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saxagliptin/dapagliflozin fixed dose combination (Qtern)

Advice

following an abbreviated submission:

saxagliptin/dapagliflozin 5mg/10mg (Qtern®) is accepted for restricted use within NHS Scotland.

Indication under review: in adults aged 18 years and older with type 2 diabetes mellitus:

  • to improve glycaemic control when metformin and/or sulphonylurea and one of the monocomponents of Qtern® do not provide adequate glycaemic control,

  • when already being treated with the free combination of dapagliflozin and saxagliptin

SMC restriction: for use in combination with metformin when the use of a sulphonylurea is inappropriate.

In patients for whom this combination is appropriate, saxagliptin/dapagliflozin (Qtern) offers a single tablet at a lower cost per dose compared with the individual components. 

The marketing authorisation for saxagliptin currently specifies the medicines that may be given concomitantly but is to be amended to ‘use in combination with other diabetes medicines’. It is anticipated that this licence change will be outwith SMC remit.

Drug Details

Drug Name: saxagliptin/dapagliflozin fixed dose combination (Qtern)
SMC Drug ID: 1255/17
Manufacturer: AstraZeneca UK Ltd
Indication: in adults aged 18 years and older with type 2 diabetes mellitus: •to improve glycaemic control when metformin and/or sulphonylurea and one of the monocomponents of Qtern® do not provide adequate glycaemic control. •When already being treated with the free combination of dapagliflozin and saxagliptin
BNF Category:
Submission Type: Abbreviated Submission
Status: Restricted
Date Advice Published: 10 July 2017

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