Without such actions there is a continuing financial risk to NHS Borders and there will be opportunity costs elsewhere within local services.

Transcription

1 Appendix Borders NHS Board ICDs & CRT: A NEEDS ASSESSMENT AND LOCAL POLICY Aim In the light of rising demand to assess the level of need for and agree a local policy for Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy (CRT). Background The number of requests from Lothian cardiac services for fitting ICDs and CRT in Borders residents has increased over the last few years, and particularly in 2010/11 when it contributed significantly to the commissioning budget overspend. Although there have been discussion within SEAT about this issue it appears that a regional consensus on criteria for implantation and a regional policy is some way off. Key Issues The attached paper collates data on recent trends in numbers and costs, discusses national guidance from SIGN, NICE and NHS QIS including recommended criteria for the interventions, calculates local estimates of need and assesses their reliability. Conclusions and recommendations are presented on page 7 covering: The prevention of CVD Adoption of local interim criteria for ICDs and CRT (Appendices 2 and 3) Agreement on a number of devices to be implanted each year or a defined budget Agreement on a mechanism to consider future requests and monitor numbers/budget expenditure and implementation of the criteria Consideration of improvements to a conservative care pathway for suitable patients with severe heart failure. Without such actions there is a continuing financial risk to NHS Borders and there will be opportunity costs elsewhere within local services. Criteria for ICDs and CRT The criteria for ICDs in SIGN 94, NICE Technology Appraisal 95 and QIS standard 13 and 17 differ and therefore any local criteria cannot be consistent with them all. Appendix 4 of the attached paper explains where the local criteria (which appear in Appendix 2) differ from these national documents. Many of the differences are to reflect recent clinical practice changes and to promote cost effectiveness. 1

2 Appendix Similarly the criteria for CRT in SIGN 95, NICE Technology Appraisal 120 and QIS standard 17 also differ and Appendix 4 outlines where and how the local criteria (which appear in Appendix 3) differ from these national guidance documents. As for ICDs the differences in the local criteria are aiming to improve cost effectiveness and respond to recent clinical practice changes. Although the local criteria in Appendices 2 and 3 are on the whole more restrictive than those in the national guidance documents, the local cardiological view is that their implementation would substantially increase implantation rates. This suggests that there is a substantial unmet need within the local population and, if such increases are not supported, a need for an explicit annual number or budget for ICDs and CRT to be agreed and monitored. Number of ICD and CRT devices required The estimates outlined in the attached paper for ICDs for the Borders population were 6-11 p.a., but they do not have a firm epidemiological basis. In 2010/11 there were 10 ICDs implanted. For CRT estimates range from 6-12 p.a. for the local population with the more reliable estimate being 9 p.a., one third of which should be CRT-D (with defibrillator function). These figures compare with 6 CRT-D fitted in 2010/11. CRT-D is approximately 12,000 more expensive than CRT per device and cost effectiveness was assessed by NICE as 40,000 per QALY. NICE therefore recommended careful selection of those at highest risk of sudden cardiac death for CRT- D. Dr Neary, NHS Borders local cardiologist, has confirmed that all patients referred for CRT for heart failure also fulfil the criteria for CRT-D according to NICE, SIGN and the local criteria in Appendix 3. A figure of 7/8 new ICDs and 7/8 new CRTs per annum would seem to be a reasonable interim level of provision. Replacement of devices when batteries are failing should be automatic unless the patient s condition has changed when the local criteria should be applied. Monitoring of criteria would help to inform future discussion on ICD and CRT/CRT-D numbers. These figures would suggest a budget of approximately ,000 p.a. for new devices is required if all CRT devices are CRT-D, ,000 if around one third are CRT-D. Adding an estimated 5 replacement devices each year increases these figures to ,000 p.a. (all CRT-D) and ,000 p.a. (one third CRT-D) In agreeing a limit to the number of or budget for particular conditions or interventions there is always the possibility of a challenge, and potentially a legal challenge. However, there are a number of factors that would enable the Board to mount a rigorous defense of its action, including the following: Having undertaken a process to carefully consider the evidence on effectiveness, cost effectiveness and the level of need for these interventions Having consulted widely whilst developing the local policy (further details below) Agreeing to provide an appeals mechanism through the ECR Panel 2

3 Appendix The need for the Board to consider needs across the whole population, the opportunity cost of investing more in any one area, and ultimately its responsibility to achieve financial balance. Consultation The following have been consulted when undertaking this work: Dr P Neary, Consultant Cardiologist, NHS Borders Dr N Grubb, Consultant Electrophysiologist, NHS Lothian Mrs I McGonnigle, Regional Cardiac Service Improvement Manager Mrs L Bellis, Commissioning Manager Dr R Cameron, Medical Director An earlier version of these papers went to the Strategy Group on 14 April with the following outcome: Prior to going to the Board further discussion with some Non-Executive Directors should be arranged, mirroring the process adopted for Optimal Reperfusion Therapy (ORT) A mechanism should be agreed to spread activity across the year to ensure equity An appeals process should be available through the ECR Panel On 3 May a meeting with the Chairman, Mr A Lucas (Non-Executive Director), the Chief Executive, Mrs L Bellis, Dr P Neary and Dr A Mordue was held to brief on and discuss the recommendations. Key points arising were: costs for these devices from other centres should be sought to compare to those from Lothian and a split of the NHS Lothian costs requested (device, implantation, follow up etc). These have been requested and if available can be tabled at the Board meeting. ICD device implantation for secondary prevention, after a life threatening arrythymia, are usually progressed as emergencies and therefore prior approval may not be feasible or desirable. An agreed number or budget per annum may therefore be better focused upon devices implanted for primary prevention reasons only (data is not available at present to separate these categories, but monitoring against the local criteria will make this possible in the future). If the number of patients fulfilling the agreed criteria exceed an agreed annual number or budget some will have to wait for approval for implantation and be maintained on medical therapy meanwhile. The implications for waiting time targets and guarantees should be examined. There should be a review of the arrangements agreed and how they are operating after one year. Further discussion with Non-Executive Directors at the Clinical Governance Committee meeting on 15 June should occur prior to presentation to the full Board. Other Non-Executive Directors should have the opportunity to comment and raise questions at the Clinical Governance Committee by circulation of the Committee papers before the meeting. At the Clinical Governance Committee meeting on 15 June several of the points covered on 3 May were discussed, in addition the following were raised: The benefit of undertaking an equality impact assessment (attached) 3

4 Appendix A request to outline the position should a legal challenge materialise (now included on page 2 of this paper) There was also debate about the implications of agreeing a limited number of devices per annum or budget for waiting time targets. The Referral to Treatment (RTT) 18 week target will apply when a patient is referred by local cardiologists to Lothian electro-physiologists and a device is recommended. However, given current numbers of requests for device implantation, the recommended level of provision, and the flexibility provided by the 18 week waiting time period this is felt to be manageable. Summary Following recent increases in the numbers of ICD and CRT implants this work has attempted to assess local need and evidence. Page 7 of the attached paper contains the conclusions and six recommendations about prevention of CVD, local criteria for these two interventions, agreeing the number of devices for implantation per annum, approval and monitoring arrangements and improved palliative care. Recommendation The Board is asked to discuss the findings of this needs assessment, in particular the recommendations on page 7 of the attached paper and the points raised during consultation, and approve:- the adoption of the interim local criteria in Appendices 2 and 3, an agreed number of ICD devices and CRT devices to be implanted each year or a budgetary equivalent 7/8 ICDs and 7/8 CRT devices are recommended per annum, plus an estimated 5 replacement devices p.a. implementation of the recently agreed mechanism to approve individual device implants through the UNPACS system improved monitoring arrangements for the future providing an appeals mechanism through the ECR Panel a review of this policy and its implementation after one year, and finally engagement with colleagues in SEAT and the Regional Cardiac Planning Group to develop a regional consensus for the longer term. Policy/Strategy Implications Consultation Consultation with Professional Committees Risk Assessment The suggested policy will help to manage demand for and deliver equitable provision of these interventions, and improve financial control. There has been wide consultation during the development of this policy as outlined above. Strategy Group on 14 April and Clinical Governance Committee on 15 June. Implementation of this policy will reduce the risk of inequity in service provision and also the financial risk to NHS Borders. There is a small risk of a legal challenge and this is addressed on page 2. 4

5 Appendix Compliance with Board Policy requirements on Equality and Diversity Resource/Staffing Implications See Equality Impact Assessment attached. At current costs ,000 p.a. for new devices is required (if all CRT devices are CRT-D) and around 115,000 p.a. to cover the estimated cost of replacement devices 5 p.a.) Approved by Name Designation Name Designation Dr Eric Baijal Joint Director of Public Health Author(s) Name Designation Name Designation Dr Alan Mordue Consultant in Public Health Medicine 5

6 Implantable Cardioverter Defibrillators & Cardiac Resynchronisation Therapy A needs assessment and local policy Introduction Over a period of a few weeks in 2010 NHS Borders received seven letters from NHS Lothian seeking approval for insertion of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy devices (CRTs) at a total cost of approximately 160,000. This unusual spike in requests led to a report and discussion in the BET with the result that funding was approved for five patients (one being a duplicate letter on the same patient and another a Northumberland resident registered with a Borders practice) and a request that a local policy be developed to guide future decisions. Background What are ICDs and CRT? ICDs are battery-powered devices implanted below the skin on the chest wall with a single wire into the heart. They deliver an electrical impulse when a life threatening arrhythmia is detected and so reduce the risk of sudden cardiac death. They can be fitted in patients who have already had a life threatening arrhythmia (secondary prevention) or in those who are felt to be at risk of one (primary prevention). Coronary heart disease (CHD, often after myocardial infarction), and inherited heart conditions are the main causes of sudden cardiac death and therefore indications for ICDs. CRT devices are also battery-powered and implanted below the skin on the chest wall, they have three wires /leads into the right atrium and both right and left ventricles of the heart. CRT is a treatment for heart failure, specifically when the pumping function of the heart is impaired by a lack of synchrony between its four chambers. Heart failure can be a serious condition with a mortality up to 40% in the first year after diagnosis. Patients with heart failure can also be at risk of sudden death caused by cardiac arrhythmias and therefore CRT is sometimes combined with a cardiac defibrillator function when it is called CRT-D or biventricular ICD. Local trends in ICDs and CRT The table below shows the trend in numbers and costs of ICDs and CRT taken from the ECR and UNPACS systems. Requests for approval/payment have come through both channels over the last few years, and so have been combined: 2005/6 2006/7 2007/8 2008/9 2009/ /11 Number Cost ( ) 173, , , , , ,328 The numbers and costs in 2009/10 and 2010/11 represent a significant increase from earlier years. Collation of figures for ICDs and CRT in 2010/11 was not straight-forward with three different lists from separate sources needing to be reconciled using patient names and unique episode numbers to ensure there was no duplication.

7 These uncertainties because of separate approval/payment channels and difficulties in monitoring are now being addressed. Funding approval for individual device implantation must be sought by the Lothian cardiac service via the UNPACS process; in the case of emergencies it is retrospective, but if planned is prospective. For 2010/11 a detailed breakdown by device type (ICD, CRT and CRT-D) and whether the implantation was of a new or replacement device is shown. Data were not available to distinguish patients having ICDs fitted for primary and secondary prevention: New/replacement status Type of Device Implanted ICDs CRT CRT-D New Replacement Total Total The most significant finding from this analysis is that there were no CRT devices fitted and that all patients needing CRT for heart failure were provided with the additional defibrillator function. The other finding of note is that replacement devices, largely because batteries are failing, are significant. National guidance and regional coordination SIGN guideline 94 on Cardiac arrhythmias in coronary heart disease published in February 2007 contains recommendations on the use of ICDs in CHD. NICE Technology Appraisal 95 on Implantable cardioverter defibrillators for arrhythmias published in January 2006 also provides guidance on the use of ICDs. The QIS Clinical standards for Heart Disease published in April 2010 contain two standards relevant to ICDs numbers 13 and 17. For CRT the relevant SIGN guideline is 95 on Management of chronic heart failure (also published in February 2007) and NICE Technology Appraisal 120 on Cardiac resynchronisation therapy for the treatment of heart failure (published May 2007). QIS Clinical standard number 17 concerns CRT. There have been discussions at the SEAT Regional Cardiac Planning Group about the need to develop regional guidance on ICDs and CRT and a group was set up to do this. However, progress has been slow. The need for such guidance was raised again at a regional cardiac planning workshop on 5 November 2010 where priorities for future work were discussed and the benefits of this work being coordinated across the three regional planning areas was highlighted. Given the fact that this work may take a while to reach a conclusion, and the need for guidance to inform local decisions meanwhile, an interim local policy was felt to be required. 2

8 Needs assessment Trends in CHD CHD is the main underlying disease in the majority of patients needing ICDs and CRT. Therefore the level of and trends in CHD within the local population is important when considering the need for these interventions. The August 2009 Review of cardiological activity and assessment of future need and demand for cardiological interventions (focusing upon angiograms, angioplasties and bypass grafts) reached the conclusion that both CHD incidence and mortality were falling over the 10 year period locally, and that prevalence was static or falling slightly. This is reassuring, however there is no information on the severity of CHD within the local population, and this will influence how many people meet any given criteria or threshold for these interventions. ICDs effectiveness, cost effectiveness and criteria for treatment Secondary Prevention There are three secondary prevention trials and meta-analyses which show that ICDs compared to anti-arrhythmic drugs reduce the risk of cardiac death by 50% (relative risk reduction (RRR),95% CIs 35-65%) and all cause mortality by 25-28% (95% CIs 10-40%). Mortality in this group of patients is high 61.5% over 5 years in the drug treatment group and this is reduced to 44% with ICDs (absolute risk reduction (ARR) = 17.5%). The number of patients needed to treat (NNT) for 5 years to prevent one death is relatively low at 6, but because of the high baseline mortality in these patients, the gain in life is on average only 4.4 months over 6 years. Patients with poorer left ventricular function (LV ejection fraction <35% of normal) appear to benefit more, whereas in those with better LV function (LVEF >35%) ICDs seem to be no better than drug treatment. LVEF was assessed using radionuclide ventriculograms but in current practice the simpler and less invasive echocardiography is used. This does not give such a precise estimate of LVEF and therefore the following classification is usually used - normal, mildly impaired, mild-moderate, moderate, moderate-severe and severely impaired. The last category severely impaired is taken to match <35% LVEF and is used in the local criteria in this report.. The NICE Technology Appraisal 95 reviewed the available health economic analyses on ICDs for secondary prevention, conducted new analyses with updated assumptions (including restricting ICDs to those with LVEF <35%) and concluded that cost effectiveness, at 28,000 per additional quality adjusted life year (QALY), was within acceptable limits. On this basis NICE, and SIGN, recommend ICDs for secondary prevention in patients who have survived one of the following ventricular arrhythmias in the absence of treatable causes: Cardiac arrest due to Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF), or VT with syncope or haemodynamic compromise, or Sustained VT without syncope if LVEF <35% (excluding NYHA IV because of poor prognosis). NYHA is a classification of heart failure based on the severity of patients symptoms (see Appendix 1). The draft NHS Borders criteria for ICDs in Appendix 2 applies the exclusion of NYHA IV to all arrhythmias rather than only the last, and also includes life expectancy with good functional status > 2 years (with the ICD implanted), to try to ensure there is time for the patient to benefit. These two additional criteria should improve cost effectiveness further. Primary Prevention 3

9 There are more trials in primary prevention patients (who have not already had a life threatening arrhythmia), but they include very different patient groups. This means that drawing conclusions is difficult and combining their results in a meta-analyses is inadvisable. However, one of the key trials (MADIT II) seems to have very similar results to those above for secondary prevention in terms of overall mortality (60%), risk reductions with ICDs (ARR18%) and NNT (6). As for secondary prevention NICE Technology Appraisal 95 reviewed the available health economic analyses on ICDs for primary prevention and conducted new analyses with updated assumptions. In the earlier trials electrophysiological assessment of patients included testing the ability to induce VT; if this was possible the patient was deemed to be at higher risk and therefore could benefit more from an ICD. The later trials, and current clinical practice, no longer use this technique so that NICE assessed other parameters to identify high risk patients. Patients with a QRS duration of 120 milliseconds or greater (part of the ECG when the ventricles contract) and LVEF <30% were found to benefit more and cost effectiveness in such patients was estimated to be around 30,000 per additional QALY gained. However, NICE also concluded that electrophysiological testing of VT inducibility does identify high risk patients in whom cost effectiveness is even better in the range 21-23,000 per QALY. On this basis they recommended ICDs for primary prevention in patients who have had a myocardial infarction more than 4 weeks ago and have: symptoms suggesting NYHA I to III categories (IV excluded), and LVEF <35%, and non-sustained VT on 24 hour ECG monitoring, and inducible VT on electrophysiological testing Or: symptoms suggesting NYHA I to III categories (IV excluded), and LVEF <30%, and QRS duration of 120 ms or more. Given that electrophysiological testing of VT inducibility is not currently practised, despite the NICE recommendation, the draft criteria in Appendix 2 for ICDs omits this criterion. The criteria for primary prevention also include life expectancy with good functional status >2 years (and the exclusion of NYHA IV included in NICE recommendations above but not SIGN 94). A number of inherited conditions lead to a high risk of sudden cardiac death, as does previous heart surgery for congenital heart disease. ICDs are recommended for such patients, including by NICE Technology Appraisal 95 they are also included in the draft criteria in Appendix 2. Appendix 4 provides a comparison of the local criteria and where they differ from SIGN, NICE and QIS national guidance. Population estimates of those fitting ICD criteria Two papers discuss this question CRT and Primary Prevention of Sudden Cardiac Death a pragmatic approach to making a start (2005) from Glasgow and the NICE Technology Appraisal 95 Costing Report. However, the recommendations of 50 and 100 per million population per year respectively for ICDs (equating to 6 and 11 for Borders) are not based upon firm epidemiological foundations, but seem to be pragmatic guesses of those who might fit current (at that time) and NICE criteria. The tighter criteria suggested in Appendix 2 are likely to reduce the numbers eligible compared to NICE and SIGN recommendations, but it is not possible to estimate their impact in relation to the 50/100 pmp estimates above. 4

10 CRT effectiveness, cost effectiveness and criteria for treatment CRT NICE Technology Appraisal 120 discussed four randomised controlled trials comparing CRT with optimal drug treatment for heart failure and reported meta-analysis results after combining data from all the trials. This demonstrated statistically significant improvements in all cause mortality, death from heart failure, hospitalisation rate, exercise capacity and health-related quality of life, but not for sudden cardiac death. Reduction in mortality was similar to those for ICDs with a RRR of 28% and a NNT of 5-6. In these trials and clinical practice the need for CRT in patients with heart failure is based primarily on a diagnosis of electrical dys-synchrony as indicated by a widened QRS complex of more than 150 milliseconds on standard ECG. With a lesser degree of electrical dys-synchrony, with QRS ms, confirmation of mechanical dys-synchrony by echocardiography is also usually required. CRT is also usually reserved for more severe stages of heart failure falling into the NYHA III and IV categories (see Appendix 1). Despite these selection criteria between 11-46% of people who have a CRT device implanted do not respond to the treatment and they cannot be identified beforehand. The NICE Technology Appraisal reviewed the available health economic analyses on CRT and conducted new economic modelling and concluded that CRT was cost effective at 16,735 per QALY in patients with heart failure caused by LV systolic dysfunction who fulfil all of the following: symptoms suggesting NYHA III or IV, and LVEF <35%, and In sinus rhythm and o either QRS duration of 150 ms or longer o or QRS ms and mechanical dys-synchrony on echocardiography, and on optimal drug therapy. Local criteria appear in Appendix 3 and follow those from NICE with the addition, as for ICDs, of an estimated life expectancy with good functional status > 2 years, after implantation. CRT-D (Biventricular ICD) Two trials have compared CRT-D to optimal drug treatment and a meta-analysis of their results shows similar outcomes to those reported above for CRT. Only one trial provided a direct comparison between CRT and CRT-D (although it was not designed for this and was underpowered) and it did not demonstrate statistically significant differences in outcomes except for cardiac death and sudden cardiac death. The NICE economic modelling mentioned under CRT above also focused on CRT-D, noting that device costs for CRT-D are approximately 12,000 more than for CRT. These additional costs combined with the additional benefits for CRT-D of reduced cardiac and sudden cardiac deaths results in an incremental cost effectiveness of 40,000 per QALY. Whilst NICE considered that this would not represent an efficient use of NHS resources the report noted that the cost per QALY was sensitive to assumptions on the level of risk of sudden cardiac death and suggested that CRT-D could be considered for patients who also fulfil the criteria for ICDs. In effect NICE are suggesting the selection of a patient group for CRT-D who have a higher risk of arrhythmias and sudden cardiac death (based upon previous life threatening arrhythmia (secondary prevention) or non-sustained VT on 24 hour ECG and lower LVEF <30%). NICE also recommended an early review of the ICD guidance and an examination of which patient groups could be considered for a CRT-D. Appendix 3 contains these criteria with the additional life expectancy >2 years with good functional status criterion. 5

11 Appendix 4 provides a comparison of the local criteria and where they differ from SIGN, NICE and QIS national guidance. Population estimates of those fitting CRT criteria A paper to the West of Scotland Planning Group recommended a CRT implantation rate of per million per annum (6-7 for Borders population), but the basis of this rate is not clear. The Glasgow 2005 paper mentioned on page 3 reported that estimates of the proportion of CRT-D were between 10-30% of all CRT devices, although the basis of these estimates are not clear either. It went on to say that each patient needs to be considered individually to identify those with the highest risk of sudden cardiac death, and that the default device in NYHA III and IV should be CRT. Health Commission Wales produced a commissioning policy for CRT in 2008 and it recommended a rate of 100 CRTs per million population, 67 CRT and 33 CRT-D. The epidemiological basis of these recommendations is not clear. A potentially more reliable estimate of CRT numbers based upon data from the Lothian Chronic Heart Failure database was for 75 per million population or 8-9 per annum for Borders. 6

12 Conclusions ICDs are effective and cost effective interventions which reduce, but do not eliminate, sudden cardiac deaths from arrhythmias. They are indicated in those who have already suffered a life threatening arrhythmia, have advanced coronary heart disease or rarer inherited conditions. CRT is also effective and cost effective in treating patients with severe heart failure who have ventricular dysfunction. However, a significant percentage of patients do not respond to therapy (11-46%) and peri-operative mortality is significant (around 0.8%). The cost effectiveness of CRT-D is less certain. Given these facts and the costs of these devices (ranging from around 18,000 for an ICD device and implantation to 29,000 for CRT-D and implantation) inevitably they will be used in a relatively small number of people towards the end of the patient pathway. Estimates of numbers needed each year within the Borders population are not reliable for ICDs (6-11 p.a), but are more reliable for CRT (up to 8-9 p.a. of which 1-3 CRT-D). The draft criteria in Appendices 2 and 3 are tighter than NICE and SIGN guidelines, are therefore likely to increase cost effectiveness further, but the number of ICDs and CRTs that will result if they are implemented is not known and local cardiological opinion is that they will increase numbers substantially. The importance of effective and cost effective interventions earlier in the patient pathway to prevent the development of CHD (primary prevention), reducing both incidence and prevalence, and delay disease progression (secondary prevention) is crucial. These actions will improve population health, patients quality of life and limit the number of patients who will require ICDs and CRT in the future. The need to improve conservative or palliative care for severe heart failure patients has been discussed over recent years and, as for renal replacement therapy, a more formal and well developed conservative care pathway could provide improved and more appropriate care for some patients and also help to limit CRT numbers in the future. QIS standard 18 focuses upon supportive and palliative care of people with heart disease. Recommendations 1. Vigorous primary and secondary prevention of CVD is needed to reduce incidence, prevalence and disease progression through for example population wide health improvement work on diet, smoking, physical activity and weight; high risk primary prevention of CVD such as the Borders Keep Well service; and thorough implementation of secondary prevention measures in primary care. 2. Agreement and implementation of local interim criteria for ICDs and CRT (recommendations in Appendix 2 and 3). 3. Agreement on the number of new ICD and CRT devices to be implanted each year (7/8 p.a. for each recommended), the proportion of CRT-D devices (of CRT overall numbers), or a budgetary equivalent. 4. Implementation of the agreed mechanism to approve individual requests for implantation, a new process to monitor application of the criteria in the future, and monitoring of the numbers/expenditure prospectively. 5. Local involvement in SEAT discussions on ICDs and CRT designed to reach a regional consensus on criteria for the longer term. 6. Development of a conservative care pathway for patient with severe heart failure. 7

13 Appendix 1 New York Hearth Association classification of symptoms of heart failure Class I II III IV Symptoms No limitation: ordinary physical exercise does not cause undue fatigue, dyspnoea or palpitations Slight limitation of physical activity: comfortable at rest but ordinary activity results in fatigue, palpitations or dyspnoea Marked limitation of physical activity: comfortable at rest but less than ordinary activity results in symptoms Unable to carry out any physical activity without discomfort: symptoms of heart failure are present even at rest with increased discomfort with any physical activity. 8

14 Appendix 2 NHS Borders Criteria for Implantable Cardioverter Defibrillators ICDs are used to reduce the risk of sudden death caused by cardiac arrhythmias. They can be fitted to patients who have already had a life threatening arrhythmia (secondary prevention) or those who are felt to be at risk of one (primary prevention). The criteria below for these two categories are based on the evidence on effectiveness and cost effectiveness outlined in SIGN 94 (Feb 2007) and NICE Technology Appraisal 95 (Jan 2006). ICDs should be considered: Secondary prevention In patients who have survived one of the following ventricular arrhythmias in the absence of treatable causes: cardiac arrest due to VT or VF, or VT with syncope or haemodynamic compromise, or sustained VT without syncope if LV function is severely impaired on echo And: have symptoms suggesting NYHA I to III categories (IV excluded), and have a life expectancy with good functional status > 2 years. Primary prevention In patients who have had a myocardial infarction more than 4 weeks ago, or who have nonischaemic cadiomyopathy, and have: symptoms suggesting NYHA I to III categories (IV excluded), and LV function is severely impaired on echo, and non-sustained VT on 24 hour ECG monitoring. Or: symptoms suggesting NYHA I to III categories (IV excluded), and LV function is severely impaired on echo, and QRS duration of 120 ms or more. And: have a life expectancy with good functional status > 2 years. In patients who have a familial condition with a high risk of sudden death including long QT syndrome, hypertrophic cardiomyopathy, Brugada syndrome, or arrhythmogenic right ventricular dysplasia, or have undergone surgical repair of congenital heart disease. Glossary ICDs VT VF LVEF ECG NYHA QRS Implantable cardioverter defibrillators Ventricular tachycardia Ventricular fibrillation Left ventricular ejection fraction Electrocardiogram New York Heart Association (system for classifying symptoms of heart failure) Part of the ECG recording depolarisation of the ventricles 9

15 NHS Borders Appendix 3 Criteria for Cardiac Resynchronisation Therapy CRT is a treatment for heart failure, specifically when the pumping function of the heart is impaired by a lack of synchrony between its four chambers. Heart failure can be a serious condition with a mortality up to 40% in the first year after diagnosis. Patients with heart failure can also be at risk of sudden death caused by cardiac arrhythmias and therefore CRT is sometimes combined with a cardiac defibrillator function (CRT-D). The criteria below are for CRT with additional criteria for CRT-D, both sets of criteria must be fulfilled for CRT-D: CRT CRT should be considered in patients with heart failure caused by LV systolic dysfunction who fulfil all of the following: symptoms suggesting NYHA III or IV, and LV function is severely impaired on echo, and In sinus rhythm and o either QRS duration of 150 ms or longer o or QRS ms and mechanical dys-synchrony on echocardiography, and on optimal drug therapy And have a life expectancy with good functional status > 2 years. CRT-D CRT-D should be considered for patients with heart failure who fulfil the criteria for CRT and who are deemed to be at significant risk of sudden cardiac death because of: Secondary prevention Having survived one of the following ventricular arrhythmias in the absence of acute ischaemia or treatable causes: cardiac arrest due to VT or VF, or VT with syncope or haemodynamic compromise, or sustained VT without syncope, and symptoms suggesting NYHA III category (IV excluded). Primary prevention Having had a myocardial infarction more than 4 weeks ago, or who have non-ischaemic cadiomyopathy, and have: symptoms suggesting NYHA III category, and non-sustained VT on 24 hour ECG monitoring. Or: symptoms suggesting NYHA III category, and LV function is severely impaired on echo. Have a familial condition with a high risk of sudden death including long QT syndrome, hypertrophic cardiomyopathy, Brugada syndrome, or arrhythmogenic right ventricular dysplasia, or have undergone surgical repair of congenital heart disease. And have a life expectancy with good functional status > 2 years. 10

16 Glossary CRT VT VF LVEF ECG NYHA QRS Cardiac resynchronisation therapy Ventricular tachycardia Ventricular fibrillation Left ventricular ejection fraction Electrocardiogram New York Heart Association (system for classifying symptoms of heart failure) Part of the ECG recording depolarisation of the ventricles 11

17 Appendix 4 Comparison of local criteria to national guidance ICDs The criteria for ICDs in SIGN 94, NICE Technology Appraisal 95 and QIS standard 13 and 17 differ and therefore the local criteria cannot be consistent with them all. The table below tries to show where and how the local criteria differ significantly from these national guidance documents: Criterion (included in local criteria unless stated o/w)* NYHA IV (most severe symptom category) exclusion applies to all SP patients Life expectancy >2 years with good functional status for SP patients Patients with non-ischaemic cardiomyopathy (PP) Inducible VT on EP testing not included (PP) Diverges from? Comment Effect on demand In SIGN, NICE and QIS applies to only 1 of 4 categories (VT without syncope if LVEF <35%) Not included in SIGN, NICE or QIS. Remit of SIGN 94 was for CHD only, NICE did not include this group, QIS does include them. Included in SIGN and NICE but not in QIS. Prognosis of NYHA IV patients is poor, ability to benefit therefore reduced. Likely to be considerable overlap with NYHA IV exclusion. Aim is to ensure time to benefit. Significant proportion of cardiomyopathy is nonischaemic with increased risk of sudden cardiac death. VT inducibility not part of current clinical practice. Decrease Decrease Increase Increase Life expectancy >2 years with good functional status for PP patients QRS duration of 120 ms or more Not included in SIGN or NICE, QIS includes expected survival 1 year or greater Included in SIGN and NICE but not QIS Likely to be considerable overlap with NYHA IV exclusion. Aim is to ensure time to benefit. A clinical indicator of increased risk of sudden cardiac death. Decrease Decrease * SP=secondary prevention; PP=primary prevention; VT=ventricular tachycardia; EP=electrophysiological The local criteria exclude NYHA IV (see Appendix 1 for explanation of classification) and include the life expectancy requirement to ensure patients have time to benefit from this invasive procedure and to improve cost effectiveness. Local criteria also respond to current practice by removing inducibility of VT and pick up the non-ischaemic cardiomyopathy group of patients. 12

18 CRT The criteria for CRT in SIGN 95, NICE Technology Appraisal 120 and QIS standard 17 also differ and, as for ICDs, the table below outlines where and how the local criteria differ significantly from these national guidance documents: Criterion (included in local criteria unless stated o/w) LV function is severely impaired on echocardiography Life expectancy with good functional status > 2 years QRS ms and mechanical dys-synchrony on echo Diverges from? Comment Effect on demand SIGN, NICE and QIS use LVEF 35% or less. Not included in SIGN, NICE or QIS. Included in NICE but not in SIGN or QIS (specify >120 ms only) Radionuclide ventriculograms to estimate LVEF precisely rarely used in clinical practice now, echo is standard Life expectancy with good functional status >1 years included in draft SEAT guidance. Attempt to restrict CRT to highest risk groups Uncertain Decrease Decrease For CRT-D criteria listed in table above for ICDs also apply As for ICDs the differences in the local criteria aim to improve cost effectiveness and respond to recent clinical practice changes. 13

19 Title of Policy/Function/Service: Owning Directorate/Department: Lead Officer: Telephone No: Address: Names/ Job titles of Assessors Summary of Policy / Service /Function aims: Equality Impact Assessment (EIA) Template SUMMARY (Publishing Form) ICDs & CRT: a needs assessment and local policy Public Health Dr Alan Mordue alan.mordue@borders.scot.nhs.uk Consultant in Public Health Medicine Date(s) of Assessment: Aim is to assess the evidence and level of need for ICDs and CRT so that an explicit policy can be agreed that balances effectiveness, cost effectiveness, opportunity costs and financial control. Strands Impacted: Age x Disability x Gender x Race Religion or Belief Sexual Orientation Socio Economic Homeless Background Language/ Criminal Justice Mental Health Social Origin System Rural Barriers Staff Carers/Families Marital Status Key Issues & Judgments Key Recommendations Explicit and objective criteria for identifying patients to receive interventions should help to avoid discrimination because of age, disability and ethnic group particularly, but also across other equality groups, and improve equity of access Implement recommended improved data collection and monitoring arrangements and review operation of policy in June Agreed by Head of Directorate/ Department Name: Date: For further information, a copy of the full assessment or if you require this information in an alternative format or language please contact: Joint Equality & Diversity Service, Business Improvement Unit, Scottish Borders Council HQ, Newtown St Boswells, TD6 0SA Tel: NHS Borders SBC July

20 Section One: 1.1 This is a: Policy/ Service/ Function The Policy/Function/Service Background 1.2 What is the Aim/ Purpose/Outcomes of this Policy/Function/Service? (consider explicit and implicit aims and outcomes, both positive and negative) Aim is to assess the evidence and level of need for ICDs and CRT so that an explicit policy can be agreed that balances effectiveness, cost effectiveness, opportunity costs and financial control. Implicit is the aim for the policy to be fair and ensure equity of access to these interventions between individuals and over time, based upon their assessed clinical need and ability to benefit only 1.3 Who are the relevant stakeholders? The NHS Board itself, cardiological staff in NHS Borders and Lothian, and future potential patients who might need the interventions. 1.4 Who is to benefit? (e.g. employees/service users; equality groups, other stakeholders) In what way? Same groups as in Who will it affect? (e.g. employees/service users; equality groups, other stakeholders) In what way Service users/patients who could fall into some of the equality groups, e.g. older people, disabled and higher proportion of black and asian ethnic groups. 1.6 Has this Policy/Service/Function been EIA before? No If yes supply date : Give details of outcomes etc: 1.7 What research or consultation has been done? Research review of national guidance and selected studies referenced, review of some studies and papers on level of need. Consultation - with cardiological staff in NHS Borders and Lothian, Strategy Group, Non-Executive Directors of NHS Borders and Clinical Governance Committee. 1.8 What research or consultation will be done? Further discussion at Board meeting on 30 June planned prior to approval. This policy is an interim one which will be reviewed after a regional policy has been developed, which will involve wide consultation within SEAT and its Regional Cardiac Planning Group. 1.9 Is this policy open to interpretation/discretion? (Does someone at service delivery level have the power or ability to make a decision about how it is applied?) Yes, cardiologists and electrophysiologists must interpret the policy and criteria it contains and discuss these interventions with patients prior to reaching a decision to request approval for implantation or not. NHS Borders SBC July

21 Section Two: Impact Assessment - Data Examination of Available Data (when examining the data available consider all the equality strands and cross influencing factors listed on page 5 & 6 to identify gaps in information, weak areas for action and positive and negative outcomes for these groups) Data collection may include: consultations, surveys, databases, focus groups, in-depth interviews, pilot projects, reviews of complaints made, user feedback, academic or professional publications, consultations' reports etc 2.1 Referring to the above list, name any experts and/or relevant groups/bodies you have approached/consulted with regards to the impact of this policy/strategy/service/ function on the equality target groups? (What were their views/opinions/recommendations?) See 1.7 above for individuals and groups consulted. Page 3 of the Board paper outlines the results of this consultation including agreeing a mechanism to spread activity across the year to ensure equity, providing an appeals process and reviewing the operation of the policy after one year. 2.2 What do you know from existing in-house quantitative/qualitative data, research, consultation, focus groups and analysis? (what does the information tell you about: Different needs; Different experiences; Different access to services, information or opportunities; Different impacts/different outcomes?) No data is currently collated to document the characteristics of those receiving these devices and whether they fulfil clinical criteria or not, and which criteria. Improved monitoring of such data is a recommendation of the policy and will enable better assessments of equity, types of need being met, and likely outcomes. 2.3 What do you know from existing external quantitative/qualitative data, research, consultation, focus groups and analysis? (what does the information tell you about: Different needs; Different experiences; Different access to services, information or opportunities; Different impacts/different outcomes?) Expert opinion suggests that many more patients could benefit from these devices than currently do. However, the data that is available on the level of need is poor quality where it is better it suggests that the level of recommended provision is reasonable (number of CRT devices 7.5/100,000 compared to 7/8 recommended for 112,000). No data seems to be available on equity of provision across equality groups although there is anecdotal evidence of geographical inequity. 2.4 Have any knowledge gaps been identified with regard to the equality target groups? (e.g. do you need to gather further evidence/information or consult now/later?) Yes and the recommended improved data collection will allow for better monitoring in the future, for example by age, gender and compliance with criteria (some being proxies for disability). Regional discussion could also lead to improvements in the collection of comparative data across the SEAT region to examine geographical equity. 2.5 Describe any actual/potential difficulties - with availability of information? (e.g. how valid/reliable/ up-to-date is the information you have?) No data collated routinely but new policy will improve, see 2.4 above. NHS Borders SBC July

22 Section Three: Impact Assessment - Equality Target Groups Complete the following table, recognising that differential positive and adverse impacts (whether intended or unintended) could apply to each equality target group. A) The policy/function/service could have a positive impact and contribute to NHS Borders Equality Duties by: Eliminating unlawful discrimination; (Is an individual or group likely to be negatively impacted on by this policy/ service function?) Promoting equal opportunities; (could this policy /service /function increase or restrict access for any of the groups mentioned below?) Promoting good relations; (could this policy/service/ function improve or erode relations between particular groups of people?) Taking account of the different needs of equality target groups. (Is it likely that different people will have different requirements when trying to access or use this policy/ service function?) Promoting positive attitudes towards different groups (Will this policy/ service/ function help improve or hinder attitudes of service users or employees towards the groups below?) Increase participation in public life (Will this policy/service/function increase or restrict participation in public life e.g. women standing for election or people with disabilities applying for jobs?) N.B. Having a positive impact on one group alone does not automatically mean a negative impact would be placed on another group (e.g. a service aimed at the health & wellbeing of men to address specific male related health issues may have no impact on women at all), but we should work to be inclusive wherever possible. B) The policy/function/service could have an adverse impact by disadvantaging any of the equality groups. Particular attention should be given to unlawful direct and indirect discrimination. N.B NHS Borders has a legal duty to promote equality wherever possible under current equalities and human rights legislation. If a negative impact is identified we must (wherever possible) work to eliminate it. If we cannot eliminate it, we must identify it and look for ways to possibly eliminate it in the future. Impact Rating After considering all the information gathered so far and through discussion you must decide what the overall impact rating will be for each Equality Target Group your Policy, Function or Service will impact on. The rating should be based on the most significant impact (i.e. There may be a significant positive impact on older people and an incidental minor negative impact on children, on balance (and through discussion) the overall rating may be High Positive but a description of the negative impact must be written into the Decision Rationale box and a recommendation must be made to reduce the negative impact if possible. * Warning if an impact is deemed unlawful (no matter how minor the significance may seem) it must be noted in the impact rating and appropriate procedures followed. Guide to Rating: Low: A minor positive/ negative impact which may have an impact on some or all of the group indicated High: A substantial positive/ negative impact which will have a definite effect on some or all of the indicated group (but is not unlawful) Unlawful: Contravenes (or potentially contravenes) current equalities and human rights legislation (e.g. direct or indirect discrimination either institutionally and/or individually) Advice from the Equality and Diversity Lead and/or legal advice must be sought. NHS Borders SBC July