Added benefit of insulin degludec is not proven

Study pool partly incomplete / Important information is missing on study methods and results / Drug manufacturer objects to publication of data

Insulin degludec (trade name: Tresiba) has been approved since January 2013 for adults with type 1 and type 2 diabetes mellitus. 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) has now examined whether this new drug, alone or in combination with other blood-glucose lowering drugs, offers an added benefit over the appropriate comparator therapy.

The dossier is incomplete and thus no added benefit can be derived from it. On the one hand, relevant studies were excluded for no obvious reason; on the other, important information is missing on the methods and results of the studies included in the dossier.

G-BA specifies appropriate comparator therapy

Insulin degludec is a long-acting insulin. According to its approval it can be used in patients with type 1 diabetes together with a short-acting insulin (bolus insulin). For this therapeutic indication, the Federal Joint Committee (G-BA) has specified a combination of a long-acting and a short-acting human insulin as the appropriate comparator therapy. For type 2 diabetes, three different options of use are specified for insulin degludec according to the approval valid at the time of the dossier submission: Firstly, as monotherapy; secondly, in combination with oral antidiabetics (OAD); and thirdly, in combination with short-acting insulins, whereby the latter can be administered alone or together with OAD. Correspondingly, the G-BA has defined the following appropriate comparator therapy:

  • For monotherapy: human insulin (vs. insulin degludec)
  • For combination therapies:
    - human insulin plus metformin (vs. insulin degludec plus OAD
    - human insulin plus metformin, if applicable (vs. insulin degludec plus a short-acting insulin; with or without OAD).

A precedent: Required data are not allowed to be published

Modules 1 to 4 of the dossier did not contain all information on study methods and results required for the benefit assessment. IQWiG could extract this information from Module 5; however, in contrast to Modules 1 to 4, this module is confidential and not intended for publication. In such cases, IQWiG may publish the missing information in its report, as long as the manufacturer does not object to this (G-BA resolution). But the company specifically did so. However, IQWiG cannot consider data in the assessment that are not allowed to be published in the report or have to be redacted. The result of the report would then no longer be transparent and comprehensible. Assessments based on incomplete data are obviously not meaningful as the result may be affected by unforeseeable bias.

This could have an impact on the conclusions about the added benefit of insulin delgudec, especially for the combination therapies of insulin delgudec with OAD and with short-acting insulin (with or without OAD).

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, published by IQWiG, provides easily understandable and brief German-language information on insulin degludec.

The G-BA website contains both general English-language information on benefit assessments pursuant to §35a Social Code Book (SGB) V and specific German-language information on the assessment of insulin degludec.


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