script.reportAU
Endocrinology

Sitagliptin phosphate

Brand: Januvia

PBAC's latest decision on Sitagliptin phosphate: Recommended with restriction (2008). Considered for Type 2 diabetes mellitus in combination with metformin or a sulfonylurea, where HbA1c remains greater than 7% despite monotherapy and where combination with sulfonylurea is contraindicated or not tolerated (Proposals A and B), or as earlier replacement of sulfonylurea in dual therapy with metformin (Proposal C).

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
1
first 2008
Submissions
1
2008 → 2008

Eligible population

Adults aged 18 years and older with type 2 diabetes whose HbA1c is greater than 7% despite treatment with metformin monotherapy or sulfonylurea monotherapy, in whom combination therapy with metformin and sulfonylurea is contraindicated or not tolerated.

Therapy area
Endocrinology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
HbA1c
Pivotal trial size
793 patients
Key trials
P801, P020, P024, P035, Gomez-Perez 2002, Fonseca 2000, Einhorn 2000, Matthews 2005, Umpierrez 2006, Phillips 2001, Hanefeld 2007, Lebovitz 2001, P028
Comparator
rosiglitazone (Proposal A), placebo (Proposal B), glipizide (Proposal C)
Economic model
Unknown
ICER note
The PSD does not state a numeric ICER value. Section 10 ('Economic Analysis') is incomplete/truncated in the provided text.

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