Prevention of RSV through immunization with monoclonal antibodies in young children during their first year of life.

- information flow
- what do we know?
- Issues for which we are still in discussion with the government
- what can you already do now?

INFORMATION FLOW

In the context of preventing severe RSV infections and hospitalizations in infants, Federal Health Minister Frank Vandenbroucke recently approved the reimbursement of the monoclonal antibody Nirsevimab (Beyfortus™).

In collaboration with the Belgian pediatricians (BVK-SBP and BAoP) and general practitioners (Domus Medica and SSMG), we are coordinating this project and will soon provide you with transparent information flowcharts, communication materials, and FAQs, both for you as a doctor and for parents. However, we are not directly accessible to parents and ask that communication with parents would be done through you as a doctor. The practical organization of the immunization is also up to you as a doctor/hospital/private practice to adapt to your target audience, region, and collaborations.

As during the COVID-19 period, a Pediatric RSV Task Force has been established, consisting of various stakeholders. Your questions can be addressed there.

All this information will soon be available in different languages on the RSV page of the BAoP website (www.baop.be) and via our specific newsletters. The information will always be recognizable by the specific project logo.

Additionally, one or more surveys will be organized in the coming months in which you can participate to collect data.

WHAT DO WE KNOW?

Inclusion criteria:

• Any child born during the RSV season.
• Any child born from April 1, 2024.
  • For children born before April 1, 2024 but younger than 13 months at the start of the 2024-2025 RSV season and who, for specific reasons, did not go through the 2023-2024 RSV season (cf. Advice from the CSS), the modalities for possible reimbursement are still under discussion and will be clarified.
• The child must have a valid Belgian national register number.
• The mother must NOT have received the RSV vaccine Abrysvo™ during pregnancy.
• Approval must be given by the advising physician through Chapter 4, either electronically (CIVARS) or via paper document.

The product:

• Name: Nirsevimab (Beyfortus™) – Sanofi (package leaflet).
• It is not a vaccine but a monoclonal antibody. Therefore, the term vaccine should not be used.
• It is a single intramuscular injection per season.
• It offers protection for 5 to 6 months.
• It reduces the risk of severe RSV infection, including the need for hospitalization.
• It has a good safety profile (as studied in phase 2/3 studies with over 10,000 preterm and term-born infants).
• Dosage:
  • <5kg: 50mg intramuscular.
  • >5kg: 100mg intramuscular.
• It is almost fully reimbursed and costs the parents:
  • 12 euros.
  • 8 euros with increased reimbursement.

Practical administration:

• Can be administered to newborns during their stay in the maternity ward (for example, at the time of neonatal screening sample collection), in pediatric consultation at the hospital, or in private practice. Different flowcharts will be provided for this.
• In Flanders, Kind&Gezin will only inform but not immunize. In Wallonia and Brussels, ONE will do both.

STILL IN DISCUSSION WITH THE GOVERNMENT CONCERNING:

We are still in discussion with various authorities and the RIZIV/INAMI regarding several ambiguities and practical difficulties. We continue to communicate with you about this.

• Lack of a uniform consensus on the start and end dates of the RSV season;
• The definition of "any child <13 months" in government communication can be interpreted in different ways. It has been agreed to practically define this as "any child born from April 1, 2024". The regulation gives a double description: "children <13 months old and not born during the previous RSV season '23-'24 (ending March 31, 2024)". It is assumed that any child born before April 1, 2024 has already been exposed to RSV unless the child was hospitalized in neonatology for a long period during this time.
• The defined "catch-up" group of children born between April 1, 2024, and September 30, 2024, will only be reimbursed if they are immunized before the start of the RSV season (usually October 1, 2024). This will be further communicated. However, the product will only be available from October 1, 2024.
• The procedure to obtain approval from the advising physician through Chapter 4 in the Electronic Patient Record (CIVARS) or via paper document is cumbersome and complicated. This makes conducting a proactive campaign very difficult and is expected to limit the implementation rate.
• Only infants with a Belgian national register number are eligible. However, newborns do not yet have these numbers during their stay in the maternity ward. Additionally, 23% of infants in Brussels do not have a national register number. This large vulnerable group is completely excluded and is at higher risk of hospitalization. Solutions are being sought.
• Inability to register the product in Flanders in Vaccinet;
• There are still some practical questions about what to do with preterm infants also eligible for Synagis™;
• Inability for pediatricians to check in the mother's record whether she received the RSV vaccine Abrysvo™ during pregnancy;
• Inability to link systems to collect structured and clear data for reporting and benchmarking.

We therefore ask you, for the time being, only to communicate to the parents what is already known and to plan the first appointment in October. This is to avoid that parents would have to bear the cost of the product (776,57 euros).

WHAT CAN YOU ALREADY DO NOW?

• Proactively contact and inform the parents of your eligible patients. You can do this using the model letter that will soon be available.
• Plan a first appointment with them starting in October 2024.
• Prepare the practical organization of the immunization in your consultation (both intramural and extramural) with your colleagues. Some hospitals will organize immunization weeks and will make arrangements with their local GP circle for information provision and practical implementation. Also, contact your hospital or nearby pharmacy regarding the expected number of doses.
• Inform your nurses and midwives if they are involved in immunization.
• Update your policy regarding the avoidance of pain, anxiety, and stress during painful procedures in infants.
• Update your brochure on general non-pharmacological RSV and Bronchiolitis prevention and also hand it to parents after immunization.

Register yourself and your colleagues for our specific RSV newsletter. You can register via the BAoP or BVK-SBP website.