GREATER MANCHESTER ASSOCIATION GOVERNING GROUP MEETING Date of Meeting 1 st April 2014 Issue under Consideration Brief Paragraph Summary Greater Manchester Effective Use of Resources (EUR) Policy Tonsillectomy Procedure This policy document outlines the arrangements for the funding of Tonsillectomy procedures for the population of Greater Manchester. It has been produced in order to provide and ensure equity, consistency and clarity in the commissioning of Tonsillectomy procedures by all Clinical Commissioning Groups in Greater Manchester. Adoption of this policy will alleviate the disparity currently faced by patients within Greater Manchester, (dependent on their registered GP/CCG) when requesting funding for a Tonsillectomy procedure. Adoption of Greater Manchester EUR policies will also ensure that all acute trusts within Greater Manchester are working to the same policy, which will also relieve any possible differences in accessing this treatment dependent on where the patient is referred. Impact of this policy across Greater Manchester Commissioning Recommendation - Tonsillectomy Procedures are commissioned where there is a history of: seven or more well documented, clinically significant, adequately treated sore throats in the preceding year; OR five of more such episodes in each of the preceding two years; OR three or more such episodes in each of the preceding three years; OR where there has been a second episode of quinsy; OR where there is a diagnosis of obstructive sleep apnoea for children 16 or under. Currently, there are 6 CCGs who use the above criteria and 6 CCGs who use less stringent criteria, i.e. 5 five episodes in the preceding year. Obstructive Sleep Apnoea is also included within 4 CCG policies and a second episode of Quinsy in 1 CCG policy. The introduction of this policy will impact on 6 CCGs, where a decrease in activity may be seen. There should be little or no impact on the remaining 6 CCGs. The additional criteria for some CCGs around Obstructive Sleep Apnoea and Quinsy is not thought to impact significantly as it is likely that Tonsillectomy procedures are performed currently on such patients. Further details of each individual CCG s current commissioning arrangements are outlined in the attached document, along with a summary of the activity and spend on tonsillectomy procedures during financial years 2011/12, 2012/13 and 2013/14 (April to December). Decision/Opinion Required The Greater Manchester Association Governing Group is asked to ratify this policy.
Item is for Information Author of Paper and contact details The item has been discussed previously at these meetings include the outcome Lynne Duxbury, Head of Effectiveness and Equitable Access. Telephone: 0161 212 6143, Mobile: 07795505688, Email: lynneduxbury@nhs.net This policy has been developed and approved by the Greater Manchester EUR Steering Group. The Greater Manchester EUR Steering Group is quorate when all 12 CCGs are represented. Decisions taken by the Steering Group are by consensus. Consultation on the policy has also taken place, with feedback being reviewed by the Greater Manchester EUR Steering Group prior to approval of the final attached policy. Notification of the policy consultation was disseminated to: Within Greater Manchester Clinical Commissioning Groups (GMCCG): CCG Chief Operating Officers; CCG Heads of Commissioning; CCG EUR Leads; CCG IFR Panel/Process Review Panel Members; Greater Manchester EUR Steering Group Members; Within the Greater Manchester Commissioning Support Unit (GMCSU): Executive Team; Medicines Management; Total Provider Management; Service Redesign; Patient Services; EUR team, including Clinical Triage GP members. Communication teams to be disseminated to patients/public through existing communication mechanisms. GPs and practice managers. Named contacts within each Greater Acute Trust to be disseminated to appropriate clinicians/managers within each organisation. This policy has been reviewed at Greater Manchester Heads of Commissioning (HOC) Meeting and Greater Manchester Chief Finance Officers (CFO) Meeting, both of which took place on the 11 th March 2014. Both groups recommended that the policy is ratified by the Greater Manchester Association Governing Group. Comments from the HOCs however, indicated that Tameside and Glossop CCG may wish to adopt alternative criteria, i.e. 5 or more well documented, clinically significant, adequately treated sore throats in the preceding year, as opposed to 7, which is the criteria specified within the Greater Manchester EUR policy.
Policy Statement Title/Topic: Tonsillectomy Date: February 2014 Reference: GM028
VERSION CONTROL Version Date Details Page number 0.1 09/09/2013 Initial draft N/A 0.2 19/09/2013 Inclusion of criteria following discussion at the GM EUR Steering Group meeting on 18/09/2013. 0.3 15/10/2013 Date of policy changed to October. Policy Summary moved to Introduction in line with template. Absence of Evidence Summary added. Mechanism for Funding paragraph reworded in line with template. Inclusion of Appendix 1 Evidence Review Formatted 0.4 29/10/2013 Section 4, Mandatory criteria changed and where there is a history of: inserted between 2 nd and 3 rd bullet point to make clear that patients must meet first 2 bullet points and either one of the following 3. 0.5 15/01/2014 Feedback from the consultation reviewed by the Steering Group. 25 people responded to the consultation. Following a review of the comments, the group agreed the following amendments: Obstructive Sleep Apnoea in children has been added to the criteria. The policy criteria has also been reformatted so that it is more explicit. Under Policy Exclusions For adults (> 16 years) has been added to the second paragraph. Addition of reference number 6: ENT UK / RCS Commissioning Guide: Tonsillectomy 2013, including additional reference in Search Strategy and section extract in Appendix 1. 7 1 5 8 9 11-13 N/A 3 & 7 7 8 10, 11 & 15 2
POLICY STATEMENT Title/Topic: Tonsillectomy Issue Date: To be confirmed Commissioning Recommendation: Tonsillectomy is commissioned for children and adults who meet the following criteria: AND AND Sore throats are due to acute tonsillitis and recorded as such in medical notes. The episodes of sore throat are disabling and prevent normal functioning. OR Where there is a history of: o Seven or more well documented, clinically significant, adequately treated sore throats in the preceding year OR o OR o OR o Five or more such episodes in each of the preceding two years Three or more such episodes in each of the preceding three years A second episode of Quinsy, irrespective of the timescale. Tonsillectomy is the treatment of choice where there is secondary care confirmation of a primary care assessment of Obstructive Sleep Apnoea in a child (< or = 16 years), either on the basis of history and examination or, if necessary, findings from further investigations (e.g. Sleep study). Date of Review: One year from the date of adoption and annually thereafter. Prepared By: The Greater Manchester Commissioning Support Unit Effective Use of Resources Policy Team. Approved By Greater Manchester Effective Use of Resources Steering Group Greater Manchester Association of Clinical Commissioning Groups Date Approved Variance 3
Bury Clinical Commissioning Group Bolton Clinical Commissioning Group Heywood, Middleton & Rochdale Clinical Commissioning Group Central Manchester Clinical Commissioning Group North Manchester Clinical Commissioning Group Oldham Clinical Commissioning Group Salford Clinical Commissioning Group South Manchester Clinical Commissioning Group Stockport Clinical Commissioning Group Tameside & Glossop Clinical Commissioning Group Trafford Clinical Commissioning Group Wigan Borough Clinical Commissioning Group 4
CONTENTS Policy Statement... 6 Equality & Equity Statement... 6 Governance Arrangements... 6 1. Introduction... 6 2. Definition... 6 3. Aims and Objectives... 7 4. Criteria for Commissioning... 7 5. Description of Epidemiology and Need... 8 6. Evidence Summary... 8 7. Absence of Evidence Summary... 8 8. Rationale behind the Policy Statement... 9 9. Mechanism for Funding... 9 10. Audit Requirements... 9 11. Documents which have informed this Policy... 9 12. Links to other Policies... 9 13. Date of Review... 9 14. Glossary... 9 References... 10 Appendix 1 Evidence Review... 11 5
Policy Statement The Greater Manchester Commissioning Support Unit (GMCSU) has developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester who will commission Tonsillectomy in accordance with the criteria outlined in this document. In creating this policy the GMCSU has reviewed this treatment and the clinical conditions for which it is prescribed. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester. Equality & Equity Statement The GMCSU/CCG has a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012. The GMCSU/CCG is committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex (gender) or sexual orientation. In carrying out its functions, the GMCSU/CCG will have due regard to the different needs of protected equality groups, in line with the Equality Act 2010. This document is compliant with the NHS Constitution and the Human Rights Act 1998. This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GMCSU policy team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. An Equality Analysis has been carried out on 1 st November 2013. For more information about the Equality Analysis, please contact policyfeedback.gmscu@nhs.net. Governance Arrangements Greater Manchester EUR policy statements will be ratified by the Greater Manchester Association Governing Group (AGG). Further details of the governance arrangements can be found in the Greater Manchester EUR Operational Policy. 1. Introduction This commissioning policy has been produced in order to provide and ensure equity, consistency and clarity in the commissioning of Tonsillectomy procedures by Clinical Commissioning Groups in Greater Manchester. When this policy is reviewed all available additional data on outcomes will be included in the review and the policy updated accordingly. 2. Definition Tonsillectomy is a surgical procedure during which the tonsils are removed from either side of the throat. Tonsillectomy is carried out for the management of recurrent tonsillitis in adults and children who meet the current policy criteria. Tonsillitis is an acute infection of the palatine tonsils. Episodes last for 5 to 14 days, during which the patient experiences some or all of the 6
following: o Fever o Malaise o Nausea o severe throat pain o white spots on the tonsils o enlarged lymph glands in the neck (and sometimes abdomen) The attacks are common in children and their frequency may reduce with age. 3. Aims and Objectives Aim This policy document aims to specify the conditions under which Tonsillectomy will be routinely commissioned by Clinical Commissioning Groups in Greater Manchester. Objectives To reduce the variation in access to Tonsillectomy. To ensure that Tonsillectomy is commissioned for conditions where there is acceptable evidence of clinical benefit and cost-effectiveness, and are not commissioned where there is evidence to the contrary. To reduce unacceptable variation in the commissioning of Tonsillectomy across Greater Manchester. To promote the cost-effective use of healthcare resources. 4. Criteria for Commissioning Mandatory Criteria Tonsillectomy is commissioned for children and adults who meet the following criteria: AND AND OR Sore throats are due to acute tonsillitis and recorded as such in medical notes. The episodes of sore throat are disabling and prevent normal functioning. Where there is a history of: o Seven or more well documented, clinically significant, adequately treated sore throats in the preceding year OR o Five or more such episodes in each of the preceding two years OR o Three or more such episodes in each of the preceding three years OR o A second episode of Quinsy, irrespective of the timescale. Tonsillectomy is the treatment of choice where there is secondary care confirmation of a primary care assessment of Obstructive Sleep Apnoea in a child (< or = 16 years) either on 7
the basis of history and examination or, if necessary, findings from further investigations (e.g. Sleep study). Policy Exclusions This policy does not apply to possible malignant disease of the tonsils which should be managed via the two week pathway. For adults (> 16 years), tonsillectomy for obstructive sleep apnoea will require consideration via the Individual Funding Request (IFR) exceptionality route until such time as a sleep apnoea policy is in place. Clinicians can submit an Individual Funding Request (IFR) if they feel there is a good case for exceptionality. Exceptionality means a person to which the general rule is not applicable. Greater Manchester sets out the following guidance in terms of determining exceptionality; however the over-riding question which the IFR process must answer is whether each patient applying for exceptional funding has demonstrated that his/her circumstances are exceptional. A patient may be able to demonstrate exceptionality by showing that s/he is: Significantly different to the general population of patients with the condition in question. and as a result of that difference They are likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition. 5. Description of Epidemiology and Need Source: BMJ Best Practice In UK general practice, recurrent sore throat has an annual incidence of 100 per 1000 population. In the US, sore throat accounts for 2.1% of ambulatory visits. Acute tonsillitis is more common in children between the ages of 5 and 15 years. The prevalence of bacterial tonsillitis, specifically group A beta-haemolytic streptococci (GABHS), is 15% to 30% of children with sore throat and 5% to 15% of adults with sore throat. Acute tonsillitis is most commonly seen in winter and early spring in temperate climates, although it may occur at any time of the year. 6. Evidence Summary An initial search was carried out of NHS evidence, NICE Guidance and SIGN; as well as BMJ Best Practice and BMJ clinical evidence and the Royal College of Surgeons databases. Full details of the Evidence Review are contained with Appendix 1. 7. Absence of Evidence Summary See Search Strategy Table in Appendix 1. 8
8. Rationale behind the Policy Statement There needs to be a period of watchful waiting in the management of sore throat before tonsillectomy is performed. The criteria that define that period for this policy are derived from SIGN 117 with local adaptation in relation to managing quinsy. The rationale for the period of watchful waiting is to find a balance between intervening too early, as episodes of recurrent tonsillitis will diminish over time, and avoiding unnecessary episodes of debilitating illness. There is evidence (Cochrane review of tonsillectomy or adeno-tonsillectomy versus non-surgical treatment for chronic/recurrent tonsillitis) that tonsillectomy does not always result in total prevention of recurrent sore throats although the numbers of attacks are reduced. The exceptionality route is available for those patients where the episodes are particularly frequent or debilitating and those where tonsillar enlargement is causing difficulties. Applications need to show that these patients will gain more benefit from earlier intervention than their peer group (all patients with recurrent tonsillitis). 9. Mechanism for Funding Funding will be monitored approval via the relevant contracting arrangements and referrals may be accepted in line with the criteria. Where a patient does not meet the above criteria, but their clinical circumstances are deemed to be exceptional, funding will be made available on an individual funding request (exceptional case) basis and funding approval should be sought from the Greater Manchester Commissioning Support Unit IFR Team. 10. Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request. 11. Documents which have informed this Policy Greater Manchester Effective Use of Resources Operational policy 12. Links to other Policies This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR). 13. Date of Review One year from the date of adoption and annually thereafter. 14. Glossary Term BMJ Exceptionality NICE Meaning British Medical Journal A person to which the general rule is not applicable (see policy exclusions sections above for a detailed definition). National Institute for Health and Care Excellence 9
Quinsy SIGN Tonsillectomy Tonsillitis Obstructive Sleep Apnoea An abscess that forms between the tonsils and the wall of the throat also known as a peritonsilar abscess. Scottish Intercollegiate Guidelines Network A surgical procedure during which the tonsils are removed from either side of the throat. An acute infection of the palatine tonsils. A condition that causes interrupted breathing during sleep. References 1. SIGN (Scottish Intercollegiate Guidelines Network): Management of sore throat and indications for tonsillectomy, A national clinical guideline (117) 2. BMJ Clinical Evidence: Tonsillectomy versus no surgery in adults Christos C Georgalas, Neil S Tolley, and Antony Narula Search date: March 2009 3. BMJ Clinical Evidence: Tonsillectomy versus no surgery in children Christos C Georgalas, Neil S Tolley, and Antony Narula Search date: March 2009 4. Cochrane Review of Tonsillectomy or adeno-tonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis (Cochrane Review) 5. North of England and Scotland Study of Tonsillectomy and Adeno-tonsillectomy in Children (NESSTAC): a pragmatic randomised controlled trial with a parallel nonrandomised preference study Health Technol Assess. 2010 Mar;14(13):1-164, iii-iv. doi: 10.3310/hta14130. Lock C, Wilson J, Steen N, Eccles M, Mason H, Carrie S, Clarke R, Kubba H, Raine C, Zarod A, Brittain K, Vanoli A, Bond J. Source: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. 6. ENT UK / RCS Commissioning Guide: Tonsillectomy 2013 10
Appendix 1 Evidence Review Title/Topic: Tonsillectomy Ref: GM028 Search Strategy Database NICE (includes NHS Evidence) Result None related to clinical guidelines but treatment related reviews include IPGs 9,150,178,186,196 and 328 and MTG 11 not cited here SIGN SIGN 117 Cochrane York Tonsillectomy or adeno-tonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis (Review) North of England and Scotland Study of Tonsillectomy and Adenotonsillectomy in Children (NESSTAC): a pragmatic randomised controlled trial with a parallel nonrandomised preference study BMJ Clinical Evidence Tonsillitis: Tonsillectomy versus no surgery in adults and Tonsillectomy versus no surgery in children Search date: March 2009 Christos C Georgalas, Neil S Tolley, and Antony Narula BMJ Best Practice General Search (Google) Medline Patient information from the BMJ Group Tonsillitis (information leaflet not cited below) NHS Choices Quinsy leaflet UHSM guidelines for tonsillectomy (Available on request not cited below) Due to the volume of high quality evidence reviews available the search was restricted to key papers related to the above reviews (not cited below as they support those cited) ENT UK / RCS Commissioning Guide: Tonsillectomy 2013 reference used following feedback from consultation and agreement to include Obstructive Sleep Apnoea in children (<16) as part of the policy. Summary of the evidence The key papers relevant to the commissioning of tonsillectomy were the SIGN guidance and the York review. SIGN 117 advocates a period of watchful waiting and suggests that the patient should have had either: 7 episodes of confirmed tonsillitis in the last year 5 episodes a year in the previous 2 years 3 episodes a year in the preceding 3 year period 11
These criteria are based the inclusion criteria for a single trial using best practice criteria from an experienced surgeon. Ref: Paradise JL, Bluestone CD, Bachman RZ. Efficacy of tonsillectomy for recurrent throat infection in severely affected children. Results of parallel randomized and nonrandomized clinical trials. N Engl J Med 1984;310(11):674-83. 74. Laing MR, McKerrow WS. Adult tonsillectomy. Clin Otolaryngol. SIGN classes the evidence for these criteria as level D (Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+). The benefits of surgery compared to non-surgical treatment was the subject of a Cochrane Collaboration review which provided additional evidence for the SIGN guidance. The consensus is that these criteria help to identify patients most likely to gain benefit from surgical intervention however the evidence level is low at 3/4 and clinical judgement is needed to identify patients where exceptionality applies. The UHSM guidelines and the NHS choices information suggest that tonsillectomy should take place after the second confirmed episode of Quinsy this reduces the risk of complications associated with surgery. Treatment for sleep apnoea was outside the scope of the current review however the Cochrane review of this topic does suggest that in some cases tonsillectomy can correct sleep apnoea in children where the tonsils are very enlarged. The evidence Levels of evidence Level 1 Level 2 Level 3 Level 4 Level 5 Meta-analyses, systematic reviews of randomised controlled trials Randomised controlled trials Case-control or cohort studies Non-analytic studies e.g. case reports, case series Expert opinion 1. Level N/A SIGN (Scottish Intercollegiate Guidelines Network): Management of sore throat and indications for tonsillectomy, A national clinical guideline (117) Extract from Section 2.3: Surgical Management Watchful waiting is more appropriate than tonsillectomy for children with mild sore throats. Tonsillectomy is recommended for recurrent severe sore throat in adults. The following are recommended as indications for consideration of tonsillectomy for recurrent acute sore throat in both children and adults: sore throats are due to acute tonsillitis the episodes of sore throat are disabling and prevent normal functioning seven or more well documented, clinically significant, adequately treated sore throats in the preceding year or 12
five or more such episodes in each of the preceding two years or three or more such episodes in each of the preceding three years. 2. Level 1: Review Tonsillectomy or adeno-tonsillectomy versus non-surgical treatment for chronic / recurrent acute tonsillitis (Cochrane Review) This review includes five studies: four undertaken in children (719 participants) and one in adults (70 participants). Good information about the effects of tonsillectomy is only available for children and for effects in the first year following surgery. Children were divided into two subgroups: those who are severely affected (based on specific criteria which are often referred to as the Paradise criteria ) and those less severely affected. For more severely affected children adeno-/tonsillectomy will avoid three unpredictable episodes of any type of sore throat, including one episode of moderate or severe sore throat in the next year. The cost of this is a predictable episode of pain in the immediate postoperative period. Less severely affected children may never have had another severe sore throat anyway and the chance of them so doing is modestly reduced by adeno-/tonsillectomy. For them, surgery will mean having an average of two rather than three unpredictable episodes of any type of sore throat. The cost of this reduction is one inevitable and predictable episode of postoperative pain. The average patient will have 17 rather than 22 sore throat days but some of these 17 days (between five and seven) will be in the immediate postoperative period. Whilst the concept of the average patient is attractive, in practice, wide variability is likely. One reason why the impact of surgery is so modest, is that many untreated patients get better spontaneously. There is a trade-off for the physician and patient who must weigh up a number of different uncertainties: what proportion of my throat symptoms are attributable to my tonsils, and will I get better without any treatment? Similarly, the potential benefit of surgery must be weighed against the risks of the procedure. Authors conclusions Adeno-/tonsillectomy is effective in reducing the number of episodes of sore throat and days with sore throats in children, the gain being more marked in those most severely affected. The size of the effect is modest, but there may be a benefit to knowing the precise timing of one episode of pain lasting several days - it occurs immediately after surgery as a direct consequence of it. It is clear that some children get better without any surgery, and that whilst removing the tonsils will always prevent tonsillitis, the impact of the procedure on sore throats due to pharyngitis is much less predictable. 3. Level 1: BMJ Clinical Evidence Reviews Tonsillectomy versus no surgery in adults Data from one good-quality RCT (albeit with limited follow-up) confirm consensus that tonsillectomy is an effective treatment for adults with severe recurrent sore throat, and that it should be offered to patients unless there are contraindications, despite the absence of strong evidence from RCTs. Tonsillectomy versus no surgery in children The effectiveness of tonsillectomy has to be judged against the potential harms. Tonsillectomy is more beneficial in children with severe symptoms, while in populations with a low incidence of tonsillitis, the modest benefit may be outweighed by the morbidity associated with the surgery. 13
Tonsillectomy is associated with intraoperative and postoperative morbidity, including haemorrhage, while antibiotics are associated with adverse effects, such as rash. The above is taken from three systematic reviews (search dates 1998, 2003, and 2008, respectively), which identified seven RCTs in total. 4. Level 2: Randomised Control Trial North of England and Scotland Study of Tonsillectomy and Adeno-tonsillectomy in Children (NESSTAC): a pragmatic randomised controlled trial with a parallel nonrandomised preference study Health Technol Assess. 2010 Mar;14(13):1-164, iii-iv. doi: 10.3310/hta14130. Lock C, Wilson J, Steen N, Eccles M, Mason H, Carrie S, Clarke R, Kubba H, Raine C, Zarod A, Brittain K, Vanoli A, Bond J. Source: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. Abstract: Objectives: To examine the clinical effectiveness and cost-effectiveness of tonsillectomy/adenotonsillectomy in children aged 4-15 years with recurrent sore throats in comparison with standard non-surgical management. Design: A pragmatic randomised controlled trial with economic analysis comparing surgical intervention with conventional medical treatment in children with recurrent sore throats (trial) and a parallel non-randomised cohort study (cohort study). Setting: Five secondary care otolaryngology departments located in the north of England or west of Scotland. Participants: 268 (trial: 131 allocated to surgical management; 137 allocated to medical management) and 461 (cohort study: 387 elected to have surgical management; 74 elected to have medical management) children aged between 4 and 15 years on their last birthday with recurrent sore throats. Participants were stratified by age (4-7 years, 8-11 years, 12-15 years). Interventions: Treatment was tonsillectomy and adeno-tonsillectomy with adenoid curettage and tonsillectomy by dissection or bipolar diathermy according to surgical preference within 12 weeks of randomisation. The control was non-surgical conventional medical treatment only. Main Outcome Measures: The primary clinical outcome was the reported number of episodes of sore throat in the 2 years after entry into the study. Secondary clinical outcomes included: the reported number of episodes of sore throat; number of sore throat-related GP consultations; reported number of symptom-free days; reported severity of sore throats; and surgical and anaesthetic morbidity. In addition to the measurement of these clinical outcomes, the impact of the treatment on costs and quality of life was assessed. Results: Of the 1546 children assessed for eligibility, 817 were excluded (531 not meeting inclusion criteria, 286 refused) and 729 enrolled to the trial (268) or cohort study (461). The mean (standard deviation) episode of sore throats per month was in year 1 - cohort medical 0.59 (0.44), cohort surgical 0.71 (0.50), trial medical 0.64 (0.49), trial surgical 0.50 (0.43); and in year 2 - cohort medical 0.38 (0.34), cohort surgical 0.19 (0.36), trial medical 0.33 (0.43), trial surgical 0.13 (0.21). During both years of follow-up, children randomised to surgical management were less likely to record episodes of sore throat than those randomised to medical management; the incidence rate ratios in years 1 and 2 were 0.70 [95% confidence interval (CI) 0.61 to 0.80] and 0.54 (95% CI 0.42 to 0.70) respectively. The incremental cost-effectiveness ratio was estimated as 261 pounds per sore throat avoided (95% confidence interval 161 pounds to 586 pounds). Parents were willing to 14
pay for the successful treatment of their child's recurrent sore throat (mean 8059 pounds). The estimated incremental cost per quality-adjusted life-year (QALY) ranged from 3129 pounds to 6904 pounds per QALY gained. Authors Conclusions: Children and parents exhibited strong preferences for the surgical management of recurrent sore throats. The health of all children with recurrent sore throat improves over time, but trial participants randomised to surgical management tended to experience better outcomes than those randomised to medical management. The limitations of the study due to poor response at follow-up support the continuing careful use of 'watchful waiting' and medical management in both primary and secondary care in line with current clinical guidelines until clearcut evidence of clinical effectiveness and cost-effectiveness is available. 5. Level N/A ENT UK / RCS Commissioning Guide: Tonsillectomy 2013 Relevant section extract: 1.2 High Value Care Pathway: Children (<16) with sleep disordered breathing Primary care assessment Referral Carefully assess (history and examination) a child with symptoms of significant snoring and disruptive breathing patterns whilst asleep. Make note of large tonsils with or without nasal obstruction. Carefully assess and document impact on development, behaviour and quality of life. If sleep disordered breathing is suspected, refer to secondary care. Secondary care Confirmation of primary care assessment, either on basis of history and examination or, if necessary, findings from further investigations (e.g. Sleep study) Consider impact on quality of life, behaviour and development. Consultation with parent/carers about management options using shared decision making strategies and tools where appropriate. Management options: tonsillectomy or adenotonsillectomy, or, if appropriate, referral to paediatrician or discharge back to primary care. Surgical setting Within a paediatric surgical facility. Children with severe symptoms will need access to paediatric intensive care facilities. 15
Greater Manchester Clinical Commissioning Groups - Current Commissioning Criteria for Tonsillectomy Procedure
Introduction Clinical Commissioning Groups (CCGs) across Greater Manchester have inherited Effective Use of Resources (EUR) policies from their predecessor Primary Care Trusts (PCTs). Consequently, there are varying positions regarding the commissioning of certain procedures/treatments across Greater Manchester. Work is now being undertaken by the Greater Manchester Commissioning Support Unit s (GMCSU) Policy Team, led by the Greater Manchester EUR Steering Group to align EUR policies across Greater Manchester. Purpose of the Report This report aims to inform the Greater Manchester EUR Steering Group of each CCG s current commissioning arrangements in place for Tonsillectomy Surgery. Body of the Report Tonsillectomy The table below describes each CCG s current policy on Tonsillectomy: Bolton Bury It is recommended that the guidelines issued by NICE on coblation tonsillectomy and tonsillectomies that involve diathermy are adopted. Adoption of the SIGN indications for tonsillectomy is also recommended: i) Patients should meet all the following criteria: Sore throats are due to tonsillitis Five or more documented episodes of sore throat per year Symptoms for at least a year Episodes of sore throat are disabling and demonstrably prevent normal functioning ii) Following specialist referral, a six month period of watchful waiting is recommended to establish the pattern of symptoms. There will also be evidence that the patient has had options and risks explained and has considered fully the implication of the operation iii) Once a decision is made for tonsillectomy, this should be performed as soon as possible to maximise the period of benefit. Tonsillectomy may be of modest benefit for children who experience severe recurrent bouts of tonsillitis, but this benefit may be outweighed by the risks associated with surgery. The risk-benefit ratio is less favourable for children who experience less severe tonsillitis All tonsillectomies will be subject to prior approval by the PCT. Providers will not be paid for tonsillectomies carried out in advance of formal approval having been obtained form the PCT. Requests for approval should include any evidence noted above. Watchful waiting is more appropriate than tonsillectomy for children with mild sore throats. All patients should have a six month period of watchful 2
waiting to establish the pattern of symptoms and allow the patient to consider fully the implications of the operation unless there is an indication for early referral. Patients meeting the following criteria can be considered for referral: Sore throats due to acute tonsillitis If the episodes of sore throat are disabling and prevent normal functioning and meet the following history criteria: Seven or more well documented, clinically significant, adequately treated episodes of sore throat in the last year, OR Five or more such episodes in each of the preceding two years, OR Three or more such episodes in each of the preceding three years. Indications for early referral Unilateral enlargement Obstructive sleep apnoea Exacerbates another condition Suspected malignancy Heywood, Middleton and Rochdale Watchful waiting is more appropriate than tonsillectomy for children with mild sore throats. All patients should have a six month period of watchful waiting to establish the pattern of symptoms and allow the patient to consider fully the implications of the operation unless there is an indication for early referral. Patients meeting the following criteria can be considered for referral: Sore throats due to acute tonsillitis If the episodes of sore throat are disabling and prevent normal functioning and meet the following history criteria: Seven or more well documented, clinically significant, adequately treated episodes of sore throat in the last year, OR Five or more such episodes in each of the preceding two years, OR Three or more such episodes in each of the preceding three years. Manchester (Central, North and South) Indications for early referral Unilateral enlargement Obstructive sleep apnoea Exacerbates another condition Suspected malignancy Referrals for tonsillectomy are only accepted where patients meet the SIGN (Scottish Intercollegiate Guidelines Network) criteria for referral: 3
Sore throats are due to tonsillitis Five or more episodes of sore throat per year Symptoms for at least a year Episodes of sore throat are disabling and prevent normal functioning. Oldham Following specialist referral, a six month period of watchful waiting is recommended to establish the pattern of symptoms and allow the patient to consider the implications of operation. Watchful waiting is more appropriate than tonsillectomy for children with mild sore throats. All patients should have a six month period of watchful waiting to establish the pattern of symptoms and allow the patient to consider fully the implications of the operation unless there is an indication for early referral. Patients meeting the following criteria can be considered for referral: Sore throats due to acute tonsillitis If the episodes of sore throat are disabling and prevent normal functioning and meet the following history criteria: Seven or more well documented, clinically significant, adequately treated episodes of sore throat in the last year, OR Five or more such episodes in each of the preceding two years, OR Three or more such episodes in each of the preceding three years. Salford Indications for early referral Unilateral enlargement Obstructive sleep apnoea Exacerbates another condition Suspected malignancy Only commissioned when patients meet the criteria specified in SIGN guideline 117 - Watchful waiting is more appropriate than tonsillectomy for children with mild sore throats. Tonsillectomy is recommended for recurrent severe sore throat in adults. The following are recommended as indications for consideration of tonsillectomy for recurrent acute sore throat in both children and adults: sore throats are due to acute tonsillitis the episodes of sore throat are disabling and prevent normal functioning seven or more well documented, clinically significant, adequately treated sore throats in the preceding year or five or more such episodes in each of the preceding two years or 4
Stockport Tameside and Glossop three or more such episodes in each of the preceding three years. Based on SIGN guidelines 117: Management of sore throat and indications for tonsillectomy. Watchful waiting is more appropriate than tonsillectomy for children with mild sore throats. Tonsillectomy is recommended for recurrent severe sore throat in adults. The following are recommended as indications for consideration of tonsillectomy for recurrent sore throat in both children and adults: sore throats are due to tonsillitis; the episodes of sore throat are disabling and prevent normal functioning; seven or more well documented, clinically significant, adequately treated sore throats in the preceding year; or five or more such episodes in each of the preceding two years; or three or more such episodes in each of the preceding three years. Referrals for tonsillectomy are only accepted where patients meet the SIGN guideline 117, Apr 10, criteria for referral: Sore throats are due to tonsillitis Episodes of sore throat are disabling and prevent normal functioning Seven or more well documented, clinically significant, adequately treated sore throats in the preceding year or Five or more such episodes in each of the preceding two years or Three or more such episodes in each of the preceding three years Following specialist referral, a six month period of observation is recommended to establish the pattern of symptoms and allow the patient to consider the implications of the operation. In addition the PCT may consider: Quinsy (Peritonsillar absess) Obstructive sleep apnoea Suspected or proven malignancy Trafford Referrals for tonsillectomy are only accepted where patients meet the SIGN criteria for referral: Sore throats are due to tonsillitis; and Five or more episodes of sore throat per year; and Symptoms for at least a year; and Episodes of sore throat are disabling and prevent normal functioning. Following specialist referral, a six month period of watchful waiting is recommended to establish the pattern of symptoms and allow the patient to consider the implications of operation. 5
Wigan Borough There is evidence that the patient has had a six month period of watchful waiting prior to tonsillectomy. This is to establish firmly the pattern of symptoms. There is evidence that the patient has had options and risks explained and has considered fully the implication of the operation. Once the decision is made for tonsillectomy, this should be performed as soon as possible to maximise the period of benefit. The patient should meet all of the following criteria: Sore throat is due to tonsillitis Had five or more documented episodes of sore throat per year Had symptoms for at least one year Episodes of sore throat are disabling and demonstrably prevent normal functioning Tonsillectomy may be of modest benefit for children who experience severe recurrent bouts of tonsillitis, but this benefit may be outweighed by the risks associated with surgery. The risk-benefit ratio is less favourable for children who experience less severe tonsillitis. As detailed above, there are 6 CCGs who commissioning tonsillectomy procedures in line with current SIGN guideline 117. The remaining 6 CCGs criteria are aligned in line with previous SIGN guideline 34. Conclusion The above information has been produced in order to support the policy decision making process across Greater Manchester. The Greater Manchester EUR Steering Group are asked to review the above information, along with the Policy Options and make a decision regarding the policy criteria which will be used across Greater Manchester. Author: Rachel McDonald Date: 30/08/2013 6
Greater Manchester Clinical Commissioning Groups Cost and Activity for Tonsillectomy Procedures 2011/12 to 2013/14
Introduction Clinical Commissioning Groups (CCGs) across Greater Manchester have inherited Effective Use of Resources (EUR) policies from their predecessor Primary Care Trusts (PCTs). Consequently, there are varying positions regarding the commissioning of certain procedures/treatments across Greater Manchester. Work is now being undertaken by the Greater Manchester Commissioning Support Unit s (GMCSU) Policy Team, led by the Greater Manchester EUR Steering Group to align EUR policies across Greater Manchester. Purpose of the Report This report aims to inform the Greater Manchester EUR Steering Group of the activity and spend on Tonsillectomy procedures during financial years 2011/12, 2012/13 and 2013/14 (April to December) for each CCG. Body of the Report The table attached at Appendix 1 provides details of each CCG s activity and costs for tonsillectomy procedures (Source Data: Inpatient Spell PbR). The following procedures were selected to inform the report: Bilateral coblation tonsillectomy Bilateral dissection tonsillectomy Bilateral excision of tonsil NEC Bilateral guillotine tonsillectomy Bilateral laser tonsillectomy Excision of lingual tonsil Excision of remnant of tonsil Other specified excision of tonsil Unspecified excision of tonsil Conclusion The information contained in Appendix 1 has been produced in order to support the policy decision making process across Greater Manchester. The Greater Manchester EUR Steering Group are asked to review this information to assist the policy decision taken for tonsillectomy procedures across Greater Manchester. 2
Appendix 1 Primary Procedure Name (Multiple Items) Financial Year 2011/2 012 2012/2 013 2013/2 014 GM Commissioner Name GM Provider Name No of Inpatients Values Amount in 's No of Inpatients Amount in 's No of Inpatients Amount in 's Table A - Tonsillectomy No of Inpatients Amount in 's No of Inpatients Amount in 's BOLTON 75 389,482 11 15,990 25 33,313 4 4,674 2 2,432 1 1,088 118 446,979 BURY 5 5,619 11 16,351 3 3,591 49 91,806 3 3,404 71 120,771 CENTRAL MANCHESTER 58 166,117 7 7,889 2 2,286 1 1,302 11 14,258 1 1,283 1 1,279 81 194,414 HEYWOOD, MIDDLETON AND ROCHDALE 12 15,784 4 6,826 51 128,193 1 1,151 1 1,104 69 153,058 NORTH MANCHESTER 37 92,288 49 123,855 2 2,253 1 1,106 2 2,375 91 221,877 OLDHAM 17 36,801 1 1,129 50 94,675 1 1,102 1 1,155 1 1,104 16 24,934 1 0 88 160,900 SALFORD 15 20,071 41 136,272 6 6,754 13 18,120 44 88,936 2 2,212 1 1,283 1 1,150 123 274,798 SOUTH MANCHESTER 31 56,168 8 9,550 3 3,755 43 118,683 3 3,552 88 191,708 STOCKPORT 19 31,779 1 1,144 1 1,102 24 43,730 58 237,619 4 4,492 3 2,451 110 322,317 TAMESIDE AND GLOSSOP 22 40,619 3 3,333 2 2,253 2 2,261 13 18,966 50 190,738 92 258,170 TRAFFORD 24 36,989 2 2,180 3 3,604 34 101,225 1 1,104 40 85,458 104 230,560 WIGAN BOROUGH 24 33,754 14 20,021 19 23,251 4 5,304 1 1,101 42 186,134 104 269,565 2011/2012 Total 119 448,926 297 665,179 76 95,627 221 466,942 67 116,598 118 284,630 76 262,463 72 222,539 50 94,991 43 187,222 1,139 2,845,117 BOLTON 81 255,274 12 22,335 32 35,935 2 1,652 1 1,279 3 2,664 131 319,139 BURY 8 8,193 17 19,841 2 1,471 43 57,167 2 2,186 72 88,858 CENTRAL MANCHESTER 62 117,061 11 9,684 8 8,637 1 832 82 136,214 HEYWOOD, MIDDLETON AND ROCHDALE 14 16,517 15 12,204 71 114,509 1 831 101 144,061 NORTH MANCHESTER 31 58,512 50 69,288 1 776 82 128,576 OLDHAM 22 32,621 5 4,061 35 41,466 1 776 16 21,016 79 99,940 SALFORD 19 26,110 43 91,030 9 9,491 7 6,172 47 67,373 3 2,502 1 1,079 129 203,757 SOUTH MANCHESTER 23 25,679 6 5,422 58 120,899 87 152,000 STOCKPORT 24 32,947 3 3,003 32 41,423 59 158,903 5 5,241 123 241,517 TAMESIDE AND GLOSSOP 27 39,149 2 1,472 3 2,424 1 777 2 2,380 9 9,343 55 195,183 99 250,728 TRAFFORD 66 122,825 2 1,772 1 776 41 88,102 1 828 111 214,303 WIGAN BOROUGH 18 24,420 7 9,633 21 20,464 2 1,597 4 3,108 2 6,882 77 204,898 131 271,002 2012/2013 Total 126 313,997 348 588,150 108 104,979 213 294,275 59 77,882 146 270,825 69 169,078 77 222,268 81 208,641 1,227 2,250,095 BOLTON 67 233,256 5 9,539 18 23,479 1 851 1 1,172 2 2,156 94 270,453 BURY 14 18,779 10 13,924 4 4,029 35 49,459 4 3,485 67 89,676 CENTRAL MANCHESTER 51 110,743 5 6,109 2 2,175 8 8,634 1 1,004 67 128,665 HEYWOOD, MIDDLETON AND ROCHDALE 10 17,719 11 13,033 50 98,824 1 851 2 2,331 74 132,758 NORTH MANCHESTER 28 37,352 40 70,717 4 3,716 1 1,172 1 1,009 2 2,093 76 116,059 OLDHAM 1 1,085 16 32,100 3 2,969 35 50,212 2 2,186 11 15,421 68 103,973 SALFORD 18 20,465 27 53,173 11 13,241 5 4,704 30 53,374 1 1,328 92 146,285 SOUTH MANCHESTER 24 36,531 4 4,850 1 845 1 851 40 84,673 70 127,750 STOCKPORT 30 44,802 6 5,675 1 1,007 23 32,237 40 110,401 100 194,122 TAMESIDE AND GLOSSOP 16 26,393 1 1,358 2 1,616 2 1,944 2 3,369 8 7,920 47 119,357 78 161,957 TRAFFORD 54 98,665 2 1,858 40 65,571 96 166,094 WIGAN BOROUGH 21 24,896 10 12,725 17 21,442 1 3,307 69 193,926 118 256,296 2013/2014 Total Grand Total BOLTON CENTRAL MANCHESTER NON-GM PENNINE ACUTE SALFORD ROYAL SOUTH MANCHESTER STOCKPORT No of Inpatients 121 298,481 281 493,666 80 96,185 168 276,377 50 72,298 117 201,463 51 121,661 61 137,875 71 196,082 1,000 1,894,088 366 1,061,404 926 1,746,995 264 296,791 602 ######### 176 266,778 381 756,918 196 553,202 210 582,682 50 94,991 195 591,945 3,366 6,989,300 Amount in 's No of Inpatients Amount in 's TAMESIDE AND GLOSSOP No of Inpatients Amount in 's TRAFFORD WWL Total No Amount No of Amount in of in 's Inpatients 's Inpatients No of Inpatients Total Amount in 's