The National Institute for Health and Care Excellence (NICE) today (15 August), opens a consultation on its draft medical technology guidance on the use of a device to heal fractured bones. The draft medical technology guidance supports the case for adopting the EXOGEN ultrasound bone healing system in treating long bone fractures with non-union (bone fractures that have failed to heal after 9 months). However, the current evidence is not as strong in adoption of EXOGEN for long bone fractures with delayed healing (fractures that do not show radiological evidence of healing after 3 months).

EXOGEN delivers low-intensity pulsed ultrasound waves that aim to stimulate bone healing through promoting 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 which is secured by a strap. For patients wearing a cast, a hole is cut to allow the transducer to make contact with the skin at the fracture site. 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 £1164 per patient compared with current management. The saving is achieved through avoidance of surgical treatment. For delayed healing fractures, there is some radiological evidence of improved healing but there is too much uncertainty about the rate at which healing progresses between 3 and 9 months after fracture and about whether or not surgery would otherwise be necessary. These uncertainties make cost modelling complex.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “The independent Medical Technologies Advisory Committee (MTAC) considered that there was evidence to support the use of EXOGEN for treating long bone fractures which have not healed after 9 months. In this situation, using the device resulted in high rates of fracture healing. This use was estimated to potentially save the NHS £1164 per patient compared to standard management as surgery would be avoided. The device is also more convenient for patients as it's intended to be used in the patient's home.

“Whilst there was some evidence that EXOGEN can improve healing in fractures which have not healed appropriately after 3 months, there were uncertainties about the rate at which healing progresses and whether surgery would otherwise be needed. The cost modelling was therefore complex, and the case for routine adoption in the NHS could not be convincingly made. We welcome comments on the draft guidance as part of the current consultation.”

More information on the medical technology draft guidance consultation for EXOGEN is available at MTG12. The consultation closes on 12 September 2012.

ENDS

Notes to Editors

About the guidance

1. The draft medical technologies guidance, “EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing”, is available at MTG12. Please contact the NICE press office for an embargoed copy.

2. The EXOGEN ultrasound bone healing system is manufactured by Smith & Nephew.

3. The potential for cost savings for use in non-union fractures is estimated at £1164 per patient compared with current management.

There is an estimated increased cost for use in delayed healing fractures of £504 per patient compared with current management.

4. The costs of the two types of EXOGEN device stated in the sponsor's submission are: £2562.50 (excluding VAT) for the EXOGEN 4000+ (used for non-union fractures) and £999.38 (excluding VAT) for the EXOGEN Express device (used for delayed healing fractures.

About the Medical Technologies Evaluation Programme

5. Established by NICE in 2009, the focus of this area of work is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.

See the NICE website for more information about the Medical Technologies Evaluation Programme .

About NICE

6. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

7. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

8. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
• Commissioning Outcomes Framework - NICE develops the potential indicators for the COF, the scheme starting in 2013, which will help measure the health outcomes and quality of care commissioned by Clinical Commissioning Groups.

9. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates high quality guidance and evidence-based information to help professionals deliver the best patient care through NHS Evidence.