Policy number: SRP 044
Policy name: Exogen® Bone healing ultrasound system
Status: Individual Funding Approval
Effective date: 1 April 2024
Next review date: 1 April 2026
Mid and South Essex ICB commissions EXOGEN® ultrasound bone healing system for non-union in long bone (defined as humerus, ulna, radius, femur, tibia and fibula) fracture on a restricted basis.
The case for adopting the EXOGEN® ultrasound bone healing system to treat long bone fractures with non-union i.e. failure to heal after 9 months is supported by the clinical evidence, which shows high rates of fracture healing.
On this basis, MSE ICB only funds EXOGEN® in patients meeting ALL the following criteria:
- Patients with non-union fractures in long bones which have failed to heal after 9 months.
- Patient age ≥18 years.
- Patient does not have fractures related to or secondary to malignancy.
- The bones are well aligned, and the inter-fragment gap is < 10mm.
- The patient has been screened and referred by a Consultant Radiologist/Consultant Orthopaedic Surgeon following review on at least two occasions at least 90 days apart to allow examination of serial x-rays.
- The patient has received a further assessment in a non-union clinic by surgeon with expertise of dealing with non-union of long bones AND appropriateness of EXOGEN® has been determined through agreement of two specialist non-union Consultants.
- The patient has been counselled and has the ability to comply with usage protocol and criteria in line with the EXOGEN International Performance Program* which includes a 90% minimum adherence to the treatment regimen.
*Only patients registered on the EXOGEN® International Performance Program meeting the above criteria and who successfully heal will be funded. It is the provider’s responsibility to confirm that the patient is eligible for the ‘money-back guarantee.’
Providers must fund this treatment themselves initially and may only claim reimbursement from MSE ICB when healing has occurred, and on the basis that individual prior approval was obtained before treatment commences and evidence is provided to MSE ICB to support the application. For treatment failures, it is the provider’s responsibility to claim reimbursement in accordance with the manufacturers “money back guarantee” arrangement; MSE ICB does not fund these patients.
MSE ICB does not commission the use of EXOGEN® in patients with long bone delayed healing fractures.
MSE ICB does not commission the use of EXOGEN® for any other indications.
Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances.
Individual funding requests should only be made where the patient demonstrates clinical exceptionality.
Find out more information on applying for funding in exceptional clinical circumstances
References:
EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing
NICE Medical technologies guidance [MTG12]
Published: 09 January 2013 Last updated: 08 October 2019