Resistant Chronic Spontaneous Urticaria – A Case Series Narrative Review of Treatment Options

1417PD - Nice Technology Appraisals and the Uptake of Breast Cancer Drugs in the UK

ObjectivesTo compare the timelines and recommendations of the Scottish Medicines Consortium (SMC) and National Institute of Health and Clinical Excellence (NICE), in particular since the single technology assessment (STA) process...

Editorial

Scientific-bureaucratic medicine (SBM) has been the dominant discourse on evidence-based medicine in the English National Health System (NHS). It has being claimed that SBM has led to new forms of medical professionalism with an emphasis on organisational values and the control of autonomy. This paper explores the medical professions’ response to SBM, where SBM is manifested in the form of National Institute of Health and Clinical Excellence (NICE) guidelines. Seventy-four face-to-face informal interviews were carried out with clinicians and managers between 2007 and 2009. Three major themes emerged from the analysis each of which was linked to doctors’ receptiveness to NICE guidelines implementation. The first emphasised organisational values, which accounted for conditional acceptance of NICE guidelines. The second was proactive professionalism or entrepreneurial professionalism, which was linked to the rejection of NICE guidelines and the emergence of alternative forms of introducing new ideas for the expansion of their clinical practice. The third was related to the prominence of clinical autonomy linked with doctors’ resistance to the use of NICE guidelines. It is argued that this evidence does not reflect a significant emergence of new forms of professionalism but the development of multiple occupational identities.

Knee pain due to osteoarthritis is an increasing health problem.1 ,2 Acupuncture is a promising treatment for osteoarthritis that may provide symptom relief without the adverse cardiovascular events associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs). When the UK National Institute of Health and Clinical Excellence (NICE) reviewed the evidence for its 2008 osteoarthritis guideline,3 they concluded that it seemed likely that acupuncture can provide some short-term to medium-term relief for some people living with osteoarthritis. However, in contrast with NICE back pain guidance,4 they did not make a positive recommendation for acupuncture. Importantly, as reported in one of the linked papers,5 the approach to the health economic analysis in the NICE osteoarthritis guideline compared verum and sham acupuncture whereas the NICE back pain guideline compared acupuncture with usual care. The Osteoarthritis Research Society International has recommended that ‘acupuncture may be of symptomatic benefit’6 and a subsequent Cochrane review of acupuncture7 concluded that there were small benefits from acupuncture when …

Objective: Since 2004, the National Institute of Health and Clinical Excellence (NICE) has required manufacturers to conduct a probabilistic sensitivity analysis (PSA) in their technology appraisals. The objective of this review is to assess the cost-effectiveness of different technology appraisals and compare them with the actual decision made by the NICE based on PSA.Methods: The search term ‘probabilistic sensitivity analysis’ was used on the NICE home page (25 January 2012). The appraisals identified in the search were assessed and subjected to further review, if a probability of being cost-effective was provided, regardless of the threshold indicated. If several probabilities were provided, the number provided by the evidence review group was used. If several scenarios were presented, the base case scenario was chosen. Finally, the probabilities of being cost-effective were compared with the actual decision made, which could result in two outcomes: recommended or not recommended.Results: A total of 31 assessments were included for the final review. The results were plotted on a graph to illustrate whether there was a relationship between the PSA outcomes and the final recommendation. The assessments were ranked according to their probability of being cost-effective.Conclusion: A higher probability of a technology being cost-effective was correlated with more positive decision-making. There appeared to be a clear threshold at which technologies with a 40% certainty of being cost-effective tended to be recommended, whereas those below the threshold were not recommended. The reports suggested that the incremental cost-effectiveness ratios (ICER) estimate was not a robust driver of decision-making. A NICE applicant should pay increased attention to the PSA in addition to the ICER estimate.

Not a NICE CT protocol for the acutely head injured child

The marked increase in prevalence of diabetes has not been matched by equivalent improvements in diabetes outcomes. Despite the acceptance that near-normal glycaemia is associated with optimal outcomes and the increasing number of medical treatments and therapy options, most people do not achieve target blood glucose levels. Although psychosocial support for people with diabetes has improved over the last 10 years, in many clinical settings the availability and delivery of this support falls short of what it should be and this shortcoming may mitigate against improvements in other health outcomes. Improved psychosocial outcomes will depend on an accurate assessment of the availability and performance of psychosocial support and, where needed, appropriate action to eliminate gaps, including training in psychosocial support for healthcare professions. Diabetes mellitus continues to represent a major public health burden both globally and in the UK. It is estimated that approximately 366 million people worldwide had diabetes in 2011 and by 2030 it is projected that more than 552 million people will be affected as a consequence of changing population demographics and changes in lifestyle [1]. In England, an estimated 3.1 million people had diabetes in 2011 and by 2030 this number is predicted to rise to 4.6 million [1]. This marked increase in prevalence, however, has not been matched by equivalent improvements in diabetes outcomes. Despite the acceptance that near-normal glycaemia is associated with optimal outcomes, most people are still not achieving target blood glucose levels. National Diabetes Audit data in 2009–2010 [2] reported that 66.5% of adults with Type 2 diabetes and only 28.2% of adults with Type 1 diabetes achieved HbA1c results of less than 58 mmol/mol (7.5%). Furthermore, 17.0% of adults with Type 1 diabetes and 6.7% of adults with Type 2 diabetes had markedly elevated glucose levels [HbA1c > 86 mmol/ mol (10%)]. These results have remained consistent over the past 3 years, indicating little improvement in diabetes control. Medical treatments and therapy options for people with diabetes have never been greater. Self-blood glucose monitoring, including new devices such as continuous glucose monitoring systems, improved means of insulin delivery, including a range of insulin pump choices, insulin analogues and a broader range of oral medications have all contributed to improved biomedical diabetes care for millions of people. Alongside these technological improvements, patient self-management education has improved with the development of behaviourally oriented, theory-based programmes. Given these advances, it is perhaps surprising that outcomes have not improved more, but this lack of improved treatment outcomes may reflect a lack of psychosocial care. When discussing the stigma associated with having diabetes, people with the condition often describe the burden as not only affecting health issues but also social functioning and quality of life. Diabetes burnout is reported to be common, with people feeling overwhelmed and defeated by diabetes and frustrated by self-care regimens. Many describe how diabetes is controlling their lives yet feel unable or unmotivated to change. This is compounded by a high prevalence of depressive and anxiety symptoms which occur 2–3 times more frequently in people with diabetes than the general population [3,4]. The psychosocial sequelae of diabetes have been recognized in a number of UK and international guidelines that have set out standards of psychological care, which individuals with diabetes should expect. Despite these guidelines, there remains a gulf in the provision of psychological services, with widespread evidence of poor service despite clinical need. In the UK, the National Service Framework (NSF) 2001 [5] aimed to ensure that people with diabetes are empowered to enhance their personal control over the day-to-day diabetes management in a way that enables them to experience the best possible quality of life. Similarly, the National Institute of Health and Clinical Excellence (NICE) states that 'diabetes professionals should ensure they have appropriate skills in the detection and basic management of non-severe psychological disorders in people from different cultural backgrounds… while arranging prompt referral to specialists of those in whom psychological difficulties continue to interfere significantly with well-being or diabetes self-management' [6]. NICE recommends all service developments should be needs-led, and the psychological needs of people with diabetes should be addressed in an organized and planned way. Other national and international guidelines provide similar recommendations; the International Diabetes Federation (IDF) states that healthcare professionals should, in communicating with a person with diabetes, adopt a whole-person approach and respect the person's central role in their ongoing diabetes education and care [7]. Well-being and psychological status (including cognitive dysfunction) should be assessed periodically, with outcomes and clinical implications discussed with the person with diabetes. The American Diabetes Association (ADA) guidelines state that assessment of psychological and social situations should be included as an ongoing part of the medical management of diabetes. They specifically state that psychosocial screening should examine attitudes about the illness, expectations of medical management and outcomes, affect and mood, general and diabetes-related quality of life, resources (financial, social and emotional) and psychiatric history. Screening should be provided for psychosocial problems such as depression, diabetes-related distress, anxiety, eating disorders and cognitive impairment, particularly when self-management is poor [8]. Despite these consistent recommendations, Minding the Gap, a Diabetes UK report on the provision of psychological support and care for people with diabetes, concluded that access to psychological services is poor and estimated that 41% of people with diabetes suffer from poor psychological well-being [9]. Only 31% of diabetes centres had access to psychological services and as few as 2.6% complied with all psychologically relevant NSF standards and NICE guidance recommendations; 25.8% of centres failed to comply with any of the recommendations. Expert psychological support is unavailable in the majority of UK diabetes centres and significant geographical variations exist both in terms of service provision and skill sets within the diabetes team, with consequent inequity of service provision [10]. Most of the burden of diabetes care lies with the individual and their families. While many people with diabetes cope well with their illness, it is no wonder that the rates of psychological problems and poor quality of life are high in those with diabetes. These psychological issues are important because they negatively impact the person's ability to care for their diabetes. The ability to take medication as prescribed may be reduced and in the long term these individuals have poorer outcomes [11]. In 2001, a global survey of Diabetes Attitudes Wishes and Needs (DAWN) provided useful insights into the psychosocial challenges facing people with diabetes globally and needs expressed by them. It 'confirmed that diabetes causes multiple psychosocial problems, that these issues are barriers to achieving adequate glycaemic control… and health care systems are poorly equipped to support chronic illness care' [12]. Following the study, a number of goals were established by the DAWN programme board (an international collaborative group established in 2001 by Novo Nordisk in partnership with the IDF and an international expert advisory panel) to promote active self-management, enhanced psychological care and better communication and coordination between people with diabetes and healthcare providers to reduce barriers to effective therapy. The lessons learned from the DAWN studies have contributed to position statements from the American Association of Diabetes Educators on psychological issues of diabetes management, the chronic care model, to the expanded role of pharmacists in Type 2 diabetes management [14], and the US national standards for Diabetes Self-Management Education [13–15]. This work has been carried out since DAWN and has coincided with an increasing international interest in non-communicable diseases, including the 2006 adoption of a resolution on diabetes by the United Nations [16] and a non-communicable diseases summit organized by the World Health Organization in 2011 to address chronic care [17]. The World Diabetes Foundation and the IDF are directing funds to translational research programmes studying healthcare delivery models. Despite the progress made over the last decade, there is still a long way to go. There remains a lack of recognition of the impact of the psychosocial burden of diabetes. Too few healthcare professionals truly understand what the 'diabetes epidemic' means in terms of psychosocial outcomes. There has been a failure by healthcare commissioners to create the necessary organizational and structural changes to provide optimal care. Patients do not understand their rights and responsibility to influence service provision and affect healthcare change in their own region. Furthermore, medical advice continues to be commonly provided by 'expert' doctors in didactic consultations to patients rather than through collaboration with patients and evaluation of patients' personal needs and barriers [18,19]. So what will the future bring to improve psychosocial outcomes for people living with diabetes? A deeper understanding of psychosocial needs of people living with diabetes is still needed. Ten years after the original DAWN Study, a new multinational DAWN study is underway, again with the UK as one of the participating nations. The DAWN-2 study will include more countries and will draw on lessons learnt from the original DAWN Study. In addition to obtaining the views of people with diabetes and healthcare professionals, as in the original DAWN Study, the views of patients' family members also will be obtained. This is an important addition, not least because previous research has indicated that family members play an important role in the psychosocial adjustment and self-management of adults with diabetes [20]. This multi-constituency will help identify differences between the laypersons and healthcare providers in their perceptions and attitudes [21,22], which can lead in turn to confusion, conflict and poor outcomes. This new global survey should address many unanswered questions in diabetes care and identify gaps in healthcare delivery and differences in perspectives across participant groups. DAWN-2 will establish a benchmark of service provision that will enable identification of countries providing best practice and comparisons to be drawn on future developments. Despite the improvements in psychosocial support for people with diabetes over the last 10 years, the reality is that the delivery and availability of this support falls a long way short of what should be expected in many clinical settings. With the broader focus of DAWN-2, an opportunity exists to inform current understanding and improve the way that psychosocial care is delivered. This will require a national discussion to face up to these challenges and answer difficult questions about the way high-quality patient-centred diabetes healthcare is achieved. Recommendations to facilitate such improved care include the conduct of audits of psychosocial provision and appropriate action taken to eliminate gaps; assessment of availability of psychosocial support services in catchment areas and the establishment of referral relationships with those providers; a standard level of training in psychosocial support for healthcare professions; and an updated national study of psychosocial support in diabetes centres. Only by visiting and re-visiting this issue will we succeed in reducing the psychosocial burden for those with diabetes and their families. None. RIGH and MP are members of the DAWN-2 International Publication Planning Committee (IPPC) and have received funding to attend DAWN-2 planning meetings. KDB leads the UK advisory group for DAWN-2 and has received funding to attend DAWN-2 planning meetings. KB leads the UK advisory group of DAWNZ and has received funding to attend DAWNZ planning meetings.

BackgroundBiologic drugs are expensive treatments used in rheumatoid arthritis (RA). Switching among them is common practice in patients who have had an inadequate response or intolerable adverse events. The National Institute of Health and Clinical Excellence (NICE) UK, which aims to curtail postcode prescribing, has provided guidance on the sequential prescription of these drugs. This study sought to evaluate the extent to which rheumatology centres across the Midlands were complying with NICE guidance on the switching of biologic drugs in RA, as well as analyse the various prescribing patterns of these drugs.MethodsData was collected via a web-based tool on RA patients who had undergone at least one switch of a biologic drug during 2011. The standards specified in NICE technology appraisals (TA130, TA186, TA195, TA198, and TA225) were used to assess compliance with NICE guidance. Descriptive statistical analysis was performed.ResultsThere were 335 biologic drug switches in 317 patients. The most common reason given for switching to a drug was NICE guidelines (242, 72.2%), followed by Physician's choice (122, 33.4%). Lack of effect was the most common reason for discontinuing a drug (224, 67%). For patients on Rituximab, Methotrexate was used in 133 switches (76.9% of the time). Overall NICE compliance for all units was 65% (range 50 to 100%), with anti-TNFα to anti-TNFα switches for inefficacy making up the majority of non-compliant switches.ConclusionThis study draws attention to the enigma and disparity of commissioning and prescribing of biologic drugs in RA. Currently the evidence would not support switching of a biologic drug for non-clinical purposes such as economic pressures. Flexibility in prescribing should be encouraged: biologic therapy should be individualised based on the mode of action and likely tolerability of these drugs. Further work should focus on the evidence for using particular sequences of biologic drugs.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2474-15-290) contains supplementary material, which is available to authorized users.

The introduction of new healthcare technologies requires an appropriate discourse between clinicians who identify problems to be overcome and industrial partners who provide potential solutions. New products go through a...

Intense immunosuppression in patients with rapidly worsening multiple sclerosis: treatment guidelines for the clinician

Sir, We read with interest the observations made by Patterson et al .1 The study determines the likelihood of coronary artery disease (CAD) in ALL subjects using Table 1 of the National Institute of Health and Clinical Excellence (NICE) Clinical Guidance 95 (CG95) and reports the number of subjects in each likelihood category. This is at odds with guidance which states that the likelihood of CAD should be estimated in people without confirmed CAD in whom stable angina cannot be diagnosed or excluded based on clinical assessment alone. The authors do not report the number of patients with confirmed CAD and consequently do not exclude these patients when analysing the likelihood …

A recall system is a continuing care regime which provides opportunities to reassess and monitor the oral health of patients and to inform future treatment planning. There is some evidence that recall visits have a positive impact on the natural and functional dentition. Unfortunately, there is a general paucity of reliable evidence about the timing of recall visits despite the widely adopted 6-month interval. In response to political, professional and patient uncertainty, the UK National Institute of Health and Clinical Excellence (NICE) convened a guideline development group to consider both best evidence and best practice in this field. The NICE issued a guidance document in 2004 recommending that the individual risk status should determine the patient's recall interval. The recommendations cover risk factors such as caries incidence and restorations; periodontal health and tooth loss, patients' well-being, general health and preventive habits, pain and anxiety. Methods and tools to facilitate and standardize the collection of risk information are currently being developed and/or collated by the Scottish Dental Clinical Effectiveness Programme. The selection of a recall interval is a multifaceted and complex decision involving the judgement of both clinician and patient. More research is needed into the rate of progression of oral diseases and the impact of recall on oral health and quality of life. Nevertheless, the NICE guidance is based on the best available evidence, and it should be used to determine personalized variable time intervals to assess, reassess and monitor the oral health and caries status of patients.

Dual antiplatelet therapy consisting of clopidogrel in addition to aspirin has previously been the standard of care for patients with acute coronary syndromes (ACS) but international guidelines have been evolving over the last 4 years with the introduction of prasugrel and ticagrelor. In October 2009, prasugrel was approved in the UK by the National Institute of Health and Clinical Excellence (NICE) for use in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), diabetic patients with non-ST-elevation (NSTE) ACS undergoing PCI and patients with stent thrombosis while other ACS patients were to continue receiving clopidogrel. Ticagrelor was approved in October 2011 by NICE for use in patients with moderate-to-high risk NSTE ACS and STEMI undergoing primary PCI and was recommended in preference to clopidogrel in European guidelines. These recommendations were adopted in our region, constituting a population of 1.8 million. We studied the effect of changing patterns of P2Y12 inhibitor usage on levels of platelet inhibition during maintenance therapy. Patients admitted to Northern General Hospital, Sheffield, with NSTE ACS or STEMI managed with primary PCI were enrolled over two periods of time: May 2010 to November 2011 (T1); and October 2012 to February 2013 (T2). Venous blood samples were obtained at 1 month after the onset of ACS. Light transmittance aggregometry (LTA) was performed and maximum aggregation response to ADP 20 μM was determined. A total of 116 patients were enrolled in T1 of whom 82 were receiving clopidogrel and 34 were receiving prasugrel. Twenty-nine patients were enrolled in T2, all of whom were receiving ticagrelor. Mean LTA results according to treatment with clopidogrel, prasugrel and ticagrelor were 57 ± 18%, 41 ± 20%, and 31 ± 12%, respectively. Prasugrel was associated with significantly lower platelet aggregation responses than clopidogrel (p < 0.001) and ticagrelor was associated with significantly lower platelet aggregation responses than both prasugrel (p = 0.015) and clopidogrel (p < 0.001). We conclude that international guidelines and NICE approval have led to increasing levels of P2Y12 inhibition in ACS patients in this UK centre between May 2010 and February 2013. Ticagrelor was associated with significantly greater P2Y12 inhibition than both clopidogrel and prasugrel during maintenance therapy.

As part of its Medical Technologies Evaluation Programme, the National Institute of Health and Clinical Excellence (NICE) invited the manufacturer, Covidien, to provide clinical and economic evidence for the evaluation of the Pipeline™ embolization device (PED) for the treatment of complex intracranial aneurysms. Cedar; a consortium between Cardiff and Vale University Health Board and Cardiff University, was commissioned to act as an External Assessment Centre (EAC) for NICE to independently critique the manufacturers’ submissions. This article gives an overview of the evidence provided, the findings of the EAC and the final guidance published by NICE.The scope issued by NICE considered PED as the intervention in a patient population with complex unruptured intracranial aneurysms (IAs), specifically large/giant, wide-necked and fusiform aneurysms. The comparator treatments identified were stent-assisted coiling, parent vessel occlusion, neurosurgical techniques and conservative management. The manufacturer claimed that PED fulfils a currently unmet clinical need in the treatment of large or giant, wide-necked or fusiform IAs.Thirteen studies were identified by the manufacturer as being relevant to the decision problem, with two of these included for data extraction. The EAC identified 16 studies as relevant, three of which had been published after the manufacturer’s search. Data extraction was carried out on these studies as, although many were low level research comprising of case reports and case series, they provided useful, pertinent safety and outcome data.No relevant economic studies of the device were identified; therefore, a new economic model was designed by the manufacturer. The base-case scenario provided recognized the costs of PED to be higher than the costs for endovascular parent vessel occlusion, neurosurgical parent vessel occlusion, neurosurgical clipping and conservative management. However, PED was found to be cost saving compared with stent-assisted coiling, with a saving of £13,110 per patient.Analysis of the clinical data suggested that treatment with PED has high rates of clinical success with high rates of aneurysm occlusion and acceptable adverse events for the patient population. Economic evidence suggested that the costs in the base-case for PED may have been underestimated, meaning that PED would only become cost saving in patients who would otherwise require treatment with 32 coils or more. NICE Medical Technologies Guidance MTG10, issued in May 2012, recommends the adoption of PED in selected patients within the UK National Health Service (NHS).