Dapagliflozin/Saxagliptin
Deferred DiabetesRestrictedThird-line line
Type 2 diabetes in adults with inadequate glycaemic control on dual therapy of metformin and a dipeptidyl peptidase 4 (DPP4) inhibitor.
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/saxagliptin fixed dose combination (FDC) for treatment of type 2 diabetes in combination with metformin, to allow further work to establish a price for the triple therapy that could be considered cost-effective.PSD · Jul 2017
7.2 The PBAC considered the nominated comparators as the individual components of FDC, dapagliflozin and saxagliptin, were appropriate. However, the component parts are not currently PBS listed for triple oral therapy in combination with metformin.PSD · Jul 2017
Economic analysis
6.15 A cost-minimisation analysis was presented. The equi-effective doses were estimated as dapagliflozin/saxagliptin 10 mg/5 mg FDC once daily and individual components of dapagliflozin 10mg and saxagliptin 5 mg, once daily.PSD · Jul 2017
6.16 The cost-effectiveness of treatment with dapagliflozin, saxagliptin and metformin was dependent on consideration the July 2017 dapagliflozin major submission. The PBAC noted that they deferred this submission on the basis that cost-effectiveness had not been established.PSD · Jul 2017
Clinical claim
6.13 The submission described dapagliflozin/saxagliptin FDC as bioequivalent to the individual components taken concomitantly. The PBAC considered that this claim was adequately supported. The TGA delegate assessed bioequivalence and considered that it had been demonstrated.PSD · Jul 2017
6.14 However, the PBAC noted that the individual components are not currently PBS listed for use in combination with metformin, and therefore the relevance of this clinical claim is dependent on the clinical claim in the related dapagliflozin submission (item 6.01 refers) being accepted. The PBAC noted that they considered that the clinical claim in item 6.01 was uncertain.PSD · Jul 2017
Financial management – risk sharing
6.28 The sponsor acknowledged that a Risk Share Arrangement may be required but did not provide a proposal.PSD · Jul 2017
6.29 The PBAC noted that in the context of high potential market growth and uptake, a Risk Sharing Arrangement with the sponsor may be required, but that is concern could also be potentially addressed through an appropriate price reduction.PSD · Jul 2017
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission based on bioequivalence rather than cost-effectiveness.
Listing was requested on a cost-minimisation basis compared with corresponding doses of the individual components, dapagliflozin and saxagliptin. PSD · 2017
Decision context
PopulationAdults with type 2 diabetes who do not achieve glycaemic control on dual therapy of metformin and any DPP4 inhibitor.
Why it was knocked back
- Deferral rather than rejection; concerns include: restriction inappropriately limits use compared to clinical guidelines, wording of clinical criteria inconsistent with dapagliflozin major submission (item 6.01), proposed restriction assumes all DPP4 inhibitors interchangeable, potential for quadruple therapy not excluded, cost-effectiveness not established as dapagliflozin triple therapy had not yet been recommended for listing, submission dependent on concurrent dapagliflozin major submission being recommended.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Deferred | individual components of dapagliflozin 10 mg and saxagliptin 5 mg | — | RCT · Bioequivalence (pharmacokinetic parameters); supportive efficacy data from trials on HbA1c change |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to third-line use after dual metformin + DPP4 inhibitor failure; TGA label has no line-of-therapy restriction.