'We let bureaucracy get in the way': Call for faster appraisal of new RSV treatment

A stethoscope on top of patient's files at the Temple Fortune Health Centre GP Practice near Golders Green, London.

A leading pharmacist has called for a swifter assessment of a new preventative treatment for RSV (respiratory syncytial virus).

The Beyfortus RSV antibody treatment has been approved by the European Medicines Agency (EMA) and is undergoing assessment to be used in Ireland. However, Sheena Mitchell said the process should be sped up given the current high rates of RSV — the virus that spreads from winter to early spring. 

Ms Mitchell said health services "have a chance to get out ahead of" the 2024 RSV season by moving faster. She said otherwise "it will be too late for this year’s babies". 

“Every time we have a chance to be proactive, we let bureaucracy get in the way of common sense."

Based on the case numbers, she estimated that it cost the Government "over €6m to treat the infants hospitalised due to RSV infection during the six-month RSV season ending this week". 

Sheena Mitchell said in light of the current high rates of RSV the process should be sped up.

This winter there were 7,704 RSV cases among all ages up to March 16. While numbers are dropping now, there were 11 new hospitalisations in mid-March, data from the Health Protection Surveillance Centre shows.

During the winter children aged under 14 were the most affected. In just one week in late November some 785 children this age were infected.

The Beyfortus antibody is currently undergoing a health technology assessment (HTA) by the Health Information and Quality Authority (Hiqa). A Hiqa spokeswoman said their assessment is “ongoing and is expected to be completed and published later this year”. 

It will be for use of the new treatment for one season only. A full HTA of immunisation against RSV for children and adults starts later this year and it will examine permanent changes, she added.

The EMA findings included a study showing just 12 of 994 children given Beyfortus developed severe RSV compared with 25 out of 496 children given a placebo.

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Currently in Ireland, infants can be given Palivizumab which is a monoclonal antibody therapy for babies at high risk of infection. The National Immunisation Advisory Committee (NIAC) advised in December that once Beyfortus is available it should “replace” Palivizumab for eligible babies and children.

The Irish Pharmacy Union said the NIAC decision in December indicated “further analysis of cost-effectiveness” and impacts of any changes for the immunisation programme are needed.

“The IPU would welcome the addition of an RSV immunisation and vaccination update to the National Immunisation Programme, when all considerations have been completed, in order to provide protection to the more vulnerable members of our community,” a spokesman said.

The Department of Health asked Hiqa "to prioritise a rapid HTA on infant immunisation against RSV", a department spokeswoman said on Monday. This will ensure evidence for an immunisation programme "as early as possible" for the group most seriously affected by RSV, she said.

"Beyfortus RSV is a monoclonal antibody, which is a passive immunisation for infants i.e. it is not a vaccine, but instead an immunisation," she added. Beyfortus, jointly developed by Sanofi and AstraZeneca, is a prescription-only treatment.