NICE Guidance TAG 16 (review) - WhatDoTheyKnow Web viewThe word “exception ... are enlarged...

NHS Black Country Cluster

Procedures of Limited Clinical Priority Guideline

& Commissioning Policy

February 2012

NHS Black Country Cluster comprises NHS Dudley, Sandwell PCT, NHS Walsall and Wolverhampton City PCT

1

Policy Developed by: Jane Hayman (Walsall)Neeraj Malhotra (Wolverhampton)Nighat Hussain (Dudley)Dr Simon Mitchell (Sandwell)Dr Steve Mann (Dudley)Wendy Godwin (Walsall)Dr Nick Hall (Wolverhampton)Dr Alexis Macherianakis (Sandwell)Shirley Weston-Hayles (Sandwell)

Policy Reviewed by: Dr Sumit Agrawal (Wolverhampton)Dr Andrew Booshan (Wolverhampton)Dr Shadia Abdalla (Walsall)Dr R Kumar (Walsall)Dr Julian Parkes (Wolverhampton)Denise Bell (Dudley)

Individual Consulted: Sandwell PCT:Primary Care Contracting ManagersStephen Phillips - Senior Contracting ManagerSylvia Woodhall - IFR & Contracts Support ManagerNick Griggs – Medical DirectorCCG Business ManagersAssistant Director of Medicines ManagementAnna Hunt - Consultant in Dental Public HealthMembers of commissioning Policies Development Group

Walsall PCT:Primary Care Contract ManagersDavid Pitches – Public Health ConsultantNicky Bourne – Head of Corporate Affairs

Peter RockettLocal Optical Committee

Organisations consulted: Dudley Group Foundation Trust:

Richard Beeken - Director of OperationsPaul Harrison - Medical DirectorRichard Price - Deputy Director of FinancePolicy was also consulted to respective Clinical Colleagues and Senior Managers DGFT

Royal Wolverhampton Hospitals Trust:Helen Read, Trauma and Orthopaedics DirectorateMr Ramanathan, Consultant Ophthalmologist,

2

Other Clinicians consulted viaDavid Butterworth - Head of commissioning & Contracting andIan Badger - Clinical Director

Sandwell & West Birmingham Hospital Trust:

Mathew DoddDonal O'Donoghue – Medical DirectorRachel BarlowSpeciality Clinicians

Walsall Healthcare Trust:

Mr Amir Khan – Medical DirectorNicky Lloyd – Deputy Director of FinanceSukjit Kooner – Head of Costing and IncomePolicy was also consulted to respective Clinical Colleagues and Senior Managers

Document Status: Draft version 3.0Changes since version 2.0:Tidying up, reformatting, page numbersCarpal tunnel amendmentJoint injections amendmentRemoval of reference to an appendix that didn’t exist

Issue Date/Publication date February 2012

Review Date: March 2013

Distribution: All acute providers across the Black CountryAll Black Country Clinical Commissioning Groups

Committee Ratifying Policy andDate of approval

CCG Boards and NHS Black Country Cluster Clinical Senate

3

Specific guidelines included: Page

1. Adenoidectomy 82. Insertion of Grommets 103. Routine Ear Irrigation 114. Surgery for Snoring 125. Tonsillectomy 13

6. Carpal Tunnel Syndrome 147. Dupuytren’s Disease 158. Ganglion 179. Trigger Finger 1810. Autologous Cartilage Transplantation 2011. Arthroscopy for Knee Osteoarthritis 2112. Hip and Knee Replacement Surgery 2313. Hip Resurfacing Techniques (Primary Resurfacing Arthroscopy of Joint) 2514. Spinal Fusion for Chronic Low Back Pain 2615. Joint Injections 27

16. Cholecystectomy for Gallstones 2817. Circumcision 3018. Surgical Haemorrhoidectomy 3119. Varicose Veins 32

20. Removal of Anal Skin Tags 33

21. Hysterectomy for Heavy Menstrual Bleeding 3422. Hysteroscopy for Menorrhagia 3523. Reversal of Male Sterilisation 3624. Reversal of Female Sterilisation 3725. Routine Doppler Ultrasound of Umbilical and Uterine Artery in

Antenatal Care 38

26. Radiofrequency and Electrothermal Ablation for Chronic Back Pain 3927. Spinal / Epidural Injections Non Specific Back Pain 40

28. Spinal Cord Stimulation for Chronic Back Pain 4129. Facet Joint Injections 42

30. Cataract Surgery 4331. Laser Surgery for Short-Sightedness (Myopia) 45

32. Apicectomy 4633. Dental Implants 4834. Wisdom Teeth Removal 49

35. Botulinum Toxin Type A for Hyperhidrosis 5036. Botulinum Toxin Type A for Spasticity 5337. Complementary Medicines Therapies 5638. Extracorporeal Shockwave Therapy for Refractory Plantar Fasciitis 58

4

39. Extracorporeal Shockwave Therapy for Refractory Achilles Tendinopathy 5940. Hyperbaric Oxygen Therapy 6041. Inpatient Cognitive Behavioural Therapy Residential Placements for Chronic

Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME) 61

Introduction

This policy describes the exclusions and access criteria in respect of procedures of limited clinical priority and its application in accordance to both the clinical and administrative adherence protocols detailed in this policy.

This policy does not apply to cosmetic treatments and procedures which are covered by a separate policy (please refer to Aesthetic Procedures Guidelines and Commissioning Policy). It incorporates the evidence relating to clinical and cost-effectiveness.

Definitions

Exceptional clinical circumstances refers to a patient who has clinical circumstances which, taken as a whole, are outside the range of clinical circumstances presented by a patient within the normal population of patients with the same medical condition and at the same stage of progression as the patient.

There can be no exhaustive definition of the conditions which may potentially fall within the definition of an exceptional case. The word “exception” means “a person, thing or case to which the general rule is not applicable”. The following criteria, however, are indicative of the presence or absence of exceptionality in the present context:

To be an exception, there must be unusual or unique clinical factors about the patient that suggest that he or she is:

I. Significantly different from the wider group of patients with the same condition; or

II. Likely to gain significantly more benefit from the intervention than might be expected from the average patient with the same condition.

The fact that a treatment is likely to be effective for a patient is not, in itself, a sufficient basis for establishing an exception.

If a patient’s clinical condition matches the ‘accepted indications’ for a treatment, but the treatment is not funded, then the patient’s circumstances are not, by definition, exceptional.

It is for the requesting clinician (or patient) to make the case for exceptional circumstances.

Social value judgments are rarely relevant to the consideration of exceptional status.

An Individual Funding Request (IFR) is a request received from a provider or a patient with explicit support from a clinician, which seeks funding for a single identified patient for a specific treatment.

5

Background

Since the Primary Care Trusts and emerging Clinical Commissioning Groups within the Black Country NHS Cluster operate within finite budgetary constraints the policy makes explicit the need for the NHS Black Country Cluster to prioritise resources and provide interventions with the greatest proven health gain. The intention is to ensure equity and fairness in respect of access to NHS funding for interventions and to ensure that interventions are provided within the context of the needs of the overall population and the evidence of clinical and cost effectiveness.

To do this the policy provides:

The list of interventions ‘not normally funded’ by the four PCTs comprising of the Black Country Cluster

The specified criteria required for the funding of certain other interventions

Please note that the policy guidance relating to these interventions should be read with reference to the principles detailed below, which includes the West Midlands Strategic Commissioning Group’s definition of exceptionality (see section on definitions).

Commissioners, General Practitioners, Service Providers and Clinical Staff treating residents of the Black Country Cluster are expected to implement this policy. When interventions are undertaken on the basis of meeting criteria specified within the policy, this should be clearly documented within the clinical notes. Failure to do so will be considered by the Black Country NHS Cluster as lack of compliance.

The PCTs and CCGs explicitly recognise that for each of the interventions listed in this policy there may be exceptional clinical circumstances in which to fund these interventions. Whilst it is not feasible to consider every possible scenario within this document, they will be considered on a case by case basis to enable due consideration of the individual merits of each case. Thus, funding for ‘interventions not normally funded’ and for interventions where specified criteria are not met will be considered by each individual PCT/CCG following application to the respective IFR Patient Panel.

This policy will be kept under regular review, to ensure that it reflects developments in the evidence base regarding clinical and cost effectiveness.

ImplementationPatients with problems/conditions that require treatments included in this policy should only be referred to a Consultant/Specialist after a clinical assessment is made by the GP and there is a symptomatic or functional requirement for surgery.

GPs wishing to seek a specialist opinion for patients who meet this policy criterion should ensure that when making a referral to secondary care, the basic clinical information is included in the referral letter that assures that the patient has been assessed in line with this policy.

Consultants in secondary care and provider finance departments need to be aware that the PCTs comprising the NHS Black Country Cluster will not pay for the procedures listed in this policy unless the patient meets the criteria outlined in this policy.

6

This is not a blanket ban. The PCT recognises there will be exceptional, individual or clinical circumstances when funding for treatments designated as low priority will be appropriate.

Individual treatment requests should only occur in exceptional circumstances where the patient does not meet the core criteria. In this instance the completion of an Exceptional Treatment Request is required.

Exceptional Treatment request cases where referral on the NHS is being requested should ONLY be sent to the respective NHS.net accounts or Safe Haven fax:

NHS DudleyExceptional Treatment Request ManagerSt John’s HouseUnion StreetDudleyDY2 8PPTel: 01384 321757Secure Fax: 01384 [email protected]

Sandwell PCTContracts Support ManagerKingston House438 High StreetWest BromwichWest MidlandsB70 9LDTel: 0121 612 1408Secure Fax: 0121 612 [email protected]

NHS WalsallCorporate Affairs AdministratorJubilee HouseBloxwich LaneWS2 7JLTel: 01922 618339Secure Fax: 01922 [email protected]

Wolverhampton City PCTIndividual Funding Requests Commissioning ManagerConiston HouseChapel AshWolverhamptonWV3 0XETel: 01902 444858Secure Fax: 01902 [email protected]

7

mailto:[email protected]

Monitoring

It is envisaged that this policy will be subject to continued monitoring using a mix of the following approaches:

Prior approval process

Post activity monitoring through routine data

Post activity monitoring through case note audits

Dudley Clinical Commissioning Group is aiming to agree that the following procedures are subject to prior approval via the ETR team for a period of time during the 2012/13 contract period to ensure robust activity baselines are set.

The following procedures will need to have prior approval before being treated, this will apply to all patients for whom a decision to admit is made from the 1st of April 2012:

Joint Injection - Orthopaedic Injections only (excluding hips) Facet Joint Injections Cholecystectomy for Gallstones Varicose Veins Tonsillectomy Botulinum Toxin Type A for Hyperhidrosis Laser Surgery for Short Sight (Myopia)

Please note all other procedures should also only be referred if the patient meets the respective criteria outlined in this policy. Dudley CCG reserve the right to introduce prior approval for additional procedures within 2012/13.

Intervention 1. Adenoidectomy

8

Policy Unless the following criteria are met, adenoidectomy is not normally funded

Adenoidectomy will only be funded if undertaken in conjunction with Tonsillectomy and/or Grommets.

Rationale An adenoidectomy is an operation to remove the adenoids. It is usually done if the adenoids become so enlarged that children cannot breathe through their noses properly, or if they are thought to be causing health problems such as ‘glue ear’. Removal of the adenoids is often combined with tonsillectomy and/or grommet insertion

Minimum Eligibility Criteria

Unless the following criteria are met adenoidectomy is not normally funded:

Adenoidectomy will be funded in line with the policy above for the following conditions:

• Nasal obstruction (enlarged adenoids)• Recurrent otitis media with effusion (OME)• Chronic rhinosinusitis• Obstructive sleep apnoea (OSA)• Chronic sinusitis.

All referrals should be through an agreed pathway to optimise access to conservative treatment and advice. Regular audit of the indications for the surgical procedures carried out should be undertaken. 3

Evidence for inclusion and threshold

Cochrane Database of Systematic Reviews. Tonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis (Review):

Van Staaij et al. Adeno-tonsillectomy for upper respiratory infections: evidence based? Arch Dis Child 2005; 90:19–25.

Cochrane Database of Systematic Reviews. Adeno-tonsillectomy for obstructive sleep apnoea in children.

Gerber ME, O'Connor DM, Adler E, Myer CM. Selected risk factors in Pediatric adenotonsillectomy. Archives of Otolaryngology - Head & Neck Surgery 1996;122:811-4.

Loughlin GM, Brouilette RT, Brooke LJ, et al. Standards and indications for cardiopulmonary sleep studies in children. American Journal of Respiratory and Critical Care Medicine 1996;153:866-78.

Brouillete RT, Fernbach SK, Hunt CE. Obstructive sleep apnoea in infants and children. Journal of Pediatrics 1982;100(1):31-40

Ryan, C.F (2005). Sleep 9: An approach to treatment of obstructive sleep apnoea/hypopnoea syndrome including upper airway surgery. Thorax (60);595-604.

Lim, J and McKean, M (2001). Adenotonsillectomy for obstructive sleep apnoea in children. Cochrane Database of Systematic Reviews Issue 3.

BMJ Clinical Evidence: Otitis media with effusion (available online athttp://www.clinicalevidence.com/ceweb/conditions/ent/0502/0502.pdf

9

http://www.clinicalevidence.com/ceweb/conditions/ent/0502/0502.pdf

Cochrane Database of Systematic Reviews. Grommets (ventilation tubes) for hearing loss associated with OME in children. http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001801/pdf.fs.html

Oomen. K et al (2005). Effect of adenotonsillectomy on middle ear status in children. Laryngoscope Apr;115(4):731-4.

http://www.nice.org.uk/nicemedia/live/12127/44968/44968.pdf

Interventional procedure guidance NICE 368 Suction Diathermy Adenoidectomy

Comparative policies

NHS organisations

NHS Essex

NHS Cambridgeshire and Peterborough

NHS Derby

10

http://www.nice.org.uk/nicemedia/live/12127/44968/44968.pdf

http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001801/pdf.fs.html

http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001801/pdf.fs.html

Intervention 2. Insertion of Grommets

Policy Unless one or more of the following criteria are met grommets are not normally funded for children with Otitis Media with Effusions (OME)

Rationale Grommets are small tubes that are put inside children's ears to help drain away sticky fluid that is trapped there and to aid their hearing. Evidence suggests that the benefit of grommets on children’s hearing gradually decreases in first year of insertion. Potentially adverse effects on the tympanic membrane (e.g. tympanosclerosis) are common after grommet insertion. The following criteria are based on the findings of a Cochrane review (2005) and NICE clinical guidelines (2008).


Unless one or more of the following criteria are met grommets are not normally funded for children with Otitis Media with Effusions (OME):

5 or more documented episodes of acute otitis media (in the same ear) in the previous 12 months OR

Persistent bilateral OME documented over a period of 3 months, with a hearing level in the better ear of 25–30 dBHL or worse averaged at 0.5, 1, 2 and 4 kHz (or equivalent dBA where dBHL not available) OR

Persistent bilateral OME with a hearing loss less than 25–30 dBHL in the better ear but where the impact of the hearing loss on a child’s developmental, social or educational status is judged to be significant


NICE Clinical Guideline 60 - Surgical Management Of OME

http://guidance.nice.org.uk/CG60

Position Paper ENT UK 2009 – OME (Glue Ear) / Adenoid and Grommet


NHS organisations

NHS Herefordshire Low Priority Treatment Policy

11


Intervention 3. Routine Ear Irrigation

Policy Routine ear irrigation will not be funded in a Secondary Care setting

Rationale Routine ear syringing is not a procedure normally carried out in a secondary care setting. Treatment should be delivered in primary care prior to referral to secondary care.


This will only be funded in exceptional circumstances


SIGN Guidance – Ear Care Best Practice Statement:

http://www.healthcareimprovementscotland.org/previous_resources/best_practice_statement/ear_care.aspx


NHS organisations


NHS South West Essex

12



Intervention 4. Surgery for Snoring

Policy Surgery for snoring is not normally funded unless supported by sleep study.

Rationale There is no evidence to support funding for surgery for snoring where sleep apnoea is not implicated.

This policy explicitly refers to isolated snoring. It is recognised that some patients may have snoring in conjunction with obstructive sleep apnoea (OSA) – if such patients are considered eligible for surgery this will be funded only when it is required for treatment of their OSA.


Surgery for snoring will only be considered for OSA when supported by a sleep study.


Jones TM et al. Acoustic analysis of snoring before and after palatal surgery. ERJ June1, 2005 vol. 25 no. 6 1044-1049.

Franklin KA et al. Effects and side-effects of surgery for snoring and obstructive sleep apnoea--a systematic review. Sleep, 2009 Jan 1;32(1):27-36.

Brouillete RT, Fernbach SK, Hunt CE. Obstructive sleep apnoea in infants and children. Journal of Pediatrics 1982;100(1):31-40

Ryan, C.F (2005). Sleep 9: An approach to treatment of obstructive sleep apnoea/hypopnoea syndrome including upper airway surgery. Thorax (60);595-604.


NHS organisations


13

Intervention 5. Tonsillectomy

Policy Unless the following criteria are met tonsillectomy for recurrent sore throats is not normally funded.

Rationale These criteria are in line with SIGN 2010 guidance. It should be noted that there is no high quality evidence in adults for the effectiveness of tonsillectomy as a treatment for recurrent sore throats, and benefits may be outweighed by the morbidity associated with surgery in children who are not severely affected.


Unless the following criteria are met tonsillectomy for recurrent sore throats is not normally funded:

In both children and adults with recurrent acute sore throats:

7 or more well documented, clinically significant, adequately treated sore throats in the preceding year or 5 or more such episodes in each of the preceding two years or 3 or more such episodes in each of the preceding three years AND

Sore throats are due to acute tonsillitis AND The episodes of sore throat are disabling and prevent normal functioning

(e.g. such as school attendance or work)

Other funded indications include:

Peri-tonsillar abcess with a history of recurrent tonsillitis OR Tonsillar enlargement in children sufficient to cause airway obstruction Confirmed by overnight pulseoximetry interpreted by an appropriately

qualified / experienced clinician OR Suspected or proven malignancy

When in doubt as to whether a tonsillectomy would be beneficial, a six month period of watchful waiting is recommended.


SIGN 2010 Guidance - Management of sore throat and indications for tonsillectomy. SIGN Publication Number 34. Last modified Jan 2001

Position Paper ENT UK 2009 – Indications for Tonsillectomy


NHS organisations


NHS Brighton and Hove

14

Intervention 6. Carpal Tunnel Syndrome

Policy Unless one or more of the minimum criteria are met, surgical treatment will not normally be funded.

Rationale Many cases of carpal tunnel syndrome will resolve spontaneously and can be managed conservatively with physiotherapy, wrist splints, NSAIDS and steroid injections. There are recognised criteria whether surgical release may be beneficial.


Unless one or more of the minimum criteria are met, surgical treatment will not normally be funded;

Acute severe symptoms uncontrolled by conservative treatmentOR

Chronic mild to moderate symptoms that have not responded to 4 months of conservative management (Injection and splints)

OR

Neurological deficit i.e. sensory blunting or weaknessAND

Supported by Nerve Conductions studies


Sholten R et al (2009) ‘Surgical Treatment options for Carpal Tunnel Syndrome ‘ 2009 Cochrane Neuromuscular Disease Group Cochrane Library

Verdugal R et al (2008) ‘ Surgical versus Non Surgical Treatment for Carpal Tunnel Syndrome’ 2008 Cochrane Neuromuscular Disease Group Cochrane Library


NHS organisations

NHS Herefordshire

15

Intervention 7. Dupuytren’s Disease

Policy Unless one or more of the minimum criteria are met, surgical treatment will not normally be funded.

Rationale Dupuytren’s contracture is a benign, slowly progressive condition of unknown origin. The disease is characterised by a thickening of the connective tissue in the palm of the hand, leading to difficulties in extending the fingers.

Most individuals with Dupuytren’s contracture are affected in both hands. The most commonly involved digit is the ring finger, followed by the little finger and then the middle finger.

Treatment seeks to restore hand function and prevent progression, because the underlying disease will remain. Both surgical and nonsurgical options exist. Data are lacking on the effectiveness of most non-surgical treatments for Dupuytren’s contracture, such as vitamin E cream and ultrasonic therapy.


British Society for Surgery of the Hand recommendations for TreatmentMild

MildDescription: No functional problems No contracture. Mild metacarpo-phalangeal joint contracture only (<30 degrees)Intervention: Reassure. Observe

ModerateDescription: Notable functional problems or moderate metacarpo-phalangeal joint

contracture (30 - 60 degrees ). Moderate proximal inter-phalangeal joint contracture (<30 degrees). First web contracture]Intervention: Needle fasciotomy if appropriately trained; for MCPJ contracture Possibly collagenase Refer for surgery – limited fasciectomy

SevereDescription:Severe contracture of both metacarpo-phalangeal (>60 degrees) joint and proximal inter-phalangeal joint (>30 degrees).Intervention: Refer for surgery limited fasciectomy dermofasciectomy

16


NICE Guidance on Needle Fasciotomy for Dupuytren’s Contracture Interventional Procedure Guidance 43 Feb 2004

http://guidance.nice.org.uk/IPG43


NHS organisations

NHS Herefordshire

17

http://guidance.nice.org.uk/IPG43

Intervention 8. Ganglion

Policy Unless one or more of the minimum criteria are met, surgical removal of ganglion will not normally be funded.

Rationale Ganglia are benign fluid filled, firm and rubbery texture lumps. They occur most commonly around the wrist but also around fingers, ankles and the top of the foot. They are usually painless and completely harmless. Many resolve spontaneously especially in children (up to 80%).

Reassurance should be the first therapeutic intervention. Aspiration alone can be successful but recurrence rates are up to 70%. Surgical excision is the most invasive therapy but recurrence rates of up to 40% have been reports. Complications of surgical excision include scar sensitivity, joint stiffness and distal numbness.


Unless one or more of the minimum criteria are met, surgical removal of ganglion will not normally be funded;

Ganglia at the wrist–symptomatic (painful) or neurovascular compromisedOR

Ganglia arising in the base of the digitis –(symptomatic and/or painful)OR

Mucoid cysts arising in the DIP joint disturbing nail growth or have a tendency to discharge


Vroon P et al (2009) ‘Interventions for Ganglion Cysts in Adults’ Protocol Cochrane Neuromuscular Disease Group Cochrane Library


NHS organisations

NHS Herefordshire

18

Intervention 9. Trigger Finger

Policy Surgical treatment will only be funded in accordance with the criteria specified below.

Surgical treatment will only be considered if:

Patient has failed to respond to conservative measures (e.g. up to 2 steroids injections);

OR Patient has fixed deformity that cannot be corrected (severe–fixed

contracture or failed non operative treatment)Rationale Trigger finger is a "snapping" condition of any of the digits of the hand when

opened or closed. Trigger finger is medically termed stenosing tenosynovitis.Management should be in accordance with British Society for Surgery of the Hand (BSSH) recommendations;

Mild (“pre-triggering”)

• History of pain or of catching or “click”• Tender A1 pulley; but fully mobile finger

Moderate

• Triggering with:• A - Difficulty actively extending finger• B - Need for passive finger extension

Loss of complete active flexion

Severe

• Fixed contracture

Treatment recommendations:

Mild

• Analgesia

Moderate

• Steroid injection to flexor sheath

Severe

• Surgical trigger release


Surgical treatment will only be funded in accordance with the criteria specified below.

19

Surgical treatment will only be considered if:

• Patient has failed to respond to conservative measures (e.g. up to 2 steroid injections); or

• Patient has fixed deformity that cannot be corrected (severe–fixed contracture or failed non operative treatment)


BSSH (2011) BSSH Evidence for Surgical Treatment (BEST): Trigger Finger (Thumb) [Online] Available from:

http://www.bssh.ac.uk/education/guidelines/trigger.pdf

[Retrieved 25

January 2011]


NHS organisations

NHS Herefordshire

NHS Warwickshire

20

http://www.bssh.ac.uk/education/guidelines/trigger.pdf

Intervention 10. Autologous Cartilage Transplant

Policy Autologous Cartilage Transplant will not normally be funded except as part of a randomised controlled trial.

Rationale NICE guidance states that autologous chondrocyte implantation (ACI) is not recommended for the treatment of articular cartilage defects of the knee joint, except in the context of ongoing or new clinical studies that are designed to generate robust and relevant outcome data, including the measurement of health-related quality of life and long-term follow-up. Patients should be fully informed of the uncertainties about the long-term effectiveness and the potential adverse effects of this procedure.

Minimum eligibility criteria

Only considered as part of a randomised controlled trial or in exceptional circumstances.


NICE Guidance TAG 16 (review) - Cartilage injury - autologous chondrocyte implantation:

http://www.nice.org.uk/page.aspx?o=72659

National Public Health Service. Autologous chondrocyte implantation for the ankle joints. Cardiff: NPHS; 2006.

Comparative policiesNHS organisations


NHS County Durham and Darlington

21

http://www.nice.org.uk/page.aspx?o=72659

Intervention 11. Arthroscopy for Knee Osteoarthritis

Policy Arthroscopy referral for arthroscopic lavage and debridement should not be offered as part of treatment for osteoarthritis and will only be funded in accordance with the criteria specified below:

• The person has knee osteoarthritis with a clear history of mechanical locking (not gelling), ‘giving way’ or x-ray evidence of loose bodies.

Rationale Osteoarthritis is the most common disease of the joints, and one of the most widespread of all chronic diseases. Frequently described as ‘wear and tear’, its prevalence increases steadily with age and by retirement age the associated radiological changes can be observed in over half the population. Symptoms can vary from minimal to severe pain and stiffness, but overall the disease is responsible for considerable morbidity and is a common reason for GP consultation. Unfortunately, it is also difficult to treat and inevitably a wide range of potential therapies have been advocated, both by conventional and complementary practitioners, and not necessarily with strong supporting evidence.

The exact incidence and prevalence of osteoarthritis is difficult to determine because the clinical syndrome of osteoarthritis (joint pain and stiffness) does not always correspond with the structural changes of osteoarthritis (usually defined as abnormal changes in the appearance of joints on radiographs). This area is becoming more complex with sensitive imaging techniques such as magnetic resonance imaging, which demonstrate more frequent structural abnormalities than detected by radiographs. Magnetic resonance imaging (MRI) is of great aid in the diagnosis of knee lesions. Most diagnostic studies comparing MRI and arthroscopy have shown good diagnostic performance in detecting lesions of the menisci and cruciate ligaments.


Arthroscopy referral for arthroscopic lavage and debridement should not be offered as part of treatment for osteoarthritis and will only be funded in accordance with the criteria specified below.

• The person has knee osteoarthritis with a clear history of mechanical locking (not gelling), ‘giving way’ or x-ray evidence of loose bodies.

Arthroscopy solely for diagnosis of knee conditions should only be undertaken in patients that an MRI scan is contraindicated.

22


Ruth Crawford, Gayle Walley, Stephen Bridgman, and Nicola Maffulli (2007) Magnetic resonance imaging versus arthroscopy in the diagnosis of knee pathology, concentrating on meniscal lesions and ACL tears: a systematic review British Medical Bulletin 2007; 84: 5–23 DOI:10.1093/bmb/ldm022

NICE CG 59 2008

The National Collaborating Centre for Chronic Conditions

Funded to produce guidelines for the NHS by NICE 2008 ‘Osteoarthritis National clinical guideline for care

and management in adults’ Published by the Royal College of Physicians 2008


NHS organisations

NHS Herefordshire

Intervention 12. Hip and Knee Replacement Surgery

23

Policy Unless all of the following criteria are met, primary hip and knee replacement surgery will not be normally funded.

Rationale As per NICE guidance, prosthesis should only be used if the evidence shows they require revision at a rate of less than 1 in 10 (10%) in 10 years.

For patients with a BMI of 40 and above, documented participation in a comprehensive weight management programme of at least 6 months duration is required prior to surgery.


• The patient has a BMI below 40 supported by a primary care referral.

AND

• Conservative means (e.g. Analgesics, NSAIDS, physiotherapy, advice on walking aids, home adaptations , curtailment of inappropriate activities and general counselling as regards to the potential benefits of joint replacement) have failed to alleviate the patients pain and disability

AND

• Pain and disability should be sufficiently significant to interfere with the patients’ daily life and or ability to sleep/patients whose pain is so severe

AND

• Underlying medical conditions should have been investigated and the patient’s condition optimised before referral

AND

• Patient must accept and want surgery

Or

• Mobility is so compromised that they are in immediate danger of losing their independence and that joint replacement would relieve this threat

Or

• Patients in whom the destruction of their joint is of such severity that delaying surgical correction would increase technical difficulty of the procedure.

Evidence for NICE Guidance TAG 2 - Hip disease - replacement prostheses

24

inclusion and threshold

http://guidance.nice.org.uk/TA2

Dawson J et all 1996 ‘QUESTIONNAIRE ON THE PERCEPTIONS OF PATIENTS

ABOUT TOTAL HIP REPLACEMENT’

From the University of Oxford and the Nuffield Orthopaedic Centre, Oxford, England ©1996 British Editorial Society of Bone and Joint Surgery VOL. 78-B, NO. 2, MARCH 1996


NHS organisations

NHS Herefordshire

NHS Suffolk

NHS Derby City and NHS Derbyshire County

25

http://guidance.nice.org.uk/TA2

Intervention 13. Hip Resurfacing Techniques (Primary Resurfacing Arthroplasty of Joint)

Policy Except in the following patients MoM hip resurfacing techniques are not normally funded;

Rationale Metal on metal (MoM) hip resurfacing arthroplasty involves removal of the diseased or damaged surfaces of the head of the femur and the acetabulum. The femoral head is fitted with a metal surface and the acetabulum is lined with a metal cup to form a pair of metal bearings.

There is sufficient evidence to conclude that hip resurfacing is clinically and cost effective but the studies have been undertaken in people aged 65 years. NICE guidance recommends their use in those likely to outlive the conventional THR ( i.e. young and active) but advises surgeons’ to discuss the lack of long term evidence on safety and reliability with patients.


Except in the following patients MoM hip resurfacing techniques are not normally funded;

• Who qualify for primary total hip replacementAND

• Who are likely to outlive conventional primary hip replacements

As per NICE guidance , prosthesis should only be used if the evidence shows they require revision at a rate of less the 1 in 10 (10%) in 10 years.


NICE Guidance April 2000 ‘Guidance on the selection of prosthesis for Primary total hip replacement’


NHS organisations

NHS Herefordshire

26

Intervention 14. Spinal Fusion for Chronic Low Back Pain

Policy Unless all of the following criteria are met Spinal Fusion for Chronic Low Back Pain will not normally be funded.

Rationale There is a body of evidence demonstrating that spinal fusion is no more clinically effective or cost-effective than a multi-disciplinary rehabilitation programme (physiotherapy, exercise and psychological input) for chronic (>1 year) degenerative back pain.


Unless the following criteria are met spinal fusion will not normally be funded for chronic degenerative low back pain:

The patient has been assessed by a clinician trained in the diagnosis and management of chronic low back pain AND

The low back pain has lasted more than one year and is documented as significantly interfering with daily life (e.g. loss of function > 50% on EuroQol or BPI tool) AND

All conservative management functions, undertaken as part of a comprehensive pain management programme, have failed (physiotherapy guided exercise, maximal analgesia and muscle relaxants, psychological therapy)


NICE Clinical Guideline 88 - Low Back Pain



NHS Suffolk

27

Intervention 15. Joint Injections

Policy Wherever possible joint injections should be provided within a Primary Care setting.

Joint injections in adults should not be done in a sterile theatre unless general anaesthetic or an image intensifier is required. They will normally be funded as an outpatient procedure. (This policy statement relates only to adults (i.e. aged 19 and over), as it is recognised that children often require joint injections under general anaesthesia.)

Comparative policiesNHS organisation


28

Intervention 16. Cholecystectomy for Gallstones

Policy PCTs within the Black Country Cluster will not fund cholecystectomy for asymptomatic gallstones unless one of the criteria below is met.

Rationale

Asymptomatic gallstones are defined as the presence of gallstones detected incidentally in patients who do not have any abdominal symptoms.


PCTs within the Black Country Cluster will not fund cholecystectomy for asymptomatic gallstones unless one of the following criteria is met:

Acute symptomatic onset

OR

Patient has Diabetes Mellitus, is a transplant recipient or has Cirrhosis, and has been managed conservatively within Primary Care but subsequently develops symptoms which cause significant functional impairment.

OR

Where there is clear evidence from an ultrasound scan that the patient is at risk of Gallbladder Carcinoma.

OR

Confirmed episode of gall stone induced pancreatitis.

OR

Confirmed recurrent episodes of abdominal pain typical of biliary colic.

OR

Confirmed episode of obstructive jaundice in the presence of gallstones where the gallstones are thought to be the cause.

The definition of functional impairment is as follows;

Symptoms prevent the patient fulfilling vital work or educational responsibilities

Symptoms prevent the patient carrying out vital domestic or carer activities

Exception

Emergency care patients and patients with suspected cancer are excluded. No request for treatment in these circumstances is required but the provider will be

29

expected to demonstrate the clinical need as part of the payment verification process. This will be undertaken on the PCT’s behalf by Healthcare Commissioning Service (HCS).

The preferred procedure is laproscopically unless clinical indications suggest otherwise


Afdhal N. Approach to the patient with incidental gallstones. UpToDate July 2006. Available at: http://www.utdol.com/utd/content/topic

Meshikhes A. Asymptomatic Gallstones in the Laparoscopic Era. J.R. College of Surgery, Edinburg. December 2002 742-748. Available at www.rcsed.ac.uk/journal/vol47_6/47600004.html

Gurusamy KS, Samraj K. Cholecystectomy for patients with silent gallstones. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD006230. DOI: 10.1002/14651858.CD006230.pub2.

McAlister V, Davenport E, Renouf E. Cholecystectomy deferral in patients with endoscopic sphincterotomy. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD006233. DOI: 10.1002/14651858.CD006233.pub2.


NHS organisations

NHS South Gloucestershire

North Somerset

30

http://www.rcsed.ac.uk/journal/vol47_6/47600004.html

http://www.utdol.com/utd/content/topic

Intervention 17. Circumcision

Policy Unless one or more of the following criteria are met circumcision will not normally be funded.

N.B. Female genital circumcision is a separate issue. Any related activity would need to be in accordance with the Female Genital Mutilation Act 2003. The BMA’s views on this issue are published in British Medical Association. Female genital mutilation. Caring for patients and child protection. London: BMA, 2001. An additional education resource is available from the Royal College of Nursing.

Rationale Circumcision is a surgical procedure that involves partial or complete removal of the foreskin of the penis. It is an effective procedure and confers benefit for a range of medical indications. Sometimes it is requested on cultural, social and religious reasons. These non medical circumcisions do not confer any health gain but do carry measurable health risk.


Unless one or more of the following criteria are met circumcision will not normally be funded:

Phimosis in children with spraying, ballooning and/or recurrent infection OR Adult Phimosis or paraphimosis OR Recurrent (>3 documented episodes) of balantitis or balanoposthitis OR Balanitis xertotica obliterans OR Suspected malignancy OR Dermatological disorders unresponsive to treatment OR Congenital urological abnormalities when skin is required for grafting OR Interference with normal sexual activity in adult males


British Medical Association: http://www.bma.org.uk/ethics/consent_and_capacity/malecircumcision2006.jsp

General Medical Council


NHS organisations


Intervention 18. Surgical Haemorrhoidectomy

31

http://www.bma.org.uk/ethics/consent_and_capacity/malecircumcision2006.jsp

Policy Unless all the following criteria are met haemorrhoidectomy will not normally be funded.

Rationale Haemorrhoids, also known as piles, are enlarged and swollen blood vessels in or around the lower rectum and anus. They can occur at any age and affect both sexes. Conservative management consists of high fibre diet, exercise, weight loss and topical preparations, followed by non-surgical ablative/fixative interventions and rubber band ligation. Surgical haemorrhoidectomy can be used for third or fourth degree haemorrhoids.


Unless all the following criteria are met surgical haemorrhoidectomy will not normally be funded:

fourth degree haemorrhoids or recurrent third degree AND Persistent pain or bleeding AND Failed conservative treatment such as banding


http://www.cks.nhs.uk/haemorrhoids

NICE guidance for circular stapled haemorrhoidectomy

http://www.nice.org.uk/nicemedia/pdf/ip/IPG034aguidance.pdf


NHS organisations


32

http://www.nice.org.uk/nicemedia/pdf/ip/IPG034aguidance.pdf

http://www.cks.nhs.uk/haemorrhoids

Intervention 19. Varicose veins

Policy Unless one or more of the criteria below are met, interventional procedures for varicose veins will not normally be funded:


Varicose veins which have bled and are at risk of bleeding again OR

A history of varicose ulceration OR

Signs of prolonged venous hypertension (haemasiderin pigmentation, eczema,

induration [lipodermatosclerosis], or significant oedema associated with skin

changes) OR

Superficial thrombophlebitis in association with varicose veins OR

Significant symptoms attributable to chronic venous insufficiency which are having a significant impact on quality of life


http://www.rsm.ac.uk/academ/downloads/venous_referral_guidelines_jan11.pdf

The RSM guidelines have a grading system for chronic venous insufficiency (which includes varicose veins):

C0 No visible or palpable signs of venous diseaseC1 Telangiectasias or reticular veinsC2 Varicose veins; diameter >3mmC3 OedemaC4 Changes in skin and subcutaneous tissue: pigmentation, eczema, lipodermatosclerosis or atrophie blancheC5 Healed venous ulcerC6 Active venous ulcer

The guidelines recommend for uncomplicated C1 – C3 disease this should be managed in primary care with reassurance, advice on exercise, weight loss, elevation and the use of compression hosiery.


NHS organisations


33

http://www.rsm.ac.uk/academ/downloads/venous_referral_guidelines_jan11.pdf

Intervention 20. Removal of Anal Skin Tags

Policy Statement Surgery for anal skin tags will only be performed if there is an urgent clinical need.

Rationale Hypertrophied papillae, also called anal skin tags, fibro epithelial polyps are common; they arise due to oedema, inflammation, fibrosis. They can protrude into anal canal. They are benign. Their appearance is polypoid and they may resemble haemorrhoids. Microscopically they are projections of sub mucosa and overlying mucosa; squamous epithelium with central core of inflamed, oedematous, myxoid or fibrovascular stroma with thin walled vessels; 80% have large, multinucleated, CD34+ stellate cells, often with atypical nuclear features; frequent mast cells; no thick walled vessels, no organizing thrombi, no haemorrhage. Under the electron microscope they consist of fibroblastic and myofibroblastic stromal cells.

Urgent referral should take place in people with suspected malignancy.

For information on Haemorrhoidectomy, please refer to the Procedures of Limited Clinical Priority Policy. (Section 18)


Not routinely commissioned surgery for patients with anal skin tags where there is:

Haemorrhoids, pruritis or solely a cosmetic problem Referral for non-urgent assessment and treatment:

This policy supports referral where:

Where there are underlying pathologies such as inflammatory bowel disease

This policy supports the commissioning of surgery for patients with anal skin tags where this forms part of the treatment of an underlying pathology such as inflammatory bowel disease.


Kuehn HG,Gebbensleben O,Hilger Y,Rohde H Relationship between anal symptoms and anal findings. International Journal of Medical Sciences, 2009; 6: 1431-42

Bonheur JL,Braunstein J,Korelitz BI,Panagopoulos G Skin tags in inflammatory bowel disease: new observations and a clinical review. Inflammatory Bowel Diseases 2008; 14; 1236-9


34

Intervention 21. Hysterectomy for Heavy Menstrual Bleeding

Policy Hysterectomy for heavy menstrual bleeding will not be routinely funded except where it is in accordance with the criteria listed below.

Rationale NICE guidance (2007) states Hysterectomy should not be used as a first-line treatment solely for heavy menstrual bleeding.

A Cochrane systematic review concluded that levonorgestrel intrauterine system/Mirena coil improved the quality of life of women with menorrhagia as effectively as hysterectomy.


• There has been a prior trial with a levonorgestrel intrauterine system (e.g. Mirena®) (unless contraindicated) which has not successfully relieved symptoms

AND• Other treatments (such as non-steroidal anti-inflammatory agents,

tranexamic acid, endometrial ablation, uterine-artery embolisation) have failed, are not appropriate or are contra-indicated in line with NICE guidelines i.e.o There is a desire for amenorrhoeao The woman (who has been fully informed) requests it.o The woman no longer wishes to retain her uterus and fertility.

Contraindications to the levonorgestrel intrauterine system are:

• Severe anaemia, unresponsive to transfusion or other treatment, whilst a levonorgestrel intrauterine system trial is in progress

• Distorted or small uterine cavity (with proven ultrasound measurements)• Genital malignancy• Active trophoblastic disease• Pelvic inflammatory disease• Established or marked immunosuppression


NICE Clinical Guidance CG44 (January 2007)

http://guidance.nice.org.uk/CG44/NICEGuidance/pdf/English

Marjoribanks J, Lethaby A, Farquhar C. Surgery versus medical therapy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2006 (last assessed as up to date May 2010)


NHS organisations

South Staffs PCT

NHS Dudley

Walsall PCT

NHS Suffolk

NHS Herefordshire

35


Intervention 22. Hysteroscopy for Menorrhagia

Policy 1) Investigation of menorrhagia. Hysteroscopy will not normally be funded for the investigation of menorrhagia, unless there is structural abnormality or cancer is suspected

2) Management of menorrhagia. Hysteroscopy is not normally funded for the management of menorrhagia.

Rationale There are a number of studies and systematic reviews examining the investigation and management of menorrhagia. The following policy statements for the funding of hysteroscopy in this condition are based upon 2007 NICE guidance.


• Investigation of menorrhagia. Hysteroscopy will not normally be funded for the investigation of menorrhagia, unless there is structural abnormality or cancer is suspected unless patient is:

o Above the age of 40 after simple treatment failso After the age of 45, before treatment

• Management of menorrhagia. Hysteroscopy is not normally funded for the management of menorrhagia.

N.B. It is recognised that hysteroscopy may be required to confirm placement of devices for ablative procedures, but it is anticipated that this will not attract additional funding


NICE CG 44 – Heavy Menstrual Bleeding



NHS organisations


36


Intervention 23. Reversal of Male Sterilisation

Policy Reversal of male sterilisation will not normally be funded.

Rationale Reversal of male sterilisation is a surgical procedure that involves the reconstruction of the vas deferens. Sterilisation procedures are available on the NHS and couples seeking sterilisation should be fully advised and counselled that the procedure is intended to be permanent.


Male sterilisation is provided by the NHS as an irreversible procedure. This should be made clear to patients at referral and prior to treatment.

Reversal of NHS sterilisation is not commissioned except in exceptional circumstances.


Royal College of Obstetricians and Gynaecologists. Guideline summary - Male and Female Sterilisation, RCOG 1998.


NHS organisations


NHS Westminster

NHS Wirral

37

Intervention 24. Reversal of Female Sterilisation

Policy Reversal of female sterilisation will not normally be funded.

Rationale Reversal of sterilisation is a surgical procedure that involves the reconstruction of the fallopian tubes. One study of 85 women concluded that reversal of sterilisation is a safe and effective method of restoring fertility.

Sterilisation procedures are available on the NHS and couples seeking sterilisation should be fully advised and counselled (in accordance with RCOG guidelines) that the procedure is intended to be permanent.


Reversal of Female sterilisation will not be funded except in the most exceptional of circumstances and by agreement of the Individual Funding Panel.

Thus, reversal of female sterilisation is not commissioned except in exceptional circumstances.


RCOG - Male and Female Sterilisation, Evidence-based Clinical Guideline Number 4 (Jan 2004) http://www.rcog.org.uk/files/rcog-corp/uploaded-files/NEBSterilisationFull060607.pdf


NHS organisations


NHS Hull

38

http://www.rcog.org.uk/files/rcog-corp/uploaded-files/NEBSterilisationFull060607.pdf

http://www.rcog.org.uk/files/rcog-corp/uploaded-files/NEBSterilisationFull060607.pdf

Intervention 25. Routine Doppler Ultrasound Of Umbilical and Uterine Artery In Antenatal Care

Policy Routine doppler ultrasound of umbilical and uterine arteries will not normally be funded for low risk pregnancies.

Rationale Existing data does not provide conclusive evidence that the use of routine umbilical artery doppler ultrasound, or combination of umbilical and uterine artery doppler ultrasound in low-risk or unselected populations benefits either mother or baby. At present, doppler ultrasound examination should be reserved for use in high-risk pregnancies.


Routine doppler ultrasound of umbilical and uterine arteries will not normally be funded for low risk pregnancies.


NICE Guidance CG 62: Antenatal care: routine care for the healthy pregnant woman:



NHS organisations


39


Intervention 26. Radiofrequency and Electrothermal Ablation for Chronic Back Pain

Policy Unless all of the following criteria are met Radiofrequency and Electrothermal Ablation for Chronic Low Back Pain will not normally be funded.

Rationale These are minimally invasive procedures which can usually be done as a day-case or outpatient procedure. The major drawback is that nerves regenerate over time, so the pain relief achieved lasts for only a short duration (6–24 months) in most patients.


Pain originating in the cervical, thoracic, or lumbar spinal regions lasting more than 12 months:

Pain is documented as significantly interfering with daily life (e.g. loss of function > 50% on EuroQol or BPI tool), despite maximal conservative management (physiotherapy guided exercise, maximal analgesia and muscle relaxants, psychological treatment) AND

Symptoms are NOT consistent with identifiable pathology including disc herniation, spondylolisthesis, spinal stenosis AND

Absence of any neurologic deficit AND It is recommended by a dedicated pain management clinician AND It is part of a comprehensive/dedicated pain management programme

(they will not be funded as standalone treatments) AND Two diagnostic medial branch nerve blocks, provided under a standard protocol that alternates long- and short-acting anesthetic blocks, produce symptom relief physiologically consistent with medial nerve branch pathology.

Limitations For the purposes of this policy, a procedure consists of one or more

ablations during a single visit.

Procedures are limited to two per year.Evidence for inclusion and threshold




40

Intervention 27. Spinal / Epidural Injection non-specific lower back pain

Policy Policy area temporarily removed pending review

41

Intervention 28. Spinal Cord Stimulation for Chronic Back Pain

Policy Unless all of the following criteria are met, Spinal Cord stimulation for Chronic low back pain will not normally be funded.

Rationale Spinal cord stimulators stimulate the dorsal columns of the spinal cord with an implanted device, with the aim of modifying the perception of pain. They have been assessed by NICE as cost-effective in neuropathic pain, with more recent reviews identifying subgroups where they are cost-effective.


Adults with chronic pain of neuropathic origin that is either Failed Back Surgery Syndrome or Complex regional Pain Syndrome Type I AND

Ongoing chronic pain (measuring at least 50 mm on a 0–100 mm visual analogue scale) for at least 6 months despite a comprehensive pain management programe (physiotherapy guided exercise, maximal analgesia and muscle relaxants, psychological treatment) AND

Have been assessed by a multidisciplinary team experienced in chronic pain assessment and in management of people with spinal cord stimulation devices, including experience in the provision of ongoing monitoring and support of the person assessed AND

Have had a successful trial of stimulation as part of that assessment ANDWhen there are equally suitable spinal cord stimulation systems for a particular patient, the least expensive is used.





42

Intervention 29. Facet Joint Injections

Policy Unless all of the following criteria are met, Facet Joint Injections will not normally be funded.

Rationale Procedures such as facet joint injections and radiofrequency lesioning are performed regularly in specialist pain clinics. There is evidence that pain arising from the facet joints can be a cause of low back pain, but the role of specific therapeutic interventions remains unclear. Case studies provide some evidence for the effectiveness of facet joint injections and medial branch blocks, but randomised controlled trials give conflicting evidence. For these reasons Epidural and facet joint injections for non-specific should not be undertaken except under exceptional circumstances.


Unless all of the following criteria are met, Spinal / Epidural Injection will not normally be funded :

Pain lasting more than six weeks but less than 12 monthsAND Maximum oral and topical analgesia have failedAND A Clinician trained in back pain assessment, diagnosis and management has

assessed the patient and considers it would enable mobilisation and participation in rehabilitation

AND It is a dedicated physiotherapy based mobilisation programme i.e. the

intervention is intended to enable mobilisation and participation in rehabilitation (they will not be funded as stand-alone treatments)

No more than two injections sessions ( facet joint) will be funded


NICE Clinical Guideline 88 – Low Back Pain



43

Intervention 30. Cataract Surgery

Policy Unless one or more of the following criteria are met, a best corrected visual acuity of better than 6/12 in the affected eye will not normally be funded.

Rationale Since the level of visual acuity that an individual requires to function without altering their lifestyle varies, measurements of visual acuity do not necessarily reflect the degree of visual disability patients may experience as a result of cataracts. The criteria set out below attempt to explicitly take that into account.

The legal visual requirement for driving falls somewhere between 6/9 and 6/12 (strictly speaking it is based on the number plate test) and it is anticipated that the thresholds set out below will not render the majority of people unable to drive. This policy also recognises the increasing body of evidence that second eye surgery does benefit patients.


This applies to both first and second eyes, with a best corrected visual acuity of 6/12 or worse in the affected eye used as the threshold for cataract surgery.

Unless one or more of the following criteria are met, a best corrected visual acuity of better than 6/12 in the affected eye will not normally be funded:

Patients who are still working in an occupation in which good acuity is essential to their ability to continue to work (e.g. watchmaker) OR

Patients with posterior subcapsular cataracts and those with cortical cataracts who experience problems with glare and a reduction in acuity in daylight or bright conditions OR

Patients who need to drive at night who experience significant glare due to cataracts which affects driving OR

Difficulty with reading due to lens opacities OR Patients with visual field defects borderline for driving, in whom

cataract extraction would be expected to significantly improve the visual field OR

Significant optical imbalance (anisometropia or anisekonia) following cataract surgery on the first eye OR

Patients with glaucoma who require cataract surgery to control intra ocular pressure OR

Patient with diabetes who require clear views of their retina to look for retinopathy OR

Patients with wet macular degeneration or other retinal conditions who require clear views of their retina to monitor their disease or treatment (e.g. treatment with anti-VEGFs)

N.B. The reasons why the patient’s vision and lifestyle are adversely affected by cataract and the likely benefit from surgery, or other exceptional circumstances, must be clearly documented in the clinical

44

records. Where referrals are not of a quality, the Provider will reserve the right to return to the referring organisation for greater clarity.


(1) Busbee BG, Brown MM, Brown GC, Sharma S. Incremental cost-effectiveness of initial cataract surgery. Ophthalmology 109 (3): 606-612 MAR 2002(2) B. Busbee Cost-utility analysis of cataract surgery in the second eye. Ophthalmology, Volume 110, Issue 12, Pages 2310-2317(3) Tobacman JK, Lee P, Zimmerman B, Kolder H, Hilborne L, Assessment of appropriateness of cataract surgery at ten academic medical centers in 1990. Ophthalmology. 1996 Feb;103(2):207-15.(4) Choi YJ, Hong YJ, Kang H. Appropriateness ratings in cataract surgery. Yonsei Med J 2004;45:396-405(5) CSI= 0.1 (preoperatoin activities of daily Vision Scale) + Points for age + 1 (Macular Degeneration) + 2 (DM) – 1 (posterior subcapsular cataract)(6) Mangione CM, Oray EJ, Lawrence MG et al. Prediction of visual function after cataract surgery. A prospectively validated model. Arch Opthal. 1995;113:1305-1311.(7) Brogan C, Lawrence D, Pickard D, Benjamin L. Can the use of visual disability questionnaires in primary care help reduce inequalities in cataract surgery rates?–a long term cohort study. In press


NHS organisations


South West London Commissioning Initiative

45

Intervention 31. Laser Surgery for Short Sight (Myopia)

Policy Laser surgery for correction of short sight will not normally be funded.

Rationale Current evidence suggests that photorefractive (laser) surgery for the correction of refractive errors is safe and efficacious in appropriately selected patients. Refractive errors are usually corrected by wearing spectacles or contact lenses, and these treatments are currently not available on the NHS. Both have limitations and contact lens wear is associated with an increased risk of sight-threatening corneal infection. Surgical treatments have been developed to permanently improve refraction by re-shaping the cornea.


Laser surgery for correction of short sight will not normally be funded


NICE IPG 164 - Photorefractive (laser) surgery for the correction of refractive errors.


NHS organisations


NHS Kent & Medway List of Low Priority Procedures policy

Brighton and Hove City Teaching PCT

NHS North of Tyne

46

Intervention 32. Apicectomy

Policy Unless one or more of the following criteria are met Apicetomy will not normally be funded in secondary care:

Rationale Apicectomy is a surgical procedure involving the removal of infected tip of a tooth’s root and a small amount of surrounding bone and tissue. It is a second-line treatment used after the failure of, or occasionally as a supplement to, orthograde endodontics (root filling).

Success depends on a range of factors including position of the tooth in the mouth, the shape of the tooth and number and size of roots, the method of anaesthesia used (local anaesthesia should be used in preference to general anaesthesia) and whether a tooth has had a previous apicectomy - success is highest on first attempt.

The success rate of apical surgery on molar teeth is low and should not be routinely undertaken. Apicectomy should not routinely be performed under general anaesthesia. The Faculty of Dental Surgery Criteria has identified a number of conditions in which apicectomy is indicated:

Referral for apicetomy should not be considered if there is no conventional root canal treatment present and this should be done first (even if a crown is present). Molar teeth should not be referred.


Unless one or more of the following criteria are met Apicetomy will not normally be funded in secondary care.

Presence of periradicular disease, with or without symptoms in a root filled tooth, where non-surgical root canal re-treatment cannot be undertaken or has failed, or where conventional re-treatment may be detrimental to the retention of the tooth OR

Presence of periradicular disease in a tooth where iatrogenic or developmental anomalies prevent non-surgical root canal treatment being undertaken OR

Where a biopsy of periradicular tissue is required OR Where visualisation of the periradicular tissues and tooth root is required

when perforation, root crack or fracture is suspected OR Where procedures are required that require either tooth sectioning or root

amputation ORWhere it may not be expedient to undertake prolonged non-surgical root canal re-treatment because of patient considerations.


British Association Oral and Maxillofacial Surgeons. Referral guidelines. Apical surgery. Available at: http://www.baoms.org.uk/CDROM/guidelines/Apical%20surgery.pdf. 2007.

47

http://www.baoms.org.uk/CDROM/guidelines/Apical%20surgery.pdf

http://www.baoms.org.uk/CDROM/guidelines/Apical%20surgery.pdf

Royal College of Surgeons of England. Guidelines for surgical endodontics. RCS 2001. Available at:

http://www.rcseng.ac.uk/fds/clinical_guidelines/documents/surg_end_guideline .pdf


NHS organisations


NHS North East

48

http://www.rcseng.ac.uk/fds/clinical_guidelines/documents/surg_end_guideline.pdf

Intervention 33. Dental Implants

Policy Unless one or more of the following criteria are met dental implants will not normally be funded.

Rationale Dental implants have been shown to be a successful treatment for replacing missing teeth by providing support for fixed bridge prostheses, individual crown and overdentures. Evidence from randomised controlled trials shows increased ability to chew tough food, and increased patient satisfaction with implants in comparison to normal dentures.

Complications of implant surgery include swelling, pain, bleeding, possible infection, and partial numbness at implant site. Nerve disturbances that may be permanent and bone fracture can occur, as can rejection of the implant. However, severe complications are rare.


Unless one or more of the following criteria are met dental implants will not normally be funded:

As part of reconstructive treatment following surgery to the mouth and surrounding tissues for the treatment of malignant or other disease OR

As part of oral and facial reconstructive treatment following severe facial trauma involving two or more teeth OR

For rehabilitation of patients with congenital defects e.g. cleft palate, or multiple congenitally missing teeth (hypodontia or anodontia) OR

Prevention of severe alveolar bone loss following tooth loss


1. Royal College of Surgeons. Guidelines for selecting appropriate patients to receive treatment with dental implants: Priorities For the NHS. RCS 1997. Available at

http://www.rcseng.ac.uk/dental/fds/pdf/ncg97.pdf.

2. Awad MA, Locker D, Korner-Bitensky N et al. Measuring the effect of intra-oral implant rehabilitation on health related quality of life in a randomised controlled clinical trial. J Dent Res 2000; 79:1659.

3. McCord JF, Michelinakis G. Systematic review of the evidence supporting intra-oral maxillofacial prosthodontic care. European Journal of Prosthodontics and Restorative Dentistry. 2004;12:129-35.

4. Attard NJ, Zarb GA, Laporte A. Long-term treatment costs associated with implant-supported mandibular prostheses in edentulous patients. International Journal of Prosthodontics. 2005;18: 117-23.



NHS North East

49

http://www.rcseng.ac.uk/dental/fds/pdf/ncg97.pdf

Intervention 34. Wisdom Teeth Removal

Policy Unless one or more of the following criteria are met the removal of wisdom teeth will not normally be funded.

Rationale The routine removal of asymptomatic wisdom teeth is not recommended (NICE Guidance on the removal of wisdom teeth; 2000), and it should be noted that plaque formation is a risk factor but is not in itself an indication for surgery.


Unless one or more of the following criteria are met the removal of wisdom teeth will not normally be funded:

Pathology such as unrestorable caries, non-treatable pulpal and/or periapical pathology, cellulitis, abscess 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 OR

When a tooth is involved in or within the field of tumour resection OR Second or subsequent episodes of pericoronitis.


NICE TA01 – Wisdom Teeth Removal


NHS organisations


50

Intervention 35. Botulinum Toxin Type A for Hyperhidrosis

Policy Botulinum Toxin Type A will not be funded for the following treatments;

Cosmetic reasons Treatment during pregnancy

BOTOX A is only licensed for axillary hyperhidrosis (in UK)

Rationale In humans, sweating is induced by heat or exercise and is part of thermoregulation. Sweat is a weak salt solution produced by the eccrine sweat glands. These are distributed over the entire body but they are most numerous on the palms and soles, with about 700 glands per square centimetre. Primary hyperhidrosis is defined as excessive, uncontrollable sweating without any discernible cause. Severely affected patients also develop skin maceration and secondary microbial infections, as a result of continual dampness.

Based on the literature review and costs it is recommended that at the primary care level GPs should assess disease severity (using the HDSS). If the score is 1-2 advice and topical treatments (aluminium chloride deodorants) should be given. If the score is 3-4 and topical treatment is unsuccessful referral to secondary care should be made where upon treatment differs according to site of hyperhidrosis:

For both palmar and plantar hyperhidrosis the first line of treatment in secondary care is iontophoresis.

BTA injection and sympathectomy are not recommended in plantar hyperhidrosis and the use of oral anticholinergics should be considered secondary to iontophoresis.

BTA injection is recommended as a first line treatment for Frey’s syndrome (100U or 50U/cm2) and can be used in conjunction with or instead of oral anticholinergic medication.

Evidence

Based on two large well-designed, double-blind, placebo-controlled study there is some evidence for the efficacy of BTA in axillary hyperhidrosis and less for gustatory and palmar sweating. Other indications (forehead sweating, plantar hyperhidrosis, truncal sweating) are only anecdotally reported.

There are currently no studies considering cost effectiveness.


Botulinum toxin type A will only be funded when medically necessary for intractable, disabling focal primary hyperhidrosis, when all of the following

51

criteria are met:

• Topical aluminium chloride or other extra-strength antiperspirants are ineffective or result in a severe rash;

AND

• Patient is unresponsive or unable to tolerate pharmacotherapy prescribed for excessive sweating (e.g., anticholinergics, beta-blockers) if sweating is episodic;

AND

• The patient has documented medical complications due to Hyperhidrosis, ie skin maceration with secondary skin infections

AND

• Significant disruption of professional and / or social life has occurred because of excessive sweating.

Pregnant women and nursing mothers should avoid treatment.

Please Note: funding will be approved on an ongoing basis however The Provider will avoid repeated injection with intervals less than four months.

Note: Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist, that warrant deviation from the rule of this policy.

Individual cases will be reviewed at the PCT Exceptional Funding Panel upon receipt of a completed application form from the Patient’s GP, Consultant or Clinician. Applications cannot be considered from patients personally.


NICE Clinical knowledge summary – Hyperhidrosis http://cks.nhs.uk/hyperhidrosis

Guidelines for the primary care treatment and referral of focal hyperhidrosis [Lowe et al, 2003]

Naumann, & Lowe,(2001) Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial BMJ 2001;323:596

Botulinum Toxin B and Treatment of Hyperhidrosis http://www.ihhs.net/English/HCP_Treatment_Botox_Botulinum_B.asp

52

http://www.ihhs.net/English/HCP_Treatment_Botox_Botulinum_B.asp

Http://www.evidence.nhs.uk/search ;botox

Clinical Knowledge Summaries –http://cks.nhs.uk/hyperhidrosis

The Cochrance Library- http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD006499/frame.html


NHS Herefordshire

North West London Cluster

53

http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD006499/frame.html


http://cks.nhs.uk/hyperhidrosis

http://www.evidence.nhs.uk/search

Intervention 36. Botulinum Toxin Type A - Spasticity

Policy Botulinum Toxin Type A will not be funded for the following treatments;

Cosmetic Reasons

Rationale Spasticity is a significant feature of an upper motor neurone syndrome, which occurs quite commonly in many neurological conditions like stroke, multiple sclerosis, brain injury, cerebral palsy etc. It can lead to disabling complications like contractures and pressures sores, which in turn places a huge burden on the patient, family, social services and the NHS. [£10,551 for one pressure sore]. Prompt and effective management of spasticity by a multi-modal, multi-agency approach co-ordinated by an interdisciplinary team can prevent these complications. It is estimated that approximately one-third of stroke patients (van Kuijk et al 2007; Watkins et al 2002), 60% of patients with severe multiple sclerosis (MS) and 75% of patients with physical disability following severe traumatic brain injury will develop spasticity requiring specific treatment. Of these, approximately one-third may require treatment with Botulinum Toxin injections. (Verplancke et al 2005).

BTA has been used for Management of spasticity since 1989 and its use is further recommended in the UK National Guidelines 2009.

Effective management of spasticity using Botulinum Toxin injections can lead to benefits-

1) at impairment level: reduce pain; prevent pressure sores and contractures; improved seating etc.

2) at activity level: improved mobility; increase in an ability to use limbs for function like feeding, dressing, grooming; reduce carer burden and

3) at participation level: improve self-esteem and self image; facilitate social interaction etc.

This should be supplemented by;

a) Use of other pharmacological agents: oral anti-spasticity agents like baclofen, tizanidine etc, phenol nerve blockade

b) Non-pharmacological interventions including effective management of noxious stimuli like constipation, bladder and skin issues

c) Post injection goal-oriented therapy input and

d) Liaising with and incorporating the support of allied agencies like Orthotics, Wheelchair services, Social Services etc.

The clinical benefit can persist for many months (particularly when accompanied by an appropriate physical management regimen) but wears off gradually. Repeat injections generally follow a similar course. Experience in other neurological

54

conditions has demonstrated that spasticity in adults may become biologically resistant to BTA as a result of antibody formation, especially with frequent, large dose injections (Greene and Fahn 1992, 1993; Hambleton and Moore1995).

This has led to the general advice to avoid repeated injection at less than three month intervals. Although secondary non-response is theoretically an issue for the use of BTA in spasticity, it is rarely reported in practice. This may be because spasticity is often self-limiting in the course of natural recovery, e.g. following stroke or brain injury, so that long-term repeated injections are required for only a minority of patients.


Botulinum Toxin Type A (BTA) will not be funded for the following treatments;

Cosmetic ReasonsBTA is contraindicated in patients who are hypersensitive to any botulinum toxin reparation or to any components in the formulation

Infection at the Injection Site(s)

BTA is contraindicated in the presence of infection at the proposed injection site(s)

SpasticityBotulinum Toxin Type A will be funded when medically necessary for Spasticity when the following criteria are met:

1. Spasticity due to a diagnosed neurological condition:a) Strokeb) Multiple Sclerosis [MS]c) Acquired Brain Injury- Traumatic and Non-Traumaticd) Acquired Spinal Injury: Traumatic and Non-traumatice) Motor Neurone Disease [MND]f) Parkinson’s diseaseg) Miscellaneous condition

2. Spasticity not responding to physical therapy and oral anti-spasticity agents

3. Focal spasticity and not generalised spasticity [ therefore not needing systemic oral agents]

4. To improve function in upper and lower limbs5. To facilitate therapy/ splinting/orthotics/positioning6. To facilitate carer input/ reduce carer burden7. To prevent severe complications which require expensive interventions

like pressure sores, contractures etc8. Reduce severe pain from spasticity in spite of optimal treatment with

different pharmacological agents, positioning etc

Please Note: funding will be approved on an ongoing basis however The Provider will avoid repeated injection with intervals less than three monthsNote: Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes

55

exceptional circumstances exist, that warrant deviation from the rule of this policy.

Individual cases will be reviewed at the PCT Exceptional Funding Panel upon receipt of a completed application form from the Patient’s GP, Consultant or Clinician. Applications cannot be considered from patients personally.


Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review): Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology Naumann et al. Neurology. 2008 May 6; 70(19):1707-14.

Http://www.evidence.nhs.uk/search ;botox

The Cochrane Library- http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD006499/frame.html

Royal College Physicians / BSRM National Guidelines for Management of Spasticity using Bot Toxin [2009]


Intervention 37. Complementary Medicines/Therapies

56


http://www.evidence.nhs.uk/search

Policy Complementary therapies listed below will not normally be funded

Rationale Complementary and alternative therapy covers a wide range of therapies some of which lack evidence of effectiveness and are not supported by PCT funding.

There is no national policy for the use of complementary and alternative therapies.

Complementary and alternative therapies listed below are not normally funded.

Active release technique. Acupressure, Aimspro, AMMA therapy, Antineoplastons, Antineoplaston therapy and sodium Phenylbutyrate; Apitherapy; Applied kinesiology; Art therapy; Auto urine therapy;Bioenergetic therapy; Biofield Cancell (Entelev) cancer therapy; Bioidentical hormones;Carbon dioxide therapy; Cellular therapy; Chelation therapy for Atherosclerosis; Chung Moo Doe therapy; Coley's toxin; Colonic irrigation; Conceptual mind-body techniques; Craniosacral therapy; Cupping; Dance/Movement therapy; Digital myography; Ear Candling; Egoscue method; Electrodiagnosis according to Voll (EAV); Equestrian therapy; Essential Metabolics Analysis (EMA); Essiac; Feldenkrais method of exercise therapy; Flower essence; Fresh cell therapy; Functional intracellular analysis; Gemstone therapy; Gerson therapy; Glyconutrients; Graston technique; Greek cancer cure; Guided imagery; Hair analysis; Hako-Med machine (electromedical horizontal therapy); Hellerwork; Homeopathy; Hoxsey method; Humor therapy; Hydrazine sulphate; Hypnosis; Hyperoxygen therapy; Immunoaugmentive therapy; Infratronic Qi-Gong machine; Insulin potentiation therapy; Inversion therapy; Iridology; Iscador; Kelley/Gonzales therapy; Laetrile; Live blood cell analysis; Macrobiotic diet; Magnet therapy; Meditation/transcendental meditation; Megavitamin therapy; Meridian therapy; Mesotherapy; Misletoe therapy; Moxibustion (except for fetal breech presentation) - see MTH-68 vaccine; Music therapy; Myotherapy Neural therapy; Ozone therapy; Pfrimmer deep muscle therapy; Polarity therapy; (Poon's) Chinese blood cleaning; Primal therapy; Psychodrama; Purging; Qigong longevity exercises; Ream's testing; Reflexology (zone therapy); Reflex Therapy; Reiki; Remedial massage; Revici's guided chemotherapy;Rolfing (structural integration); Rubenfeld synergy method (RSM); 714-X (for cancer); Sarapin injections; Shark cartilage products ;Therapeutic Eurythmy-movement therapy; Therapeutic touch; Thought field therapy (TFT) (Callahan Techniques Training); Trager approach; Visceral manipulation therapy; Whitcomb technique; Wurn technique/clear passage therapy; Yoga.


This policy does not preclude individual patients being referred to the Exceptional Treatment Approval Panel (ETAP) where the referrer feels that the therapy may be appropriate and where the referrer can demonstrate that the patient’s condition and presentation is significantly different from other

57

cohort of patients. Funding requests are not required where particular therapies are commissioned as part of a wider treatment provided within a package of care.


The House of Commons Science and Technology Committee enquiry into the provision of homeopathic services within the NHS in 2009 recommended that homeopathic treatments should not be routinely available within the NHS. The committee report included a robust review of the evidence base for a variety of homeopathic treatments but found no evidence of effectiveness for any condition from published RCTs and systematic reviews.

A previous report commissioned by the Association of Directors of Public Health in 2007 and more recent reviews by AETNA 3 are all consistent in confirming the lack of sufficient evidence of effectiveness of homeopathic treatments despite many years of research and hundreds of studies. There is some evidence of clinical benefit for some complementary therapies such as acupuncture, osteopathy, biofeedback and hypnotherapy for certain conditions.

1. Evidence Check 2: Homeopathy. House of Commons Science and Technology

Committee Report. 2009-10.

http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/45.pdf

2. Association of Public Health Report on the evidence for homeopathy (unpublished commissioned Report on the evidence for Homeopathy)

3. AETNA Clinical Policy Bulletin 0388. Complementary and Alternative Medicine. Last review date 05/04/2010. http://www.aetna.com/cpb/medical/data/300_399/0388.html


NHS organisations

NHS Dudley

NHS Herefordshire

North West London Cluster

Intervention 38. Extracorporeal Shockwave Therapy for Refractory Plantar Fasciitis

58

http://www.aetna.com/cpb/medical/data/300_399/0388.html

http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/45.pdf

Policy Extracorporeal shockwave therapy for refractory plantar fasciitis will not normally be funded

Rationale Plantar fasciitis is characterised by chronic degeneration of the plantar fascia, which causes pain on the underside of the heel. It is usually caused by injury or biomechanical abnormalities and may be associated with microtears, inflammation or fibrosis.

Conservative treatments include rest, application of ice, analgesic medication, non-steroidal anti-inflammatory drugs, orthotic devices, physiotherapy, eccentric training/stretching and corticosteroid injection.

Extracorporeal shockwave therapy (ESWT) is a non-invasive treatment in which a device is used to pass acoustic shockwaves through the skin to the affected area. Ultrasound guidance can be used to assist with positioning of the device. Extracorporeal shockwave therapy may be applied in one or several sessions. Local anaesthesia may be used because high-energy ESWT can be painful. Different energies can be used and there is evidence that local anaesthesia may influence the outcome of ESWT.

The evidence on extracorporeal shockwave therapy (ESWT) for refractory plantar fasciitis raises no major safety concerns; however, current evidence on its efficacy is inconsistent, therefore this procedure will not normally be funded.


Extracorporeal shockwave therapy for refractory plantar fasciitis will not normally be funded


NICE IPG 311- Extracorporeal shockwave therapy for

refractory plantar fasciitis


Intervention 39. Extracorporeal Shockwave Therapy for Refractory Achilles Tendinopathy

59

Policy Extracorporeal shockwave therapy for refractory Achilles tendinopathy will not normally be funded

Rationale Achilles tendinopathy is characterised by chronic degeneration of the Achilles tendon, and is usually caused by injury or overuse. Symptoms include pain, swelling, weakness and stiffness over the Achilles tendon and tenderness over the heel (insertional tendinopathy). Conservative treatments include rest, application of ice, non-steroidal anti-inflammatory drugs, orthotic devices, physiotherapy (including eccentric loading exercises) and corticosteroid injection. Surgery may be considered in some patients with refractory symptoms.

Extracorporeal shockwave therapy (ESWT) is a non-invasive treatment in which a device is used to pass acoustic shockwaves through the skin to the affected area. Ultrasound guidance can be used to assist with positioning of the device. Extracorporeal shockwave therapy may be applied in one or several sessions. Local anaesthesia may be used because high-energy ESWT can be painful. Different energies can be used and there is evidence that local anaesthesia may influence the outcome of ESWT.

The evidence on extracorporeal shockwave therapy (ESWT) for refractory Achilles tendinopathy raises no major safety concerns; however, current evidence on its efficacy is inconsistent, therefore this procedure will not normally be funded.


Extracorporeal shockwave therapy for refractory Achilles tendinopathy will not normally be funded


NICE IPG 312 - Extracorporeal shockwave therapy for refractory Achilles tendinopathy.

Comparative policies NHS organisations

NHS North West London

Intervention 40. Hyperbaric Oxygen Therapy

60

Policy Unless one or more of the criteria below are met Hyperbaric Oxygen Therapy will not normally be funded.

Rationale Despite the increasing use of Hyperbaric Oxygen Therapy (HBOT) in a range of conditions there is very little evidence from clinical trials regarding its clinical effectiveness or cost effectiveness. In line with findings from the review of HBOT by NHS Quality Improvement.

HBOT will be funded for conditions where there is a theoretical basis for its effectiveness, sufficient empirical evidence and clinical consensus.


Unless one or more of the criteria below are met Hyperbaric Oxygen Therapy will not normally be funded:

Emergency conditions

• Decompression illness – only for patients not covered by diver’s insurance arrangements

• Air and Gas Embolism• Acute Carbon monoxide poisoning

Other conditions

• Diabetic Lower Extremity Ulcers where all the conditions listed below are met:o Type I or II diabetes mellituso Wounds/Ulcers classified as Wagner grade III only.o History of failed standard wound therapy for at least 30 days for a

Wagner Grade 3 Wound/Ulcer i.e. failure of objective evidence of any improvement

o For HBOT to continue at 30 day intervals, re-evaluation must show continued progression to healing

Radiation-induced Proctitis

Evidence for inclusion and threshold The clinical and cost effectiveness of hyperbaric oxygen therap. HTA

programme: HTA systematic review 2 – May 2008. NHS Quality Improvement Scotland


NHS organisations


NHS North West London

Intervention 41. Inpatient Cognitive Behavioural Therapy (Residential Placements) for

61

Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME)

Policy Cognitive Behavioural Therapy Residential Placements will not normally be funded for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)

This policy excludes Fibromyalgia

Rationale Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) comprises a range of symptoms including fatigue, headache, sleep disturbance, difficulty in concentration and muscle pain. An individual’s symptoms may vary in severity and there is variation between patients. Although many patients improve over time, others do not. The cause of CFS/ME is unknown. Many different interventions for CFS/ME have been investigated in clinical trials of varying quality. There is increasing evidence from good quality trials to support CBT and/or GET in the management of CFS/ME. CBT with or without GET is more effective than standard medical care and does not appear to be more expensive. There is evidence for effectiveness in both adults and children.

There is currently insufficient evidence to support any other intervention in terms of clinical or cost effectiveness. This includes immunological treatments, anti-viral therapy, pharmacological treatments, dietary supplements, complementary or alternative medicine, multi-treatment regimes, buddy-mentor schemes, group therapy and ‘low sugar low yeast’ diets. There is currently no evidence relating to patients with severe CFS/ME (who are house or bed-bound)’. There is currently no evidence to support the use of in-patient or residential settings to deliver effective interventions for CFS/ME. There is currently no evidence to suggest that any group or sub-group of patients with CFS/ME will benefit particularly from any specific intervention or that patients who have failed to improve on one intervention may do better on another.

NOTES:

1. Exceptional circumstances may be considered where there is evidence of significant health impairment and there is also evidence of the intervention improving health status.


Cognitive Behavioural Therapy (Residential Placements) will not normally be funded for chronic fatigue syndrome.


The Treatment and Management of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis in Adults and Children. Feb 2007. CRD, University of York.

Chalder T et al. Inpatient treatment of CFS. Behavioural Cognitive Psychotherapy.1996;24:351-365

62

NICE clinical guideline 53 August 2007 Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management of CFS/ME in adults and children

Fukuda et al (1994) The Chronic Fatigue Syndrome: A Comprehensive Approach to Its Definition and Study Annuls of Internal Medicine December 15, 1994 vol. 121 no. 12 953-959

Map of Medicine April 2011 (Appendix 1)

Royal College of Paediatrics and Child Health (RCPCH). Evidence based guideline for the management of CFS/ME (Chronic Fatigue Syndrome/myalgic encephalopathy) in children and young people. London: RCPCH; 2004.


NHS organisations


NHS South Staffordshire

63

NICE Guidance TAG 16 (review) - WhatDoTheyKnow Web viewThe word “exception ... are enlarged...

Documents

Transcript of NICE Guidance TAG 16 (review) - WhatDoTheyKnow Web viewThe word “exception ... are enlarged...