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Sitagliptin With Simvastatin

Recommended EndocrinologyAuthority Required

Type 2 diabetes mellitus and hypercholesterolaemia in patients currently receiving treatment with simvastatin and who satisfy the criteria for prescribing DPP-4 inhibitors.

2
Submissions
2012–12
On the record
ICER range
Cost-min
Cost basis

Decision on record

1 decision
  • Meeting Nov 2012 Recommended Type 2 diabetes and high cholesterol levels

Access path

2 submissions · public record
  1. Nov 2012
    Recommended · restricted

    Evidence: RCT → Single-arm

  2. Nov 2012
    Recommended · restricted

    Evidence: RCT → Single-arm

  3. PBS listing · Authority Required
RecommendedDeferredNot recommended

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated

The PBAC considered that the requirements under the National Health Act for recommending listing of a product were met, provided that, as claimed in the submission the listing is cost neutral to the PBS. PBAC · 2012
Cost-effectiveness accepted

Decision context

PopulationPatients with type 2 diabetes currently receiving treatment with simvastatin who satisfy the criteria for prescribing DPP-4 inhibitors, with HbA1c greater than 7% or blood glucose levels greater than 10 mmol/L in more than 20% of tests despite treatment with metformin or a sulfonylurea.

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Nov 2012 Recommended · restricted sitagliptin and simvastatin taken concomitantly RCT
Nov 2012 Recommended · restricted sitagliptin and simvastatin taken concomitantly Single-arm

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to later-line use in patients already on simvastatin and meeting DPP-4 inhibitor prescribing criteria; TGA label is broader.