In new draft guidance NICE has recommended a genetic test to establish if a newborn baby is vulnerable to hearing loss if treated with an often-used antibiotic.
Gentamicin is commonly used to treat neonatal bacterial infections. However, its use carries the "risk of hearing loss", NICE pointed out, if the baby has the m.1555A>G genetic variant, which is found about 1 in 500 Europeans, with around 1249 babies in England and Wales born with the variant each year.
Although other alternative antibiotics are available, NICE explained that these cannot be more widely used because they are associated with an "increased risk of antimicrobial resistance".
Current guidelines recommend that babies with suspected infection or sepsis are treated with benzylpenicillin and gentamicin, and that this should be given as soon as possible and always within one hour of the decision to treat. However, NICE cautioned that at present, available laboratory testing for m.1555A>G cannot produce results quickly enough to achieve this target, and added that at the moment, babies treated with gentamicin who develop hearing loss are only discovered to have the genetic variant with DNA testing afterwards.
Mark Chapman, interim director of medical technology at NICE, said: "Until now there has not been a test quick enough to ensure that newborn babies with a bacterial infection and the m.1555A>G variant gene are treated with an appropriate antibiotic."
Recommendation With Conditions Attached
Within its guidance, which applies to England and Wales, NICE "conditionally" recommended the use of the genedrive MT-RNR1 ID kit – a diagnostic test for detecting the m.1555A>G variant – in newborn babies being cared for in hospital, to guide antibiotic (aminoglycoside) use and prevent hearing loss in babies.
A DNA swab from inside the newborn's cheek is put through the genedrive device to identify if the baby has the genetic variant, with results displayed in "under an hour". "If the m.1555A>G variant is found, the baby can be treated with alternative, equally effective, antibiotics," said NICE.
The NICE recommendation is "conditional on further evidence" being generated on how the test affects time to antibiotics, how the test result affects antibiotic prescribing decisions, and the technical performance and accuracy of the test, NICE emphasised.
The regulator added that healthcare professionals should tell parents about the possible implications of positive test results for their baby and their family at an appropriate time, and give support and information.
"Having this test available to NHS staff can avoid the risk of hearing loss in babies with the variant who need treatment with antibiotics," echoed Mr Chapman. "Hearing loss has a substantial impact on the quality of life of the baby and their family," he said.
NICE said that evidence from the PALOH study carried out in Manchester and Liverpool showed "no statistically significant difference" between the time to antibiotic treatment between standard care and when using the genedrive device. This suggested that introducing the test "will not delay" the time it takes to administer antibiotics, stressed NICE.
The assessment of the genedrive kit was carried out through NICE's Early Value Assessment pilot project, which had been created to enable earlier access to digital products, medical devices, and diagnostics that address national unmet needs in health and social care. It aims to provide quicker assessments of early value to identify the most promising technologies that can be safely used in the NHS. "It means clinicians and patients can benefit from medical technologies while further data is collected to inform a full NICE assessment of the device’s cost and clinical effectiveness," NICE said.
Last week, NICE issued its first rapid health technology guidance and recommended digital CBT for children and young people with mild to moderate symptoms of anxiety or low mood. Early value assessment guidance is expected to take around 6 months to produce – quicker than the current time scale for NICE medical technologies guidance, said NICE.
Susan Daniels OBE, chief executive of the National Deaf Children's Society and lay specialist committee member, said: "It's very encouraging that more evidence will be gathered on this important development," and expressed hope that "additional evidence will support the argument for the roll out of technology", which she added could play a "pivotal role" in preventing deafness in a small number of babies in the future.
NICE alluded to the high cost of identifying one baby with the m.1555A>G variant because it is relatively uncommon in the population, with the "upfront" costs of buying the genedrive system potentially being high. However, the early economic model showed that the genedrive test has the "potential to be cost effective", it said, because over the lifetime of the baby it is "cheaper and more effective" than standard care.
The long-term savings to the NHS associated with hearing loss and fitting cochlear implants could be "substantial", it postulated. The estimated cost of treating hearing loss with a bilateral cochlear implant is around £65,000 in the first year.
Consequently, it reinforced that the guidance will be reviewed within 4 years and that the recommendations may change.
"The costs associated with hearing loss to the NHS are high, so driving an innovation like genedrive into the hands of health and care professionals to enable best practice can also ensure that we balance the best care with value for money, delivering both for individuals and society as a whole," reassured Mr Chapman.
Ralph Holme, director of research and insight at RNID expressed delight that the research, which the charity "helped to kickstart", had led to a simple test that NICE had provisionally approved and that could "save the hearing of hundreds of babies a year".
"We look forward to the next steps as this test is rolled out to a range of hospitals, and eagerly anticipate all babies having access to this important test as soon as possible," Mr Holme said.
Comments on the recommendations can be made until Tuesday 21 February 2023.