Updated Schedule of Procedures of Limited Clinical Value for 2017/18

Transcription

1 NHS Cumbria CCG Governing Body Agenda Item 1 February Updated Schedule of Procedures of Limited Clinical Value for 2017/18 Purpose of the Report The CCG has adopted and follows the North East schedule of Procedures of Limited Clinical Value (PLCV) managed by NECS on behalf of the CCGs in Cumbria and the North east. This paper updates the policy document for 2017/18 with a number of new procedures, including cataracts, hips and knees. Although the PLCV schedule is compiled and maintained by NECS, each CCG is required to get approval through its committee structure. In Cumbria, the approval process is via the Transition Executive for the North and the Governing Body. Outcome Required: Approve X Ratify For Consideration For Information Assurance Framework Reference: Recommendation(s): The Governing Body is asked to: Following the discussion and recommendation from the Transition Executive of 19 January 2017 Agree the updated schedule of PLCV, noting that a further update is expected from NECS in relation to Pain Management, and this will be reported at a subsequent meeting; Note the intention to review the arrangements for IFR approval in 2017/18 taking into account the expected significant increase in the volume of referrals subjected to PLCV criteria; Note the implications of the new NICE Guidance around Low Back Pain and Sciatica in the Over 16s and confirm that this should be adopted as soon as practically possible, pending the future update to the full PLCV guidance. This paper and its proposals refer only to the north of Cumbria. Separate arrangements will be agreed between Lancashire North CCG and the South of Cumbria for the management of PLCV in the south from April 2017.

2 Executive Summary: Key Issues: The schedule of PLCV forms part of the contract between the CCG and its main acute providers and is a key part of the quality and management regime for elective care. The update has made significant changes from that agreed last year as summarised below. These include a number of new procedures being brought into the overall policy, including cataracts and hip / knee replacement: Frequently Asked Questions Clarity added to existing FAQ as well as the addition of new FAQs to provide referrers with additional understanding/clarity around the application and funding processes. Cosmetic Treatments Clarity added that funding will not be provided for treatments that are requested to achieve a cosmetic outcome. Clarity added that psychological distress does not constitute exceptionality Autologus Serum Eye Drops Clarity added that funding will only be provided on a trial basis. Back Pain Inclusion of New Policy Breast Prosthesis Title changed to Breast Prosthesis Removal. Replacement removed from title. Clarity added that Breast Prosthesis replacement will not routinely be funded Breast Reduction Clarity added that repeat surgery will not be funded Carpal Tunnel Link to shared decision making tool added Cataracts Inclusion of new policy Cholecystectomy Link to shared decision making tool added Circumcision Clarification of wording to emphasise that surgery will only be carried out for functional issues. Clarity added to the medical indications for treatment Complementary Therapies Inclusion of new policy 2

3 Discectomy Re-termed as Back Pain Discectomy Epidural Injections Removed as covered within Back Pain Policy Face or Brow Lift Clarity added the funded will only be considered based on functional impairments Facet Joint injections Removed as covered within Back Pain Policy Ganglia Amalgamation of criterion Groin Hernia Inclusion of new policy Grommets in Children Inclusion of new policy Hip Prosthesis Clarity added that this is a quality statement around prosthesis Hip Replacement Surgery Inclusion of new policy Hysterectomy for Heavy Menstrual Bleeding Inclusion of new policy IVF Clarity added around surrogacy pathways Knee Replacement Surgery Inclusion of new policy Lipomata Treatment type removed as captured within removal of benign skin lesion policy Removal of Tattoo Definition of a tattoo added for clarity and that funding will not routinely be provided. Removal of Benign Skin Lesion Clarity added to confirm that this policy covers lesions on the eye lid; criterion amended to clarify that suspected malignancy does not fall within the scope of this policy. Resurfacing Procedures Examples provided over treatments within the scope of the policy. Rhinoplasty Removal of criterion indicating that funding can be approved for deformity caused by direct 3

4 trauma as this is outside of the policy as reduction of facial bones would need to be completed within two weeks of acute trauma and is not defined as rhinoplasty. Tonsillectomy Clarity added to detail the previous history of the patient. Clarity added around exclusions to policy. Vaginoplasty Link added to the RCOG guidelines on this treatment. The Transition Executive discussed the paper at its meeting on 19 January 2017 and recommends that the Governing Body confirm its agreement and adoption for 2017/18. Key Risks: The volume of additional referrals requiring IFR approval will be considerable and the CCG will need to agree how these will be handled to ensure no delays in the approvals process. Financial Impact on the CCG: None specifically arising due to this paper. PLCV are a key part of the financial recovery and activity management plans for the CCG and the new policies may reduce the volumes of referrals to secondary care which is likely to generate savings. At this stage it has not been possible to assess the extent to which the current volumes of activity fall outside of the future referral parameters, although this will be part of the work programme being used to inform savings opportunities through 2017/18. Implications/Actions for Public and Patient Engagement: None Strategic Objective(s) supported by this paper: Support quality improvement within existing services including General Practice Commission a range of health services appropriate to Cumbria s Needs Develop our system leadership role and our effectiveness as a partner Improve our organisation and support our staff to excel Impact assessment: (Including Health, Equality, Diversity and Human Rights) Please select (X) X X X No Lead Director David Rogers, Medical Director Presented By David Rogers, Medical Director Contact Details David.Rogers@cumbriaccg.nhs.uk Date Report Written 23 January

5 Updated Schedule of Procedures of Limited Clinical Value for 2017/18 (PLCV) 1. Introduction The CCG participates in the North East and Cumbria schedule of PLCV maintained on our behalf by NECS. This schedule was updated a year ago, and approved by the CCG in January The schedule is now being further updated for 2017/18 with a number of changes and new procedures being brought into the policy. The updated schedule was presented to the North Transition Executive on 19 January 2017 where it was agreed. It is now being passed to the CCG Governing Body for final approval. 2. Updated Schedule The schedule of PLCV forms part of the contract between the CCG and its main acute providers and is a key part of the quality and management regime for elective care. The update has introduced a range of changes, including a number of new procedures being brought into the policy, the most significant of which are cataracts and hip / knee replacement surgery. The amendments to the policy are as follows: Frequently Asked Questions Clarity added to existing FAQ as well as the addition of new FAQs to provide referrers with additional understanding/clarity around the application and funding processes. Cosmetic Treatments Clarity added that funding will not be provided for treatments that are requested to achieve a cosmetic outcome. Clarity added that psychological distress does not constitute exceptionality Autologus Serum Eye Drops Clarity added that funding will only be provided on a trial basis. Back Pain Inclusion of New Policy Breast Prosthesis Title changed to Breast Prosthesis Removal. Replacement removed from title. Clarity added that Breast Prosthesis replacement will not routinely be funded Breast Reduction Clarity added that repeat surgery will not be funded. Carpal Tunnel Link to shared decision making tool added. 5

6 Cataracts Inclusion of new policy Cholecystectomy Link to shared decision making tool added. Circumcision Clarification of wording to emphasis that surgery will only be carried out for functional issues. Clarity added to the medical indications for treatment Complementary Therapies Inclusion of new policy Discectomy Re-termed as Back Pain Discectomy Epidural Injections Removed as covered within Back Pain Policy Face or Brow Lift Clarity added the funded will only be considered based on functional impairments Facet Joint injections Removed as covered within Back Pain Policy Ganglia Amalgamation of criterion Groin Hernia Inclusion of new policy Grommets in Children Inclusion of new policy Hip Prosthesis Clarity added that this is a quality statement around prosthesis Hip Replacement Surgery Inclusion of new policy Hysterectomy for Heavy Menstrual Bleeding Inclusion of new policy IVF Clarity added around surrogacy pathways 6

7 Knee Replacement Surgery Inclusion of new policy Lipomata Treatment type removed as captured within removal of benign skin lesion policy. Removal of Tattoo Definition of a tattoo added for clarity and that funding will not routinely be provided. Removal of Benign Skin Lesion Clarity added to confirm that this policy covers lesions on the eye lid; criterion amended to clarify that suspected malignancy does not fall within the scope of this policy. Resurfacing Procedures Examples provided over treatments within the scope of the policy Rhinoplasty Removal of criterion indicating that funding can be approved for deformity caused by direct trauma as this is outside of the policy as reduction of facial bones would need to be completed within two weeks of acute trauma and is not defined as rhinoplasty. Tonsillectomy Clarity added to detail the previous history of the patient. Clarity added around exclusions to policy Vaginoplasty Link added to the RCOG guidelines on this treatment The full document, including the referral criteria for the new procedures is available to print from the icon on the cover sheet and is shown in Appendix Managing the IFR Implications of the Extended Policy Currently individual funding requests (IFRs) are required for all procedures of limited value. The process was strengthened in November 2015 when positive approval was introduced for a range of higher volume procedures such as Carpal Tunnels and Tonsillectomies. With the introduction of further high volume procedures such as cataracts, hips and knees, consideration is needed as to whether positive IFR approval delivers value for money, or whether self policing of certain procedures delivers adequate safeguards. In particular, the proposed new MSK pathway includes triage by physiotherapists who will have the PLCV criteria as part of their decision tree. The MSK service specification also includes the use of decision aids with patients. There has been considerable discussion and debate in the North East regarding the management of the cataract referrals and whether the volumes render the positive approvals process impractical. Following fifteen months of the tighter approvals policy within 7

8 Cumbria, this now needs to be assessed to ensure that the arrangements for 2017/18 are both workable and meet the objectives of ensuring PLCV compliance. 4. NICE Guidance on Low Back Pain and Sciatica The PLCV document presented for approval was written prior to the publication of the new NICE guidance around low back pain which introduces significantly tighter referral criteria than currently in place. The PLCV guidance is being revised by NECS, and, once published, will be presented here for approval. In the interim, the CCG needs to consider the recommendations of the new NICE guidance and confirm whether it wishes to adopt the new guidance as soon as is practically possible, in advance of, and pending the update to the PLCV. The key elements of the guidance are as follows: Do not routinely offer imaging for low back pain; Do not offer opioids for chronic low back pain; Do not offer spinal injections; Do consider psychological therapy referrals; Do focus on self management and exercise; The full document is attached as Appendix 2 and is available from the icon on the cover sheet. The Transition Executive recommended the adoption of the guidance with immediate effect (pending the availability of pathways and local capacities to implement the pathways). 5. Recommendations and Next Steps At its meeting of 19 January 2017, the Transition Executive endorsed the paper and recommended it to the Governing Body for approval: Agree the updated schedule of PLCV, noting that a further update is expected from NECS in relation to Pain Management, and this will be reported at a subsequent meeting; Note the intention to review the arrangements for IFR approval in 2017/18 taking into account the expected significant increase in the volume of referrals subjected to PLCV criteria; Note the implications of the new NICE Guidance around Low Back Pain and Sciatica in the Over 16s and confirm that this should be adopted as soon as practically possible, pending the future update to the full PLCV guidance. 8

9 In parallel to the approval through Cumbria s governance structures, the policy will be being subject to similar approvals in other North-east CCGs and NECS. If the document is approved without modification it will then be subject to implementation across Cumbria and the North-east. Any changes will be presented for consideration as an update to this paper. The workload implications of the finalised schedule of procedures will be assessed and proposals put forward to the Transition Executive to confirm how these will be managed in conjunction with NECS, to ensure value for money in how the PLCV arrangements are administered. The local Map of Medicine guidance will be updated as required to reflect the new arrangements. Note - This paper and its proposals refer only to the north of Cumbria. Separate arrangements will be agreed between Lancashire North CCG and the South of Cumbria for the management of PLCV in the south of the County from April

10 Appendix 1 Schedule of PLCV for Adoption for 2017/18 Value Based Clinical Commissioning Policies Version 4 Review: November 2016 Implementation: April 2017 Page 10 of 39

11 Contents Introduction Guidance for making referrals Frequently asked questions Cosmetic Procedures Abdominoplasty or Apronectomy Autologous Cartilage Transplantation Autologous Serum Eye Drops Back Pain Facet Joint Injections Back Pain - Discectomy for Lumbar Spine Prolapse Back Pain - Injections for Radicular Leg Pain Blepharoplasty Bone Morphogenetic Proteins Breast - Asymmetry Breast - Augmentation Breast Inverted Nipple Correction Breast Mastopexy Breast Prosthesis Removal Breast Reduction Bunions Carpal Tunnel Surgery Cataract Surgery Cervical Spinal Disc Prosthesis Cholecystectomy (for asymptomatic gall stones) Circumcision Complementary and Alternative Medicines Dupuytren s Contracture Excimer Laser for Cases with Poor Refraction After Corneal Transplant or Cataract Surgery34 Exogen Ultrasound Bone Healing Extracorporeal Shock Wave Therapy for Plantar Fasciitis Face Lift or Brow Lift Fertility Preservation for Cancer Patients Ganglia Page 11 of 39

12 Grommets in Children Gynaecomastia Hair Grafting Male Pattern Baldness and Hair Transplantation Hip Prostheses and Resurfacing Hip Replacement Surgery Hirsutism Hyperhidrosis Treatment with Botulinium Toxin Hysterectomy for Heavy Menstrual Bleeding Invitro Fertilisation (IVF) and Intracytlopasmic Sperm Injection (ICSI) Knee Arthroscopy Knee Replacement Surgery Liposuction Pinnaplasty Removal of Benign Skin Lesions Including Scars Removal of Tattoos Repair of Lobe of External Ear Resurfacing Procedures: Dermabrasion, Chemical Peels and Laser Treatment Reversal of Female Sterilisation Reversal of Male Sterilisation Rhinoplasty Thigh Lift, Buttock Lift and Arm Lift, Excision of Redundant Skin or Fat Tonsillectomy Trigger Finger Vaginoplasty, Labial Vulvoplasty and Vulvar Lipoplasty Varicose Veins in the Leg Document History *These procedure are not routinely funded by Commissioners in the North East and Cumbria Page 12 of 39

13 Value Based Clinical Commissioning Policies Introduction Across the country most, if not all, CCGs have a set of policies and procedures for limiting the number of low clinical value interventions. The Audit Commission s report 'Reducing expenditure on low clinical value treatments' 1 analyses variation on approaches to this work. This approach was based on the 'Save to Invest' programme developed by the London Health Observatory 2 incorporating the 'Croydon List' of 34 low priority treatments. Healthcare commissioners in the North East have adopted a common set of policies since These were reviewed in and adopted by all CCGs in the North East in January Revisions to the policy are now managed and co-ordinated by a clinically-led North East Policy Development and Review Group Guidance for making referrals This guide has been developed to assist clinicians answer questions in relation to individual funding requests (IFRs). At the end of this guide you will find quick links to qualifying criteria of individual policies contained within the Value Based Clinical Commissioning Treatment Policies document. Frequently asked questions 1 Why do we need policies? NHS resources come under ever greater pressures each year. Ensuring that treatment and care is focused where it can make the biggest difference is a key part of making best use of these resources. This is a key challenge for all NHS organisations, and a prime focus for commissioning among CCGs. These policies help clinicians identify interventions with limited benefit, thereby providing potential for reinvesting elsewhere, where potential benefits are greater. The alternative to having policies of this kind is to leave each decision to individual GPs, to manage individual dilemmas without guidance and without the context of the health needs of the wider population. The Academy of Medical Royal Colleges has launched a Choosing Wisely campaign ( which is aligned to the North East and Cumbria approach to increasing value and improving population health. At the heart of the Choosing Wisely initiative is a call to both doctors and patients to have a fully informed conversation about the risks and benefits of treatments and procedures. As well as releasing resources for other activities, it says patients should always ask five key questions when seeking 1 Reducing expenditure on low clinical value treatments. Audit Commission, April Save to Invest: Developing criteria-based commissioning for planned health care in London. Malhotra N. Jacobson B %20Commissioning%20for%20Equity.pdf Page 13 of 39

14 treatment. They are: 1. Do I really need this test, treatment or procedure? 2. What are the risks or downsides? 3. What are the possible side effects? 4. Are there simpler, safer options? 5. What will happen if I do nothing? In a study carried out last year, 82% of doctors said they had prescribed or carried out a treatment which they knew to be unnecessary. The vast majority of this group cited patient pressure or patient expectation as the main reason 2 What do these policies cover? These cover interventions where there is significant risk that patients undergoing them will gain little health benefit. The procedures have low rather than no clinical value. Some may be effective, but may have low value because other (medical) treatments could be tried first. Other effective procedures may provide large benefits for some patients but less to those with few symptoms, where risks and benefits are closely balanced. There are interventions which are effective in some but give no clinical value in others. Finally, there are those interventions that whilst effective, are undertaken for primarily cosmetic reasons, which commissioners often consider as providing low clinical value. 3 Who are they for? They are to assist clinicians in making referral decisions, where the principal reason for referral is for surgical intervention. They are also to assist providers of treatment and surgical services. 4 How has the list been compiled? The list of procedures is a historical one, starting with declarations about plastic surgery and IVF, and have grown with greater understanding about health benefits from surgical intervention, publication of authoritative national guidelines and unexplained variations in clinical practice. The policies have been compiled by a group of clinical decision-makers, GPs, and Public Health specialists, with advice and guidance from clinical specialists and regional networks. The group has used published evidence and guidance, alongside expert opinion to develop and refine this set of policies. 5 How have they been developed? Every effort has been made to get an up to date view of practice. However, some will contain contentious criteria - for example among eligibility for plastic surgery and IVF. We aim to take account of the most up to date clinical evidence, legal precedent and gain consensus from local experts before publication. These policies are kept under constant review to ensure the policies are in-line with evidence and best practice. This process is managed and co-ordinated across the North East and Cumbria to ensure that there is consistency in the policies and their application. Page 14 of 39

15 6 Can you give any general guidance about what is in the policies? Here is some general advice about those policies which are most commonly referred to. For procedures that are often carried out for cosmetic reasons: breast surgery (reduction or augmentation), benign skin lesions or lipomata, you should consider the extent to which the individual deviates from the normal range, and the impact of any anomaly on function and activities of daily living. Unhappiness is a common experience among people wanting plastic surgery who do not receive NHS funding. This unhappiness is not, on its own, sufficient to make an individual exceptional. Much of the varicose vein surgery undertaken in England is for cosmetic reasons, so you should also consider the impact on activities of daily living before referring. For IVF- there is an age limit for starting treatment that is based on the probability of success. Please alert couples about the lead time to establish infertility (two years) and to undertake relevant investigation and medical treatment. Age and lack of understanding of the pathway are not exceptional reasons for access to IVF. 7 Is securing funding a guarantee of treatment? Approval for NHS funding is NOT the same as a guarantee of treatment. Funding (the role of the commissioner for a whole population) is often requested before specialist assessment. However, the ultimate decision about safety and appropriateness of treatment is a clinical one, which must be discussed with the patient. 8 What happens when funding is approved? It is the applicant i.e. the patient s clinical representative s responsibility to refer the patient for treatment. It is expected that this will take place within a maximum period of 12 months. It is expected that any approved treatment will be completed within 12 months, and if a treatment is not completed within this time, a new application for funding would need to be submitted. In the case of ongoing treatments, the approval of such treatments will be for a maximum period of 12 months unless the referring clinician explicitly requests (and justifies) longer-term treatment. Continuing treatments after that time will need a new application for funding and this will be assessed against the policy in place at the time of the new application. 9 What if funding is declined? If there are individual circumstances to be considered, and the decision is to decline funding, you will be sent details of how to appeal. 10 Who tells the patient if funding is declined? We will tell the referring clinician, who remains responsible for ongoing treatment and care. The correspondence lays out this responsibility, and any timescales for action. 11 What about treatments that have already started under private arrangements? If treatments have already been started under private arrangements, the assumption is that a whole package of care has been purchased and its potential complications taken account of. Therefore, it would be unreasonable to expect the NHS to pick up the costs associated with private treatment Page 15 of 39

16 unless there is a medical emergency, or some other exceptional circumstance. Running out of funds, whilst unfortunate, is not exceptional. Likewise, if a device has been privately purchased and initiated, the NHS will not pick up the costs of consumables or maintenance, unless the patient meet NHS criteria. For example a patient who has purchased a continuous glucose monitor would be expected to have sufficient funds to purchase consumables for the life of the device. 12 What about treatments that have been started and completed under private arrangements? Funding is not provided retrospectively. If treatment has been completed under private arrangements it is assumed that the patient has sufficient funds to cover this treatment. 13 What about the continuation of experimental treatments/loaned device trials? The continuation of experimental treatments/loaned device trials will not be routinely funded. Initiating patients on treatments without clear evidence of safety, efficacy, effectiveness or costeffectiveness raises patient expectations that the treatment will be continued. Where treatments are initiated by providers on a loan/ experimental basis this is done at the provider s own risk. The provider must be clear with the patient about the end point/ exit strategy for the trial and/ or continuing care. This excludes formal clinical research trials for which there are separate arrangements between funders and providers. 14 What if I have a patient whose needs are exceptional? Exceptionality is defined as: The patient or their circumstances are significantly different from the general population of patients with the condition in question and the patient is likely to gain significantly more benefit from the intervention than might normally be expected for patients with that condition. We welcome Individual Funding Requests - either for patients who are clearly different from the group of patients covered by the policy - or for those with very unusual conditions or clinical presentations. Please: check the policies (see list below), use the web based application system to indicate how your patient is exceptional and include all the information requested as clearly and comprehensively as possible to avoid delays in considering the request. Applications must include details of all the conventional treatments undertaken and their impact. 15 What about psychological considerations? Accounting for psychological factors in arriving at a decision about eligibility for NHS funding is hard to do in a clear and fair way. These considerations have been removed from this policy as psychological distress unfortunately does not constitute clinical exceptional circumstance. NICE guidance indicates that clinicians should consider the possibility of Body Dysmorphic Syndrome when making referral for plastic surgery (NICE Clinical Guideline 31). Page 16 of 39

17 16 Are photographs helpful? Photographs are not used in consideration of exceptionality - and handling them presents significant risks of compromising confidentiality. Please do NOT submit photographs. Any photographs received will be returned to sender upon receipt and an incident will be logged on Safeguard Incident and Risk Management System (SIRMS). 17 What if GPs make referrals outside the criteria outlined in these policies? The implication is that there is no guarantee of payment, although the level of detail in these policies is not fully reflected in financial agreements with hospital providers. 18 What if surgeons undertake procedures outside the indications in these policies? The implication is that there is no guarantee of payment, although legally binding contracts govern financial transactions. 19 What about the smoking status of the patient? There is clear evidence that stopping smoking prior to surgical interventions improves patient outcomes and recovery. We recommend that patients who smoke should have attempted to stop smoking 8 to 12 weeks before referral to reduce the risk of surgery and the risk of post-surgery complications. Patients should be routinely offered referral to smoking cessation services to reduce these surgical risks and this should be detailed in the application 20 Describing pain and significant functional impairments/ limitations to activities of daily living endured by patients Pain has been defined as an unpleasant sensory and emotional experience arising from actual or potential tissue damage with clinical pain being whatever the person says he or she is experiencing whenever he or she says it occurs and is therefore subjective. 3 There is insufficient evidence to use questionnaire derived scores to evidence pain in individuals. Therefore, in lieu of a standard assessment tool, alternative clear and objective evidence must be provided when demonstrating patient pain and significant functional impairments/ limitations to activities of daily living. This evidence should include documented assessments and/ or patient history, including: A description of the pain and which daily activities are no longer achievable; Prescribing history; Recorded sickness/ absence due to pain/ functional impairment; Evidence from functional tests/ investigations, such as gait analysis, physiotherapy/ OT assessment; History of the pain/ impairment and the response to/ impact/ effect of conventional therapies available. Significant functional impairment is defined as: 3 Fink, R. (2000) Pain assessment: the cornerstone to optimal pain management, Baylor University Medical Centre Proceedings, 13(3): Page 17 of 39

18 Symptoms that result in a physical/ functional inability to sustain employment/ education despite reasonable occupational adjustment, or act as a barrier to employment or undertaking educational responsibilities; Symptoms preventing the patient carrying out routine domestic or carer activities; Symptoms preventing the patient carrying out self-care or maintaining independent living. Who can make an application for funding under this policy? Usually a patient's GP will be the person making the application for funding on a patient's behalf. However, any professionally registered clinician (eg surgeon, nurse, therapist etc) can make a request for funding when that is in the best interest of the patient (eg to speed up an application when they are already seeing a patient, rather than cause delay by sending them back to their GP for an application to be made). Although a clinician might delegate completing the application form to an administrative assistant, they remain responsible for ensuring the correct information is provided so the right decision is made for their patient. Cosmetic Procedures Treatments or surgery primarily to achieve a cosmetic outcome are not eligible for NHS funding. A significant degree of exceptionality must be demonstrated before funding can be considered outside of these policies. Specifically, psychological factors are not routinely taken into consideration in determining NHS funding. Whilst some degree of distress is usual among people who consider aspects of their physical appearance as undesirable, the degree of this will not routinely be taken into account in any funding decision. Further, it is expected clinicians consider the possibility of psychological problems including Body Dysmorphic Syndrome (NICE Clinical Guideline 31), assess for these and ensure appropriate management before considering any referral for plastic surgery. This guidance applies to many of the following policies, in particular: Abdominoplasty Breast augmentation (Breast enlargement) Breast prosthesis removal or replacement Breast reduction Gynaecomastia Inverted nipple correction Mastopexy Revision mammoplasty Blepharoplasty Pinnaplasty Repair of lobe of external ear Rhinoplasty Varicose veins Circumcision Vaginoplasty, Labial Vulvoplasty and Vulvar lipoplasty Hirsutism Removal of tattoos Resurfacing procedures Abdominoplasty or Apronectomy Face lift or brow lift Liposuction Removal of benign skin lesions Thigh lift, buttock lift and arm lift Hair grafting - Male pattern baldness Page 18 of 39

19 Abdominoplasty or Apronectomy Background: abdominoplasty (also known as tummy tuck) is a surgical procedure performed to remove excess fat and skin from the mid and lower abdomen. Many people develop loose abdominal skin after pregnancy or substantial weight loss. However, surgery is not part of the usual response to these normal, physiological processes. Policy: Abdominoplasty or Apronectomy will not be routinely funded Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8. Autologous Cartilage Transplantation Policy: Autologous cartilage transplantation will not be routinely funded. Autologous Serum Eye Drops Background: Autologous serum eye drops treat severe keratoconjunctivitis sicca (dry eye). Dry eyes can be helped with intensive treatment with artificial teardrops; however for some patients the symptoms are not completely relieved. The National Blood Service has developed an alternative to these artificial drops. Autologous serum eye drops are a last resort measure where all other conservative interventions have failed. Policy: Autologous serum eye drops will only be funded on a 5 month initial trial basis in accordance with the criteria specified below: Patients have been treated unsuccessfully with maximal tolerated conventional and NICE approved therapies (for example, Ciclosporin). Note: Further funding will be subject to the submission of a progress report following a 5 month trial, outlining the improvements in objective measures. Back Pain Facet Joint Injections This commissioning policy statement will be reviewed in the light of new evidence or guidance from NICE (CG88) which is expected in November Background: This policy relates to recurrent (>6 weeks) and chronic (> 12 months) back pain in the adult population including neck and upper back pain, non-specific lower back pain and radicular pain including sciatica. In areas where the relevant CCGs have adopted the North East Regional Back Pain Pathway (NERBPP), patients presenting with new episodes of persistent back pain will follow the pathway. Page 19 of 39

20 Policy: Facet Joint Injections for non-specific lower back pain will only be funded in accordance with the criteria specified below: The pain has lasted for more than one year (except in case of trauma) AND The pain has resulted in moderate to significant impact on daily functioning (assessed using a validated tool such as Oswestry Disability Index) AND All conservative management options (exercise, pharmacotherapy including analgesia and muscle relaxants) have been tried and failed. AND EITHER The patient is part of a comprehensive pain management programme (including physiotherapy, psychological support, medication and patient education) OR The patient is unable to tolerate physiotherapy treatment due to pain, facet joint injection will be followed by return to the physiotherapy programme (minimum 8 weeks) If facet joint pain is confirmed after a diagnostic local anaesthetic block the patient should be considered for medial branch blocks and then a denervation procedure. There may be a small group of patients unable to tolerate this whom might need repeated facet joint injections. A maximum of 2 injections per year will be funded. Page 20 of 39

21 Back Pain - Discectomy for Lumbar Spine Prolapse Policy: Discectomy for lumbar disc prolapse will only be funded in accordance with the criteria specified below: Symptoms persist despite some non-operative treatment for at least 6 weeks (e.g.analgesia, physical therapy, bed rest etc.) provided that analgesia is adequate and there is no imminent risk of neurological deficit. AND The patient has had magnetic resonance imaging, showing disc herniation (protrusion, extrusion, or sequestered fragment) at a level and side corresponding to the clinical symptoms; AND EITHER The patient has radicular pain (below the knee for lower lumbar herniations, into the anterior thigh for upper lumbar herniations) consistent with the level of spinal involvement; OR There is evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raisepositive between 30 and 70 or positive femoral tension sign); Back Pain - Injections for Radicular Leg Pain Policy: Injections for radicular leg pain (caudal epidural, lumbar epidural, transforaminal epidural or nerve root injections) will only be funded in accordance with the criteria specified below: Symptoms persist despite some non-operative treatment for at least 6 weeks (e.g. analgesia, physical therapy, rest etc.) AND EITHER The patient has radicular leg pain (below the knee for lower lumbar herniation, into the anterior thigh for upper lumbar herniation) consistent with the level of spinal involvement; OR There is evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raisepositive between 30 and 70 or positive femoral tension sign); Patients may receive up to three injections to diagnose and achieve therapeutic effect. If therapeutic effect is achieved, patient may receive up to six injections in total, minimum 2-3 months apart as part of a comprehensive pain management programme (including physiotherapy, psychological support, medication and patient education). Note for ongoing therapy: Occasionally, injections for radicular leg pain may be the only effective treatment for a cohort of patients. These patients may be considered for prior approval for further epidural or nerve root injections if they: demonstrate sustained benefit from the procedure objectively evidenced; AND They must have participated Value in a Based comprehensive Clinical Commissioning back Policy pain programme including psychology and Page 21 of 39

22 physiotherapy e.g. Coping with pain course AND They must have had a surgical review and must participate in self-directed physiotherapy. Page 22 of 39

23 Blepharoplasty Background: blepharoplasty is a surgical procedure performed to correct puffy bags below the eyes and droopy upper eyelids. It can improve appearance and widen the field of peripheral vision. It is usually done for cosmetic reasons. Consideration should be given to whether blepharoplasty or brow lift is the more appropriate procedure, particularly in the case of obscured visual fields. Policy: Blepharoplasty will only be funded in accordance with the criteria specified below: Impairment of visual fields in the relaxed, non-compensated state OR Clinical observation of poor eyelid function leading to discomfort, e.g. headache worsening towards end of day and/or evidence of chronic compensation through elevation of the brow. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8. Bone Morphogenetic Proteins Policy: Bone morphogenetic protein is funded in line with its licensed indication: Non-union of tibia of at least 9 month duration, secondary to trauma AND Skeletally mature patient AND Previous treatment with autograft has failed or the use of autograft is unfeasible. Breast - Asymmetry Policy: Surgical correction of breast asymmetry will not be routinely funded. This policy does not apply to breast reconstruction as part of the treatment for breast cancer. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8. Breast - Augmentation This policy does not apply to breast reconstruction following mastectomy for treating breast cancer. Policy: Breast augmentation will not be routinely funded. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8. Page 23 of 39

24 Breast Inverted Nipple Correction Background: the term inverted nipple refers to a nipple that is tucked into the breast instead of sticking out or being flat. It can be unilateral or bilateral. It may cause functional and psychological disturbance. Nipple inversion may occur as a result of an underlying breast malignancy and it is essential that this be excluded. Policy: Surgery for the correction of inverted nipple for cosmetic reasons will not be funded. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8. Breast Mastopexy Background: breasts begin to sag and droop with age as a natural process. Pregnancy, lactation and substantial weight loss may escalate this process. This is sometimes complicated by the presence of a prosthesis which becomes separated from the main breast tissue leading to double bubble appearance. This policy does not apply to breast reconstruction as part of the treatment for breast cancer. Policy: Mastopexy will not be routinely funded. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8. Breast Prosthesis Removal Background: breast prosthesis may have to be removed after some complications such as leakage of silicone gel or physical intolerance. This policy does not apply to breast reconstruction as part of the treatment for breast cancer. Policy: The removal of breast implants for any of the following in patients who have undergone cosmetic augmentation mammoplasty that was performed either in the NHS or privately will be funded for the following indications: Breast disease Implants complicated by recurrent infections Implants with capsule formation that is associated with severe pain Implants with capsule formation that interferes with mammography Intra or extra capsular rupture of silicone gel filled implants. Breast Prosthesis replacement will not routinely be funded. Page 24 of 39

25 Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8. Page 25 of 39

26 Breast Reduction Background: excessively large breasts can cause physical and psychological problems. Breast reduction procedures involve removing excess breast tissue to reduce size and improve shape. As excess weight is likely to exacerbate symptoms associated with large breasts, it is assumed that patients going forward for surgery will be near normal weight. Assessing eligibility for surgery is problematic not least because there are several recognised approaches to measuring bra size some of which relate to historical manufacturing standards. The following approach to calculating cup size is recommended for standardisation (extracted from Modern Sizing section of above reference): subtract band size (below the breast) from the bust size (at the widest point). The difference between the two numbers determines cup size: Less than 1 inch difference = AA 1 inch difference= A 2 inches = B 3 inches = C 4 inches = D 5 inches = DD 6 inches = DDD (E in UK sizing) 7 inches = DDDD/F (F in UK sizing) 8 inches = G/H (FF in UK sizing) 9 inches = I/J (G in UK sizing) 10 inches = J (GG in UK sizing) This policy does not apply to breast reconstruction as part of the treatment for breast cancer. Policy: Breast reduction will only be funded in accordance with the criteria specified below. For women: With documented evidence of significant chronic or repeated neck ache or, backache that has not responded to conservative management and breast reduction is likely to significantly reduce the level of pain AND wearing a professionally fitted brassiere has not relieved the symptoms; AND has a preoperative body mass index (BMI) of less than 27.0 kg/m 2. Has a minimum cup size of >=E (6 inches difference as measured above) Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8. Page 26 of 39

27 Repeat surgeries will not be routinely commissioned. Page 27 of 39

28 Bunions Policy: Surgery to treat bunions will only be funded in accordance with the criteria specified below: There is ulceration over the bunion OR Conservative methods of management have failed including Avoiding high heel shoes and wearing wide fitting leather shoes which stretch Applying ice and elevating painful and swollen bunions Non-surgical treatments such as bunion pads, splints, insoles or shields available from community pharmacies Specialist podiatry/biomechanical referral (where available) AND The patient suffers from significant functional impairment (please refer to FAQs): AND Functional impairment is caused by either severe deformity (overriding toes) or significant pain. Carpal Tunnel Surgery Background: Evidence from observational studies shows that symptoms resolve spontaneously in some people: good prognostic indicators are short duration of symptoms, a young age, and carpal tunnel syndrome due to pregnancy. There is good evidence that surgical treatment relieves the symptoms of carpal tunnel syndrome (CTS) more effectively than splinting. However splinting is effective in about 50% of people in the short term. Carpal tunnel surgery is a low priority procedure for patients with intermittent or mild to moderate symptoms. Referral guidance: Consider referral for electromyography and nerve conduction studies if the diagnosis is uncertain. Policy: Carpal tunnel surgery will be funded if the following criteria are met: Confirmation that the referrer and the patient have discussed the NHS Rightcare Shared Decision- Making tool on carpal tunnel syndrome AND Symptoms persist or recur after at least 3 months of conservative therapy, including 8 weeks of nocturnal splinting and local corticosteroid injections if clinically appropriate. AND EITHER Page 28 of 39

29 There is neurological deficit, for example sensory blunting, thenar muscle wasting or motor weakness OR There are severe symptoms that significantly interfere with daily activities (see FAQs) Page 29 of 39

30 Cataract Surgery Background: Cataracts are a common condition of later life, affecting the lens of the eye. If left untreated, cataracts can cause a gradual loss of clarity of vision, which may have a significant impact on the quality of life of many elderly people. The presence of a cataract does not in itself indicate a need for surgery. The decision to refer a patient for surgery should be based on consideration of their visual acuity, visual impairment as well their potential for functional benefits derived from the surgery and patient s willingness to undergo surgery. Policy: cataract extraction (phaco-emulsification with intra-ocular standard mono focal lens) for patients who, following a recent sight test, and any further pre-operative cataract assessment, meet the following criteria: Clear and documented evidence that despite best refractive correction the cataract impairs the patient s lifestyle (for example affecting activities of daily living, leisure activities, not meeting DVLA requirements to maintain driving license or have risk of falls) AND The cause of the visual impairment of the patient is assessed as caused by the cataract by an experienced clinician, AND the surgery is assessed as likely to improve the symptoms AND Evidence has been supplied that the risks and benefits of surgery have been discussed with the patient and relevant written information has been given to the patient. Use the NHS Rightcare Shared Decision Making tool for cataracts Patients requiring surgery to the second eye must meet the criteria as outlined above or: Where there are binocular considerations OR Where there is anisometropia OR Where there is disabling glare Special considerations: Cataract surgery will also be funded for patients where the cataract surgery addresses another clinical need, like the control of glaucoma, having ongoing treatment for macular degeneration or the need of eye monitoring for retinopathy in patients with diabetes or previously treated choroidal melanoma. A patient should not be referred for cataract surgery if: Solely on the presence of a cataract, The patient does not desire surgery. Glasses or other visual aids provide functional vision satisfactory to the patient. Page 30 of 39

31 The patient s quality of life or ability to function is not compromised. The patient has concomitant ocular disease where functional improvement is unlikely. Page 31 of 39

32 Cervical Spinal Disc Prosthesis Policy: Cervical spinal disc prosthesis is not routinely funded for degenerative cervical disc disease Cholecystectomy (for asymptomatic gall stones) Background: Cholecystectomy is the surgical removal of the gall bladder. Prophylactic cholecystectomy is not indicated in most patients with asymptomatic gallstones. Possible exceptions include patients who are at increased risk for gallbladder carcinoma or gallstone complications, in which prophylactic cholecystectomy or incidental cholecystectomy at the time of another abdominal operation can be considered. Although patients with diabetes mellitus may have an increased risk of complications, the magnitude of the risk does not warrant prophylactic cholecystectomy. Policy: Cholecystectomy for asymptomatic gall stones will only be funded in exceptional clinical circumstances through an Individual Funding Request. Bile duct clearance and laparoscopic cholecystectomy will be funded for both symptomatic and asymptomatic stones in the common bile duct. Note: The referrer should include evidence that the risk and benefits have been discussed with the patient using the NHS Rightcare Shared Decision-Making tool Circumcision Background: Circumcision is a surgical procedure that involves partial or complete removal of the foreskin of the penis. It is an effective procedure and confers benefit for a range of medical indications. Policy: Circumcision is not funded for social, cultural or religious reasons. Circumcision will only be funded for specific medical reasons in accordance with the criteria specified below. Medical reasons for funding circumcision include: Carcinoma of the penis. Pathological phimosis: the commonest cause is lichen sclerosus balanitis xerotica obliterans (BXO) is an old fashioned descriptive term Recurrent episodes of balanoposthitis Relative indications for circumcision or other foreskin surgery: Prevention of urinary tract infection in patients with an abnormal urinary tract Recurrent paraphimosis Page 32 of 39

33 Traumatic (e.g. zipper injury) Tight foreskin causing pain on arousal/ interfering with physical function Congenital abnormalities. Page 33 of 39

34 Complementary and Alternative Medicines Background: Complementary and alternative medicines (CAMs) are treatments that fall outside of mainstream healthcare. These medicines and treatments range from acupuncture, massage and homeopathy to aromatherapy, meditation transcutaneous electrical nerve stimulation (TENS) and colonic irrigation. Policy: Complementary and alternative therapies, outside of existing CCG commissioned services and pathways, will not be routinely funded. Dupuytren s Contracture Policy: Surgery of Dupuytrens contracture will only be funded in accordance with the criteria specified below: Flexion deformity >30 at the MCPJoint or PIPJoint OR Rapidly progressive disease OR Contracture interferes with lifestyle and/or occupation Collagenase injections Limited to one joint or cord AND Flexion contracture is greater than 40º from the horizontal plane Radiotherapy for Dupuytren s contracture is not routinely funded. Excimer Laser for Cases with Poor Refraction After Corneal Transplant or Cataract Surgery Background: This is a last resort measure where all other conservative and surgical interventions have failed. Policy: This procedure will only be funded if all other conservative and surgical interventions have failed. Exogen Ultrasound Bone Healing Policy: Exogen ultrasound for bone healing only be funded in accordance with the criteria specified below: Page 34 of 39

35 Where there is a long bone fracture with non-union (failure to heal after 9 months) Page 35 of 39

36 Extracorporeal Shock Wave Therapy for Plantar Fasciitis Policy: Extracorporeal shock-wave therapy for plantar fasciitis is not routinely funded. Face Lift or Brow Lift Background: these surgical procedures are performed to lift the loose skin of the face and forehead to get a firm and smoother appearance of the face. These procedures will not be funded to treat the natural processes of ageing or to achieve a cosmetic outcome. Policy: Face lift or brow lift will only be funded in accordance with the criteria specified below. These procedures will only be considered for treatment of the functional impairments arising from: Congenital facial abnormalities Facial palsy (congenital or acquired paralysis) As part of the treatment of specific conditions affecting the facial skin eg. Cutis laxa, pseudoxanthoma elasticum, neurofibromatosis To correct the functional consequences of trauma To correct functional consequences of deformity following surgery In some cases of impaired visual fields, where it may be a more appropriate primary procedure than blepharoplasty Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8. Fertility Preservation for Cancer Patients Best practice recommends that the consideration of the potential impact of the cancer treatment on fertility is one of the issues that should be discussed before that treatment is started. In some cases the individual s fertility will return after the cancer treatment is completed but in other cases fertility never returns, or is severely impaired. Preservation of fertility involves some form of freezing, technically called cryopreservation. The methods used in this service involve the cryopreservation of semen, oocytes and embryos. The service does not cover the storage of ovarian or testicular tissue. Policy: Fertility preservation will be funded through requests from adult and paediatric oncology teams in accordance with the criteria specified below: Page 36 of 39

37 Men: The service should be offered to men and adolescent boys who are preparing for medical treatment for cancer that is likely to make them infertile. Adolescent boys who may also be capable of producing mature sperm and therefore benefiting from semen storage should be known to those treating their cancer and specialist advice and counselling should be available. Women: The service should be offered to women of reproductive age (including adolescent girls) who are preparing for medical treatment for cancer that is likely to make them infertile if: they are well enough to undergo ovarian stimulation and egg collection AND this will not worsen their condition AND enough time is available before the start of their cancer treatment. Staff must be aware of and take account of the child protection law for anyone under the age of 18. The service will store cryopreserved material for an initial period of 10 years. The service will offer men the option to continue the storage of cryopreserved sperm beyond the 10 years if they remain at risk of significant infertility. Ganglia Background: Ganglia are benign fluid filled, firm and rubbery lumps attached to the adjacent underlying joint capsule, ligament, tendon or tendon sheath. They occur most commonly around the wrist, but also around fingers, ankles and the top of the foot. They are usually painless and completely harmless. Many resolve spontaneously especially in children (up to 80%). Reassurance should be the first therapeutic intervention. Aspiration alone can be successful but recurrence rates are up to 70%. Surgical excision is the most invasive therapy but recurrence rates up to 40% have been reported. Complications of surgical excision include scar sensitivity, joint stiffness and distal numbness. Referral guidance: Include reference to the degree of pain and restriction of normal activities caused by the ganglion. Policy: Surgical treatment for ganglia will only be funded in accordance with the criteria specified below. There is significant pain and/ or a significant functional impairment affecting activities of daily living (see FAQs) Groin Hernia Background: An inguinal hernia is the most common hernia (about 70% of all hernias). Femoral hernias account for less than 10% of all groin hernias. However, they frequently become incarcerated or strangulated due to the small size of this space through which they protrude and hence present as emergencies in most cases 4 with 40% presenting as emergencies 5. The incidence of femoral hernias is 4 Page 37 of 39

38 higher in women than men. In general, women have an increased risk of emergency procedure from groin hernias compared to men. Policy: Referral to secondary care and subsequent surgical treatment will be provided where patients meet one or more of the following criteria: History of incarceration, difficulty in reducing the hernia, OR Increased risk of strangulation (high risk in female patients) OR Inguino-scrotal hernia OR Progressive increase in size of hernia (month-on-month) OR Significant pain or discomfort sufficient to cause significant functional impairment (see FAQs) AND The referrer should include evidence that the risk and benefits have been discussed with the patient using the NHS Rightcare Shared Decision-Making tool 5 McIntosh A, Hutchinson A, Roberts A and Withers H. Evidence-based management of groin hernia in primary care a systematic review. Family Practice 2000; 17: Page 38 of 39

39 Grommets in Children Background: Otitis media with effusion (OME) has a good prognosis. It is a self-limiting condition and 90% of children will have complete resolution within 1 year. Active observation for at least 3 months (watchful waiting) rarely results in long-term complications. There is no proven benefit from treatment with any medication or complementary or alternative treatments. Insertion of ventilation tubes, or grommets, is the most common surgical treatment. Evidence suggests that the benefit of grommets on children s hearing gradually decreases in first year of insertion. The procedure improves hearing in the short term (up to 12 months after surgery) but has not been shown to improve language or speech development. Parents/ cares should have the risks and benefits of treatment clearly discussed with them. Use the NHS Rightcare Shared Decision Making tool on glue ear Referral for a Specialist opinion when: Persistence of bilateral otitis media with effusion (OME) and hearing loss over 3 months OR If hearing loss of any level is associated with a significant impact on the child's developmental, social, or educational status. OR If hearing loss is severe. OR The hearing loss persists on two documented occasions (usually following repeat testing after 6 12 weeks). OR The tympanic membrane is structurally abnormal (or there are other features suggesting an alternative diagnosis). OR There is a persistent, foul-smelling discharge suggestive of a possible cholesteatoma. (Referral should be urgent within 2 weeks). OR The child has Down's syndrome or has a cleft palate. Ventilation tube (grommet) insertion will be funded in accordance with NICE guidance: There is evidence that the risks and benefits of treatments options have been clearly discussed with the parent/ carer using the NHS Rightcare Shared Decision Making tool AND EITHER Children with persistent bilateral OME documented over a period of 3 months with a hearing level in the better ear of dbhl or worse, when averaged at 0.5, 1, 2 and 4 khz (or equivalent dba where dbhl not available). OR Exceptionally in children with persistent bilateral OME with a hearing loss less than dbhl where the impact of the hearing loss on a child s developmental, social or educational status is judged to be significant. Page 39 of 39

40 Note: Adjuvant adenoidectomy is not recommended in the absence of persistent and/or frequent upper respiratory tract symptoms. Page 40 of 39

41 Gynaecomastia Background: Gynaecomastia is benign enlargement of the male breast. Most cases are idiopathic. For others endocrinological disorders and certain drugs such as oestrogens, gonadotrophins, digoxin, spironolactone, cimetidine and proton pump inhibitors could be the primary cause. Obesity can also give the appearance of breast development as part of the wide distribution of excess adipose tissue. Early onset gynaecomastia is often tender but this usually resolves in 3 to 4 months. Full assessment of men with gynaecomastia should be undertaken, including screening for endocrinological and drug related causes and necessary treatment is given prior to request for NHS funding. It is important to exclude inappropriate use of anabolic steroids or cannabis. Policy: Surgery to correct gynaecomastia will not be routinely funded. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8 Hair Grafting Male Pattern Baldness and Hair Transplantation Background: male pattern baldness is a common type of hair loss and for many men it is a normal process at whatever age it occurs. Almost all men have some baldness in their 60s. Hair grafting is mostly done for aesthetic reasons. Policy: Hair grafting for male pattern baldness will not be funded. Hair transplantation will not normally be funded Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8 Hip Prostheses and Resurfacing Policy: Prostheses for total hip replacement and resurfacing arthroplasty will only be funded where the prosthesis to be used has a rate (or projected rate) of revision of 5% or less at 10 years (ODEP 10A* rating, or A* rating at less than 10 years). Hip Replacement Surgery Policy: Hip replacement surgery will only be funded in accordance with the criteria specified below: The patient has accessed core (non-surgical) treatment options for at least 3 months as part of their management plan: o Access to appropriate information as an ongoing, integral part of the management plan rather than a single event at time of presentation o Access to activity and exercise including aerobic fitness and local muscle strengthening Page 41 of 39

42 irrespective of age, co-morbidity, pain severity or disability o Access to facilitated interventions to achieve weight loss if the patient is overweight or obese. Use the NHS Rightcare Shared Decision-making tool on weight loss. AND The patient has moderate to severe persistent joint pain that is refractory to non-surgical treatment, including joint injections and recommended use of non-steroidal anti-inflammatories and other analgesics and has a substantial impact on their quality of life. AND There is clinically significant moderate to severe functional limitation which is refractory to use of walking aids and other forms of physical therapies and results in diminished quality of life (see FAQs) AND Evidence that the risks and benefits of treatments options have been clearly discussed with the patient using the NHS Rightcare Shared Decision Making tool Note: referral for joint surgery should be considered before there is prolonged and established functional limitation and significant pain. Page 42 of 39

43 Hirsutism Background: Laser treatment is increasingly being used as a cosmetic intervention to remove body hair. Patients with excessive body hair are described as having hirsutism. Hair depilation (for the management of hypertrichosis) involves permanent removal/reduction of hair from face, neck, legs, armpits and other areas of body usually for cosmetic reasons. Hair depilation is most effectively achieved by laser treatment. Policy: Hair depilation will only be funded in accordance with the criteria specified below. One course of treatment will be funded for those patients: Who are undergoing treatment for pilonidal sinuses to reduce recurrence Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8 Hyperhidrosis Treatment with Botulinium Toxin Background: Hyperhidrosis is a condition characterised by excessive sweating, and can be generalised or focal. Generalised hyperhidrosis involves the entire body, and is usually part of an underlying condition, most often an infectious, endocrine or neurological disorder. Focal hyperhidrosis is an idiopathic disorder of excessive sweating that mainly affects the axillae, the palms, the soles of the feet, armpits and the face of otherwise healthy people. The principal management strategies for hyperhidrosis are medical Botulinum Toxin is only licensed for the treatment of severe axillary hyperhidrosis and its cost effectiveness compared to other treatment options is yet to be established. Policy: Botulinum Toxin will only be funded in the management of severe axillary hyperhidrosis in accordance with the criteria below: The search for an underlying cause has been exhausted AND Advice on lifestyle management has been followed (use an antiperspirant frequently, Avoid tight clothing and manmade fabrics, wear white or black clothing to minimize the signs of sweating, consider dress shields to absorb excess sweat) AND 20% aluminium chloride hexahydrate has failed or is contraindicated AND Any underlying anxiety has been identified and managed AND In the opinion of an experienced dermatologist, other treatment options have been exhausted Hysterectomy for Heavy Menstrual Bleeding Hysterectomy should not be used as a first-line treatment solely for heavy menstrual bleeding. Page 43 of 39

44 Policy: For women diagnosed with heavy menstrual bleeding (menorrhagia), with or without fibroids, hysterectomy will not be commissioned unless ALL of the following criteria are met: Recommendations for the medical treatment of heavy menstrual bleeding (and/or symptomatic large or multiple fibroids) set out in NICE Clinical Guideline No. 44 for Heavy Menstrual Bleeding ( have failed, or are contraindicated. This includes the use of a progestogen-releasing intrauterine device (levonorgestrel releasing systems - LNG-IUS). AND Uterine endometrial ablation methods have failed or are not clinically appropriate. AND The woman has been fully informed of the implications of surgery, and does not wish to retain her uterus and fertility. AND Evidence that the risks and benefits of treatments options have been clearly discussed with the patient using the NHS Rightcare Shared Decision Making tool Page 44 of 39

45 Invitro Fertilisation (IVF) and Intracytlopasmic Sperm Injection (ICSI) This policy describes the eligibility criteria for NHS funded infertility treatment including: In vitro fertilisation (IVF) Intracytoplasmic sperm injection (ICSI) This policy does not apply to the investigation and assessment of infertility in general. Background: The Clinical Guideline on fertility assessment and treatment was published by NICE in February 2013 (NICE CG156, 2013) and covers all clinical procedures/pathways relating to fertility assessment and treatment. This document provides a single infertility specific commissioning policy for the NHS with the aim to ensure consistency in the application of the guideline across the North East region. Over 80% of couples in the general population will conceive within 1 year if: the woman is aged under 40 years AND they do not use contraception and have regular sexual intercourse (every 2 3 days). Of those who do not conceive in the first year, about half will do so in the second year (cumulative pregnancy rate over 90%). [NICE 2004, amended 2013]. The estimated prevalence of infertility is one in seven couples in the UK. A typical Clinical Commissioning Group can expect about 230 new consultant referrals (couples) per 250,000 head of population per year (NICE CG11, 2004). All couples are eligible for consultation and advice from the specialist service. Definition of infertility: A woman of reproductive age who has not conceived after 1 year of unprotected vaginal sexual intercourse, in the absence of any known cause of infertility, should be offered further clinical assessment and investigation along with her partner. IVF will only be funded after at least 2 years of unexplained infertility. Offer an earlier referral for specialist consultation to discuss the options for attempting conception, further assessment and appropriate treatment where: the woman is aged 36 years or over there is a known clinical cause of infertility or a history of predisposing factors for infertility. Definition of a full cycle: This term is used to define a full IVF treatment, which should include 1 episode of ovarian stimulation and the transfer of any resultant fresh and frozen embryo(s). Page 45 of 39

46 Additional background notes to accompany this policy are available on request. Policy: Funding for egg donation and/or surrogacy is not routinely funded. IVF treatment involving a privately arranged surrogate is undertaken at the discretion of the provider. IVF treatment will be funded in accordance with the criteria specified below: Page 46 of 39

47 Ref Eligibility criteria for treatment 1. Female Age under 40 years Definition In women aged under 40 years who have not conceived after 2 years of regular unprotected intercourse or 12 cycles of artificial insemination using partner s sperm or 6 cycles of donor sperm (where six or more are by intrauterine insemination), offer 3 full cycles of IVF, with or without intracytoplasmic sperm injection (ICSI). If the woman reaches the age of 40 during treatment, complete the current full cycle but do not offer further full cycles. For people with unexplained infertility, mild endometriosis or 'mild male factor infertility', who are having regular unprotected sexual intercourse: do not routinely offer intrauterine insemination, either with or without ovarian stimulation (exceptional circumstances include, for example, when people have social, cultural or religious objections to IVF) advise them to try to conceive for a total of 2 years before IVF will be considered. Additional Notes 3 full cycles of IVF Inform people that normally a full cycle of IVF treatment, with or without ICSI should comprise 1 episode of ovarian stimulation and the transfer of any resultant fresh and frozen embryo(s) The age limit also applies to all treatments including those using gonadotrophins for fertility treatment including ovulation induction and for donor insemination. Access to three cycles is not an automatic right the outcome of any previous cycle will be taken into account. Treatment must be medically indicated at the start of each cycle. As IVF success rates decline significantly after 3 cycles, previous cycles received irrespective as to whether they were funded by the NHS or privately will be taken into account. If patients have funded 3 or more IVF cycles privately they will not be entitled to any NHS funded cycles. If patients have funded 2 cycles privately they will be entitled to 1 NHS cycle. If patients have funded 1 cycle privately they will be entitled to 2 NHS cycles 2. Female Age 40 to 42 In women aged years who 1 full cycle of IVF Page 47 of 39

48 Ref Eligibility criteria for treatment years 3. Minimum length of unexplained infertility 4. Female Body Mass Index (BMI) Definition have not conceived after 2 years of regular unprotected intercourse or 12 cycles of artificial insemination using partner s sperm or 6 cycles of donor sperm (where 6 or more are by intrauterine insemination), offer 1 full cycle of IVF, with or without ICSI, provided all the following 4 criteria are fulfilled: They have never previously had IVF treatment AND There is evidence of good ovarian reserve as identified by a specialist clinician AND There has been a discussion of the additional implications of IVF and pregnancy at this age AND Specialist clinical opinion that there is no likelihood of pregnancy with expectant management e.g. confirmed tubal blockage (absolute infertility) Treatment must start before the woman s 43 rd birthday 2 years of regular unprotected intercourse and unexplained infertility at time of treatment. BMI greater than 19.0 and lower than or equal to 30.0 at the start of treatment. This applies to all treatments including those using gonadotrophins for fertility treatment including Page 48 of 39 Additional Notes (Including associated frozen/thaw transfers) provided that all other criteria are met. Ovarian reserve testing The aim is to select those with at least 10% chance of successful treatment. The criteria remain under review. At present use the following criteria to predict the likely ovarian response to gonadotrophin stimulation in women who are eligible for IVF treatment. - total antral follicle count of more than or equal to 4 AND anti-müllerian hormone of more than or equal to 5.4 pmol/l. Unexplained infertility is a diagnosis made by exclusion in couples who have not conceived and in whom standard investigations including semen analysis, tubal patency tests and assessment of ovulation have not detected any abnormality. This criterion reflects the increased efficacy of infertility treatment in this weight range. Women with a BMI of 30 or above should be informed that: They are likely to take

49 Ref Eligibility criteria for treatment 5. Male Body Mass Index (BMI) Definition ovulation induction and for donor insemination. If the male partner has mild male factor infertility which, after clinical assessment could be improved should weight be reduced, then the male partner should be re-assessed for fertility once weight has reduced to a BMI of 30 or below Additional Notes longer to conceive If they are not ovulating then losing weight is likely to increase their chance of conception Women who have a BMI less than 19 and who have irregular menstruation or are not menstruating should be advised that increasing body weight is likely to improve their chance of conception Men who have a BMI of 30 or over should be informed that they are likely to have reduced fertility 6. Existing children Treatment will only be offered to couples where neither partner has any living children from current or previous relationship This applies to all treatments including those using gonadotrophins for fertility treatment including ovulation induction and for donor insemination. 7. Smoking Status Both partners should be non-smokers when referred for IVF. This is part of primary care general assessment procedures. Assessment of smoking status will be through the use of carbon monoxide monitors in primary care or stop smoking services. This applies to all treatments including those using gonadotrophins for fertility treatment including ovulation induction and for donor insemination. Page 49 of 39 This criterion includes adopted children, but excludes fostered children. Women who smoke should be informed that this is likely to reduce their fertility Women who smoke should be offered a referral to a smoking cessation programme to support their efforts to stop smoking Women should be informed that passive smoking is likely to affect their chance of conceiving Men who smoke should be informed that there is an association between smoking and reduced semen quality

50 Ref Eligibility criteria for treatment 8. Same sex couples and single women Definition Treatment will only be offered where the partner wishing to become pregnant is sub-fertile Documentary evidence for subfertility is either no live birth following donor insemination from an accredited sperm bank for at least six cycles over two years or absolute infertility documented after clinical investigation. 9. Previous Sterilisation No previous sterilisation history in either partner. This applies to all treatments including those using gonadotrophins for fertility treatment including ovulation induction and induction of spermatogenesis, and for donor insemination. 10. Length of time resident in catchment area Both partners should be patients registered for one year with a GP practice that is itself a member of one of the Clinical Commissioning Groups subscribing to these policies This applies to all treatments including those using gonadotrophins for fertility treatment including ovulation induction and for donor insemination. 11. Residence in UK Must be eligible for free hospital treatment in line with the Overseas Visitors Charging Regulations. This applies to all treatments including those using gonadotrophins for fertility treatment including ovulation induction and for donor insemination. Additional Notes Treatment is offered to couples irrespective of sexual orientation. The NHS does not fund donor insemination to establish fertility in same sex couples. This excludes short term students who are otherwise eligible for NHS treatment. Page 50 of 39

51 Knee Arthroscopy Policy: Knee arthroscopy will only be funded in accordance with the criteria specified below: Clinical examination (or MRI scan) has demonstrated clear evidence of an internal joint derangement (meniscal tear, ligament rupture or loose body) AND Where conservative treatment has failed or where it is clear that conservative treatment will not be effective. In exceptional cases, intractable knee pain considered likely to benefit from arthroscopic treatment according to assessment by a Consultant Knee Surgeon. There is continuing diagnostic uncertainty following MRI, such that a Consultant Knee Surgeon recommends diagnostic arthroscopy. Arthroscopy is not commissioned: For diagnostic purposes only (noting the exception above); To provide arthroscopic washout alone as a treatment for chronic knee pain due to osteoarthritis. This procedure may be appropriate in conditions such as septic arthritis This policy restriction does not apply where there is an urgent need for investigation/treatment. Knee Replacement Surgery Policy: Knee replacement surgery will only be funded in accordance with the criteria specified below: The person has been offered the core (non-surgical) treatment options for at least 3 months as part of their management plan: o Access to appropriate information as an ongoing, integral part of the management plan rather than a single event at time of presentation o Access to activity and exercise including aerobic fitness and local muscle strengthening irrespective of age, co-morbidity, pain severity or disability o Access to facilitated interventions to achieve weight loss if the patient is overweight or obese. Use the NHS Rightcare Shared Decision Making Tool on weight loss AND The patient has moderate to severe persistent joint pain that is refractory to non-surgical treatment, including joint injections and recommended use of non-steroidal anti-inflammatories and other analgesics and has a substantial impact on their quality of life. Page 51 of 39

52 AND There is clinically significant moderate to severe functional limitation which is refractory to use of walking aids and other forms of physical therapies and results in diminished quality of life (see FAQs) AND Evidence that the risks and benefits of treatments options have been clearly discussed with the patient using the NHS Rightcare Shared Decision Making tool Note: referral for joint surgery should be considered before there is prolonged and established functional limitation and significant pain. Page 52 of 39

53 Liposuction Background: Liposuction (also known as liposculpture), is a surgical procedure performed to improve body shape by removing unwanted fat from areas of the body such as abdomen, hips, thighs, calves, ankles, upper arms, chin, neck and back. Liposuction is sometimes done as an adjunct to other surgical procedures. Policy: Liposuction simply to correct the distribution of fat will not be funded. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8. Pinnaplasty Background: Pinnaplasty is performed for the correction of prominent ears or bat ears. Prominent ears are a condition where one's ears stick out more than normal. Correction is considered to be a primarily a cosmetic procedure. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p 8. The exception to this policy is procedures (remodelling of external ear lobe) in children with congenital abnormalities of the ear to improve hearing as this is covered by Specialised commissioning and should be managed through the specialised commissioning route. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p 8. Policy: Pinnaplasty will not normally be funded. Removal of Benign Skin Lesions Including Scars Background: Benign skin lesions (across the body including eyelids) include a wide range of skin disorders such as sebaceous cyst, dermoid cyst, lipoma(ta), skin tags (including anal skin tags),, milia, molluscum contagiosum, seborrhoeic keratoses (basal cell papillomata), spider naevus (telangiectasia), viral warts (excluding in immunocompromised patients), sebaceous cysts, thread veins, xanthelasma, dermatofibromas, benign pigmented moles, comedones and corn/callous. Disfiguring scars and keloid or hypertrophic scars (including acne scarring), whether arising from prior injury or surgery, are also included in the scope of this policy. Mostly these are removed on purely cosmetic grounds. The risks of surgical scarring must be balanced against the appearance of the lesion. Patients with multiple subcutaneous lipomata may need a biopsy to exclude neurofibromatosis. Policy: Removal, cryotherapy or treatment (in secondary care) of benign skin lesions will only be funded in accordance with the criteria specified below: OR There is well documented evidence of significant pain (see FAQs) Page 53 of 39

54 OR OR recurrent infection recurrent bleeding is subject to unavoidable recurrent trauma leading to bleeding Where the lump is rapidly growing, abnormally located and/ or is displaying features suspicious of malignancy, specialist assessment should be sought using the 2 week wait pathway. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8 Note: If an IFR is obtained for the treatment of a keloid or hypertrophic scar, the number of treatments with intralesional triamcinolone will be limited to 3. Page 54 of 39

55 Removal of Tattoos A tattoo is defined as: a form of body modification, made by inserting indelible ink into the dermis layer of the skin to change the pigment. Policy: Tattoo removal will not be routinely funded. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8 Repair of Lobe of External Ear Background: the external ear lobe can split partially or completely as result of trauma or wearing ear rings. Correction of split earlobes is not always successful and the earlobe is a site where poor scar formation is a recognised risk. Policy: Repair of lobe of external ear will only be funded in accordance with the criteria specified below. If the totally split ear lobe is a result of direct trauma and the treatment is required at the time of, or soon after the acute episode and before permanent healing has occurred. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8 Resurfacing Procedures: Dermabrasion, Chemical Peels and Laser Treatment Background: dermabrasion involves removing the top layer of the skin with an aim to make it look smoother and healthier. Scarring and permanent discolouration of skin are the rare complications. This policy includes all laser skin treatments, for example for Rhinophyma or Rosacea. Policy: Resurfacing procedures will not be routinely funded. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8 Reversal of Female Sterilisation Background: Reversal of sterilisation is a surgical procedure that involves the reconstruction of the fallopian tubes. Sterilisation procedure is available on the NHS and couples seeking sterilisation should be fully advised and counselled (in accordance with RCOG guidelines) that the procedure is intended to be permanent. Policy: Reversal of sterilisation will not be routinely funded. Page 55 of 39

56 Reversal of Male Sterilisation Background: Reversal of male sterilisation is a surgical procedure that involves the reconstruction of the vas deferens. Sterilisation procedure is available on the NHS and couples seeking sterilisation should be fully advised and counselled (in accordance with RCOG guidelines) that the procedure is intended to be permanent. Policy: Reversal of sterilisation will not be routinely funded. Rhinoplasty Background: rhinoplasty is a surgical procedure performed on the nose to change its size or shape or both. People usually ask for this procedure to improve self-image. Policy: Rhinoplasty will only be funded in accordance with the criteria specified below: OR Problems caused by obstruction of the nasal airway Correction of complex congenital conditions to improve function e.g. cleft lip and palate. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8 Thigh Lift, Buttock Lift and Arm Lift, Excision of Redundant Skin or Fat Background: These surgical procedures are performed to remove loose skin or excess fat to reshape body contours. As the patient groups seeking such procedures are similar to those seeking abdominoplasty (see above), the functional disturbance of skin excess in these sites tends to be less and so surgery is less likely to be indicated except for appearance, in which case it should not be available on the NHS. Policy: These procedures will not be routinely funded. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8 Tonsillectomy Background: Tonsillectomy is one of the most common surgical procedures in the UK. There is good evidence for the effectiveness of tonsillectomy in children but only limited evidence in adults. Policy: Tonsillectomy will only be funded in accordance with the criteria specified below. For recurrent acute sore throat in adults and children in the following circumstances: Page 56 of 39

57 The sore throats are due to tonsillitis; AND The episodes of sore throat are disabling and prevent normal functioning AND Seven or more well documented, clinically significant, adequately treated episodes of sore throat in the previous year; OR Five or more such episode have occurred in each of the previous two years OR Three or more such episodes have occurred in each of the previous three years This policy does not apply to suspected malignancy, management of acute quinsy, bleeding or deep neck infection or OSAS in children. There is no restriction on funding for tonsillectomy to treat adult obstructive sleep apnoea with tonsillar enlargement (if trials of continuous positive airway pressure (CPAP) and the use of mandibular advancement devices are unavailable or unsuccessful). Tonsillectomy for the treatment of halitosis associated with tonsilloliths will not be routinely funded. Page 57 of 39

58 Trigger Finger Policy: Surgery for trigger finger will only be funded in accordance with the criteria specified below: The patient has co-morbidities associated with an increased risk of trigger finger (e.g. rheumatoid arthritis or diabetes mellitus) and the patient s symptoms have not improved with at least 4 months of conservative treatment (e.g. NSAIDs, splintage, physiotherapy). OR The patient s symptoms have not resolved despite at least one steroid injection in the last 4 months. OR The specialist opinion is that surgery is needed promptly to prevent the development of flexion contractures. Vaginoplasty, Labial Vulvoplasty and Vulvar Lipoplasty Surgery for Vaginoplasty, Labial Vulvoplasty and Vulvar lipoplasty are all cosmetic procedures. This policy does not cover vaginal repair following delivery and is part of obstetric or gynaecological treatment. Clinicians should refer to the following guidance from the Royal College of Obstetricians and Gyaencologists : Joint RCOG BritSPAG release - vaginoplasty Policy: Vaginoplasty will not routinely be funded. Surgery for primarily cosmetic reasons is not eligible for NHS funding- see p8 Varicose Veins in the Leg Background: Varicose veins are dilated, often palpable subcutaneous veins with reversed blood flow. They are most commonly found in the legs. Estimates of the prevalence of varicose veins vary. Visible varicose veins in the lower limbs are estimated to affect at least a third of the population. Risk factors for developing varicose veins are unclear, although prevalence rises with age and they often develop during pregnancy. In some people varicose veins are asymptomatic or cause only mild symptoms, but in others they cause pain, aching or itching and can have a significant effect on their quality of life. Varicose veins may become more severe over time and can lead to complications such as changes in skin pigmentation, bleeding or venous ulceration. It is not known which people will develop more severe disease but it is estimated that 3 6% of people who have varicose veins in their lifetime will develop venous ulcers. Referral to a vascular service guidance 1 :Refer people with bleeding varicose veins to a vascular service 6 immediately. Referral guidance: Refer people to a vascular service 1 if they have any of the following: 6 A team of healthcare professionals who have the skills to undertake a full clinical and duplex ultrasound assessment and provide a full range Value of treatment. Based Clinical Commissioning Policy Page 58 of 39

59 History of bleeding from a varicosity which are at risk of bleeding again Ulceration which is progressive and/or causing significant pain despite treatment Active or healed ulceration and/or progressive skin changes that may benefit from surgery Recurrent superficial thrombophlebitis Significant pain attributable to varicose veins having a severe impact on quality of life and interfering with actives of daily living (see FAQ). Assessment and treatment in a vascular service 1 Assessment: Use duplex ultrasound to confirm the diagnosis of varicose veins and the extent of truncal reflux, and to plan treatment for people with suspected primary or recurrent varicose veins. Interventional treatment: For people with confirmed varicose veins and truncal reflux: Offer endothermal ablation and Endovenous laser treatment of the long saphenous vein If endothermal ablation is unsuitable, offer ultrasound-guided foam sclerotherapy If ultrasound-guided foam sclerotherapy is unsuitable, offer surgery. If incompetent varicose tributaries are to be treated, consider treating them at the same time. Non-interventional treatment: Compression hosiery to treat varicose veins is not recommended unless interventional treatment is unsuitable for clinical reasons or patient choice. Policy: Interventional treatments for varicose veins outlined above will only be funded in accordance with the criteria specified below. Persistent ulceration that is progressive or causing significant pain (see FAQs) OR Recurrent superficial thrombophlebitis where there is significant pain and disability OR Progressive skin changes that suggest potential ulceration due to venous insufficiency OR Significant haemorrhage from a ruptured superficial varicosity OR Patients with significant pain attributable to chronic venous insufficiency which is having a significant impact on quality of life and interfering with activities of daily living (see FAQs) Patients whose primary concern is cosmetic will not be funded for surgical treatment. Page 59 of 39

60 Surgery for primarily cosmetic reasons is not eligible for NHS funding - see page 8. Page 60 of 39

61 Document History Revision date Summary of Changes May 2012 Removed the policy on Gender Reassignment surgery in Adults as this is included in Specialised Services Commissioning for Mental Health Services. Removed the reference to Gender Reassignment in the policy on the treatment of hirsutism. Modified the criteria for orthodontic treatment in line with DH guidance. Clarification of the criteria for mastopexy. Clarification of the criteria for Pre-implantation Genetic Diagnosis. August 2012 BMI criteria specified to one decimal point. BMI added as a criterion for mastopexy- as excess weight is likely to be a contributing to the magnitude of the problems experienced. BMI added as a criterion for thigh lift- as excess weight is likely to be a contributing to the magnitude of the problems experienced. Excimer laser laser for refractive error limited to patients when all other conservative interventions have failed. This moves the policy in line with prevailing clinical practice Clarification is offered on the rationale for age limits for pinnaplasty. Laser treatment for hirsutism limited to face and neck only- bringing the wording of the policy in line with decision precedents. December 2012 Cosmetic surgery inclusion of a general statement applying to a number of procedures. Breast augmentation replacement needing a new funding application. Breast reduction clarifying the degree of neck ache, back ache and intertrigo; rewording the assessment of breast size. Gynaecomastia endocrine problems treated before referral Pinnaplasty removed age criteria. Repair of ear lobe - clarifying the timing of surgery following trauma. Varicose veins inclusion of progressive skin changes due to venous insufficiency. Resurfacing procedures clarification of criteria Removal of benign skin lesions one change in the order of the wording. September 2013 Varicose veins BMI criterion for safe surgery Tonsillectomy Fertility treatment Hyperhidrosis Policy reviewed in light NICE guideline (CG168) published in July 2013 and discussed with chair of the cardiovascular network. Recommended interventions include the newer treatments: endothermal (radiofrequency) ablation endovenous laser treatment of the long saphenous vein and ultrasound-guided foam sclerotherapy. The policy now refers to Interventional rather than surgical treatment the removal of the criterion for patients to have tried at least 6 months of conservative management, for lack of an evidence base Consideration of evidence base for this criterion- all weight related eligibility criteria reviewed Complete new criterion based policy(s) based on RCS guidance (section on sleep disordered breathing in adults remains Policy revised in light of NICE guidelines- age limit raised (in restricted circumstances) but priority for families where both parents are childless remains The policy covers eligibility for fertility treatments as covered in NICE guidelines. There are further elements of guidance that require consideration, particularly embryo transfer and fertility preservation. Further analysis on these topics is available on request. Added link to CKS best practice guidance Added criteria based on CKS medical management of hyperhidrosis Page 61 of 39

62 Hirsuitism Excimer laser for corneal erosions Ophthalmology- correction of refractive error Rhinophyma Eligibility for treatment restricted, no longer available routinely for those with excessive facial hair Specialised service commissioned by NHS England, policy removed Policy removed as not in Cumbria policy and not considered as a priority- NE and Cumbria policies now consistent Included Cumbria policy Vulvoplasty Clarification that this is not usually funded Keloid scarring Included Cumbria policy within Benign skin lesions policy Breast asymmetry Breast prosthesis removal or replacement Gynaecomastia Default to breast reduction- as in Cumbria policy- new policy guidance and clearer criteria- as distinct from breast augmentation policy NHS funding position on part payment clarified Changed default to not routinely funded- primary consideration is already of exceptionality Pre-implantation diagnosis genetic specialised service commissioned by NHS England, policy removed Reversal of male sterilisation Clarification that this is not normally funded Reversal of female sterilisation Clarification that this is not normally funded Collagen cross-linking for corneal irregularities including keratoconus specialised service commissioned by NHS England, policy removed September 2014 Carpal tunnel syndrome Breast augmentation (Breast enlargement) Inclusion of shared decision making in the criteria. Delete specific criteria to emphasise this is not normally funded. Rationale: There appears to be little clinical support to undertake this treatment and there is varied interpretation of criteria. By removing the criteria we are making a consistent statement that the NHS will no longer fund cosmetic surgery. Where applications are submitted emphasis will need to be made on clinical exceptionality. Delete specific criteria to emphasise this is not normally funded. Breast asymmetry Breast prosthesis removal Rationale: There appears to be little clinical support to undertake this treatment and there is varied interpretation of criteria. By removing the criteria we are making a consistent statement that the NHS will no longer fund cosmetic surgery. Where applications are submitted emphasis will need to be made on clinical exceptionality. Limit the funding to criteria to prosthesis removal to make safe only. Replacements will not be funded. Rationale: There appears to be little clinical support to undertake this treatment and there is varied interpretation of criteria. By removing the criteria we are making a consistent statement that the NHS will no longer fund cosmetic surgery. Where applications are submitted emphasis will need to be made on clinical exceptionality. Page 62 of 39

63 Breast reduction Gynaecomastia Mastopexy Revision mammoplasty Blepharoplasty Apicectomy Dental implants Orthodontic treatments for essentially cosmetic nature Varicose veins in the legs Resurfacing procedures: Dermabrasion, chemical peels and laser treatment Abdominoplasty Apronectomy or Removal of benign skin lesions including scars Thigh lift, buttock lift and arm lift, excision of redundant skin or fat Change the wording for the severity of functional problems Clarification on the place of mastectomy for painful gynaecomastia Rationale: This is based on advice from surgical colleagues taking into account the lack of evidence for the effectiveness of surgical treatment for painful gynaecomestia. Delete specific criteria to emphasise this is not normally funded. Rationale: There appears to be little clinical support to undertake this treatment and there is varied interpretation of criteria. By removing the criteria we are making a consistent statement that the NHS will no longer fund cosmetic surgery. Where applications are submitted emphasis will need to be made on clinical exceptionality. Policy deleted as covered by other policies. Clarification of wording to emphasise that surgery will only be funded for functional problems and not for cosmetic issues. Removed. NHS England commissioning responsibility Removed. NHS England commissioning responsibility Removed. NHS England commissioning responsibility Revised wording of criteria around significant discomfort and quality of life as indication for referral and surgical treatment in line with NICE guidance. Remove specific criteria to emphasise this is not normally funded. Rationale: There appears to be little clinical support to undertake this treatment and there is varied interpretation of criteria. By removing the criteria we are making a consistent statement that the NHS will no longer fund cosmetic surgery. Where applications are submitted emphasis will need to be made on clinical exceptionality. Remove specific criteria to emphasise this is not normally funded. Rationale: There appears to be little clinical support to undertake this treatment and there is varied interpretation of criteria. By removing the criteria we are making a consistent statement that the NHS will no longer fund cosmetic surgery. Where applications are submitted emphasis will need to be made on clinical exceptionality. Deleted the criteria of prominent facial lesion Added repeated infection Remove specific criteria to emphasise this is not normally funded. Rationale: There appears to be little clinical support to undertake this treatment and there is varied interpretation of criteria. By removing the criteria we are making a consistent statement that the NHS will no longer fund cosmetic surgery. Where applications are submitted emphasis will need to be made on clinical exceptionality. Clarifying the scope of the policy to IVF and ICSI Females aged 40 to 42 treatment to start before 43rd birthday Infertility Treatment Same sex couples to include single women For same sex couples clarification around the evidence of infertility based on documentary proof of artificial insemination provided by a reputable centre of at least six cycles over 2 years Clarification of the minimum time of unexplained infertility for IVF. Page 63 of 39

64 Fertility preservation This is a new policy developed in response to NICE guidance and endorsed by the North CCG forum. November 2015 Breast - Asymmetry Breast - Mastopexy Breast Prosthesis removal and/or replacement Breast - Reduction Clarification added that this policy does not apply to breast reconstruction as part of the treatment for breast cancer. Clarification added that this policy does not apply to breast reconstruction as part of the treatment for breast cancer. Clarification added that this policy does not apply to breast reconstruction as part of the treatment for breast cancer. Removal of specific criteria to emphasise that removal of implants is only undertaken for clinical reasons. Removal of criteria detailing documented evidence of intractable intertrigo that has not responded to conservative treatment to ensure consistency across this policy. Cholecystectomy Circumcision Infertility Treatment Criteria amended to include section on bile duct clearance. Clarification added that Circumcision is not funded for social, cultural or religious reasons Title changed to In vitro fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI). Clarification added that this policy does not apply to the investigation and assessment of infertility in general. Pinnaplasty Removal of benign skin lesions Tonsillectomy Removal of narrative detailing the psychological issues faced. Include cryotherapy as removal option. Added more specific criteria to clarify clinical condition of the lesion. Clarification added that Tonsillectomy for the treatment of halitosis associated with tonsilloliths will not be routinely funded. December 2015 Autologous Transplantation Bunions Cartilage New policy inclusion to clarify that treatment is not routinely funded New policy inclusion. Discectomy for Lumbar Spine Prolapse Dupuytrens Contracture Hip Prosthesis and Resurfacing Facet Joint Injection Epidural Injections for Lumbar Back Pain New policy inclusion New policy inclusion New policy inclusion New policy inclusion New policy inclusion Page 64 of 39

65 Exogen Ultrasound Bone Healing Knee Arthroscopy Trigger Finger Cervical Spinal Disc Prosthesis Extracorporeal Shock-wave Therapy for Planta Fasciitis Bone Morphogenetic Proteins In vitro fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI). Breast Reduction New policy inclusion New policy inclusion New policy inclusion New policy inclusion to clarify that treatment is not routinely funded New policy inclusion to clarify that treatment is not routinely funded New policy inclusion Clarity added that funding is not routinely provided for egg donation or surrogacy. Removal of narrative advising that 500gms of tissue is to be removed as this detail is not always possible to confirm at the time of assessment. Clarity of cup sizing threshold added. June 2016 Frequently Asked Questions Clarity added that psychological distress does not constitute exceptionality Carpal Tunnel Syndrome Title amended to Carpal Tunnel Surgery Breast Prosthesis Removal Clarity added that Breast Prosthesis replacement will not routinely be funded Tonsillectomy Rhinoplasty Hip Prosthesis Clarity added around exclusions to policy Removal of criterion indicating that funding can be approved for deformity caused by direct trauma as this is outside of the policy as reduction of facial bones would need to be completed within two weeks of acute trauma and is not defined as rhinoplasty. Clarity added that this is a quality statement around prosthesis. Circumcision Clarity added to the medical indications for treatment. November 2016 Frequently Asked Questions Cosmetic Treatments Autologus Serum Eye Drops Clarity added to existing FAQ as well as the addition of new FAQs to provide referrers with additional understanding/clarity around the application and funding processes. Clarity added that funding will not be provided for treatments that are requested to achieve a cosmetic outcome. Clarity added that funding will only be provided on a trial basis. Back Pain Inclusion of New Policy Page 65 of 39

66 Breast Prosthesis Title changed to Breast Prosthesis Removal. Replacement removed from title. Breast Reduction Clarity added that repeat surgery will not be funded. Carpal Tunnel Link to shared decision making tool added. Cataracts Inclusion of new policy Cholecystectomy Circumcision Complementary Therapies Link to shared decision making tool added. Clarification of wording to emphasis that surgery will only be carried out for functional issues. Inclusion of new policy Discectomy Re-termed as Back Pain Discectomy Epidural Injections Removed as covered within Back Pain Policy Face or Brow Lift Clarity added the funded will only be considered based on functional impairments Facet Joint injections Removed as covered within Back Pain Policy Ganglia Amalgamation of criterion Groin Hernia Inclusion of new policy Grommets in Children Inclusion of new policy Hip Replacement Surgery Hysterectomy for Heavy Menstrual Bleeding IVF Inclusion of new policy Inclusion of new policy Clarity added around surrogacy pathways Knee Replacement Surgery Lipomata Inclusion of new policy Treatment type removed as captured within removal of benign skin lesion policy. Removal of Tattoo Removal of Benign Skin Lesion Resurfacing Procedures Definition of a tattoo added for clarity and that funding will not routinely be provided. Clarity added to confirm that this policy covers lesions on the eye lid; criterion amended to clarify that suspected malignancy does not fall within the scope of this policy. Examples provided over treatments within the scope of the policy Tonsillectomy Clarity added to detail the previous history of the patient Page 66 of 39

67 Vaginoplasty Link added to the RCOG guidelines on this treatment Page 67 of 39

68 Appendix 2 NICE Guidance Low Back Pain Low back pain and sciatica in over 16s: assessment and management NICE guideline Published: 30 November 2016 nice.org.uk/guidance/ng59 NICE All rights reserved.

69 Low back pain and sciatica in over 16s: assessment and management (NG59) Your responsibility The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian. Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties. NICE All rights reserved. Page 2 of 18

70 Low back pain and sciatica in over 16s: assessment and management (NG59) Contents Overview... 4 Who is it for?... 4 Recommendations Assessment of low back pain and sciatica Non-invasive treatments for low back pain and sciatica Invasive treatments for low back pain and sciatica... 9 Putting this guideline into practice Context More information Recommendations for research Pharmacological therapies Pharmacological therapies Radiofrequency denervation Epidurals Spinal fusion NICE All rights reserved. Page 3 of 18

71 Low back pain and sciatica in over 16s: assessment and management (NG59) This guideline replaces CG88. Overview This guideline covers assessing and managing low back pain and sciatica in people aged 16 and over. It outlines physical, psychological, pharmacological and surgical treatments to help people manage their low back pain and sciatica in their daily life. The guideline aims to improve people's quality of life by promoting the most effective forms of care for low back pain and sciatica. Who is it for? Healthcare professionals Commissioners and providers of healthcare People with low back pain or sciatica, and their families and carers NICE All rights reserved. Page 4 of 18

72 Low back pain and sciatica in over 16s: assessment and management (NG59) Recommendations People have the right to be involved in discussions and make informed decisions about their care, as described in your care. Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding. 1.1 Assessment of low back pain and sciatica Alternative diagnoses Think about alternative diagnoses when examining or reviewing people with low back pain, particularly if they develop new or changed symptoms. Exclude specific causes of low back pain, for example, cancer, infection, trauma or inflammatory disease such as spondyloarthritis. If serious underlying pathology is suspected, refer to relevant NICE guidance on: Metastatic spinal cord compression in adults Spinal injury Spondyloarthritis Suspected cancer Risk assessment and risk stratification tools Consider using risk stratification (for example, the STarT Back risk assessment tool) at first point of contact with a healthcare professional for each new episode of low back pain with or without sciatica to inform shared decisionmaking about stratified management Based on risk stratification, consider: simpler and less intensive support for people with low back pain with or without sciatica likely to improve quickly and have a good outcome (for example, reassurance, advice to keep active and guidance on self-management) NICE All rights reserved. Page 5 of 18

73 Low back pain and sciatica in over 16s: assessment and management (NG59) Imaging more complex and intensive support for people with low back pain with or without sciatica at higher risk of a poor outcome (for example, exercise programmes with or without manual therapy or using a psychological approach) Do not routinely offer imaging in a non-specialist setting for people with low back pain with or without sciatica Explain to people with low back pain with or without sciatica that if they are being referred for specialist opinion, they may not need imaging Consider imaging in specialist settings of care (for example, a musculoskeletal interface clinic or hospital) for people with low back pain with or without sciatica only if the result is likely to change management. 1.2 Non-invasive treatments for low back pain and sciatica Non-pharmacological interventions Self-management Provide people with advice and information, tailored to their needs and capabilities, to help them self-manage their low back pain with or without sciatica, at all steps of the treatment pathway. Include: Exercise information on the nature of low back pain and sciatica encouragement to continue with normal activities Consider a group exercise programme (biomechanical, aerobic, mind body or a combination of approaches) within the NHS for people with a specific episode or flare-up of low back pain with or without sciatica. Take people's specific needs, preferences and capabilities into account when choosing the type of exercise. NICE All rights reserved. Page 6 of 18

74 Low back pain and sciatica in over 16s: assessment and management (NG59) Orthotics Do not offer belts or corsets for managing low back pain with or without sciatica Do not offer foot orthotics for managing low back pain with or without sciatica Do not offer rocker sole shoes for managing low back pain with or without sciatica. Manual therapies Do not offer traction for managing low back pain with or without sciatica Consider manual therapy (spinal manipulation, mobilisation or soft tissue techniques such as massage) for managing low back pain with or without sciatica, but only as part of a treatment package including exercise, with or without psychological therapy. Acupuncture Do not offer acupuncture for managing low back pain with or without sciatica. Electrotherapies Do not offer ultrasound for managing low back pain with or without sciatica Do not offer percutaneous electrical nerve simulation (PENS) for managing low back pain with or without sciatica Do not offer transcutaneous electrical nerve simulation (TENS) for managing low back pain with or without sciatica Do not offer interferential therapy for managing low back pain with or without sciatica. NICE All rights reserved. Page 7 of 18

75 Low back pain and sciatica in over 16s: assessment and management (NG59) Psychological therapy Consider psychological therapies using a cognitive behavioural approach for managing low back pain with or without sciatica but only as part of a treatment package including exercise, with or without manual therapy (spinal manipulation, mobilisation or soft tissue techniques such as massage). Combined physical and psychological programmes Consider a combined physical and psychological programme, incorporating a cognitive behavioural approach (preferably in a group context that takes into account a person's specific needs and capabilities), for people with persistent low back pain or sciatica: when they have significant psychosocial obstacles to recovery (for example, avoiding normal activities based on inappropriate beliefs about their condition) or when previous treatments have not been effective. Return-to-work programmes Promote and facilitate return to work or normal activities of daily living for people with low back pain with or without sciatica. Pharmacological interventions For recommendations on pharmacological management of sciatica, see NICE's guideline on neuropathic pain in adults Consider oral non-steroidal anti-inflammatory drugs (NSAIDs) for managing low back pain, taking into account potential differences in gastrointestinal, liver and cardio-renal toxicity, and the person's risk factors, including age When prescribing oral NSAIDs for low back pain, think about appropriate clinical assessment, ongoing monitoring of risk factors, and the use of gastroprotective treatment Prescribe oral NSAIDs for low back pain at the lowest effective dose for the shortest possible period of time. NICE All rights reserved. Page 8 of 18

76 Low back pain and sciatica in over 16s: assessment and management (NG59) Consider weak opioids (with or without paracetamol) for managing acute low back pain only if an NSAID is contraindicated, not tolerated or has been ineffective Do not offer paracetamol alone for managing low back pain Do not routinely offer opioids for managing acute low back pain (see recommendation ) Do not offer opioids for managing chronic low back pain Do not offer selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors or tricyclic antidepressants for managing low back pain Do not offer anticonvulsants for managing low back pain. 1.3 Invasive treatments for low back pain and sciatica Non-surgical interventions Spinal injections Do not offer spinal injections for managing low back pain. Radiofrequency denervation Consider referral for assessment for radiofrequency denervation for people with chronic low back pain when: non-surgical treatment has not worked for them and the main source of pain is thought to come from structures supplied by the medial branch nerve and they have moderate or severe levels of localised back pain (rated as 5 or more on a visual analogue scale, or equivalent) at the time of referral Only perform radiofrequency denervation in people with chronic low back pain after a positive response to a diagnostic medial branch block. NICE All rights reserved. Page 9 of 18

77 Low back pain and sciatica in over 16s: assessment and management (NG59) Do not offer imaging for people with low back pain with specific facet join pain as a prerequisite for radiofrequency denervation. Epidurals Consider epidural injections of local anaesthetic and steroid in people with acute and severe sciatica Do not use epidural injections for neurogenic claudication in people who have central spinal canal stenosis. Surgical interventions Surgery and prognostic factors Do not allow a person's BMI, smoking status or psychological distress to influence the decision to refer them for a surgical opinion for sciatica. Spinal decompression Consider spinal decompression for people with sciatica when non-surgical treatment has not improved pain or function and their radiological findings are consistent with sciatic symptoms. Spinal fusion Do not offer spinal fusion for people with low back pain unless as part of a randomised controlled trial. Disc replacement Do not offer disc replacement in people with low back pain. NICE All rights reserved. Page 10 of 18

78 Low back pain and sciatica in over 16s: assessment and management (NG59) Putting this guideline into practice NICE has produced tools and resources to help you put this guideline into practice. Putting recommendations into practice can take time. How long may vary from guideline to guideline, and depends on how much change in practice or services is needed. Implementing change is most effective when aligned with local priorities. Changes recommended for clinical practice that can be done quickly like changes in prescribing practice should be shared quickly. This is because healthcare professionals should use guidelines to guide their work as is required by professional regulating bodies such as the General Medical and Nursing and Midwifery Councils. Changes should be implemented as soon as possible, unless there is a good reason for not doing so (for example, if it would be better value for money if a package of recommendations were all implemented at once). Different organisations may need different approaches to implementation, depending on their size and function. Sometimes individual practitioners may be able to respond to recommendations to improve their practice more quickly than large organisations. Here are some pointers to help organisations put NICE guidelines into practice: 1. Raise awareness through routine communication channels, such as or newsletters, regular meetings, internal staff briefings and other communications with all relevant partner organisations. Identify things staff can include in their own practice straight away. 2. Identify a lead with an interest in the topic to champion the guideline and motivate others to support its use and make service changes, and to find out any significant issues locally. 3. Carry out a baseline assessment against the recommendations to find out whether there are gaps in current service provision. 4. Think about what data you need to measure improvement and plan how you will collect it. You may want to work with other health and social care organisations and specialist groups to compare current practice with the recommendations. This may also help identify local issues that will slow or prevent implementation. NICE All rights reserved. Page 11 of 18

79 Low back pain and sciatica in over 16s: assessment and management (NG59) 5. Develop an action plan, with the steps needed to put the guideline into practice, and make sure it is ready as soon as possible. Big, complex changes may take longer to implement, but some may be quick and easy to do. An action plan will help in both cases. 6. For very big changes include milestones and a business case, which will set out additional costs, savings and possible areas for disinvestment. A small project group could develop the action plan. The group might include the guideline champion, a senior organisational sponsor, staff involved in the associated services, finance and information professionals. 7. Implement the action plan with oversight from the lead and the project group. Big projects may also need project management support. 8. Review and monitor how well the guideline is being implemented through the project group. Share progress with those involved in making improvements, as well as relevant boards and local partners. NICE provides a comprehensive programme of support and resources to maximise uptake and use of evidence and guidance. See our into practice pages for more information. Also see Leng G, Moore V, Abraham S, editors (2014) Achieving high quality care practical experience from NICE. Chichester: Wiley. NICE All rights reserved. Page 12 of 18

80 Low back pain and sciatica in over 16s: assessment and management (NG59) Context Low back pain that is not associated with serious or potentially serious causes has been described in the literature as 'non-specific', 'mechanical', 'musculoskeletal' or 'simple' low back pain. For consistency, we have used the term 'low back pain' throughout this guideline. However, 'nonspecific low back pain' was used when creating the review questions. Worldwide, low back pain causes more disability than any other condition. Episodes of back pain usually do not last long, with rapid improvements in pain and disability seen within a few weeks to a few months. Although most back pain episodes get better with initial primary care management, without the need for investigations or referral to specialist services, up to one-third of people say they have persistent back pain of at least moderate intensity a year after an acute episode needing care, and episodes of back pain often recur. One of the greatest challenges with low back pain is identifying risk factors that may predict when a single back pain episode will become a long-term, persistent pain condition. When this happens, quality of life is often very low and healthcare resource use high. Unlike the previous NICE guidance on the management of persistent low back pain between 6 weeks and 12 months, we have moved away from the traditional duration-based classification of low back pain (acute, sub-acute and chronic) and have looked at low back pain as a whole where risk of poor outcome at any time point is almost always more important than the duration of symptoms. This guideline gives guidance on the assessment and management of both low back pain and sciatica from first presentation onwards in people aged 16 years and over. We use 'sciatica' to describe leg pain secondary to lumbosacral nerve root pathology rather than the terms 'radicular pain' or 'radiculopathy', although they are more accurate. This is because 'sciatica' is a term that patients and clinicians understand, and it is widely used in the literature to describe neuropathic leg pain secondary to compressive spinal pathology. This guideline does not cover the evaluation or care of people with sciatica with progressive neurological deficit or cauda equina syndrome. All clinicians involved in the management of sciatica should be aware of these potential neurological emergencies and know when to refer to an appropriate specialist. NICE All rights reserved. Page 13 of 18

81 Low back pain and sciatica in over 16s: assessment and management (NG59) We hope to address the inconsistent provision and implementation of the previous guidance and provide patients, carers and healthcare professionals with sensible, practical and evidence-based advice for managing this important and common problem. More information You can also see this guideline in the NICE pathway on low back pain and sciatica. To find out what NICE has said on topics related to this guideline, see our web page on low back pain. NICE All rights reserved. Page 14 of 18

82 Low back pain and sciatica in over 16s: assessment and management (NG59) Recommendations for research The guideline committee has made the following recommendations for research. The committee's full set of research recommendations is detailed in the full guideline. 1 Pharmacological therapies What is the clinical and cost effectiveness of benzodiazepines for the acute management of low back pain? Why this is important Guidelines from many countries have said that muscle relaxants should be considered for shortterm use in people with low back pain when the paraspinal muscles are in spasm. The evidence for this mainly comes from studies on medications that are not licensed for this use in the UK. The 2009 NICE guideline on low back pain recommends to consider prescribing diazepam as a muscle relaxant in this situation, but the evidence base to support this particular medicine is extremely small. Benzodiazepines are not without risk of harm, even for short-term use. Because of this, there is a need to find out if diazepam is clinically and cost effective in the management of acute low back pain. 2 Pharmacological therapies What is the clinical and cost effectiveness of codeine with and without paracetamol for the acute management of low back pain? Why this is important Codeine, often together with paracetamol, is commonly prescribed in primary care to people presenting with acute low back pain. This often happens with people who cannot tolerate nonsteroidal anti-inflammatory drugs (NSAIDs) or when a person has contraindications to these medications. Although there is evidence that opioids are not effective in chronic low back pain, there are relatively few studies that look at their use for acute low back pain (a problem commonly seen in primary care). Also, it is not known if using paracetamol and codeine together has a synergistic effect in the treatment of back pain. NICE All rights reserved. Page 15 of 18

83 Low back pain and sciatica in over 16s: assessment and management (NG59) 3 Radiofrequency denervation What is the clinical and cost effectiveness of radiofrequency denervation for chronic low back pain in the long term? Why this is important Radiofrequency denervation is a minimally invasive and percutaneous procedure performed under local anaesthesia or light intravenous sedation. Radiofrequency energy is delivered along an insulated needle in contact with the target nerves. This focused electrical energy heats and denatures the nerve. This may allow axons to regenerate with time, requiring the repetition of the radiofrequency procedure. The length of pain relief after radiofrequency denervation is uncertain. Data from randomised controlled trials suggest relief is at least 6 12 months but no study has reported longer-term outcomes. Pain relief for more than 2 years would not be an unreasonable clinical expectation. The economic model presented in this guideline suggested that radiofrequency denervation is likely to be cost effective if pain relief is above 16 months. If radiofrequency denervation is repeated, we do not know whether the outcomes and duration of these outcomes are similar to the initial treatment. If repeated radiofrequency denervation is to be offered, we need to be more certain that this intervention is both effective and cost effective. 4 Epidurals What is the clinical and cost effectiveness of image-guided compared with non-image-guided epidural injections for people with acute sciatica? Why this is important Epidural injection of treatments, including corticosteroids, is commonly offered to people with sciatica. Epidural injection might improve symptoms, reduce disability and speed up return to normal activities. Several different procedures have been developed for epidural delivery of corticosteroids. Some practitioners inject through the caudal opening to the spinal canal in the sacrum (caudal epidural), but others inject through the foraminal space at the presumed level of nerve root irritation (transforaminal epidural). Some people believe transforaminal epidurals might be most effective because they deliver corticosteroids directly to the region where the nerve root might be compromised. But because NICE All rights reserved. Page 16 of 18

84 Low back pain and sciatica in over 16s: assessment and management (NG59) transforaminal epidural injection needs imaging, usually within a specialist setting, this potentially limits treatment access and increases costs. Caudal epidural injection can be done without imaging, or with ultrasound guidance in a non-specialist setting. But it has been argued the treatment might not reach the affected nerve root, meaning this method might not be as effective as transforaminal injection. Evidence that one method is clearly better than the other is currently lacking. Use of the 2 methods varies between healthcare providers, and people whose sciatica does not respond to caudal corticosteroid injection might go on to have image-guided epidural injection. This means people with sciatica might currently experience unnecessary symptoms at unnecessary cost to the NHS than they would if the most clinically and cost-effective way of delivering epidural corticosteroid injections was always used. 5 Spinal fusion Should people with low back pain be offered spinal fusion as a surgical option? Why this is important An increasing number of procedures have been proposed for surgically managing low back pain. One of these procedures is surgical fixation with internal metalwork applied from the back, front, side, or any combination of the 3 routes. The cost of these operations has risen, and now that minimally invasive approaches are used, more of these operations are done with uncertain benefit. As well as the cost, surgery can lead to complications some studies report around a 20% complication rate in the short to medium term. There have been several studies (both randomised and cohort) looking at the clinical effectiveness of spinal fusion versus usual care, no surgery, different surgeries, and other treatments. Overall, the studies do not show a clear advantage of fusion but do show some modest benefit for some elements of pain, function and quality of life. The studies also show healthcare use was lower. It is not known what treatments should be tried before surgery is considered. The evidence from the studies was weak because of low numbers of patients, large crossover and in-case selection bias. This means there is a need for a large, multicentre randomised trial with sufficient power to answer these important questions. ISBN: NICE All rights reserved. Page 17 of 18

85 Low back pain and sciatica in over 16s: assessment and management (NG59) Acered itation NICEaccredited NI CE 2016.AII rights reserved. Page 18of 18