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• W1513212484 abstract "Diabet. Med. 27, 973–976 (2010) The number of people with Type 2 diabetes continues to increase and the UK has, in theory, reconfigured its health services to meet the challenge, notably by devolving diabetes management from specialist to primary care. This initiative has been guided by the introduction of national standards for diabetes as part of the National Services Framework in 2003 and by the introduction of financial incentives for primary care physicians within the Quality and Outcomes Framework (QOF) for diabetes and other common chronic conditions in 2004 [1]. Further guidance is provided by the National Institute of Clinical Excellence (NICE) [2]. It is sobering to reflect that we have, as yet, had relatively little feedback as to the impact of these policy changes at a population level. A series of four articles in succeeding editions of Diabetic Medicine is therefore of considerable interest. The studies, commissioned by Diabetes UK and conducted by a team in Cardiff, have examined changes in the prevalence of diagnosed diabetes and its vascular complications [3], the financial costs of acute hospital care for diabetes [4], prescription patterns and related costs [5], and treatment efficacy in relation to these costs [6]. Findings from observational studies such as these should always be interpreted with caution, but the conclusions from these studies are consistent with other sources of information and will be described and commented upon in that light. The headline findings from the four studies are listed in Figure 1. The first of these, a follow-up survey performed in a Welsh health district, found that the adjusted prevalence of identified diabetes had increased from 2.3% in 1996 to 3.4% in 2005 and that the proportion of those with known diabetes and diabetes-related complications had fallen from half to approximately one third [3]. The increase is consistent with other studies [7], but the prevalence estimate should be extrapolated to the rest of the UK with caution, as the Yorkshire and Humber Public Health Observatory (YHPHO) has estimated an almost twofold range in prevalence between health districts in the UK, mediated by factors such as differences in age structure, ethnicity, obesity and social deprivation [8]. The observed rise in prevalence is likely to be a composite of improved screening efficiency, longer survival and a true increase in the number of people affected. A Scottish study estimated that mortality in the diabetic population decreased by approximately 20% over a 10-year period and accounted for 40% of the increase in Type 2 diabetes over the same interval; the remaining 60% was attributable to rising incidence [7]. The decrease in the proportion of those with known complications of diabetes in the paper under discussion might therefore be because of a combination of better clinical management and an influx of recently diagnosed individuals; the report could not distinguish between these two possibilities [3]. Headline findings from the studies of Morgan, Currie and coworkers [3–6]. The second study, conducted in the same health district, compared adjusted hospital inpatient costs for diabetes in 1994 and 2004 and found that these increased from 8.7 to 12.3% of total acute hospital expenditure. The increased costs largely mirrored the increasing prevalence of diabetes in the surrounding district [4]. The third study, based on open-source data from the prescription authorities for England, Northern Ireland, Scotland and Wales, showed that prescription costs for diabetes, at £702m per year (adjusted to 2008 prices), now represent 6.9% of the national drug bill. A report from the Yorkshire and Humber Public Health Observatory published in 2007 supports this estimate and comments that ‘diabetes-related prescriptions… are now the highest single cost in the NHS prescribing budget’ [9]. England alone accounted for £591m in 2008, as against £290m in 2000, costs having been adjusted for inflation. The increase was largely driven by the cost of insulin, which rose from £128m (44% of the total spend) to £286m (48.4%) over the 8-year period. Diagnostic reagents came next, accounting for £95m in 2000 and £139m in 2008: in percentage terms, however, costs fell from 32.8 to 23.6%. Next were the glitazones, which accounted for 0.5% of expenditure in 2000 and 13.2% in 2007, falling back to 11.7% in the following year as a consequence of safety concerns relating to rosiglitazone. Metformin accounted for 4.6% of the drug spend in 2000, as against 10.7% in 2008, but in the latter year it accounted for 52.8% of all prescriptions, whereas the glitazones represented a mere 2.8%. Twenty people received metformin for the cost of one receiving a glitazone. In contrast, the cost of the insulin secretagogues (mainly sulphonylureas) fell from 16.2% of expenditure in 2000 to 3.7% in 2008, while volume fell from approximately one third to one fifth over the same interval. Prandial glucose regulators and acarbose, meanwhile, have almost vanished from circulation and guar gum has reverted to its previous role as wallpaper paste. Insulin dominates the diabetes drug bill. In England, for example, it accounted for £286m of the diabetes spend in 2007, £234m of which (82%) was accounted for by insulin analogues. Opinions differ as to whether routine use of insulin analogues is justified in Type 2 diabetes, but the heavyweight systematic reviews are unanimous that it is not, with possible exception for the minority who experience troublesome symptomatic hypoglycaemia [10]. The cost for one quality-adjusted life year on insulin glargine, as compared with human insulin, has been estimated at approximately £400 000 for Type 2 diabetes [11]. The German advisory body, the German Institute for Quality and Efficiency in Health Care, known as IQWiG, concluded in 2008 that reimbursement for the short-acting analogues in Type 2 diabetes is not justified on present evidence; it later reached the same conclusion for the long-acting analogues [12]. The resulting controversy was resolved when the manufacturers reduced the price of their analogues to that of human insulin [10]. A similar concession for all analogues would have reduced the English drug budget for diabetes in that year by some £80m (13.5%). Conversely, the recently announced withdrawal of human Mixtard insulin will (assuming that all 90 000 patients affected transfer to analogue mixtures) increase costs by some £15m. The inordinate cost of glucose test strips deserves further scrutiny. It is notorious that manufacturers compete by giving away free meters, thus locking the patient and prescriber into use of their own test strips. Central price reductions were imposed upon diagnostic monitoring items in 2006, but had little effect in containing costs [13]. The bulk of the evidence indicates that blood glucose testing does not in itself improve glucose control in Type 2 diabetes, while negative consequences such as depression also need to be taken into account [14]. This apart, blood tests are undoubtedly a helpful educational tool, provide reassurance to many and seem essential for some. Although these benefits may be useful, they can scarcely be said to justify the expenditure of £139m in 2007. The excessive cost of the thiazolidinediones is not in dispute, given their second-line place in the treatment of diabetes and the billions in profit that they have generated for their manufacturers. The situation is unlikely to change until generic versions come onto the market. More puzzling, however, is the declining use of the sulphonylureas. Despite concerns about hypoglycaemia, these remain a very cost-effective and evidence-based therapeutic option. In contrast to some more recent agents, their safety profile is not in doubt. If the sulphonylureas were newly discovered today, the market would be in ecstasies about them. Once again, marketing seems to have trumped the evidence. The last of the four studies is the most challenging [6], as it purports to examine both treatment and efficacy in primary care. The study is based upon analysis of a UK general practice database known as The Health Improvement Network (THIN). The authors compare consultation and prescription costs for those with and without a diagnosis of diabetes over the period 1997–2007 and relate these costs to three surrogate outcomes, HbA1c, blood pressure and lipids, for the period 2001–2007. Primary care consultations for diabetes increased from 5.4 to 11.5 per annum between 1997–2007 and adjusted drug costs per patient year rose from £391 to £740. Combined consultation and per-person prescription costs rose from £602 in 1997 to £1080 in 2007 for those with Type 2 diabetes. In relative terms, combined costs were 50% greater than those for a non-diabetic subject in 1997 and 80% greater in 2007. Interestingly enough, drug costs related to blood glucose management constituted a mere 28% of the total drug spend for those with diabetes. Use of cholesterol-lowering agents rose from 8 to 85% between1997 and 2007; use of ACE inhibitors and angiotensin receptor blockers rose from 20 to 71% and use of anti-platelet agents rose from 17 to 61%. Over the period from 2001 to 2007, for which data are available, total cholesterol levels fell by approximately 1.4 mmol/l (25%) in those with Type 2 diabetes and systolic blood pressure fell by 8 mmHg (5%). These reductions would be expected to have a useful impact upon the progression of cardiovascular disease. In contrast, there was effectively no change in HbA1c in those with either Type 1 or Type 2 diabetes requiring insulin. Mean values were 8.7 and 8.4% at the end of a 7-year observation period, by which time the majority of patients had been transferred on to analogue insulins. Those on combined therapy with metformin and a sulphonylurea, in contrast, showed a reduction from 8.4 to 7.7%, suggesting earlier or more aggressive use of this combination. Those on monotherapy with either metformin or a sulphonylurea had an HbA1c of 7.2% in 2007, as against 6.8% in those on no pharmacological therapy. Thiazolidinediones, unfortunately, were not studied. What does this tell us about glucose control? Previous reports from primary care in the UK have been encouraging. The proportion of patients with a diagnosis of Type 2 diabetes and an HbA1c below 7.5%, for example, reportedly increased from 37.8% in 1997 to 54.9% in 2007 [1,15]. How can this be reconciled with the findings of the study under discussion? The most likely explanation is that the reported improvement in glucose control is because of earlier detection and more aggressive management of those in the earlier stages of Type 2 diabetes. Sadly, there is little evidence to suggest that those with more advanced B-cell failure, whether due to Type 1 or Type 2 diabetes, are any better off than they were 10 years ago. The four studies have confirmed previous indications of a rapid rise in the number of people with diabetes who are known to the healthcare system in the UK. The increasing burden of diabetes is reflected in a recent 50% increase in hospital costs for those with a diagnosis of diabetes. Of every £8 spent on acute hospital care in the UK, £1 now goes to someone with diabetes [4]. The study on prescription costs [5] should be read in conjunction with reports from the Yorkshire and Humber Public Health Observatory published in 2007 and 2009 [9,13]. Diabetes-related prescriptions have become the highest single cost in the National Health Service (NHS) prescribing budget [9]. In line with worldwide trends [16], the cost of these prescriptions is rising at approximately 50% in excess of their volume, in contrast to the falling costs for other high-volume prescribed items such as the statins and cardiovascular drugs. A further anomaly was a 2.5-fold variation in the cost (per patient) of oral glucose-lowering medications between Primary Care Trusts (PCTs) and a twofold variation in the cost of insulin, undoubtedly attributable to differing usage of the glitazones and of the insulin analogues [13]. One remarkable observation is that prescribing practice in the UK is completely unrelated to NICE guidance. NICE recommend sulphonylureas as first-line treatment in some patients and as the preferred second-line treatment in the remainder. NICE places very strict restrictions upon the use of the thiazolidinediones. NICE firmly recommends human NPH insulin as the first-line choice in Type 2 diabetes, with biphasic human insulin as the first-line alternative. Insulin analogues should, according to NICE, be restricted to second line-use, and then only in special circumstances. Routine blood glucose testing should be restricted to those with Type 1 diabetes; more directed use in Type 2 diabetes is recommended. Simple adherence to these guidelines would cut the UK bill for diabetes-related agents by something in the region of 25%. The sad fact is that NICE guidelines are toothless, except where [as with use of glucagon-like peptide-1 (GLP-1) agonists or insulin infusion pump therapy] there are special cost implications. This apart, NICE, like Cassandra in the fable, seems fated to speak the truth but to be utterly ignored—to the extent that one insulin manufacturer is busily removing its entire line of human insulins. The encouraging news is that public health policy in the UK seems to be working well in many respects, as shown by massively increased use of cardioprotective agents and useful reductions in lipids and blood pressure [6]. The news about HbA1c is more equivocal, with the suggestion that we are identifying diabetes and treating glucose levels more effectively in the earlier stages of the condition, but have made little progress at a population level for those with end-stage B-cell failure, whether as a result of Type 1 or Type 2 diabetes. Quality and Outcomes Framework fanciers may note that the apparent boost to performance seen following their introduction was not sustained and that ‘there may have been unintended consequences, including reductions in the quality of some aspects of care not linked to incentives’ [15]. Now there’s a surprise. Health policies come and go, as do the politicians, but diabetes is here to stay. The centre of gravity of diabetes care is now firmly located in primary care and there is every reason to believe that people with diabetes are being diagnosed and treated earlier and more effectively, and may be living longer in consequence. Lipid control has been effectively implemented and blood pressure control has improved. Improvements in glucose control have been less convincing and the main impact may have been upon those in the earlier stages of B-cell failure. If you believe that people with Type 2 diabetes should maintain an HbA1c below 7%, you will be frustrated. If, like me, you believe that 8% plus anti-hypertensive therapy and a statin represents a reasonable compromise between vascular protection and quality of life in older people with Type 2 diabetes, you will be more satisfied with the progress that has been made. Cost is a four-letter word that is insufficiently used in diabetes. As we enter a financial recession, which some believe will be the worst since the 1930s, cost-effective evidence-based management of diabetes will be at a premium. The studies reviewed here make it clear, if further proof were needed, that our prescribing habits for diabetes are neither evidence-based nor cost-effective. It might be argued that the prescribing budget is a relatively minor part of the total bill for diabetes, and so it is. It is also a painless way of saving the NHS approximately £150m per year, opportunity costs that could (if only the system allowed) make a real difference to the quality of care for people with diabetes. Many years ago a mentor of mine called John Hampton wrote an article entitled ‘the end of clinical freedom’, which was cited in a recent editorial [13]. ‘If we do not have resources to do all that is technically possible’, he said, ‘then medical care must be limited to what is of proved value and the medical profession will have to set opinion aside’ [16]. Nothing to declare." @default.
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• W1513212484 title "Diabetes in the UK: time for a reality check?" @default.
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