Elisabetta Fenu

Management of venous thromboembolic diseases and the role of thrombophilia testing: summary of NICE guidance

Venous thromboembolic diseases range from asymptomatic deep venous thrombosis (DVT) to fatal pulmonary embolism. Non-fatal venous thromboembolic diseases may also cause serious long term conditions such as post-thrombotic syndrome or chronic thromboembolic pulmonary hypertension. In the United Kingdom, pathways to diagnosis and to decisions on long term treatment or further investigation for thrombophilia and cancer vary, so guidance is needed in these areas. This article summarises the most recent recommendations from the National Institute for Health and Clinical Excellence (NICE) on the management of confirmed or suspected venous thromboembolic diseases in adults (excluding pregnant women).1 NICE recommendations are based on systematic reviews of best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the Guideline Development Group’s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are given in italic in square brackets. ### Diagnostic investigations for deep venous thrombosis

Rehabilitation after stroke: summary of NICE guidance

Each year, about 150 000 people in the UK have a first or recurrent stroke.1 Despite UK health policies that place a great emphasis on reducing stroke (such as the National Stroke Strategy2) and improvements in mortality and morbidity, guidance is needed on access to and provision of effective rehabilitation services to maximise quality of life after stroke. This article summarises the most recent recommendations from the National Institute for Health and Care Excellence (NICE) on long term rehabilitation after stroke.3 NICE recommendations are based on systematic reviews of the best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations can be based on the Guideline Development Group’s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are given in italic in square brackets. ### Organising rehabilitation and care for people with stroke Rehabilitation may take place in a variety of settings—in hospital, in outpatient clinics, in the community, and in individuals’ own homes. ### Planning and delivering stroke rehabilitation To ensure the safety of the person with stroke while maintaining a patient centred approach, key processes need to be in place. These processes include assessment on admission …

National Clinical Guideline Centre Cost-Effectiveness Assessment for the National Institute for Health and Clinical Excellence

The National Clinical Guideline Centre (NCGC) develops evidence-based clinical guidelines on behalf of the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom. The U.K. Department of Health has commissioned NICE to make recommendations on the basis of both clinical effectiveness and cost-effectiveness. This article describes how cost-effectiveness is evaluated and accounted for in NCGC guidelines. Six recent case studies are presented, in which consideration of cost-effectiveness has informed recommendations in various ways for clinical guidelines on alcohol use disorders, chronic obstructive pulmonary disease, glaucoma, lower urinary tract symptoms, non-ST-segment elevation myocardial infarction and unstable angina, and venous thromboembolism prophylaxis. Some of the challenges faced in trying to account for cost-effectiveness in clinical guidelines are outlined, as well as some of the difficulties in adapting cost-effectiveness guidelines for other settings.

Management of stable angina: summary of NICE guidance

Stable angina is common. In England about 8% of men and 3% of women aged 55-64 years and about 14% of men and 8% of women aged 65-74 years have or have had angina.1 Stable angina is associated with a low but appreciable risk of acute coronary events and increased mortality. However, evidence exists of inconsistencies in management.2 This article summarises the most recent recommendations from the National Institute for Health and Clinical Excellence (NICE) on the management of stable angina.3 The diagnosis of stable angina is considered in an earlier NICE guideline.4 NICE recommendations are based on systematic reviews of best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the Guideline Development Group’s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are given in italic in square brackets. ### Information and support for people with stable angina [ Based on low to high quality evidence from qualitative studies and experience and opinion of the GDG ]

Cost-Effectiveness Analysis of Alternative Antiviral Strategies for the Treatment of HBeAg-Positive and HBeAg-Negative Chronic Hepatitis B in the United Kingdom

BACKGROUND Seven drugs are licensed for the treatment of chronic hepatitis B (CHB) in the United Kingdom. Which initial treatment, secondary therapy, and whether antivirals should be given alone or in combination are questions of considerable uncertainty. OBJECTIVE The aim of this model was to undertake a comprehensive economic evaluation of all antiviral treatments for CHB to recommend the most cost-effective therapeutic sequence. METHODS We developed a probabilistic Markov model to compare the cost-effectiveness of all clinically relevant antiviral treatment sequences for nucleos(t)ide-naive adults with hepatitis B e-antigen (HBeAg)-positive or HBeAg-negative CHB. Relative rates of HBeAg seroconversion and viral suppression were obtained from a network meta-analysis. Data on mortality, antiviral drug resistance, durability of response, adverse events, and costs were obtained from published literature. Results are reported in terms of lifetime costs, quality-adjusted life-years (QALYs), and expected net benefit. RESULTS In the base-case analysis, pegylated interferon alpha-2a (peg-IFN α-2a) followed by tenofovir disoproxil fumarate was most effective and cost-effective in HBeAg-positive patients, with a cost of £7488 per QALY gained compared with no treatment. In HBeAg-negative patients, peg-IFN α-2a followed by entecavir was most effective and cost-effective, with a cost of £6981 per QALY gained. The model was robust to a wide range of sensitivity analyses. CONCLUSIONS Peg-IFN α-2a followed by tenofovir disoproxil fumarate or entecavir is the most effective antiviral treatment strategy for people with both variants of CHB. At a cost of less than £10,000 per QALY gained, these sequences are considered cost-effective in England and Wales. The results of this analysis were used to inform 2013 National Institute for Health and Care Excellence guideline recommendations.

Basal Insulin Regimens for Adults with Type 1 Diabetes Mellitus: A Cost-Utility Analysis

OBJECTIVES To assess the cost-effectiveness of basal insulin regimens for adults with type 1 diabetes mellitus in England. METHODS A cost-utility analysis was conducted in accordance with the National Institute for Health and Care Excellence reference case. The UK National Health Service and personal and social services perspective was used and a 3.5% discount rate was applied for both costs and outcomes. Relative effectiveness estimates were based on a systematic review of published trials and a Bayesian network meta-analysis. The IMS CORE Diabetes Model was used, in which net monetary benefit (NMB) was calculated using a threshold of £20,000 per quality-adjusted life-year (QALY) gained. A wide range of sensitivity analyses were conducted. RESULTS Insulin detemir (twice daily) [iDet (bid)] had the highest mean QALY gain (11.09 QALYs) and NMB (£181,456) per patient over the model time horizon. Compared with the lowest cost strategy (insulin neutral protamine Hagedorn once daily), it had an incremental cost-effectiveness ratio of £7844/QALY gained. Insulin glargine (od) [iGlarg (od)] and iDet (od) were ranked as second and third, with NMBs of £180,893 and £180,423, respectively. iDet (bid) remained the most cost-effective treatment in all the sensitivity analyses performed except when high doses were assumed (>30% increment compared with other regimens), where iGlarg (od) ranked first. CONCLUSIONS iDet (bid) is the most cost-effective regimen, providing the highest QALY gain and NMB. iGlarg (od) and iDet (od) are possible options for those for whom the iDet (bid) regimen is not acceptable or does not achieve required glycemic control.