The Cardiac and Respiratory Foundation NZ is urging Pharmac to move quickly to fund a key respiratory syncytial virus (RSV) vaccine which has now been approved by Medsafe.
In July, Medsafe approved Beyfortus (nirsevmab) for neonates and infants born during or entering their first winter, and for children up to 2 years old who remain vulnerable to severe RSV.
"While decisions about whether and when to supply products in New Zealand rest with pharmaceutical companies, regulatory approval is an important step that can support the availability of medicines and vaccines in the New Zealand market," said a Ministry of Health spokesperson.
"Medsafe has also engaged with Pfizer regarding an application for the Abrysvo vaccine, which is administered during pregnancy."
The decision would now stand with Pharmac to fund the vaccine that would reduce hospitalisations of children by up to 80%.
Cardiac and Respiratory Foundation chief executive Letitia Harding told Breakfast "it's exciting news that we're halfway there”.
"We now have Medsafe approval for this vaccine, but there's no reason that Pharmac can't move quickly on this," she said.
She said for the vaccine to be most effective for winter it should be given around April, so it likely won’t have an impact this year.
"We know that it reduces hospitalisation by up to 80%. I mean, it's a no-brainer from our perspective. It should have been funded a long time ago and gone through the process of Medsafe approval.”
Harding said the vaccine had been approved in more than 40 other countries, including Australia.
"We have been really slow to get this moving, and for us it has such a big impact on our wee ones for the winter season and a big impact on families who have to take time off work to look after their kiddies.
"Having the Medsafe approval, now there's no reason why it can't be funded by Pharmac. It has such a big impact. We know that for our wee Māori tamariki over 30% are more likely to get hospitalised, more than that with our Pacific as well. I mean, I just don't know why we're taking so long.
"We've done it before with other fast tracks, so we need to get on to this."
'Reached a milestone'
Pediatrician Maneesh Deva told Breakfast that babies who contract RSV "struggle to breathe and they struggle to feed", calling the impacts "heartbreaking".
“And just to paint a picture, I was on call from my hospital over the weekend and the capacity issue we face every winter is really due to RSV.
"So under ones, half of them will have this RSV bug and I'm on the phone constantly with Starship or our other hospital we work alongside to juggle where to put these kids because we run out of space.
"That's not only for the heartbreaking ones who've got RSV, but that's for the other children who need to be in hospital, who need to be in ICU for other reasons and can't get in there because there isn't that space," he explained.
Deva said while it was frustrating not to have Pharmac fund the medicine yet, it was a "great opportunity".
"For many, many years and decades we did not have any treatment or management. Management was like, 'you look pretty sick, you stay in hospital, you look really sick, you go to intensive care'. We can do something now to prevent RSV. So this is a fantastic opportunity," he said.
"We've reached a milestone with Medsafe approval, and now we have to do the mahi with Pharmac, and it's sitting in their court. So we wait to see, but I think there's a great opportunity, and it probably won't be this winter, but maybe for next, and that's fantastic."
Pharmac responds
In a previous statement on July 23, Pharmac's Director Advice and Assessment, Dr David Hughes said Pharmac recognised the impact RSV can have on infants and adults.
"We have been funding one medicine for RSV prevention – palivizumab (Synagis) since May 2022, which is used for infants (including newborns) at high risk of severe RSV infection.
"We are currently assessing two funding applications for RSV prevention in infants, including an infant immunisation and one maternal immunisation that helps protect babies from birth. Another immunisation for the protection of infants has been ranked on our Options for Investment list. This is a list of treatments we would like to fund if we have the available budget," he said.
Asked about the most recent Medsafe approval, Pharmac said: "As per our previous statement, we have two funding applications for RSV prevention in infants on Pharmac’s application tracker, including one for Nirsevimab".
"The funding application for Nirsevimab has been assessed and ranked on our Options for Investment List. This is a list of treatments we would like to fund if we have the available budget."
It would not appear on Breakfast for an interview.
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