Navigation Links
Added benefit of saxagliptin as monotherapy is not proven
Date:12/5/2013

The drug saxagliptin (trade name: Onglyza) has been approved also as monotherapy in Germany since July 2013 for certain adults with type 2 diabetes mellitus. It is an option when drug treatment is needed, but the drug metformin is not tolerated or cannot be used.

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether saxagliptin offers an added benefit over the current standard therapy. Such an added benefit cannot be derived from the dossier, however, as the manufacturer did not submit any suitable data.

G-BA specified sulfonylurea as appropriate comparator therapy

Saxagliptin in combination with other drugs has already been available in Germany since 2009 and was already assessed by IQWiG as part of the assessment of the established drug market. Since the middle of this year, it can also be used as monotherapy. However, the precondition is that the patient has metformin intolerance or contraindication.

The Federal Joint Committee (G-BA) specified a sulfonylurea (glibenclamide or glimepiride) as appropriate comparator therapy.

No studies for direct comparison

The drug manufacturer did not provide a direct comparative study in its dossier. However, it did conduct a so-called simple adjusted indirect comparison. For this comparison, it used studies that tested saxagliptin or a sulfonylurea versus placebo. The two drugs can then be compared with each other indirectly using placebo as the common comparator. In principle, such an indirect comparison with the studies described can be suitable to prove an added benefit.

Relevant patient group was not studied

However, this was not the case in the dossier on saxagliptin as monotherapy: In none of the eight studies in total, patients were investigated for whom metformin was not an option. Moreover, the duration in some of the studies was too short to draw conclusions on benefit. Finally, in two of the studies, sulfonylureas were not used in compliance with the approval.

No added benefit of saxagliptin could be derived from the dossier because no suitable data were available for a direct or an indirect comparison with sulfonylurea.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.

An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on saxagliptin.


'/>"/>

Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Related medicine news :

1. No Added Cancer Risk From Hip Replacement Materials: Study
2. Tafamidis: Approval denotes proven added benefit
3. Nurse Alert Provides Added Level of Senior Alert Care With New Nurse Triage Feature
4. Abiraterone: Indication of considerable added benefit in certain patients
5. Collagenase for Dupuytrens contracture: Added benefit not proven
6. Added benefit of linagliptin is not proven
7. Added benefit of eribulin in breast cancer is not proven
8. Added benefit of fampridine is not proven
9. Belimumab for lupus erythematosus: Added benefit not proven
10. Keeping Up a Healthy Lifestyle Pays Off in Added Years: Study
11. Telaprevir: Added benefit in certain patients with hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/6/2016)... ... May 06, 2016 , ... Logically, spring weather, with its moderate humidity ... is too cold, dry or hot, water on the eye surface can evaporate, creating ... the surrounding air. There’s only one problem, according to radio show and water advocate ...
(Date:5/6/2016)... ... ... From the Speaker Podium to the Exhibit Floor at Booth#514, Worldwide Leading Contact ... Engagement at SpeechTek 2016 Event, taking place May 23-25 at the Omni Shoreham in ... on “5 Customer Engagement Strategies to improve Customer Satisfaction in your Contact Center” on ...
(Date:5/6/2016)... ... May 06, 2016 , ... Expert mattress researchers and ... launching in September, 2014 Sleepopolis has resided at Sleepopolis-mattress-reviews.com . The move ... sheets, mattress toppers, bed frames, and more. , Founder and Editor-in-Chief Derek Hales ...
(Date:5/6/2016)... NJ (PRWEB) , ... May 06, 2016 , ... ... December 2013 arrival of Sovaldi, which made headlines mostly for its cost despite ... then, policy and moral questions surrounding the drug—part of a class called direct-acting ...
(Date:5/6/2016)... (PRWEB) , ... May 06, 2016 , ... ... System and David Konur, CEO of Cardiovascular Institute of the South announced today ... be performing a live case of an Intravascular Ultrasound Guided Coronary Atherectomy. ...
Breaking Medicine News(10 mins):
(Date:5/6/2016)... ReportsnReports.com adds "Cochlear Implants ... database. The report provides comprehensive information on the ... at various stages of development. The report reviews ... It also provides information about clinical trials in ... start and end dates, and, the number of ...
(Date:5/6/2016)... ORANGE COUNTY, Calif. , May 6, 2016  Ampronix is excited to announce that ... 4K Ultra HD 3MOS. First launched last November, the UHD camera was released to the ... ... ... The finely crafted GP-UH532 ...
(Date:5/6/2016)... According to a new ... (Sso-PCR, Ssp-PCR, NGS, Sanger,s Sequencing), Products & Services ... (Hospitals, Academia, Diagnostic Center) - Forecast to 2021", ... to reach USD 753.9 Million by 2021 from ... of 7.1% from 2016 to 2021. ...
Breaking Medicine Technology: