Ertugliflozin With Sitagliptin
Recommended · restricted EndocrinologyRestricted
Type 2 diabetes mellitus in patients inadequately controlled on dual oral therapy with metformin and a dipeptidyl peptidase 4 inhibitor or sodium-glucose co-transporter 2 inhibitor.
1
Submissions
1 resub
2018–18
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Jul 2018Recommended · restricted
vs dapagliflozin plus saxagliptin plus metformin…
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the Authority Required (STREAMLINED) listing of ertugliflozin with sitagliptin FDC products for use in triple oral therapy in combination with metformin in patients with T2DM who are inadequately controlled on metformin and a DPP4 or SGLT2 inhibitor based on cost-minimisation to dapagliflozin with saxagliptin plus metformin and empagliflozin with linagliptin plus metformin.PSD · Jul 2018
7.2 The PBAC considered that the comparators presented in the submission, dapagliflozin with saxagliptin and empagliflozin with linagliptin, were appropriate.PSD · Jul 2018
Economic analysis
6.24 For the economic evaluation the submission presented a cost-minimisation approach.PSD · Jul 2018
Table 6: Key components and assumptions of the cost-minimisation analysis Component Claim or assumption Therapeutic claim: Effectiveness of [ERTU] + SITA + MF compared to the comparators, [DAPA] + SAXA + MF and effectiveness [EMPA] + LINA + MF, was assumed to be non-inferior Therapeutic claim: Safety of [ERTU] + SITA + MF compared to the comparators, [DAPA] + SAXA + MF and [EMPA] + safety LINA + MF, was assumed to be non-inferior Indirect comparison of …PSD · Jul 2018
Clinical claim
6.18 The submission described the triple therapy combination of ertugliflozin plus sitagliptin plus metformin as non-inferior in terms of effectiveness and safety compared with the comparators, dapagliflozin plus saxagliptin plus metformin and empagliflozin plus linagliptin plus metformin. The PBAC and ESC considered that the therapeutic conclusions presented in the submission were adequately supported.PSD · Jul 2018
6.19 The PBAC considered that there were no statistically significant differences in terms of efficacy or safety between triple therapy regimens based on ertugliflozin 5 mg or ertugliflozin 15 mg. However, both the PBAC and ESC noted that both strengths of the empagliflozin with linagliptin FDC products (10 mg/5 mg and 25 mg/5 mg) were listed on the PBS despite not demonstrating statistically significant differences in terms of efficacy.PSD · Jul 2018
Financial management – risk sharing
6.37 The submission did not propose a risk sharing arrangement.PSD · Jul 2018
For more detail on the PBAC’s view, see Section 7 PBAC outcome. 15PSD · Jul 2018
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated.
The submission presented a cost-minimisation analysis for ertugliflozin with sitagliptin (5 mg/100 mg, 15 mg/100 mg) FDC products based on non-inferior efficacy and safety compared to dapagliflozin with saxagliptin and empagliflozin with linagliptin FDC products. PSD · 2018
Decision context
PopulationAdults with Type 2 diabetes mellitus with inadequate glycaemic control (HbA1c >7%) on dual oral therapy with metformin and either a DPP4 inhibitor or SGLT2 inhibitor.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2018 | Recommended · restricted | dapagliflozin plus saxagliptin plus metformin; empagliflozin plus linagliptin plus metformin | — | RCT · HbA1c |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to dual therapy failures with metformin plus DPP4i or SGLT2i; TGA label allows use when both drugs are appropriate without prior therapy requirement.