Minor added benefit of Novartis' Ultibro/Xoterna Breezhaler in COPD, says IQWiG

In an early benefit assessment under 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 the drug combination indacaterol/glycopyrronium (trade name: Ultibro Breezhaler, Xoterna Breezhaler) offers an added benefit over the appropriate comparator therapy.

The products, from Swiss drug major Novartis (NOVN: VX), have been approved for marketing in Europe for adults with chronic obstructive pulmonary disease (COPD) since last September (The Pharma Letter September 24). The Breezhaler technology was licensed to Novartis by the UK-based Vectura Group (LSE: VEC).

According to the findings, the drug combination is better at relieving breathing difficulties (dyspnoea) than a combination treatment with tiotropium and formoterol. However, this only applies to patients who do not yet need inhaled corticosteroids because they have no more than two acute flare-ups (exacerbations) per year. Furthermore, there is an indication that the severity of the disease may influence the treatment result, and hence is a so-called "effect modifier." Hence overall, there is only a hint of a minor added benefit for patients with COPD grade 2. In contrast, there is an indication of a minor added benefit for patients with COPD grade 3 and no more than 2 exacerbations per year, the IQWiG sated.