Dapagliflozin With Sitagliptin
Treatment of patients with Type 2 diabetes mellitus with inadequate response to dual therapy with metformin and either a SGLT2 inhibitor or a DPP4 inhibitor, as triple therapy in combination with metformin.
Decision on record
- Meeting Mar 2024 Recommended Type 2 diabetes mellitus (T2DM)
Access path
- Mar 2024Recommended · restricted
vs dapagliflozin 10 mg and sitagliptin 100 mg given…
- PBS listing · Authority Required
From the public summary
The PBAC recommended that dapagliflozin (DAPA) 10 mg with sitagliptin (SITA) 100 mg (Sidapvia) fixed dose combination (FDC) be listed on the PBS as an Authority Required (Streamlined) listing for use in conjunction with metformin (MET), for patients with type 2 diabetes mellitus (T2DM) with an inadequate response to treatment with dual therapy of MET and an inhibitor of sodium glucose co-transporter 2 (SGLT2i), or dipeptidyl peptidase 4 (DPP4i).PSD · Mar 2024
The PBAC considered there was a clinical place for SGLT2i + DPP4i FDC products in the management of T2DM. The PBAC noted the consumer comments, particularly from 17PSD · Mar 2024
The submission presented a cost-minimisation approach comparing the cost of the FDC to its components. The key components are summarised in Table 8. 12PSD · Mar 2024
Bioequivalence between the FDC and individual formulations was demonstrated in healthy individuals in a 2-period, 2-treatment, single-dose crossover study (Study 14). Bioequivalence was based on:PSD · Mar 2024
The submission described the FDC as bioequivalent to the components taken separately. The PBAC considered that the claim of non-inferior comparative effectiveness and safety was reasonable. The TGA Delegate’s Overview (p23) stated the efficacy and safety of dapagliflozin and sitagliptin for the use in T2DM was established.PSD · Mar 2024
The PBAC noted and welcomed the input from a consumer group/organisation (1) via the Consumer Comments facility on the PBS website. The PBAC noted the advice received from the National Aboriginal Community Controlled Health Organisation (NACCHO).PSD · Mar 2024
DAPA individual (B) AUCinf (h·ng/mL) A 42 429.8 (399.8, 462.1) 98.77 (96.87, 100.71) B 42 435.2 (404.7, 467.9) Reference AUClast (h·ng/mL) A 43 424.3 (394.4, 456.5) 99.49 (97.50, 101.51) B 43 426.5 (396.5, 458.9) Reference Cmax (ng/mL) A 43 112.9 (103.5, 123.1) 96.96 (90.57, 103.81) B 43 116.4 (106.7, 127.0) Reference SITA in FDC (A) vs.PSD · Mar 2024
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design. Economic model compares FDC against individual components on a cost basis only.
The total cost to the PBS/RPBS of listing DAPA/sitagliptin FDC presented in the submission was estimated to be $0 to < $10 million in Year 6, and a total of $0 to < $10 million in the first 6 years of listing. PSD · 2024
Decision context
PopulationAdults with Type 2 diabetes mellitus inadequately controlled with dual oral combination therapy with metformin and a DPP4 inhibitor or SGLT2 inhibitor, with HbA1c >7% or blood glucose >10 mmol/L in >20% of tests over 2 weeks.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | dapagliflozin 10 mg and sitagliptin 100 mg given individually | — | Cost-minimisation · Cost-minimisation |
Consumer voice
The National Aboriginal Community Controlled Health Organisation (NACCHO) supported listing of dapagliflozin/sitagliptin FDC to reduce pill burden and provide supply alternatives, while raising concerns about metformin treatment burden including large tablet size causing non-compliance and difficulties with dose administration aids, and recommending that metformin not be a requirement for the FDC.
The comment supported the listing of dapagliflozin/sitagliptin FDC as it would reduce pill burden and provide an alternative FDC in this treatment space to ensure adequate supply in the event of product shortages. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to inadequate response to dual therapy and third-line use; TGA label covers all T2DM without treatment history requirement.