On 5 November 2026 the G-BA decided that added benefit is not proven for Dupixent (dupilumab) in chronic spontaneous urticaria (CSU). The decision reads like a verdict on the drug. The decision document shows it is a verdict on the evidence: for every endpoint category, it records that no data were available. The same comparator is about to be applied to a second CSU product.
What G-BA decided
The decision covers adults and adolescents from 12 years with moderate to severe CSU who respond inadequately to H1 antihistamines and have not had anti-IgE therapy. The G-BA names omalizumab combined with second-generation H1 antihistamines as the appropriate comparator and estimates the population at 530–590 patients. A separate decision of the same date reaches the same result for children aged 2 to 11, about 420 patients, with the same comparator.
No study to assess
The pivotal evidence is the LIBERTY-CUPID programme. Two phase III studies enrolled 284 patients aged 12 and over and compared dupilumab added to standard antihistamines with antihistamines alone. That design supports a marketing authorisation but answers a different question from the one G-BA asks.
IQWiG's dossier assessment says that, in agreement with the manufacturer, it found no relevant randomised trial allowing a direct comparison with the comparator. The manufacturer followed the G-BA's comparator, so scope was agreed. With no study to assess, there was nothing to weigh against omalizumab, and the rating followed.
The comparator is more than omalizumab
The same IQWiG document sets a second requirement. The G-BA assumes that, before dupilumab, second-generation antihistamine options are exhausted, including up-dosing to 4 times the approved dose, which the German S3 guideline recommends at its highest grade. A supporting trial would need patients in that position and short-term systemic glucocorticoids available in both arms for acute exacerbations. IQWiG also derives benefit only from randomised trials of at least 24 weeks.
The cost table adds a different angle. After statutory rebates, annual therapy cost per patient is €15,759.96 for dupilumab and €10,234.12 for omalizumab, a gap of €5,525.84 before the antihistamine that both arms receive.
The next test is scheduled
Novartis's remibrutinib is in the same indication. Its G-BA procedure started on 1 June 2026, the oral hearing took place on 6 October, and the decision is due in mid-November. The listed comparator is again omalizumab with second-generation antihistamines. The listed population is adults with inadequate response to H1 antihistamines, so the evidence package may differ from dupilumab's. The outcome will show how G-BA treats a second mechanism facing the same active comparator.
What it means for market access teams
- Fix the comparator before the pivotal trial. A placebo add-on design satisfies regulators and can still leave the German dossier empty. If the standard of care makes the comparator predictable, plan for it when the programme is designed.
- Plan the bridge early. Without a head-to-head study, an indirect comparison against omalizumab needs comparable populations, outcomes and background therapy. Test whether the existing trials can support one before the dossier, not during it.
- Build the antihistamine history into the evidence. The G-BA expects up-dosed antihistamines as the background. Check how far trial populations match that expectation.
- Keep value and rating apart. A rating of not proven says the dossier could not show benefit against the comparator. It says nothing about whether the drug works, and payer messaging should keep the two separate.
If you are planning evidence for an indication where an active comparator will be set after your pivotal programme is fixed, get in touch to talk through your options.