NHS Somewhere: Individual Funding Request Policy Application for Individual Funding Requests (IFRs) Patient Name or initials Date of Birth Address NHS No Practice name, address and contact number Name, address & contact number of referring clinician requesting funding Patient diagnosis / indication ZZ 24/03/81 XX XXX XXX XXX GP Details of exceptional circumstances for this patient Non union of tibial facture Loss of income due to severely limited mobility and pain NICE approved but not currently commissioned Prof XXXXX Dept of Orthopaedics XX NHS FT ZZ Street, ZZ City Non Union of tibial fracture Device / non drug treatment Treatment /device Exogen (Low Intensity Pulsed Ultrasound) (LIPUS) requested Proposed provider of requested treatment (where known) Anticipated cost of device / full treatment Length of treatment & review date Evidence of clinical effectiveness for indication in question or a statement stating compliance with NICE or other recognised guidance XX Hospitals £25 000 6 months NICE IPG374 Low-intensity pulsed ultrasound to promote fracture healing https://www.nice.org.uk/guidance/ipg374/resources/lowintensity-pulsed-ultrasound-for-promotion-of-fracture-healingoverview2 Busse JW, et al. (2009) Low intensity pulsed ultrasonography for fractures: systematic review of randomised controlled trials. BMJ 338:b351 doi:10.1136/bmj.b351 Webb M. (2008) Low Intensity Ultrasound (Exogen) Therapy for Non Union of Fractures. Public Health Wales. AETMIS. Low intensity ultrasound (Exogen™) for the treatment of fractures. Technology brief prepared by Reiner Banken. (AETMIS 03-05). Montréal: AETMIS, 2004, Medicare Services Advisory Committee (2001) Low intensity ultrasound treatment for acceleration of bone fracture healing: Exogen bone growth stimulator. Report 52 Leung KS et al. (2004) Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound. Ultrasound in Medicine & Biology 30:389–395 Schofer M, Schmelz A, Schultz M. Comparative Effectiveness Of Low Intensity Pulsed Ultrasound Versus Sham Treatment Of Tibia Fracture In Patients With Nonunion: A Double-Blind, Multi-Center Randomized Controlled Trial. ISPOR 14th Annual International Meeting 2009 Mayr E, Frankel V, and Ruter A. (2000) Ultrasound-an alternative healing method for nonunions? Archives of Orthopaedic & Trauma Surgery 120:1–8. Jingushi S, Mizuno K, Matsushita T et al. (2007) Low-intensity pulsed ultrasound treatment for postoperative delayed union or nonunion of long bone fractures. Journal of Orthopaedic Science 12:35-41. Rutten S, et al. (2007) Use of low-intensity pulsed ultrasound for posttraumatic nonunions of the tibia: a review of patients treated in the Netherlands. Journal of Trauma-Injury Infection & Critical Care 62:902-908. Heckman JD, Ryaby JP, McCabe J et al.(1994) Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. Journal of Bone & Joint Surgery -American 76:26–34. Leung KS, Lee WS, Tsui HF et al. (2004) Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound. Ultrasound in Medicine & Biology 30:389–395 Gebauer D, Mayr E, Orthner E et al. (2005) Low-intensity pulsed ultrasound: effects on nonunions. Ultrasound in Medicine & Biology 31:1391-1402. Drug treatment only Intervention requested Anticipated cost of full course of treatment Planned duration of treatment & review date How will the effectivesness be monitored? Is the treatment licensed for this indication? Has this treatment been approved / rejected by NICE? Evidence of clinical effectiveness for indication in question Clinical reasons for the request and relevant detailed medical history, including all treatments tried to date (include privately funded treatment) Explanation of why 1st line or alternative treatments are not suitable if applicable Summary of the clinical benefits the referrer believes the treatment will have for the specific patient: N/A Yes Yes- approved As above Fracture following traumatic injury- skiing Closed reduction and mobilisation (overseas) and return to UK Failed to unite Unable to weight-bear – severely limited mobility See above Improve fracture healing, reduced need for further operative interventions, and reduced time to return to function. Decreased costs to NHS and to patient Name & address of any other clinicians involved in current patient management: Is the patient aware of the request for funding? Are you happy for us to obtain consent and contact the patient regarding this request for funding? Any other relevant information: Please provide declaration of interests GP Yes Yes I declare no conflicting interests in this case Signed:…………………………………………………(requesting Clinician) Name:………….……………………………………….. Date:……………………………………………………..