20 January 2022 - The Federal Joint Committee (G-BA) today exempted three drugs classified as reserve antibiotics from the regular early benefit assessment.
A comprehensive examination of the additional benefit in relation to a comparator therapy is therefore not necessary.
This is because reserve antibiotics, which may be the last treatment option against multi-resistant bacteria, are to be treated with priority according to the will of the legislator: an additional benefit - which is the basis for subsequent price negotiations for new drugs - is automatically considered proven here.
With its exemption from the additional benefit assessment, the G-BA also asked the pharmaceutical companies to demonstrate how they ensure that the new antibiotic is only used in limited quantities.