Blackburn with Darwen Clinical Commissioning Group and East Lancashire Clinical Commissioning Group. Policies for the Commissioning of Healthcare

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1 Blackburn with Darwen Clinical Commissioning Group and East Lancashire Clinical Commissioning Group Policies for the Commissioning of Healthcare Policy for Managing Back Pain Spinal /Facet Joint and Epidural Injections Document information Document type: Policy Document title: Managing Back Pain Spinal/Facet Joint and Epidural Injections Document Author: Samantha Jones Version control: 0.3 Approving Committee/Group: Review date: Version Date Amendments V0.1 27/07/2016 Change to limitation criteria for Epidural Injections. Change to limitation criteria for Facet Joint Injections. Codes added to each procedure. Reference included. V0.2 24/08/2016 Removal of summary page (pg 2). Reword of section 2.2. Removal of section 2.3. Removal of section 3.3. Under facet joint injections policy statement: - Amendment of criteria from low back pain lasting more than 6 weeks but less than 1 year to symptoms have been present for at least twelve months. - Rewording of the wording in the limitations section. Section (6) included relating to the cases of exceptional circumstances. Reference section Additional references included and web links to documents. V0.4 12/09/16 Insert section 5.2 Insert in section 8.3 b - radiology Page V0.4 1 of 11

2 1 Introduction 1.1 This document is part of a suite of policies that the CCGs will use to drive its commissioning of healthcare. Each policy in that suite is a separate public document in its own right, but will be applied with reference to other polices in that suite. 1.2 This policy is based on the CCGs Statement of Principles for Commissioning of Healthcare (version in force on the date on which this policy is adopted). 1.3 This paper presents a policy for spinal facet joint and epidural injections for MSK related pain in relation to back, leg and neck pain for Blackburn with Darwen CCG (BwD CCG) and East Lancs CCG (EL CCG). The policy recommends that facet joint injections and epidural injections are a restricted procedure requiring threshold criteria. This policy will apply to all contracts and MSK services and treatments commissioned by both CCGs. 2 Scope and definitions 2.1 There are three groupings of pathologies that commonly affect the lumbar spine for which injections have been considered. These groups however, are very different in their response to injection therapy. (1) Radicular pain - Patients with nerve root compression and/or inflammation. They typically present with predominantly leg pain or sciatica. The two most common causes of radicular pain are prolapsed intervertebral disc and spinal stenosis. Patients should be managed on an explicit care pathway with explicit review and decision points. Injection therapy for radicular pain in a carefully selected patient is an appropriate procedure and suitable for commissioning. (2) Non-specific pain - A very large group of patients with back pain but without nerve root involvement. This is often referred to nonspecific low back pain. The management of non-specific low back pain represents one of the greatest challenges in health care provision. (3) Specific low back pain, emanating from the spinal facet joints - This is a smaller group of patients, but is important as they may have pain amenable to injection treatment. 2.2 Spinal facet joint and epidural injections are used in two ways. First, epidural injections can be used to diagnose the source of radicular back or neck pain. Second, spinal facet joint and epidural injections are used as therapeutic treatment to relieve both radicular and non-specific pain. Page V0.4 2 of 11

3 Relevant evidence and guidelines have been reviewed taking into account the recommendations published in NICE Clinical Guidelines, NHSE National Pathway of Care for Low Back Pain & Radicular Pain December 2014, Royal College of Surgeons Commissioning Guide: Low back pain 2013 and NHSE Guide to Commissioners of Spinal Services January This policy has been developed in conjunction with local clinicians. This policy describes the exclusions and access criteria regarding interventional procedures in the management of spinal pain. 3. Process/Requirements 3.1 Background and Evidence Relevant to Review Spinal facet joints are small flat joints located on both sides of the vertebrae where they overlap with neighbouring vertebrae and provide stability and mobility allowing the spine to bend and twist. (See diagram 1.) Diagram Clinical assessment and radiological investigations are unreliable in diagnosing the spinal facet joints as the source of back pain. Local anaesthetic blocks may be required to make the diagnosis. These blocks may be either intra-articular spinal facet joint injections (local anaesthetic applied into the facet joint capsule) or medial branch blocks (local anaesthetic applied close to the medial branch of the dorsal primary ramus (nerve which supplies the facet joint). 4. Appropriate Healthcare Page V0.4 3 of 11

4 4.1 The CCG considers that the purpose of facet joint injections is to prevent, diagnose and treat a medical condition and therefore, accords with the Principle of Appropriateness. 4 Effective Healthcare 4.1 If the CCGs are satisfied by evidence in relation to a particular treatment or service that the probable effect on a population of patients is that the benefits of the treatment or service will substantially outweigh the harm done by the treatment or service, then the CCGs regard the treatment or service as effective (Ref 4). 5. Cost Effectiveness 5.1 The CCGs recognises that the outcome cost effectiveness of this treatment is within the threshold, and that the service satisfies the criterion of cost effectiveness. 6 Ethics 6.1 The Commissioning Organisation recognises that this service satisfies the criteria within the Ethical component of the Principles for Commissioning Health and Health Care document. 7 Affordability 7.1 The CCGs recognise that this service satisfies the criteria within the Affordability component of the Principles for Commissioning Health and Health Care document. 8 Policy BwD CCG or EL CCG will only fund the treatment outlined in the policy below and if an individual funding request application proves exceptional clinical need which is supported by the relevant CCGs. Injections of therapeutic substances into the back for non-specific low back pain should not be offered. Therapeutic facet joint intra-articular injections are only to be done in the context of either special arrangements for clinical governance and clinical audit or research. The relevant codes for each procedure can be found at appendix 1. This policy has been reviewed by clinicians within Blackburn with Darwen CCG and East Lancashire CCG through the relevant governance process which includes the Pennine Lancashire Quality Committee, Commissioning Business Group, Local Delivery Group and the CCGs relevant Policy ratification groups. 8.3 Epidural Injections (Lumbar and Caudal) and Facet Joint Injections for Back Pain Epidural injections, either sacral or interlaminar and nerve root injections are not of value for patients with non-specific low back pain. This means the CCGs will only Page V0.4 4 of 11

5 fund the treatment if an Individual Funding Request (IFR) application proves exceptional clinical need and that is supported by the CCGs. 1). Unless all the following criteria are met epidurals (lumbar and caudal) for low back pain is not routinely funded: a) Non-specific low back pain Pain lasting more than 6 weeks but less than one year Maximal oral and topical analgesia has failed A clinician trained in back pain assessment, diagnosis and management has assessed the patient and considers it would enable mobilisation and participation in rehabilitation It is part of a dedicated physiotherapy based mobilisation programme, i.e. the intervention is intended to enable mobilisation and participation in rehabilitation (they will not be funded as standalone treatments). Limitation: No more than 2 therapeutic epidurals in the course of the entire treatment will be funded. b) Acute radicular low back pain Pain lasting more than 3 weeks but less than one year. Radicular pain is consistent with the level of spinal involvement (below the knee for lower lumbar herniations and into the anterior thigh for upper lumbar herniations) Symptoms have persisted for at least 3 weeks despite maximal oral and topical analgesia Radiology MRI findings (e.g. disc bulge, lateral recess or exit formina stenosis) Page V0.4 5 of 11

6 correlate with patients symptoms and signs. A clinician trained in back pain assessment, diagnosis and management has assessed the patient and considers it would enable mobilisation and participation in rehabilitation It is part of a dedicated physiotherapy based mobilisation programme, i.e. the intervention is intended to enable mobilisation and participation in rehabilitation (they will not be funded as stand-alone treatments). With the ima of the injection to reduce patient s pain and improve function (enable mobilisation and participation in rehabilitation). Limitation: No more than 2 therapeutic epidurals in the course of the entire treatment will be funded. 2. Unless all the following criteria are met facet joint injections of any type are not routinely funded for lower back pain (in line with NICE guidance CG88): Symptoms have been present for at least twelve months. A clinician trained in back pain assessment, diagnosis and management has assessed the patient and considers the facet joint as the cause of pain Maximal oral and topical analgesia has failed It is part of a dedicated physiotherapy based mobilisation programme, i.e. the intervention is intended to enable mobilisation and participation in rehabilitation (they will not be funded as standalone treatments). Limitation: Repeated treatments can only be justified where alternative treatments such as analgesic medication are intolerable or produce undesirable Page V0.4 6 of 11

7 side effects, such as unsteadiness in the elderly, and should not be performed more often than 8-12 month intervals. 3) Unless all the following criteria are met, medial branch blocks for chronic cervical, thoracic or lumbar back pain are not routinely funded: Cervical, Thoracic or Lumbar back pain lasting more than one year. A clinician trained in back pain assessment, diagnosis and management has assessed the patient and considers the facet joint as the cause of pain Pain documented as significantly interfering with daily life (e.g. loss of function > 50% on *EuroQol or BPI tool) All conservative management functions have failed (physiotherapy guided exercise, maximal analgesia and muscle relaxants, psychological therapy) It is part of a comprehensive/dedicated pain management programme (they will not be funded as standalone treatments). Limitation: Up to 2 diagnostic injections will be funded, 1-2 weeks apart. Up to 3 therapeutic injections (2-3 months apart) will be funded provided that facet joint pain was confirmed by controlled diagnostic local anaesthetic block. There is a >50% reduction in symptoms for 6 weeks as measured by *EuroQol or BPI tools. The patient remains part of a comprehensive pain management Page V0.4 7 of 11

8 programme. *The EuroQol measure is a quality of life questionnaire that has been widely accepted as a generic measure of quality of life. Brief Pain Intervention (BPI) tool - used to assess the severity of pain and the impact of pain on daily functions. 8.4 Radiofrequency and Electrothermal Ablation in chronic back pain 1) Percutaneous Intradiscal radio-frequency thermo-coagulation (PIRFT), Intradiscal electrothermal therapy (IDET) and Radiofrequency facet joint denervation are not routinely funded. 2) Unless all of the following criteria are met radiofrequency denervation of ramus communicans are not routinely funded: Pain originating in the cervical, thoracic, or lumbar spinal regions lasting more than 12 months. Pain is documented as significantly interfering with daily life (e.g. loss of function > 50% on EuroQol or BPI tool), despite maximal conservative management (physiotherapy guided exercise, maximal analgesia and muscle relaxants, psychological treatment) Symptoms are NOT consistent with identifiable pathology including disc herniation, spondylolisthesis, spinal stenosis Absence of any neurologic deficit It is recommended by a dedicated pain management clinician It is part of a pain management programme (they will not be funded as standalone treatments) Page V0.4 8 of 11

9 One diagnostic medial branch nerve blocks, provided under a standard protocol that alternates long- and short-acting anaesthetic blocks, produce symptom relief physiologically consistent with medial nerve branch pathology. Limitations: For the purposes of this policy, a Radiofrequency Ablation procedure consists of one or more ablations during a single visit. Radiofrequency Ablation procedures are limited to two per year. 8.5 Spinal Cord Stimulation for Chronic Pain Unless all of the criteria below are met spinal cord stimulation is not routinely funded for chronic pain. Adults with chronic pain of neuropathic origin that is either Failed Back Surgery Syndrome or Complex regional Pain Syndrome Type I On-going chronic pain (measuring at least 50 mm on a mm visual analogue scale) for at least 6 months despite a comprehensive pain management programme (physiotherapy guided exercise, maximal analgesia and muscle relaxants, psychological treatment) Have been assessed by a multidisciplinary team experienced in chronic pain assessment and in management of people with spinal cord stimulation devices, including experience in the provision of on-going monitoring and support of the person assessed Have had a successful trial of stimulation as part of that assessment Page V0.4 9 of 11

10 When there are equally suitable spinal cord stimulation systems for a particular patient, the least expensive is used. 9 Exceptions 9.1 The CCGs will consider exceptions to this policy in accordance with the Policy for Considering Applications for Exceptionality to Commissioning Policies. 10 Force 10.1 This policy remains in force until it is superseded by a revised policy. Date of adoption Date for review References NHS England (2013) Guide to the Commissioners of Spinal Services Royal College of Surgeons Commissioning Guide: Low back pain NHS Guidelines CG 88 (May 2009) Low Back Pain in Adults: Early Management NHS England National Pathfinder Projects (December 2014) National Pathway of Care for Low Back and Radicular Pain (Report of the Clinical Group) NHS Wiltshire CCG Managing Back Pain - Spinal Facet Joint and Epidural Injections Policy (July 2014) Jpint-and-Epidural-Injections-Policy-AMENDED.pdf NHS Shropshire CCG PROCEDURES OF LIMITED CLINICAL VALUE POLICY (September 2015) Page V of 11

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