Public Involvement in the Identification of Low ....docDocument Transcript
12th January 2007 Kestrel House Hedgerows Business Park Colchester Road Chelmsford Essex CM2 5PF Tel: 01245 398770 Fax: 01245 398712Dear ColleagueClinical and Patient/Public Involvement in the Identification of Low PriorityProceduresMid Essex PCT is currently clarifying its health policies for designating treatments as low priorityand is requesting comments from clinicians and patients to contribute to this work.A process of determining low priority treatments, based on evidence of effectiveness, has beendeveloped by the public health team and endorsed by the PCT Professional ExecutiveCommittee.The aim of this work is to maximize the effectiveness of the treatments which the PCTcommissions by limiting access to those treatments where there is little or no evidence ofeffectiveness. This will have outcomes both in terms of clinical effectiveness and in freeing upresources to be channelled to more effective interventions.This is an important piece of work for the PCT, its patients and all local clinicians. It will have adirect impact on patient care and on the financial situation within the health economy.Both primary care and hospital clinicians are important in ensuring that patients are referred andtreated appropriately. Patients are key partners in decisions about their care. It is important thatthose who have an interest in this work have the opportunity to commentWe hope that you will appreciate, as we do, the importance of this work and will be able to sendus your comments on the attached draft list of procedures which may be designated low priority.The list will also be available on the Public Health section of the PCT website under Trustdocuments section.A reply slip is attached for your convenience. Please email comments firstname.lastname@example.org by Thursday 6th February 2007.Yours sincerelyJan YatesPublic Health
Clinical and Patient/Public Involvement in the Identification of Low PriorityTreatmentsComments on the draft list of low priority proceduresComments on the proposal to expand the list of low priority procedures, basing newpolicies on evidence of effectivenessComments on specific clinical policies proposedPolicy Comment
Mid Essex PCT Clinical Prioritisation Policies – Draft 4Draft 4 prepared by Jan Yates, January 2006.Table. Draft list of procedures which may be designated low priority for Mid Essex based on evidence of effectiveness(Includes those treatments where a referral threshold can be set)This list has been derived from:1. Policy statements from other PCTs which have been based on evidence of effectiveness.2. Restatements of policies currently in effect across Essex.Clinical and PPIF engagement and comment is important before the PCT Board ratifies these policies.This list includes two categories of procedure: • Those which, as routine are not provided by the PCT and where provision is only possible on an individual patient basis, via the referral of the case by the relevant clinician to the PCT Exceptional Cases Panel. These are listed as “PARTIALLY EXCLUDED PROCEDURE (PE)” In this case the criteria list form guidance to referring clinicians and the Exceptional Cases Panel on what may be considered exception but the final decision rest with the Exceptional Cases Panel. • Those which may be offered on a routine basis but only for patients who meet defined criteria. These are listed as “THRESHOLD APPLIES (TA)”. The responsibility for adherence to these policies lies with the referring and accepting clinicians and prior approval should be sought where this is part of the contracting arrangements.Sources:TVPC = Thames Valley Priorities CommitteesSuffolk Low Priority Procedure ListCambridgeshire Clinical Priorities PoliciesNorfolk policiesBedfordshire and Hertfordshire policies
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? COSMETIC AND LIFESTYLE1 Cosmetic surgery Referrals for plastic surgery from both primary and tertiary sources will be assessed in line with the Service c Essex (general principles) Restriction Policy and the clinical evidence provided. service restriction For an authorised first appointment, the Plastic Surgery Specialist to whom the referral is subsequently passed should policy decide whether the patient would benefit from plastic surgical intervention, and if so, establish that the patient fully understands the risks and benefits of surgery. All referrals should be assessed for both first OPD appointments and subsequent procedure appointments, in line with the policy and clinical evidence. Cosmetic surgery undertaken exclusively to improve appearance should not be funded in adults, in the absence of previous trauma, disease or congenital deformity. Assessment of patients being considered for referral who have an underlying genetic, endocrine or psychosocial condition should have had this fully investigated by a relevant specialist prior to the referral to plastic surgery being made. Referrals within the NHS for the revision of treatments originally performed outside the NHS will not usually be permitted. Referrers should be encouraged to re-refer to the practitioner who carried out the original treatment. Surgery should be supported where a patient has been accepted onto an NHS waiting list prior to taking up residence in Mid Essex, providing the existing clinical evidence has remained the same. Where a patient has previously had NHS funded treatment, procedures necessary for dealing with complications or an outcome that, because of complications or technical difficulties, has resulted in cosmetic or physical problems that, from a professional point of view, are severe enough to oblige the NHS to fund corrective treatment should be supported. An undesirable outcome from an aesthetic perspective and the questions of whether revision should be funded is an issue that the referrer should discuss with the patient prior to referring on to plastic surgery. The National Service Framework for Children (National Service Framework for Children, Young People and Maternity Services. DH October 2004), defines childhood as ending at 19 years. Funding for this age group should only be considered if there is a problem likely to impair normal emotional development. Children under the age of five rarely experience teasing and referrals may reflect concerns expressed by the parents rather than the child, which should be taken into consideration prior to referral. Some patients are only able to seek correction surgery once they are in control of their own healthcare decisions and again should be taken into consideration prior to referral.
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ?1 Abdominoplasty or Abdominoplasty and apronectomy may be offered to the following groups of patients who should have achieved a P Essex Apronectomy stable BMI between 18 and 27 Kg/m² and be suffering from sever functional problems: service Those with scarring following trauma or previous abdominal surgery restriction (PE) Those who are undergoing treatment for morbid obesity and have excessive abdominal folds (generally a weight loss policy of 10 points on the BMI scale) Previously obese patients who have achieved significant weight loss and have maintained their weight loss for at least two years Where it is required as part of abdominal hernia correction or other abdominal wall surgery Severe Functional problems include: • Recurrent intertrigo beneath the skin fold • Experiencing severe difficulties with daily living i.e. ambulatory restrictions. These patients will need full assessment by the appropriate professional e.g. OT. Prior to referral • Where previous post trauma or surgical scarring (usually midline vertical or multiple) leads to very poor appearance and results in disabling psychological distress or risk of infection. • Abdominal wall prolapse with proven urinary symptoms • Problems associated with poorly fitting stoma bags2 Other skin excision Buttock lifts, thigh lifts and arm lifts (brachioplasty), procedures will only be funded in exceptional circumstances. B Essex for contour service (PE) restriction policy3 Liposuction Liposuction may be useful for contouring areas of localised fat atrophy or pathological hypertrophy e.g. multiple s Essex lipomatosis, lipodystropies. Liposuction is sometimes an adjunct to other surgical procedures. It will not be funded service (PE) simply to correct the distribution of fat. restriction policy4 Acne Vulgaris The treatment of active acne vulgaris should be provided in primary care or through a dermatology service. t Essex Patients with severe facial post-acne scarring can benefit from resurfacing and other surgical interventions, which service (PE) may be available from the plastic surgery service. All resurfacing techniques, including laser, dermabrasion and restriction chemical peels may be considered for post-traumatic scarring, including post surgical and serve acne scarring once policy the active disease is controlled. This will need to be evaluated as being inactive by the referrer.
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ?5 Benign Skin A patient with a skin or subcutaneous lesion that has features suspicious of malignancy must be referred to an Essex Lesions appropriate specialist for urgent assessment. service (PE and T) restriction Clinically benign skin lesions should not be removed on purely cosmetic grounds. This will include: policy • Benign Pigmented Moles: combined • Comedones: with Suffolk • Corn/Callous: LPP • Lipoma • Male Pattern Baldness: • Hirsuitism: • Sweating/ hyperhidrosis (see policy later): • Milia: • Molluscum Contagiosum: • Seborrhoeic Keratoses (Basal Cell Papillomata): • Skin Tags • Spider Naevus (Telangiectasia): • Warts • Sebaceous cysts • Xanthelasma • Dermatofibromas These lesions may be funded in the following circumstances: If a benign skin lesion has become complicated eg by infection or it is interfering with physical function and the clinician wishes to refer the patient to secondary care then funding must be approved by the PCT. If a benign skin lesion of the eye obscures vision or is causing a separate ocular problem then the patient can be referred to an ophthalmologist for removal. Most viral warts will clear spontaneously or following application of topical treatments. The following warts may be referred to dermatology or genitourinary medicine: • Warts on the face • Warts in patients who are immunosuppressed • Genital warts • Painful, persistent or extensive warts, particularly in the immuno-suppressed patient, will need specialist assessment from a dermatologist. Facial electrolysis is a cosmetic procedure that will not be funded.
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ?6 Rhinophyma The first-line treatment of the nasal skin condition is medical. Severe cases or those that do not respond to medical t Essex treatment may be considered for surgery or laser treatment. service (PE) restriction policy7 Tattoo Removal The funding for removal of tattoos will be considered in the following circumstances: n Essex (PE) • Funding should be considered for allergy to pigments service • Where the tattoo is the result of trauma, inflicted against the patient’s will restriction • The patient was not found to be Fraser (formally Gillick) competent, and therefore not responsible for their policy actions, at the time of the tattooing. • Exceptions may also be made for tattoos inflicted under duress during adolescence or disturbed periods where it is considered that psychological rehabilitation, break up of family units or prolonged unemployment could be avoided, given the treatment opportunity. (Only considered in very exceptional circumstances where the tattoo causes marked limitations of psychosocial function). Psychiatric/psychological reports will need to be provided with the initial referral.
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ?8 Scar Revision Scars that are resulting in physical disability due to contractors, tethering or recurrent breakdown will be funded. i Essex (PE) service Keloid scars, due to an over vigorous reaction in a scar, is more common in certain parts of the body and in certain restriction racial groups. policy Funding will be available for: • Keloid scars that result in physical distress due to significant pain or pruritis • Significant keloid scarring on the face • Keloid scarring following ear piercing Funding will not be available for: • Keloid scars on other parts of the body • Keloid scars secondary to body piercing procedures Scars secondary to trauma/accidents Scars on the face that are ragged, over 2cm in length or can otherwise be regarded, as particularly disfiguring will be funded. Scars on the rest of the body. Scar revision for cosmetic purposes will not be funded unless the disfigurement can be regarded as particularly grave. Cases will be judged on an individual basis. In both cases, medical photography will be required with the initial referral. Scars as a result of self-harm These are very difficult to treat and usually the only achievable outcome is to make the scars resemble trauma or burns rather than be obviously due to self-harm. Treatment will only be funded when there has been a minimum period of three years where there has been no self-harm and where there is a supporting report from a psychiatrist indicating that the behaviour would be unlikely to recur.9 Face lifts and brow These procedures will be considered for treatment of: T Essex lifts (Rhytidectomy) • Congenital face abnormalities service (PE) • Facial palsy (congenital or acquired paralysis) restriction • As part of the treatment of specific conditions affecting the facial skin e.g. cutis laxa, pseudoxanthoma policy elasticum, neurofibromatosis • To correct the consequences of trauma • To correct deformity following surgery • They will not be available to treat the natural processes of ageing.
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ?10 Blepharoplasty Upper Lid T (Suffolk Essex (upper and lower This procedure will be funded to correct functional impairment (not purely for cosmetic reasons) Cosmetic service lid) Indications: and restriction (PE) • Impairment of visual fields in the relaxed, non-compensated state. Evidence will be required that that eyelids Lifestyle) policy impinge on visual fields reducing field to 120° laterally and 40° vertically amended • Clinical observation of poor eyelid function, discomfort, e.g. headache worsening towards end of day and/or using evidence of chronic compensation through elevation of the brow Suffolk LPP Lower Lid This will be funded for correction of ectropion or entropian or for the removal of lesions of the eyelid skin or lid margin.11 Rhinoplasty Rhinoplasty should be funded for: c Essex (PE) • Problems caused by obstruction of the nasal airway service • Objective nasal deformity caused by trauma restriction • Part of reconstructive head and neck surgery policy • Correction of complex congenital conditions e.g.cleft lip and palate Patients with isolated airway problems, in the absence of visible nasal deformity, should be referred initially to an ENT consultant for assessment and treatment.12 Pinnaplasty/ The following criteria should be met for funding to be made available: a Essex Otoplasty • The patient must be between the ages of 5 and 14 years at the time of referral service (PE) restriction Patients seeking pinnaplasty should be seen by a plastic surgeon and following assessment, if there is any concern, policy assessed by a psychologist13 Repair of external This will not be routinely funded other than primary suture post trauma T (Suffolk Essex ear lobes Cosmetic service (PE) and restriction Lifestyle) policy/Suffo lk14 Aesthetic Facial Funding should be considered for: C Essex Surgery • Anatomical abnormalities in children <19 years, likely to cause impairment of normal emotional development service (PE) • Pathological abnormalities restriction • Correction of post traumatic bony and soft tissue deformity of the face policy15 Alopecia Funding will be available when it is a result of previous surgery or trauma including burns F Essex (PE) service restriction policy
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ?16 Male pattern Is excluded from funding. I Essex baldness service (PE) restriction policy17 Hair transplantation Will not be funded, regardless of gender, other than in exceptional cases, such as reconstruction of the eyebrow f Essex following cancer or trauma. service (PE) restriction policy18 Hair depilation Hair depilation will be funded for patients who: A Essex (PE) • Have undergone reconstructive surgery leading to abnormally located hair-bearing skin service • Those with a proven underlying endocrine disturbance resulting in Hirsutism e.g. polycystic ovary syndrome restriction • Are undergoing treatment for pilonidal sinuses to reduce recurrence policy19 Breast Reduction Breast reduction surgery is an effective intervention that should be funded if the following criteria are met: p (Suffolk Essex (PE) Cosmetic service • The patient is suffering from neck ache or backache. Clinical evidence will need to be produced that this has and restriction been investigated to rule out any other medical/physical problems to cause these symptoms Lifestyle) policy • The wearing of a professionally fitted brassiere has not relieved the symptoms amended • Persistent intertrigo using • Serious functional impairment Suffolk LPP • The patient has a BMI of less than 30 kg/m² • (or the patient is male with hormonal or drug related breast growth) Patients should have an initial assessment by the referrer prior to an appointment with a consultant plastic surgeon to ensure that these criteria are met. At, or following this assessment, there should be access to a trained bra fitter, to assess if this alone will relieve the symptoms experienced by the patient. Assessment of the thorax should be performed, including the use of x-ray, scan etc.20 Breast Augmentation will only be performed for reconstructive purposes and will not be carried out for small but normal b Essex augmentation breasts or for breast tissue involution, including post partum changes. service (PE) restriction policy21 Asymmetry Funding will only be considered if there is gross disparity of breast cup sizes on initial consultation with the patients G Essex GP. service (PE) restriction policy
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ?22 Revision of Breast Revisional surgery is carried out for implant failure, causing proven health problems the decision to replace the a Essex Augmentation implants rather than simply remove them should be based upon the clinical need for replacement and whether the service patient meets the criteria for augmentation at the time of revision. restriction (PE) policy Replacement should not be funded if the original operation was done for cosmetic reasons in the private sector, although it would be acceptable to replace implant failures with an implant purchased by the patient23 Mastopexy (Breast This is included as part of the treatment of breast asymmetry and reduction but not for purely cosmetic/aesthetic p Essex Lift) purposes such as post-lactational ptosis. service (PE) restriction policy24 Nipple Inversion Nipple inversion may occur as a result of underlying breast malignancy. If the inversion is newly developed, it t Essex (PE) requires urgent referral and assessment. service restriction Surgical correction of nipple inversion should only be available for functional reasons in a post-pubertal woman and if policy the inversion has not been corrected by correct use of a non-invasive suction device.24 Gynaecomastia Surgery to correct gynaecomastia should be allowed if the patient is: p Essex (PE) • Post pubertal service • Normal BMI < 25 Kg/m2 restriction True gynaecomastia that is mainly caused by an excess of glandular breast tissue will be funded if the normal medical policy treatments have failed. Re assurance that the problem is not due to the abuse of drugs with bodybuilding. Pseudo-gynaecomastia, where the enlargement of the male breast is due to an excess of adipose tissue and the BMI is outside the range of a normal BMI, funding will not normally be agreed unless there is clear evidence that the problem has persisted in spite of rigorous dieting and weight loss.26 Reversal of male Funding will only be considered if death of an existing child of the man has occurred, OR remarriage following death (Suffolk Suffolk LPP sterilization of spouse, OR loss of unborn child when vasectomy had taken place during the pregnancy. Cosmetic policy (PE) and Lifestyle)27 Reversal of female Funding will only be considered if death of an existing child of the woman has occurred, OR remarriage following d (Suffolk Suffolk LPP sterilization death of spouse, Cosmetic policy (PE) and Lifestyle)28 Treatment for As there is currently insufficient evidence on the risks and benefits of gender reassignment this procedure should only (Suffolk Suffolk LPP gender dysphoria be considered under exceptional circumstanced. These are some of the criteria that would be taken into account Cosmetic policy (PE) before funding the procedure. and Lifestyle) Referrals should be made by a consultant psychiatrist. A written recommendation will be needed from the psychiatrist, who should have had clinical responsibility for the patient for at least 6 months. Referrals should not be accepted
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? directly from GPs or other professionals. Prior to genital sex reassignment the patient will also need to be seen by a consultant urologist to identify and possibly treat abnormalities of the genito-urinary tract. This is commonly accepted as good practice. Prospective patients should be required to live and work for at least two years in the social role of the opposite sex. This is referred to as the "real life" test.29 Assisted Intrauterine insemination (IUI) is considered a low priority treatment for couples who are mutually eligible for both in- U (Suffolk Suffolk LPP conception using vitro fertilisation (IVF) and IUI and will only be provided under the NHS when there is strong patient preference for IUI. Cosmetic policy IVF/ICS/IUI for One full cycle of (IVF) intracytoplasmic sperm injection (ICSI) will only be provided under the NHS to couples who and combined infertility satisfy the eligibility criteria. Referrals should be made to a hospital consultant with a special interest in infertility for Lifestyle) with current (T) investigation and then to the Isis Fertility Centre if criteria are met. Essex-wide This policy does not cover preimplantation genetic diagnosis or cryopreservation of gametes policy and/or embryos. Criteria for funding: 1. Maximum FSH level 15 U/L. 2. Minimum maternal age 23 years at the start of super-ovulation. 3. Maximum maternal age 39 (ie < 40) at the start of super-ovulation. 4. Maximum BMI 30 kg/m2. 5. Minimum BMI 19 kg/m2, if anovulatory. 6. Duration of sub-fertility: No criterion for cases with a diagnosed severe cause of infertility; 3 years for cases with unexplained or mild-moderate cause of sub-fertility. 7. Previous IVF treatment: Ineligible if there have been 3 or more unsuccessful previous fresh embryo cycles (either NHS or self-funded). Donor insemination: Ineligible if 12 or more unsuccessful previous cycles (however funded). 8. Smoking status. Where a couple smoke, only couples who agree to take part in a supportive programme of smoking cessation will be accepted on the IVF treatment waiting list and should be nonsmoking at time of treatment. 9. Parental status Couples are ineligible if there are any children from current relationship. Priority should be given to childless couples (i.e. no previous children for either partner). 10. Previous sterilization has taken place (either partner), even if it has been reversed. 11. Child welfare Couples should conform to statutory ‘Welfare of the Child’ requirements. 12. Medical conditions Treatment may be denied on other medical grounds not explicitly covered in this document. A “full cycle’ of IVF (IVF/ICSI) includes one ‘fresh embryo’ cycle (when appropriate including egg donation subject to UK availability of donor eggs, sperm donation in the context of subfertility, or surgical sperm retrieval).30 Endoscopic Will not be routinely funded W TVPC thoracic sympathectomy for excessive sweating and/or facial blushing
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? (PE) ENT31 Treatment for Radiofrequency ablation should not be used for snoring. o Suffolk LPP snoring Laser treatment will only be considered for snoring in the context of treatment under specialist supervision for policy (PE) obstructive sleep apnoea.32 Grommets / A period of watchful waiting is the best management strategy for children with otitis media with effusion. Grommets C Suffolk LPP Adenoidectomy should only be considered for patients satisfying defined criteria. Patients and parents should be advised of the risk of policy (with (T) potential harm e.g. tympanosclerosis. Newcastle Children with hearing impairment should have a period of at least 6 months of watchful waiting from the onset of the period of 6 symptoms. months, Grommet should only be considered if Suffolk has A - glue ear persists, and the child (3 years or over) also suffers from one of the followings: 3) 1. Recurrent acute otitis media with more than 5 times per year. Combined 2. Evidenced delay in speech development with Cambs 3. Educational or behavioural problems attributable to persistent hearing impairment, with a hearing loss of at draft policy least 25dB particularly in the lower tones (low frequency loss 4. A second disability, such as Down’s syndrome 5. Severe collapse of the eardrum Or B. the child has had at least 5 occurrences of acute otitis media in the last year with additional complications such as perforations, persistent discharge, febrile convulsions, sensorineural deafness or cochlear implantation. Or C. for children aged 2 years, the child has: • OME with prolonged effusion (6 months or longer); • AND measured hearing loss; • AND disability attributable to hearing loss (delay in speech development or other problems). Indications 1-5 are similar to the referral guidelines outlined in ‘Prodigy’. Combine adenoidectomy and grommet insertion if the child has nasal symptoms on top of otitis media with effusion33 Tonsillectomy A six-month period of watchful waiting is recommended prior to tonsillectomy to establish firmly the pattern of t Suffolk (T) symptoms and allow the patient to consider fully the implications of operation. combined with Cambs Patients should meet all of the following criteria: • sore throats are due to tonsillitis • five or more episodes of sore throat per year • symptoms for at least a year • the episodes of sore throat are disabling and prevent normal functioning.
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? OR the patient should have: • intractable cough with a high level of streptococcal antibody; OR • severe halitosis which has been demonstrated to be due to tonsil crypt debris. Note should also be taken of whether the frequency of episodes is increasing or decreasing. Tonsillectomies for other indications will need to go via exceptional cases panel before surgery is undertaken. Other indications for Tonsillectomy that the exceptional cases panel may consider include: Sleep apnoea (demonstrated by a sleep study or other accepted method of diagnosis). Significant failure to thrive in children. Once a decision is made for tonsillectomy, this should be performed as soon as possible, to maximise the period of benefit before natural resolution of symptoms might occur (without tonsillectomy). GENERAL SURGERY34 Bariatric surgery Funded patients are those who fulfill criteria for treatment under NICE guidance. Treatment will not be funded without a Suffolk LPP (PE) prior approval of the EFP panel. Treatment should be carried out in accordance with NICE guidance. policy The NICE guidance includes the following: It is recommended that patients with morbid obesity who are considering surgery to aid weight loss should discuss the treatment with the specialist responsible for their treatment. This discussion should cover, in detail, the potential benefits, risks and complications of having surgery to aid weight reduction. NICE has recommended that surgery to aid weight loss should be available as a treatment option for people with morbid obesity provided that they meet all of the following criteria • They are aged 18 years or over • They have tried all other appropriate non-surgical treatments to lose weight but have not been able to lose weight or maintain weight loss • There are no specific medical or psychological reasons why they should not have this type of surgery • They are generally fit enough to have an anaesthetic and surgery • They should understand that they will need to be followed-up by a doctor and other healthcare professionals such as dieticians or psychologists over the long-term People with morbid obesity should have surgery to aid weight loss only after they have had a full assessment by the specialist and other healthcare professionals involved in their care. In addition, counselling and support should be arranged for people before and after the surgery. Smoking cessation advice should be offered as necessary.35 Varicose vein Any patient presenting to their GP with Varicose Veins shall be referred directly to the Tier 2 Varicose Vein Suffolk LPP surgery or injection Assessment service. Any patient who is referred directly to MEHT with varicose veins shall be redirected to Tier 2 for policy (T) assessment.
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? Surgery or injection will not be performed unless the patient meets one or more of the following criteria: • Patient has varicose eczema which has not responded to the regular use of compression hosiery for a period of six months • Patient has lipodermatosclerosis or ulcer • Patient has had at least two episodes of superficial thrombophlebitis • Patient has had two minor episodes of bleeding from a varicosity or one major episode • Patient has significant aching, discomfort or oedema in the affected leg(s) that is thought to be due to varicose veins, requires analgesia (in the case of aching or discomfort) and has not responded to the regular use of compression hosiery for a period of six months.36 Endoscopy Awaiting regional policy Beds/Herts (T) All patients requiring routine diagnostic and screening endoscopy should be referred directly to the Tier 2 Community endoscopy service. Any patient who is referred directly to MEHT shall be redirected to Tier 2 for assessment. Beds/Herts policy: Criteria for upper GI endoscopy for the investigation of dyspepsia should be based on NICE guidance1: Urgent specialist referral for endoscopic investigation is indicated for patients of any age with dyspepsia when presenting with any of the following: · chronic gastrointestinal bleeding · progressive unintentional weight loss · progressive difficulty swallowing · persistent vomiting · iron deficiency anaemia · epigastric mass or suspicious barium meal. Routine endoscopic investigation of patients of any age, presenting with dyspepsia and without alarm signs, is not necessary. However, in patients aged 55 years and older with unexplained and persistent recent onset dyspepsia alone despite treatment, an urgent referral for endoscopy should be made. Relevant OPCS code(s): G16, G19, G45 Audit note: These OPCS coded procedures will also be used for other indications, so audit of implementation of guidance should be specific to dyspepsia.37 Non-urgent elective Elective surgery will not be carried out (unless urgent) on patients unless they have attended a course of stop j SHA advice surgery for smoking support (provided either by the specialist stop smoking service or in primary care) London smokers Patients who have not achieved smoke free status for 3 months are not excluded from referral – this is down to Health clinical judgment of risks and benefits. It is recognised that exceptional individual circumstances may require clinical Observator judgement that the referral may be necessary. y Evidence MUSCULOSKELETAL38 Spinal surgery: Exceptional patients are those who fulfill criteria for treatment under NICE guidance. E Suffolk LPP
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? Endoscopic laser The only indications for this spinal surgery to be considered are those from NICE guidance (IPG027, IPG031, policy spinal surgery, IPG061, IPG088, IPG081) and must conform to this guidance ie should not be used without special arrangements for percutaneous audit, consent and research. intradiscal • IPG061 Percutaneous endoscopic laser thoracic discectomy is used to treat symptomatic thoracic disc electrothermal herniation. therapy • IPG027 Laser lumbar discectomy is considered when there is nerve compression or persistent symptoms (PE) that are unresponsive to conservative treatment. Laser discectomy can be performed when the prolapse is contained. It is one of several minimally invasive surgical techniques, which are alternatives to open repair procedures such as open lumbar discectomy or laminectomy. • IPG031 endoscopic laser foraminoplasty for chronic back and leg pain from a variety of causes. • IPG088. Endoscopic division of epidural adhesions for lower back pain, particularly when radiculopathy (a disorder of the spinal nerve roots) is present. • IPG081 Percutaneous intradiscal electrothermal therapy for discogenic back pain39 Spinal surgery for Patients will only receive non-acute+ spinal surgery under the following circumstances: r Suffolk LPP non-acute lumbar policy conditions Surgical discectomy (standard or microdiscectomy) in selected patients with sciatica secondary to disc prolapse (T) where conservative management for at least 4-6 weeks has failed. It is recommended that Primary Care Referral for assessment for spinal surgery or other invasive intervention should only be considered if radicular pain has not responded to non-invasive treatment after 4-6 weeks. Fusion surgery for chronic low back pain may be considered if severe pain despite two years of an ‘active rehabilitation programme’ (cognitive intervention combined with exercises is recommended when available). + Acute conditions include back pain due to fracture, dislocation, complications of tumour or infection and/or nerve root or spinal compression responsible for progressive neurological deficit.40 Hip and knee Any patient presenting to their GP with hip or knee pain shall be referred directly to the Tier 2 Community Suffolk LPP replacement Orthopaedic Service. Any patient who is referred directly to MEHT with any condition included below shall be policy surgery redirected to Tier 2 for assessment. (Pain (T) Patients should be referred for consideration of total joint replacement when all conservative means have failed to scoring alleviate the patient’s pain and disability, which should be significantly interfering with their activities of daily living and from their ability to sleep. Referral should only be for patients satisfying defined criteria. Newcastle) Replacement surgery will not be performed unless all the following criteria are met: • The patient is suffering from pain and disability that is sufficiently severe as to interfere with their daily life and/or ability to sleep (eg Salisbury Score 14 or an Oxford Hip and Knee Score of 60) AND • The patient has used a range of conservative treatments – analgesics, NSAIDS, exercise and physiotherapy (as appropriate) – and these have failed to alleviate the patient’s pain AND • If obese (BMI >30), the patient has undertaken a supervised weight reduction programme with the aim of
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? reducing the BMI to below 30.41 Chronic hand GANGLION Suffolk LPP conditions Cystic degeneration from joint capsule or tendon sheath. Lesions at the base of the digits are often small but very policy (T) tender (seed ganglion). Mucoid cysts arise at the distal interphalangeal joint and may disturb nail growth. Ganglions arising at the level of the wrist are rarely painful and most will resolve spontaneously within 5 years. The recurrence rate after excision of wrist ganglia is between 10 – 45 %. Conservative management is largely a matter of reassurance. When there is doubt aspiration will confirm diagnosis. After a first aspiration 50-80% of ganglia recur, but after a third aspiration only 20% recur. Refer • Painful seed ganglia. • Mucoid cysts that are disturbing nail growth or have a tendency to discharge (risk of septic arthritis in distal inter-phalangeal joint). There is no indication for the routine excision of simple wrist ganglia. These should not generally be referred. CARPAL TUNNEL SYNDROME Patients typically present with nocturnal dysaethesia in the hands wearing off with activity. The presence of a positive Phalen’s (wrist flexion test) or Tinel’s sign confirms. Nerve conduction studies are NOT generally needed to confirm the diagnosis. In elderly patients the condition may develop insidiously. Conservative treatment may include adjustment of activities or posture, with night splintage in neutral wrist position. Non-steroidal anti-inflammatory drugs and diuretics are occasionally of benefit. Steroid injections may be of value in uncomplicated cases (requires clinical experience). Refer • Acute severe symptoms (fewer than 5% of patients) uncontrolled by conservative measures, particularly in pregnancy, significantly interfere with daily activities. • Mild to moderate symptoms with failure of conservative management, (4 months) • Neurological deficit ie. Sensory blunting or weakness of thenar abduction ( wasting or weakness of abductor pollicis brevis). DUPUYTRENS DISEASE Nodular or cord-like thickening of the palmar skin. May tend to cause tethering of the digits with loss of extension range. Refer • Loss of extension in one or more joints exceeding 25 degrees. • Young patients (under 45 years) with disease affecting 2 or more digits and loss of extension exceeding 10 degrees. TRIGGER FINGER Snapping of the fingers as they are extended from a fully flexed posture, associated with a tender nodule in flexor
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? tendon at base of finger or thumb. Conservative treatment may include rest from precipitating activities, Non-steroidal anti-inflammatory drugs. Injection of hydrocortisone into the tissue IN FRONT of the tendon at the level of the distal palmar crease (MCPJ) will often settle early cases (requires clinical experience). Refer • Failure to respond to conservative treatment (max 2 injections) • Fixed flexion deformity that cannot be corrected42 Temporomandibula This should not be routinely funded h TVPC r Joint Indications for intervention in rare cases with prior approval. Replacement The affected patients usually have severe disease of the temporomandibular joint which may be more serious if (PE) patients cannot open their mouths adequately, as dentistry, anaesthesia and resuscitation may be severely complicated and even life-threatening. In such rare cases, TMJ replacement may be considered. Contraindications are: 1) active or chronic infection; 2) patient conditions where there is insufficient quantity or quality of bone to support the components; 3) systemic disease with increased susceptibility to infection; 4) patients with extensive perforations in the mandibular fossa and/or bony deficiencies in the articular eminence or zygomatic arch that would severely comprise support for the artificial fossa component; 5) partial TMJ joint reconstruction; 6) known allergic reaction to any materials used in the components; 7) patients with mental or neurological conditions who are unwilling or unable to follow post-operative care instructions; 8) skeletally immature patients; and 9) patients with severe hyper-functional habits (e.g. clenching, grinding etc.). DRUGS Further work is needed to ensure drug policies are incorporated into the low priority procedure list The lists below are those in force in other PCTs43 Drugs – secondary The following drugs will not be routinely funded: B Suffolk LPP care (Suffolk • Infliximab for Crohns disease in children under 18 years (PE) policy source) • Bevacizumab for first and second line colorectal cancer (PE) (PE) • Alemtuzumab for chronic lymphocytic leukaemia (PE) • Growth hormone for growth disturbance in children born small for gestational age (PE) • Rituximab as first line in stage III-IV follicular lymphoma (PE) • Bortozomib for relapsing, refractory myeloma (PE)44 Drugs – secondary • Pemetrexed for unresectable malignant pleural mesothelioma (TVPC) (PE) e Others care (other • Pegvisomant for the management of acromegaly (TVPC) (PE) sources) • Inosine Pranobex for Chronic Fatigue Syndrome/Chronic Epstein Barr Virus Infection (TVPC) (PE) (PE) • Terbinafine (& other antifungal preparations) for fungal nail infections Exceptions to this are where the onychomycosis causes significant pain; secondary infection (cellulitis); functional impairment (eg inability to use footwear or difficulty walking) or where the patient is at significant risk of complications due to, for example, diabetes, peripheral vascular disease or immunosuppression (Beds/Herts) (PE).45 Drugs – primary The following drugs should not be routinely prescribed: List Norfolk care • Calcium and vitamin D (Calcichew) – use other calcium and vitamin D products (see BMF 9.6.4) available grey list (PE) • Co-proximol (use paracetemol) – there may be occasions where this is used in specialist pain treatment
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? • Desloratidine (Neoclarityn) – use Loratidine or other antihistamine unless not tolerated or inadequate response • Duloxetine (Cymbalta) – use other antidepressants • Duloxetine (Yentreve) – may be some use in acute treatment of urinary incontinence • Escitalopram (Cipralex) – use citalopram • Glicazide (*modified release - Diamicron) – use standard release formulation • Levocetirizine (Xyzal) – use cetirizine or other antihistamine unless not tolerated or inadequate response • Malaria prophylaxis – provide using private prescription • Sumatriptan as Imigran-RADIS – use off patent formulation • Tramadol + paracetemol (Tramacet) – use established analgesics - there may be occasions where this is used in specialist pain treatment46 Drugs – primary Inhaled insulin (Oxfordshire) (PE) E Various care Primary care prescribing for subfertility should be restricted to Clomiphene, Tamoxifen and Metformin only (Current (other sources) Essex policy) DENTAL47 Dental implants Implants offer the possibility of a stable prosthesis for individuals who have suffered extensive loss of oral tissue. i Suffolk LPP (T) They can also be used to provide support for fixed bridges and individual crowns. policy The technique currently used was developed by Professor Brånemark in the late 1970s and relies on the principle of osseointegration. This means that the material (titanium) of the implant is not merely tolerated by the tissues but becomes integrated within the jaw bone giving the implant firm stability. The prosthesis is then attached to the implant. With earlier blade type implants results were unpredictable with the possibility of the implant loosening within a few years of placement. Osseointegrated implants, however, have a much higher success rate. With the increasing popularity of Professor Brånemark’s technique an increasing demand for implants is inevitable and it is important, therefore, to prioritise the categories of individuals for whom implant treatment is appropriate. The vast majority of the population can tolerate wearing dentures and these remain a successful and well-established method of replacing missing teeth. CRITERIA The categories of patient for whom implants should be considered are those where there is no practical alternative. The categories are: - • Patients with maxillofacial and cranial defects. These individuals have considerable amounts of missing hard tissue and/or teeth, may be due to developmental disorders, trauma or tumours. These include: Clefts of the hard and/or soft palate, Major maxillary/mandibular resections, Extensive alveolar ridge deformities • Patients with multiple congenitally missing teeth where conventional prostheses have proved to be ineffective
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? • Patients who have suffered major trauma that cannot be restored by conventional prostheses • Patients with edentulous jaw(s) who: have gross atrophy of their jaw(s) with unacceptable stability or pain following the utilisation of appropriate specialist techniques in the constructions of the prosthesis or have problems in retaining a conventional prosthesis due to atypical movements, such as dyskinesias and Parkinson’s Disease. Only in the most exceptional circumstances will implants be available for patients with problem dentures or who require single tooth replacement.48 Orthodontics Patients should be referred for orthodontic care for the following categories of need: S Suffolk LPP (T) policy Grade 5 Index of Orthodontic Treatment Need 5a Increased overjet greater than 9mm 5h Extensive hypodontia with restorative implications (more than one tooth missing in any quadrant) requiring pre-restorative orthodontics. 5i Impeded eruption of teeth (with the exception of third molars due to crowding, misplacement, the presence of supernumerary teeth, retained deciduous teeth and any pathological cause). 5m Reverse overjet greater than 3.5mm with reported masticatory and speech difficulties. 5p Defects of cleft lip and palate 5s Submerged deciduous teeth.49 Wisdom teeth Surgical removal of impacted third molars should be limited to patients with evidence of pathology: w Suffolk LPP removal • unrestorable caries, policy (T) • non-treatable pulpal and/or periapical pathology, • cellulitis, abcess and osteomyelitis, • internal/external resorption of the tooth or adjacent teeth, • fracture of tooth, • disease of follicle including cyst/tumour, • tooth/teeth impeding surgery or reconstructive jaw surgery, • when a tooth is involved in or within the field of tumour resection. EYES50 Filtered/coloured These will not be offered for specific reading difficulties Suffolk LPP lenses policy (PE)51 Photodynamic Photodynamic therapy (PDT) should only be used in accordance with NICE guidance (TA68). Suffolk LPP therapy (PDT) for policy age related PDT should only be considered for the treatment of wet age-related macular degeneration for individuals who have a macular confirmed diagnosis of classic with no occult subfoveal choroidal neovascularisation (CNV) (that is, whose lesions degeneration are composed of classic CNV with no evidence of an occult component) and best-corrected visual acuity 6/60 or (T) better. PDT should be carried out only by retinal specialists with expertise in the use of this technology. PDT is not recommended for the treatment of people with predominantly classic subfoveal CNV (that is, 50% or
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? more of the entire area of the lesion is classic CNV but some occult CNV is present) associated with wet age-related macular degeneration, except as part of ongoing or new clinical studies that are designed to generate robust and relevant outcome data, including data on optimum treatment regimens, long-term outcomes, quality of life and costs.52 Cataract surgery First eye Based North East (T) Surgery will not be offered for patients with visual acuity of 6/12 or better without any other significant ophthalmic on Essex pathology unless they drive or have problems with work or are unsafe because of glare clinical policy consens combined Second eye us with Suffolk As benefits of second eye surgery have been demonstrated patients will be offered this procedure provided they full LPP fill the referral criteria. The only exception to the above is when there is resultant anisometropia (a large refractive difference between the two eyes), which would result in poor binocular vision or even diplopia. The following scoring system should be used to determine referral. Assessment of visual and social difficulties: Visual acuity Less than 6/36 3 Less than 6/18 in both eyes 3 Less than 6/18 in poorer eye 2 Less than 6/12 in either eye 1 6/9 or better but with significant visual disturbance 1 All patients scoring 3 points in this section should be referred for the worst eye Visual disability Affected by glare 2 Difficulty with reading 1 Difficulty watching television 1 Difficulty performing work or hobbies 1 Social functioning (Tick ONE box only) Lives independently 2 Cares for partner 2
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? Lives in sheltered accommodation 1 Lives with carer 1 Lives in a residential or nursing home 1 Other Drives a car/is in paid employment 1 Mild/moderate hearing impairment 1 Severe hearing impairment (Deaf) 2 Has fallen twice or more in the last 12 months 2 Total points scored: Patients with a VA score of 3 or a cumulative score of 6 or more should be referred. Please Note: Patients with retinal pathology should be referred to a general ophthalmology clinic.53 Laser treatment of Not routinely funded N/A Norfolk myopia (PE) UROLOGICAL/GENITAL54 Circumcision Circumcision should only be performed for the following indications: t Suffolk LPP (T) 1. Redundant prepuce, phimosis (inability to retract the foreskin due to a narrow prepucial ring) and paraphimosis policy (inability to pull forward a retracted foreskin). 2. Balanitis Xerotica Obliterans (chronic inflammation leading to a rigid fibrous foreskin). 3. Balanoposthis (recurrent bacterial infection of the prepuce). There are several alternatives to treating retraction difficulties before circumcision is carried out. It is important that all those performing circumcision should follow the General Medical Council (GMC) guidelines.55 Prostatism Investigations will not be carried out unless the patient has one of the following: Requeste Suffolk LPP (T) • An international prostate symptom score of 8 or more d policy • Dysuria • Post voided residual volume of >200mls • More than one UTI • Deranged renal function • PSA greater than age adjusted normal values56 Vasectomies under This policy is for circumstances when vasectomy should be performed under general anaesthetic. In all other cases, Requeste Suffolk LPP general anaesthetic referral should be made to local GP based services. d policy (T) Only under the following circumstances should a vasectomy be performed under local anaesthetic. In other cases a
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? referral should be made to a primary Care Provider • Previous documented adverse reaction to local anaesthesia • Scarring or deformity distorting the anatomy of the scrotal sac or content making identification and/or control of the spermatic cord through the skin difficult to achieve57 Dilletation & Patients will not receive D&C: p Suffolk LPP curettage policy • As a diagnostic tool for heavy menstrual bleeding, or Hysteroscopy (T) • As a therapeutic treatment for heavy menstrual bleeding Patients will receive hysteroscopy in the investigation and management of heavy menstrual bleeding only when it is carried out: • as an investigation for structural and histological abnormalities where ultrasound has been used as the first line diagnostic tool and where the outcomes are inconclusive • post-dilatation, pre-procedure when undertaking endometrial ablation.58 Hysterectomy Hysterectomy for heavy menstrual bleeding will only be funded when: a Cambs (T) • There has been a prior trial, after appropriate clinical assessment, with a levonorgestrel intrauterine system (Suffolk (Mirena®) (unless contraindicated) which has not successfully relieved symptoms. • and same) • Other treatments (such as non-steroidal anti-inflammatory agents, tranexamic acid, endometrial ablation, uterine-artery embolisation in selected cases) have failed, are not appropriate or are contra-indicated in line with NICE guidelines. Contraindications to the levonorgestrel intrauterine system are: 1. Severe anaemia, unresponsive to transfusion or other treatment, whilst a Levonorgestrel intrauterine system trial is in progress. 2. Distorted or small uterine cavity (with proven ultrasound measurements). 3. Genital malignancy. 4. Active trophoblastic disease. 5. Pelvic inflammatory disease. 6. Established or marked immunosuppression. For those who for ethical reasons cannot accept the use of Mirena, they should have tried at least two of the alternative treatments (above). OTHER59 Intensive inpatient Intensive inpatient therapy will not be provided Thames therapy for severe There is limited evidence to support the use of manual lymphatic drainage and compression bandaging. Intensive, Valley
Procedure and Criteria which may be considered suitable for funding Evidence Origin of type of restriction briefing policy /rationale available ? primary short term therapy using decongestive lymphatic therapy may be beneficial when combined with long term self Priorities lymphoedema management. These treatments are suitable for local outpatient provision. Committee (PE) s60 Complementary Complementary and alternative therapies are a mixed group of therapies considered low priority treatments on the a Cambridge and alternative basis of weak evidence of clinical effectiveness. They will only be provided under the NHS as part of an existing therapies service where: (T) • The individual therapy used for a specific condition has been critically appraised. • The training and practice of the therapist is regulated by a statutory regulatory body. Complementary and alternative therapies will only be provided outside the NHS in exceptional circumstances. Complementary and alternative therapies comprise a wide range of disciplines. We have adapted the classification recently used by the House of Lords Select Committee, which divides these therapies into three groups: Group 1 - those which are regarded as the principle disciplines: 1a - with statutory regulatory control - osteopathy, chiropractic 1b - acupuncture, herbal medicine and homeopathy. Group 2 - therapies used to complement conventional medicine without embracing diagnostic skills, eg massage, aromatherapy, hypnotherapy, reflexology and the Alexander Technique. Group 3a - therapies which are long established and rational in certain cultures (eg Ayurvedic medicine) 3b - others with no credible evidence such as crystal therapy and dowsing. While some evidence of effectiveness exists for therapies in Group 1, the clinical effectiveness of the majority of these therapies has not been proved with strong evidence as obtained through properly established scientific trials. Some NHS professionals use a selection of these therapies in their practice, eg physiotherapists using manipulation or acupuncture, or GPs using homeopathy. With effective regulatory mechanisms in place for individual professionals and under NHS clinical governance arrangements use of such therapies is acceptable.61 Botox for The use of Botox for the treatment of hyperhidrosis looks clinically promising (Botulinum toxin for hyperhidrosis Will be Proposed hyperhidrosis Bandolier Extra. 2002). However, Botox is only licensed for the treatment of severe axillary hyperhisdrosis and there produced new policy (PE) is little evidence on which to judge it’s cost effectiveness in relation to other treatment options. Until evidence is available which demonstrates to the PCT that Botox is cost effective in relation to other treatment options it will not be routinely provided for hyperhydrosis other than axillary hyperhydrosis within the standard management of this condition.