During the controversial discussion, the responsible subcommittee on medicinal products didn't take things lightly, Hecken emphasised against the backdrop that those affected and their parents face an "awful problem" because even the smallest traces of peanuts or peanut products suffice to trigger drastic allergic shocks. What's more, peanut allergy is a relatively common condition. According to the dossier, the number of children and adolescents affected by this allergy is estimated to be between 44,000 and 97,000 (those covered by SHI only), which IQWiG (Institute for Quality and Efficiency in Health Care) believes to be accurate. According to Hecken, the hope is that better evidence will be available in the future.
The FJC did not see any additional benefit for the drug combination sofosbuvir/velpatasvir/voxilaprevir (Vosevir) for children and adolescents aged between 12 and under 18 years with chronic hepatitis C. Appropriate comparative therapies were ledipasavir/sofosbuvir or glecaprevir/pibrentasvir for genotypes 1, 4, 5, or 6 and sofosbuvir plus ribavarin or glecaprevir/pibrentasvir for genotypes 2 or 3. The lack of opportunities to compare were the reason for the outcome of the benefit assessment. However, the target group is extremely small: from 2004 to 2020, between 261 and 409 new infections were reported in children and adolescents.
The Federal Joint Committee also found no additional benefit in the case of albutrepenonacog in the treatment and prevention of bleedings for patients with haemophilia B (congenital factor IX deficiency). In June 2016, the product was placed on the market as an orphan drug. Since then, the 50 million euro threshold has been exceeded, making a regular benefit assessment necessary. The appropriate comparative therapies are recombinant or human plasma-derived blood coagulation factor IX compounds. The annual therapy costs are between 360,000 and 560,000 euros for adults.