An additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Insulin glargin / Lixisenatid (2) | Suliqua® | Sanofi-Aventis Deutschland GmbH | Diabetes mellitus type 2, combination with metformin and with SGLT-2 inhibitors | 532,000 | 100% additional benefit not proven | |
| Insulin glargin / Lixisenatid (1) | Suliqua® | Sanofi-Aventis Deutschland GmbH | Diabetes mellitus type 2 | 461,400–472,500 | 100% additional benefit not proven |
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