/image alliance, Philipp Znidar
Berlin – The Standing Commission on Vaccination (STIKO) yesterday recommended prophylaxis of RSV disease with the monoclonal antibody Nirsevimab in newborns and children in the first RSV season. However, the antibody is not yet available.
When it comes to STIKO vaccination recommendations, it is usually the Federal Joint Committee (G-BA) that takes the initiative, which then, following an orderly procedure, usually quickly incorporates them into its guidelines and thus incorporates them into standard care. . Reimbursements for private practices and hospitals will then be clarified.
But yesterday’s STIKO recommendation does not refer to a classic vaccine that could be included in the G-BA vaccination guidelines, but rather to a monoclonal antibody. It is therefore unlikely that G-BA will be responsible for the direct pathway to standard care or reimbursement issues.
However, Book V of the Social Code provides that the Federal Ministry of Health (BMG) may determine by legal regulation that insured persons may be entitled to other specific vaccines or other specific prophylactic measures.
For monoclonal antibodies, legal regulation by the Ministry of Health may be necessary to make the administration of the monoclonal antibody Nirsevimab a benefit of statutory (GKV) and private (PKV) health insurance.
Questions from German medical journal So far, the ministry has not provided an answer as to whether a legal regulation is in the works and what the next steps will be. Therefore, it is not clear when hospitals and private doctors will be able to administer the antibody.
Doctor and MEP Peter Liese (CDU) today called on the ministry to clarify the issue of funding in the coming weeks. “It should not be a matter of months, but of days,” Liese stressed.
Liese believes that the development was already foreseeable at the beginning of the year. He appealed to Federal Health Minister Karl Lauterbach to prepare a corresponding regulation. “Like many other letters, he did not respond to my letter about this.”
The professional association of paediatricians and adolescent doctors (BVKJ) also complained that the financing of medical services was not entirely clear due to the current legal framework. From a medical point of view, the product now available is a passive vaccination. The Federal Ministry of Health became aware of this problem more than a year ago.
“Still, nothing has happened since then. If a recommendation for RSV vaccination prophylaxis is introduced, the possibility of compensation must also be created,” said BVKJ President Michael Hubmann. If a new comprehensive service were introduced entirely without remuneration, it would place a huge burden on practices and could not be accepted.
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However, the BVKJ also points to organizational challenges. In recent winters, RSV infections have pushed pediatric and adolescent doctors’ practices and hospitals to their limits. RSV prophylaxis should help in this regard.
“However, we must ensure that an inefficient organization does not create new burdens”, he warned. The STIKO recommendation states that newborns born during the RSV season, between October and March, should receive nirsevimab as soon as possible after birth, but no later than the first week of life.
“Taking into account the high level of workload in offices and clinics, the time span seems very narrow to me,” says Hubmann. “It’s also not ideal for parents. During the first week after birth, they have countless other medical decisions to make. A more realistic time estimate would be the period until U3, which occurs between the fourth and fifth week of life.”
Hubmann emphasized that he also did not know “how we are supposed to vaccinate 350,000 to 400,000 children in a few weeks, of which there are two weeks of school holidays in many federal states”. Especially when a new vaccination recommendation is introduced, considerable additional consultation effort is often necessary.
He warned that it would be a major challenge for pediatricians in practices and clinics in the coming months to explain to legal guardians the necessity and functionality of vaccine prophylaxis. “This additional effort must also be adequately rewarded financially,” said the BVKJ president. © may/aerzteblatt.de