Irritable bowel syndrome

Costing report
Implementing NICE guidance

February 2008

National costing report: Irritable NICE clinical guideline 61 bowel syndrome (February 2008)

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This costing report accompanies the clinical guideline: Irritable bowel syndrome in adults: diagnosis and management of irritable bowel syndrome in primary care (available online at www.nice.org.uk/CG061). Issue date: February 2008

This guidance is written in the following context This report represents the view of the Institute, which was arrived at after careful consideration of the available data and through consulting healthcare professionals. It should be read in conjunction with the NICE guideline. The report and templates are implementation tools and focus on those areas that were considered to have significant impact on resource utilisation. The cost and activity assessments in the reports are estimates based on a number of assumptions. They provide an indication of the likely impact of the principal recommendations and are not absolute figures. Assumptions used in the report are based on assessment of the national average. Local practice may be different from this, and the template can be amended to reflect local practice to estimate local impact.

National Institute for Health and Clinical Excellence MidCity Place 71 High Holborn London WC1V 6NA www.nice.org.uk

National Institute for Health and Clinical Excellence, February 2008. 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 the Institute.

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Contents
Executive summary..........................................................................................4 Supporting implementation......................................................................4 Significant resource-impact recommendations ........................................4 Total cost impact .....................................................................................4 Benefits and savings ...............................................................................6 Local costing template.............................................................................7 Introduction ......................................................................................................8 1.1 1.2 1.3 1.4 2 Supporting implementation ............................................................8 What is the aim of this report? .......................................................8 Epidemiology of IBS.......................................................................9 Models of care .............................................................................11

Costing methodology.............................................................................11 2.1 2.2 2.3 2.4 Process ........................................................................................11 Scope of the cost-impact analysis................................................12 General assumptions made .........................................................15 Basis of unit costs ........................................................................17

Cost of significant resource-impact recommendations ..........................19 3.1 The use of appropriate diagnostic tests for people who meet the

IBS diagnostic criteria............................................................................19 3.2 3.3 3.4 4 Referral to dietitian .......................................................................25 Low-dose antidepressants ...........................................................26 Increasing referral for psychological interventions .......................29

Sensitivity analysis ................................................................................31 4.1 4.2 Methodology ................................................................................31 Impact of sensitivity analysis on costs..........................................32

5 6

Impact of guidance for commissioners ..................................................34 Conclusion.............................................................................................35 6.1 6.2 Total national cost for England.....................................................35 Next steps ....................................................................................36

Appendix A. Approach to costing guidelines ..................................................37 Appendix B. Results of sensitivity analysis ....................................................38 Appendix C. References ................................................................................39

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Executive summary
This costing report looks at the resource impact of implementing the NICE guideline Irritable bowel syndrome in adults: diagnosis and management of irritable bowel syndrome in primary care 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.

Supporting implementation
The NICE clinical guideline on irritable bowel syndrome (IBS) is supported by a range of implementation tools available on our website www.nice.org.uk/CG061 and detailed in the main body of this report.

Significant resource-impact recommendations

Because of the breadth and complexity of the guideline, this report focuses on recommendations that are considered to have the greatest resource impact and therefore require the most additional resources to implement or can potentially generate savings. They are: Reducing the number of diagnostic tests undertaken to exclude other diagnoses in people who meet the IBS diagnostic criteria. Increasing the use of dietitian referrals for people where diet is considered to be a major factor in their IBS symptoms. Increasing the use of psychological interventions for people who do not respond to pharmacological treatments after 12 months and who develop a continuing symptom profile. Increasing the use of tricyclic antidepressants (TCAs) as a second-line treatment for people with IBS and, if this is shown to be ineffective, increasing the use of selective serotonin reuptake inhibitors (SSRIs).

Total cost impact

The annual changes in revenue costs arising from fully implementing the guideline are summarised in the table below. National costing report: Irritable bowel syndrome (February 2008) 4 of 39

Recommendation

Estimated annual recurrent cost of implementing (000)

- 6,744 974 12,277 1,372 7,879

Use of diagnostic tests Referral to dietitian Low-dose antidepressants Psychological interventions Total

With the exception of low-dose antidepressants, the costing model is based on recurrent annual costs for newly diagnosed patients. In the case of low-dose antidepressants, the recurrent annual costs for the total prevalent population have been calculated. Much of the costing work completed for this guidance falls outside the scope of Payments by results. Diagnostic tests performed in secondary care have been costed using national indicative tariff. National indicative tariff is subject to change according to local circumstances. These circumstances should be taken into account when assessing local impact. Healthcare professionals may need training in the diagnostic criteria and management of IBS. As they gain confidence in their ability to diagnose and treat IBS in primary care, the full costs and savings of implementation will be realised. It is anticipated that implementation of the recommendation regarding referral for psychological interventions will be significantly affected by the availability of these treatments in the local area. The graph below assumes a phased implementation over 3 years. However, it is expected that some areas will implement the recommendations more rapidly, depending on local circumstances. This graph is for illustrative purposes only.

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It is possible that there may be a backlog of people with IBS who would benefit from referral to a dietitian or psychological interventions. However, provision of services to existing patients will be affected by when that patient presents to health care services to trigger a referral (perhaps when symptoms are active) and the capacity of services to treat the backlog of patients.

Benefits and savings

Implementing the clinical guideline will bring the following benefits. There will be a reduction in the number of unnecessary tests used to confirm diagnosis following implementation of the guidance; this will lead to savings of 6.7 million annually. Compliance with NICE guidance is one of the criteria indicating good risk reduction strategies, and in combination with meeting other criteria could lead to a discount on contributions to the NHS Litigation Authority schemes, including CNST.

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Local costing template

The costing template produced to support this guideline enables organisations in England, Wales and Northern Ireland to estimate the impact locally and replace variables with ones that depict the current local position. A sample calculation using this template showed that additional annual recurrent costs of 20,500 could be incurred for a population of 100,000..

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Introduction
1.1
1.1.1

Supporting implementation
The NICE clinical guideline on irritable bowel syndrome is supported by the following implementation tools available on our website www.nice.org.uk/CG061: 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. a slide set; key messages for local discussion algorithm of the NICE guidance pathway for diagnosis and management of IBS in primary care to raise awareness among primary care audiences an IBS patient information resource, based on self-care management information from within the guideline audit support.

1.1.2

A practical guide to implementation, How to put NICE guidance into practice: a guide to implementation for organisations, is also available to download from the NICE website. It includes advice on establishing organisational level implementation processes as well as detailed steps for people working to implement different types of guidance on the ground.

1.2
1.2.1

What is the aim of this report?

This report provides estimates of the national cost impact arising from implementation of guidance on IBS in England. These estimates are based on assumptions made about current practice and predictions of how current practice might change following implementation.

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1.2.2

This report aims to help organisations plan for the financial implications of implementing NICE guidance.

1.2.3

This report does not reproduce the NICE guideline on irritable bowel syndrome and should be read in conjunction with it (see www.nice.org.uk/CG061).

1.2.4

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. NICE clinical guidelines are developmental standards in the Department of Healths document Standards for better health. The costing template may help inform local action plans demonstrating how implementation of the guideline will be achieved.

1.3
1.3.1

Epidemiology of IBS
IBS is a chronic, relapsing and often life-long disorder. It is characterised by the presence of abdominal pain which may be associated with defaecation and/or accompanied by a change in bowel habit. Symptoms may include disordered defaecation (constipation or diarrhoea or both) and abdominal distension.

1.3.2

Wilson et al (2004) found that the prevalence of IBS in the general population was 10.5%, which is consistent with that stated in the NICE guideline. Prevalence was found to vary by gender and age, with women aged 3039 twice as likely to suffer from IBS as men of the same age.

1.3.3

The prevalence of IBS by age and gender is illustrated in graph 2.

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Graph 2
Prevalence of IBS by age and gender
30% 25% 20% Prevalence 15% 10% 5% 0% 18-29 30-39 40-49 50-59 Age 60-69 70-79 80+ Female Male

Data source: Wilson et al (2004)

1.3.4

The total prevalence of IBS in the UK is estimated to be more than 4 million people.

1.3.5

Wilson et al (2004) estimated that 57% of the prevalent population have consulted a healthcare professional about their symptoms in the past 6 months. This could exclude prevalent patients who may consult less frequently. Therefore, the prevalent population consulting healthcare professionals could be higher.

1.3.6

Data on the incidence of IBS in the UK are limited. Studies carried out in the US show an incidence ranging from 0.110.33% dependent upon gender and age. Using these proportions, the total incidence of IBS in the UK can be calculated as approximately 0.20%, or nearly 79,000 people annually (Locke et al 2004).

1.3.7

Locke et al (2004) incidence data are based on a diagnosis of IBS by a healthcare professional. Therefore, it is assumed that the incidence population used in the costing tool only includes those people who have consulted a healthcare professional about their symptoms.

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1.3.8

In the costing model, the prevalence and incidence of IBS for the local area can be altered to take into account specific local circumstances.

1.4
1.4.1

Models of care
In order to establish a model of care, we contacted clinicians involved in IBS to discuss the current baseline and how this may change following implementation of the guidance.

1.4.2

Currently, treatment for IBS is likely to take place in primary care. However, a large proportion of the population displaying symptoms of IBS are likely to be referred to secondary care for diagnostic tests to exclude other conditions.

1.4.3

Patients are likely to be referred to a secondary care specialist if symptoms are atypical, if bowel or ovarian cancer is suspected on clinical examination, or if there is a family history of bowel or ovarian cancer (see 'Referral guidelines for suspected cancer', NICE clinical guideline 27).

2
2.1
2.1.1

Costing methodology
Process
We use a structured approach for costing clinical guidelines (see appendix A).

2.1.2

Little information has been systematically collected about IBS, and this led to problems in building a comprehensive bottom-up model for costing (a costing methodology where the unit cost of individual elements and number of units are estimated and added together to provide a total cost). To overcome this limitation, we had to make assumptions in the costing model. We developed these assumptions and tested them for reasonableness with members of the Guideline Development Group (GDG) and key clinical practitioners in the NHS.

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2.2
2.2.1

Scope of the cost-impact analysis

The guideline offers best practice advice on the care of adults who are suspected of having, or are diagnosed with, IBS.

2.2.2

The guidance does not cover the diagnosis and treatment of other diseases suspected during the process for diagnosis of IBS and the management and diagnosis of comorbidity. Therefore, these issues are outside the scope of the costing work.

2.2.3

Due to the breadth and complexity of the guideline, we worked with the GDG and other professionals to identify the recommendations that would have the most significant resource-impact (see table 1). Costing work has focused on these recommendations.

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Table 1 Recommendations with a significant resource impact High-cost recommendations Recommendation Key priority? number
1.1.2.1 In people who meet the IBS diagnostic criteria, the following tests should be undertaken to exclude other diagnoses: - full blood count (FBC) - erythrocyte sedimentation rate (ESR) or plasma viscosity - c-reactive protein (CRP) - antibody testing for coeliac disease (endomysial antibodies [EMA] or tissue transglutaminase [TTG]) The following tests are not necessary 1.1.2.2 to confirm diagnosis in people who meet the IBS diagnostic criteria: - ultrasound - rigid/flexible sigmoidoscopy - colonoscopy; barium enema - thyroid function test - faecal ova and parasite test - faecal occult blood - hydrogen breath test (for lactose intolerance and bacterial overgrowth) 1.1.1.2 All people presenting with possible IBS symptoms should be asked if they have any of the following red flag indicators and should be referred to secondary care for further investigation if any are present: - unintentional and unexplained weight loss - rectal bleeding - a family history of bowel or ovarian cancer - a change in bowel habit to looser and/or more frequent stools persisting for more than 6 weeks in a person aged over 60 years. All people presenting with possible IBS symptoms should be assessed and clinically examined for the following red flag indicators and should be referred to secondary care for further investigation if any are present: 1.1.1.3

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- anaemia - abdominal masses - rectal masses - inflammatory markers. If diet is considered to be a major factor in a person's symptoms and they are following general lifestyle/dietary advice, they should be referred to a dietician for advice and treatment, including single food avoidance and exclusion diets. Such advice should be given only by a dietitian. Healthcare professionals should consider tricyclic antidepressants (TCAs) as second-line treatment for people with IBS if laxatives, loperamide or antispasmodics have not helped. TCAs are primarily used for treatment of depression, but are only recommended here for their analgesic effect. Treatment should be started at a low starting dose (510 mg equivalent of amytriptyline), which should be taken once at night and reviewed regularly. The dose may be increased, but does not usually need to exceed 30 mg. Selective serotonin reuptake inhibitors (SSRIs) should be considered for people with IBS only if TCAs have been shown to be ineffective. 1.2.1.8

1.2.2.5

1.2.2.6

2.2.4

Ten of the recommendations in the guideline have been identified as key priorities for implementation, and five of these are also among the seven recommendations considered to have significant resource impact.

2.2.5

The remaining five key priorities for implementation on detection (recommendations 1.1.1.1 and 1.1.1.4) and management of IBS (recommendations 1.2.1.1, 1.2.1.5 and 1.2.2.4) represent no significant change in practice. Therefore, these recommendations

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have been assessed as not generating any significant additional costs to the NHS. 2.2.6 We have limited the consideration of costs and savings to direct costs to the NHS that will arise from implementation. We have not included consequences for the individual, the private sector or the not-for-profit sector. Where applicable, any realisable cost savings arising from a change in practice have been offset against the cost of implementing the change.

2.3
2.3.1

General assumptions made

The model is based on annual prevalence and incidence and population estimates (see table 2).

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Table 2 Prevalence and incidence assumptions Gender and age England Prevalence population of IBS by gender and age
Male age 1829 Male age 3034 Male age 3539 Male age 4049 Male age 5054 Male age 5559 Male age 6069 Male age 7079 Male age 80+ 3,748,400 1,775,200 1,938,400 3,472,700 1,517,600 1,601,200 2,304,600 1,594,900 755,100 3.6% 8.2% 8.2% 7.0% 8.4% 8.4% 8.6% 7.4% 4.8%

Percentage of IBS population who consulted a healthcare professional

56.5%

Estimated number of people with IBS

76,200 82,200 89,800 137,300 72,000 76,000 112,000 66,700 20,500

Incidence of IBS by gender and age

0.11% 0.11% 0.13% 0.13% 0.13% 0.20% 0.20% 0.20% 0.20% 0.18% 0.18% 0.23% 0.23% 0.23% 0.33% 0.33% 0.33% 0.33%

Estimated number of new cases of IBS annually

4,100 2,000 2,500 4,500 2,000 3,200 4,600 3,200 1,500

Male population (18+) total

Female age 1829 Female age 3034 Female age 3539 Female age 4049 Female age 5054 Female age 5559 Female age 6069 Female age 7079 Female age 80+

18,708,200
3,740,600 1,816,300 1,981,300 3,547,700 1,553,300 1,641,900 2,433,000 1,963,900 1,450,900

13.2% 17.5% 17.5% 15.3% 17.9% 17.9% 11.4% 9.0% 8.4%

732,800
279,000 179,600 195,900 306,700 157,000 166,000 156,700 99,900 68,900

27,600
6,700 3,300 4,600 8,200 3,600 5,400 8,000 6,500 4,800

Female population (18+) total Adult population (18+) total

20,129,000 38,837,000

1,609,700 2,342,500

51,000 78,600

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2.3.2

Because of the embarrassing symptoms of IBS, many people do not seek formal medical advice and prefer to self-treat using over-the-counter remedies. These people are therefore outside the scope of this costing work.

2.3.3

The costing work has focused on patients who are in contact with healthcare professionals, rather than the total population, some of whom may not be known to healthcare services.

2.4
2.4.1

Basis of unit costs

The way the NHS is funded has undergone reform with the introduction of Payment by results, based on a national tariff. The national tariff will be applied to all activity for which Healthcare Resource Groups (HRGs) or other appropriate case-mix measures are available. Where a national tariff price or indicative price exists for an activity this has been used as the unit cost; this has then been inflated by the national average market forces factor.

2.4.2

Using these prices ensures that the costs in the report are the cost to the primary care trust (PCT) of commissioning predicted changes in activity at the tariff price, but may not represent the actual cost to individual trusts of delivering the activity.

2.4.3

Drug unit costs have been taken from the British national formulary (BNF) 54th edition and exclude VAT. NHS organisations may negotiate discounts with suppliers depending on the level of the purchase. The local costing template allows these variances to be factored into the model.

2.4.4

Staff cost calculations have been based on referrals being provided by NHS staff only. For the purpose of this report it is assumed that dietary referrals are provided by qualified dietitians and psychological interventions are provided by clinical psychologists, counsellors and hypnotherapists.

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2.4.5

Staff costs have been calculated using Agenda for Change banding information based on national job profiles and Personal Social Services Research Unit (PSSRU) estimates of client contact time (PSSRU 2007).

2.4.6

The average pay band for a dietitian is band 5, the average pay band for a clinical psychologist is band 8a and the average pay band for a counsellor and a hypnotherapist is band 6, although it is recognised that local services may be provided by staff on higher or lower grades.

2.4.7

The Agenda for Change 2008/09 pay bands are based on 2007/08 pay bands increased by 2% as recommended by NHS Employers to the NHS Pay Review Body (NHS Employers 2007).

2.4.8

The hourly rate for referral to a dietitian and psychological interventions are based on the unit costs shown in table 3.

Table 3 Hourly rates for referral to dietitian and psychological interventions Service Referral to Psychological dietitian interventions
Band (midpoint) Basic salary Oncosts Overheads Total costs per whole time equivalent Working week allowing for annual leave Working hours per week Percentage of time spent with patients Total number of contact hours Weighted proportions based on type of clinician undertaking therapy Weighted average cost per hour of patient time 5 22,631 4,934 1,132 28,696 42 37.5 75% 1,181 100% 8a 41,137 8,968 2,057 52,161 42 37.5 50% 788 33% 6 27,936 6,090 1,397 35,423 142 37.5 77% 1,213 67%

24.29

41.55

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2.4.9

Oncost payments relating to employers national insurance and superannuation contributions are assumed to be 21.8% of actual salary costs.

Cost of significant resource-impact recommendations

3.1

The use of appropriate diagnostic tests for people who meet the IBS diagnostic criteria

Background 3.1.1 Historically, diagnosis of IBS has been based on excluding other conditions. This has led to a number of unnecessary tests being carried out. The following recommendations describe what tests should be carried out for all people meeting the IBS diagnostic criteria, and in what circumstances further investigation should be undertaken. 3.1.2 In people who meet the IBS diagnostic criteria, the following tests should be undertaken to exclude other diagnoses: full blood count (FBC) erythrocyte sedimentation rate (ESR) or plasma viscosity c-reactive protein (CRP) antibody testing for coeliac disease (endomysial antibodies [EMA] or tissue transglutaminase [TTG]) (recommendation 1.1.2.1). 3.1.3 The following tests are not necessary to confirm diagnosis in people who meet the IBS diagnostic criteria: ultrasound rigid/flexible sigmoidoscopy colonoscopy; barium enema thyroid function test National costing report: Irritable bowel syndrome (February 2008) 19 of 39

 faecal ova and parasite test faecal occult blood hydrogen breath test (for lactose intolerance and bacterial overgrowth) (recommendation 1.1.2.2). 3.1.4 All people identified as presenting with the specified 'red flag' indicators should be referred to secondary care for further investigation (recommendations 1.1.1.2 and 1.1.1.3). 3.1.5 Recommendations 1.1.1.2 and 1.1.1.3 have not been costed individually as they represent no significant change in practice. However, they have been taken into account during the investigation relating to the future referral and cost of diagnostic tests in secondary care. Assumptions made 3.1.6 The assumptions about the current use of diagnostic tests when a person with IBS symptoms presents to a healthcare professional have been made using the published papers by Bellini et al. (2005) and Thompson et al. (2000) and in consultation with clinical experts. The incidence of data derived from Thompson et al and Bellini et al. have been validated as an accurate assumption of current practice by clinical experts. Details of these assumptions are shown in table 3. 3.1.7 The costs of the majority of diagnostic tests relating to this guidance are based on 2008/09 national tariff or indicative national tariff, uplifted by the national average market forces factor (MFF) of 1.1249. The exception to this is the hydrogen breath test which has been costed using average reference costs 2006/07. Reference costs 2006/07 has been uplifted by 2.5% and 2.3% to take into account inflation rates for 2007/08 and 2008/09. 3.1.8 It is assumed that only new patients who meet the IBS diagnostic criteria and present to healthcare professionals will receive

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diagnostic tests. Therefore, only the incidence population has been used to calculate the costs associated with diagnostic tests. 3.1.9 Hamilton (1995) estimated that 10% of the population had a significant fear of injections. Therefore, it is assumed that 10% of the incidence population will refuse to undertake the recommended blood tests. 3.1.10 Clinicians have estimated that there will be a 65% reduction in the use of unnecessary diagnostic tests following implementation of the guidance as healthcare professionals become more familiar with the evidence-based diagnosis criteria. 3.1.11 Some people will still need to receive additional tests as a result of presenting with 'red flag' indicators.

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Table 4 Diagnostic tests cost and uptake assumptions

Diagnostic test Current proportion of incidence population receiving test Main source Type of test Cost Estimated future proportion of incidence population receiving test 90% 90%

Full blood count (FBC) 74% Bellini et al. (2005) Haematology 3.04 Erythrocyte sedimentation rate 74% Bellini et al. (2005) Haematology 3.04 (ESR) or plasma viscosity C-reactive protein (CRP) 43% Expert opinion Biochemistry 1.60 90% Endomysial antibodies [EMA] or 18% Expert opinion Biochemistry 1.60 90% tissue transglutaminase [TTG] Ultrasound 14% Thompson et al. 2000) NA 77.61 5% Rigid sigmoidoscopy 10% Thompson et al. (2000)* NA 212.61 4% Flexible sigmoidoscopy 4% Thompson et al. (2000)* NA 365.59 1% Colonoscopy 5% Thompson et al. (2000) NA 544.45 2% Barium enema 33% Thompson et al. (2000) NA 178.86 12% Thyroid function test 36% Bellini et al. (2005) Biochemistry 1.60 13% Faecal ova and parasite test 36% Bellini et al. (2005) Microbiology 7.49 13% Faecal occult blood 5% Bellini et al. (2005) Biochemistry 1.60 2% Hydrogen breath test 6% Bellini et al. (2005) NA 48.23 2% * Thompson et al. (2000) group the usage of rigid and flexible sigmoidoscopy diagnostic testing together to give a figure of 14%. Therefore, the use of each test has been estimated using actual proportions found in reference costs for 2005/06.

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Cost summary 3.1.12 There is scope for a significant reduction in inappropriate resource use as a result of these recommendations because the number of unnecessary tests undertaken for people meeting the IBS diagnostic criteria will be considerably reduced. 3.1.13 The annual recurrent saving as a result of the recommendations describing the use of appropriate tests for people who meet the IBS diagnostic criteria is summarised in table 5.

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Table 5 Cost of diagnostic tests

Current Number of tests 58,200 Proposed Change Cost Number Cost Number Cost (000s) of tests (000s) of tests (000s) 177 70,700 215 12,600 38

Type of test Full blood count (FBC) Erythrocyte sedimentation rate (ESR) or plasma viscosity C-reactive protein (CRP)

Unit cost 3.04

3.04 1.60

58,200 33,800

177 54

70,700 70,700

215 113

12,600 36,900

38 59

Endomysial antibodies [EMA] or tissue transglutaminase 1.60 [TTG] Ultrasound 77.61 Rigid sigmoidoscopy Flexible sigmoidoscopy Colonoscopy Barium enema Thyroid function test Faecal ova and parasite test Faecal occult blood 1.60 Hydrogen breath test Totals 48.23 212.61 365.59 544.45 178.86 1.60

14,100 11,000 7,800 3,100 3,900 25,900 28,300

23 854 1,671 1,149 2,140 4,639 45 212 6 227 11,596

70,700 3,900 3,100 800 1,600 9,400 10,200 10,200 1,600 1,600 325,400

113 305 668 287 856 1,687 16 77 3 76 4,705

56,600 -7,000 -4,700 -2,400 -2,400

90 -549 -1,003 -862 -1,284

-16,500 -2,952 -18,100 -29 -18,200 -136 -2,400 -3,100 43,800 -3 -152 -6,744

7.49

28,500 3,900 4,700 281,600

Other considerations 3.1.14 Implementation of the guidance will require healthcare professionals to be appropriately trained in the IBS diagnostic criteria and the necessary assessment for 'red flag' indicators. Clinical experts felt that the need for appropriate training in the IBS diagnosis criteria could delay implementation of this guidance. An

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evaluation of local circumstances will be necessary to fully estimate the additional costs. 3.1.15 Clinicians have expressed the view that the reduction in unnecessary testing may not be achieved immediately. It is expected that the number of tests requested will reduce as healthcare professionals become more confident in their diagnosis.

3.2

Referral to dietitian

Background 3.2.1 If diet is considered to be a major factor in a person's symptoms and they are following general lifestyle/dietary advice, they should be referred to a dietitian for advice and treatment, including single food avoidance and exclusion diets. Such advice should only be given by a dietitian (recommendation 1.2.1.8). Assumptions made 3.2.2 Clinicians contacted during development of this costing work estimated that approximately 11% of the population diagnosed with IBS are referred to a dietitian annually. 3.2.3 The clinicians who were contacted estimated that after implementation of the guidance approximately 28% of the population diagnosed with IBS will be referred to a dietitian annually. 3.2.4 PSSRU (2007) estimate that dietitians spend 75% of their time in face to face contact with patients. 3.2.5 The cost of referral to a dietitian is based on the unit costs shown in table 3. 3.2.6 Dietitians who were contacted considered 3 1-hour sessions to be the average number needed for people with IBS. Therefore, the

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cost of referral to a dietitian is based on 3 sessions. This equates to 73 per patient. 3.2.7 In estimating the cost associated with referring people with IBS to a dietitian, it has been assumed that each person on average would only require 3 sessions. This assumption has been confirmed by clinicians. Cost summary 3.2.8 The annual recurrent cost of increasing referrals to a dietitian is summarised in table 6. Table 6 Changes in annual recurrent costs of referrals to dietitians Unit Current Proposed Change cost Number Cost Number Cost Number Cost of (000s) of (000s) of (000s) people people people
Recurrent costs 72.88 8,600 630 22,000 1,604 13,400 974

Other considerations 3.2.9 Early referral may lead to a reduction in future costs of care for people with IBS. 3.2.10 It is possible that there may be a backlog of people with IBS who would benefit from referral to a dietitian. However, provision of services to existing patients will be affected by when that patient presents to health care services to trigger a referral (perhaps when symptoms are active) and the capacity of services to treat the backlog of patients.

3.3

Low-dose antidepressants

Background 3.3.1 Healthcare professionals should consider tricyclic antidepressants (TCAs) as second-line treatment for people with IBS if laxatives, loperamide or antispasmodics have not helped. TCAs are primarily National costing report: Irritable bowel syndrome (February 2008) 26 of 39

used for treatment of depression but are only recommended here for their analgesic effect. Treatment should be started at a low dose (510 mg equivalent of amitriptyline), which should be taken once at night and reviewed regularly. The dose may be increased but does not usually need to exceed 30 mg (recommendation 1.2.2.5). 3.3.2 Selective serotonin reuptake inhibitors (SSRIs) should be considered for people with IBS only if TCAs have been shown to be ineffective (recommendation 1.2.2.6). Assumptions made 3.3.3 Clinical opinion suggests that low-dose antidepressants should be prescribed indefinitely when they are found to be effective. Therefore, the prevalent population has been used to estimate the additional annual cost as a result of these recommendations. 3.3.4 According to clinical opinion, the proportions of the prevalent population who are currently prescribed low-dose TCAs and SSRIs for treatment of IBS are 14% and 9% respectively. Therefore, it can be estimated that nearly 313,500 people are currently prescribed TCAs and nearly 209,000 people are currently prescribed SSRIs for the treatment of IBS. 3.3.5 Expert clinical opinion suggests that the most commonly prescribed TCA for use as a co-analgesic is amitriptyline. To calculate average costs it is assumed that amitriptyline is the only TCA prescribed for this purpose. 3.3.6 Expert clinical opinion suggests that the most commonly prescribed SSRIs for use as a co-analgesic are fluoxetine (60%), citalopram (30%) and sertraline (10%). 3.3.7 As sertraline is not available as a low-dose preparation it is not included in the calculations to establish the average cost of SSRIs.

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3.3.8

Annual costs of low-dose antidepressants have been calculated using the prices quoted in the British national formulary (BNF) 54th edition.

3.3.9

The average cost of a 28-tablet pack of low-dose TCAs and SSRIs was multiplied by 13 to calculate costs for 365 days.

3.3.10

The average annual cost of TCAs is calculated as 21.13. Details of these costs can be found in table 7.

3.3.11

The average annual cost of SSRIs is calculated as 25.73. Details of these costs can be found in table 7.

Table 7 Annual low-dose antidepressant costs

Type Type of antidepressant Dose (mg) Cost 28tablet pack Proportion used as a coanalgesic 50% 50% 17% 66% 17% 1.98 21.13 Average Annual cost 28costs tablet pack 28-tablet pack x 13 (365 days) 1.63 22.44

TCAs

SSRIs

Amitriptyline Hydrochloride Amitriptyline Hydrochloride Citalopram Hydrobromide Citalopram Hydrobromide Fluoxetine Hydrochloride

10 20 10 20 20

1.62 1.63 2.84 1.38 3.44

3.3.12

Clinical approximations of the proportion of the prevalent population who will be prescribed low-dose TCAs and SSRIs for treatment of IBS after publication of the guidance are 31% and 15% respectively. Therefore, it can be estimated that nearly 720,000 people will be prescribed TCAs and just over 348,000 people will be prescribed SSRIs in the future.

Cost summary 3.3.13 The increase in the number of people prescribed low-dose antidepressants as a second-line treatment of IBS leads to an National costing report: Irritable bowel syndrome (February 2008) 28 of 39

increase in the prescription costs of antidepressants of 12.3 million. 3.3.14 The net cost of prescribing low-dose antidepressants as a secondline treatment of IBS is summarised in table 8. Table 8 Net cost of antidepressants Type of Annual Current antidepressant unit Number Cost cost of (000s) people
TCAs SSRIs Total 21.13 25.73 316,200 210,800 527,100 6,681 5,425 12,105

Proposed Number of people

Change Cost Number Cost (000s) of (000s) people

409,900 140,600 550,500 8,660 3,616 12,277

726,200 15,341 351,400 9,041 1,077,600 24,382

Other considerations 3.3.15 The number of GP consultations may change as a result of the recommendation. An evaluation of local circumstances will be necessary to fully estimate any additional costs. 3.3.16 Antidepressants do have unpleasant side-effects. Therefore, some people with IBS who would benefit from taking these drugs may not choose to do so on a long-term basis. 3.3.17 There will be a proportion of people with IBS who are already prescribed high-dose antidepressants to treat depression. However, these people have not been included in our estimates of current and future uptake of low-dose antidepressants recommended for their analgesic effect in treating the symptoms of IBS.

3.4

Increasing referral for psychological interventions

Background 3.4.1 Referral for psychological interventions (cognitive behavioural therapy [CBT], hypnotherapy and/or psychological therapy) should be considered for people with IBS who do not respond to

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pharmacological treatments after 12 months and who develop a continuing symptom profile (described as refractory IBS) (recommendation 1.2.3.1). Assumptions made 3.4.2 Clinicians estimate that approximately 5% of the population diagnosed with IBS who continue to have symptoms after 12 months are referred for psychological interventions annually. 3.4.3 Clinicians estimate that after implementation of the guidance approximately 11% of the population diagnosed with IBS who continue to have symptoms after 12 months will be referred for psychological interventions annually. 3.4.4 PSSRU (2007) estimate that providers of psychological therapy and hypnotherapy spend 75% of their time in face to face contact with patients and providers of CBT spend 50% of their time in face to face contact with patients. 3.4.5 It is assumed that 67% of psychological therapies are provided by band 6 staff and 33% of psychological therapies are provided by band 8a staff. 3.4.6 The cost of referral for psychological interventions is based on the unit costs shown in table 3. 3.4.7 An average price of psychological interventions was then calculated using these costs. 3.4.8 The cost of psychological interventions is based on 7 sessions based on a unit cost of 41.55. This equates to 291 per patient. Cost summary 3.4.9 The annual recurrent cost of psychological interventions is summarised in table 9.

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Table 9 Changes in annual recurrent costs of psychological interventions Unit Current Proposed Change cost Number Cost Number Cost Number Cost of (000s) of (000s) of (000s) people people people
Recurrent costs 290.86 3,900 1,143 8,600 2,515 4,700 1,372

Other considerations 3.4.10 Clinicians and experts considered psychological interventions an effective treatment in the management of IBS. However, there was a great deal of concern regarding the levels at which this kind of treatment is currently available. Many clinicians felt that the number of people who would benefit from it could be much higher than the 11% quoted. An evaluation of local circumstances will be necessary to fully estimate any additional costs. 3.4.11 It is possible that there may be a backlog of people with IBS who would benefit from psychological interventions. However, provision of services to existing patients will be affected by when that patient presents to health care services to trigger a referral (perhaps when symptoms are active) and the capacity of services to treat the backlog of patients 3.4.12 Early referral may lead to a reduction in future costs of care for people with IBS.

4
4.1
4.1.1

Sensitivity analysis
Methodology
There are a number of assumptions in the model for which no empirical evidence exists. Because of the limited data, the model developed is based mainly on discussions of typical values and predictions of how things might change as a result of implementing the guidance and is therefore subject to a degree of uncertainty.

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4.1.2

As part of discussions with practitioners, we discussed possible minimum and maximum values of variables, and calculated their impact on costs across this range.

4.1.3

Wherever possible we have used the national tariff plus market forces factor to determine cost. We used the variation of costs for the 25th and 75th percentiles from reference costs compared with the reference cost national average as a guide to inform the maximum and minimum range of costs.

4.1.4

It is not possible to arrive at an overall range for total cost because the minimum or maximum of individual lines would not occur simultaneously. We undertook one-way simple sensitivity analysis, altering each variable independently to identify those that have greatest impact on the calculated total cost.

4.1.5

Appendix B contains a table detailing all variables modified and the key conclusions drawn are discussed below.

4.2

Impact of sensitivity analysis on costs

Recurrent annual costs

Prevalence of IBS 4.2.1 Using the specific gender and age prevalence rates detailed by Wilson et al (2004) we have calculated that the total prevalence of IBS in the UK is 10.68%. 4.2.2 Camilleri et al (2002) quotes a prevalence range of IBS of 812%. When these minimum and maximum prevalence rates are added to the costing model, the overall resource impact of the recommendations ranges from 4.8 million to 9.4 million. Low-dose antidepressants 4.2.3 In the cost assessment, the estimated proportion of people with IBS who are currently prescribed low-dose TCAs as a second-line National costing report: Irritable bowel syndrome (February 2008) 32 of 39

treatment is 14%. This is the average estimate from a number of clinical experts. 4.2.4 When the minimum, 5% and maximum, 30% proportions are added to the costing model, the overall resource impact of the recommendations ranges from 12 million to a saving of 0.3 million. 4.2.5 The cost assessment estimates the proportion of people with IBS who will be offered low-dose TCAs as a result of the guidance will be 31%. This is the average estimate from a number of clinical experts. 4.2.6 When the minimum, 15% and maximum, 40% proportions are added to the costing model, the overall resource impact of the recommendations ranges from a saving of 0.3 million to a cost of 12 million. 4.2.7 In the cost assessment, the estimated proportion of people with IBS who are currently prescribed low-dose SSRIs as a second-line treatment is 9%. This is the average estimate from a number of clinical experts. 4.2.8 When the minimum, 5% and maximum, 20% proportions are added to the costing model, the overall resource impact of the recommendations ranges from 10 million to 1.2 million. 4.2.9 The cost assessment estimates the proportion of people with IBS who will be offered low-dose SSRIs as a result of the guidance will be 15%. This is the average estimate from a number of clinical experts. 4.2.10 When the minimum, 10% and maximum, 20% proportions are added to the costing model, the overall resource impact of the recommendations ranges from 4.6 million to 10.6 million.

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5
5.1.1

Impact of guidance for commissioners

With the exception of some of the diagnostic tests undertaken in secondary care, the majority of the costs identified in this report are outside the national tariff because they will be incurred in primary care.

5.1.2

Healthcare professionals may need training in the diagnostic criteria and management of IBS. As they gain confidence in their ability to diagnose and treat IBS in primary care, the full costs and savings of implementation will be realised.

5.1.3

It is anticipated that implementation of the recommendation regarding referral for psychological interventions will be significantly affected by the availability of these treatments in the local area.

5.1.4

The graph below assumes a phased implementation over 3 years. However, it is expected that some areas will implement the recommendations more rapidly, depending on local circumstances. This graph is for illustrative purposes only.

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5.1.5

It is possible that there may be a backlog of people with IBS who would benefit from referral to a dietitian or psychological interventions. However, provision of services to existing patients will be affected by when that patient presents to health care services to trigger a referral (perhaps when symptoms are active) and the capacity of services to treat the backlog of patients.

5.1.6

Procedures undertaken for IBS are likely to fall within the programme budgeting category 13A 'Problems of the gastrointestinal system, upper GI'.

6
6.1
6.1.1

Conclusion
Total national cost for England
Using the significant resource-impact recommendations shown in table 1 and assumptions specified in section 3 we have estimated

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the annual cost impact of fully implementing the guideline in England to be 7,911,900. Table 10 shows the breakdown of cost of each significant resource-impact recommendation. Table 10 Net resource impact of recommendations Recommendation Estimated recurrent cost of implementing (000s)
Use of diagnostic tests Referral to dietitian Low-dose antidepressants Psychological interventions Total -6,892 974 12,277 1,372 7,879

6.1.2

We applied reality tests against existing data wherever possible, but this was limited by the availability of detailed data. We consider this assessment to be reasonable, given the limited detailed data regarding diagnosis and treatment paths and the time available. However, the costs presented are estimates and should not be taken as the full cost of implementing the guideline.

6.1.3

Clinicians also felt that implementation of the recommendations regarding referral for psychological interventions will be significantly affected by the availability of these treatments in the local area.

6.2
6.2.1

Next steps
The local costing template produced to support this guideline enables organisations such as primary care trusts (PCTs) or health boards in Wales and Northern Ireland to estimate the impact locally and replace variables with ones that depict the current local position. A sample calculation using this template showed that a population of 100,000 could expect to incur additional annual recurrent costs of 20,500. Use this template to calculate the cost of implementing this guidance in your area.

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Appendix A. Approach to costing guidelines Guideline at first consultation stage

Identify significant recommendations and population cohorts affected through analysing the clinical pathway

Identify key cost drivers gather information required and research cost behaviour Develop costing model incorporating sensitivity analysis Draft national cost -impact report Determine links between national cost and local implementation

Internal peer review by qualified accountant within NICE

Develop local cost template

Circulate report and template to cost -impact panel and GDG for comments Update based on feedback and any changes following consultations Cost -impact review meeting

Final sign off by NICE

Prepare for publication in conjunction with guideline

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Appendix B. Results of sensitivity analysis

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Appendix C. References
Bellini M, Tosetti C, Costa F et al. (2005) The general practitioner's approach to irritable bowel syndrome: from intention to practice. Digestive and Liver Disease 37: 9349. Hamilton J (1995) Needle phobia: a neglected diagnosis. Journal of Family Practice 41: 16975. Locke G, Yawn B, Wollan P et al. (2004) Incidence of clinical diagnosis of the irritable bowel syndrome in a United States population. Alimentary Pharmacology & Therapeutics 19: 102531. NHS Employers (2007) NHS Employers' evidence to the NHS Pay Review Body 2008/09. London: NHS Employers. PSSRU (2007) Unit cost of health and social care 2007. University of Kent: Personal Social Services Research Unit. Thompson WG, Heaton KW, Smyth GT et al. (2000) Irritable bowel syndrome in general practice: prevalence, characteristics, and referral. Gut Online 46: 7882. Wilson S, Roberts L, Roalfe A et al. (2004) Prevalence of irritable bowel syndrome: a community survey. British Journal of General Practice 54: 495 502.

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