Dapagliflozin (2) – Forxiga®
Diabetes mellitus type 2
Characteristics
| Start date | 01.01.2018 |
|---|---|
| Resolution | 21.06.2018 repealed |
| INN | Dapagliflozin |
| Brand name | Forxiga® |
| Pharm. company | AstraZeneca GmbH |
| G-BA Procedure ID | D-335 |
| ATC code | A10BK01 SGLT2 inhibitors (A10BK) |
| DDD | 10 mg O |
| Therapeutic area | Metabolic diseases Diabetes mellitus (DM type 1-2) |
| Reason for procedure |
Reassessment: §14 (manufacturer request)
Original resolution: Dapagliflozin (1) (06.06.2013) Repealed by: Dapagliflozin (4) (19.12.2019) |
| Specialty | ACT change |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Forxiga® is indicated in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:Monotherapy - When diet and exercise alone do not adequately control blood glucose in patients in whom the use of metformin is considered inappropriate due to intolerance.Add-on combination therapy - In combination with other blood glucose-lowering medicines, including insulin, when these, together with diet and exercise, do not adequately control blood glucose. | Metformin + sulphonylurea (glibenclamide or glimepiride) or metformin + empagliflozin or metformin + liraglutide |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (DapaZu) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT (off-label) |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 07.11.2017 – vor Dossiereinreichung, |
b) In combination with another blood-glucose-lowering medicinal product (other than insulin; in this case, metformin), if this medicinal product does not adequately control blood glucose levels in conjunction with diet and exercise
- For patients being treated with dapagliflozin in combination with another blood glucose-lowering medicinal product (other than insulin; in this case, metformin), where this medicinal product, together with diet and exercise, does not adequately control blood glucose, the additional benefit is not proven.
- Conclusion
- Overall, the G-BA concludes that the studies submitted for the benefit assessment – DapaZu and D1690C00004 – are not suitable for establishing an additional benefit for dapagliflozin plus metformin compared with the appropriate comparator therapy.
- In the DapaZu study, the titration regimen for glimepiride used in the control arm does not correspond to an adequate, patient-specific titration in accordance with the recommendations of the guidelines and the information provided in the summary of product characteristics (SmPC).
- Similarly, the results of the D1690C00004 study cannot be interpreted due to methodological shortcomings.
- Taken together, the results of the two studies are highly biased due to the study design, and a valid interpretation of the endpoints is not possible. For this reason, the G-BA concludes that for patients treated with dapagliflozin in combination with another blood glucose-lowering medicinal product (other than insulin, in this case metformin) – where this does not adequately control blood glucose levels in conjunction with diet and exercise – additional benefit is not proven compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
<< List of all resolutions