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PCT Prescribing Report (May 2009) Type 2 Diabetes – Prescribing Guidance and Discussion Points Discussion Points 1. Does your PCT have a strategy for the prevention of type 2 diabetes? Does your PCT have a programme of support for the multifactorial lifestyle interventions shown to prevent type 2 diabetes? 2. Does your PCT provide structured education programmes for people with type 2 diabetes in line with the National Institute of Health and Clinical Excellence (NICE) Commissioning Guide? Does this programme meet the criteria laid down by the Department of Health and Diabetes UK Patient Education Working Group? 3. Does local guidance on prescribing for type 2 diabetes follow the NICE guidance on the management of type 2 diabetes May 2008? 4. Are you planning to update and/or agree local protocols for the prescribing of newer agents following the publication of the NICE clinical guideline (expected May 2009)? 5. Does local guidance include advice on the role of self-monitoring of blood glucose in the management of type 2 diabetes? Does this advice include the purpose of self-monitoring and agreement about how the results should be interpreted and acted upon? Does local guidance recommend that the person with type 2 diabetes should be involved in decisions about their individual target level for glycated haemoglobin (HbA1c)? Type 2 diabetes is the most common form of diabetes, accounting for 90–95% of cases. There are estimated to be 1.9 million adults diagnosed with the condition and around 0.5 million people with undiagnosed diabetes against a background of rising prevalence. The direct costs of type 2 diabetes are estimated to be around 7 – 12% of total NHS expenditure. People with type 2 diabetes are at increased risk of developing microvascular e.g. kidney, eye and nerve damage and macrovascular e.g. cardiovascular and cerebrovascular disease complications. These multiple vascular risk factors mean that diabetes care is typically complex and time-consuming. Foot problems, kidney disease, and the presence of neuropathy should be assessed at diagnosis and at least annually thereafter. All people with diabetes should be referred for retinal screening at diagnosis as part of a formal screening programme. The lifestyle changes, complexities of management and side effects of therapy make self monitoring and education for people with diabetes central parts of management. Structured education and self-management programmes aim to improve outcomes by addressing the person’s health beliefs, optimizing their metabolic control, addressing their cardiovascular (CV) risk factors, helping them to change behaviour, e.g. increasing physical activity, improving their quality of life and reducing depression. The potential consequences of not investing in such programmes are increased complications, greater future healthcare costs and an inability to make future individual, local and national improvements. In May 2008 NICE updated its clinical guidance on the management of type 2 diabetes and recommended that structured education should be offered to every person and/or their carer at or around the time of diagnosis, with annual reinforcement and review. A full lipid profile should be performed when assessing CV risk after diagnosis and annually, and before starting lipid-modifying therapy. If the person is considered not to be at high CV risk their CV risk should be estimated annually using the UK Prospective Diabetes Study risk engine. Simvastatin 40mg or a statin of similar efficacy and cost is recommended by NICE to achieve target cholesterol levels. NICE recommends offering lifestyle advice to lower blood pressure (BP) and if this does not reduce BP to below the target values then medication should be added. The first-choice antihypertensive drug recommended by NICE is a once-daily ACE-inhibitor. The NICE guidance also advises the use of aspirin 75mg daily however in October 2008 the results of the POPADAD trial were published. This study raises questions over the level of CV risk at which the benefits of aspirin use outweigh the gastrointestinal risks. Aspirin should still be given for secondary prevention of CV disease in people with type 2 diabetes. However, for primary prevention in type 2 diabetes, consideration on an individualized basis following an assessment of the benefits and risks may be more appropriate. The prescribing and spending on products to control glucose levels has increased steadily over the last 5 years (Figures 1 and 2). Figure 1: Trends in prescribing of products to treat Type 2 Diabetes in General Practice in England 3.5 3.0 Items (Millions) 2.5 2.0 1.5 1.0 0.5 0.0 Dec-08 Sep-08 Jun-08 Mar-08 Dec-07 Sep-07 Jun-07 Mar-07 Dec-06 Sep-06 Jun-06 Mar-06 Dec-05 Biphasic insulins Sulphonylureas Glitazones Other antidiabetic drugs Sep-05 Jun-05 Mar-05 Dec-04 Sep-04 Jun-04 Mar-04 Dec-03 Quarter to Other intermediate and long-acting insulins Metformin Metformin combination products Figure 2: Trends in spending on products to treat Type 2 Diabetes in General Practice in England 35 30 NIC (£ Millions) 25 20 15 10 5 Dec-08 Sep-08 Jun-08 Mar-08 Dec-07 Sep-07 Jun-07 Mar-07 Dec-06 Sep-06 Jun-06 Mar-06 Dec-05 Biphasic insulins Sulphonylureas Glitazones Other antidiabetic drugs Sep-05 Jun-05 Mar-05 Dec-04 Sep-04 Jun-04 Mar-04 Dec-03 0 Quarter to Other intermediate and long-acting insulins Metformin Metformin combination products When oral glucose control therapies are required NICE recommends metformin as first choice. Metformin items have increased by 81% over the last 5 years and account for 56% of antidiabetic drug items (3.1 million for the quarter to December 2008, £12.2 million). Sulphonylureas may be considered in the non-overweight or if metformin is contraindicated or not tolerated. There has been a 27% increase in items for sulphonylureas to 1.7 million items for the quarter to December 2008, whereas cost has fallen by 42% to £5.9 million. NICE recommends that if blood glucose control remains or becomes inadequate on metformin then a sulphonylurea may be added. For people with non-routine daily lifestyle patterns then a rapid acting insulin secretagogue (repaglinide or nateglinide) may be considered. A thiazoldinedione (pioglitazone or rosiglitazone) should only be considered at this stage if hypoglycaemia on a sulphonylurea is a problem. Thiazolidinediones should not be commenced or continued in people who have evidence of heart failure or who are at higher risk of fracture and account should be taken of up-to-date advice from the relevant regulatory bodies (European Medicines Agency and Medicines and Healthcare products Agency) prior to prescribing. Figure 1 shows the number of items for the thiazolidinediones (glitazones) leveling off, due to a decrease in the number of items for rosiglitazone (173,000 items for the quarter to December 2008, £6.8 million) and an increase in the number of items for pioglitazone (275,000 items, £10.6 million). Prescribing of metformin combinations (multi-ingredient products containing metformin with either rosiglitazone, pioglitazone or vildagliptin) is now 144,000 items (3%) and accounts for 12% of all spending on antidiabetic drugs (£5.3 million). Repaglinide and nateglinide items are 27,300 and 7,800 per quarter at a cost of £365,000 and £215,000 respectively. Sitagliptin and vildagliptin prescribing for the quarter to December 2008 are 36,000 and 1,500 items, costing £1.5 million and £52,000 respectively. A new guideline from NICE on the use of newer agents, glitazones, gliptins and exenatide, in type 2 diabetes mellitus is expected in May 2009. This guideline has the potential to have significant resource consequences for service providers. In 2008 three trials looking at intensive glucose control compared to standard glucose control were published (ACCORD, ADVANCE and VADT). These studies have stimulated considerable debate about the benefits of intensive glycaemic control in older adults with type 2 diabetes and whether there is an increased risk of adverse outcomes. Self-monitoring of blood glucose should only be offered to a newly diagnosed patient as an integral part of their self-management education. The purpose of self-monitoring should be discussed along with agreement about how the results should be interpreted and acted upon. Prescribing of blood glucose testing strips has risen by 11% to 1.4 million items per quarter and spending has risen 13% to £35.2 million over the last 5 years. Sources of further information 1. Information on prescribing for the PCT is available using ePACT.net and the Prescribing Toolkit 2. Srinivasan, B, Taub, N, Khunti, K. and Davies, M. (2008) Diabetes: glycaemic control in type 2. Clinical Evidence. BMJ Publishing Ltd. www.clinicalevidence.com 3. NICE. Type 2 diabetes: the management of type 2 diabetes Clinical Guideline 66. May 2008. www.nice.org.uk/CG066 4. Commissioning a patient education programme for people with type 2 diabetes. www.nice.org.uk/usingguidance/commissioningguides/type2diabetes 5. Structured patient education in diabetes: report from the patient education working group. www.dh.gov.uk 6. Action to Control Cardiovascular Risk in Diabetes study group. Effects of Intensive Glucose Lowering in Type 2 Diabetes. N Engl J Med 2008;358:2545-2559 7. ADVANCE Collaborative group. Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med 2008;358:2560-2572 8. Duckworth W, Abraira C, Moritz T et al Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes. N Engl J Med 2008;360:129-139 9. Belch J, MacCuish A, Campbell I et al. The prevention of progression of arterial disease and diabetes (POPADAD) trial: factorial randomized placebo controlled trial of aspirin and antioxidants in patients with diabetes and asymptomatic peripheral arterial disease. BMJ 2008;337:a1840