Trimbow was launched onto the German market in 2017. So why did the G-BA assess its benefit now?
You likely know that the G-BA conducts an early benefit assessment for every pharmaceutical product with a new chemical entity (NCE) that received its marketing authorization on or after 1 January 2011. On the other hand, products approved before that day, i.e. those in the existing market (German: Bestandsmarkt) are not assessed.
Approval of Trimbow in 2017 – no G-BA benefit assessment
Trimbow is a fixed combination of three active ingredients, beclometasone, formoterol, and glycopyrronium. The combination was first approved on 15 August 2017 for the treatment of COPD and received new document protection. However, this did not trigger a G-BA assessment, since all three active ingredients have been licensed for the treatment of COPD already before 1 January 2011. Thus, Trimbow is not seen as a product with an NCE and instead regarded as an “existing market”-drug.
Approval of new indication in 2021 – G-BA benefit assessment
In January 2021, Trimbow was approved for a new indication, bronchial asthma. In August 2021, the G-BA published their assessment of Trimbow. Interestingly, this new indication now triggered an early benefit assessment. What is different this time? Based on the rules of procedure, 5th chapter §2 paragraph 1 sentence 3 number 1 indent 2, the combination product now reflects a product with an NCE, since the three active ingredients don’t have a license for the treatment of asthma yet.
In the assessment, the G-BA identified two subgroups but did not see an additional benefit for either of them.