Dapagliflozin With Metformin
Deferred EndocrinologyAuthority RequiredLater-line line 💬 consumer voice
Type 2 diabetes mellitus as triple oral therapy in combination with a dipeptidyl peptidase 4 (DPP4) inhibitor in patients uncontrolled on dual oral therapy.
1
Submissions
2017–17
On the record
—
ICER range
Cost-min
Cost basis
From the public summary
PBAC outcome
7.1 The PBAC deferred making a decision regarding the Authority Required (STREAMLINED) listing for dapagliflozin and metformin fixed dose combination (FDC) in combination with a dipeptidyl peptidase 4 (DPP4) inhibitor for the treatment of type 2 diabetes mellitus (T2DM) in patients who are uncontrolled on dual oral therapy.PSD · Jul 2017
7.2 The PBAC noted, similar to the concurrent submissions to the July 2017 PBAC meeting (items 5.13 and 6.01 PSDs refer), the requested restriction inappropriately restricted access to the triple therapy to patients who were already taking a DPP4 inhibitor as part of dual oral therapy (i.e. a fixed treatment sequence). This is narrower than the current clinical guidelines as both DPP4 and SGLT2 inhibitors are second line treatment for T2DM.PSD · Jul 2017
Economic analysis
6.4 As a minor submission, an economic comparison was not provided.PSD · Jul 2017
6.5 The PBAC noted that with respect to the concurrent dapagliflozin submission, it considered that the evidence did not suggest that the benefit of metformin + dapagliflozin + a DPP4 inhibitor would be of the same magnitude as the incremental benefit of adding either dapagliflozin or a DPP4 inhibitor to metformin. Therefore, the PBAC was of the view that it would not be cost-effective for dapagliflozin + a 4PSD · Jul 2017
Cost-effectiveness
No economic comparison provided; minor submission submitted on cost-minimisation basis to component parts.
ICER / price too highPrice cut / RSA needed
Decision context
PopulationAdults with type 2 diabetes mellitus uncontrolled on dual oral therapy (metformin and a DPP4 inhibitor) requiring triple oral therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Deferred | co-administered individual components (dapagliflozin and metformin taken separately) | — | RCT · Other |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Dapagliflozin And Metformin Extended Release91%Dapagliflozin With Sitagliptin80%Empagliflozin, Empagliflozin With Metformin, Linagliptin, Linagliptin With Metformin78%Dapagliflozin/Saxagliptin77%Ertugliflozin With Sitagliptin77%Dapagliflozin75%Empagliflozin With Linagliptin75%Saxagliptin And Metformin Extended Release75%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to triple therapy after dual therapy failure; TGA label permits use when both dapagliflozin and metformin are appropriate without prior therapy requirement.