Putting NICE guidance into practice

Transcription

1 Putting NICE guidance into practice Costing statement: Atrial fibrillation and heart valve disease: selfmonitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor). Published: September 2014 NICE Diagnostics Guidance DG14 National costing statement: CoaguChek XS (September 2014) 1 of 10

2 1 Introduction 1.1 The guidance on Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor) (NICE diagnostic technology appraisal guidance 14) has the potential to lead to cost savings for Clinical Commissioning Groups (CCGs) and NHS England through self-monitoring of coagulation status and improved management of long-term vitamin K antagonist therapy and associated adverse events for people with atrial fibrillation and heart disease. 1.2 A costing statement has been produced, rather than a costing report and costing template, because the level of uptake and the way in which the service is implemented will vary between areas. Therefore the cost impact cannot be estimated nationally, and should be assessed locally. 1.3 Depending on local arrangements the commissioner for anticoagulation services is NHS England area teams when provided in primary care or CCGs where provided through secondary care or community services. Commissioners should collaborate with providers to ensure that selfmonitoring services are appropriately funded. National costing statement: CoaguChek XS (September 2014) 2 of 10

3 2 Background 2.1 People with atrial fibrillation or heart valve disease who are treated with vitamin k antagonists usually attend anti-coagulation services in hospitals or clinics, such as for international normalised ratio (INR) testing. INR is a measure of the time it takes for blood to clot. The prescribed dose of vitamin k antagonist can then be adjusted depending on the test result. The number of visits can vary depending on the stability of the person s INR, but can be up to around 20 times per year (NICE Anticoagulation therapy Commissioning and budgeting tool). 2.2 Self-monitoring with coagulometers may reduce the frequency of visits to hospital or clinics for patients and enable them to be monitored more regularly. This may improve health outcomes by enabling the dose of therapy to be adjusted more accurately, thereby avoiding adverse events that can result from an inappropriate dose of long-term vitamin K antagonist therapy, such as stroke and major haemorrhage. 2.3 People using coagulometers for self-monitoring may either self-test or self-manage. Self-testing refers to the user doing the INR test themselves and then contacting their healthcare professional with the reading for advice on any change to the dosage of the anticoagulant that may be needed. Self-managing refers to the user doing the INR test themselves and then self-adjusting the dosage of their anticoagulant medication by following an agreed care protocol. 2.4 Expert opinion indicates that current use of coagulometers is limited and is dependent on local services. Funding for devices is often provided by patients. National costing statement: CoaguChek XS (September 2014) 3 of 10

4 3 Recommendations 3.1 The guidance states that: The CoaguChek XS system is recommended for self-monitoring coagulation status in adults and children on long-term vitamin K antagonist therapy who have atrial fibrillation or heart valve disease if: - the person prefers this form of testing and - the person or their carer is both physically and cognitively able to self-monitor effectively. The InRatio2 PT/INR monitor is recommended for self-monitoring coagulation status in adults and children on long-term vitamin K antagonist therapy who have atrial fibrillation or heart valve disease if: - the person prefers this form of testing and - the person or their carer is both physically and cognitively able to self-monitor effectively. Although there is greater uncertainty of clinical benefit for the InRatio2 PT/INR monitor than for the CoaguChek XS system, the evidence indicates that the precision and accuracy of both monitors are comparable to laboratory-based INR testing. Patients and carers should be trained in the effective use of the CoaguChek XS system or the INRatio2 PT/INR monitor and clinicians involved in their care should regularly review their ability to self-monitor. Equipment for self-monitoring should be regularly checked using reliable quality control procedures, and by testing patients equipment against a healthcare professional s coagulometer which is checked in line with an external quality assurance scheme. Ensure accurate patient records are kept and shared appropriately. For people who may have difficulty with or who are unable to selfmonitor, such as children or people with disabilities, their carers should be considered to help with self-monitoring. National costing statement: CoaguChek XS (September 2014) 4 of 10

5 4 Patient numbers affected 4.1 Coagulometers are appropriate for people who prefer, and are physically and cognitively able to self-monitor effectively. Table 1 shows the estimated population within England who may be eligible. However of these 450,000 people the number who prefer, or are considered able to self-monitor is unknown. Table 1 Estimated eligible population for self-monitoring in England Population group Percentage Population Notes Atrial fibrillation People with atrial fibrillation 1.3% 720,000 a People with atrial fibrillation treated with vitamin K antagonists 0.6% 340,000 Heart valve disease People with heart valve disease 2.5% 1,400,000 b People with a prosthetic heart valve 0.2% 110,000 c Estimated eligible population 0.8% 450,000 d a. Atrial fibrillation affects around 800,000 people in the UK as a whole. For more information on the management of Atrial Fibrillation, see the Patient Decision Aid, Atrial Fibrillation, NICE Clinical Guideline 180, b. Nkomo V, Gardin J, Skelton T et al. (2006) Comment in Lancet Sep 16; 368(9540):969-7 c. While the recommendations relate to people who have heart valve disease, those with a prosthetic heart valve are more likely to be treated with vitamin k antagonists and therefore affected by the guidance. As a result this group has been used in the estimated potentially eligible population. d. Additional information on the population affected by the recommendations is available in the guidance 4.2 The number of people who self-monitor may be determined by how many training slots are available and the number of devices that are commissioned. The proportion of people who are trained to self-monitor and then discontinue should be estimated locally. National costing statement: CoaguChek XS (September 2014) 5 of 10

6 5 Resource impact Potential costs 5.1 Self-monitoring incurs additional costs for purchasing coagulometers and training people to use them, as well as ongoing costs for consumables such as testing strips and lancets. A full breakdown of the estimated costs is included in appendix A. 5.2 A summary of the initial investment and annual costs is shown in table 2 below. The costs depend on whether the service is being administered in primary or secondary care. Table 2 Annual costs for self-monitoring with the CoaguChek XS in primary or secondary care Self-testing Self-management Setting Initial investment Annual administration cost Primary care Secondary care Primary care Secondary care The list prices at the time of publication of the 2 coagulometers recommended for consideration (CoaguChek XS and InRatio2) are 299 and 275 respectively. The year 1 costs shown in table 2 include initial purchase of the device, along with training and management costs. The device may have to be replaced such as due to loss or damage. 5.4 Self-testing typically involves the person being phoned by the clinic administering the service to check their test results and recommend dosage changes. This means that costs can be incurred where there are additional staffing requirements, and for telephone calls. Increasingly however, IT systems are being used to automate this system, potentially reducing such costs. The impact of implementing such a service should be assessed locally. 5.5 The cost of the device and consumables could affect CCGs where the service is provided through secondary care or community services, and/or NHS England where the service is provided in primary care. National costing statement: CoaguChek XS (September 2014) 6 of 10

7 Potential savings and benefits 5.6 Self-monitoring allows greater frequency of INR monitoring, and so more appropriate dosage of oral anticoagulants. This can reduce rates of adverse events such as stroke or major haemorrhages, and therefore future treatment costs. A detailed breakdown of the treatment costs potentially avoided are included in appendix B; a summary is provided below: Major bleed (non-cranial): 1120 Systemic embolism: 1050 Minor stroke: 5600 initial treatment cost; 310 per quarter on an ongoing basis Major stroke: 8000 initial treatment cost; 4000 per quarter on an ongoing basis 5.7 As the costs of treating adverse events are considerably higher than those of self-monitoring, avoiding a small number of high-cost adverse events has the potential to make the initial investment cost-saving. 5.8 The adverse events avoided through anti-coagulation services are predominantly treated through secondary care. As a result, savings are expected to affect CCGs. 5.9 Where self-monitoring leads to decreased demand for services such as anti-coagulation clinics there may be savings for both CCGs and NHS England. The annual cost of anti-coagulation monitoring within a primary or secondary care setting has been estimated to be approximately 250 per person (Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation, NICE Guidance TA249 increased in line with CPI inflation). These potential savings should be considered locally The guidance includes an assumption that some devices can be reused when a person who is self-monitoring discontinues, which may lead to efficiency savings in the administration of the self-monitoring service. National costing statement: CoaguChek XS (September 2014) 7 of 10

8 5.11 Additional benefits of coagulometer services for patients include not having to attend anticoagulation clinics on a regular basis and the avoidance of costs of the coagulometer device which may currently be incurred by the patient. 6 Conclusion 6.1 Self-monitoring through use of CoaguChek XS or InRatio2 PT/INR coagulometers has the potential to be cost-saving for CCGs as the increased frequency of INR monitoring may improve health outcomes by enabling the dose of therapy to be adjusted more accurately, thereby avoiding adverse events that can result from an inappropriate dose of long-term vitamin K antagonist therapy, such as stroke and major haemorrhage. 6.2 The use of self-monitoring may also result in a decreased demand for INR monitoring at anticoagulation clinics which may lead to savings in these services for CCGs and NHS England. 6.3 Additional monitoring costs can be more than offset by savings because of the avoidance of a small number of adverse events. 6.4 Rather than the purchase of the device being funded by patients, the initial investment in training, the device and the consumables may be provided by CCGs or NHS England area teams, depending on how the service is commissioned. Commissioners should collaborate with providers to ensure that self-monitoring services are appropriately funded. National costing statement: CoaguChek XS (September 2014) 8 of 10

9 Appendix A Costs of self-monitoring Self-monitoring costs Primary care Secondary care Self-testing CoaguChek XS INRatio2 CoaguChek XS INRatio2 Year 1 costs Device list price Training Initial costs Total year 1 costs Annual recurrent costs Test strips and lancets Quality control tests Phone calls (nurse time) Annual recurrent costs Self-management Year 1 costs Device list price Training Initial costs Total year 1 costs Annual recurrent costs Test strips and lancets Quality control tests Annual recurrent costs Device list prices were provided by the manufacturers. Actual cost may vary. 2. Existing literature and expert opinion suggests self-testing would require 2 hours, and self-management 4 hours of one-to-one training. Training time was costed using hourly rates for patient contact time - 45 per hour for practice nurses in primary care, and 85 per hour for hospital clinic nurses (Unit costs of health and social care, 2013). Where staff time is already available to provide this service along with current responsibilities, there may be no additional cost. 3. Unit costs of test strips were provided by the manufacturers, with test strips costing 2.81 and 2.75 for the CoaguChek XS and INRatio2 respectively. Lancets were approximately 0.04 and 0.05 respectively. It was assumed that all self-monitoring would include around 35 tests per year. 4. It was assumed that twice annually coagulometers would be checked against an externally validated one, with each visit requiring 15 minutes of face-to-face contact time (see costs on footnote 2). Where staff time is already available to provide this service along with current responsibilities, there may be no additional cost. Each test also requires a testing strip and a lancet. 5. It was assumed that where additional staff time was required for people who are self-testing to call in each test result would be 5 minutes of band 5 nurse time for each of the 35 test (see costs on footnote 2) Where staff time is already available to provide this service along with current responsibilities, there may be no additional cost. National costing statement: CoaguChek XS (September 2014) 9 of 10

10 Appendix B Adverse event treatment costs Adverse events Type of treatment Cost ( ) Source Description Transient events Minor bleed Acute treatment 118 VB07Z category 2 investigation with category 2 treatment Major bleed Cost of a gastro-intestinal bleeding treatment episode. Weighted (nonintracranial) Acute treatment 1,122 PbR Costs 2014/15 average of codes: FZ38D, FZ38E, FZ38F, FZ43A, FZ43B, FZ43C Systemic Cost of non-surgical peripheral vascular disease. Weighted average of Acute treatment 1,046 embolism codes: QZ17A, QZ17B, QZ17C Permanent events Acute treatment 3,582 PbR Costs 2014/15 AA22A and AA22B: non-transient stroke or cerebrovascular accident, nervous system infections or encephalopathy (weighted average) Minor stroke Follow-on care costs per quarter 309 Wardlaw 2006; NICE Clinical Guideline CG92 Increased by rate of inflation (CPI) to 2014 Major stroke Acute treatment / National schedule of 7,964 rehabilitation reference costs 2014/15: Per excess bed day 204 non elective inpatient Follow-on care costs per quarter 3,984 Wardlaw 2006; NICE Clinical Guideline CG92 AA22A and AA22B: non-transient stroke or cerebrovascular accident, nervous system infections or encephalopathy (weighted average); rehabilitation at 313 per day for 14 days Increased by rate of inflation (CPI) to 2014 Intracranial bleed Acute treatment / rehabilitation Follow-on care (costs per quarter) 5,856 PbR Costs 2014/15 2,674 Nice Clinical Guideline CG92 AA23A and AA23B - haemorrhagic cerebrovascular disorders with CC and haemorrhagic cerebrovascular disorders without CC (weighted average); rehabilitation at 313 per day for 14 days Increased by rate of inflation (CPI) to 2014 National costing statement: CoaguChek XS (September 2014) 10 of 10