Acsma anticoagulation services in england report by Eve Knight

AntiCoagulation services and patient access to INR self-monitoring in the NHS in England

A report by the AntiCoagulation Self-Monitoring Alliance July 2014

Contents

1. Executive Summary

2. Introduction

3. Methodology and responses

4. Main Findings

4.1 Commissioning arrangements for anticoagulation services

4.2 Location of the anticoagulation service

4.3 Access to self-monitoring

4.4 Are policies dependent upon a personâ&#x20AC;&#x2122;s underlying condition?

4.5 Prescribing of test strips

4.6 Clinical Commissioning Group guidance and guidelines on self-monitoring

4.7 Information provided to patients

5. Conclusions

6. Recommendations

7. Appendices

Appendix 1 Background to the AntiCoagulation Self-Monitoring Alliance

Appendix 2 Freedom of Information Request Questions to Clinical Commissioning Groups 31 Appendix 3 List of Clinical Commissioning Group respondents

1 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

1. Executive Summary There are more than 1.2 million people in the UK on warfarin therapy, of whom fewer than two per cent selfmonitor their International Normalised Ratio (INR) level, despite evidence that self-monitoring can cut the risk of death by nearly two-fifths and more than halve the risk of strokes1. Responses to Freedom of Information (FOI) requests for details on the current anticoagulation services offered by Clinical Commissioning Groups (CCGs) highlight substantial room for improvement in the role of CCGs, in enabling suitable people on long-term warfarin to have access to self-monitoring opportunities. ACSMA expects that the forthcoming evaluation decision from the National Institute for Health and Care Excellence (NICE) - due in September 2014 – will help convince CCGs of the clinical- and cost-effectiveness of coagulometers such as the CoaguChekXS and INRatio2. The AntiCoagulation Self-Monitoring Alliance (ACSMA) was set up in October 2012 to raise awareness of the benefits of self-monitoring and to campaign for greater access via NHS prescription to INR self-monitoring technology for patients on long-term warfarin therapy. During the course of the campaign, it became clear that, while Government and Ministers were supportive of self-monitoring and patient self-management of long-term conditions more broadly, this was not necessarily being translated into action by the 211 CCGs responsible for commissioning and funding anticoagulation services. Anecdotal evidence received from people on warfarin treatment, their carers and healthcare professionals suggested that people were routinely facing a number of obstacles to self-monitoring: some were told that their CCG did not allow self-monitoring on cost grounds or for reasons of safety; alternatively, their GP or anticoagulation nurse had never heard of self-monitoring (despite the technology having been available for twenty years), or was concerned about the medico-legal implications if ‘something went wrong’. As a result, in January 2014 ACSMA undertook an exercise to try and ascertain more clearly what was happening in CCGs across England using FOI requests to elicit information about anticoagulation service provision, current practices and policies directly from the CCGs themselves. The FOI request comprised seven questions regarding the CCG’s current anticoagulation service, how it is configured and funded, the CCG’s policy towards self-testing and self-monitoring, and the existence of local guidelines and patient information. Completed FOI responses were received from 178 of the 211 CCGs in England (84%). The FOI responses received supported ACSMA’s anecdotal evidence that the vast majority of people on longterm warfarin simply do not have access to self-monitoring opportunities. There is also a huge variation in how and where anticoagulation services are located and paid for, the reasons given why self-monitoring is, or is not, supported, and the criteria applied. 1 2

Heneghan C et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006;367(9508):404-11. Anticoagulation Europe (UK) ‘Commissioning effective anticoagulation services for the future’ November 2012 Heneghan C et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006;367(9508):404-11.

AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

Disappointingly, only one-third (34%) of CCGs allow people to self-test their INR level and 28% of all CCGs allow self-management (which includes self-testing). This means that the vast majority of people on long-term warfarin are being denied the opportunity to self-monitor, despite the benefits to the patient in terms of health outcomes1, convenience and quality of life, and the long-term cost saving to the health service. The responses also highlight the reasons why CCGs do not offer self-monitoring, as well as other concerns raised: about the accuracy of the test results, perceived costs, clinical governance, safety and the lack of demand from patients. Most CCGs (63%) commission their anticoagulation services through a combination of primary care and secondary care, with only 12% of CCGs commissioning via primary care alone. Irrespective of where the service is located, a wide variety of mechanisms are used to commission and fund the service, including block contracts, payment by results (PbR), local enhanced services, local tariffs, on a cost per case, via the ‘any qualified provider’ route, or a combination of these. Even though the testing device itself is not available on NHS prescription, it has been possible for people who self-monitor to obtain the test strips on NHS prescription since 2002. ACSMA’s information suggested that more and more CCGs were now refusing to allow NHS prescribing of test strips, or were imposing limits on the number of test strips allowed. The FOI responses would seem to confirm that; only one-third (34%) of CCGs currently allow GPs to prescribe test strips on a NHS script. Only 7% of CCGs have any formal local or published guidelines or guidance in place about self-monitoring, which means that even a significant proportion of CCGs which claim to offer self-monitoring do not have any published policy in place. Similarly, 75% of CCGs do not offer information on self-monitoring to patients, or have any information available. This is perhaps not so surprising, given the large proportion of CCGs which do not currently support either self-testing or self-management, but it does highlight a key problem which many people have been writing to ACSMA about: without formal channels of information or support, people are finding out about selfmonitoring by accident, through word of mouth or via a supportive patient organisation or health professional. In conclusion, many patients on long-term warfarin are being denied the opportunity to see if they would be suitable for self-monitoring. Even in those places where people are allowed to self-monitor, the CCG often raises other concerns or adopts other criteria, which precludes self-testing or management from being made routinely available to all: these include cost, clinical safety, the accuracy of testing and medico-legal concerns. The FOI responses highlight a real lack of interest in wanting to innovate or redesign anticoagulation services around the needs and preferences of the patient. Several CCGs do not believe there is a convincing business case for supporting self-monitoring or that the opportunity costs for developing an anticoagulation service based around self-monitoring for suitable patients would be disproportionate. Other CCGs do not allow people to selfmonitor as they believe their current system of anticoagulation provision is safe and effective – in other words, 3 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

there is no reason to change. These responses are disappointing because there is already strong supporting evidence that self-monitoring can improve health outcomes, offer patient choice and convenience, and save time and money for both individuals and the NHS. ACSMA expects that the forthcoming evaluation decision from the National Institute for Health and Care Excellence (NICE) - due in September 2014 - will help convince CCGs of the clinical- and cost-effectiveness of coagulometers such as the CoaguChekXS and INRatio2. Although the majority of CCGs do not have a formal CCG-wide policy in place supporting self-monitoring on a routine basis, it does not always means that people on long-term warfarin are denied the opportunity to selfmonitor as examples of good local practices exist. A number of CCGs take into account a person’s social circumstance, home environment and whether the use of self-monitoring technology could be considered as a safe choice for them. Others have delegated the decision to the GP, for him or her to make in conjunction with the patient and, where appropriate, consultant haematologist. These encouraging examples need to be shared more widely across the country to allow other people the opportunity to self-monitor. Above all, the FOI responses highlight how little is known by CCGs and, one assumes, healthcare professionals, about the reality of self-monitoring, and the available evidence supporting its clinical and cost-effectiveness, and the benefits to patients in terms of greater control over their own lives, convenience and reassurance. To help improve access to self-monitoring for people on long-term warfarin, the report makes the following recommendations: •

NHS service commissioners and providers need to look to how anticoagulation services can be redesigned and liberated2 from the hospital and primary care clinics so as to ensure that, wherever possible, all suitable patients are given the choice to self-monitor their INR levels, should they wish to and are competent to do so.

•

There is a lack of knowledge on the part of both patients and healthcare professionals about self-monitoring. CCGs must provide information they can offer to both groups.

•

There is an urgent need to address the disconnect between national Government policies - which are supportive of greater self-management and choice for people - and poor implementation of those policies at local NHS level.

•

Those who are successfully self-monitoring should be given appropriate support and encouragement to do so; including being allowed to receive test strips on NHS prescription and in terms of information. All too often, ACSMA hears of people having to do battle with their healthcare professional or CCG in order to be allowed to continue to self-monitor.

Anticoagulation Europe (UK) ‘Commissioning effective anticoagulation services for the future’ November 2012

4 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

•

Examples of local best practice by CCGs and GPs that allow people to self-monitor need to be promoted and shared widely.

•

Whilst ACSMA welcomes NICE’s provisional recommendation for the CoaguChek XS and INRatio2 selfmonitoring devices, we need to have choice for all people on warfarin and we will work to ensure that selfmonitoring becomes available on NHS prescription to all eligible warfarin patients.

5 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

2. Introduction 2.1 Self-monitoring There are more than 1.2 million people in the UK on warfarin therapy, of whom fewer than two per cent benefit from self-monitoring of their International Normalised Ratio (INR) level, despite evidence that self-monitoring can cut the risk of death by nearly two-fifths and more than halve the risk of strokes3. There are many reasons why a person might need to have long-term anticoagulation treatment, for example, with warfarin. He or she might have been diagnosed with atrial fibrillation, have had a venous thromboembolism or deep vein thrombosis, suffer from a congenital cardiovascular condition or have had a mechanical heart valve fitted. It is essential for people on long-term warfarin therapy to have their INR level tested on a regular basis. This is a measure of the blood’s clotting level: if the blood is too “thin”, there is a risk of excessive bleeding or haemorrhage; too thick, and there is a risk of a blood clot, or embolism, or a stroke. Current estimates indicate that the management of oral anticoagulation therapy of stable patients costs the NHS approximately £409 million per year4. Self-testing allows a person to test their INR themselves at home or at a place and time convenient to them, using a simple and quick finger-prick test, and then contact their healthcare professional to adjust the dose of warfarin, as required. Self-management allows a person to test their INR at home and then adjust their own warfarin dosage (within the limits set by his or her healthcare professional). Collectively, self-testing and selfmanagement are known as patient self-monitoring. People who self-monitor use a portable INR testing device to take a simple blood test - they take a small drop of blood from their finger and report the reading to their doctor or nurse for advice, or act on it themselves. Apart from the improved health outcomes listed above, self-monitoring is convenient for the patient and reduces clinic attendance. In a 2011 survey, 70% of people on long-term warfarin therapy found regular clinic visits inconvenient5. In addition, self-monitoring provides improved quality of life such as the ability to test when it is convenient and the freedom to travel for business or pleasure. 2.2 The AntiCoagulation Self-Monitoring Alliance The AntiCoagulation Self-Monitoring Alliance (ACSMA) was set up in October 2012 to campaign for greater access via NHS prescription to INR self-monitoring technology for patients on long-term warfarin therapy and to: •

Increase awareness amongst policy-makers, patients, clinicians and commissioners of the value of selfmonitoring to patients, the NHS and health outcomes

Heneghan C et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006;367(9508):404-11. Fitzmaurice DA et al. Self-Management of Oral Anticoagulation Therapy (SMART Trial). BMJ 2005; 331: 1057 5 AntiCoagulation Europe and Roche Diagnostics survey of people on long-term warfarin, Atrial Fibrillation Association, May 2011. 3 4

AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

•

Condition, influence and shape a positive political and NHS environment which encourages and supports self-management of anti-coagulation therapy

•

Build the reputation of the Alliance and its individual member

•

Initiate and foster new relationships for the Alliance with policy-making and political audiences

•

Identify and build advocates or champions for Alliance messages

2.2 The problem Whilst the UK Government and Ministers have been consistently supportive of self-monitoring and the benefits it can bring to patients, carers and the NHS, this has not always been reflected in its availability to patients and this became increasingly apparent as the most recent round of NHS reforms started to bed in. Since the beginning of 2013, 211 Clinical Commissioning Groups (CCG) across England are responsible for commissioning and funding anticoagulation services. Anecdotal evidence received from people on warfarin treatment, their carers and healthcare professionals suggested that people were routinely facing a number of obstacles to self-monitoring: people were told that their CCG did not allow self-monitoring on cost grounds or for reasons of safety; alternatively, their GP or anticoagulation nurse had never heard of self-monitoring (despite the technology having been available for nearly 15 years), or was concerned about the medico-legal implications if ‘something went wrong’. In the summer of 2013, ACSMA conducted an online survey amongst people on long-term warfarin and their carers. More than 180 responses were received. The survey found that people were often discouraged from selfmonitoring by their GP or anticoagulation nurse, did not know that self-monitoring was even an option or available, and were routinely advised – erroneously - that test strips were not (now) available on NHS prescription and had to be paid for6. A meeting between ACSMA and senior representatives from NHS England, together with responses to parliamentary questions, consistently reiterated that it was a matter for each CCG to determine how best to configure its local anticoagulation service and whether or not (and, if so, on what basis) to support one or more types of self INR self-monitoring for people on long-term warfarin.

This advice is incorrect as a number of blood testing strips are available on prescription under Part IXR of the Drug Tariff for England and Wales, which is compiled on behalf of the Department of Health by the NHS Business Services Authority, NHS Prescription Services. In the current (August 2014) version of the Drug Tariff, test strips for the following three meters are available on NHS prescription: Alere INRatio, Coaguchek XS PT and ProTime 3 cuvettes. The ProTime microcoagulation system, is no longer available to the NHS and its successor model is not intended for patient self-monitoring.

NHS Prescription Services, NHS Business Authority. Drug Tariff for England and Wales. August 2014 edition. http://www.ppa.org.uk/edt/August_2014/mindex.htm Last accessed 15th August 2014.

AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

In order to better understand CCGsâ&#x20AC;&#x2122; policies regarding self-monitoring, ACSMA decided to issue Freedom of Information (FOI) Act requests to each of the 211 CCGs across England. This report details the process undertaken, the reasons why, and the responses ACSMA received.

8 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

3. Methodology and responses The Freedom of Information Act 2000 was designed to assess and improve both the openness of public sector organisations, and their accountability in the public interest. FOI requests give individuals the right to ask any public sector organisation for the recorded information they have on any given subject. This includes government departments, local councils, health trusts, hospitals, CCGs and doctors’ surgeries. Public sector organisations are legally obliged to respond to FOI requests and to supply the information requested within 20 working days of the request. ACSMA hoped that FOI requests directed at all 211 CCGs in England would quickly provide it with definitive information about CCG policies on self-monitoring for people on long-term warfarin, a clearer national picture of anticoagulation service provision and strong supporting data to share with policy-makers and other decisionmakers. The FOI request comprised seven questions (please see appendix 2 for details), drafted and agreed amongst the five ACSMA member organisations. The questions aimed to identify information about each CCG’s anticoagulation service - how it is configured and commissioned – as well as policies towards self-testing and self-management for people on long-term warfarin, available guidelines, guidance and information for patients, the provision of testing strips on prescription and any planned policy reviews. The 211 FOI requests – one per CCG – were sent in January 2014 by email to the person nominated in each CCG to receive FOI requests. 178 CCGs completed the FOI request, representing a response rate of 84%. Whilst CCGs have a legal obligation to reply to FOI requests this still represents a fantastic response rate. The vast majority – but not all - of CCGs answered all of the seven questions. Some CCGs provided additional explanatory detail, whereas the majority provided only short, factual responses.

9 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

4. Main Findings 4.1 Commissioning arrangements for anticoagulation services 174 of the 178 CCGs who responded commission some form of anticoagulation service. Three CCGs do not commission an anticoagulation service; these are Central Manchester, North East Lincolnshire and Enfield CCGs. One CCG Castle Point, Rayleigh and Rochford CCG was in the evaluation stage of procurement for a Deep Vein Thrombosis service in primary care and so did not provide an anticoagulation service currently.. CCGs commission their anticoagulation services in a number of ways: block contract, payment by results (PbR), local enhanced services, local tariffs, cost per case, any qualified provider, or a combination of these7. The vast majority of CCGs gave no further details about what this arrangement entailed. The anticoagulation service for North East Lincolnshire CCG is commissioned through the primary care/General Medical Services contract, which is overseen by NHS England. Castle Point, Rayleigh and Rochford CCG in Essex is in the evaluation stages of procuring a deep vein thrombosis service in primary care which would include anticoagulation provision. The provider/s will be paid on a per patient basis. Mixed commissioning The most common arrangement made by CCGs is to have a mixture of commissioning provision; this applied to 32% of the CCGs as shown in Figure 1. For example, West Norfolk CCG provides an anticoagulation service that is delivered through a combination of PbR (primary care) and block contract (secondary care). The service is currently under review with all other local enhanced services currently provided by general practice; it is part of the wider changes introduced as a consequence of the Health and Social Care Act 2012. Conversely, North Norfolk CCG commissions an anticoagulation service exclusively in primary care. This is funded on a cost per patient basis to cover the review of the patient, taking blood and carrying out INR analysis and dosing, with changes if necessary. However, patients newly diagnosed in secondary care are initially monitored as part of their inpatient care. This would be covered by the PbR tariff covering the reason for their admission, but is not specifically commissioned outside the overall acute hospital contract. North Norfolk CCG is likely to review the delivery of the primary care anticoagulation service within the next year. Wandsworth CCG’s anticoagulation service is located in both primary and secondary care. The secondary care service is commissioned through a block contract, whereas the primary care service is commissioned by patient ‘A block contract’ is often put in place between health care purchasers (commissioners) and health care providers, in which a wide range of services are agreed to be provided within an agreed budget. ‘Payment by results’ is when payments for the service depends upon the results achieved. ‘Local enhanced services’ are services provided to patients over and above the core (essential and additional) services,that must legally be offered to meet local health needs. ‘Local tariffs’ are locally agreed costs of providing a service/treatment. ‘Cost per case’ is when a service/treatment is provided to a patient based upon each individual’s circumstances. ‘Any qualified provider’ is when any registered healthcare provider is permitted to offer services.

10 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

activity. The CCG is currently in the process of recruiting a project manager whose remit will be to review existing anticoagulation service and to provide recommendations on future commissioning arrangements. Figure 1 - Anticoagulation service commissioning arrangements

Mixture (32%) Paymeny by results (PbR) (20%) Block contract (13%) Other (8%) (e.g. community providers or GP PracFce) Both payment by result and block contract (7%) Local tariﬀs (6%) Local enhanced services (5%) No informaFon provided (3%) Cost per case (2%)

Payment by results 20% of CCGs commission their anticoagulation service via PbR. This includes the following CCGs: Mansfield & Ashfield, Newark & Sherwood, South Kent Coast, Stoke on Trent, Castle Point, Rayleigh and Rochford. Hartlepool & Stockton on Tees and South Tees CCGs have historically commissioned a local enhanced service with GP practices, which covers the monitoring of patients. Secondary care deal with the initiation of anticoagulation therapy before handing the patient back to the GP practice for the ongoing monitoring. The local enhanced services have historically been different in each locality and this means there are currently four schemes in place within the CCG’s territory. The local enhanced services in place rewards practices with an annual PBR for each patient on their anticoagulation list, so is classed as PBR activity. St Helens CCG commissions its anticoagulation service through PbR via secondary care providers. PbR is based on 2012/13 published activity. The primary care service is funded as an annual fee per patient monitored, plus the cost of consumables. Dudley CCG commissions the service through a PbR arrangement with an additional small block value to cover consultant input.

11 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

Block Contracts 13% of CCGs commission their anticoagulation services via block contracts. This includes the following CCGs: Newbury, Doncaster, Wolverhampton, Bolton, Coastal West Sussex, West Cheshire, Rotherham and the Isle of Wight. No further information has been provided about any of these services.

4.2 Location of the anticoagulation service Unsurprisingly, given the variety of responses in section 3.1, the location of the anticoagulation service varies from CCG to CCG. The vast majority of the anticoagulation services are provided by a mixture of both primary and secondary care (see Table 1 below). Typically, this involves getting the warfarin script from your GP, but paying a regular visit to an outpatient anticoagulation clinic in a secondary care/hospital setting. Initiation of therapy often takes place in secondary care also. Only 12% of CCG respondents have located their service exclusively in primary care, where it is at least theoretically more accessible (although not necessarily any more convenient) to the patient. Table 1 â&#x20AC;&#x201C; Location of anticoagulation service Anticoagulation provider

Percentage of

Example CCGs

CCG responders Primary and secondary care

63%

Ashford; Eastern Cheshire; Liverpool; Herts Valley; and Waltham Forest.

Primary care only

12%

North East Essex; Bath & North East Somerset; Bolton; Tameside & Glossop; West Leicestershire; and Kernow.

Secondary care only

Hillingdon; Southend; Ipswich & East Suffolk; Basildon & Brentwood; Vale of York; and Redbridge.

Other settings, including community provider and mixture of settings

16%

Coastal West Sussex; Brighton & Hove; Bedfordshire; Medway; and Nottingham West.

Most of the CCGs simply stated where the service is located, without giving any explanation. Of those which did provide additional information, Dudley CCG currently commissions the anticoagulation service through secondary care, but sessions are provided in community-based clinics and there is a domiciliary service for people who are house-bound. Luton CCG currently has three services providing monitoring for patients on anticoagulation therapy: hospital foundation trust (secondary care - initiation and routine monitoring - block contract), community service (community based - routine monitoring - block contract) and a GP local enhanced service (primary care - routine monitoring - activity based funding).

12 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

4.3 Access to self-monitoring ACSMA had anecdotal evidence that CCGs do not actively encourage self-monitoring for people on long-term warfarin. Unfortunately, this has been confirmed by the FOI responses received from the CCGs. The majority of CCGs do not allow or support self-monitoring, which means that many patients on long-term warfarin are being denied the opportunity to see if they would be suitable for self-monitoring. Even when people on long-term warfarin are allowed to self-monitor, CCGs often put obstacles in their way such as cost, clinical safety and accuracy of testing. This is despite the strong evidence of the benefits of self-monitoring to the patients and the potential long-term cost savings to the NHS. Only 28% of CCGs allow people to self-manage their own INR (see Figure 2) and only one-third, or 34 %, of CCGs allow people to self-test their INR (see Figure 3). Self-testing allows a person to test their INR themselves at home and then contact their healthcare professional with the result, so that the healthcare professional can advise on any warfarin dose adjustment that is necessary. Figure 2 – Do you allow patients to self-manage their INR?

No (60%)

Yes (28%)

N/A or no policy (12%)

13 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

Figure 3 – Do you allow patients to self-test their INR?

No (54%) Yes (34%) N/A or no policy (12%) Self-testing, but not self-management As Figures 2 and 3 above show, some CCGs allow self-testing, but do not allow self-management, where the patient is given the choice of adjusting their own warfarin dose (albeit usually within parameters previously agreed with their healthcare professional). These include Oxford, Ashford, Great Yarmouth & Waveney, Bromley, Ealing, Sandwell & West Birmingham, Durham Dales, and Easington & Sedgefield CCGs. West Suffolk CCG will consider allowing self-testing if it has been deemed appropriate following a review by the anticoagulant monitoring service. Dudley CCG will allow self-testing, but this has to be agreed for patients meeting specific criteria and is commissioned on an individual basis. Barnet CCG allows self-testing, with the decision being made between the patient and the anticoagulation service provider, but not self-management. Routine management Even when CCGs do allow people to self-monitor, it is rarely offered routinely to all. For example, Mansfield & Ashfield CCG and Newark & Sherwood CCG both stated that while there is the opportunity for a patient to selfmonitor, it is not “routine management”. North Norfolk CCG, West Norfolk CCG, South Norfolk CCG and Norwich CCG all allow people to self-test or self-manage their condition, but only where this is considered clinically appropriate. However, the practice is not encouraged; this is primarily due to the cost implications such a decision entails, along with the fact that, in most cases, patients prefer GP involvement, which allows changes in dosage (where necessary) to be carried out.

14 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

The FOI request then went on to ask CCG’s to explain the reasons why they did, or did not, permit self-testing or self-monitoring. They identified a number of issues, including safety, testing accuracy, no need for change, a lack of demand for self-monitoring, and concerns that the cost of providing a self-monitoring option would be disproportionate to the benefits. Safety concerns The three CCGs in Leeds (South and East, North, and West) all currently allow self-monitoring, but state that more evidence of safety and effectiveness is required. The cost of providing self-monitoring devices and technology for communicating the result to patients is seen as being prohibitively high. Harrogate and Rural District CCG does not allow people to self-monitor as it believes its current system of anticoagulation provision is safe and effective – in other words, there is no reason to change. These responses are disappointing because there is already strong supporting evidence that self-monitoring can improve health outcomes, offer patient choice and convenience, and save time and money for both individuals and the NHS8. Well-managed anticoagulation therapy reduces the risk of stroke by nearly 70%9. Several studies10 have shown that patient self-monitoring can improve the quality of oral anticoagulant therapy, with those who selfmanage having fewer thromboembolic events and lower mortality rates. Specifically, there is evidence that selfmonitoring can cut the risk of death by nearly two-fifths and more than halve the risk of strokes11. Of those CCGs that do support self-monitoring, most have put in place reasonable criteria to ensure safety and clinical governance. North Staffordshire CCG states that the decision to allow self-monitoring is dependent upon a number of factors, including the person’s social circumstance, home environment and whether the use of self-monitoring technology could be considered as a safe choice for them. Somerset CCG insists that the patient's GP assures themselves that the monitoring is to the same standard as that undertaken by the practice and therefore that the results are accurate and communicated appropriately, to ensure that the dose prescribed by the GP is safe. To do so, the GP would need to understand what equipment is required and be reassured by the maintenance and accuracy procedures that a patient has in place for their equipment and ensure that the patient only tests at the required interval, depending on their condition and baseline INR (i.e. that they are not ‘over’ or ‘under’ testing). Accuracy of self-monitoring Several CCGs expressed concerns over the quality control of the testing strips and GPs' ability to prescribe and monitor appropriately when patients self-monitor. Cambridge and Peterborough CCG carried out a review, which suggested that self-management is more expensive, as well as less reliable, than an outpatient service. Connock M, Stevens C, Fry-Smith A, Jowett S, Fitzmaurice D, Moore D, et al. Clinical effectiveness and cost-effectiveness of different models of managing long-term oral anticoagulation therapy: a systematic review and economic modelling [online]. Health Technol.Assess. 2007 ix-66; Oct;11(38):iii-iv, ix-66. 9 NHS Information Centre. The percentage of patients with atrial fibrillation who are currently treated with anticoagulation drug therapy or an antiplatelet therapy QOF 3. 10 Self-monitoring and self-management of oral anticoagulation (Review). The Cochrane Collaboration. 11 Heneghan C et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006;367(9508):404-11. 8

AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

However, it is currently reviewing this. This is in contrast to South Tyneside CCG, which allows patients to selfmonitor based on individual circumstances and always aims to achieve safest management. Once again, the accuracy of self-monitoring test results is well supported by evidence. Self-monitoring enables people to spend more time within their therapeutic range (the range of concentrations at which drugs are effective with minimal toxicity). 80% of poorly controlled patients moved into the well-controlled category after starting selfmonitoring. The average improvement of time in therapeutic range was 16.8%. With just a 5% improvement in time in therapeutic range, 500 strokes would be prevented annually and would save the NHS £6million each year. This means that there is less need for the patient to visit their GP or anticoagulation unit and causes them less anxiety and disruption12. Costs and benefits Several CCGs - for example, Bath and North East Somerset, and Dorset CCGs – do not believe there is a convincing business case to support self-monitoring or that the opportunity costs for developing an anticoagulation service based around self-monitoring for suitable patients would be disproportionate. ACSMA would strongly challenge the perceived high costs of self-monitoring as people can measure their INR level at home, or any other convenient location. This will vastly reduce the number of clinic appointments required, saving time and money for both the NHS and the patient, and allowing people more freedom to do the things they want to do. When changes are made to enable patients to better care for themselves (by providing information, education, access to experts by telephone or internet and other support), this may then mean a person makes more appropriate use of services or other resources, or has fewer visits to the healthcare professionals13. Lack of demand from patients Calderdale CCG states the current system is considered to work well for the patients and professionals in Calderdale and there has been no negative feedback from either group indicating a need to review the current system as a priority. Mansfield & Ashfield CCG and Newark & Sherwood CCG also state that the majority of patients and clinicians appear happy with the current mainstream process of practice based/community phlebotomy and local specialist anticoagulation clinic dosing service. Dorset CCG states that the evidence for self-testing does not support widespread use across its healthcare community and it would not be suitable for the majority of its population. Appropriate training Hampshire CCG encourages patients to use the anticoagulation service in the first instance; however, it recognises that a number of patients may require self-management of their condition. Consequently, the CCG supports patients and GPs who decide that self-monitoring is more appropriate and where training and monitoring 12 13

HSJ – Evaluation of self-testing for warfarin patients - 1st November 2013 - p2 Dr John Ovretveit, Health Foundation Do changes to patient-provider relationships improve quality and save money? June 2012 p57

AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

is in place to support the patient. Coventry and Rugby CCG have a similar policy, but only if the patient is assessed as suitable by the haematologist, receives training and regularly has his or her monitoring device serviced. Exceptional cases Although the majority of CCGs do not have a formal CCG-wide policy regarding self-monitoring, it does not always means that people on long-term warfarin are denied the opportunity to self-monitor. Bristol CCG, for example, operates an ‘exceptions’ policy. The majority of patients have their anticoagulation therapy monitored and dosed, either at the secondary care anticoagulation clinic or at the GP practice. Some patients are selftesting locally, and these patients have an agreement with the secondary care/hospital trust for dosing. These tend to be patients with more exceptional circumstances and who are unable to attend the clinic for regular testing (e.g. long distance lorry drivers or travellers) and where a delay in INR testing could put the patient at risk of under or over dosing. Self-monitoring is not routinely recommended as the patient needs to be assessed as sufficiently competent to perform these tests safely, confirm regular machine calibration and be checked by the dosing clinicians. Other considerations include patient INR control, their occupation, and their circumstances (such as regular travel commitments, for example). Generally, the GP would refer the patient to a consultant haematologist to be assessed for their suitability for self-monitoring. Similarly, Birmingham South and Central CCG does not have a policy in place currently to support selfmonitoring as a matter of routine. However, there are a small number of patients who test their INR at home and then contact their anticoagulation provider for dosing adjustments. These patients are predominantly managed in secondary care. Some patients who are self-testing were historically involved with a clinical trial that investigated self-monitoring; some of these patients continued to self-test after the termination of the trial. Other patients are assessed on their suitability for self-testing by the anticoagulation clinicians and are then educated and supported accordingly when they are deemed suitable for self-monitoring. Providers and GPs offering self-monitoring Whilst some CCGs may not support self-monitoring themselves, there is an expectation that some providers will. For example, Nottingham North & East CCG expects providers to offer the type of self-monitoring that is most clinically appropriate for patients. East Riding, South Tees and Hartlepool & Stockton-On-Tees CCGs have similar policies. Some CCGs - such as Gateshead, Haringey and Somerset – do not include self-monitoring within the commissioned anticoagulation service. However, GPs may choose to allow patients to self-manage as part of core service provision. Some CCGs – including Southwark, Greenwich, and Kernow - stated that the decision regarding a patient’s access to self-monitoring was not a matter for the CCG, but was a decision for that person’s GP, in conjunction with the patient and any relevant secondary care consultant. Similarly, Birmingham Cross City CCG does not currently have a CCG-wide policy to support anticoagulation self-monitoring. Instead, it is a matter for patients, 17 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

their anticoagulation clinics and individual GPs to reach an agreement as to whether or not self-monitoring is appropriate for that particular patient. West London CCG states that patients are clinically reviewed by the service. Although they may choose to undertake their own self-testing, this is not something that is funded by the CCG, or part of the current management pathway. Review plans Some CCGs (such as Stoke on Trent, Salford, Cannock Chase, Bolton and North Staffordshire) are all in the process of reviewing their anticoagulation services and have said that self-monitoring will be looked at as part of the review. Wakefield CCG is also currently reviewing its policies on self-monitoring. The Wakefield review covers three areas: allowing patients to self-monitor if they purchase their self-monitoring device from the anticoagulant service, evaluating whether self-monitoring devices and/or strips should be commissioned by the CCG and evaluating assurances around clinical governance of self-monitoring and the pathway used. Norwich and South Norfolk CCGs do not have a policy in place for self-monitoring currently, but this is acknowledged as ‘an area of future development’ for both CCGs.

4.4 Are policies dependent upon a person’s underlying condition? Only three of the 178 CCGs (North West Surrey, Dudley, Oxfordshire) apply a different policy on selfmonitoring depending on the patient’s underlying condition, such as those who have a heart valve, are under 18 or those with Atrial Fibrillation. The other CCGs either do not have a differential policy or did not provide the information. Dudley CCG gives special consideration for children and commissions services at the discretion of the individual GP practice. A number of CCGs (including Heywood, Middleton & Rochdale and Salford) stated that a patient’s condition would be considered during the forthcoming reviews of anticoagulation services. Most (175 CCGs) simply answered that there they did not have a different policy depending upon the person’s condition or did not provide the information. Hull CCG gave some reasoning. Self-monitoring in Hull is aimed at any person who is going to be prescribed warfarin on a lifelong basis (guidance does not recommend selfmonitoring for short term durations, other than in exceptional circumstances) – so the important criterion is the expected duration of the anticoagulation therapy, rather than the underlying condition or reason why anticoagulation is required.

4.5 Prescribing of test strips One of the recent problems for people on long-term warfarin who want to self-monitor has been in obtaining the testing strips on prescription. A person who self-monitors applies the blood sample to a test strip, then inserts the strip into the self-monitoring device to give an INR reading.

18 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

Since 2002 test strips have been available on NHS prescription under Part IXR of the Drug Tariff for England and Wales, but they need to be prescribed through GPs. Whilst in theory the test strips are available on prescription there are a number of challenges that patients face to achieve this. Firstly, some CCGs do not allow GPs to issue test strips on prescription any longer because of the cost to the CCG budget, so there still remains variability of access within the NHS. Secondly, if the GP does not support their patient in self-monitoring, or has governance or other medico-legal concerns, he or she may be reluctant to prescribe the strips. Only 34% of CCGs currently provide test strips on prescription, as shown in Figure 4. Figure 4 – CCG policies regarding prescribing of test strips

No policy or N/A (64%) Test strips via NHS prescripFon (34%) Test strips via private prescripFon (2%) Test strips via NHS prescripFon, but limited (1%) CCGs’ reluctance to provide test strips Some CCGs allow people on long-term warfarin the opportunity to self-monitor but are reluctant to prescribe test strips on prescription. For example, West Suffolk CCG only provides test strips on prescription in exceptional circumstances, despite the fact that strips have been listed on the national Drug Tariff since 2002. Vale Royal and Thanet CCGs both said that the prescription of test strips would be allowed, but discouraged. Newcastle West, Gateshead, Newcastle North and East, North Durham, Northumberland and North Tyneside CCGs replied that test strips are available to patients on prescription where agreement has been reached with the CCG, but this service is not routinely commissioned for all patients. Patients who have difficultly attending for routine INR monitoring are often reviewed and considered for the newer oral anticoagulant drugs instead. 19 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

Warwickshire North and Warwickshire South CCGs provide test-strips on prescription, but these are discouraged due to concerns regarding the quality control of meters. ACSMA strongly challenge this claim as all INR self-monitoring devices have to carry a CE mark of conformity, which means the manufacturer guarantees that the product meets all the appropriate provisions of the relevant essential requirements of the European Medical Devices Directive14. These provisions include safety, quality control, and ensures the device is fit for intended purpose15. Conformity assessment procedures become more demanding as the perceived level of risk associated with the device increases. As anticoagulation self-monitoring devices come under Class IIa16 (medium risk17) due to their invasive use, there must be the involvement of independent third party certification bodies called the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has certified all selfmonitoring anticoagulation in the UK with the CE marking and INR self-monitoring devices have been available and used in a clinical setting since the late 1980s18. Studies have shown that self-monitoring devices, not only provide a safer alternative to routine hospital testing19 but also are adequate for clinical use if used by patients to determine their INR value by themselves20. Interestingly, the devices used by patients who self-monitor are usually the same devices which are used in primary care practices, if not also in secondary care anticoagulation clinics. Restricting test strips The number of strips available on prescription varies from CCG to CCG. Coventry and Rugby CCG state that only patients who have been assessed by the specialist can be prescribed test strips by their GP and up to a maximum of 16 strips per year (24 over 18 months). Newham CCG allows GP to review the prescription of testing strips if patients exceed a certain level of requests. Dorset CCG states that patients who purchase a machine privately (as is most likely to be the case, as the devices themselves are not available on prescription) are expected to pick up the costs for test strips themselves. Those who obtain meters through NHS channels can be prescribed test strips by their GP. No limit is placed upon such prescriptions at this time. North Somerset CCG states that patients may only be prescribed test strips by NHS prescription, these should be in similar quantities as would have been indicated for frequency of testing directed by the computer decision support software.

Most medical devices now placed on the UK market have to comply with device specific legislation. There are three European Directives concerning medical devices. Active Implantable Medical Devices Directive (90/385/EEC), Medical Devices Directive (93/42/EEC), and In Vitro Diagnostic Medical Devices Directive (98/79/EC). Each Directive contains a wide-ranging and comprehensive list of Essential Requirements covering items such as electrical safety, chemical and mechanical safety, biocompatibility, and labelling requirements. 15 Frequently Asked Questions, MHRA website, http://www.mhra.gov.uk/SearchHelp/Frequentlyaskedquestions/index.htm accessed online 19th August 2014 16 Devices covered by the Directive are grouped into four classes: Class I (low risk), Class IIa (medium risk), Class IIb (medium risk with added assessment checks), Class III (high risk) 17 The Classification Rules, MHRA bulletin No.10, June 2011, http://www.effectivenessevaluation.org/regactivitie/publications/ accessed 19th August 2014 18 Warfarin therapy: Tips and tools for better control, The Journal of Family Practice, February 2011, http://www.jfponline.com/Pages.asp?AID=9332 accessed 19th August 2014 19 Precision and accuracy of CoaguChek S and XS monitors: The need for external quality assessment, 19th August 2014 20 Accuracy of the point-of-care coagulometer CoaguChek XS in the hands of patients, Journal of Thrombosis and Haemostasis, January 2013, http://onlinelibrary.wiley.com/doi/10.1111/jth.12050/full accessed 19th August 2014 14

20 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

Lewisham CCG allows test strips on prescription. The quantity prescribed and frequency of repeat form part of the consultant letter to the GP. If patients become unstable without clear reason and start to need excessive numbers of test strips, then the patient is asked to make an appointment with the haematology consultant. Hull CCG states that anticoagulation services supply strips directly to the patient. There is no limit to the number of strips. However, patients are provided with three to six months’ worth based on individual bleeding risk and the frequency of monitoring required. All patients are required to attend the service to have their machine quality control validated, and usually this coincides with a collection of more strips. The number of doses of warfarin provided to the patient against the number of strips provided to the patient is monitored and if there is a significant loss of strips it can be addressed. The information stored in the patient’s device is also reviewed which again may give an indication of overuse (or obvious results that were not the patients), which would also be addressed. Wolverhampton CCG has no restriction, provided patients have the appropriate support. Cannock Chase, West Cheshire, Rotherham and Stafford & Surrounds CCGs do not have a prescribing policy, but those patients trained and competent to self-monitor will have test strips on prescriptions available to them. East Staffordshire CCG states test strips are available on the NHS if the GP makes the clinical decision for self-monitoring. There is no limit on the number of strips, it would depend on the monitoring plan agreed with the GP. Bolton CCG does not have a policy of allowing test strips on prescription as it claims that it has not had any requests for them. Birmingham South and Central CCG states that testing strips are costly and there is currently no provision in the drug budget to cover the cost of their wide scale use. Patients are carefully selected to ensure that they are suitable to self-test safely. Hospital provision of test strips Some CCGs do not prescribe test strips as they are provided by local hospitals instead. Merton and Sutton CCGs state that the hospital anticoagulation service is responsible for supplying test strips where there is a clinical need. Sandwell and West Birmingham CCG patients self-test with the support of Sandwell and West Birmingham Hospitals NHS Trust. Camden CCG states the decision to self-monitor is made by the hospital clinician, who retains prescribing responsibility for the patient. Four CCGs state that test strips are only available on private prescription. These are: Solihull, Wakefield, East Leicestershire & Rutland, and Dartford, Gravesham & Swanley.

21 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

4.6 Clinical Commissiong Group guidance and guidelines on self-monitoring The vast majority of CCGs do not have or know of any guidelines or guidance about self-monitoring: see Figure 5. CCGs are unlikely to publish any guidelines if they do not allow self-monitoring. Some of the responses received from CCGs for not publishing guidelines include the following:

•

North Norfolk CCG states self-monitoring is not an encouraged practice;

•

Coventry and Rugby CCG does not publish any guidelines as self-monitoring is handled by the haematologists although prescribing is in primary care; and

•

Kernow CCG does not have any formal guidelines. Patients there are directed to their GP or NHS Choices.

Figure 5 – CCGs which publish guidance or guidelines about self-monitoring

N/A or Unknown (68%) No (24%) Yes (7%) Under review (1%)

In fact only 7% of CCGs have any guidelines or guidance in place, a surprisingly low percentage given that approximately one-third of CCGs do support self-monitoring in one form or another. These included the following CCGs: Milton Keynes, North West Surrey, Surrey Downs, North Somerset, Mansfield & Ashfield, Newark & Sherwood, Lancashire, Dudley, Oxfordshire, Nottingham North & East, Coastal West Sussex, Newham and Great Yarmouth & Waverley. Milton Keynes CCG has guidance available for clinicians to discuss with patients.

There is a glimmer of hope for patients if their CCG does not currently have any guidelines, as a number are reviewing and developing them (for example, Wirral, Nottingham North & East and West Suffolk CCGs). Whilst North Staffordshire CCG has no guidelines currently, it has a new whole systems digital board which is 22 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

preparing a strategy for the use of technologies to promote self-monitoring. North Staffordshire CCG does promote the use of simple self-monitoring devices to help self-care in a range of conditions and this is something that the CCG will consider for the service, after the review. Medway CCG asks GPs to refer to NICEâ&#x20AC;&#x2122;s guidance for patients who come into the area, who are already selfmonitoring. Hull CCG does not publish any guidelines, but they require the provider to do so as part of the contractual arrangements. In Hull, the City Health Care Partnership CIC Anticoagulation Service publishes guidelines on self-monitoring. Of the 13 CCGs that have issued guidelines, the duration of the guidelines varies from one year to three years. The following CCGs have issued one-year guidelines (North West Surrey, Lancashire and Surrey Downs CCGs). Milton Keynes and Dudley CCGs have issued two-year guidelines. Newham and Telford & Wrekin CCGs have issued three-year guidelines. Four CCGs gave no response. In terms of guideline review, of the 13 CCGs, only four CCGs have reviewed their guidelines within the last year: North West Surrey, Lancashire, Coastal West Sussex and Surrey South Downs. Seven other CCGs reviewed their guidelines/guidance between 2012 and 2009 including Milton Keynes (2012), Newham (2011), Great Yarmouth & Waverley (2011), Dudley (2011) and Telford & Wrekin (2010). Two CCGs did not provide any information on guideline review. 10 CCGs that issued guidelines are reviewing them currently or will do so within the next year; three CCGs gave no information.

4. 7 Information provided to patients

75% of CCGs do not offer information on self-monitoring or have any available. This is because many CCGs do not have a policy and do not actively encourage self-monitoring. However, when information is not routinely provided by CCGs, it can be available in primary or secondary care. Birmingham South Central CCG states that all of the anticoagulation clinics are staffed by trained clinical staff who would be able to signpost interested and suitable patients to appropriate material. There are currently 15 clinics within Birmingham South Central CCG boundary, but the CCG does not provide these clinics with leaflets/written information about self-testing. Bristol CCG does not provide any leaflets about self-monitoring. Any support or advice would be given on an individual basis, usually via local anticoagulation clinics, haematology consultants or GP. East Cheshire CCG does not offer any information. However, East Cheshire NHS Trust, providers of the service, have information on their website about the service and contact details for patients who have comments, suggestions or queries. 23 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

Thanet CCG does not directly provide information, but patients can find out information via a community pharmacy-based monitoring service which provides patients easy access to monitoring services and information in their own homes. North Somerset CCG does not have any specific leaflets or written information on anticoagulation services. GP practices who provide anticoagulation services are responsible for communicating with patients using these services. Northern, Eastern & Western Devon CCG does not write clinical information or patient information as it considers this to be the clinician's role in pathways. The CCG monitors quality of care and patient experience on care pathways. This would include whether patients are receiving appropriate information. A patient can access more detailed information about their condition via their GP, their specialist nurse or other care provider who would be the correct clinical source to provide this to support a patient's understanding and self- management. The CCGâ&#x20AC;&#x2122;s patient advice and complaints team is available to answer queries and resolve problems for any patient. The team will assist patients to find the correct source of advice and signpost as needed. In 16% of responses, the CCG did not provide information, but the secondary provider did. This is the case in the following CCGs, for example: Fylde & Wyre, Leicester, East Ridings, Gloucestershire, Redditch and Bromsgrove, South Worcestershire, Wyre Forest, Bedfordshire, Islington, Swale South Manchester, Nottingham North & East. Dudley and Oxford CCGs both provide information through anticoagulation nurses. Telford and Wrekin CCG commissions a nurse-lead anticoagulant service from the local acute trust. The nurses provides patients with information about self-monitoring. Sandwell and West Birmingham CCG states that Sandwell and West Birmingham Hospitals NHS Trust provides patients and their GPs with verbal and written details of the self-testing service along with leaflets from the manufacturers regarding the purchase of analysers. Only 6% of CCGs offer direct information regarding self-monitoring. There are some positive examples of CCGs providing information, such Wirral CCG. Its FOI response states that every practice in the CCG is signed up to deliver an anticoagulation enhanced service, all of which attended training on 7th November 2013, which included an update on self-testing, access to patient information leaflets, etc. This information and support will be passed onto patients. Providing information will raise awareness of self-monitoring and so reduce the need to travel to clinics or GPs. Hull CCG states that its anticoagulation service offers support to patients who would like to find out more information about self-monitoring, but currently this is provided verbally. However, the service is moving forward with a telehealth solution and patient information leaflets posters etc. Individual patient training is currently provided and will continue with the roll-out of the telehealth solution. Currently patients wishing to pursue self24 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

monitoring have been required to purchase their own INR self-monitoring devices from an external company. On occasions, support for purchasing INR self-monitoring devices has been provided via a personal health budget. North Hampshire CCG states that the anticoagulation team at Hampshire Hospitals NHS Foundation Trust offers advice and information regarding self-monitoring devices. An agreement for an enhanced service delivery of anticoagulation services is provided by 20 of 21 GP practices via the North Hampshire Alliance, and provides practice-based anticoagulation monitoring of INR levels. Ealing CCG does not have any written information about self-monitoring. However, the CCG has run information evenings for patients and over half of the practices in the borough have a named practice nurse who supports anticoagulation patients. North West Surrey CCG provides information on its website and in GPs’ practices, and also provides leaflets. Currently 3% of CCGs do not offer any information about self-monitoring, but this will be considered under their anticoagulation service review. This applies to the following CCGs: Salford, Heywood, Barnet, Middleton & Rochdale and Stoke-on-Trent. Some CCGs, such as Newham, are in the process of developing more information. Newham CCG is developing its website. A patient information booklet about all community anticoagulant service options is also in the process of being developed. In addition the CCG’s intranet will hold service documents for primary care physicians to access. The CCG’s programme manager highlights the patient self-monitoring programme when she visits GP practices. A priority for Brighton and Hove CCG is to review the service model in light of updated guidance and new drugs, in order to improve the anticoagulation service. The CCG is awaiting guidance from NICE and the Strategic Clinical Network for Stroke to inform this review, as well as the updated NICE guideline on the management of atrial fibrillation. Also, Brighton and Hove CCG make reference to NICE’s draft guidance on INR self-monitoring devices (CoaguChek XS and INRatio2)

25 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

5. Conclusions The CCGs’ FOI responses confirmed ACSMA’s anecdotal evidence that the vast majority of CCGs do not allow or support self-monitoring, only 34% of CCGs allow self-testing and 28% allow self-management, which means that many patients on long-term warfarin are being denied the opportunity to see if they would be suitable for selfmonitoring. Even when people on long-term warfarin are allowed to self-monitor, CCGs often put obstacles in their way such as cost, clinical safety and accuracy of testing. Some CCG’s do not allow people to self-monitor as they believe their current system of anticoagulation provision is safe and effective – in other words, there is no reason to change. These responses are disappointing because there is already strong supporting evidence that self-monitoring can improve health outcomes, offer patient choice and convenience, and save time and money for both individuals and the NHS. Several CCGs believe there is not a convincing business case for supporting self-monitoring or that the opportunity costs for developing an anticoagulation service based around self-monitoring for suitable patients would be disproportionate. ACSMA would strongly challenge the perceived high costs of self-monitoring as people can measure their INR level at home. This will vastly reduce the number of clinic appointments required, saving time and money for both the NHS and the patient, and allowing people more freedom to do the things they want to do. One of the recent problems for people on long-term warfarin who wanted to self-monitor was getting testing strips on prescription, currently only 34% of CCGs provide test strips on prescription. A number of CCGs restrict the supply of strips. There are a number of challenges that patients face to get test strips on prescription, such as the perceived cost and accuracy of the INR monitoring devices. Test strip prescribing is often dependent on whether a GP supports their patient in self-monitoring. Of those CCGs that do support self-monitoring, most have put in place reasonable criteria to ensure safety and clinical governance. For example, a person’s social circumstance, home environment and whether the use of self-monitoring technology could be considered as a safe choice for them. The patient's GP assures themselves that the monitoring is to the same standard as that undertaken by the practice and therefore that the results are accurate and communicated appropriately. So the decision is being made between the patient and the GP. However, there are encouraging signs for people wanting to self-monitor. Although the majority of CCGs do not have a formal CCG-wide policy regarding self-monitoring, it does not always means that people on long-term warfarin are denied the opportunity to self-monitor as examples of good local practices exist.

26 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

For example, Bristol CCG operates an ‘exceptions’ policy. The majority of patients have their anticoagulation therapy monitored and dosed, either at the secondary care anticoagulation clinic or at the GP practice. Some patients are self-testing locally, and these patients have an agreement with the secondary care/hospital trust for dosing. These tend to be patients with more exceptional circumstances and who are unable to attend the clinic for regular testing (e.g. long distance lorry drivers or travellers) and where a delay in INR testing could put the patient at risk of under or over dosing. Whilst some CCGs may not directly support self-monitoring themselves, there is an expectation that some providers will. For example, Nottingham North & East CCG expects providers to offer the type of self-monitoring that is most clinically appropriate for patients. Similarly, Birmingham Cross City CCG does not currently have a CCG-wide policy to support anticoagulation self-monitoring. Instead, it is a matter for patients, their anticoagulation clinics and individual GPs to reach an agreement as to whether or not self-monitoring is appropriate for that particular patient. The vast majority of CCGs commission some form of anticoagulation service and this is done in a number of ways: via block contract, PbR, local enhanced services, local tariffs, cost per case, any qualified provider, or a combination of these. Similarly, the anticoagulation service is located in secondary care, primary care, or – in 63% of cases – a mixture if the two. Only 12% of responding CCGs currently locate their service exclusively in primary care. North East Lincolnshire is an example of a CCG which commissions its anticoagulation service through the primary care/General Medical Services contract, which is overseen by NHS England. If North East Lincolnshire CCG is able to do this via primary care, all other CCGs should be able to as well. 75% of CCGs do not offer information on self-monitoring or have any available. This is because many CCGs do not have a policy and do not actively encourage self-monitoring. However, when CCGs do not provide information about self-monitoring as a matter of routine there are still examples of help being available. For example, information could be available on CCGs’ website about services and contact details for patients who have comments, suggestions or queries; on an individual basis, usually via local anticoagulation clinics, haematology consultants or GP, or via a community pharmacy-based monitoring service. Only 6% of CCGs offer direct information regarding self-monitoring through GPs’ practices, information evenings, leaflets etc. One particularly interesting example was Hull CCG who is rolling out telehealth and providing individual patient training. On occasions, support for purchasing INR self-monitoring devices has been provided via a personal health budget. Over the last 18 months the health service has gone through huge a change which had a direct impact on local services. Hopefully this will provide an opportunity for people on long term warfarin wanting to self-monitor as a 27 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

number of CCGs are reviewing their anti-coagulation services. Several of whom said self-monitoring will be looked at as part of the review.

28 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

6. Recommendations Based on the findings from the FOI responses, and to help improve access to self-monitoring opportunities for people on long-term warfarin, ACSMA would like to make the following recommendations: •

NHS service commissioners and providers need to look to how anticoagulation services can be redesigned and liberated21 from the hospital and primary care clinics so as to ensure that, wherever possible, all suitable patients are given the choice to self-monitor their INR levels, should they wish to and are competent to do so.

•

There is a lack of knowledge on the part of both patients and healthcare professionals about self-monitoring. CCGs must provide information they can offer to both groups.

•

Examples of local best practice by CCGs and GPs that allow people to self-monitor need to be promoted and shared widely.

•

Anticoagulation Europe (UK) ‘Commissioning effective anticoagulation services for the future’ November 2012

29 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

7. Appendices

Appendix 1 – The AntiCoagulation Self-Monitoring Alliance The AntiCoagulation Self-Monitoring Alliance was set in up October 2012. ACSMA comprises four of the UK’s leading charities and patient groups – AntiCoagulation Europe; the Children’s Heart Federation; the Atrial Fibrillation Association; the Mechanical Heart Valve Support Group. The healthcare company Roche is also part of the alliance. ACSMA is campaigning for the specific objective of achieving greater access via NHS prescription to International Normalised Ratio ((INR) (how long the blood takes to clot)) self-monitoring technology for patients receiving longterm warfarin therapy. Secondary campaign objectives include: • • • • •

Increase awareness amongst policy-makers, patients, clinicians and commissioners of the value of selfmonitoring to patients, the NHS and health outcomes Condition, influence and shape a positive political and NHS environment which encourages and supports self-management of anti-coagulation therapy Build the reputation of the Alliance and its individual member Initiate and foster new relationships for the Alliance with policy-making and political audiences Identify and build advocates or champions for Alliance messages

This self-monitoring technology was featured in the Government’s flagship policy, ‘Innovation, Health and Wealth’ and the Prime Minister, the Rt. Hon. David Cameron MP, has previously described self-monitoring technology as “effective, convenient, and in the end, cheaper for the NHS”22. Additionally, self-monitoring fits with the Government policies such as through its ‘3million lives’ initiative23, the Mandate to NHS England24 and ‘No decision about me without me’25.

Speech by Prime Minister, the Rt. Hon. David Cameron MP at the FT Global Pharmaceutical and Biotechnology Conference, December 2011. NHS England ‘3million lives’ January 2012 http://3millionlives.co.uk/ Last accessed 15th August 2014 24 DH ‘The Mandate’ November 2012 https://www.gov.uk/government/publications/the-nhs-mandate Last accessed 15th August 2014 25 DH ‘Equity and Excellence: Liberating the NHS’ – July 2010 https://www.gov.uk/government/publications/equity-and-excellence-liberating-the-nhsexecutive-summary. Last accessed 15th August 2014 22 23

AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

Appendix 2- Freedom of Information Questions to Clinical Commissioning Groups 1) Does your CCG commission an anticoagulation service? If yes, please answer a, b and c. If no, go to question 2. a. Please provide further details of the commissioning arrangements, including whether it is delivered through i) a block contract or ii) payment by results. b. Is the service located in i) primary care ii) secondary care or iii) in both primary and secondary care? c. Has the anticoagulation service been reviewed? If so when? 2) Does your CCG allow people on long-term warfarin the opportunity to a. Self-manage their condition? b. Self-test their condition? NB: Self-manage: A person who tests his or her International Normal Ratio (INR) themselves via a fingerprick blood test and then adjusts his or her own warfarin dosage (within the limits set by their healthcare professional). NB: Self-test: A person who tests his or her INR themselves using a fingerprick blood test on an INR monitoring device, and then contacts his or her healthcare professional to adjust the warfarin dose. NB: Self-monitor: Another term for self-test.

3) Does your CCG policy on self-monitoring differ depending on a person’s condition and the reason for anticoagulation? e.g. those who have a heart valve, under 18 or those with Atrial Fibrillation (AF)? 4) If your CCG does not allow people on long-term warfarin to self-monitor, is there a particular reason? Please state the reason(s) 5) Does your CCG publish any guidelines/ guidance around self-monitoring? If yes, please answer a, b and c. If no, go to question 6.

a. When the guidelines/guidance around self-monitoring last were reviewed? b. What timeframe do your guidelines/guidance cover? i.e. 1 year, 2 years etc. c. When will they next be reviewed? 6) What is your CCG’s policy regarding prescribing of test strips for people who self-monitor INR? a. Test strips are available to patients by NHS prescription b. Test strips are available on private prescription only c. Test strips are available to patients by NHS prescription up to a certain limit (please specify limit); thereafter, the patient must pay for them privately. 7) Does your CCG offer any support to people who would like to find out more information about self-monitoring e.g. leaflets, written information, how to access an anticoagulation nurse? If so, please describe. 31 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

Appendix 3- List of Clinical Commissioning Group responses to the FOI request Clinical Commissioning Groups (CCGs) that responded NHS Ashford CCG NHS Aylesbury Vale CCG NHS Barking & Dagenham CCG NHS Barnet CCG NHS Barnsley CCG NHS Basildon and Brentwood CCG NHS Bath and North East Somerset CCG NHS Bedfordshire CCG NHS Bexley CCG NHS Birmingham Cross City CCG NHS Birmingham South and Central CCG NHS Blackburn with Darwen CCG NHS Bolton CCG NHS Bradford City CCG NHS Bradford Districts CCG NHS Brent CCG NHS Brighton & Hove CCG NHS Bristol CCG NHS Bromley CCG NHS Calderdale CCG NHS Cambridgeshire and Peterborough CCG NHS Camden CCG NHS Cannock Chase CCG NHS Canterbury and Coastal CCG NHS Castle Point, Rayleigh and Rochford CCG NHS Central London (Westminster) CCG NHS Central Manchester CCG NHS Chorley and South Ribble CCG NHS City and Hackney CCG NHS Coastal West Sussex CCG NHS Corby CCG NHS Coventry and Rugby CCG NHS Crawley CCG NHS Cumbria CCG NHS Darlington CCG 32 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

NHS Dartford, Gravesham and Swanley CCG NHS Doncaster CCG NHS Dorset CCG NHS Dudley CCG NHS Durham Dales, Easington and Sedgefield CCG NHS Ealing CCG NHS East and North Hertfordshire CCG NHS East Leicestershire and Rutland CCG NHS East Riding of Yorkshire CCG NHS East Staffordshire CCG NHS Eastbourne, Hailsham and Seaford CCG NHS Eastern Cheshire CCG NHS Enfield CCG NHS Fylde & Wyre CCG NHS Gateshead CCG NHS Gloucestershire CCG NHS Great Yarmouth & Waveney CCG NHS Greater Huddersfield CCG NHS Greater Preston CCG NHS Greenwich CCG NHS Halton CCG NHS Hambleton, Richmondshire and Whitby CCG NHS Hammersmith and Fulham CCG NHS Hampshire CCG NHS Haringey CCG NHS Harrogate and Rural District CCG NHS Harrow CCG NHS Hartlepool and Stockton-on-Tees CCG NHS Hastings & Rother CCG NHS Havering CCG NHS Herts Valleys CCG NHS Heywood, Middleton & Rochdale CCG NHS Hillingdon CCG NHS Horsham and Mid Sussex CCG NHS Hull CCG NHS Ipswich and East Suffolk CCG NHS Isle of Wight CCG NHS Islington CCG 33 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

NHS Kernow CCG NHS Kingston CCG NHS Knowsley CCG NHS Lambeth CCG NHS Lancashire CCG NHS Lancashire North CCG NHS Leeds North CCG NHS Leeds South and East CCG NHS Leeds West CCG NHS Leicester City CCG NHS Lewisham CCG NHS Lincolnshire East CCG NHS Lincolnshire West CCG NHS Liverpool CCG NHS Luton CCG NHS Mansfield & Ashfield CCG NHS Medway CCG NHS Merton CCG NHS Mid Essex CCG NHS Milton Keynes CCG NHS Nene CCG NHS Newark & Sherwood CCG NHS Newbury and District CCG NHS Newcastle North and East CCG NHS Newcastle West CCG NHS Newham CCG NHS North Derbyshire CCG NHS North Durham CCG NHS North East Essex CCG NHS North East Lincolnshire CCG NHS North Hampshire CCG NHS North Kirklees CCG NHS North Lincolnshire CCG NHS North Manchester CCG NHS North Norfolk CCG NHS North Somerset CCG NHS North Staffordshire CCG NHS North Tyneside CCG 34 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

NHS North West Surrey CCG NHS North, East, West Devon CCG NHS Northumberland CCG NHS Norwich CCG NHS Nottingham City CCG NHS Nottingham North & East CCG NHS Nottingham West CCG NHS Oxfordshire CCG NHS Redbridge CCG NHS Redditch and Bromsgrove CCG NHS Richmond CCG NHS Rotherham CCG NHS Salford CCG NHS Sandwell and West Birmingham CCG NHS Sheffield CCG NHS Shropshire CCG NHS Solihull CCG NHS Somerset CCG NHS South Cheshire CCG NHS South Devon and Torbay CCG NHS South East Staffs and Seisdon and Peninsular CCG NHS South Gloucestershire CCG NHS South Kent Coast CCG NHS South Manchester CCG NHS South Norfolk CCG NHS South Sefton CCG NHS South Tees CCG NHS South Tyneside CCG NHS South Warwickshire CCG NHS South Worcestershire CCG NHS Southend CCG NHS Southern Derbyshire CCG NHS Southport and Formby CCG NHS Southwark CCG NHS St Helens CCG NHS Stafford and Surrounds CCG NHS Stockport CCG NHS Stoke on Trent CCG 35 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

NHS Sunderland CCG NHS Surrey Downs CCG NHS Surrey Heath CCG NHS Sutton CCG NHS Swale CCG NHS Tameside and Glossop CCG NHS Telford & Wrekin CCG NHS Thanet CCG NHS Thurrock CCG NHS Trafford CCG NHS Vale of York CCG NHS Vale Royal CCG NHS Wakefield CCG NHS Walsall CCG NHS Waltham Forest CCG NHS Wandsworth CCG NHS Warrington CCG NHS Warwickshire North CCG NHS West Cheshire CCG NHS West Lancashire CCG NHS West Leicestershire CCG NHS West London (K&C & QPP) CCG NHS West Norfolk CCG NHS West Suffolk CCG NHS Wigan Borough CCG NHS Wiltshire CCG NHS Wirral CCG NHS Wolverhampton CCG NHS Wyre Forest CCG

36 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014

CCGs that did not respond to the FOI request NHS Airedale, Wharfedale and Craven CCG NHS Bassetlaw CCG NHS Blackpool CCG NHS Bracknell and Ascot CCG NHS Bury CCG NHS Chiltern CCG NHS Croydon CCG NHS East Lancashire CCG NHS East Surrey CCG NHS Erewash CCG NHS Fareham and Gosport CCG NHS Guildford and Waverley CCG NHS Hardwick CCG NHS Herefordshire CCG NHS High Weald Lewes Havens CCG NHS Hounslow CCG NHS North & West Reading CCG NHS Oldham CCG NHS Portsmouth CCG NHS Rushcliffe CCG NHS Scarborough and Ryedale CCG NHS Slough CCG NHS South Eastern Hampshire CCG NHS South Lincolnshire CCG NHS South Reading CCG NHS South West Lincolnshire CCG NHS Southampton CCG NHS Swindon CCG NHS Tower Hamlets CCG NHS West Essex CCG NHS Windsor, Ascot and Maidenhead CCG NHS Wokingham CCG

37 AntiCoagulation services and patient access to INR self-monitoring in the NHS in England: July 2014