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Procedures of limited clinical value 2013 - 2014 Procedures not routinely funded or requiring prior funding approval C i t y & H a c k n e y, N e w h a m , To w e r H a m l e t s a n d W a l t h a m F o r e s t ( W E L C ) Clinical Commissioning Groups Procedures of limited clinical value Document revision history Date Version Revision April 2013 1 City & Hackney, Newham, Tower Hamlets, and Waltham Forest CCGs Comment Author / Editor Maggie Harding, Consultant in Public Health Anna Stewart, Director of Technical Contracting Document approval Date Version April 2013 1 August 2013 1.1 Page 2 Revision Role of approver Approver Clinical Commissioning Group Governing Body Addition of new foreword on pages 4 to 5 Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Contents Foreword ................................................................................................... Error! Bookmark not defined. General Principles ............................................................................................................................... 6 Section 1 – interventions which require prior approval .................................................................... 8 Cosmetic and other procedures where NHS provision is low priority for WELC CCGs ............................................................................... 8 Breast procedures .................................................................................................................................................................................... 8 Cosmetic surgery - Body contouring and other cosmetic procedures ..................................................................................................... 14 Cosmetic surgery: Hair procedures ........................................................................................................................................................ 16 Cosmetic surgery: Face Procedures ...................................................................................................................................................... 18 Cosmetic Procedures: Ear Procedures ................................................................................................................................................ 201 Other cosmetic procedures that are NOT routinely funded by WELC CCGs. ......................................................................................... 21 Other: prior approval for funding is required for all these procedures ..................................................................................................... 21 Section 2 – evidence based advice to GPs ...................................................................................... 27 Cosmetic surgery - skin and subcutaneous lesions .............................................................................................................................. 257 ENT........................................................................................................................................................................................................ 29 Gynaecology .......................................................................................................................................................................................... 31 General surgery ..................................................................................................................................................................................... 34 Hand or orthopaedic surgery .................................................................................................................................................................. 35 Dental .................................................................................................................................................................................................... 41 Other ...................................................................................................................................................................................................... 42 Procedures for which access criteria have been agreed ......................................................................................................................... 41 Index ................................................................................................................................................................................................................. 42 Page 3 Procedures of limited clinical value Foreword This IFR policy describes the process by which City and Hackney, Newham, Tower Hamlets and Waltham Forest CCGs will make decisions on requests to fund treatment interventions which are not routinely funded by the CCG. This POLCV document should be read in conjunction with the IFR policy which it supplements. Procedures of limited clinical value are defined as interventions which the CCG will not normally fund, as their usual application offers limited clinical benefit to patients e.g. cosmetic surgery. The IFR team will review these applications against the agreed criteria or treatment threshold as appropriate as agreed by the CCG. Recommendations which confirm patient eligibility will be presented to the lead member or manager within the CCG for determination and if approved for funding and the applicant notified. These discussions and recommendations will take place outside of the IFR Panel through a triage process. Section 1 of this document lists a range of such treatments and describes the clinical circumstances in which their funding might be supported. Prior Approval Applications The procedures listed in Section 1 are only funded by prior approval, meaning that an application form needs to be submitted and approval for funding given before the procedure is carried out. GPs and other clinicians wishing to secure funding for an intervention listed in Section 1 of this document should therefore use the application form (Appendix 1) to identify the specific treatment requested, and to demonstrate how the patient meets the clinical circumstances in which such a funding request might be supported. IFR Applications Standard requests for treatments listed in Section 1 will be determined by reference to the prior approval criteria listed in the document for each intervention. However, there will be rare occasions when a patient has exceptional clinical circumstances which may justify the use of these treatments, even if the prior approval criteria are not met. In such circumstances the application for funding will be processed according to the CCG‟s IFR policy. IFR applications from GPs for interventions listed in Section 1 may be made using the prior approval form in Appendix 1. Applicants will be expected to provide clear evidence to demonstrate: 1. Evidence for the clinical effectiveness of the requested treatment for the diagnosed condition 2. How the patient‟s clinical circumstances make them exceptional compared to all other patients with the same condition 3. How the patient will receive greater benefit from the treatment than all other patients with the same condition. Exceptional clinical circumstances require that the criteria in 2 and 3 above are demonstrated. Processing Applications Page 4 Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs All applications against interventions listed in Section 1 must be submitted on the standard form to the Individual Funding Request team. The CCG IFR triage lead will assess each application against the prior approval criteria for the requested intervention. Applications which do not meet the prior approval criteria will be further assessed to determine whether a case for clinical exceptionality can be made. When clinical exceptionality is evident, applications will be handled by the IFR route. Introduction This document is intended to provide guidance to clinicians regarding when to refer patients directly for treatment and is in 2 parts: Section 1: Includes interventions for which prior funding approval needs to be obtained. These are separated into cosmetic procedures, newly approved procedures which merit close oversight, and low volume procedures that the Individual Funding Request (IFR) Panel has agreed are not appropriate for routine commissioning Section 2: Includes a wider range of procedures where the evidence of benefit, particularly in mild cases, tends to be limited and may be less than the risk of harm from the intervention. There is no prior funding approval for these procedures and demand management is overseen by each CCG. Funding applications should be submitted for: i. all treatments included in Section 1, even if the criteria have been met ii. interventions in Section 1 where the patient does not meet the criteria and you feel that there are exceptional reasons why treatment should be funded for the particular patient. iii. procedures for which there are agreed eligibility criteria (such as assisted conception and bariatric surgery) where the patient does not meet the criteria and you feel that there are exceptional reasons why treatment should be funded for the particular patient iv. procedures not included in this guidance that are not normally funded within current CCG contracts. Should you wish to make a referral to a voluntary or private service provider you will need to make an Individual Funding Request stating explicitly why local NHS services cannot meet the particular patient‟s needs v. for several interventions, the patient‟s GP alone will not have sufficient information to complete the IFR application, including: the final points in male and female breast reduction, most procedures in category 4, and applications before tertiary or consultant to consultant referral (specifically Open MRI), double balloon enteroscopy; ketogenic diet for epilepsy Page 5 Procedures of limited clinical value The IFR service aim to process 90% of POLCV cases by 10 working days. For further information regarding this POLCV document or the IFR process, please call 020 3688 1290, or write to us either via the secure email addresses elcasacu.ifr.nhs.net by post to IFR Team, North and East London Commissioning Support Unit, 2nd Floor Clifton House, 75-77 Worship Street, London EC2A 2DU General Principles i. City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) Clinical Commissioning Groups will commit NHS resources where there is clearly articulated need in terms of symptoms and/or clinical signs and the proposed intervention is demonstrably effective in relieving these. It follows from this that WELC CCGs will not fund procedures aiming to give a patient the body contour or appearance that they desire ii. Psychological distress alone will normally not be accepted as a reason to fund surgery. Psychological assessment and intervention may be an appropriate intervention for patients with severe psychological distress in respect of their body image but it should not be regarded as route into aesthetic surgery. Only very rarely is surgical intervention likely to be the most appropriate and effective means of alleviating disproportionate psychological distress. In these cases ideally an NHS psychologist with expertise in body image or an NHS mental health professional (depending on locally available services) should detail all treatment(s) previously used to alleviate/improve the patient‟s psychological wellbeing, their duration and impact. The clinician should also provide evidence to assure the IFR Panel that a patient who has focused their psychological distress on some particular aspect of their appearance is at minimal risk of having their coping mechanism removed by inappropriate surgical intervention. Any application citing psychological distress will need to be supported by a current psychological assessment, which specifically addresses current and prior engagement with appropriate psychological or psychiatric treatment Clinicians are requested to refer to the NICE guideline on Obsessive-Compulsive Disorder (OCD) and Body Dysmorphic Syndrome (BDS)1. Patients with this condition are not routinely funded for cosmetic surgery as the patient‟s preoccupation can be fluctuating or an episodic course, or relapse may occur after successful treatment and may move to a different part of their body. 1 National Institute for Health & Clinical Excellence (NICE) CG31 Obsessive-Compulsive Disorder (OCD) and Body Dysmorphic Syndrome (BDS), Nov 2005. Page 6 Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs For patients with anxiety or depression, clinicians might wish to consider a referral to the local Improving Access to Psychological Therapies service before requesting cosmetic surgery. iii. Bullying and disproportionate concern about personal remarks tend to be characteristics of children and adults who are vulnerable for other reasons and these patients should be supported to develop resilience to this unacceptable behaviour from others. An offer of aesthetic surgery to modify appearance is rarely the most appropriate NHS response. Where bullying of children is an issue, parents should work with teachers to prevent this. Page 7 Procedures of limited clinical value Section 1 – interventions which require prior approval All procedures in this Section require prior funding approval These are separated into cosmetic procedures, newly approved procedures which merit close oversight, and low volume procedures that the Individual Funding Request (IFR) Panel has agreed are not appropriate for routine commissioning Cosmetic and other procedures where NHS provision is low priority for WELC CCGs Breast procedures 1. Are not funded by WELC CCGs on cosmetic grounds or to treat the natural processes of ageing 2. WELC CCGs would not expect to receive applications for breast procedures for women younger than 18 years or men younger than 25 years unless exceptional circumstances apply 3. Because the aim of any NHS funded surgery is to relieve symptoms rather than give people the breast size or shape that they desire, WELC CCGs will not commit NHS funds to more than one procedure per person unless prior approval has been given by the relevant Individual Funding Request Panel 4. Given the recognised rupture rate for breast implants, all WELC CCGs‟ funding decisions for breast implants will be made by the relevant Individual Funding Request Panel, who will need information on the precise clinical indication for unilateral augmentation rather than contralateral breast reduction for breast asymmetry. Page 8 Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Female breast reduction Criteria for funding Additional information This procedure is not routinely funded by WELC CCGs Most women seeking breast reduction are not wearing a bra of the correct size and a well fitted bra may alleviate their symptoms. With prior approval it will be funded as below: Bilateral breast reduction will be funded only in the following circumstances: 1. The patient has a body mass index (BMI) of less than 28 kg/m2, documented for at least 2 years AND 2. a bra cup size of H or more AND 3. The patient has intertrigo or shoulder ulceration from bra strap pressure unresponsive to a minimum of 6 months standard treatment OR 4. has neck ache, backache or lordotic posture (curvature of the spine) for which all other causes have been excluded AND standard analgesia AND physiotherapy documented by the GP for at least 6 months has not improved these symptoms AND 5. The wearing of a professionally fitted brassiere has not relieved the symptoms AND 6. A consultant surgeon has confirmed that the reduction will exceed 500gm per side Many women seeking breast reduction have co-incidental back or neck pain and so other causes need to be excluded. Because the aim is to reduce a woman‟s symptoms not give a women the appearance she desires, WELC CCGs will only fund breast reduction if a minimum of 500g breast tissue per side will be removed. Unilateral breast reduction will be funded only in the following circumstances: 7. gross asymmetry (difference in size a minimum 2 cup sizes) AND 8. the woman‟s breasts are fully developed i.e. there has been no change in the size of either breast over the previous 18 months. Page 9 Procedures of limited clinical value Treatment Criteria for funding Additional information Male breast reduction This procedure is not routinely funded by WELC CCGs. With prior approval it will be funded in the following circumstances: Gynaecomastia is commonly seen during puberty and may correct once the post pubertal fat distribution is complete if the patient has a normal BMI. It may be unilateral or bilateral. Rarely, it may be caused by an underlying endocrine abnormality or a drug related cause including the abuse of anabolic steroids. 1. The applicant demonstrates that they have screened for and excluded all treatable causes of gynaecomastia (drug related – particularly abuse of anabolic steroids, endocrine) AND 2. The patient is both post pubertal AND in the case of idiopathic gynaecomastia has had this for at least 18 months (to allow spontaneous resolution) AND 3. gynaecomastia is causing pain unrelieved by standard analgesia AND 4. the patient has a BMI of less than 27 kg/m2 AND 5. A consultant surgeon has confirmed that the patient has grade III gynaecomastia (i.e. gross breast enlargement with skin redundancy and ptosis so as to simulate a pendulous female breast) AND the proposed reduction is greater than 100gm per side. Page 10 It is important that male breast cancer is not mistaken for gynaecomastia and, if there is any doubt, an urgent consultation with an appropriate specialist should be obtained. Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for funding Additional information Breast enlargement (augmentation mammoplasty This procedure is not routinely funded by WELC CCGs. Funding may be approved by the IFR Panel for women with: Where the application is for breast asymmetry, the applicant will be required to detail precisely why contralateral breast reduction is not appropriate, bearing in mind that the purpose of such surgery is to relieve symptoms resulting from difficulty with bra fitting NOT to give women the breast size they desire (which is cosmetic surgery). 1. congenital amastia (total failure of breast development) unilaterally or bilaterally OR 2. significant asymmetry (difference in size of a minimum of 2 cup sizes) of breast volume AND 3. the asymmetry is the result of: 3.1. previous mastectomy OR other excisional breast surgery OR 3.2. trauma to the breast during or after development OR 3.3. endocrine abnormalities AND 4. the woman‟s breasts are fully developed i.e. there has been no change in the size of either breast over the previous 18 months. See below for WELC CCGs policy on subsequent implant removal and replacement which will not routinely be available in the event of rupture or contracture. Page 11 Procedures of limited clinical value Treatment Criteria for funding Additional information Revision of breast augmentation With prior approval by the IFR Panel, this will be funded for women only in the following circumstances: Demand for breast enlargement is rising in the UK. Breast implants may be associated with significant morbidity and women commonly need revisional surgery (such as implant replacement) 1. If the NHS commissioned the original surgery for non-cosmetic reasons, WELC CCGs would fund removal of the original implant and implant replacement in the event of gross distortion caused by implant rupture. In the event of gross distortion from other causes a case for exceptionality would need to be clearly defined for an IFR Panel decision 2. If the NHS did not commission the original surgery, WELC CCGs would only fund removal of an implant where there was evidence of imminent risk to the patient of adverse health consequences and this would NOT include replacement of the implant 3. For PIP implants only, NHS funding for removal of ruptured implants will only be made available: 3.1. for PIP implants inserted by a private provider where the patient can demonstrate that her original provider is unable or unwilling to help 3.2. for removal but not replacement of the implant. Breast lift Page 12 Not all patients demonstrate improvement in psychosocial outcome measures following breast augmentation. These criteria are as advised by DH in respect of PIP implants. This cosmetic procedure is not routinely funded by WELC CCGs either as a: Breast ptosis (droopiness) is normal with increasing age and after pregnancy. Patients with breast asymmetry may have asymmetry of shape as well as volume, but surgical intervention for breast asymmetry (above) is not designed to give a patient the shape or size of breasts they desire. component of breast reduction surgery OR stand alone procedure. Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for funding Additional information Nipple inversion Nipple inversion may occur as a result of an underlying breast malignancy and it is essential that this be excluded. Idiopathic nipple inversion may be corrected by the application of sustained suction. Commercially available devices are available from major chemists or online without prescription. Best results are seen where this is used correctly for up to three months. Surgical correction of nipple inversion will be funded by WELC CCGs (with prior approval) only for functional reasons in a postpubertal woman, if the inversion has not been corrected by correct use of a non-invasive suction device. Page 13 Procedures of limited clinical value Treatment Criteria for funding Additional information Cosmetic surgery - Body contouring and other cosmetic procedures “Tummy tuck (apronectomy or abdominoplasty This procedure is not routinely funded by WELC CCGs. With prior approval, abdominoplasty and/ or apronectomy will be funded following medical or surgical treatment for morbid obesity, or other weight loss, for patients who: 1. have lost at least 50% of their excess body weight AND 2. have had a stable BMI of less than 35 Kg/m2 for at least 18 months AND 3. in the case of bariatric surgery, had their surgery at least 2 years previously AND 4. have severe functional problems (defined opposite) from excessive abdominal skin folds. Patients undergoing bariatric surgery should be clearly informed that weight loss does not entitle them to body contouring procedures outwith these criteria. „Severe functional problems‟ are defined as: With prior approval, abdominoplasty and/or apronectomy will be funded for patients: 6. following trauma or previous abdominal surgery OR where it is required as part of abdominal hernia correction or other abdominal wall surgery AND 7. With severe functional problems (defined opposite) from excessive abdominal skin folds Page 14 intertrigo beneath the skin fold that recurs or fails to respond to appropriate medical therapy for at least 6 months OR severe difficulties with daily living i.e. walking, dressing or ambulatory restrictions which have been formally assessed as attributable solely to the abdominal apron OR Disabling psychological distress that a clinical psychologist with experience in appearance related anxiety OR another appropriate mental health professional has confirmed as disproportionate AND that surgery is the most appropriate and effective intervention for this. Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for funding Additional information Other skin excision for body contouring e.g. buttock lift, thigh lift, arm lift (brachioplasty) These procedures are not routinely funded by WELC CCGs. Patients undergoing bariatric surgery should be clearly informed that weight loss does not entitle them to body contouring procedures outwith these criteria With prior approval, skin excision for body contouring will be funded for patients following medical or surgical treatment for morbid obesity, or other weight loss, who: 1. have lost at least 50% of their excess body weight AND 2. have had a stable BMI of less than 35 Kg/m2 for at least 18 months AND 3. in the case of bariatric surgery, had their surgery at least 2 years previously AND 4. have severe functional problems (defined opposite) from excessive abdominal skin folds. Liposuction „Severe functional problems‟ are: intertrigo beneath the skin fold that recurs or fails to respond to appropriate medical therapy for at least 6 months OR severe difficulties with daily living i.e. walking, dressing or ambulatory restrictions which have been formally assessed as attributable solely to the excess skin OR Disabling psychological distress that a clinical psychologist with experience in appearance related anxiety has confirmed as disproportionate AND that surgery is the most appropriate and effective intervention for this. This procedure is not routinely funded by WELC CCGs. Page 15 Procedures of limited clinical value Treatment Criteria for funding Keloid scars WELC CCGs will fund medical and excisional treatment for scars that cause: Additional information 1. symptoms (pain or itching) unresponsive to standard chronic medication in non-exposed areas of the skin OR 2. significant facial disfigurement OR 3. recurrent bleeding OR 4. obstruction of an orifice OR restricts vision. Scar revision WELC CCGs will fund excision of hypertrophic scars and aesthetic surgery for scar revision where scars cause: Significant interference with function is defined as: 1. 2. 3. 4. significant facial disfigurement OR recurrent bleeding OR obstruction of an orifice or restricted vision OR Significant interference with function (as opposite). If psychological distress is the reason for the application, a clinical psychologist specialising in appearance related anxiety should confirm that the distress is disproportionate AND that scar revision is an appropriate and effective means of addressing the psychological distress. difficulties with daily living e.g. ambulatory restrictions; inability to undertake previous employment or caring role risk of infection arising in a surgical scar (usually midline, vertical, multiple) or post trauma, that is realistically expected to reduce as a result of scar revision problems associated with poorly fitting stoma bags Cosmetic surgery: Hair procedures Treatment for hair loss (alopecia Treatment (hair grafting and flaps with/ without tissue expansion) is not routinely funded by WELC CCGs. Funding for treatment may be approved by the IFR Panel when the alopecia is a result of previous surgery or trauma including burns. Page 16 „Male pattern‟ baldness is a normal process for many men at whatever age it occurs. Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Hair transplantation Hair epilation (hair removal by electrolysis or laser Criteria for funding This procedure is not routinely funded by WELC CCGs. Funding may be approved by the IFR Panel as part of the treatment pathway for reconstruction following cancer or trauma. Additional information This procedure is not routinely funded by WELC CCGs. Because WELC CCGs do not fund maintenance treatment for hirsuitism, it is not considered appropriate to commission an intervention whose effects are likely to be transitory and psychological distress would be likely to recur. Funding for hair epilation may be approved by the IFR Panel for patients who: 1. Have undergone reconstructive surgery leading to abnormally located hair-bearing skin to the face, neck or upper chest (areas not covered by normal clothing) OR 2. Are undergoing treatment for pilonidal sinuses to reduce recurrence For patients who do not meet these criteria, an IFR application will ONLY be considered (for facial, neck or upper chest areas not covered by normal clothing) on completion of the relevant section explaining for the benefit of the IFR Panel why the patient differs from the cohort of similarly hirsute patients such that they are likely to gain more health benefit from depilation which is not available to other similar patients. Severe hirstutism due to an endocrine disorder may be referred to an endocrinology department but this is not an indication for NHS funding of epilation. Patients undergoing gender reassignment procedures will be assessed in accordance with this policy as it applies to a natural born male or female. An IFR application would need to be submitted in this context explaining precisely why the transgender person is likely to gain significantly greater health benefit than other patients for whom the same procedures are not funded. In the event that NHS funding is agreed it will be for a maximum of six treatments. Page 17 Procedures of limited clinical value Treatment Criteria for funding Additional information Cosmetic surgery: Face Procedures Face lifts and brow lifts (rhytidectomy This procedure is not routinely funded by WELC CCGs. Changes to the face and brow as a result of ageing are normal Funding will only be considered to correct: Surgery on the upper or lower eyelid (blepharoplasty) impairment of vision OR impairment of the visual field(s) (as described in the criterion for blepharoplasty below). This procedure is not routinely funded by WELC CCGs. NHS funding will only be considered to correct: 1. Impairment of visual field(s) in the relaxed, non-compensated state where visual field test results are submitted to show that eyelids impinge on visual fields reducing them to 1200 laterally and 400 vertically OR 2. Clinical observation of poor eyelid function, discomfort, e.g. headache worsening towards end of day and/or evidence of chronic compensation through elevation of the brow OR 3. Significant ectropion or entropion that requires correction. Page 18 Excessive skin in the lower lid may cause “eyebags” but does not affect eyelid function or vision and therefore does not need correction. Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for funding Additional information Rhinoplasty (surgery to reshape the nose) This procedure is not routinely funded by WELC CCGs. Correction of complex congenital conditions e.g. cleft lip and palate is commissioned by NHS England. NHS funding may be considered for: 1. Demonstrable obstruction of the nasal airway AND 2. significant symptoms confirmed by an ENT consultant as resulting from nasal obstruction AND 3. symptoms that persist despite at least three months of conservative management with, where appropriate nasal steroids or immunotherapy. Treatment of vascular lesions, including port wine stains, facial haemangiomas and benign acquired vascular lesions in adults aged ≥ 19 years Interventions for these conditions are not routinely funded by WELC CCGs because of limited evidence of effectiveness. Any IFR application on the basis of significant facial disfigurement should be accompanied by high quality colour photographs and a statement that the patient is fully aware that treatment effect may be modest. The IFR Panel will consider each case. For all patients a very clear statement of exceptionality would be required given that this intervention is not routinely commissioned. The evidence of benefit is weak, based on poor quality studies lacking in robust evaluation of patient satisfaction or changes in psychosocial status. At best the majority of patients may achieve a 25% „lightening‟ of colour, but with a risk of subsequent darkening of the treated area. Page 19 Procedures of limited clinical value Treatment Criteria for funding Treatment for scarring and skin hyper- or hypopigmentation Interventions for these conditions including laser dermabrasion and chemical peels are not routinely funded by WELC CCGs. Additional information The IFR Panel will consider each case. For all patients a very clear statement of exceptionality would be required including the following: 1. a clear description of symptoms that the intervention is expected to improve AND 2. all previous interventions for this condition and their impact AND 3. the relevant evidence of clinical benefit for the proposed intervention in the underlying condition AND 4. if the application is based on facial disfigurement, high quality, colour clinical photographs. Cosmetic Procedures: Ear Procedures Correction of prominent ears (pinnaplasty/ This procedure is not routinely funded by WELC CCGs. otoplasty If the applicant considers there are exceptional circumstances such that the child or young person (aged 5-19 years) is likely to gain significantly more benefit than others with similarly prominent ears, the IFR Panel will consider each case based on an IFR application form that should include: 1. a clear description of reason for the IFR application AND 2. if the symptoms are distress from teasing and/or bullying, the action parents, teachers and any other responsible adults have taken to reduce this AND 3. provider audit data detailing evidence of benefit from pinnaplasty in cases of similar severity, specifically in relation to distress from teasing and/ or bullying. Page 20 Children under the age of five rarely experience teasing or bullying and referrals may reflect concerns expressed by the parents rather than the child. In such cases the patient may benefit from referral with their family for a multidisciplinary assessment that includes a child psychologist. Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for funding Repair of totally split ear lobes (or lobules) This procedure is not routinely funded by WELC CCGs. Additional information Other cosmetic procedures that are NOT routinely funded by WELC CCGs. Tattoo Removal This procedure is not routinely funded by WELC CCGs. Cosmetic genital procedures (Labiaplasty) This procedure is not routinely funded by WELC CCGs. Transgender surgery is funded by NHS England for patients on a recognised NHS care programme. Other: prior approval for funding is required for all these procedures Page 21 Procedures of limited clinical value Treatment Criteria for funding Additional information Any procedure outside of current NHS service level agreements All referrals to voluntary or private sector specialists with whom WELC CCGs do not have a service level agreement and procedures carried out by them require prior funding approval. The patient should be informed before any application is made, that WELC CCGs would not normally fund an intervention that is not available to all patients with the same condition. The application should make clear to the IFR Panel why this referral is being made and address the following: 1. identify the local NHS commissioned service for this condition AND 2. state why this is not appropriate for this particular patient AND 3. What the local NHS commissioned service includes AND 4. For what assessment and/or procedure funding is being sought AND 5. The potential costs and benefits (from the provider) of the proposed assessment and/or procedure Reversal of female sterilisation and reversal of vasectomy Reversal of sterilisation and vasectomy are not routinely funded by WELC CCGs. The IFR Panel will NOT consider funding, irrespective of the merits of the individual case if: Homeopathy Page 22 sterilization used diathermy (female) or two widely separated clips because reversal is unlikely to be successful: written documentation of the original procedure should accompany any application OR the female partner is not demonstrably ovulating (day 21 progesterone levels) Homeopathy is not routinely funded by WELC CCGs due to the lack of evidence of clinical effectiveness. The original decision on sterilisation is assumed to have been made by mature adults on the understanding that the procedure is an irreversible contraceptive choice and that each patient/couple has been fully counseled to this effect. Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for funding Herbal medicines Herbal medicines are not routinely funded by WELC CCGs due to the lack of evidence of clinical effectiveness and the risk of toxicity from non-quality assured therapies. Acupuncture and osteopathy Acupuncture and osteopathy are not routinely funded by WELC CCGs due to the limited evidence of clinical effectiveness. This includes funding for acupuncture to treat dental pain and nausea and vomiting. Ketogenic diet for epilepsy This intervention is not routinely funded by WELC CCGs due to the lack of evidence of clinical effectiveness. MRI guided ultrasound (MRgFUS) for uterine fibroids WELC CCGs do not routinely fund MRgFUS for uterine fibroids for: Open MRI This diagnostic intervention is not routinely commissioned by WELC CCGs because scan quality is less good than from „standard MRI‟ so diagnostic performance is less well evidenced. fertility preservation because of lack of evidence of effectiveness relief of symptoms because other, equally effective, better established interventions are available. The IFR application needs to be completed by the specialist clinician requesting the open MRI scan because only they will be able to explain for the benefit of the IFR Panel precisely how the results of an open MRI scan will alter the clinical management of the patient. Additional information There is a routinely funded non-surgical option (uterine artery embolisation) for women with symptomatic fibroids who wish to avoid surgery. Open MRI is relatively new and before it was introduced patients whose morbid obesity or „claustrophobia‟ precluded scanning were managed by alternative means. Page 23 Procedures of limited clinical value Treatment Criteria for funding Additional information Occipital nerve stimulation for intractable or cluster headache Unless or until WELC CCGs have confirmation that this service is to be commissioned by NHS England, this procedure will not be routinely funded by WELC CCGs on the basis of limited evidence of effectiveness BASH (British Association for the Study of Headache) 2007 Guideline Cluster headache: “Surgical options include implantation of occipital nerve or deep brain stimulators, and are experimental”. Functional electrical stimulation for foot drop Criteria under development (will be agreed by IFR Panel) The NICE IPG 278 (January 2009) suggested the procedure was sufficiently safe (and efficacious) to be introduced into the NHS without special arrangements for audit, consent or clinical governance. NICE IPGs do not constitute an NHS funding recommendation. Double balloon enteroscopy Criteria under development (will be agreed by IFR Panel) Non-core gender reassignment procedures Non-core procedures are likely to be confined to epilation. Applications will be assessed in accordance with this policy as it applies to a natural born male or female by the IFR Panel. IFR applications should explain precisely why the transgender person is likely to gain significantly greater health benefit than other patients for whom the same procedures are not funded. Page 24 Core procedures (assessment, psychological support, and core surgery – genital, breast and donor site hair removal) are funded by NHS England from April 2013 Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Section 2 – evidence based advice to GPs The interventions in Section 2 are a combination of: i. Procedures which are likely to be cosmetic and the criteria are given as guidance anticipated to ensure equity of access to services based on significant symptoms rather than the desired appearance (benign skin lesions, varicose veins) Procedures with a close benefit/risk balance in mild cases where initial conservative therapy is appropriate, reserving intervention for those in whom conservative therapy does not result in improvement. Procedures for which there are agreed eligibility criteria – assisted conception and bariatric surgery – where the patient does not meet the criteria and you feel that there are exceptional reasons why treatment should be funded for the particular patient. ii. iii. Treatment Criteria for intervention Additional information Cosmetic surgery - skin and subcutaneous lesions A patient with a skin or subcutaneous lesion that has features suspicious of malignancy must be referred to an appropriate specialist for urgent assessment. Some benign skin lesions will continue to be excised in hospital for differential diagnosis. These procedures may be offered within General Practice, Community Services or Secondary Care. Pigmented lesions Clinically benign moles should not be referred for cosmetic reasons. Suspicious pigmented lesions should always be subjected to excision biopsy and sent for histology, if referred to secondary care this should be to a pigmented lesions clinic. Page 25 Procedures of limited clinical value Treatment Criteria for intervention Additional information Other benign skin lesions 1. Suspicion of malignancy OR 2. that is rapidly growing or abnormally located (e.g. sub-fascial, submuscular) OR 3. significant obstruction of orifice or vision OR 4. significant functional limitation on movement or activity OR 5. where these cause itching or pain, unrelieved by standard medication OR 6. that regularly bleed or become inflamed OR 7. lesions greater than 1cm in diameter that cause significant facial disfigurement. If there is any suspicion of malignancy, patients should be referred immediately to an appropriate service as described in the NICE improving outcomes guidance. These services must be part of local hospital or specialist skin cancer multidisciplinary teams In the interests of equity, this policy relates to the excision of skin lesions by both primary and secondary care The following common, clinically benign skin lesions should not be excised for cosmetic reasons: 8. Skin tags 9. Seborrhoeic keratoses 10.Hand or foot viral warts in adults 11.Comedones, 12.Corn/callouses 13.Lipomas 14.Milia 15.Molluscum contagiosum 16.Sebaceous (epidermoid or pilar) cysts 17.Spider Naevus (telangiectasia) 18.Xanthelasma 19.Neurofibromata 20.Angioma Keratoma 21.Benign Naevi 22.Haemangiomas. Page 26 Where there is no suspicion of malignancy, benign skin lesions are usually self-limiting, respond to conservative measures and have no long-term health consequences for patients. The decision to remove benign skin lesions causing moderate or severe facial disfigurement is a balance between the appearance of the original lesion and the likely appearance of the surgical scar. The decision should be made by an experienced clinician familiar with these factors, and excision should be carried out by a trained practitioner in an appropriate surgical setting. Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for intervention Additional information 1. Children between the ages of 3 and 12 years who have documented, persistent, bilateral otitis media with effusion (OME) AND documented persistent hearing loss on two occasions at intervals of 3 months or more AND hearing in the better ear of 25-30 dBHL or less averaged at 0.5, 1, 2 and 4 kHz OR 2. Children between the ages of 3 and 12 years who have documented, persistent otitis media with effusion (OME) AND documented persistent hearing loss on two occasions at intervals of 3 months or more AND 3. hearing loss suggestive of additional sensori-neural deafness OR 4. evidenced delay in speech development OR significant educational, social or behavioural problems attributable to persistent hearing impairment AND a hearing level of 25-30 dBHL or less OR 5. a second disability (e.g. Down‟s syndrome) OR 6. the otoscopic features are atypical and accompanied by a foulsmelling discharge suggestive of cholesteatoma OR 7. 5 or more episodes of acute otitis media. See Current NICE Guidance2 ENT Grommet (ventilation tube) insertion Insertion of ventilation tubes for patients of any age may be indicated as a component of tympanic membrane repair or to preserve function. 2 Surgery may resolve glue ear in the short term but there is less certainty about longer term outcomes and large variation in effect between children There is debate about how best to select children for intervention, given the high rate of resolution particularly in younger children A period of watchful waiting is widely recognized as good practice because timing of surgery is not critical to medium term outcome Grommets and adenoidectomy represent a trade off between benefits and harms; adenoidectomy on its own is of unknown effectiveness3 http://www.nice.org.uk/media/A8F/DC/Referraladvice.pdf Page 27 Procedures of limited clinical value Treatment Criteria for intervention Additional information Tonsillectomy with or without adenoidectomy 1. Suspected malignancy OR 2. Significant impact on quality of life resulting from documented recurrent acute tonsillitis (patients or parents should keep a diary to verify this) comprising: 2.1. Five or more episodes of tonsillitis in the preceding year OR 2.2. Four episodes/year in each of the preceding two years OR 2.3. Three episodes/year in the preceding three years AND 2.4. documented evidence of absence from playgroup, school or work OR 2.5. failure to thrive The frequency of sore throats reduces with time whether or not tonsillectomy has been performed. The benefit in the year after operation is around 2.8 fewer days off school and this needs to be balanced against the risk of surgical complications. 3. Adults with proven recurrent group A streptococcal pharyngitis (GAHSP)4 OR 4. Documented evidence of 2 or more episodes of tonsillitis or quinsy requiring admission to hospital OR 5. Tonsillitis exacerbating existing disease such as febrile convulsions, guttate psoriasis, glomerulonephritis or rheumatic fever. 6. As treatment for sleep apnoea syndrome, tonsillectomy should only be considered for children with: 6.1. Witnessed episodes or apnoea exceeding 10 seconds OR choking episodes during sleep AND 6.2. Daytime neuro-behavioural abnormalities or excessive sleepiness. 3 A revised Cochrane systematic review in 2008,5 concluded that Adeno/tonsillectomy is effective in reducing the number of episodes of sore throat and days with sore throats in children, the gain being more marked in those most severely affected. SIGN national guideline on management of sore throat and indications for tonsillectomy (2010) recommended watchful waiting is more appropriate than tonsillectomy for children with mild sore throats. Clinical Evidence. Review of adenotonsillectomy. 2005 Tonsillectomy versus watchful waiting in recurrent streptococcal pharyngitis in adults: Randomised controlled trial. BMJ 2007;334(7600):939-41. 5 Burton MJ, Glasziou PP. Tonsillectomy or adeno-tonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD001802. DOI: 10.1002/14651858.CD001802.pub2. 4 Page 28 Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for intervention Additional information Surgical treatment of chronic sinusitis ENT referral is appropriate for suspected: NHS Clinical Knowledge Summaries advise a trial of intranasal corticosteroids for 3 months for treatment in the first instance.6 1. complications, e.g. periorbital infection OR 2. suspected sinonasal tumour. Referral may be appropriate if there is: 3. recurrent or chronic sinusitis of uncertain cause AND 4. unremitting or progressive facial pain AND 5. a trial of intranasal corticosteroids for three months has been ineffective AND 6. a significant anatomical abnormality. Sinus puncture and irrigation has a poor diagnostic yield, and carries the risk of secondary contamination.6 Only short-term benefit seen in patient refractory to medical management treated with balloon catheter dilation of sinus ostia.7 Gynaecology Dilatation and curettage for heavy menstrual bleeding in women aged under 40 years 6 7 This is not normally funded. This is an inappropriate procedure because targeted endometrial sampling is at least as accurate and has lower complication rates. It is not a reliable therapeutic procedure for dysfunctional uterine bleeding for which a range of effective medical interventions is available (mefenamic acid, norethisterone). http://www.cks.nhs.uk/sinusitis/management/quick_answers#-369973 (accessed 8 February 2010) NICE Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis. IPG 273 NICE September 2008. Page 29 Procedures of limited clinical value Treatment Criteria for intervention Additional information Hysterectomy for menorrhagia (heavy menstrual bleeding) 1. Documented medical contra-indication to Mirena® coil insertion including large fibroids (uterine size >12 weeks) or distorted uterine cavity 2. Severe anaemia, unresponsive to transfusion or other treatment whilst a Mirena trial is in progress 3. Genital malignancy or active trophoblastic disease are rare causes of menorrhagia NICE clinical guidelines emphasise that: Bartholin’s cysts General surgery Page 30 Significant infection and/or rapid growth causing significant pain that is unresolved by non-surgical treatment. The Mirena® device is effective in the treatment of menorrhagia and is considerably cheaper than a hysterectomy, even if required for many years (for contraception costs estimated at £207 including consultation; removal cost £26). Other effective conservative treatments are available as second line treatment after failure of Mirena or where Mirena is contra-indicated A Cochrane systemic review showed that the Mirena® coil improved the quality of life of women with menorrhagia as effectively as hysterectomy. Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Sympathectomy for severe hyperhidrosis (palmar, plantar, axillary) Criteria for intervention Additional information Sympathectomy will only be funded if the following conditions are met: Sympathectomy is an established intervention for this condition BUT should be considered only after all other noninvasive non-surgical treatment options have been tried and failed. 1. significant focal hyperhidrosis and a 1–2 month trial of aluminium salts (under primary care supervision to ensure compliance) has been unsuccessful in controlling the condition OR 2. significant focal hyperhidrosis and intolerance of topical aluminium salts despite reduced frequency of application and use of topical 1% hydrocortisone AND all of the following conservative therapies have been tried and found to be unsuitable or unsuccessful: Compensatory sweating following sympathectomy is common and can be worse than the original problem. Patients should be made aware of this risk. 3. treatment of underlying anxiety if it is an exacerbating factor 4. referral to a dermatologist for modified topical therapy 5. prescription of oral anticholinergics (which block the effect of the nerves that stimulate the sweat glands) 6. iontophoresis (for palmar or plantar hyperhidrosis) or botulinum toxin injections (for axillary hyperhidrosis). Page 31 Procedures of limited clinical value Treatment Criteria for intervention Additional information Interventions for varicose veins Intervention, including open surgery (ligation and stripping), endovenous laser ablation, and radiofrequency ablation is appropriate only for significant and intractable symptoms and signs including: Symptoms attributable to varicose veins are common but their relationship to visible trunk varices is not clear8. 1. significant bleeding from a varicosity that has eroded the skin OR 2. a prior varicosity bleed and is at risk of re-bleeding 3. an ulcer which is progressive and/or painful despite treatment OR 4. healed venous ulceration in a patient who for clinical reasons cannot tolerate compression stockings OR 5. after an unsuccessful 6 month trial of conservative management (compression stockings AND exercise AND elevation several times daily) when varicosities result in: 6. recurrent documented thrombophlebitis (2 or more episodes) OR 7. persistent skin changes (eczema or lipodermatosclerosis). Most patients with varicose veins are never harmed by them and good explanation and reassurance are fundamental.9 NICE has published detailed guidance on what treatment should be considered for varicose veins and when10. Sclerotherapy is not normally funded because of high recurrence rates. Treatment for reticular veins and telangectasia is generally considered to be cosmetic (see section on cosmetic surgery). 8 Bradbury A, Evans C, Allan P et al. What are the symptoms of varicose veins? Edinburgh vein study cross sectional population survey. Br Med J 1999;318:353-356 9 Campbell B. Clinical Review- Varicose veins and their management. BMJ 2006;333:287-292 (5 August) 10 NICE 2001. Referral Advice: A guide to appropriate referral from general to specialist services.http://www.nice.org.uk/nicemedia/pdf/Referraladvice.pdf Page 32 Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for intervention Additional information Cholecystectomy for asymptomatic gall stones Surgery for asymptomatic gallstones is not routinely funded as there is limited evidence that intervention under these circumstances is beneficial. Approximately 10-20% of people in western countries have gallstones, and most (50-70%) are asymptomatic at the time of diagnosis. Asymptomatic disease has a benign natural course and progression to symptomatic disease is relatively low, ranging from 10-25%. The majority of patients do not develop gallstone-related complications without first having at least one episode of pain.11 11 Gurusamy KS, Samraj K. Cholecystectomy for patients with silent gallstones. Cochrane Database of Systematic Reviews 2007, Issue 1. http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD006230/frame.html Page 33 Procedures of limited clinical value Treatment Criteria for intervention Non-medical circumcision Non-medical circumcision is not routinely funded. A service for boys aged between 6 weeks and 5 months is available at a cost to the parent or guardian of the patient. Patients must be resident in either Tower Hamlets, City & Hackney or Newham and registered with a local GP. Please contact Religious & Cultural Male Circumcision Service at Mile End Hospital on 020 8223 8010 for further information. Female circumcision is prohibited by under the Prohibition of Female Circumcision Act 1995. Surgery for varicocoele Page 34 Persistent discomfort or pain despite adequate conservative management. Additional information Circumcision is funded for medical indications, including: 1. phimosis seriously interfering with urine flow and/or associated with recurrent infection 2. some cases of paraphimosis 3. suspected cancer or balanitis obliterans 4. congenital urological abnormalities when skin is required for grafting and interference with normal sexual activity in adult males 5. recurrent, significantly troublesome episodes of infection beneath the foreskin. 6. To restore functional anatomy after female circumcision to facilitate childbirth where mutilation renders this hazardous. There is no evidence that treating varicocoele can help male sub-fertility problems. Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for intervention Additional information Hand or orthopaedic surgery Surgical treatment of carpal tunnel syndrome 1. Severe symptoms persisting after 3 months of conservative therapy with local corticosteroid injection and/or nocturnal splinting OR 2. Mild to moderate symptoms persisting after at least 4 months of conservative therapy with local corticosteroid injection and/or nocturnal splinting OR 3. Significant neurological deficit or median nerve denervation with sensory blunting, muscle wasting, or weakness of thenar abduction AND 4. Severe symptoms that significantly interfere with everyday living activities that have been formally assessed. Surgical excision of ganglia 1. they are painful seed ganglia OR 2. they are mucoid cysts arising at the distal inter-phalangeal joint and cause significant skin breakdown, significant nail deformity or repeatedly discharge OR 3. they cause significant functional impairment and/ or pain is unrelieved by aspiration or injection OR 4. there is diagnostic uncertainty. Patients should be re-assured about the benign nature of other ganglia and be informed that: 33% of dorsal ganglions and 45% of volar-wrist ganglia would resolve spontaneously in six years the recurrence rate after excision of wrist ganglia is between 10 – 45%. Page 35 Procedures of limited clinical value Treatment Criteria for intervention Additional information Surgical treatment of Dupuytren’s contracture If conservative treatment has failed to resolve: Surgery is not curative, it aims to reduce the chances of progression to severe debilitating joint contractures. 1. significantly impaired function of the hand with loss of extension in 1 or more joints that exceeds 25 degrees OR 2. at least 10 degrees loss of extension in 2 or more joints AND 3. surgery is likely to restore function. Surgical treatment for trigger finger The patient has: failed to respond to hydrocortisone injections OR a fixed flexion deformity that cannot be corrected. Recurrence rates after surgery range from 26-80%. Spontaneous recovery is reported in up to 30% of cases, so initial treatment should be conservative. Corticosteroid injections can be an effective treatment of trigger finger; this and other appropriate non-invasive interventions e.g. splinting12 should precede consideration of surgery. 12 Peters-Veluthamaningal C, van der Windt DAWM, Winters JC, Meyboom- de Jong B. Corticosteroid injection for trigger finger in adults. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD005617. DOI: 10.1002/14651858.CD005617.pub2. Page 36 Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for intervention Additional information Surgical treatment for hallux valgus (bunions) 1. significant pain on walking not relieved by chronic standard analgesia OR 2. deformity such that fitting adequate footwear is difficult OR 3. overlapping or underlapping of adjacent toe(s) OR 4. hammer toes OR 5. recurrent or chronic ulceration OR 6. bursitis or tendinitis of the first metatarsal head. Before referral patients should be informed that: they will be in plaster for 6 weeks and therefore unable to drive it will take at least a further 2 months to regain full functionality the prognosis for treated and untreated HV is very variable There is very little good evidence on which to assess either conservative or operative treatments13. 13 Ferrari J, Higgins JP, Prior TD; Interventions for treating hallux valgus (abductovalgus) and bunions. Cochrane Database Syst Rev. 2004 http://www.ncbi.nlm.nih.gov/pubmed/14973960?dopt=Abstract Page 37 Procedures of limited clinical value Treatment Criteria for intervention Additional information Knee washout for osteoarthritis This intervention is not routinely funded. In accordance with NICE guidance (Aug 2007) on arthroscopic knee washout, with or without debridement, for the treatment of OA14 and the NICE clinical guideline on OA (Feb 2008) on indications for which arthroscopic lavage and debridement is clinically and cost-effective15. Referral for arthroscopic lavage and debridement should only be considered in the few patients with knee osteoarthritis AND a clear history of mechanical locking i.e. not gelling, 'giving way' or X-ray evidence of loose bodies. 14 National Institute for Health and Clinical Excellence - Arthroscopic knee washout, with or without debridement, for the treatment of osteoarthritis - Guidance issue date: 22 August 2007. http://www.nice.org.uk/IPG230 15 National Institute for Health & Clinical Excellence (NICE), Clinical guideline CG59 The care and management of patients with Osteoarthritis, February 2008 www.nice.org.uk/cg59. Page 38 Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for intervention Additional information Funding of dental implants will be considered for: Predictors of implant failure are poor bone quality, chronic periodontitis, systemic diseases, smoking, unresolved caries or infection, advanced age, implant location and number; inappropriate prosthesis design may also contribute to implant failure16,17 Dental Dental implants In primary care i.e. General Dental Practice (GDP), this procedure would be funded, through GDP contracts, by NHS England. 16 17 1. major loss of tissue as a result of trauma or cancer surgery OR 2. significant congenital abnormalities (e.g. cleft lip & palate; hypodontia), where the abnormality or its correction exclude use of other prostheses OR 3. significant neuromuscular or other disorders (e.g. Parkinson‟s Disease, Bell‟s palsy) which preclude use of conventional dentures OR 4. some oral mucosal conditions, e.g. Sjogren‟s syndrome 5. severe jaw atrophy or alveolar bone resorption which preclude use of conventional dentures AND 6. the patients underlying condition means that the procedure is likely to be cost effective. Implants in patients who have undergone irradiation to the maxilla and/ or mandible have a significantly higher failure rate.17 Patients who are over 60 years of age, smoke, have a history of diabetes or head and neck radiation, or are postmenopausal and on hormone replacement therapy experience significantly increased implant failure compared with healthy patients.17 Porter JA, von Fraunhofer JA. Gen Dent. 2005 Nov-Dec; 53(6):423-32 Moy PK, Medina D, Shetty V, Aghaloo TL. Int J Oral Maxillofacial Implants. 2005 Jul-Aug; 20(4):569-77 Page 39 Procedures of limited clinical value Treatment Criteria for intervention Additional information Wisdom tooth (third molar) removal In primary care i.e. General Dental Practice (GDP), this procedure would be funded, through GDP contracts, by NHS England. Removal of third molar is only funded for: See NICE guidance18. 1. unrestorable caries 2. non-treatable pulp and/ or periapical pathology 3. cellulitis 4. abscess and osteomyelitis 5. fracture of tooth 6. resorption of the tooth or adjacent teeth 7. disease of follicle including cyst / tumour 8. tooth impeding surgery/reconstructive jaw surgery 9. when a tooth is in the field of tumour resection/XRT 10. plaque formation and pericoronitis depending on severity and frequency of episodes. Other Botox (botulinum toxin) Botulinum A toxin is routinely funded only for: 1. Spasticity, hand and wrist disability associated with stroke, blepharospasm, hemofacial spasm, spasmodic torticollis 2. Severe hyperhidrosis, overactive bladder syndrome Botulinum B toxin is routinely funded only for: 3. spasmodic torticollis 4. as alternative to Botulinum toxin A in presence of antibodies to Botulinum A. 18 http://www.nice.org.uk/nicemedia/pdf/wisdomteethguidance.pdf (accessed 8 February 2010) Page 40 For palmar or plantar hyperhidrosis, other procedures such as iontophoresis appear to be more effective and have fewer side effects and should be considered as initial treatment. Botox treatment needs to be repeated after 6-9 months. Procedures of limited clinical value (POLCV) City & Hackney, Newham, Tower Hamlets, and Waltham Forest (WELC) CCGs Treatment Criteria for intervention Additional information Procedures for which access criteria have been agreed Assisted conception NEL CSU will support CCGs to review these criteria, taking into account revised NICE Clinical Guideline (expected 2013/14) Unless or until WELC CCGs have confirmation that this service will be commissioned by NHS England, access criteria for the couple comprise: Funding is available for eligible couples for 3 locally defined cycles; each cycle comprising an embryo transfer. 1. registration with local GP practice for at least 1 year 2. 2 years of unexplained infertility or one year of diagnosed subfertility within the current relationship 3. no living children within the current relationship and not more than four between them from previous unions 4. neither partner will have previously undergone a sterilisation procedure 5. couple have had less than three previous NHS-funded IVF cycles leading to fresh embryo transfer Neither donor sperm nor donor eggs are NHS funded. Because surgical sperm retrieval is not covered within the existing contracts within the reproductive service, this is not currently funded. Current access criteria for the female partner comprise: 6. age 23-39.9 years 7. BMI 19-30 kg/m2 Page 41 Procedures of limited clinical value Index abdominoplasty, 14 Double balloon enteroscopy, 24 Ketogenic diet for epilepsy, 23 Scars - treatment and revision 16 Acupuncture, 23 Dupuytren’s contracture, 36 labiaplasty 21 service level agreements adenoidectomy, 28 earlobes repair of split, 21 lesions alopecia, 16 ENT, 28 benign, 26 apronectomy, 14 Face lifts, 18 pigmented, 25 arm lift, 15 facial haemangiomas, 19 Liposuction, 15 skin excision, 15 Assisted conception, 41 Functional electrical stimulation nose skin lesions, 26 Bartholin’s cysts, 30 for footdrop, 24 surgery to reshape, 19 Blepharoplasty, 18 gall stones, 33 Occipital nerve stimulation body contouring, 15 ganglia, 35 Botox, 40 gender reassignment, 23 Open MRI, 23 brachioplasty, 15 General surgery, 31 osteoarthritis, 38 Breast Procedures, 8-13 Grommet, 27 osteopathy, 23 brow lifts, 18 Hair - Epilation, transplantation,laser electrolysis 17 otoplasty, 20 for intractable or cluster headache, 24 procedures outside of, 22 sinusitis, 29 surgical treatment of, 30 skin pigmentation hyper or hypo, 20 Sympathectomy for severe hyperhidrosis, 31 Tattoo Removal, 21 Tonsillectomy, 28 trigger finger, 36 bunions, 37 uterine fibroids palmar, 31 hallux valgus, 37 buttock lift, 15 MRI guided ultrasound for, 23 Pigmented lesions, 25 headache carpal tunnel syndrome, 35 varicocoele, 34 pinnaplasty, 20 varicose veins, 32 occipital nerve stimulation for, 23 Cholecystectomy, 33 plantar, 32 Herbal Medicines, 23 circumcision, 34 vascular lesions, 19 port wine stains, 19 Homeopathy, 22 Wisdom tooth, 40 reversal of sterilisation/vasectomy 22 Cosmetic surgery, 25 hyperhidrosis Dental implants, 39 Rhinoplasty, 19 sympathectomy for, 31 Dilatation and curettage, 29 Rhytidectomy, 18 Hysterectomy, 30 Page 42 For further information regarding this POLCV document or the IFR process, please call 020 7683 2724, or write to us either via the secure email address [email protected] or by post to IFR Team, North East London Commissioning Support Unit, 2nd Floor Clifton House, 75-77 Worship Street, London EC2A 2DU.