Thiazolidinediones, Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Co-Transporter 2 Inhibitors
Third-line treatment of type 2 diabetes mellitus after failure of first and second-line treatment options.
From the public summary
3.1 The PBAC considered the comments received from all seven sponsors and other stakeholders and noted that, overall, the main concern expressed by sponsors is the inconsistency of the proposed restrictions with both local (eg. Diabetes Australia/NHMRC) and international (eg. US and Europe) treatment guidelines.PSD · Jul 2014
3.2 The PBAC also acknowledged the comment made by some sponsors that the proposed restrictions, in the version circulated to sponsors, are inconsistent with the current PBS treatment algorithm as it requires patients to have tried a DPP-4 inhibitor in combination with metformin, and separately with a sulfonylurea, whereas the current second line restrictions only require a patient to have tried either metformin or a sulfonylurea.PSD · Jul 2014
Cost-effectiveness
This is not a new submission for a single drug; it concerns proposed changes to PBS restrictions for existing third-line diabetes agents. No ICER is provided or calculated.
The proposed restrictions have been developed to take account of the cost differences in treatment in the absence of evidence showing difference in effectiveness. PBAC · 2014
Decision context
PopulationAdult patients with type 2 diabetes mellitus who have failed at least two second-line dual therapy combinations, including either metformin plus sulfonylurea AND metformin plus gliptin, or gliptin with sulfonylurea.
Risk sharingThe PBAC recommended that gliflozins which remain subsidised only in the third-line setting have their risk sharing arrangements (RSA) reviewed due to expected reduction in eligible patient numbers following the shift of gliptins to second-line subsidy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Deferred | — | — | Other |