NICE has published new medical technology guidance supporting the use of a device to heal fractured bones.
The watchdog believes that Smith and Nephew’s Exogen, an ultrasound bone healing system, benefits patients and the NHS when used for treating long bone fractures with non-union (bone fractures that have failed to heal after nine months) in new final guidance issued today.
But NICE added that the case for adopting the device routinely for long bone fractures with delayed healing wasn’t supported because of “uncertainties in the evidence”.
Exogen delivers low-intensity pulsed ultrasound waves that aim to promote bone healing through stimulating the production of growth factors and proteins, which increase the removal of old bone, and increase the production of new bone.
Long bone fractures are suitable for treatment if the fracture is stable and well-aligned. Ultrasound waves are delivered straight to the fracture site via a small transducer that is secured by a strap. The device is programmed to deliver ultrasound in 20-minute sessions, which the patient administers themselves each day at home.
Treating non-union fractures using Exogen shows high rates of fracture healing, with an estimated cost saving of £1,164 per patient compared with current management – NICE says this saving is achieved through avoidance of surgical treatment.
But for delayed healing fractures, there is some radiological evidence of improved healing but the watchdog believes there is too much uncertainty about the rate at which healing progresses between three and nine months after fracture and about whether or not surgery would otherwise be necessary.
These uncertainties make modelling the cost consequences of using Exogen in this scenario complex, according to NICE. The costs of the two types of Exogen device are: £2562.50 for non-union fractures and just under £1,000 for the ‘express device’, which is used for delayed healing fractures.
Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “We are pleased to publish final medical technology guidance that supports the use of Exogen for treating long bone fractures that have not healed after nine months. NICE’s independent Medical Technologies Advisory Committee considered that there was evidence to show that using the device in this situation resulted in high rates of fracture healing. The device is also more convenient for patients as it’s intended to be used in the patient’s home.”
Prof Longson added: “While there is some evidence that Exogen can improve healing in fractures that have not healed after three months, there are uncertainties about the rate at which this healing progresses and whether or not surgery would be required. Because of these uncertainties, the modelling of the cost consequences was complex, and the case for the NHS routinely adopting Exogen for fractures that had not healed after just three months could not be supported.”