Avoid serious RSV diseases in babies - G-BA specifies options for prescribing Nirsevimab in risk groups
14.11.2023 14:59
The respiratory syncytial virus (RSV) often causes severe respiratory infections. In children, giving RSV antibodies before an infection can reduce the risk of becoming seriously ill. Since the RSV antibody Nirsevimab has recently become available on the market, the Federal Joint Committee (G-BA) has revised its previous therapy advice for the RSV antibody palivizumab. In this way, the G-BA clarifies which children with a high risk of serious illnesses will be covered by statutory health insurance companies for the prescription of RSV antibodies.
For example, premature babies and infants who have certain types of heart defects or trisomy 21 are at high risk of severe disease progression due to RSV. The decision to recast the therapy advice will be submitted to the Federal Ministry of Health for legal review and will come into force after no objections and publication in the Federal Gazette.
Why is the use of Nirsevimab limited to children with risk factors?
The monoclonal antibody nirsevimab, when given before an RSV infection, can prevent or attenuate lower respiratory tract disease through a so-called passive immunization. However, the legislature does not provide for a general obligation for statutory health insurance to provide benefits for such active ingredients for prevention. The only exceptions are active immunization through vaccinations and HIV pre-exposure prophylaxis through antiviral drugs. The contracted doctors, but also the G-BA, must adhere to these legal requirements. Despite further approval of nirsevimab, the G-BA can therefore only define in its therapy advice which patient groups the administration of the RSV antibody falls within the scope of medical preventive services or medical treatment because they are at high risk of a serious course of the disease . In children without any particular risk factors, the risk of a serious course of the disease - and therefore the potential benefit of administering antibodies - is low. Therefore, the requirements for a regulation under the legal framework are not met here.
Do I need a recommendation from the Standing Vaccination Commission?
The Standing Vaccination Commission (STIKO) at the Robert Koch Institute is also currently looking into the options for RSV prophylaxis. The therapy advice for which the G-BA is responsible only regulates the use of the antibodies Nirsevimab and Palivizumab to prevent severe disease progression as so-called secondary prevention. The legal requirements for medication supply apply; a recommendation from STIKO is not necessary. In contrast, the use of RSV vaccines for primary prevention as a statutory health insurance service requires a positive vaccination recommendation from the STIKO. If there is an STIKO recommendation for RSV vaccination, the G-BA would take this into account accordingly in its vaccination guidelines.
How did the G-BA proceed? – Did he take medical guidelines into account?
The basis for supplementing the therapy advice is a systematic literature search. With this, the G-BA gained an overview of the state of medical knowledge on the use of antibodies for RSV prophylaxis and the risk groups in question. The S2k guidelines on RSV prophylaxis in children at risk, which were only updated in September 2023, were also taken into account.
Does the therapy advice for the current RSV season come too late?
The G-BA was only able to begin its consultations when Nirsevimab was approved - that was in autumn 2022. Nirsevimab then entered the market in September 2023. Since the typical season for RSV diseases starts in November and lasts until around April, the therapy advice for the current cold season comes late - but this was due to the circumstances described above and the given advice steps. RSV prophylaxis with Nirsevimab is now also covered as a statutory benefit by some statutory health insurance companies, regardless of the G-BA therapy advice.
Background: therapy instructions
With the so-called therapy instructions from the G-BA, practicing doctors receive assistance in prescribing new and high-priced drugs in their therapy in a quality-assured manner and at the same time as specifically as possible, i.e. economically. All therapy instructions from the G-BA are in the Appendix IV of the Medicines Directive listed. They contain, among other things, information on drug approval, the effect and effectiveness of an active ingredient in the treatment of certain diseases, as well as risks and precautionary measures.