G-BA assessed a combination product, even though its active ingredients were approved - PowerPoint Presentation

1. G-BA assessed a combination product, even though its active ingredients were approved before 2011Trimbow (fixed combination of beclometasone, formoterol, glycopyrronium) was first approved in August 2017 for the treatment of COPD and received new document protection.In January 2021, Trimbow was approved for a new indication, bronchial asthma. The G-BA assessed the benefit of Trimbow only in the asthma indication.G-BA, Benefit assessment of Trimbow; 5 Aug 2021; https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/653/ The G-BA conducts an early benefit assessment (EBA) 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 in COPD in 2017 - no benefit assessmentThe first approval of Trimbow did not trigger an EBA, since all three active ingredients have been licensed for the treatment of COPD already before 1 January 2011. Thus, Trimbow was not seen as a product with an NCE, and instead regarded as an "existing market"-drug.Approval in asthma in 2021 - benefit assessmentThis new indication triggered an EBA, because the three active ingredients aren’t licensed for the treatment of asthma. Here, Trimbow was seen as a product with an NCE, according to the G-BA’s rules of procedure, 5th chapter §2 paragraph 1 sentence 3 number 1 indent 2.Product with one active ingredient approved before 2011Fixed-combination product with active ingredients approved before 2011No EBAEBALaunch in new indicationLaunch in new indication✓✗