PBAC's latest decision on Sitagliptin: Not recommended (2015). Considered for Type 2 diabetes mellitus in combination with insulin, with or without metformin, in patients with inadequate glycaemic control despite insulin treatment with or without other oral antidiabetic agents.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2015
Submissions
3
2015 → 2015
Eligible population
Adults with type 2 diabetes mellitus inadequately controlled on insulin with or without other oral antidiabetic agents, treated in combination with insulin (and optionally metformin).
Therapy area
Endocrinology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
HbA1c reduction
Pivotal trial size
305 patients
Key trials
P051, P260, Wilding 2012
Comparator
dapagliflozin
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis presented; however, PBAC considered the analysis inadequate as it did not factor in the increased insulin costs associated with sitagliptin use (+19.0 IU/day vs −1.18 IU/day for dapagliflozin).
Why PBAC said no
Reasons cited in the latest PSD: uncertain clinical effectiveness (inconsistent insulin dose outcomes across trials), inadequate evidence of non-inferiority in HbA1c reduction and insulin dose reduction compared to dapagliflozin, cost-minimisation analysis did not account for increased insulin costs with sitagliptin, clinical place in therapy not well established (clinicians unlikely to prescribe a drug resulting in increased insulin use), inconsistent safety profile across trials (hypoglycaemia and weight gain benefits not consistent)
Submission history
Jul 2015: Recommended with restriction · Authority Required