Ace anticoagulation audit report consolidated approved november 2014 by Eve Knight

Ready for change? Understanding and improving anticoagulation services An audit of local commissioning by AntiCoagulation Europe

October 2014 Support for AntiCoagulation Europe in carrying out this audit has been provided by MHP Health, whose services are paid for by Bayer HealthCare. Bayer has checked the copy for factual accuracy and compliance with the ABPI code of practice. Date of preparation: October 2014

About AntiCoagulation Europe

AntiCoagulation Europe is a leading UK charity founded in the year 2000. We work with patients, healthcare professionals, NHS trusts, Industry, governments, key opinion leaders, other charities and patient groups and a wide range of other healthcare organisations. Our Aims are:   

the prevention of thrombosis the provision of information, education and support relating to all aspects of anticoagulation the promotion of patient choice and independence – supporting people to take an active part in the decisions around their treatment options and management of their condition

For more information about our current campaigns and initiatives, please visit our website at: www.anticoagulationeurope.org

Table of contents Report of findings Foreword ...................................................................................................................................................... 3 Preface .......................................................................................................................................................... 4 Methodology ................................................................................................................................................ 5 About the conditions requiring anticoagulation therapy ............................................................................. 6 Audit findings................................................................................................................................................ 8 1.

Assessment of the local demand for and configuration of services ................................................ 9

Implementation of NICE guidance.................................................................................................. 11

Service quality monitoring.............................................................................................................. 13

Patient experience measures ......................................................................................................... 15

Anticoagulation service design/redesign ....................................................................................... 17

Conclusion .................................................................................................................................................. 19 Annex 1 – FOI requests ............................................................................................................................... 20 Annex 2 – List of CCGs which responded to the Freedom of Information requests .................................. 22 Annex 3 – List of acronyms ......................................................................................................................... 24 References – Report of findings ................................................................................................................. 25 Findings in detail Table of figures (Findings in detail) ............................................................................................................ 31 Part 1: Commissioning anticoagulation services ........................................................................................ 32 Understanding the local need ................................................................................................................ 32 Anticoagulation services: what is commissioned and where? .............................................................. 34 Different commissioning arrangements ................................................................................................ 35 The provision of guidance on treatment selection ................................................................................ 40 Part 2: Understanding local services .......................................................................................................... 43 Monitoring demand for and access to services ..................................................................................... 43 How many CCGs know how much their anticoagulation service costs?................................................ 44 How many have completed the NICE commissioning and budgeting tool for anticoagulation services? ................................................................................................................................................................ 46 Assessment of quality and patient experience ...................................................................................... 47 Part 3: Anticoagulation service redesign .................................................................................................... 51 The use of national mechanisms and guidance to support adoption of innovation ............................. 51 Consideration of the need to reconfigure anticoagulation services in light of recent treatment developments......................................................................................................................................... 53 Full list of references .................................................................................................................................. 56

Foreword Anticoagulation is a personal issue for me. My wife, a sufferer of atrial fibrillation (a disease that causes an irregular heartbeat), thankfully receives anticoagulation treatment that reduces the risk of her experiencing a stroke. Treatment like this doesn’t just impact her health, it reduces my fear of what a stroke would mean for her, and for us. Up to 1.5 million people suffer from atrial fibrillation (AF), around half of whom aren’t diagnosed and don’t know they are at risk. Around 1.25 million people in the UK currently receive oral anticoagulation therapy either for this disease, as a result of being given prosthetic heart valves, or for other conditions linked to dangerous blood clots, like deep vein thrombosis (DVT) or pulmonary embolism (PE). Therefore, it is not just a personal issue for me, it is a personal issue for a great many people – almost as many as are living with cancer in England – not to mention those who love them, and in many cases provide practical care for them. Meanwhile, it is an issue that can have a significant impact on the incidence of stroke, which costs this country £2.5 billion a year. It is therefore nothing short of a national scandal that so many with AF, as an example of one area where anticoagulation is needed, are undiagnosed; that of those diagnosed, 8.5 per cent do not receive treatment for the prevention of strokes; and that 35 per cent receive aspirin despite updated guidance from the National Institute of Health and Care Excellence (NICE) specifying that this is an ineffective treatment. It is also staggering, particularly for anyone with direct experience of the challenges of adhering to warfarin as an anticoagulation treatment, that recently developed anticoagulant therapies that are easier for patients, easier for doctors and deemed cost effective are only being used in around 6 per cent of cases of atrial fibrillation treatment, compared to an expected figure of about 40 per cent, as per NICE’s recent templates. I warmly welcome this report, along with the important work being done to advance these issues by AntiCoagulation Europe and others. The pages that follow do not make for encouraging reading but there are strong examples of good practice within what appears to be an overall message of a system lacking in detailed knowledge and over-endowed with inertia. I feel confident that campaigning in this area is now at a new level and it will not allow demands for progress to die away. Anticoagulation is a personal issue, it should be a national priority, and ensuring the spread of best practice and the addressing of areas of concern revealed in this report must be an urgent action for all involved.

Barry Sheerman, Member of Parliament for Huddersfield

Preface The outlook for people needing anticoagulation treatment has improved greatly over recent years, with improvements in diagnosis, increased flexibility in how treatment is delivered and the availability of recently developed treatments. As an organisation providing information and support to patients and their loved ones, we strive to ensure that people live well with their condition, encouraging them to engage with their treatment and be informed of their options. However, despite improvements in what can be achieved, we hear too many stories of people experiencing barriers that stand between them and the treatment they need and want. This report, based on information received from the vast majority of clinical commissioning groups (CCGs) across England, paints a detailed, and rather challenging picture suggesting that there is much more to do to ensure that those providing services locally are as engaged in this important area as we are encouraging patients to be. What we ask on behalf of patients is not â&#x20AC;&#x153;rocket scienceâ&#x20AC;?. We make simple recommendations regarding understanding the needs at a local level, monitoring services that are provided and reviewing them to ensure that the local system is fit for delivering the best cost effective care, and fits the patient, rather than the patient having to fit the system. At AntiCoagulation Europe we are committed to education and support. As well as helping patients and their families we provide materials to support local decision makers in commissioning their services so that together we can promote independence for people requiring such treatment and achieve the best outcomes both for the individuals and for the local budgets. Faced with an increasingly ageing population, and budgets that will break under the strain of more and more strokes, local commissioners need to think differently, they need to take tough decisions, and they need to be ready for change. We hope that, reviewing the findings that follow, all involved in driving forward improvements in anticoagulation treatment will redouble their efforts, challenge themselves and those around them to do more, and will commit themselves to ensuring that more patients achieve the better outcomes that are now possible.

Eve Knight, Co-Founder and Chief Executive, AntiCoagulation Europe

Methodology The purpose of this report is to evaluate processes for planning and assessing the effectiveness of local anticoagulation services and differences in approaches adopted by commissioners across England. This analysis provides a comprehensive picture of how commissioners are assessing and responding to unmet needs of people requiring anticoagulation therapy, and identifies a series of measures that should be considered to improve the services. To make such evaluation possible an audit was undertaken under the Freedom of Information Act 2000. A series of fourteen requests were submitted by AntiCoagulation Europe to all CCGs in January 2014. The information requested from commissioners focused on the following issues:  Assessments of prevalence of AF, DVT and PE  Commissioning arrangements and configuration of local anticoagulation services  Data held by the CCGs on the number of people accessing anticoagulation services  Understanding of the cost of anticoagulation services, including per person costs  Awareness of commissioning guidance on anticoagulation services  Use of the NICE commissioning and budgeting tool for anticoagulation therapy  Awareness of NICE technology appraisals and steps taken to encourage implementation  Awareness of the Catalogue of potential innovations The full list of questions is included as Annex 1 of this report.

Response rate In total, 176 responses were received by 19 March 2014, representing a response rate of 83 per cent. We are grateful to all the CCGs that responded, and a list of those CCGs is available in Annex 2. It should be noted that more than half of responses (51 per cent) were provided by Commissioning Support Units (CSUs), which provide administrative support to CCGs. Differences in the quality and quantity of information supplied by CCGs was observed, suggesting that questions regarding data collection arrangements and how this information is used to inform robust and evidence-based commissioning decisions. As a result of variation in the detail of responses, the information provided has been subject to analysis and interpretation in the writing of this report.

About the conditions requiring anticoagulation therapy Long-term anticoagulation therapy is needed for a range of conditions which can be identified and managed in a variety of health and care settings as set out in guidance from the National Institute for Health and Care Excellence (NICE)1. The planning and commissioning of care for people requiring longterm anticoagulation therapy can be particularly complex. Conditions requiring long-term anticoagulation therapy notably include:    

Atrial fibrillation Deep vein thrombosis Pulmonary embolism Prosthetic heart valves

Atrial fibrillation Atrial Fibrillation (AF) causes an irregular and often abnormally fast heart rate and affects up to 835,000 people in England alone, a number which is rising year on year2, 3. AF is a known risk factor for stroke, which is currently the third largest cause of death in England, and costs the NHS £2.8 billion a year4, 5. It has been estimated that 12,500 strokes are directly attributable to AF each year and that AF increases the risk of strokes by five to six times6, 7. The consequences can be devastating for patients, their families, carers and the wider NHS. For patients diagnosed with AF, anticoagulation is an effective treatment option to help reduce their risk of having a stroke, as set out in guidance from NICE8. However, the Sentinel Stroke National Audit Programme (SSNAP) recently found in August 2013 that only 36 per cent of patients with known AF admitted to hospital with a stroke are taking anticoagulants9. The Government has estimated that up to 7,100 AF-related strokes could be prevented annually if everyone with AF was appropriately managed10.

Deep vein thrombosis and pulmonary embolism Deep vein thrombosis (DVT) and pulmonary embolism (PE) sit within the broader umbrella of venous thromboembolisms (VTE), commonly called blood clots11. A DVT is a thrombus, or a blood clot, in one of the deep veins in the body12. If the clot lodges in the lung, this can lead to a potentially serious condition, PE, which is a blockage in the pulmonary arterial system13. These conditions are a major cause of disability and death in England14. In fact, one in 20 people in the UK will have a blood clot at some point in their life15. It has been estimated that as many as one in 1,000 adults could be affected by DVT in England each year, with 86.3 in 100,000 affected by PE16. Aside from the physical impact, the Health Select Committee estimated in 2005 that the total cost to the UK for the management of blood clots was approximately £640 million a year, and that the annual costs of treating venous leg ulcers, a consequence of VTE, in the UK were in the region of £400 million1718.

Prosthetic heart valves Prosthetic or artificial heart valves can be required for people with heart valve disease, which consists of abnormalities of the heart valves19. These artificial valves help to ensure appropriate blood flow to the heart, making sure that the blood cannot leak backwards and that it flows onward in the correct direction20. When people have prosthetic valves, they will need anticoagulation therapy for the rest of their lives to prevent clots forming21. Anticoagulation is indeed effective in preventing clot formation on the artificial surfaces of the valve22. 6

Summary of recommendations

1. Assessment of the local demand for and configuration of services – All CCGs should undertake a robust assessment of the local need for anticoagulation services, including evaluation of:  The prevalence (estimated and diagnosed) of AF, DVT and PE, and the number of people with a prosthetic valve across all care settings in the local area  The type and setting of anticoagulation services delivered locally so as to clearly map out what services are available to patients 2. Implementation of NICE guidance – CCGs should take steps to encourage the implementation of the latest NICE guidance. This should include taking account of the latest recommendations when:  Developing service specifications for the procurement of anticoagulation services under the ‘Any Qualified Provider’ (AQP) model  Producing local guidance for providers, ensuring that it does not duplicate analysis carried out by NICE or guide selection of therapy in a way that imposes restrictions on access to particular treatments, or undermines confidence in any particular NICE-approved treatment 3. Service quality monitoring – As part of quality monitoring requirements, all local anticoagulation service providers should be reporting to their CCG against a series of quality indicators. These indicators should be developed by clinicians in consultation with patients as well as taking account of the latest national guidance available, and should include:  Minimum time in therapeutic range  Percentage of unplanned hospital admissions  Year on year improvement in the percentage of people in therapeutic range  Number of adverse events which did not result in an unplanned admission  Number of complaints received out of the number of patients treated  Number of patients with DVT diagnosed and treated in primary care  Number of patients on novel oral anticoagulants being managed in primary care 4. Patient experience measures – CCGs should ensure they collect information on patient experience and clinical outcomes for all the anticoagulation services they commission in the local area. As part of this, they should take steps to encourage providers to gather feedback from clinicians and patient support groups on their services, and to share this feedback with commissioners through their quality monitoring requirements. Questions to include could ask:  How long it took to access anticoagulation therapy after suspecting there was a problem  Whether the patient understood the explanation of what was wrong  Whether the need for anticoagulation therapy was explained to the patient  Whether the patient was supported in making an informed decision about their treatment, eg through the use of the new NICE patient decision aid resource for people with AF23  Whether the patient was given a choice of different types of treatment and was involved in decisions about treatment

5. Anticoagulation service design/redesign – CCGs should ensure they take account of the views of patients and predicted trends in uptake of innovations when reviewing the need to redesign local anticoagulation services. To this end, they should ensure that they involve patients and patient support groups from the very beginning of the design/redesign of services 7

Audit findings

have contraindications, are not able to stay on the treatment, or are not offered it32.

Context

Recently developed treatments have been recommended by NICE for a number of indications, including apixaban, dabigatran and rivaroxaban. These treatments, collectively referred to as non-Vitamin K antagonist oral anticoagulants (NOACs), hold the potential to improve quality of life as they do not necessitate regular coagulation monitoring, providing predictable levels of anticoagulation on a fixed dose.

There are around 1.25 million people in the UK who currently receive long-term anticoagulation therapy to prevent them from developing dangerous blood clots24. The therapy can be prescribed for a number of conditions or circumstances, including people suffering from atrial fibrillation (AF), deep vein thrombosis (DVT) and pulmonary embolism (PE), and people with prosthetic heart valves. This patient population is expected to grow as the UK population ages25, 26. This growing need, set against a context of increasing wider pressures on the NHS, requires the design of services that not only achieve high quality outcomes for patients, but also deliver value for money for the NHS. However, recent figures indicate that the performance of some anticoagulation services is sub-optimal27. For example, the National Institute for Health and Care Excellence (NICE) recently found that around 29 per cent of people with AF in England are not receiving any treatment, and over 22 per cent are being treated with aspirin28. Given the recommendation in the updated NICE guideline to avoid prescribing aspirin in stroke prevention for people with AF, the demand for anticoagulation therapy is set to increase29, 30. Traditional models of care have relied on the prescription of warfarin which, when appropriately used, can be an effective means to prevent blood clots and strokes. However, the treatment has a number of disadvantages, particularly in terms of patient experience, as it requires regular monitoring of coagulation parameters (often requiring frequent visits to clinics), adjustments to dosage and dietary modifications31. Moreover, NICE has found that 46 per cent of patients with AF who should be on warfarin are not receiving it, because they

Recently developed treatment options for anticoagulation, and the rising demand for treatment, offer an opportunity to look at the most appropriate service design to achieve good experience and improved outcomes for patients while achieving efficiencies for the NHS. In recognition of this, NICE recently updated its commissioning guide on anticoagulation services to reflect its guidance on NOACs, and outline the resulting opportunities for service redesign33. AntiCoagulation Europe also published a Commissioning Resource Pack which was shared with all clinical commissioning groups (CCGs) as they took on responsibility for the commissioning of anticoagulation services34. Until now there has been no published comprehensive audit of the extent to which commissioners are prepared for the changes brought about by innovations in anticoagulation or are using current guidance and tools. This audit report evaluates the readiness of CCGs for change in anticoagulation and explores the efforts being made to understand the local need and potential requirement for service reconfiguration. It reveals key findings on local practice and makes recommendations on: ď&#x201A;ˇ ď&#x201A;ˇ ď&#x201A;ˇ

Assessment of the local demand for and configuration of services Implementation of NICE guidance Service quality monitoring

 

Patient experience measures Anticoagulation service design/redesign

1. Assessment of the local demand for and configuration of services Recommendation: All CCGs should undertake a robust assessment of the local need for anticoagulation services. This should include an evaluation of:  The prevalence of AF, DVT and PE, and the number of people with a prosthetic valve across all care settings in the local area  The type and setting of anticoagulation services delivered locally so as to clearly map out what services are available to patients

CCGs are responsible for designing and commissioning services based on the needs of their local population35. Understanding information about prevalence and incidence of people requiring anticoagulation and the current services being delivered to address these needs is fundamental to commissioning effective services. However, as the audit has found, there is a limited understanding among CCGs of local needs. Assessment of local prevalence A relatively low proportion of CCGs have assessed the local prevalence of AF, DVT and PE, with clear difference between AF and DVT/PE (Figure A). Nearly half (48 per cent, n=85) of the CCGs that responded to the audit reported not having assessed the prevalence of AF in their local area and 78 per cent (n=137) in DVT and 83 per cent (n=146) in PE had not assessed prevalence. Of the 72 CCGs that reported having assessed or being in the process of assessing the local prevalence of AF, a quarter (26 per cent, n=19)

stated using data collected through the Quality and Outcomes Framework (QOF) disease register. In addition to QOF data, 13 per cent (n=9) referred to data uncovered through the Guidance on Risk Prevention in Atrial Fibrillation (GRASP-AF) tool. Figure A. CCGs that have made an assessment of the local prevalence of AF, DVT and PE 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%

Unclear/information not provided In progress

No assessment undertaken Assessment undertaken

DVT

The gap between assessment of AF prevalence and that of DVT and PE, as demonstrated in Figure A above, suggests that the existence of tools and incentives in the case of AF, such as GRASP-AF and the QOF register, can play an important role in helping commissioners to assess the local prevalence. There are currently no such incentives or supporting tools in place to encourage collection of data on the prevalence of DVT and PE36. The actual number of people affected by AF is likely to be higher than shown on the QOF register, as some people may not have reported symptoms to their GPs or have not yet been diagnosed. It has been estimated that as many as 700,000 people in the UK may have undiagnosed AF37. This was highlighted in the response from the CCG in Lincolnshire, which noted that there are an estimated 3,500 people with undiagnosed AF in the CCG area38. North Manchester CCG has taken extra steps to assess the local need relating to AF, noting that it “has run searches on practice systems to identify those who appear to have AF but are

not optimally managed and not on the (QOF) AF register, and worked with practices to optimally manage patients” 39.

Figure B. Care setting where anticoagulation services currently sit 1%

As efforts are being made to increase the diagnosis of AF, it should be noted that this will undoubtedly have an impact on demand for local anticoagulation services. Based on an understanding of prevalence, CCGs should work closely with clinicians, local stakeholders and patients to understand how to design services that best meet the local needs now, and as they develop, as set out in the NICE commissioning guide40. Interrogation of modelled or estimated prevalence against the number diagnosed should be carried out to ensure there is not an undetected and therefore untreated population41. CCGs should regularly interrogate modelled prevalence levels against reported levels to enable understanding like reported by Hull CCG which noted that “recorded prevalence [for AF] was 3,652 against a modelled prevalence of 3,528”42. As the prevalence of AF, DVT and PE increases with age 43, prevalence estimates will depend on local demographics. Local assessments, rather than national averages, are therefore essential to understanding the local need and ensuring appropriate service provision. Local configuration of services The vast majority of CCGs (n=173; 98 per cent) provided information on the anticoagulation service they commission, including whether it is in primary or secondary care:   

62 per cent (n=108) have services in place in both primary and secondary care settings 21 per cent (n=36) have services in secondary care settings only 16 per cent (n=27) commission services in primary care exclusively

Both

21% 16%

Primary care

62%

Secondary care Unclear/information not provided

32 CCGs also said that they commissioned anticoagulation services in the community, mostly anticoagulation monitoring clinics offered by the secondary care provider. The findings highlight that there is not a single adopted approach to anticoagulation service delivery, which means that the patient pathway may vary significantly from one CCG area to another. There is indeed an array of possibilities when it comes to the configuration of anticoagulation services for people with AF, DVT and PE, including hospital outpatient models, primary care and community-based models, as well as patient self-testing and management. This could be welcomed as a means to allow commissioners to design services that address the specific needs of local populations. However, where there is a mixed model of care locally, it is particularly important to ensure an integrated, patient-centric pathway so that patients are appropriately followed up – particularly between secondary and primary care settings. As NICE’s commissioning guide sets out: “Commissioners may wish to consider commissioning anticoagulation services in several different ways, and mixed models of provision may be appropriate across a local health economy.” 44

A recent report by the General Medical Council (GMC) showed that in some cases GPs did not even know which of their patients were on anticoagulation, and that some patients had not been monitored for over two years45. There are indeed numerous cases of patients that have been affected by the disconnect between primary and secondary care, where patients are prescribed one medicine when in hospital, but find their prescription changed when they see their GP46. In some cases, patients can be left without treatment for periods of time, or resort to buying their treatment privately47. NICE’s commissioning guide recognises the importance of integrating care for people who require long-term anticoagulation therapy and recommends that the anticoagulation care pathway should be “person-centred and integrated with other elements of care”48.

2. Implementation of NICE guidance Recommendation: CCGs should take steps to encourage the implementation of the latest NICE guidance. This should include taking account of the latest recommendations when:  Developing service specifications for the procurement of anticoagulation services under the ‘Any Qualified Provider’ (AQP) model  Producing local guidance for providers, ensuring that it does not duplicate analysis carried out by NICE or guide selection of therapy in a way that imposes restrictions on access to particular treatments, or undermines confidence in any particular NICE-approved treatment

Local commissioners have an important role to play in ensuring that national guidance is implemented by service providers. In particular, it is a statutory obligation for commissioners to make funding for treatments available within three months of being recommended by a NICE technology appraisal49. However, CCGs retain flexibility in how they make this happen and what models to use50.

Case study – Delay in diagnosis Margaret waited seven months from first going to her GP before being diagnosed with AF. She was not involved in choices about her treatment and feels that she was forced into accepting what the hospital wanted regardless of whether it suited her lifestyle.

Findings from the audit suggest that a number of CCGs have local guidance or protocols in place that depart from NICE guidance for the treatment of nonvalvular AF, DVT and PE. The analysis found that some guidelines or protocols, while referring to the introduction of NOACs, recommended initiation of these treatments only after trying warfarin, despite NICE technology appraisals making no restriction to the place of NOACs in the treatment algorithm.

In response to the audit, 54 CCGs provided information on guidance in place to support anticoagulation prescribing decisions:  



Six per cent (n=3) were guidelines issued by the provider rather than the CCG 83 per cent (n=45) applied across the CCG area, issued by the CCG itself, the former stroke network or the local prescribing area team 78 per cent (n=42) either referred to warfarin as the preferred option, or did not refer to NOACs as a treatment option for people with nonvalvular AF, DVT or PE, despite recommendations from NICE guidance

Figure C. Proportion of local guidelines favouring warfarin over NOACs

Reported local guideline favouring warfarin over NOACs

9% 13%

Reported local guideline not favouring warfarin over NOACs 78% Unclear/information not provided

Lack of alignment with NICE guidance may be due to the fact that some local guidelines were several years old. However, even within more recent guidelines, while reference was made to the need to follow NICE guidance, a number of CCGs appeared to impose restrictions on the use of NOACs, despite NICE recommendations. In the case of AF some maintained that warfarin should remain the first-line option. One CCG shared information stating that “well controlled Warfarin is a well-established, safe and effective treatment option for the prevention of stroke in atrial fibrillation and should be considered the treatment of choice for all current and new patients. It remains the first line treatment” 51. Such advice is contrary

to NICE guidance, including the updated 2014 NICE clinical guideline on AF (CG 180), which stipulates that NOACs are recommended for use in nonvalvular atrial fibrillation as equal first line with warfarin52. One local guideline for the prevention of AFrelated strokes recommended prescribing aspirin for patients with low to medium stroke/thromboembolic risk53. While this was common practice in the past, evidence has shown that antiplatelets such as aspirin reduce the risk of AF-related stroke by only 19 per cent versus 64 per cent for oral anticoagulants such as warfarin54. This has been reflected in the updated 2014 NICE clinical guideline on AF55. The updated NICE guideline on AF recommends that clinicians “do not offer aspirin monotherapy solely for stroke prevention to people with atrial fibrillation” 56. In recognition of current challenges in access to NOACs and of “the myth about the superior safety of aspirin”, the NICE Implementation Collaborative (NIC) recently published a consensus statement on the use of NOACs to reduce stroke risk in nonvalvular AF57. The statement outlines the barriers to using NOACs, and how these might be overcome to facilitate appropriate use. It has been endorsed by a range of healthcare professional and patient group representatives including the Royal College of Physicians, Royal College of General Practitioners and Royal College of Nursing58. By creating restrictions or failing to provide upto-date advice, CCGs may exacerbate regional variations in prescribing practice and access to treatments, precisely the kind of variation that NICE appraisals are designed to remove. Such strong consensus is, therefore, an important and welcome step.

Case study – Local protocols and gaps between secondary and primary care John was diagnosed with AF and was prescribed a NOAC by his hospital consultant. However, when he went to see his GP for a repeat prescription he was told that their protocols did not allow them to prescribe his anticoagulant and that he would either need to get his consultant to regularly prescribe the drug or go onto warfarin. He is now having to pay privately in order to obtain the anticoagulant of his choice.

3. Service quality monitoring Recommendation: As part of quality monitoring requirements, all local anticoagulation service providers should be reporting to their CCG against a series of quality indicators. These indicators should be developed by clinicians in consultation with patients as well as taking account of the latest national guidance, and should include:  Minimum time in therapeutic range  Percentage of unplanned hospital admissions  Year on year improvement in the percentage of people in therapeutic range  Number of adverse events which did not result in an unplanned admission  Number of complaints received out of the number of patients treated  Number of patients with DVT diagnosed and treated in primary care  Number of patients on novel oral anticoagulants being managed in primary care

CCGs however still appear not to be doing enough to ensure that services they commission are fit for purpose and constitute the most effective use of NHS resources. Monitoring demand for and access to services Commissioners have a limited understanding of the demand for and costs of the services they commission. Of the CCGs providing information:  



43 per cent (n=74) have not assessed the number of people using these services 15 per cent (n=26) provided only partial information on this topic, covering only one type of anticoagulation service or care setting in their local area, or one condition Only 33 per cent (n=57) reported having undertaken an assessment of the number of people using services in their area Six per cent (n=10) were in the process of conducting such an assessment

Figure D. CCGs that have assessed the number of people using anticoagulation services 3% 15%

Particularly at a time of significant budgetary pressures, it is important that services are reviewed regularly to ensure resources are put to optimum use and patients achieve the best outcomes and experiences of treatment. Many

43%

Assessment undertaken

33%

No assessment undertaken Assessment in progress Partial response Unclear/information not provided

A number of CCGs reported recording the number of patients accessing local anticoagulation services through Secondary Uses Service (SUS) data held by the Health and Social Care Information Centre (HSCIC), or via commissioning support unit (CSU) contracting. NHS Brent CCG, which only commissions anticoagulation services in secondary care, noted that it “records, on a monthly basis the number of patients using the secondary care service using SUS data”59. Most CCGs reported that they haven’t assessed the costs of the anticoagulation services they commission, which questions their ability to monitor the cost-effectiveness of their services. Only a third (34 per cent, n=58) of CCGs were able to confirm that they have assessed the total costs of those local services and only 28 per cent (n=48) have taken steps to calculate the costs per patient. Figure E. CCGs that have made an assessment of the total costs and per patient costs of their local anticoagulation services

services is essential as it supports commissioners in planning and managing their budgets effectively. The cost assessment, whether total or per patient, should take account of all costs associated with the provision of anticoagulation therapy, and contain as many breakdowns as possible for a greater understanding of potential for savings across the care pathway60. Assessing the quality of services Beyond the financial monitoring of the services commissioned, the audit sought to establish the extent to which commissioners are taking steps to assess the quality of their local anticoagulation services. The findings suggest that a large proportion of CCGs that commission an anticoagulation service have not yet conducted such assessments (Figure F):  

 60% 50% 40%

30% 20%



10% 0% Assessment of total costs

Assessment of costs per patient

Assessment undertaken No assessment undertaken Assessment in progress Partial response Unclear/information not provided

Only 41 (24 per cent) out of the 173 CCGs that responded on this point reported having assessed both the total costs and the costs per patients of the services. Assessing the full extent of the resources required to deliver

41 per cent (n=71) reported not having assessed the quality of their services Six per cent (n=11) provided a partial response – eg where quality had been assessed for one condition but not all 24 CCGs reported having only monitored the quality of their primary care or community service whereas they also commission an anticoagulation service in secondary care Five per cent (n=9) also reported being in the process of conducting such assessment

Figure F. CCGs that have assessed the quality of their anticoagulation services 60%

40% 20% 0% Data collection undertaken No data collection undertaken Data collection in progress Partial response Unclear/information not provided

These findings suggest that there are variations among CCGs in the extent and the scope of monitoring quality. There should be a greater focus on quality reporting on clinical and patient outcomes and there should therefore be requirements for all local anticoagulation service providers to report to their CCG against a series of clinical outcomes quality indicators. NHS South Worcestershire CCG and NHS Wyre Forest CCG indicated that an annual audit of the primary care service has been undertaken to look at the following quality measures61, 62 Initiation of treatment: -

Record keeping, including recording all complications of treatment, bleeding and hospital referrals or admissions Clinical audit, including untoward incidents and the success of the practice in establishing an INR within the planned range within 3 months of initiating treatment Details of training and education of staff providing services

Patient monitoring/ Review of treatment, reflecting nationally recommended safety indicators for patients on anticoagulants including: -

Number of patients on register Number of bleeding episodes requiring hospital admission Deaths caused by anticoagulants Untoward incidents Numbers of patients whose INRs are subtherapeutic

4. Patient experience measures

Recommendation: CCGs should ensure they collect information on patient experience and clinical outcomes for all the anticoagulation services they commission in the local area. As part of this, they should take steps to encourage providers to gather feedback from clinicians and patient support groups on their services, and to share this feedback with commissioners through their quality monitoring requirements. Questions to include could ask:  How long it took to access anticoagulation therapy after suspecting there was a problem  Whether the patient understood the explanation of what was wrong  Whether the need for anticoagulation therapy was explained to the patient  Whether the patient was supported in making an informed decision about their treatment, eg through the use of the new NICE patient decision aid resource for people with AF  Whether the patient was given a choice of different types of treatment and was involved in decisions about treatment

The provision of effective anticoagulation treatment can significantly improve the outcomes of patients at risk of stroke and blood clots. However, achieving good management presents challenges for many patients and the impact on quality of life can be significant. In a reformed NHS, with great emphasis on patientcentred or ‘whole-person’ care, it is particularly timely for commissioners to take steps to understand patients’ experience of services so

that their overall health outcomes and quality of life can be improved.

CCGs shared details of their CQUIN indicator measuring patient experience, as follows63:

However, a considerable proportion of CCGs reported not having collected data on the experience of patients who attend their local anticoagulation services (Figure G):

  

Two thirds (67 per cent, n=116) had not taken steps to assess patient experience Five per cent (n=9) indicated that they were in the process of collating this information A fifth (21 per cent, n=36) reported collecting data on the experience of patients but, of these, 16 CCGs were found to be only collecting data from primary care/community services despite also commissioning services in secondary care

Figure G. CCGs that have collected data on the experience of patients accessing their local anticoagulation services

Data collection undertaken

5% 7% 21%

No data collection undertaken

67%

Data collection in progress Unclear/information not provided

Among the CCGs which did report having collected patient experience data, a number referred to a local Commissioning for Quality and Innovation (CQUIN) scheme for AQP providers, which rewards the collection of data on patient experience. For example, NHS Newcastle West and NHS Newcastle North East

“Commissioners will not prescribe a method of collecting the views of patients but the following key areas should be included:  

  

 

Pre-appointment information How well the patient felt they were dealt with on the day (environmental eg facilities, access etc.) Patient/professional relationship i.e. being fully involved in the shared decision making Waiting times Overall level of happiness (including patient information and education advice and materials, clarity on what happens next, who to contact with concerns or questions) Family and friends test Patient views on how well his/her experience is integrated across their whole patient journey.”

This process of collecting patient experience data is all the more important as there is not, at this time, a national patient experience survey for people using anticoagulation services. Despite the commitment in the Cardiovascular Disease (CVD) Outcomes Strategy that “[NHS England] will consider the scope to carry out a CVD patient experience/PROMs survey […]”64, no announcement has yet been made on the development of such a survey.

Case study – Involvement in decision-making Ken had two DVTs within a year at the age of 55. He was told he needed lifelong anticoagulation. His doctor knew that his job often took him away for weeks at a time, and so discussed all the options of treatment with him. Ken said: “I felt fully involved and all the benefits and risks were explained to me in a way that made it easy for me to understand. It made sense for me to take one of the newer anticoagulants as having regular appointments for monitoring would have been very difficult.” 16

It appears that currently few steps are being taken to listen to patients’ voices, but findings from a survey trialled by AntiCoagulation Europe, following a workshop with a coalition of interested charities, have underlined the importance of capturing patient experiences and revealed wide scope for improvements65.

5. Anticoagulation service design/redesign Recommendation: CCGs should ensure they take account of the views of patients and expected trends in uptake of innovations when reviewing the need to redesign local anticoagulation services. To this end, they should ensure that they involve patients and patient support groups from the very beginning of the design/redesign of services.

In spring 2013, AntiCoagulation Europe piloted a survey of over 270 people who use, or care for people who use, anticoagulation services. It found that66: 

52 per cent of respondents reported that they have some concerns about managing their anticoagulation therapy



Only 10 per cent were offered a written assessment or care plan



Only 25 per cent of respondents were completely happy with the overall level of information they were given when they first started anticoagulation therapy



75 per cent of respondents said that when their anticoagulation was discussed they were not made aware of the different options of anticoagulation available to them



56 per cent would have liked to be more involved in decisions about their treatment

Understanding patients’ experiences is essential to improving services and outcomes. This will help to ensure that patients receive effective anticoagulation treatment that significantly improves both the length and the quality of their lives.

The publication of Innovation, health and wealth in 2011 committed the NHS to embracing innovation in order for the health system to provide world class, high quality care, in times of increased demand and financial constraint67. As part of this agenda, NHS England published a Catalogue of Potential Innovations to identify innovations which could transform patient care while supporting the NHS to deliver care more efficiently, which included68: 



All NICE-recommended NOACs for stroke prevention for people with AF (apixaban, dabigatran and rivaroxaban) One NICE-recommended NOAC for the treatment of DVT and PE (rivaroxaban)

The availability of NOACs has the potential to bring significant changes to treatment pathways due to their reduced requirement for monitoring and intervention. They also provide commissioners with an opportunity to consider the most appropriate service design to achieve good outcomes for patients while achieving efficiencies for the NHS. This has been recognised by NICE in its recently updated commissioning guide on relevant services, which takes into account its own guidance on NOACs and outlines the opportunities for service redesign in light of 17

their introduction69. AntiCoagulation Europe also published a Commissioning Resource Pack in January 2013 which was recently disseminated to all CCGs70. Improving treatment for people requiring anticoagulation therapy has, rightly, been recognised as an area where the NHS should embrace innovation to improve outcomes for patients and deliver care more effectively. However, findings from this audit suggest that relatively few CCGs have considered service redesign linked to introduction of NOACs (Figure H). 50 per cent (n=87) have not made an assessment of the need to reconfigure services in light of recent treatment developments and only a fifth (19 per cent, n=32) have carried out such an assessment. Figure H. CCGs that have made an assessment of the need to reconfigure anticoagulation services 4%

Assessment undertaken 19% No assessment undertaken

27%

50%

Assessment in progress Unclear/information not provided

An analysis of the rationales provided for choosing not to conduct an assessment of the need to redesign services revealed that some CCGs have only adopted a reactive approach to NOAC uptake, and are not planning proactively to encourage the diffusion of innovative treatments. For example, two CCGs claimed that, given that the uptake of NOACs was still low in the local area, there was no need for a reconfiguration of services71, 72. Another CCG explained that they would not make an assessment of the need to reconfigure its services until NOACs are more established73.

A few CCGs suggested that they had already benefited locally from the use of NOACs and, given that they had updated their pathways to take account of NOACs, they did not plan to consider a potential redesign of their services. NHS North, East, West Devon CCG said that “the new developments in treatment have been added as options to treatment plans and pathways so that currently [they] have services that support new developments and traditional approaches”74. It is worth noting, however, that 27 per cent of CCGs (n=47) were reviewing, or planning to review their local anticoagulation services to take account of the introduction of NOACs. NHS Gloucestershire CCG reported, for example, that it has been reviewing the current local pathway for the treatment of DVT and is now proposing a new approach to offer both NOACs and more conventional treatments75. “Gloucestershire CCG has reviewed the local care pathways in the treatment of DVT prompted by the availability of new oral anticoagulants and associated NICE guidance. This review process is still underway. The availability and possible advantages and disadvantages of the new oral anticoagulants have been an important part of the assessment. The CCG is proposing a new community pathway for adult patients with suspected DVT with the option for clinicians to use either the NOACs or more conventional treatment.” 76 When it comes to actually redesigning the services in light of the introduction of NOACs, 71 per cent (n=122) are not planning to reconfigure their services. Only 16 per cent (n=28) have plans to reconfigure services to take account of treatment developments and eight per cent (n=13) are currently in the process of determining whether a reconfiguration will need to take place.

However, given the increasing number of patients requiring long-term anticoagulation therapy, CCGs may be further pushed to consider a reconfiguration of services in the long term. Furthermore, with more AF patients potentially being switched from aspirin to anticoagulation, as recommended in the updated NICE guideline77, it is likely that pressures on services will increase, thereby pressing the need for service review and reconfiguration. Chiltern CCG recognised in its response that current pressures on local services may require service redesign, noting it had â&#x20AC;&#x153;assessed the need to reconfigure anticoagulation services, however this is mainly due to pressures in the systemâ&#x20AC;?78. As CCGs consider the design or redesign of local services, it is particularly important that they take account of latest treatment developments, especially as these affect the care pathway for patients. As part of this, commissioners will need to ensure that they involve patients and patient support groups from the very beginning of the process.

As the report shows, simple steps can be taken in terms of understanding needs at a local level, monitoring services that are provided, and reviewing them to ensure that the local system is fit for purpose. NICE and AntiCoagulation Europe have also developed commissioning support guides, which summarise some of the key actions that can be taken locally to meet the challenge of growing needs in anticoagulation therapy. The introduction of recently developed technologies, such as NOACs in the field of anticoagulation, represent an unique opportunity for commissioners to reconsider the way anticoagulation services are delivered locally, notably by improving patientsâ&#x20AC;&#x2122; quality of life and delivering efficiencies that support other parts of the local health and care system. Those who are not ready for change should take these findings as a clear and resounding wake up call.

Conclusion This report, based on information received from most CCGs in England, provides a detailed and rather challenging picture of the commissioning of anticoagulation services in the reformed NHS. Although some areas show promise in the diffusion of innovation, and the delivery of services that fit the needs of patients, there is still much to do to ensure that CCGs evaluate and optimise services so as to improve patient outcomes and make the best use of NHS resources. There is great variation in the configuration and delivery of anticoagulation services across the country, and evidence suggests that some CCGs are not adequately implementing NICE guidance for the treatment of AF, DVT and PE, exacerbating variations in access to treatment.

Annex 1 â&#x20AC;&#x201C; FOI requests 1. Please confirm or deny whether your CCG has made an assessment of prevalence of i) atrial fibrillation, ii) deep vein thrombosis and iii) pulmonary embolisms in your area a. If confirmed, please provide details of the assessment

2. Please confirm or deny whether your CCG commissions an anticoagulation service a. If confirmed, please provide details of the commissioning arrangements, including whether it is through i) block contract or ii) payment by results b. If confirmed, is your service located in i) primary ii) secondary care iii) in both primary and secondary care

3. Please confirm or deny whether your CCG commissions an anticoagulation service under the Any Qualified Provider model a. If confirmed, please provide details of the commissioning arrangements

4. Please confirm or deny whether your CCG has made an assessment of the number of people using anticoagulation services in your area a. If confirmed, please provide details of the assessment

5. Please confirm or deny whether your CCG has made an assessment of i) the total costs ii) the per patient costs of anticoagulation services in your area a. If confirmed, please provide details of the assessments

6. Please confirm or deny whether the CCG has an agreement in place for enhanced service delivery of anticoagulation services a. If confirmed, please provide details of the enhanced service agreement

7. Please confirm or deny whether your CCG has a protocol for i) nonvalvular atrial fibrillation ii) deep vein thrombosis iii) pulmonary embolism a. If confirmed, please provide the protocols

8. Please confirm or deny whether your CCG collects data on the experience of patients using anticoagulation services a. If confirmed, please provide details

9. Please confirm or deny whether your CCG collects data on the quality of anticoagulation services in your area a. If confirmed, please provide details of the quality measures that you use 20

10. Please confirm or deny whether your CCG has completed the National Institute for Health and Care Excellence (NICE) commissioning and budgeting tool for anticoagulation services a. If confirmed, please provide details 11. Please confirm or deny whether your CCG has made an assessment of NHS England’s Catalogue of potential innovations a. If confirmed, please provide details including those innovations which are being adopted in your area 12. Please confirm or deny whether your CCG has made an assessment of the innovations i) ‘New oral anti-coagulants’ and ii) ‘Treatment of DVT and PE’ in NHS England’s Catalogue of potential innovations a. If confirmed, please provide details including how those innovations are being adopted in your area 13. Please confirm or deny whether your CCG has made an assessment of the need to reconfigure anticoagulation services in the light of developments in treatment a. If confirmed, please provide details of that assessment 14. Please confirm or deny whether your CCG has plans to reconfigure anticoagulation services in the light of developments in treatment a. If confirmed, please provide details of those plans

Annex 2 â&#x20AC;&#x201C; List of CCGs which responded to the Freedom of Information requests NHS Airedale, Wharfedale and Craven CCG NHS Ashford CCG NHS Aylesbury Vale CCG NHS Barking and Dagenham CCG NHS Barnet CCG NHS Bath and North East Somerset CCG NHS Bedfordshire CCG NHS Bexley CCG NHS Birmingham CrossCity CCG NHS Birmingham South and Central CCG NHS Blackburn with Darwen CCG NHS Blackpool CCG NHS Bolton CCG NHS Bradford City CCG NHS Bradford Districts CCG NHS Brent CCG NHS Brighton and Hove 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 and Rochford CCG NHS Central London (Westminster) CCG NHS Central Manchester CCG NHS Chiltern CCG NHS Coastal West Sussex CCG NHS Corby CCG NHS Coventry and Rugby CCG NHS Crawley CCG NHS Croydon CCG NHS Cumbria CCG NHS Darlington CCG 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 East Surrey CCG NHS Eastbourne, Hailsham and Seaford CCG

NHS Eastern Cheshire CCG NHS Enfield CCG NHS Erewash CCG NHS Fareham and Gosport CCG NHS Fylde and Wyre CCG NHS Gateshead CCG NHS Gloucestershire CCG NHS Greater Huddersfield CCG NHS Greater Preston CCG NHS Greenwich CCG NHS Guildford and Waverley CCG NHS Halton CCG NHS Hambleton, Richmondshire and Whitby CCG NHS Hammersmith and Fulham CCG NHS Hardwick CCG NHS Haringey CCG NHS Harrow CCG NHS Hartlepool and Stockton-on-Tees CCG NHS Hastings and Rother CCG NHS Havering CCG NHS Herefordshire CCG NHS Herts Valleys CCG NHS Heywood, Middleton and Rochdale CCG NHS High Weald Lewes Havens CCG NHS Hillingdon CCG NHS Horsham and Mid Sussex CCG NHS Hounslow CCG NHS Hull CCG NHS Ipswich and East Suffolk CCG NHS Islington CCG NHS Kernow CCG NHS Kingston CCG NHS Knowsley 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 and Ashfield CCG NHS Medway CCG NHS Merton CCG 22

NHS Mid Essex CCG NHS Milton Keynes CCG NHS Nene CCG NHS Newark and Sherwood 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 NHS North West Surrey CCG NHS North, East, West Devon CCG NHS Northumberland CCG NHS Norwich CCG NHS Nottingham City CCG NHS Nottingham North and East CCG NHS Nottingham West CCG NHS Oldham CCG NHS Oxfordshire CCG NHS Redbridge CCG NHS Redditch and Bromsgrove CCG NHS Richmond CCG NHS Rotherham CCG NHS Rushcliffe CCG NHS Salford CCG NHS Sandwell and West Birmingham CCG NHS Scarborough and Ryedale CCG NHS Sheffield CCG NHS Shropshire CCG NHS Solihull CCG NHS South Cheshire CCG NHS South Devon and Torbay CCG NHS South East Staffs and Seisdon Peninsula CCG

NHS South Eastern Hampshire CCG NHS South Kent Coast CCG NHS South Lincolnshire 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 Southwark CCG NHS Stafford and Surrounds CCG NHS Stockport CCG NHS Stoke on Trent CCG NHS Sunderland CCG NHS Sutton CCG NHS Swale CCG NHS Telford and Wrekin CCG NHS Thanet CCG NHS Tower Hamlets CCG NHS Trafford 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 Essex CCG NHS West Kent CCG NHS West Lancashire CCG NHS West London (Kensington and Chelsea, Queen's Park and Paddington) 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

Annex 3 â&#x20AC;&#x201C; List of acronyms AF

Atrial fibrillation

AQP

Any qualified provider

CAB

Commissioning and budgeting

CCG

Clinical commissioning group

CQUIN

Commissioning for Quality and Innovation

CSU

Commissioning support unit

CVD

Cardiovascular disease

DVT

Deep vein thrombosis

GMC

General Medical Council

General practitioner

GRASP-AF

Guidance on Risk Prevention in Atrial Fibrillation

HSCIC

Health and Social Care Information Centre

INR

International normalised ratio

JHWS

Joint health and wellbeing strategy

JSNA

Joint strategic needs assessment

LES

Locally enhanced service

NHS

National Health Service

NHS IQ

NHS Improving Quality

NIC

NICE Implementation Collaborative

NICE

National Institute for Health and Care Excellence

NOAC

Non-Vitamin K antagonist oral anticoagulant

NPSA

National Patient Safety Association

PbR

Payment by Results

PCT

Primary care trust

Pulmonary embolism

PROMs

Patient reported outcome measures

QOF

Quality and Outcomes Framework

SSNAP

Sentinel Stroke National Audit Programme

SUS

Secondary Uses Service

VTE

Venous thromboembolism

References – Report of findings 1

National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 2 NHS Choices, Atrial fibrillation. Accessed on 16 January 2012 via http://www.nhs.uk/conditions/atrialfibrillation/Pages/Introduction.aspx 3 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 4 Department of Health, Atrial Fibrillation Cost-Benefit Analysis, Marion Kerr 2008 5 National Institute for Health and Care Excellence (NICE), Cost impact and commissioning assessment 6 National Audit Office, Progress in improving stroke care, 3 February 2010 7 Department of Health, Cardiovascular Disease Outcomes Strategy: Improving outcomes for people with or at risk of cardiovascular disease, March 2013 8 National Institute for Health and Care Excellence (NICE), Clinical Guideline – Atrial Fibrillation (CG 180), June 2014. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cg180/resources/guidanceatrial-fibrillation-the-management-of-atrial-fibrillation-pdf 9 Royal College of Physicians Clinical Effectiveness and Evaluation Unit on behalf of the Intercollegiate Stroke Working Party, Sentinel Stroke National Audit Programme – Clinical Audit First Public Report, August 2013 10 Department of Health, Cardiovascular Disease Outcomes Strategy: Improving outcomes for people with or at risk of cardiovascular disease, March 2013 11 NHS Choices, Blood Clots. Accessed on 2 June 2014 via: http://www.nhs.uk/Conditions/thrombosis/Pages/Introduction.aspx 12 NHS Choices, Deep vein thrombosis. Accessed on 3 June 2014 via: http://www.nhs.uk/Conditions/Deep-veinthrombosis/Pages/Introduction.aspx 13 NHS Choices, Pulmonary embolism. Accessed on 3 June 2014 via: http://www.nhs.uk/conditions/pulmonaryembolism/Pages/Introduction.aspx 14 NHS Choices, Embolism. Accessed on 18 September 2014 via: http://www.nhs.uk/conditions/Embolism/Pages/Introduction.aspx 15 Baglin, Kakkar, Arya and Fitzmaurice, Demographics, Epidemiology and Risk of VTE, webpage: http://reception.e-lfh.org.uk/vte/content/VTE_01_01/d/ELFH_Session/321/tab_442.html, accessed 17 January 2014 16 Baglin, Kakkar, Arya and Fitzmaurice, Demographics, Epidemiology and Risk of VTE, webpage: http://reception.e-lfh.org.uk/vte/content/VTE_01_01/d/ELFH_Session/321/tab_442.html, accessed 17 January 2014 17 Bayer HealthCare. Data on file: Incidence of VTE from database linkage study. 2011 18 Health Select Committee, The prevention of venous thromboembolism in hospitalised patients, February 2005 19 British Heart Fooundation, Heart Valve Disease, 2014. 20 British Heart Fooundation, Heart Valve Disease, 2014. 21 AntiCoagulation Europe, ‘Prosthetic valves’. Accessed on 20 June 2014 via: http://www.anticoagulationeurope.org/conditions/prosthetic-valves 22 AntiCoagulation Europe, ‘Prosthetic valves’. Accessed on 20 June 2014 via: http://www.anticoagulationeurope.org/conditions/prosthetic-valves 23 National Institute for Health and Care Excellence (NICE), Patient decision aid – atrial fibrillation: medicines to help reduce your risk of a stroke – what are the options?, June 2014 24 Department of Health, Innovation, health and wealth: accelerating adoption and diffusion in the NHS, December 2011 25 Stewart S, et al. Heart, 2001; 86(5):516-21 26 Atrial Fibrillation Association and Anticoagulation Europe, The AF Report, Atrial Fibrillation: Preventing a stroke crisis, 2011 27 NHS Improvement, Heart: Anticoagulation for Atrial Fibrillation - A simple overview to support the commissioning of quality services, 2011. Available at:

http://www.atrialfibrillation.org.uk/files/file/Articles_Medical/NHSI%20Anticoagulation%20for%20AF%20Com missioning%20Guide.pdf 28 National Institute for Health and Care Excellence, Costing Report: atrial fibrillation - Implementing the NICE guideline on atrial fibrillation (CG180), June 2014. Available at: http://www.nice.org.uk/guidance/cg180/resources/cg180-atrial-fibrillation-update-costing-report2 29 National Institute for Health and Care Excellence, Costing Report: atrial fibrillation - Implementing the NICE guideline on atrial fibrillation (CG180), June 2014. Available at: http://www.nice.org.uk/guidance/cg180/resources/cg180-atrial-fibrillation-update-costing-report2 30 National Institute for Health and Care Excellence, Atrial fibrillation: the management of atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 31 National Patient Safety Agency, Patient Safety Alert. Actions that can make anticoagulation therapy safer, 2007 32 NHS Improvement, Commissioning for Stroke Prevention in Primary Care. Accessed on 18 September 2014 via: http://www.nhsiq.nhs.uk/media/2335814/af_commissioning_guide.pdf 33 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 34 AntiCoagulation Europe, Commissioning effective anticoagulation services for the future: a resource pack for commissioners, November 2012 35 NHS Commissioning Board (NHS England), Commissioning fact sheet for clinical commissioning groups, August 2012. Accessed via: http://www.england.nhs.uk/wp-content/uploads/2012/09/fs-ccg-respon.pdf 36 Bayer HealthCare, From prevention to treatment: deep vein thrombosis and pulmonary embolism – Taking the pulse of NHS services, November 2013 37 Atrial Fibrillation Association and AntiCoagulation Europe, The AF Report, Atrial Fibrillation: Preventing a stroke crisis, 2011 38 NHS Lincolnshire CCG, Response to Freedom of Information audit on file 39 NHS Central Manchester CCG, Response to Freedom of Information audit on file 40 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 41 AntiCoagulation Europe, Commissioning effective anticoagulation services for the future: a resource pack for commissioners, November 2012 42 NHS Hull CCG, Response to Freedom of Information audit on file 43 Stewart S, et al. Heart, 2001; 86(5):516-21 44 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 45 GMC, Investigating the prevalence and causes of prescribing errors in general practice: The PRACtICe Study, May 2012 46 Bayer HealthCare, From prevention to treatment: deep vein thrombosis and pulmonary embolism – Taking the pulse of NHS services, November 2013 47 Bayer HealthCare, From prevention to treatment: deep vein thrombosis and pulmonary embolism – Taking the pulse of NHS services, November 2013 48 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 49 NICE Implementation Collaborative, Consensus – Supporting local implementation of NICE guidance on use of the novel (non-vitamin K antagonist) oral anticoagulants in non-valvular atrial fibrillation, June 2014 50 NICE Implementation Collaborative, Consensus – Supporting local implementation of NICE guidance on use of the novel (non-vitamin K antagonist) oral anticoagulants in non-valvular atrial fibrillation, June 2014 51 West Yorkshire Cardiovascular Network, Recommendations for the Introduction of New Oral Anticoagulants, July 2012 52 National Institute for Health and Care Excellence, Atrial fibrillation: the management of atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 53 NHS Sheffield CCG, Sheffield Guidelines for the Management of Atrial Fibrillation, Date unknown. 54 Hart RG, Pearce LA, Aguilar MI, ‘Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta analysis’, Ann Intern Med, 2007;146:857-67 55 National Institute for Health and Care Excellence, Atrial fibrillation: the management of

atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 56 National Institute for Health and Care Excellence, Atrial fibrillation: the management of atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 57 NICE Implementation Collaborative, Consensus – Supporting local implementation of NICE guidance on use of the novel (non-vitamin K antagonist) oral anticoagulants in non-valvular atrial fibrillation, June 2014 58 NICE Implementation Collaborative, Consensus – Supporting local implementation of NICE guidance on use of the novel (non-vitamin K antagonist) oral anticoagulants in non-valvular atrial fibrillation, June 2014 59 NHS Brent CCG, Response to Freedom of Information audit on file 60 AntiCoagulation Europe, Commissioning effective anticoagulation services for the future: A resource pack for commissioners, December 2012 61 NHS Wyre Forest CCG, Response to Freedom of Information audit on file 62 NHS South Worcestershire CCG, Response to Freedom of Information audit on file 63 NHS Newcastle West and NHS Newcastle North East CCGs, Response to Freedom of Information audit on file 64 Department of Health, Cardiovascular Disease Outcomes Strategy – Improving outcomes for people with or at risk of cardiovascular disease, March 2013 65 AntiCoagulation Europe, Patient experience of anticoagulation services: ACE survey, October 2013 66 AntiCoagulation Europe, Patient experience of anticoagulation services: ACE survey, October 2013 67 Department of Health, Innovation, health and wealth – Accelerating adoption and diffusion in the NHS, December 2011 68 NHS Commissioning Board (NHS England), Catalogue of potential innovations – Innovation, health and wealth, March 2013 69 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 70 AntiCoagulation Europe, Commissioning effective anticoagulation services for the future: a resource pack for commissioners, November 2012 71 NHS Luton CCG, Response to Freedom of Information audit on file 72 NHS Oxfordshire CCG, Response to Freedom of Information audit on file 73 NHS Durham Dales, Easington and Sedgefield CCG, Response to Freedom of Information audit on file 74 NHS North, East, West Devon CCG, Response to Freedom of Information audit on file 75 NHS Gloucestershire CCG, Response to Freedom of Information audit on file 76 NHS Gloucestershire CCG, Response to Freedom of Information audit on file 77 National Institute for Health and Care Excellence, Atrial fibrillation: the management of atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 78 NHS Chiltern CCG, Response to Freedom of Information audit on file

Ready for change? Findings in detail

Support for AntiCoagulation Europe in carrying out this audit has been provided by MHP Health, whose services are paid for by Bayer HealthCare

Table of figures (Findings in detail) Figure 1. Percentage of CCGs that have made an assessment of the local prevalence of AF, DVT and PE ........................................................................................................................................................... 32 Figure 2. Care setting where anticoagulation services currently sit ..................................................... 34 Figure 3. Types of payment systems applied to anticoagulation services ............................................ 36 Figure 4. Percentage of CCGs that have a LES in place for the commissioning of anticoagulation services .................................................................................................................................................. 37 Figure 5. Percentage of CCGs that commission an anticoagulation service under AQP ....................... 39 Figure 6. Proportion of local guidelines favouring warfarin over NOACs ............................................. 41 Figure 7. Percentage of CCGs that have assessed the number of people using anticoagulation services ............................................................................................................................................................... 43 Figure 8. Percentage of CCGs that have made an assessment of the total costs and per patient costs of their local anticoagulation services................................................................................................... 45 Figure 9. Percentage of CCGs that have completed the NICE commissioning and budgeting tool ...... 46 Figure 10. Percentage of CCGs that have assessed the quality of their anticoagulation services ........ 47 Figure 11. Percentage of CCGs that have collected data on the experience of patients accessing their local anticoagulation services ............................................................................................................... 49 Figure 12. Percentage of CCGs that have made an assessment of NHS England's Catalogue of Potential Innovations ............................................................................................................................ 52 Figure 13. Percentage of CCGs that have made an assessment of the innovations ‘NOACs’ and ‘Treatment of DVT and PE’ in Catalogue of potential innovations ....................................................... 52 Figure 14. Percentage of CCGs that have made an assessment of the need to reconfigure anticoagulation services ........................................................................................................................ 53 Figure 15. Percentage of CCGs that are planning to reconfigure anticoagulation services in light of recently developed treatments ............................................................................................................. 54

Part 1: Commissioning anticoagulation services Following the passage of the 2012 Health and Social Care Act, CCGs have assumed responsibility for the commissioning of a range of local NHS services, including anticoagulation services. They have inherited some of the complex commissioning arrangements for anticoagulation therapy that previous primary care trusts (PCTs) had put in place. This section explores how CCGs are currently commissioning these services.

Understanding the local need CCGs are responsible for designing and commissioning services that are based on the needs of their local population79. As a member of the local health and wellbeing board(s), they play a key role in assessing local needs and strategic priorities, notably through the development of joint strategic needs assessments (JSNAs) and joint health and wellbeing strategies (JHWSs)80. The audit found that a relatively low proportion of CCGs have undertaken an assessment of the local prevalence of AF, DVT and PE, with clear difference between AF and DVT/PE. As Figure 1 below demonstrates, nearly half (48 per cent, n=85) of the CCGs that responded to the audit reported not having assessed the prevalence of AF in their local area. This compares to 78 per cent (n=137) and 83 per cent (n=146) of respondents who stated that they had not assessed the prevalence of DVT and PE respectively. A small proportion of CCGs (n=3-5, 2-3 per cent) also said that they were in the process of gathering data on the prevalence of AF, DVT and PE. Figure 1. Percentage of CCGs that have made an assessment of the local prevalence of AF, DVT and PE 100% 90% 80% 70%

Unclear/information not provided

60%

In progress

50% 40%

No assessment undertaken

30%

Assessment undertaken

20% 10%

0% AF

DVT

A number of CCGs provided links to their local joint strategic needs assessments (JSNAs), stating that data collection was a public health responsibility sitting with local authorities and health and wellbeing boards rather than CCGs. However, as set out in guidance from the Department of Health, local authorities and CCGs have equal and joint duties to prepare JSNAs and JHWSs, through the health and wellbeing board81. While JSNAs are an important tool in providing a picture of the local 32

need, their chapters on CVD may fall short of providing enough detail on the anticoagulation requirements of the local population. One CCG indeed acknowledged that it had undertaken a broad assessment through the local JSNA but not specifically for AF, DVT and PE82. CCGs must be able to demonstrate that they understand and reflect any assessment of the prevalence of AF, DVT and PE as they commission local anticoagulation services. As the NICE commissioning guide for anticoagulation services sets out, commissioners should work closely with clinicians, local stakeholders and patients to understand how to design anticoagulation services that are best suited to the local need83. This should include regularly interrogating modelled prevalence levels against reported levels to ensure there is not an undetected and therefore untreated population that could be at high risk of an event84. This is already the practice of a number of CCGs, such as Hull CCG which reported that “recorded prevalence [for AF] was 3,652 against a modelled prevalence of 3,528”85. Furthermore, as the prevalence of AF, DVT and PE tends to increase with age86, prevalence estimates will depend on each local population’s demographics. Local assessments, rather than using national averages, are therefore essential to understanding the local need and to ensuring appropriate service provision. Of the 72 CCGs that reported having assessed or being in “We have run searches on practice the process of assessing the local prevalence of AF, a systems to identify those who appear to quarter (26 per cent, n=19) stated using data collected have AF but are not optimally managed through the Quality and Outcomes Framework (QOF) and not on the AF register, and worked disease register. The QOF includes financial incentives for with practices to optimally manage GP practices to “establish” and “maintain” a register of patients” people with AF through its indicator AF00187. However, it NHS North Manchester CCG, Response on file should be noted that the actual number of people affected by AF is likely to be higher than shown on the QOF register, as some people may have not reported symptoms to their GPs or have not yet been diagnosed. Research has in fact estimated that as many as 700,000 people in the UK may have undiagnosed AF88. This was recognised in the response from the NHS Lincolnshire CCGs, which noted that there are an estimated 3,500 people with undiagnosed AF in the CCG area89. North Manchester CCG also highlighted that it had been working with local GP practices to support patients with AF who are not on the QOF register90. In this context, it is worth noting that efforts being made to increase the diagnosis of AF will undoubtedly have an impact on demand for local anticoagulation services. In addition to QOF data, 13 per cent (n=9) of the CCGs that had assessed or were currently assessing the prevalence of AF referred to data uncovered through the Guidance on Risk Prevention in Atrial Fibrillation (GRASP-AF) tool. The GRASP-AF audit tool has been rolled out by NHS Improving Quality (NHS IQ) across the country as part of a systematic approach to encourage the identification, diagnosis and the optimum management of patients with AF in primary care to reduce the risks of stroke91. The tool notably contains a case finder which is intended to support GPs in identifying patients with potential symptoms of undiagnosed AF92. The gap between assessment of AF prevalence and that of DVT and PE, as demonstrated in Figure 1 above, suggests that the existence of tools and incentives, such as GRASP-AF and the QOF register, can play an important role in helping commissioners to understand the local need. At this 33

stage there are no incentives or supporting tools in place to encourage community healthcare professionals to collect data on the prevalence of DVT and PE, and much of the data that are publically available only cover cases of DVT and PE that are acquired or managed in hospital settings93. It is therefore important that measures are taken to encourage improvements in data collection so that the full extent of the burden of these conditions can be recognised and reflected in the local commissioning of services. Recommendation: All CCGs should undertake a robust assessment of the local need for anticoagulation services, including the prevalence of AF, DVT and PE and the number of people with a prosthetic valve in the local area. Recommendation: NHS England should take steps to improve the collection and analysis of data on the prevalence of DVT and PE. This should include an audit of both acute and community settings, to be incorporated into the work of the National Cardiovascular Intelligence Network. Recommendation: As part of its review of incentives in primary care, NHS England should ensure it includes provisions to encourage CCGs to assess the full local need for anticoagulation services, including the prevalence of AF, DVT and PE in the local area.

Anticoagulation services: what is commissioned and where? The vast majority of CCGs (n=173; 98 per cent) indicated that they commission an anticoagulation service, whether it is in primary or secondary care, and one CCG reported being in â&#x20AC;&#x153;the evaluation stages of a procurement for a DVT serviceâ&#x20AC;?94. In addition, 62 per cent (n=108) of those CCGs that commission an anticoagulation service reported having services in place in both primary and secondary care settings. 21 per cent (n=36) reported commissioning services in secondary care settings only, while another 16 per cent (n=27) reported commissioning services in primary care exclusively (Figure 2). A selection of CCGs (n=32) also said that they commissioned anticoagulation services in the community, mostly in the form of anticoagulation monitoring clinics offered by the secondary care provider. Figure 2. Care setting where anticoagulation services currently sit 1% Both

21%

Primary care

16%

Secondary care 62% Unclear/information not provided

These findings highlight that there is not an adopted ‘one-size fits all’ approach to anticoagulation service delivery across the country, and that the patient pathway may vary significantly from one CCG area to another. There are several models of anticoagulation services for people with AF, DVT and PE, including hospital outpatient models, primary care and community-based models, as well as patient self-testing and management. This array of possibilities could be welcomed as a means to allow commissioners to design services that respond to the specific needs of local populations. However, where there is a mixed model of care locally, it is particularly important to provide an integrated, patient-centre pathway to ensure that patients are appropriately followed up, notably between secondary and primary care settings. A recent report by the General Medical Council (GMC) found that in some cases GPs did not even know who their patients were, and that some patients had not been monitored for over two years95. The importance of integrating care for people who require long-term anticoagulation has been recognised by NICE in its commissioning guide for anticoagulation services, which recommends that the anticoagulation care pathway should be “person-centred and integrated with other elements of care”96. Recommendation: CCGs should take steps to collect information on the type and setting of services delivered and map out the services that are being provided in their local area. This would also help to enhance transparency and clarify the accountability for the commissioning and delivery of anticoagulation services. Recommendation: CCGs should take measures to ensure that patients receiving anticoagulation therapy are appropriately followed up. This should include the provision of a care plan, where anticoagulation needs are clearly explained.

Different commissioning arrangements The different payment systems in place Traditionally, most commissioners have tended to have block contracts with hospitals, where providers received a fixed lump sum of money, irrespective of the number of patients treated, while GPs have normally run their practices under separate national contracts. However, in a context of increasing pressures on the NHS and problems of inefficiencies, the Department of Health gradually introduced a new payment system, Payment by Results (PbR), in the early 2000s97. It is a payment system under which commissioners pay healthcare providers for each patient seen or treated, while taking into account the complexity of the patient’s healthcare needs98. It is based on nationallydetermined currencies and tariffs. While block contracts may have been appropriate at a time when treatment and provider options were limited, there have indeed been concerns that they may be hampering the spread of innovation, and not providing sufficient flexibility to support patient choice and drive up the quality of care. In this context, PbR has been increasingly understood as a means to control rising expenditure and costs, to improve the quality of care provided and encourage an effective use of available resources99. The Department of Health’s rationale for introducing PbR was indeed to100: 35

   

Support patient choice by allowing the money to follow the patient to different types of provider Reward efficiency and quality by allowing providers to retain the difference if they could provide the required standard of care at a lower cost than the national price Reduce waiting times by paying providers for the volume of work done Refocus discussions between commissioner and provider away from price and towards quality and innovation

The audit found that there is considerable variation across the country in terms of commissioning arrangements and payment systems for anticoagulation services. Of the CCGs responding to this survey and commissioning an anticoagulation service, 45 per cent (n=77) reported commissioning a service via PbR, while 21 per cent (n=36) said they used block contracts, and 11 per cent (n=19) used both payment systems (Figure 3). The remaining few CCGs reported using a mix of mechanisms, from locally agreed tariff payments to fees for individual service. In addition, some CCGs indicated that services were resourced through local enhanced services agreements (LESs). This is further explored in the section below. Figure 3. Types of payment systems applied to anticoagulation services

23%

21% Block contract PbR Both

11%

Other/unclear 45%

The response from NHS East Riding of Yorkshire CCG provides an interesting example of the complex blend of anticoagulation services and the diversity of payment systems that can be found in a given area: “The CCG currently commissions an anti-coagulation service from Primary Care via a Local Enhanced Service. This service has been recently reviewed and the CCG is currently procuring a revised service to commence 1 April 2014 from Primary Care. In addition the CCG also commissions services from our local Secondary Care providers via PbR, local Social Enterprise provider via PbR and also our local Community Services via a block contract.”101 Understandably, different service configurations require different payment systems, as providers will have to meet a different set of objectives. As NICE’s commissioning guide sets out: “Commissioners may wish to consider commissioning anticoagulation services in several different ways, and mixed models of provision may be appropriate across a local health economy” 102. It is therefore down to CCGs to put in place the type of payment systems that they consider will enable them to drive 36

improvements in the quality of care and treatment locally. However, this should be underpinned by high-quality data and analysis. Furthermore, NICE suggested in its commissioning guidance that commissioners should carefully consider the advantages and disadvantages locally of block contracting versus service activity-based contracts such as PbR for anticoagulation services103. It highlighted that, for example, with the introduction of NOACs, service activity contracts may offer more flexibility in terms of releasing funds as the patient switches anticoagulation therapy and no longer requires regular attendance at an anticoagulation clinic104. It is indeed important that payment systems retain enough flexibility so that they can rapidly respond to developments in service provision, standards of care and to the local context. Finally, they should be chosen so that they drive better outcomes and incentives innovation, rather than simply contain costs. This is one of NHS England’s key ambitions in its updated business plan for 2013/14 and 2015/16, Putting patients first, which aims “to ensure that we use pricing as effectively as possible to drive better outcomes for people”105.

Local enhanced service agreements (LESs) This audit revealed that 73 per cent (n=126) of CCGs commissioning an anticoagulation service have an enhanced service agreement in place (Figure 4). A detailed analysis of supporting documents enclosed with audit responses highlighted that most of the LESs focused on anticoagulation monitoring, thus offering INR check-ups and treatment advice for people on warfarin. The growing number of patients requiring oral anticoagulation therapy has put considerable pressures on existing hospital anticoagulation clinics. This has resulted in the search for alternative models of service provision, hence the agreement of LESs by PCTs to move anticoagulation monitoring into primary care and the community, closer to patients’ homes. Figure 4. Percentage of CCGs that have a LES in place for the commissioning of anticoagulation services 80% 70% 60% 50% 40% 30% 20% 10% 0% LES agreement in place

No LES agreement in place

Unclear/information not provided

As a number of responses pointed out, all LES contracts in place at the time of the audit were due to come to an end on 31 March 2014, as set out in national guidance from NHS England106. PCTs were 37

allowed to agree with emerging CCGs to extend existing LESs to 2013/14, while the transition to the new NHS was taking place107. However, as of April 2014, these services can no longer be called ‘LES’, as overall responsibility for enhanced services lie with NHS England, and CCGs have had to decide how to procure these community-based or practice-based services under the NHS standard contract, as part of their statutory responsibility for improving the quality of primary care108. This explains why, for example, NHS Camden CCG stated that its LES would “move to a ‘Locally Commissioned Service’ in April 2014”109. This begs the question of what has happened upon expiration of the LES contracts. Under NHS England procurement rules, CCGs are required to put all their LESs out to tender or to procure them under ‘Any Qualified Provider’ (AQP) unless they can prove the service can only be offered by a single provider110. According to responses to this audit, some CCGs have issued a one-year contract with their existing provider while a review of the service is underway. However, other CCGs are already in the process of moving their local anticoagulation services from LES to AQP procurement. Some health commentators have argued that this move is set to force many practices to compete for a significant proportion of their existing funding, and GPs have claimed that some practices could lose as much as 10-15 per cent of their income111. The section below explores the extent to which CCGs have adopted the AQP procurement model for all anticoagulation services, beyond previous LESs. “The CCG is in the process of transferring existing arrangements for community anticoagulation from Local Enhanced Service to a Community Service via an open procurement process.” NHS East and North Hertfordshire CCG, Response on file

“A Local Enhanced Service (LES) is in place for 2013/14. A one year contract for 2014/15 will be issued using current providers to provide sufficient time for review of the service which is currently underway”

“Anticoagulation has previously been commissioned through a LES by the PCT/CCG which expires 31/03/14. The CCG is currently out to procurement via an AQP process for Anticoagulation and we are looking to place new contracts as of 01/04/14 with successful applicants” NHS Walsall CCG, Response on file

NHS Redditch and Bromsgrove, South Worcestershire and Wyre Forest CCGs, Response on file

Uptake of the Any Qualified Provider model The ‘Any Qualified Provider’ (AQP) scheme was created following the passage of the 2012 Health and Social Care Act in a move to allow a wider variety of providers to run NHS services, and to enable patients to have more choice about which service provider they use112. Patients and GPs (in the case of referrals) can choose a service based on what matters to them – for example one that is closer to home, has a shorter waiting list or better outcomes. The audit revealed that only 10 per cent (n=18) 38

of those CCGs that commission an anticoagulation service have so far chosen to procure services under AQP, while 86 per cent (n=150) have not used the scheme yet (Figure 5). Figure 5. Percentage of CCGs that commission an anticoagulation service under AQP 1% 2% 10%

Commissioning under AQP in place No commissioning under AQP in place Commissioning under AQP in progress

87%

Unclear/information not provided

With such low current levels of uptake, it seems that the AQP scheme has not yet generated much interest among CCGs for the procurement of anticoagulation services. However, as set out above, this number is likely to grow as LESs come to an end113. Indeed, two CCGs, NHS Walsall and NHS Greenwich CCGs reported being in the process of procuring services via AQP114, 115. The delay in uptake of AQP may also be explained by the fact that CCGs would need to develop full service specification and tariffs for those services. To aid this process, NICE has summarised the key issues for commissioners to consider in the development of service specifications as follows116: 

What parts of the care pathway for anticoagulation therapy will be included – for example, initiation, monitoring of INR, dosing, annual review



The advantages and disadvantages locally of block contracting versus service activity contracts – for example, with the introduction of rivaroxaban, dabigatran and apixaban service activity contracts may offer more flexibility in terms of releasing funds as the patients change anticoagulation therapy



The anticoagulants the service is responsible for – for example, vitamin K antagonists, low molecular weight heparin and the novel oral anticoagulants



The level of capacity required within local anticoagulation monitoring services as the prescribing of novel oral anticoagulants within primary care increases



The differing requirements for monitoring and review for rivaroxaban, dabigatran and apixiban and how this has an impact on local delivery of anticoagulation therapy



Quality measures to be used, and the process for monitoring and review



Ease of access to clinics, including location of the service



Local support for medicines adherence for people taking anticoagulation therapy



Local procedures for self-testing INR, including who is responsible for paying for testing strips



Required competencies of, and training for, staff responsible for providing anticoagulation therapy care and service monitoring criteria



Communication between service provider and other services, particularly for the safe transfer of a person's care between an anticoagulation service and secondary care



Information and audit requirements, including IT support and infrastructure

These suggested themes could prove particularly helpful in the design of services that are fit for purpose and respond to the local need, while embracing latest guidance and innovation in the field of anticoagulation therapy. Recommendation: When developing service specifications for the procurement of anticoagulation services under AQP, CCGs should take account of the latest NICE guidance available on anticoagulation therapy.

The provision of guidance on treatment selection In this audit CCGs were also asked to confirm whether they had local protocols in place for the treatment of nonvalvular AF, DVT and PE, and if so, to provide details of these protocols. At the heart of this question was a need to understand the extent to which CCGs have issued local guidelines that either follow or deviate from NICE guidance, and whether this could lead to local restrictions in access to some treatments. There was clearly a low level of certainty among responding individuals regarding what constituted a protocol. For example, some sent formulary guidance without any particular commentary or guidelines, while others sent clinical pathways with prescription guidelines recommending warfarin as first line treatment. When analysing responses, ‘protocols’ were defined as a guideline provided at a local level, which provides direction beyond the NICE guidance regarding a preferred treatment option, or particular considerations in the selection of different treatments. It should be noted that the findings from the audit are only based on an interpretation of the information provided in the responses received. In response to the audit, 54 CCGs reported having at least one local guideline in place to support anticoagulation prescribing decisions. Among the 54 CCGs, six per cent (n=3) provided guidelines issued by the provider rather than the CCG itself, and 83 per cent (n=45) shared guidelines that apply across the CCG area, issued by the CCG itself, the former stroke network or the local prescribing area team. Importantly, among the 54 CCGs that reported having at least one local guideline in place, 78 per cent (n=42) either referred to warfarin as the preferred option, or did not refer to NOACs as a treatment option for people with nonvalvular AF, DVT or PE, despite recommendations from NICE guidance (see Figure 6). Poor alignment with NICE guidance may be due to the fact that some local guidelines were several years old. However, within the more recent guidelines, while reference was made to the need to follow NICE guidance, it appeared that a number of CCGs have attempted to impose restrictions on the use of NOACs, thus leading to potential barriers to access of a NICE approved medicine.

Figure 6. Proportion of local guidelines favouring warfarin over NOACs Reported local guideline favouring warfarin over NOACs

9% 13%

Reported local guideline not favouring warfarin over NOACs 78%

Unclear/information not provided

The analysis found that some guidelines or protocols, while referring to the introduction of NOACs, recommended initiation of these treatments only after trying warfarin, despite NICE technology appraisals making no restriction to the place of NOACs in the treatment algorithm. For example, in the case of AF, some CCGs clearly maintained that warfarin should remain the first-line option. One CCG shared information stating that “well controlled Warfarin is a well established, safe and effective treatment option for the prevention of stroke in atrial fibrillation and should be considered the treatment of choice for all current and new patients. It remains the first line treatment”117. Such advice is contrary to NICE guidance, including the updated 2014 NICE clinical guideline on AF (CG 180), which stipulates that NOACs are recommended for use in nonvalvular atrial fibrillation as equal first line with warfarin, as set out it its updated algorithm118. Another local guideline shared uncovered through the audit stated that “warfarin has been prescribed for more than 50 years” and that “each NOAC has a higher acquisition cost than warfarin”119. If cost is often raised as a concern for prescribing NOACs, the cost of strokes or INR monitoring at anticoagulation clinics, for example, is rarely taken into account in local assessment of overall NOAC cost effectiveness120. In addition, some of the commentary contained in local guidance risks fuelling clinicians’ lack of confidence in prescribing NOACs. This problem is apparent in parts of the country, with some protocols prominently stressing the lack of antidotes in NOACs and implying that doctors may have more confidence in prescribing warfarin over NOACs given that it has been prescribed for decades. This is despite positive NICE recommendations and the fact that NOACs have been used in the UK for the more than two years in nonvalvular AF, and five years in VTE prevention after hip/knee replacement surgery121. One local guideline for the prevention of AF-related strokes recommended prescribing aspirin for patients with low to medium stroke/thromboembolic risk122. While this was common practice in the past, evidence has shown that antiplatelets such as aspirin reduce the risk of AF-related stroke by only 19 per cent versus 64 per cent for oral anticoagulants such as warfarin123. This has been reflected in the updated 2014 NICE clinical guideline on AF, which recommends that clinicians “do not offer aspirin monotherapy solely for stroke prevention to people with atrial fibrillation”124. Positively, however, some other respondents, such as Southend CCG, provided advice to support 41

clinicians in switching anticoagulation therapy to a NOAC where this was considered clinically appropriate, and even stated that â&#x20AC;&#x153;the European Society of Cardiology guideline now recommends them as broadly preferable to warfarin in the vast majority of patients with non-valvular AF, when used as studied in the clinical trials performed so farâ&#x20AC;?125. It is understandable, and welcome, that CCGs may wish to facilitate the implementation of NICE guidance by issuing or using local guidance or protocols. However, it is concerning if such local guidance seeks to replicate assessment carried out robustly by NICE, and particularly worrying if this leads to restrictions by direction or by implication to treatments recommended by NICE that have the potential to improve patientsâ&#x20AC;&#x2122; outcomes and experiences. It should be noted that it is statutory obligation for commissioners to make funding available within three months for drugs that have been recommended by a NICE technology appraisal126. This was recently highlighted in a recent NICE Good Practice Guidance on developing and updating local formularies, which stresses that formularies should not duplicate NICE assessments or question an appraisal recommendation127. By creating further restrictions or failing to provide up-to-date advice, CCGs may exacerbate regional variations in prescribing practice and access to treatments, precisely the kind of variation that NICE appraisals are designed to remove. Recommendation: CCGs should ensure that any local guidance is in line with the latest recommendations from NICE guidance and does not impose restrictions on access to treatments through direct guidance on selection of therapy or the undermining of confidence in any particular treatment option.

Part 2: Understanding local services At a time when the NHS is under significant financial pressure, it is particularly important that services are reviewed on a regular basis to ensure resources are put to their optimum use and patients achieve the best outcomes and good experiences of treatment. CCGs have a key responsibility in making sure that the services they commission are fit for purpose and constitute the most effective use of NHS resources to respond to the local demand.

Monitoring demand for and access to services The audit sought to explore the steps that CCGs are taking to monitor local demand for and access to services, including whether they had assessed the number of people using anticoagulation services and if they had completed the NICE commissioning and budgeting tool. Responses to the audit questions revealed that 43 per cent (n=74) of the CCGs that commission anticoagulation services have not assessed the number of people using these services (Figure 7). Among these, four CCGs indicated that they had not conducted this assessment because the previous local PCT had already collected the relevant information. Figure 7. Percentage of CCGs that have assessed the number of people using anticoagulation services 3% Assessment undertaken 15% 33% 6%

No assessment undertaken Assessment in progress Partial response

43%

Unclear/information not provided

It is of course wholly appropriate that data collected by previous commissioning bodies are taken into account. However, it is also important to ensure that information is as up-to-date and accurate as possible. In fact, a significant proportion of CCGs (15 per cent, n=26) provided only partial information on this topic, covering only one type of anticoagulation service or care setting in their local area, or one condition. Among these, ten CCGs only provided information for primary care and community settings, despite the fact that they also commission services in secondary care settings. For example, one CCG only included data from the community provider, and explained that it could not provide information from secondary care services â&#x20AC;&#x153;as they are part of a block contract and not separated out at presentâ&#x20AC;?128. Understandably, a proportion of those patients who attend 43

anticoagulation services in secondary care can be found in primary care as well. However, to get a full picture of the local demand for services, it is essential that information is collected from all the settings where anticoagulation services are being delivered. As set out in Figure 7, just a third (33 per cent, n=57) of the CCGs that commission anticoagulation services reported having undertaken an assessment of the number of people using those services in their area. Another six per cent (n=10) also explained that they were in the process in conducting such an assessment. Among examples of good practice, NHS Brent CCG, which only commissions anticoagulation services in secondary care, noted that it â&#x20AC;&#x153;records, on a monthly basis the number of patients using the secondary care service using [Secondary Uses Service] SUS dataâ&#x20AC;?129. Central London CCG also reported recording the number of patients accessing local anticoagulation services through SUS data. The SUS is a comprehensive repository for healthcare data in England which is run by the Health and Social Care Information Centre. It is intended to support healthcare planning, the commissioning of services, procurement through PbR as well as improving public health130. In addition, NHS Central Manchester CCG reported that its assessment of the local demand for anticoagulation services had been undertaken via CSU contracting, which suggests that CSUs can play a useful role in supporting CCGs in the collection of data on the number of patients attending local anticoagulation services131. Others, such as NHS Wakefield CCG explained that it had not been able to assess the number of people using the local anticoagulation services secondary care, but had used NICEâ&#x20AC;&#x2122;s commissioning and budgeting tool to model an estimate132. This tool is further explored in a later in this the report. Recommendation: CCGs should ensure that they collect information on the number of people managed in each of the anticoagulation services they commission and record the outcomes achieved by those services.

How many CCGs know how much their anticoagulation service costs? As many as 43 per cent (n=73) of the CCGs that commission an anticoagulation service had not undertaken an assessment of the total costs of their local anticoagulation services. Considering commentary above on service usage data, it is not surprising that this proportion climbs yet higher (49 per cent, n=84) when it comes to having measured the costs of anticoagulation services per patient. In fact, only a third (34 per cent, n=58) of CCGs that commission anticoagulation services have assessed the total costs of those local services, and only 28 per cent (n=48) have taken steps to calculate the costs per patient (Figure 8). Among those who reported not having assessed service costs, two CCGs explained that previous PCTs had carried out the evaluation. Some also indicated that they were in the process of conducting such an assessment.

Figure 8. Percentage of CCGs that have made an assessment of the total costs and per patient costs of their local anticoagulation services 60%

50% 40% 30% 20% 10% 0% Assessment of total costs

Assessment of costs per patient

Assessment undertaken

No assessment undertaken

Assessment in progress

Partial response

Unclear/information not provided Furthermore, only 41 out of the 173 CCGs (24 per cent) that commission anticoagulation services reported having assessed both the total costs and the costs per patients of the services. For example, NHS Tower Hamlets CCG explained that: â&#x20AC;&#x153;Secondary care activity and costs are recorded as part of the national payment by results tariff. This includes a breakdown of costs per patient for first outpatient appointment and follow up outpatient appointment costs. The activity and costs of community services is reviewed as part of the contract. Both secondary and community care costs have been reviewed to ensure high quality services are provided whilst ensuring value for money.â&#x20AC;?133 This example highlights once again that procurement decisions can have an impact on commissionersâ&#x20AC;&#x2122; capacity to monitor the costs of and demand for their services. Tower Hamlets also recognised the importance of conducting an evaluation of costs to ensure that services remain high quality while achieving value for money. Some CCGs, such as NHS West Kent CCG, provided detailed figures on the total annual costs and costs per patient, including breakdowns of cost per initiation of anticoagulation therapy, outpatient appointment, DVT diagnosis and for the annual registration of a patient receiving anticoagulation services from a GP practice134. Understanding the financial resources that local anticoagulation services demand is necessary to ensure an effective delivery of services and avoid waste. The cost assessment, whether total or per patient, should take account of all costs associated with the provision of anticoagulation therapy, and contain as many breakdowns as possible for a greater understanding of where resources are being consumed135. For example, in the case of warfarin, assessments should take account of the costs associated with anticoagulation clinics, including staff time in running clinics, costs for conducting blood tests and capital costs for use of a clinical room/building, heating, lighting, etc.136 This exercise 45

is essential to ensuring better value for money, as it supports commissioners to manage their commissioning budgets more effectively. NICE has developed a tool to help commissioners in conducting cost evaluations for their anticoagulation services137. The section below explores the extent to which CCGs are aware of this tool and have used it. Recommendation: All CCGs should ensure they take the appropriate steps to measure these costs and interrogate them on a regular basis. Recommendation: When evaluating the cost of the local anticoagulation services, CCGs should ensure they determine the cost of each element of existing services. The costs should be broken down as much as possible or presented in bundles of costs.

How many have completed the NICE commissioning and budgeting tool for anticoagulation services? The NICE commissioning and budgeting (CAB) tool for anticoagulation services was published in conjunction with NICEâ&#x20AC;&#x2122;s commissioning guide for anticoagulation services in May 2013138. The tool aims to inform commissioners of potential service costs when commissioning anticoagulation services139. It is also intended to help commissioners in determining the activity and capacity requirements of the anticoagulation service that might be needed locally, and as such can be used to model future activity and capacity requirements140. Finally, it can also be used to support CCGs in reviewing current commissioned activity141. The tool includes details on the potential cost impact of reducing capacity in traditional INR monitoring services as more people are prescribed NOACs in primary care setting142. Responses to this audit suggest that only nine per cent (n=16) of CCGs that commission anticoagulation services have so far completed the NICE CAB tool (Figure 9). In addition, six per cent (n=11) reported being in the process of completing the tool for their local services. Overall, 80 per cent (n=138) of CCGs indicated that they had not utilised the tool for their local anticoagulation services. Figure 9. Percentage of CCGs that have completed the NICE commissioning and budgeting tool 6%

9% Tool completed Tool not completed 80%

Completion of tool in progress

Such a big proportion of negative responses seems to suggest that the level of awareness and understanding of NICE guidance and the NICE commissioning support guide among CCGs is still low. 46

Effort should therefore be made to ensure that CCGs are aware of the tools that are at their disposal to support effective modelling and commissioning of anticoagulation services. Recommendation: NICE should ensure that its commissioning and budgeting tool for anticoagulation services is further communicated to all commissioners to ensure a greater uptake of the tool.

Assessment of quality and patient experience Responses to this audit indicated that 41 per cent (n=71) of CCGs which commission anticoagulation services have not assessed the quality of their services (Figure 10). Six per cent (n=11) provided a partial response â&#x20AC;&#x201C; for instance where quality had been assessed for one condition such as VTE, but not all. In addition, 24 CCGs reported having only monitored the quality of their primary care or community service whereas they also commission an anticoagulation service in secondary care. However, five per cent (n=9) also reported being in the process of conducting such assessment. Figure 10. Percentage of CCGs that have assessed the quality of their anticoagulation services 50%

Data collection undertaken

40% No data collection undertaken 30% Data collection in progress 20% Partial response 10% 0%

Unclear/information not provided

Prioritisation of assessing quality in the primary care setting is likely to be linked to the contracting methods utilised, namely LES or AQP. 12 CCGs confirmed that their primary care providers had to report at least annually, if not six-monthly or quarterly, on the quality of their services as part of the LES agreement. For example, NHS South Worcestershire CCG and NHS Wyre Forest CCG indicated that an annual audit of the primary care LES has been undertaken to look at the following examples of quality measures143, 144: ď&#x201A;ˇ ď&#x201A;ˇ -

Initiation of treatment: Record keeping, including recording all complications of treatment, bleeding and hospital referrals or admissions Clinical audit, including untoward incidents and the success of the practice in establishing an INR within the planned range within 3 months of initiating treatment Details of training and education of staff providing services Patient monitoring/ Review of treatment, reflecting nationally recommended safety indicators for patients on anticoagulants including: Number of patients on register Number of bleeding episodes requiring hospital admission 47

Deaths caused by anticoagulants Untoward incidents Numbers of patients whose INRs are sub-therapeutic

In addition, seven CCGs referred to quality-reporting requirements which are part of the AQP procurement process, and which involve providing monthly monitoring reports against agreed key performance indicators. The relevant CCGs provided additional details on those indicators, which include considerations such as145:          

Percentage of complaints received as proportion of total number of patients treated Percentage of complaints not responded to within 20 working days Percentage of GPs informed in writing within 2 working days of patients discharge from service Number of patients receiving National Patient Safety Association (NPSA) Oral Anticoagulant Therapy Pack including yellow book Average number of monitoring appointments per patient Percentage of inappropriate referrals returned to referrer within 2 working days Percentage of paper based referral patients contacted within 5 working days Number of patient appointments cancelled by provider Patient experience and satisfaction with the service Average number of stabilisation appointments per patient

A number of CCGs also reported monitoring the quality of services for a particular type of condition and setting. For example, two CCGs reported that they had been monitoring the quality of their secondary care services for people suffering from VTE through the national VTE Commissioning for Quality and Innovation (CQUIN) indicator and the NHS Safety Thermometer (which is also a CQUIN). The NHS Safety Thermometer is intended to measure how safe services are and to deliver improvements locally146. It is worth noting that up until recently, there was both a VTE CQUIN indicator measuring the proportion of all adult inpatients that have had a VTE risk assessment on admission to hospital, as well as a similar VTE risk-assessment measure within the NHS Safety Thermometer. However, to avoid duplications and confusions, the separate national VTE CQUIN was removed, which implies that the corresponding data collection must be done through the NHS Safety Thermometer147. Overall, these audit findings suggest that there are variations among CCGs in the extent to which they monitor quality and the scope of such monitoring. Some CCGs focus quality monitoring on clinical outcomes and safety, and others focus on processes such as record keeping and referrals. In the context of a NHS where measuring outcomes is preferred over measuring processes, there should be a greater focus of quality reporting on clinical and patient outcomes.

Recommendation: As part of quality monitoring requirements, all local anticoagulation service providers should be reporting to their CCG against a series of quality indicators that measure clinical outcomes. These indicators should be developed by clinicians in consultation with patients and should take account of the latest national guidance available. Example of clinical outcomes to measure should include:       

Minimum time in therapeutic range Percentage of unplanned admissions Year on year improvement in the percentage of people in therapeutic range Number of adverse events which did not result in an unplanned admission Number of complaints received out of the number of patients treated Number of patients with DVT diagnosed and treated in primary care Number of patients on novel oral anticoagulants being managed in primary care

With regard to patient experience, a significant proportion of CCGs reported not having collected data on the experience of patients who attend their local anticoagulation services. Two thirds (67 per cent, n=116) of CCGs that commission anticoagulation services had not taken steps to assess patient experience (Figure 11). Five per cent (n=9) indicated that they were in the process of collating this information. In addition, a fifth of CCGs (21 per cent, n=36) reported collecting data on the experience of patients using the anticoagulation services commissioned locally. However, of these, 16 CCGs were found to be collecting data from primary care or community services only despite commissioning services in secondary care as well. Figure 11. Percentage of CCGs that have collected data on the experience of patients accessing their local anticoagulation services 5% 7% 21%

Data collection undertaken

No data collection undertaken Data collection in progress

67%

Unclear/information not provided

Among the CCGs which reported having collected patient experience data for primary care/community services, a number made reference to a local CQUIN scheme for AQP providers, which rewards the collection of data on patient experience. For example, NHS Newcastle West and NHS Newcastle North East CCGs noted in their response that “patient experience data collection forms 50 [per cent] of the CQUIN scheme for AQP providers”148. The criteria for the CQUIN indicator were described as follows149:

“To devise and implement a method of capturing patient views about the service he/she has received in real time. Subsequently implement changes in response to results and measure improvement in patient experience. “Commissioners will not prescribe a method of collecting the views of patients but the following key areas should be included:  Pre-appointment information  How well the patient felt they were dealt with on the day (environmental eg facilities, access etc.)  Patient/professional relationship i.e. being fully involved in the shared decision making  Waiting times  Overall level of happiness (including patient information and education advice and materials, clarity on what happens next, who to contact with concerns or questions)  Family and friends test  Patient views on how well his/her experience is integrated across their whole patient journey.” In response to this audit, some CCGs also stressed that they did not have patient experience information, but that this should be available from providers. However, without proactively gathering such information centrally, CCGs are not able to make a comprehensive assessment of the effectiveness of the current service provision or ensure that services are responsive to patients’ needs. Such information is key to improving service provision, and making sure that services are fit for purpose. This process of collecting patient experience data is all the more important as there is not, at this time, a national patient experience survey for people using anticoagulation services. Indeed, despite the commitment in the CVD Outcomes Strategy that “[NHS England] will consider the scope to carry out a CVD patient experience/PROMs survey, along the lines of similar surveys run for cancer patients”150, no announcement has yet been made on the development of such a survey. At this stage, therefore, there is no other resource to help commissioners understand patients’ overall experience of anticoagulation therapy. Recommendation: CCGs should ensure they collect information on patient experience and clinical outcomes for all the anticoagulation services they commission in the local area. Recommendation: CCGs should take steps to encourage providers to gather feedback from clinicians and patient support groups on their services, and to share this feedback with commissioners as part of quality monitoring requirements. Examples of questions to include are as follows:    

How long it took for the patient to access anticoagulation therapy after they suspected there was a problem Whether the patient understood the explanation of what was wrong Whether the need for anticoagulation therapy was explained to the patient Whether the patient was given a choice of different types of treatment and was involved in decisions about treatment

Recommendation: CCGs should consider the development of local financial incentives such as CQUINs to encourage the collection of data on patient experience. 50

Part 3: Anticoagulation service redesign The publication of Innovation, health and wealth in 2011 committed the NHS to embracing innovation in order for the health system to provide world class, high quality care in times of increased demand and financial constraint151. Improving the treatment for people requiring anticoagulation therapy has, rightly, been recognised as an area where the NHS should embrace innovation to improve outcomes for patients and deliver care more effectively. This includes improving the uptake of recently developed therapies and redesigning existing services around the needs of the individual, rather than established institutional silos. This audit therefore sought to measure the extent to which CCGs have reviewed and redesigned their services in a move to adopt the latest innovations in the field of anticoagulation therapy.

The use of national mechanisms and guidance to support adoption of innovation The NHS Catalogue of Potential Innovations was developed as part of Innovation, health and wealth to identify innovations which could transform patient care while supporting the NHS to deliver care more efficiently152. The Catalogue includes references to innovations in the field of anticoagulation therapy which are set out below153: “New oral anticoagulants (NOACs)

“Treatment of DVT or PE with rivaroxaban

Stroke is the third highest cause of death in the UK. Atrial fibrillation (AF) is one of the leading causes of thrombo-embolic stroke (estimated 15% of all strokes). Effective stroke prevention in patients with AF is, therefore, a clear clinical priority. New oral anti-coagulants (NOACs) were designed to provide a predictable, stable and reliable level of anticoagulation to reduce risk of stroke in patients with AF without the need for routine anticoagulation monitoring, and with a lower propensity for interactions with other agents. More than 50,000 patients with AF have been studied in clinical trials of NOACs against warfarin”

The current treatment of patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) is burdensome, requiring a dual drug approach of low molecular weight heparin (LMWH) injections and vitamin K antagonist (VKA), such as warfarin and frequent INR monitoring. rivaroxaban provides innovation in being the first oral single agent approach to treat DVT and PE, with no INR monitoring required .

NHS England’s Catalogue of Potential Innovations

NICE appraised rivaroxaban for treatment of DVT and prevention of recurrent DVT/PE in 2012 (TA261), and is currently conducting an appraisal in treatment of PE and prevention of recurrent DVT/PE (ID569) . NICE found that rivaroxaban was less costly than other DVT treatments for three months, as commonly required, and cost-effective for longer-term treatment. NICE recommended rivaroxaban as an option (without restriction) for adults with deep vein thrombosis” NHS England’s Catalogue of Potential Innovations

Findings of this audit reveal that 72 per cent (n=127) of all CCGs which responded had not made an assessment of NHS England’s Catalogue of Potential Innovations (Figure 12). In fact, only 14 per cent of CCGs (n=24) have considered the Catalogue, while six per cent (n=11) indicated that they were currently in the process of reviewing it. 51

Figure 12. Percentage of CCGs that have made an assessment of NHS England's Catalogue of Potential Innovations

14%

Assessment undertaken No assessment undertaken Assessment in progress Unclear/information not provided

72%

CCGs were also asked in this audit whether they had made an assessment of the two innovations relating to anticoagulation therapy in the Catalogue, ie ‘NOACs’ and ‘Treatment of DVT and PE’. Cross referencing the responses that were provided for this request against those given to the previous request found that 72 per cent (n=128) of CCGs have not assessed the ‘NOACs’ innovation, and 76 per cent (133) of CCGs have not assessed the ‘Treatment of DVT and PE’ innovation in the Catalogue (Figure 13). Figure 13. Percentage of CCGs that have made an assessment of the innovations ‘NOACs’ and ‘Treatment of DVT and PE’ in Catalogue of potential innovations 80% 70% 60% 50% 40% 30% 20% 10% 0%

Assessment undertaken No assessment undertaken Assessment in progress

'NOACs'

'Treatment of DVT and PE'

Unclear/information not provided

The above figures suggest that awareness and understanding of the purpose of the Catalogue among CCGs remains low. Furthermore, these findings raise questions regarding the impact that Innovation, health and wealth has had on the ground since its publication in 2011. Recommendation: NHS England should publish further guidance to increase understanding of its Catalogue of Potential Innovations and encourage the rapid adoption and diffusion of such innovations. Recommendation: As part of consideration of the design of local services, CCGs should explore the innovations referenced in NHS England’s Catalogue of Potential Innovations. 52

Consideration of the need to reconfigure anticoagulation services in light of recent treatment developments The availability of NOACs has the potential to bring significant changes to treatment pathways due to their reduced requirement for monitoring and intervention. It can impact usage of staff time and clinic capacity while also providing a simpler treatment experience for patients. It is these factors that bring NOACs into the NHS Catalogue of Potential Innovations, and these factors that suggest potential need to reconfigure services to cater for the different patient needs. Findings from this audit reveal that half of CCGs (50 per cent, n=87) which currently commission anticoagulation services have not made an assessment of the need to reconfigure anticoagulation services in light of recent treatment developments. Only a fifth (19 per cent, n=32) have carried out such an assessment, and 28 per cent (n=47) are currently reviewing or planning to soon review their services to take account of NOACs. The findings are set out in Figure 14 below. Figure 14. Percentage of CCGs that have made an assessment of the need to reconfigure anticoagulation services

19% 27%

Assessment undertaken No assessment undertaken Assessment in progress

50%

Unclear/information not provided

The reasoning behind assessments undertaken was unclear, but some CCGs provided interesting insights into the rationale for not undertaking a review. For example, two CCGs claimed that, given that the uptake of NOACs was still low in the local area, there was no need for a reconfiguration of services154, 155. One CCG said: “We will consider the need to configure anticoagulant services following greater use of new oral anticoagulants” 156. Another CCG also explained that they would not make an assessment of the need to reconfigure its services until NOACs are more established157. In addition, one CCG claimed that there is “no need to reconfigure as […] impact of NOACs is not expected to have significant effect yet per our guidance”158. Finally, another CCG provided a rationale which departed from NICE guidance, saying: “as there are indications for which the traditional treatments are still required there is no plan to alter the anticoagulation service at this time. The money invested in this service is not close to the NICE assumptions and therefore there is significantly less saving to be made in reducing this service than is forecast in the costing tools.”159 The above series of rationales for not reviewing the configuration of local services suggests that some CCGs have only adopted a reactive approach to NOAC uptake, and 53

are not planning to proactively encourage the diffusion of innovative treatments, and to redesign services accordingly. Others highlighted that they had already benefited locally from the use of NOACs. A number of CCGs also indicated that they had updated their pathways to take account of NOACs, and therefore did not plan to consider a potential redesign of their services. NHS North, East, West Devon CCG said that “the new developments in treatment have been added as options to treatment plans and pathways so that currently we have services that support new developments and traditional approaches”160. The conclusions drawn by those CCGs that have undertaken (or are undertaking) a review of the need to reconfigure services varied widely. For example one CCG conducted a review “in line with new local and national guidance and through wide stakeholder and expert consultation” and clinical service delivery and pathways were updated accordingly. However, it decided not to physically reconfigure the services. NHS Gloucestershire CCG has also been reviewing the current local pathway for the treatment of DVT, in light of the advantages and disadvantages of NOACs. The CCG is now proposing a new approach to offer both NOACs and more conventional treatments161.

“Gloucestershire CCG has reviewed the local care pathways in the treatment of DVT prompted by the availability of new oral anticoagulants and associated NICE guidance. This review process is still underway. The availability and possible advantages and disadvantages of the new oral anticoagulants have been an important part of the assessment. The CCG is proposing a new community pathway for adult patients with suspected DVT with the option for clinicians to use either the NOACs or more conventional treatment” NHS Gloucestershire CCG, Response on file

On the whole, this audit found that 71 per cent (n=122) of the CCGs that currently commission anticoagulation services are not planning to reconfigure their services in light of recent innovations in anticoagulation treatments. Only 16 per cent (n=28) have plans to reconfigure services to take account of treatment developments and eight per cent (n=13) are currently in the process of determining whether a reconfiguration will need to take place (Figure 15). Figure 15. Percentage of CCGs that are planning to reconfigure anticoagulation services in light of recently developed treatments

16%

Plan in place No plan in place Plan in development

71%

Unclear/information not provided

However, with increasing number of patients requiring long-term anticoagulation therapy, a number of CCGs may be further pushed to consider a reconfiguration of services in the long term. This has been recognised by NHS Chiltern CCG, which said in its response that it had â&#x20AC;&#x153;assessed the need to reconfigure anticoagulation services, however this is mainly due to pressures in the systemâ&#x20AC;?162. Recommendation: CCGs should ensure they take account of the views of patients and expected trends in uptake of innovations when reviewing the need to redesign local anticoagulation services. To this end, they should ensure that they involve patients and patient support groups from the very beginning of the design/redesign of services.

Full list of references 1

National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 2 NHS Choices, Atrial fibrillation. Accessed on 16 January 2012 via http://www.nhs.uk/conditions/atrialfibrillation/Pages/Introduction.aspx 3 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 4 Department of Health, Atrial Fibrillation Cost-Benefit Analysis, Marion Kerr 2008 5 National Institute for Health and Care Excellence (NICE), Cost impact and commissioning assessment 6 National Audit Office, Progress in improving stroke care, 3 February 2010 7 Department of Health, Cardiovascular Disease Outcomes Strategy: Improving outcomes for people with or at risk of cardiovascular disease, March 2013 8 National Institute for Health and Care Excellence (NICE), Clinical Guideline – Atrial Fibrillation (CG 180), June 2014. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cg180/resources/guidanceatrial-fibrillation-the-management-of-atrial-fibrillation-pdf 9 Royal College of Physicians Clinical Effectiveness and Evaluation Unit on behalf of the Intercollegiate Stroke Working Party, Sentinel Stroke National Audit Programme – Clinical Audit First Public Report, August 2013 10 Department of Health, Cardiovascular Disease Outcomes Strategy: Improving outcomes for people with or at risk of cardiovascular disease, March 2013 11 NHS Choices, Blood Clots. Accessed on 2 June 2014 via: http://www.nhs.uk/Conditions/thrombosis/Pages/Introduction.aspx 12 NHS Choices, Deep vein thrombosis. Accessed on 3 June 2014 via: http://www.nhs.uk/Conditions/Deep-veinthrombosis/Pages/Introduction.aspx 13 NHS Choices, Pulmonary embolism. Accessed on 3 June 2014 via: http://www.nhs.uk/conditions/pulmonaryembolism/Pages/Introduction.aspx 14 NHS Choices, Embolism. Accessed on 18 September 2014 via: http://www.nhs.uk/conditions/Embolism/Pages/Introduction.aspx 15 Baglin, Kakkar, Arya and Fitzmaurice, Demographics, Epidemiology and Risk of VTE, webpage. Accessed 17 January 2014: http://reception.e-lfh.org.uk/vte/content/VTE_01_01/d/ELFH_Session/321/tab_442.html, accessed 17 January 2014 16 Baglin, Kakkar, Arya and Fitzmaurice, Demographics, Epidemiology and Risk of VTE, webpage. Accessed 18 September 2014 via http://reception.e-lfh.org.uk/vte/content/VTE_01_01/d/ELFH_Session/321/tab_442.html 17 Bayer Data on File VTE Incidence from database linkage study, 2011 18 Health Select Committee, The prevention of venous thromboembolism in hospitalised patients, February 2005 19 British Heart Foundation, Heart Valve Disease, 2014. 20 British Heart Foundation, Heart Valve Disease, 2014. 21 AntiCoagulation Europe, ‘Prosthetic valves’. Accessed on 20 June 2014 via: http://www.anticoagulationeurope.org/conditions/prosthetic-valves 22 AntiCoagulation Europe, ‘Prosthetic valves’. Accessed on 20 June 2014 via: http://www.anticoagulationeurope.org/conditions/prosthetic-valves 23 National Institute for Health and Care Excellence (NICE), Patient decision aid – atrial fibrillation: medicines to help reduce your risk of a stroke – what are the options?, June 2014 24 Department of Health, Innovation, health and wealth: accelerating adoption and diffusion in the NHS, December 2011 25 Stewart S, et al. Heart, 2001; 86(5):516-21 26 Atrial Fibrillation Association and Anticoagulation Europe, The AF Report, Atrial Fibrillation: Preventing a stroke crisis, 2011 27 NHS Improvement, Heart: Anticoagulation for Atrial Fibrillation - A simple overview to support the commissioning of quality services, 2011. Available at: http://www.atrialfibrillation.org.uk/files/file/Articles_Medical/NHSI%20Anticoagulation%20for%20AF%20Com missioning%20Guide.pdf

National Institute for Health and Care Excellence, Costing Report: atrial fibrillation - Implementing the NICE guideline on atrial fibrillation (CG180), June 2014. Available at: http://www.nice.org.uk/guidance/cg180/resources/cg180-atrial-fibrillation-update-costing-report2 29 National Institute for Health and Care Excellence, Costing Report: atrial fibrillation - Implementing the NICE guideline on atrial fibrillation (CG180), June 2014. Available at: http://www.nice.org.uk/guidance/cg180/resources/cg180-atrial-fibrillation-update-costing-report2 30 National Institute for Health and Care Excellence, Atrial fibrillation: the management of atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 31 National Patient Safety Agency, Patient Safety Alert. Actions that can make anticoagulation therapy safer, 2007 32 NHS Improvement, Commissioning for Stroke Prevention in Primary Care. Accessed on 18 September 2014 via: http://www.nhsiq.nhs.uk/media/2335814/af_commissioning_guide.pdf 33 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 34 AntiCoagulation Europe, Commissioning effective anticoagulation services for the future: a resource pack for commissioners, November 2012 35 NHS Commissioning Board (NHS England), Commissioning fact sheet for clinical commissioning groups, August 2012. Accessed via: http://www.england.nhs.uk/wp-content/uploads/2012/09/fs-ccg-respon.pdf 36 Bayer HealthCare, From prevention to treatment: deep vein thrombosis and pulmonary embolism – Taking the pulse of NHS services, November 2013 37 Atrial Fibrillation Association and AntiCoagulation Europe, The AF Report, Atrial Fibrillation:Preventing a stroke crisis, 2011 38 NHS Lincolnshire CCG, Response to Freedom of Information audit on file 39 NHS Central Manchester CCG, Response to Freedom of Information audit on file 40 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 41 AntiCoagulation Europe, Commissioning effective anticoagulation services for the future: a resource pack for commissioners, November 2012 42 NHS Hull CCG, Response to Freedom of Information audit on file 43 Stewart S, et al. Heart, 2001; 86(5):516-21 44 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 45 GMC, Investigating the prevalence and causes of prescribing errors in general practice: The PRACtICe Study, May 2012 46 Bayer HealthCare, From prevention to treatment: deep vein thrombosis and pulmonary embolism – Taking the pulse of NHS services, November 2013 47 Bayer HealthCare, From prevention to treatment: deep vein thrombosis and pulmonary embolism – Taking the pulse of NHS services, November 2013 48 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 49 NICE Implementation Collaborative, Consensus – Supporting local implementation of NICE guidance on use of the novel (non-vitamin K antagonist) oral anticoagulants in non-valvular atrial fibrillation, June 2014 50 NICE Implementation Collaborative, Consensus – Supporting local implementation of NICE guidance on use of the novel (non-vitamin K antagonist) oral anticoagulants in non-valvular atrial fibrillation, June 2014 51 West Yorkshire Cardiovascular Network, Recommendations for the Introduction of New Oral Anticoagulants, July 2012 52 National Institute for Health and Care Excellence, Atrial fibrillation: the management of atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 53 NHS Sheffield CCG, Sheffield Guidelines for the Management of Atrial Fibrillation, Date unknown. 54 Hart RG, Pearce LA, Aguilar MI, ‘Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta analysis’, Ann Intern Med, 2007;146:857-67 55 National Institute for Health and Care Excellence, Atrial fibrillation: the management of atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 56 National Institute for Health and Care Excellence, Atrial fibrillation: the management of 57

atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 57 NICE Implementation Collaborative, Consensus – Supporting local implementation of NICE guidance on use of the novel (non-vitamin K antagonist) oral anticoagulants in non-valvular atrial fibrillation, June 2014 58 NICE Implementation Collaborative, Consensus – Supporting local implementation of NICE guidance on use of the novel (non-vitamin K antagonist) oral anticoagulants in non-valvular atrial fibrillation, June 2014 59 NHS Brent CCG, Response to Freedom of Information audit on file 60 AntiCoagulation Europe, Commissioning effective anticoagulation services for the future: A resource pack for commissioners, December 2012 61 NHS Wyre Forest CCG, Response to Freedom of Information audit on file 62 NHS South Worcestershire CCG, Response to Freedom of Information audit on file 63 NHS Newcastle West and NHS Newcastle North East CCGs, Response to Freedom of Information audit on file 64 Department of Health, Cardiovascular Disease Outcomes Strategy – Improving outcomes for people with or at risk of cardiovascular disease, March 2013 65 AntiCoagulation Europe, Patient experience of anticoagulation services: ACE survey, October 2013 66 AntiCoagulation Europe, Patient experience of anticoagulation services: ACE survey, October 2013 67 Department of Health, Innovation, health and wealth – Accelerating adoption and diffusion in the NHS, December 2011 68 NHS Commissioning Board (NHS England), Catalogue of potential innovations – Innovation, health and wealth, March 2013 69 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 70 AntiCoagulation Europe, Commissioning effective anticoagulation services for the future: a resource pack for commissioners, November 2012 71 NHS Luton CCG, Response to Freedom of Information audit on file 72 NHS Oxfordshire CCG, Response to Freedom of Information audit on file 73 NHS Durham Dales, Easington and Sedgefield CCG, Response to Freedom of Information audit on file 74 NHS North, East, West Devon CCG, Response to Freedom of Information audit on file 75 NHS Gloucestershire CCG, Response to Freedom of Information audit on file 76 NHS Gloucestershire CCG, Response to Freedom of Information audit on file 77 National Institute for Health and Care Excellence, Atrial fibrillation: the management of atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 78 NHS Chiltern CCG, Response to Freedom of Information audit on file 79 NHS Commissioning Board (NHS England), Commissioning fact sheet for clinical commissioning groups, August 2012. Accessed via: http://www.england.nhs.uk/wp-content/uploads/2012/09/fs-ccg-respon.pdf 80 Department of Health, Statutory Guidance on Joint Strategic Needs Assessments and Joint Health and Wellbeing Strategies, 22 March 2013, available here: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/223842/Statutory-Guidanceon-Joint-Strategic-Needs-Assessments-and-Joint-Health-and-Wellbeing-Strategies-March-2013.pdf 81 Department of Health, Statutory Guidance on Joint Strategic Needs Assessments and Joint Health and Wellbeing Strategies, 22 March 2013, available here: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/223842/Statutory-Guidanceon-Joint-Strategic-Needs-Assessments-and-Joint-Health-and-Wellbeing-Strategies-March-2013.pdf 82 NHS South Warwickshire CCG, Response to Freedom of Information audit on file 83 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 84 AntiCoagulation Europe, Commissioning effective anticoagulation services for the future: a resource pack for commissioners, November 2012 85 NHS Hull CCG, Response to Freedom of Information audit on file 86 Stewart S, et al. Heart, 2001; 86(5):516-21 87 NHS Employers, Quality and Outcomes Framework 2014/15, March 2014 88 Atrial Fibrillation Association and AntiCoagulation Europe, The AF Report, Atrial Fibrillation:Preventing a stroke crisis, 2011 89 NHS Lincolnshire CCG, Response to Freedom of Information audit on file 90 NHS Manchester CCG, Response to Freedom of Information audit on file

University of Nottingham, PRIMIS, GRASP the initiative in improving the management of patients with long term conditions – Help for GP practices, November 2013. Available at: http://www.nottingham.ac.uk/primis/documents/information/grasp-suite-information-flyer.pdf 92 University of Nottingham, PRIMIS, GRASP the initiative in improving the management of patients with long term conditions – Help for GP practices, November 2013. Available at: http://www.nottingham.ac.uk/primis/documents/information/grasp-suite-information-flyer.pdf 93 Bayer HealthCare, From prevention to treatment: deep vein thrombosis and pulmonary embolism – Taking the pulse of NHS services, November 2013 94 NHS Castle Point and Rochford CCG, Response to Freedom of Information audit on file 95 GMC, Investigating the prevalence and causes of prescribing errors in general practice: The PRACtICe Study, May 2012 96 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 97 Department of Health, A simple guide to Payment by Results, 2013. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213150/PbR-Simple-GuideFINAL.pdf 98 Department of Health, A simple guide to Payment by Results, 2013. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213150/PbR-Simple-GuideFINAL.pdf 99 Department of Health, A simple guide to Payment by Results, 2013. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213150/PbR-Simple-GuideFINAL.pdf 100 Department of Health, A simple guide to Payment by Results, 2013. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213150/PbR-Simple-GuideFINAL.pdf 101 NHS East Riding of Yorkshire CCG, Response to Freedom of Information audit on file 102 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 103 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 104 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Accessed on 18 September 2014 via: http://www.nice.org.uk/guidance/cmg49/resources/non-guidancesupport-for-commissioning-anticoagulation-therapy-pdf 105 NHS England, Putting patient first - The NHS England business plan for 2013/14 – 2015/16. Available at: http://www.england.nhs.uk/wp-content/uploads/2013/04/ppf-1314-1516.pdf 106 NHS Commissioning Board (NHS England), Enhanced services commissioning factsheet, July 2012. Available at: http://www.england.nhs.uk/wp-content/uploads/2012/03/fact-enhanced-serv.pdf 107 NHS Commissioning Board (NHS England), Enhanced services commissioning factsheet, July 2012. Available at: http://www.england.nhs.uk/wp-content/uploads/2012/03/fact-enhanced-serv.pdf 108 NHS Commissioning Board (NHS England), Enhanced services commissioning factsheet, July 2012. Available at: http://www.england.nhs.uk/wp-content/uploads/2012/03/fact-enhanced-serv.pdf 109 NHS Camden CCG, Response to Freedom of Information audit on file 110 NHS Commissioning Board (NHS England), Enhanced services commissioning factsheet, July 2012. Available at: http://www.england.nhs.uk/wp-content/uploads/2012/03/fact-enhanced-serv.pdf 111 Alisdair Stirling, Christina Kenny, “Local enhanced services worth millions to be opened up to competition from April” Pulse, 3 January 2014. Available at: http://www.pulsetoday.co.uk/20005439.article#.U4DCNPldWSq 112 British Medical Association, Understanding the reforms…Choice and Any Qualified Provider, April 2013 113 NHS Commissioning Board (NHS England), Enhanced services commissioning factsheet, July 2012. Available at: http://www.england.nhs.uk/wp-content/uploads/2012/03/fact-enhanced-serv.pdf 114 NHS Walsall CCG, Response to Freedom of Information audit on file 115 NHS Greenwich CCG, Response to Freedom of Information audit on file 116 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 59

117

West Yorkshire Cardiovascular Network, Recommendations for the Introduction of New Oral Anticoagulants, July 2012 118 National Institute for Health and Care Excellence, Atrial fibrillation: the management of atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 119 NHS Greater Manchester Commissioning Support Unit, Prescriber Decision Support of New Oral AntiCoagulants, December 2013 120 Association of the British Pharmaceutical Industry (ABPI) Stroke in Atrial Fibrillation Initiative (SAFI), NOACS: Innovation in anticoagulation – optimising the prevention of AF-related stroke, March 2014 121 Association of the British Pharmaceutical Industry (ABPI) Stroke in Atrial Fibrillation Initiative (SAFI), NOACS: Innovation in anticoagulation – optimising the prevention of AF-related stroke, March 2014 122 NHS Sheffield CCG, Sheffield Guidelines for the Management of Atrial Fibrillation, Date unknown. 123 Hart RG, Pearce LA, Aguilar MI, ‘Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta analysis’, Ann Intern Med, 2007;146:857-67 124 National Institute for Health and Care Excellence, Atrial fibrillation: the management of atrial fibrillation, 18 June 2014. Available at: http://www.nice.org.uk/nicemedia/live/14573/68045/68045.pdf 125 NHS Southend CCG, Guidelines for considering novel anti-coagulants in atrial fibrillation, January 2014 126 NICE Implementation Collaborative, Consensus – Supporting local implementation of NICE guidance on use of the novel (non-vitamin K antagonist) oral anticoagulants in non-valvular atrial fibrillation, June 2014 127 National Institute for Health and Care Excellence (NICE), Developing and updating local formularies – Good practice guidance 1, 2012 128 NHS Knowsley CCG, Response to Freedom of Information audit on file 129 NHS Brent CCG, Response to Freedom of Information audit on file 130 Health and Social Care Information Centre, ‘Secondary Uses Service’. Accessed on 27 May 2014 via: http://www.hscic.gov.uk/sus 131 NHS Central Manchester CCG, Response to Freedom of Information audit on file 132 NHS Wakefield CCG, Response to Freedom of Information audit on file 133 NHS Tower Hamlet CCG, Response to Freedom of Information audit on file 134 NHS West Kent CCG, Response to Freedom of Information audit on file 135 AntiCoagulation Europe, Commissioning effective anticoagulation services for the future: A resource pack for commissioners, December 2012 136 AntiCoagulation Europe, Commissioning effective anticoagulation services for the future: A resource pack for commissioners, December 2012 137 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 138 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 139 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 140 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 141 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 142 National Institute for Health and Care Excellence, Support for commissioning: anticoagulation therapy, May 2013. Available at: http://publications.nice.org.uk/support-for-commissioning-anticoagulation-therapy-cmg49/ 143 NHS Wyre Forest CCG, Response to Freedom of Information audit on file 144 NHS South Worcestershire CCG, Response to Freedom of Information audit on file 145 NHS Darlington CCG, Response to Freedom of Information audit on file 146 NHS England, Commissioning for quality and innovation (CQUIN): 2014/15 guidance, February 2014. Available at: http://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2013/09/CQUIN-Guidance2014-15-PDF-751KB.pdf 147 NHS England, Commissioning for quality and innovation (CQUIN): 2014/15 guidance, February 2014. Available at: http://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2013/09/CQUIN-Guidance2014-15-PDF-751KB.pdf 148 NHS Newcastle West and NHS Newcastle North East CCGs, Response to Freedom of Information audit on file 149 NHS Newcastle West and NHS Newcastle North East CCGs, Response to Freedom of Information audit on file 150 Department of Health, Cardiovascular Disease Outcomes Strategy – Improving outcomes for people with 60

or at risk of cardiovascular disease, March 2013 151 Department of Health, Innovation, health and wealth – Accelerating adoption and diffusion in the NHS, December 2011 152 NHS Commissioning Board (NHS England), Catalogue of potential innovations – Innovation, health and wealth, March 2013 153 NHS Commissioning Board (NHS England), Catalogue of potential innovations – Innovation, health and wealth, March 2013 154 NHS Luton CCG, Response to Freedom of Information audit on file 155 NHS Oxfordshire CCG, Response to Freedom of Information audit on file 156 NHS Oxfordshire CCG, Response to Freedom of Information audit on file 157 NHS Durham Dales, Easington and Sedgefield CCG, Response to Freedom of Information audit on file 158 NHS West Lancashire CCG, Response to Freedom of Information audit on file 159 NHS Stockport CCG, Response to Freedom of Information audit on file 160 NHS North, East, West Devon CCG, Response to Freedom of Information audit on file 161 NHS Gloucestershire CCG, Response to Freedom of Information audit on file 162 NHS Chiltern CCG, Response to Freedom of Information audit on file