Tiotropium / Olodaterol -- Addendum to Commission A15-31 [Internet]

Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2016 Jan 14. Extract of Dossier Assessment No. A15-57.


Background On 22 December 2015, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to conduct supplementary assessments for Commission A15-31 (Tiotropium / Olodaterol – Benefit Assessment According to §35a Social Code Book (SGB) V).

The 2 studies TONADO 1 and TONADO 2 on the comparison of tiotropium/olodaterol with tiotropium were included in dossier assessment A15-31. Subpopulations of both studies were relevant for the 2 research questions. Research question 1 comprises patients with chronic obstructive pulmonary disease (COPD) grade II and patients with COPD grades ≥ III with < 2 exacerbations per year. Research question 2 comprises patients with COPD grades ≥ III with ≥ 2 exacerbations per year. Treatment in both studies was conducted over a period of 52 weeks. Correspondingly, IQWiG’s assessment was based on the data at the end of the study treatment after 52 weeks. In its dossier, the pharmaceutical company (hereinafter referred to as “the company”) had also presented data at the time point after 24 weeks of treatment for individual outcomes. The G-BA commissioned IQWiG to assess the data of the studies TONADO 1 and TONADO 2 at the time point 24 weeks available in the company’s dossier.

In the commenting procedure, the company, with its written comments, additionally submitted supplementary information to the G-BA for the proof of added benefit, which went beyond the information in the dossier. In particular, these were data on health status (European Quality of Life-5 Dimensions visual analogue scale [EQ-5D VAS]), quality of life (St.George’s Respiratory Questionnaire [SGRQ] responder) and data on study dis- continuations due to adverse events (AEs). The G-BA’s commission also included the assessment of these data subsequently submitted.

The responsibility for the present assessment and the results of the assessment lies exclusively with IQWiG. The assessment is forwarded to the G-BA. The G-BA decides on the added benefit.

Keywords: Tiotropium; Olodaterol; Pulmonary Disease – Chronic Obstructive; Benefit Assessment.

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