Insulin icodec (1) – Awiqli®
Diabetes mellitus type 2
Characteristics
| Start date | 01.09.2024 – Marketing authorisation: 17.04.2024 |
|---|---|
| Resolution | 20.02.2025 |
| INN | Insulin icodec |
| Brand name | Awiqli® |
| Pharm. company | Novo Nordisk Pharma GmbH |
| G-BA Procedure ID | D-1084 |
| ATC code | A10AE07 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, I115660Type 2 diabetes mellitus with diabetic foot syndrome, I119462Type 2 diabetes mellitus in conjunction with malnutrition (malnutrition), I127364Insulin resistance syndrome, type A, I127366Insulin resistance syndrome, type B, I133534MODY (maturity onset diabetes of young people) with peripheral vascular complication, derailed, I133535MODY (maturity onset diabetes of young people) with complication, derailed, I135045MODY (maturity onset diabetes of young people) without complication, derailed, I135047MODY (maturity onset diabetes of young people) with multiple complications, derailed, I135048MODY (maturity onset diabetes of young people) with diabetic foot syndrome, derailed, I135451Insulin resistance syndrome, type A, derailed, I135452Insulin resistance syndrome, type B, derailed, I135745E13.91, I2202Diabetes mellitus without complications, I25560Insulin coma in diabetes mellitus, I25564Diabetes mellitus with coma, I31391Diabetes mellitus with multiple complications, I97452Diabetes mellitus with hypoglycemia, I98004Diabetes mellitus with ketoacidosis, I99009Type 2 diabetes mellitus with coma, I99030Type 2 diabetes mellitus with peripheral vascular complication, I99034Type 2 diabetes mellitus with multiple complications, I99043Type 2 diabetes mellitus without complications, I99065Insulin coma in type 2 diabetes mellitus, I99131Complication of type 2 diabetes mellitus, I99192Type 2 diabetes mellitus with ketoacidosis, I99238Diabetes mellitus type 2 with hypoglycemia |
| Therapeutic area | Metabolic diseases Diabetes mellitus (DM type 1-2) |
| Reason for procedure | Initial assessment |
| Specialty | Bundling Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Treatment of type 2 diabetes mellitus in adults |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a1) | Insulin-naïve adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not responded to their previous drug therapy consisting of at least two blood glucose-lowering medicinal products in addition to diet and exercise, and for whom there is an indication for insulin therapy | Human insulin + metformin |
| a2) | Insulin-naive adults with type 2 diabetes mellitus with manifest cardiovascular disease who have not achieved adequate blood glucose control with their previous drug therapy consisting of at least two blood glucose-lowering medicinal products in addition to diet and exercise, and for whom there is an indication for insulin therapy | - Human insulin + metformin + empagliflozin, or – human insulin + metformin + dapagliflozin, or – human insulin + metformin + liraglutide |
| b1) | Insulin-experienced adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved adequate glycaemic control with their current insulin regime in addition to diet and exercise | Escalation of insulin therapy (conventional therapy (CT) possibly + metformin or dulaglutide or intensified insulin therapy (ICT)) |
| b2) | Insulin-experienced adults with type 2 diabetes mellitus with manifest cardiovascular disease who have not achieved adequate glycaemic control with their previous insulin regime in addition to diet and exercise | Escalation of insulin therapy: conventional therapy (CT) or intensified insulin therapy (ICT), each in combination with metformin and empagliflozin or dapagliflozin or liraglutide |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (ONWARDS 4) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT (off-label)) |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Disease stage |
- Clinical trials
- ONWARDS 1 is an open-label, randomised, active-controlled trial with a treatment duration of 78 weeks. The trial compared the administration of insulin icodec with that of insulin glargine, each in combination with non-insulin antidiabetic agents.
- The open-label, randomised, active-controlled ONWARDS 4 trial investigates the comparison of insulin icodec with insulin glargin, each in combination with insulin aspart, in adults with prior experience of insulin therapy.
a1) Insulin-naïve adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved adequate blood glucose control with their current medication regimen consisting of at least two blood glucose-lowering medicinal products in addition to diet and exercise, and for whom there is an indication for insulin therapy
- The additional benefit is not proven.
- Data from a sub-population of the ONWARDS 1 study were presented to assess the additional benefit of insulin icodec for the treatment of insulin-naïve adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved adequate blood glucose control with their previous therapy consisting of at least two blood glucose-lowering medicinal products, and for whom there is an indication for insulin therapy for the first time, data from a patient population of the ONWARDS 1 study were presented.
- Overall, it cannot be reliably assumed that all participants had an indication for insulin therapy.
- Furthermore, the guideline recommendation for setting individualised target values for patients was not followed.
- Due to these limitations, no conclusions regarding the additional benefit of insulin icodec can be drawn from the ONWARDS 1 study.
- Overall assessment
- Overall, the ONWARDS 1 study is not suitable for the present assessment.
- Additional benefit is therefore not proven.
a2) Insulin-naïve adults with type 2 diabetes mellitus and manifest cardiovascular disease who have not achieved adequate blood glucose control with their current medication regimen consisting of at least two blood glucose-lowering medicinal products in addition to diet and exercise, and for whom there is an indication for insulin therapy
- An additional benefit is not proven.
- For the assessment of the additional benefit of insulin icodec for the treatment of insulin-naïve adults with type 2 diabetes mellitus and manifest cardiovascular disease who have not achieved adequate glycaemic control with their previous therapy consisting of at least two glucose-lowering medicinal products, and for whom there is an indication for insulin therapy for the first time, no data were submitted.
b1) Insulin-experienced adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved adequate blood glucose control with their current insulin regimen in addition to diet and exercise
- The additional benefit is not proven.
- Data from a patient population of the ONWARDS 4 study were submitted for the assessment of the additional benefit of insulin icodec for the treatment of adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved adequate blood glucose control with their current insulin regimen.
- The ONWARDS 4 study is not suitable due to methodological limitations.
- Firstly, deviations from the recommendations of the clinical practice guidelines and the summary of product characteristics (SmPC) were observed.
- Secondly, it is not possible to conclusively assess whether the appropriate comparator therapy was correctly implemented.
- Overall, therefore, no conclusions regarding the additional benefit of insulin icodec in the treatment of insulin-experienced adults can be drawn on the basis of this study.
- Overall assessment
- In summary, the ONWARDS 4 study is not suitable for the present assessment due to methodological limitations.
- The additional benefit is therefore not proven.
b2) Insulin-experienced adults with type 2 diabetes mellitus and manifest cardiovascular disease who have not achieved adequate blood glucose control with their current insulin regimen in addition to diet and exercise
- An additional benefit is not proven.
- No data were submitted for the assessment of the additional benefit of insulin icodec for the treatment of adults with type 2 diabetes mellitus and manifest cardiovascular disease who have not achieved adequate blood glucose control with their current insulin regimen.
Courtesy translation only, please refer to the German original.
Associated procedures
| Insulin icodec (1) | Awiqli® | Novo Nordisk Pharma GmbH | Diabetes mellitus type 2 | 855,000–1,184,000 | 100% additional benefit not proven | |
| Insulin icodec (2) | Awiqli® | Novo Nordisk Pharma GmbH | Diabetes mellitus type 1 | 161,750 | 100% additional benefit not proven |
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