Osteoporosis: fragility fracture risk Costing report Implementing NICE guidance August 2012 NICE clinical guideline 146 1 of 15
This costing report accompanies the clinical guideline: Osteoporosis: assessing the risk of fragility fracture'](available online at www.nice.org.uk/guidance/cg146). Issue date: August 2012 This guidance is written in the following context This report represents the view of NICE, which was arrived at after careful consideration of the available data and through consulting with healthcare professionals. It should be read in conjunction with the NICE guideline. The report is an implementation tool and focuses on the recommendations that were considered to have a significant impact on national resource utilisation. Assumptions used in the report are based on assessment of the national average. Local practice may be different from this, and the impact should be estimated locally. Implementation of the guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement this guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in the costing assessment should be interpreted in a way that would be inconsistent with compliance with those duties National Institute for Health and Clinical Excellence Level 1A City Tower Piccadilly Plaza Manchester M1 4BT www.nice.org.uk National Institute for Health and Clinical Excellence (2012). All rights reserved. This material may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the express written permission of NICE. 2 of 15
Contents Executive summary... 4 Potential resource-impact recommendations... 4 Costs... 4 Benefits and savings... 5 1 Introduction... 5 1.1 Supporting implementation... 5 1.2 What is the aim of this report?... 6 1.3 Epidemiology of osteoporosis... 6 1.4 Current service provision... 7 2 Costing methodology... 7 2.1 Process... 7 2.2 Scope of the cost-impact analysis... 7 3 Analysis of the potential resource impact... 8 3.1 Targeting risk assessment... 8 3.2 Methods of risk assessment... 11 4 Impact of guidance for commissioners... 11 Osteoporotic fractures - denosumab (TA204)... 12 5 Conclusion... 12 Appendix A. Approach to costing guidelines... 14 3 of 15
Executive summary This costing report looks at the resource impact of implementing the NICE guideline Osteoporosis: assessing the risk of fragility fracture (available online at www.nice.org.uk/guidance/cg146) in England. The costing method adopted is outlined in appendix A; it uses the most accurate data available, was produced in conjunction with key clinicians, and reviewed by clinical and financial professionals. Potential resource-impact recommendations This report focuses on the recommendations that are likely to have the greatest resource impact and therefore require the most additional resources to implement or can potentially generate the biggest savings. They are: Targeting risk assessment (recommendation 1.1) Methods of risk assessment (recommendation 1.7) This report discusses the potential costs and savings that need to be considered at a local level. Because of the variation in current practice and insufficient data a national resource impact is not provided. This report discusses the potential costs and savings that need to be considered at a local level. A local costing template has been developed to help organisations calculate the local resource impact Overall the Guideline development group (GDG) indicated that this guidance may reduce costs to the NHS due to the potential reduction in the number of DXA 1 scans performed. Costs A national estimate of costs or savings of implementing the guideline is not provided due to the degree of uncertainty. 1 DXA (or DEXA) stands for Dual Energy X-ray Absorptiometry. A DXA scan (also known as bone density scans or bone densitometry scans) is a type of X-ray that measures bone density. They are most commonly used to diagnose osteoporosis, but can also be used to assess the risk of osteoporosis developing. 4 of 15
It is anticipated that there may be an increase in costs associated with an increase in the number of fragility fracture risk assessments carried out, mainly in relation to extra clinical time needed to perform the assessments. However, it is anticipated that many of these extra risk assessments could be undertaken opportunistically, as part of a consultation with a healthcare professional that the person is attending for other reasons, which would reduce the cost impact of the recommendations. Benefits and savings Implementing the clinical guideline may result in savings and benefits associated with more appropriate use of dual-energy X-ray absorptiometry (DXA) scans, because the use of DXA should be directed at those most at risk of fragility fracture, identified by risk assessment tools. Osteoporotic fractures can cause substantial pain and severe disability, often leading to reduced quality of life, and hip and vertebral fractures are associated with decreased life expectancy. Hip fracture nearly always results in hospitalisation, is fatal in 20% of cases and permanently disables 50% of those affected; only 30% of people fully recover. Therefore, strategies which reduce the number of osteoporotic fractures should improve quality of life for people with osteoporosis and reduce costs associated with treating these fractures. 1 Introduction 1.1 Supporting implementation 1.1.1 The NICE clinical guideline on osteoporosis fragility fracture risk is supported by the following implementation tools available on our website: costing tools a national costing report; this document a local costing template; a simple spreadsheet that can be used to estimate the local cost of implementation 5 of 15
baseline assessment tool; assess your baseline against the recommendations in the guidance in order to prioritise implementation activity, including clinical audit a package of audit support. 1.2 What is the aim of this report? 1.2.1 This report aims to help organisations assess and plan for the financial implications of implementing NICE guidance. 1.2.2 This report does not reproduce the NICE guideline on osteoporosis fragility fracture risk and should be read in conjunction with it. 1.2.3 The costing template that accompanies this report is designed to help those assessing the resource impact at a local level in England, Wales or Northern Ireland 1.3 Epidemiology of osteoporosis 1.3.1 The British Orthopaedic Association estimates that in the UK over 300,000 people present to hospital with fragility fractures every year. Around a quarter of these fractures are hip fractures. 1.3.2 The National Osteoporosis Society estimates that there are 2.3 million people in England with osteoporosis and that over 1100 deaths in the UK every month are a result of hip fracture. 1.3.3 The National Osteoporosis Society estimates that 1 in 2 women and 1 in 5 men aged over 50 in the UK will break a bone because of poor bone health. 1.3.4 Direct medical costs to the UK healthcare economy from fragility fractures have been estimated at 2.3 billion in 2011, with the potential to increase to more than 6 billion by 2036. Most of these costs relate to hip fracture care. 6 of 15
1.4 Current service provision 1.4.1 The aim of identifying people at risk is to offer preventive treatment. There are many treatments available for preventing fragility fractures but it is difficult to identify who will benefit from them. 1.4.2 A number of risk assessment tools are available to predict risk of fracture, including: the fracture risk assessment tool (FRAX); QFracture; Women's Health Initiative (WHI) hip fracture risk calculator; and Foundation for Osteoporosis Research and Education (FORE) 10-year fracture risk calculator. The guideline recommends the use of FRAX and QFracture. 1.4.3 In 2012/13, three new indicators relating to secondary prevention of fragility fractures (OST1, 2 and 3) were added to the Quality Outcomes Framework (QOF). 1.4.4 Expert opinion suggests that targeted risk assessment is not routine practice in primary care. It is therefore anticipated that the guidance recommendations will have an impact on primary care time needed to carry out the risk assessment. 2 Costing methodology 2.1 Process 2.1.1 We use a structured approach for costing clinical guidelines (see appendix A). 2.1.2 We have to make assumptions in the costing model. These are tested for reasonableness with members of the Guideline Development Group (GDG) and key clinical practitioners in the NHS. 2.2 Scope of the cost-impact analysis 2.2.1 The guideline offers best practice advice on osteoporosis fragility fracture risk. 7 of 15
2.2.2 The guidance does not cover children and young people (younger than 18), drugs to prevent fractures or fractures and post-fracture management. Therefore, these issues are outside the scope of the costing work. 2.2.3 Rather than cost each individual recommendation, costing work has focused on the areas that will potentially need the most resources to implement or generate the biggest savings. These areas were determined in discussion with the clinical guideline project team and the members of the GDG. 2.2.4 Of the 12 recommendations in the guideline, 2 were identified as having the greatest resource impact. 3 Analysis of the potential resource impact 3.1 Targeting risk assessment Recommendations 3.1.1 Consider assessment of fracture risk in: all women aged 65 years and over and men aged 75 years and over women aged under 65 years and men aged under 75 years who have risk factors, for example: previous fragility fracture current use or frequent recent use of oral or systemic glucocorticoids history of falls family history of hip fracture other causes of secondary osteoporosis 2 2 Causes of secondary osteoporosis include endocrine (hypogonadism in either sex including untreated premature menopause and treatment with aromatase inhibitors or androgen deprivation therapy; hyperthyroidism; hyperparathyroidism; hyperprolactinaemia; Cushing s disease; diabetes), gastrointestinal (coeliac disease; inflammatory bowel disease; chronic liver disease; chronic pancreatitis; other causes of malabsorption), rheumatological 8 of 15
low body mass index (BMI) (less than 18.5 kg/m 2 ) smoking alcohol intake of more than 14 units per week for women and more than 21 units per week for men (recommendation 1.1). Potential cost impact 3.1.2 Expert opinion suggests that it is not current practice to perform risk assessment for people defined in paragraph 3.1.1, therefore it is anticipated that these recommendations would affect primary care time needed to carry out the risk assessment. 3.1.3 A calculation of the number of men aged under 75 and women aged under 65 who smoke, shows that approximately 4.2 million males and 3.5 million females could be considered for assessment of fracture risk on the basis of their smoking. (NHS Information centre, Statistics on Smoking, England 2011). 3.1.4 A calculation of the number of men aged under 75 with alcohol intake of more than 21 units per week and the number of women aged under 65 with alcohol intake of more than 14 units per week, shows that approximately 4.8 million men and 3.2 million women could be considered for assessment of fracture risk on the basis of their alcohol intake (ONS Statistics on Alcohol, England 2011 - Table 2.4). 3.1.5 The GDG estimated that an additional 10 minutes of time would be needed to perform a FRAX or QFracture risk assessment. The GDG acknowledged that this may be an overestimate. The length of time needed for a GP consultation may be longer or shorter than 10 minutes, depending upon the outcome of the FRAX or QFracture risk assessment. (rheumatoid arthritis; other inflammatory arthropathies), haematological (multiple myeloma; haemoglobinopathies; systemic mastocytosis), respiratory (cystic fibrosis; chronic obstructive pulmonary disease), metabolic (homocystinuria), chronic renal disease and immobility (due, for example, to neurological injury or disease). 9 of 15
3.1.6 It is estimated that 81% of men and 86% of women aged 65 years and over would visit their general practice in the first year. Therefore the majority of people eligible for assessment under recommendation 1.1 could be assessed opportunistically, as part of a consultation with a healthcare professional that the person is attending for other reasons. This would reduce the cost of assessing this group of people, because the time taken to perform the assessment would be part of the existing attendance. 3.1.7 There are no costs to use the FRAX and QFracture risk assessment tools. The GDG considered that the time to undertake either assessment would be the same. 3.1.8 The cost of a GP consultation is 36.00 for a surgery consultation lasting 11.7 minutes. However, the risk assessment could be carried out by other suitably qualified healthcare professionals, for example, practice nurses. This would reduce the cost of a consultation; for example, the cost of a consultation with a practice nurse is 51.00 per hour, so a 10-minute consultation would cost 8.50 (Curtis 2011). 3.1.9 The cost impact of this recommendation is dependent on current local practice. 3.1.10 The cost of a DXA scan payable by commissioners is 69.00. The latest available reference costs for a DXA scan incurred by providers in 2010/11 is 77.00 (Department of Health, National Tariff 2012-13). 3.1.11 Therefore the maximum additional cost per person is 105.00 the cost of a GP consultation plus the cost of a DXA scan. (This would decrease to 77.00 if the risk assessment was performed by a practice nurse, as detailed in section 3.1.7, and would be reduced further if the assessment could be undertaken on an opportunistic basis). 10 of 15
3.1.12 Although prevention and treatment are outside the scope of the guideline, there may be considerable benefits associated with the use of a risk assessment tool that facilitates early intervention and prevention of fragility fracture. 3.2 Methods of risk assessment Recommendation 3.2.1 Following risk assessment with FRAX (without a bone mineral density (BMD) value) or QFracture, consider measuring BMD with DXA in people whose fracture risk is in the region of an intervention threshold 3 for a proposed treatment, and recalculate absolute risk using FRAX with the BMD value (recommendation 1.7). Potential cost impact 3.2.2 Expert opinion suggests that recommendation 1.7 may lead to a reduction in the number of DXA scans in the general population because DXA would be used for people identified, using risk assessment tools, as being most at risk of fragility fracture. 3.2.3 It is not possible to estimate the potential resource impact nationally because of the difficulty in identifying the number of scans that would be avoided. For each DXA scan avoided there is a potential saving of 69.00. Organisations are encouraged to review local practice and estimate savings locally. 4 Impact of guidance for commissioners 4.1.1 The cost of a DXA scan is included in the Payment by Results national tariff. The costs of GP and practice nurse consultation time are not included in the national tariff. 3 An intervention threshold is the level of risk at which an intervention is recommended. People whose risk is in the region from just below to just above the threshold may be reclassified if BMD is added to assessment. It is out of the scope of this guideline to recommend intervention thresholds. Healthcare professionals should follow local protocols or other national guidelines for advice on intervention thresholds. 11 of 15
4.1.2 Costs fall under programme budgeting code 15: problems of the musculoskeletal system. 4.1.3 The 2012/13 Quality and Outcomes Framework (QOF) introduced 3 new indicators (OST1, 2 and 3) that record the number of people aged 50 and older with a fragility fracture who are being treated with an appropriate bone-sparing agent. The aim of the QOF indicators is to support high-quality, cost-effective patient care. It is likely that the introduction of these indicators may lead to an increase in osteoporosis diagnoses. The inclusion of these indicators in the QOF supports the implementation of this guidance as assessment of fracture risk is to be considered in women aged under 65 years and men aged under 75 years who have risk factors including previous fragility fracture. 4.1.4 Commissioners need to develop procedures for risk assessment, for example, whether this should be undertaken by GPs or another appropriate healthcare professional such as a practice nurse. 4.1.5 Whilst the treatment of osteoporosis is outside the scope of this guideline NICE has published a number of technology appraisals which commissioners may wish to refer to as follows -: Osteoporosis-primary prevention-ta160 Osteoporosis-secondary prevention-ta161 Osteoporotic fractures - denosumab (TA204) 5 Conclusion 5.1.1 This guideline covers the selection and use of risk assessment tools in the care of people who may be at risk of fragility fractures in all settings in which NHS care is received. It is not possible to calculate the national resource impact of the recommendations. However the costing template that accompanies this report is 12 of 15
designed to help those assessing the resource impact at a local level in England, Wales or Northern Ireland. 5.1.2 NHS organisations and local authorities are advised to assess local resource implications, and the level of costs or savings that may be expected in their area. 5.1.3 Although it is not possible to calculate the national resource impact of this guideline, the GDG considers that implementation would lead to an overall reduction in the number of DXA scans performed. 13 of 15
Appendix A. Approach to costing guidelines Guideline at first consultation stage Analyse the clinical pathway to identify significant recommendations and population cohorts affected Identify key cost drivers gather information needed and research cost behaviour Develop costing report Internal peer review by qualified accountant within NICE Circulate report to cost impact panel and GDG for comments Update based on feedback and any changes following consultation Cost-impact review meeting Final sign-off by NICE Prepare for publication in conjunction with guideline 14 of 15
Appendix B. References British Orthopaedic Association (2007) The care of patients with fragility fracture Curtis L (2011) Unit costs of health and social care 2011. Canterbury: University of Kent Personal Social Services Research Unit. Department of Health Payment by Results, National tariff 2012 13. National Osteoporosis Society Osteoporosis facts and figures version 1.1. NICE clinical guideline 146 Osteoporosis fragility fracture risk NICE public health guidance 24 Alcohol-use disorders preventing harmful drinking: costing report. ONS Statistics on Alcohol, England 2011 Table 2.4. NHS Information centre, Statistics on Smoking, England 2011 Table 2.1 15 of 15