BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC)

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1 BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC) Sept 2015 Review: Sept 2018 Bulletin 227: EXOGEN ultrasound bone healing system used for the management of long bone fractures JPC Recommendations: To support the East of England Priorities Advisory Committee (PAC) policy statement and recommendations (See attachment)

2 The East of England Priorities Advisory Committee A function of the Programme GUIDANCE STATEMENT EXOGEN ultrasound bone healing system used for the management of long bone fractures PAC recommendation PAC recommends the use of EXOGEN for the treatment of non-union fractures in long bones which have failed to heal after 9 months but less than 12 months in patients aged > 18 years, in accordance with defined process criteria (see page 3). PAC does not recommend the use of EXOGEN for the treatment of non-union fractures in long bones in cases of unstable surgical fixation, where not well aligned or where interfragment gap is > 10mm. PAC does not recommend the use of EXOGEN in patients with delayed healing fractures that have no radiological evidence of healing after 3 months. PAC does not recommend use of EXOGEN ultrasound bone healing system for any other indications. Summary NICE published Medical Technology Guidance (MTG12) for EXOGEN in January This demonstrates that this ultrasound technique is cost-saving over traditional surgery when used for treatment of long bone fractures with non-union. The NICE recommendations are: 1. The case for adopting the EXOGEN ultrasound bone healing system to treat long bone fractures with non-union (failure to heal after 9 months) is supported by the clinical evidence, which shows high rates of fracture healing. 2. The EXOGEN ultrasound bone healing system to treat long bone fractures with non-union is associated with an estimated cost saving of 2,310 per patient compared with current management, through avoiding surgery. (te: this level of cost-saving has not been established locally.) 3. There is some radiological evidence of improved healing when the EXOGEN ultrasound bone healing system is used for long bone fractures with delayed healing (no radiological evidence of healing after approximately 3 months). There are substantial uncertainties about the rate at which bone healing progresses without adjunctive treatment between 3 and 9 months after fracture, and about whether or not surgery would be necessary. These uncertainties result in a range of cost consequences, some cost-saving and others that are more costly than current management. The current evidence supports the use of EXOGEN ultrasound bone healing system to treat long bone fractures with non-union (failure to heal after 9 months), whereas the evidence for its use in long bone fracture and delayed healing is more limited and the outcomes varied. 1 of 6

3 MTG12 states: When treatment with EXOGEN was started within 6 months of the most recent operation, the union rate was approximately 90%. When treatment was started after 12 months, the union rate was less than 65% (follow-up not reported). 1 The NICE MTG12 costing template was based on the use of EXOGEN for the treatment of nonunion at 9 months of long bone fractures which are stable, aligned and where the inter fragment gap is <1cm in patients in patients > 18 years of age. 2 PAC, in line with NICE technology guidance (MTG12), therefore recommends it for use in patients with non-union fractures in long bones which have failed to heal after 9 months but less than 12 months, but not for use in patients with delayed healing fractures that have no radiological evidence of healing after 3 months. Background information The EXOGEN ultrasound bone healing system delivers low-intensity pulsed ultrasound waves with the aim of stimulating bone healing. It is thought that healing is promoted by stimulating the production of growth factors and proteins that increase the removal of old bone, increase the production of new bone and increase the rate at which fibrous matrix at a fracture site is converted to mineralised bone. Long bone fractures are suitable for treatment if the fracture is stable and well aligned. EXOGEN is not indicated for use in fractures of the skull or vertebrae or in children or adolescents because of their skeletal immaturity. 3-5 The EXOGEN system is available as two disposable devices, which differ only in the number of treatments they deliver. The EXOGEN 250 units (previously known as the 4000+) is intended for use in patients with nonunion fractures (fractures that have failed to heal after 9 months). The device delivers a minimum of 191 x 20 minute treatments (more than 6 months treatment). The EXOGEN 150 (previously called Exogen express) is intended for use in patients with delayed healing fractures (fractures that have no radiological evidence of healing after 3 months). The device delivers a maximum of 150 x 20 minute treatments (less than 5 months treatment). The EXOGEN device consists of a main operating unit with a permanently connected transducer and a separate fixture strap. The strap is placed around the fractured bone, coupling gel is applied to the transducer head (to aid conduction of ultrasound) and the transducer is secured directly over the fracture site by a fixture on the strap. The ultrasound signal emitted by the device is derived from a combination of defined electrical signal parameters and the proprietary transducer design, which generate an acoustic wave pattern specific to EXOGEN. If the patient s limb is immobilised in a cast then a hole is cut in the cast to allow access of the transducer to the skin. The device is programmed to deliver ultrasound in 20-minute sessions and these are self-administered by the patient each day. It is intended to be used in the patient s home. Safety and tolerability Contraindications There are no known contraindications to the use of EXOGEN. 3-5 Warnings The safety and effectiveness of this device has not been established for: 3-5 Fractures with post-reduction displacement of more than 50% (i.e. fractures in which the opposing broken bone ends are out of alignment by more than one half of the width of the bone). Pathological fractures due to bone pathology or malignancy (fractures due to disease). 2 of 6

4 Pregnant or nursing women. PAC - EXOGEN bone healing system v1 Individuals with thrombophlebitis (blood clot in a vein), vascular insufficiency (poor blood supply), abnormal skin sensitivity (very sensitive skin), sensory paralysis (lack of sensation), alcoholism and/or nutritional deficiency. Individuals receiving steroid, anti-coagulant, prescription non-steroidal anti-inflammatory, calcium channel blocker and/or diphosphonate therapy. Individuals using these therapies were excluded from the studies because of the possible effects of these therapies on bone metabolism. Osseous defects of the vertebra and the skull. n-unions of the vertebra and the skull. Individuals lacking skeletal maturity. Fresh fracture locations other than the distal radius or tibial diaphysis Fresh fractures that are open Grade II or III (fractures with large wounds) or that require surgical intervention with internal or external fixation or that are not sufficiently stable for closed reduction and cast immobilization. Complications device related adverse reactions or medical complications related to the use of this device were reported during the clinical studies. Some patients have experienced mild skin irritation caused by skin sensitivity to the coupling gel. Resolution can be obtained by a change of coupling medium to mineral oil or glycerin. 3-5 Adverse events The ultrasound intensity is comparable to diagnostic ultrasound, such as the intensities used in obstetrical sonogram procedures (fetal monitoring). Unlike conventional (physical therapy) ultrasound devices, the EXOGEN device is incapable of producing harmful temperature increases in body tissue. In addition, there is no evidence of non-thermal adverse effects. 3-5 Process criteria Prior funding approval and patient monitoring is required as specified locally. See Appendix 1 for draft prior approval and monitoring form to be adapted to local CCG requirements. Patient must be registered with the EXOGEN International Performance Program and have the ability to comply with its usage protocol and criteria which includes a 90% minimum adherence to the treatment regimen. Patients to be screened and referred by a Consultant Radiologist/Consultant Orthopaedic Surgeon following review on at least two occasions at least 4 weeks apart to allow examination of serial x-rays. Further assessment in non-union clinic by surgeon with expertise of dealing with non-union of long bones; Appropriateness of EXOGEN to be determined through agreement of 2 specialist non-union Consultants. For treatment failures, providers will ensure that a reimbursement is obtained in accordance with the manufacturers money back guarantee arrangement; commissioners will not fund these patients. These criteria will be reviewed and updated on publication of new evidence in the form of relevant trial data, updated national guidance or national or local audit outcomes. 3 of 6

5 Author: Joanne Lowe on behalf of PAC Document history PAC approval date 13th April 2015 Version 1 Consultation process QA process Local stakeholders via PAC members Katie Smith Director of East Anglia Medicines Information Service, 28th April 2015 References 1. NICE medical technologies guidance [MTG12] Published date: January 2013 EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing. (accessed 10/11/14) 2. NICE MTG12 costing template. (accessed 10/02/15) 3. EXOGEN ultrasound bone healing system user guide. (accessed 10/11/14) 4. EXOGEN ultrasound bone healing system resources for clinicians - treatment pathway. (accessed 10/11/14) 5. EXOGEN instructions for use (English), Bioventus Exogen OUS IFU Rev 0, , available from Bioventus customer services. Acknowledgement This policy is based on the South Worcestershire Clinical Commissioning Group (CCG), NHS Redditch & Bromsgrove Clinical Commissioning Group (CCG), NHS Wyre Forest Clinical Commissioning Group (CCG), commissioning policy for EXOGEN Ultrasound Bone Healing System for Long Bone Fractures with n-union or Delayed Healing, September of 6

6 Appendix 1: Exogen ultrasound bone healing system - prior approval and monitoring form EXOGEN ultrasound bone healing system used for the management of long bone fractures This form to be used to notify the patient s commissioner of treatment initiation. Xxx CCG will not normally fund any treatment where the patient does not meet the NICE criteria, as outlined in this Group Prior Approval (GPA). If the consultant wishes to treat with outside the terms of this GPA, the funding for the therapy would have to be borne from within the Trust s existing drug budget, subject to local hospital approval mechanisms. The completed form must be sent by the hospital commissioning team to the High Cost Drugs Team via xxxx@nhs.net Payment by the commissioner will only be made if the completed form is received no later than 15 days after INITIAL treatment commences. If the patient does not fulfil the criteria applications can be made via xxx CCG s Individual Funding Requests process for consideration, where the patient has exceptional clinical and personal circumstances. Contact xxx for the appropriate form: Patient NHS. Patient Hospital Number: Patient initials Trust: Consultant Making Request: GP Name: GP code / Practice code: Date of birth / / GP Post code: Please confirm the following The patient is over 18 years old. Yes The patient has a non-union fracture for > 9months and <12 months. The bones are well aligned and the inter-fragment gap is < 10mm. Date of fracture / / and type and location of long bone fracture The patient has been screened and referred by a Consultant Radiologist/Consultant Orthopaedic Surgeon following review on at least two occasions at least 4 weeks 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; 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. The patient is registered on the EXOGEN International* Performance Program. Purchaser Code For treatment failures, the provider will ensure that a reimbursement is obtained in accordance with the manufacturers money back guarantee arrangement; the CCG will not fund these patients. The funding of EXOGEN will be made available at the end of treatment when the outcomes in terms of success or failure are known and the section below is completed and submitted to the CCG within 1 month of completion of treatment. Yes Yes Yes 5 of 6

7 Name of consultant : Signature: Signature (or confirmation) by Department Service Manager (or nominated deputy) Name: Date: / / Signature: Date: / / Section below to be submitted on completion of treatment Treatment was successful If no, seek reimbursement from the manufacturer Cost of EXOGEN Yes claimed Time to heal/fail (weeks) Date final assessment / / Name of consultant : Signature: Date: / / Signature (or confirmation) by Department Service Manager (or nominated deputy) Name: Signature: Date: / / 6 of 6