1. Category: Prior Approval

Prior approval from the Integrated Care Board (ICB) will be required before any treatment proceeds in secondary care unless an alternative contract arrangement has been agreed with the ICB that does not necessitate the requirement of prior approval before treatment

2. Background

This commissioning policy has been produced in order to provide and ensure equity, consistency and clarity relating to the approach to Functional Electrical Stimulation (FES) by the Integrated Care Board (ICB)

Conditions affecting upper motor neuronal pathways are conditions of central neurological origin (CNO) and include stroke, cerebral palsy or multiple sclerosis

Footdrop can occur as a result of a condition of CNO. It is the inability to dorsiflex the foot (lift the toes) which can result in an abnormal, slow, tiring and sometimes unsafe gait

Treatments for drop foot include physiotherapy, orthotic devices, medical therapy and electrical stimulation of the affected nerves and surgery

First-line treatment is usually physiotherapy and/or the use of an ankle foot orthosis (AFO). An AFO is a device, usually made of plastic, which is worn on the lower part of the leg and on the foot

It is used to align the lower leg correctly and control the motion of the ankle and foot, to provide stability and improve gait. Evidence will be required to demonstrate that first-line treatments have been tried

3. Eligibility Criteria

In accordance with national guidelines carefully selected patients may be eligible to be considered for FES if certain pre-requisite criteria are fulfilled:

• The individual has a upper motor neuron lesion resulting from stroke, multiple sclerosis, cerebral palsy or spinal cord injury (but has an intact peroneal nerve)
• There is evidence that the dropped foot interferes significantly with the individual’s day to day living, arising from problems such as frequent falls and severe fatigue
• There is evidence that FES has been recommended for the individual after a thorough assessment of their suitability by the local physiotherapy service or MDT specialising in rehabilitation (this recommendation must specify how any benefit will be measured for the individual)
• There is evidence to demonstrate that first-line treatments have been tried

Note: If a patient meets the policy criteria it is expected that the patient will demonstrate a positive trial of FES before proceeding to a permanent stimulator. In this case the patient will proceed with a surface electrode device, but an additional individual funding request will need to be made if an implanted electrode is being considered

4. Commissioning position

For all other indications the use of FES and FES cycle are interventions NOT ROUTINELY COMMISSIONED due to a lack of high quality evidence of clinical and cost effectiveness

For patients who DO NOT meet the eligibility criteria, the ICB will only consider funding the treatment if an Individual Funding Request (IFR) detailing the patient’s clinical presentation is submitted to the ICB