-Business Case

[This front sheet should reflect the branding requirements of the Trust. The below is only a guide and your local Trust Business Case template may require additional information. Costs are for guidance only and vary between Trusts/regions. Green text is for your guidance and should be removed before business case sent for submission or review]

Project Name: IV Iron Anaemia ClinicDate: Release: Draft/FinalAuthor:

Owner:

Client:

Document Number:

[Major headings are included in contents list – edit as required]

Contents Executive SummaryIntroductionDrivers for change that support the need for a coordinated approach to anaemia management:Reason, aims and purposeExpected Benefits & OutcomesOutcome measures:Expected Dis-benefitsTimescaleFinancial AppraisalClinical / Non-Financial Benefits AssessmentEnvironmental Impact AssessmentRisk Assessment and Management

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Service Description/Care PathwayEvidence Base for an IV iron anaemia clinicConclusion and approvalsAppendicesAppendix 1: Intravenous iron preparations licensed in the UKAppendix 2: Patient InformationAppendix 3: HRG code/tariffReferencesAcknowledgements

Executive Summary

[Highlight the key points in the Business Case, which should include important benefits and the return on investment. These could be from the template below but should be made specific to the Trusts decision and aims you hope to achieve]

Introduction

Pre-operative iron deficiency anaemia (IDA) is common and associated with poor post-operative outcomes. It is good clinical practice to diagnose and appropriately treat preoperative anaemia. This is likely to reduce the risk of such patients requiring intra/post-operative blood transfusion which exposes patients to additional risks including increased morbidity. This strategy is likely to improve clinical outcomes for patients undergoing planned major surgery and reduce the associated cancellation rate. A standardised approach for the detection, evaluation and management of anaemia in the pre-operative setting has been internationally identified as an unmet medical need.

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A 2012 data briefing by The Kings Fund (Tian et al 2012) indicated IDA as an ambulatory care-sensitive condition (ACSC – a condition for which effective management and treatment should prevent admission to hospital). It went on to say that, high levels of admissions for ACSAs often indicate poor co-ordination between the different elements of the health care system and that an emergency admission for an ACSC is a sign of the poor overall quality of care. (See Evidence Base for an IV iron anaemia clinic)

Drivers for change that support the need for a coordinated approach to anaemia management:

[Add in information from local audit or results from National Comparative Audit surgical PBM, that show the size of the problem within Trust – expand this point as required to make issue a local concern that needs an anaemia clinic to improve situation] NHS Outcomes Framework 2013/14, Domain 2, Improvement area 2.3: Enhancing quality of life for people with long-term conditions. Reducing time spent in hospital by people with long-term conditions – unplanned hospitalisations for chronic ambulatory care sensitive patients. (CCG Quality Premium attached to this service) [Add in other NHS Outcomes Framework domains and indications that fit your Trust] National Blood Transfusion Committee Patient Blood Management Recommendations 2014 (http://www.transfusionguidelines.org/uk-transfusion-committees/national-blood-transfusion-committee/patient-blood-management) advise the following:

o Provide arrangements for the timely identification and correction of anaemia before elective surgery which is likely to involve significant blood loss using WHO definitions of anaemia i.e. Hb in adult males<130g/l and adult females <120g/l

o Avoid transfusion for managing anaemia if alternatives are available e.g. oral iron for iron deficiency and intravenous iron for functional iron deficiency

o Identify and correct the underlying cause of the anaemia before considering transfusion

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The NHS Plan (DH 2000) recommends the setting up of “preparing patients for surgery” clinics where all aspects of the patient’s health relevant to their possible treatment requirements should be investigated. The National Institute for Health and Clinical Excellence (NICE) guidance on preoperative testing of patients (BCSH Guidelines: The management of anaemia pre-operatively: Alternatives to allogeneic transfusion- soon to be published) NHS Enhanced Recovery partnership programme (Department of Health 2010) has an element on preoperative assessment, planning, and preparation before operation and recommends that anaemia is investigated and treated before planned surgery. Reduction in numbers of inappropriate transfusions Current unmet need due to the inadequate pre-optimisation of patients before surgery. An NHSBT national survey of Patient Blood Management (2014) indicated that 31% of NHS Trusts did not have arrangements in place for identification and correction of anaemia before surgery. There is a need for the provision of a rapid access anaemia service to improve the patient journey :-

o Reduction in the number of emergency admissions due to anaemia

o Streamlined pre-operative managemento Efficient out patient investigation and treatment pathways

[NICE guidelines on blood transfusion will be out in October 2015 and will refer to elements in this initiative. These should be incorporated into your business case]

Reason, aims and purpose

The purpose of an anaemia clinic is to provide a streamlined care pathway for diagnosis and treatment of anaemia in patients requiring planned major surgery.

At present patients are often referred back to their GP for investigations of anaemia or onward referral to a haematology clinic resulting in, last minute cancellations and / or significant delays in their surgery.

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It is good clinical practice to diagnose and appropriately treat pre-operative anaemia. This strategy is likely to improve clinical outcomes for patients undergoing planned major surgery by reducing the risk of such patients requiring peri-operative blood transfusion. Various studies as have shown that blood transfusion is an independent risk factor for mortality and morbidity after surgery. (See: Evidence Base for an IV iron anaemia clinic) The Health Service Circular Better Blood Transfusion: Appropriate Use of Blood (HSC 2002/009) recommends that pre-operative haemoglobin (Hb) levels and haemostasis are optimised in pre-operative assessment clinics (POAC) for patients with planned surgical procedures.

The National Good Practice Guidance on Pre-operative Assessment for Inpatient Surgery (2002) states that pre-operative assessment should identify any condition that may require intervention prior to admission and surgery and appropriate action taken.

The Royal College of Anaesthetists Guidelines for the provision of anaesthetic services 2014 state that pre-operative assessment and preparation business planning by Trusts and anaesthetic departments should ensure that necessary time and resources are directly targeted towards pre-operative preparation of patients to clearly identify, mitigate or manage risks in a planned and consistent way.They state each Trust should have agreed written policies, protocols or guidelines covering: pre-operative tests and investigations management of anaemia to reduce risk of allogenic blood transfusion management of anticoagulant therapy

The National Institute for Health and Clinical Excellence (2003) indicates the tests required for specific types of surgery. However, there is currently no guidance on how anaemic patients should be managed by POAC. BCSH guidelines are in development.

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Expected Benefits & Outcomes

[The benefits that the project will deliver expressed in measurable terms against the situation as it exists prior to the project. Benefits should be both qualitative and quantitative – an audit to see the possible impact may have to be completed (See National Comparative Audit Surgical Patient Blood Management proforma and results). Expected benefits and outcomes should be aligned to corporate/Trust strategic aims. Tolerances should be set for each benefit and for the aggregated benefit. Any benefits realisation requirements should be stated]

Outcome measures: % patients having surgery with treatable anaemia uncorrected % patients having surgery with treatable anaemia corrected % transfusion rate for surgical patients (pre-op, intra-op, post-op) Cancellation rate (because of anaemia) might be difficult to capture systematically – low numbers, variable reasons for cancellation Complication rate e.g.: transfusion reactions such as TACO and TRALI, wound infections Length of stay – in critical care and in hospital Readmission within 30 days The patient experience Compliance to QIPP agenda and QIPP initiatives. Such as;

1. Operate a well planned and clear pathway for anaemia management (agreed, in place and working) delivering safe, evidence based care

2. Each patient is seen by a professional with the relevant skills and right equipment

3. Reduce blood transfusions

Expected Dis-benefits

[Outcomes perceived as negative by one or more stakeholders. Below are general but should be made Trust specific. Balancing factors should be added to show that the dis-benefit does not outweigh any benefit. This section can be excluded from the business case] Additional staff will be needed to manage the anaemia clinic – these may

come from the areas where post-operative transfusion rates will drop

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An area will be occupied for the anaemia clinic – the clinic will be held once a week and at a time when surgical outpatients lists are completed

Timescale

[Add details of the period over which the project will run and the period over which the benefits will be realised.]

Financial Appraisal[Add details on costs and savings from information available from audits, blood usage and iron preparation costs. Details about activity based costs/savings can also be included. Add details as required by your Trust. Below are lists of cost savings and implications which should be considered. Others may exist]

Savings to be considered: Decreased costs due to:

Reduction in length of stay Reduction in number of red cell transfusions Avoidance of re-admission especially emergency re-admission Reduction in time spent investigating transfusion related incidents Reduction in treatment of wound infections Early (or earlier) detection of the cause of anaemia which may be secondary to previously undiagnosed disease (E.g malignancy)

Cost implications: Consultant time Nursing staff time Secretarial support Drugs & consumables cost Investigation costs Capital costs and variable costs Transport costs

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Revenue: Tariff for treatment of IDA (with/without complications)

Projected saving/revenue: [Table below is a worked example of use of Red cells vs. an IV iron preparation. Costs are those as per the Summary of Product Characteristics (SPC) and National Price lists as of 2015/16. Nursing cost excludes weighted premiums (e.g. London allowance) as are taken from ‘unit costs for health and social care, 2014’ (Curtis 2014) – amend based on your local Trust structure as required. 2 units of RBC used as a comparison as Shander A. et. Al states that one unit of blood contains 190-210 mg of heam iron (mean 200mg). Update example as required. Additional lab testing has not been included in worked example as its assumed test frequency will not be affected – if this is to be affected in your Trust factor this into the example below. Also consider the cost of giving set as some IV preparations can be given as bolus injection]

  Current Situation

Proposed Iron Service

Intervention Red blood cells FerinjectAmount 2 units 1g

Cost of Drug per unit/g (£) £243.70 £154.23time in required hours 6 0.45

band 5 nurse (cost per Hour) £84.00 £84.00cost of nurse per infusion £504.00 £37.80

Giving set Cost £6.75 £6.75Cost of Treatment £754.45 £198.78

Day case Payment via HRG  £406.00 (SA13A)

£294.00 (SA04F)

Income to dept per patient -£348.45 £95.22If all patients treated during 

audit period [from audit] [from audit]

Annual scope for patients [from scope] [from scope]

Clinical / Non-Financial Benefits Assessment

Lower risk to patients due to lower probability of receiving an allogeneic transfusion Decreased length of stay post-operatively

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Meets best practice for surgical patients Reduced risk of hospital acquired infection Improved patient experience Increase in day case and community management Early (or earlier) detection of the cause of anaemia which may be

secondary to previously undiagnosed disease (e.g. malignancy)

Environmental Impact AssessmentThe clinic will necessitate the patient travelling to clinic for up to a maximum of 6 visits, dependent upon iron preparation. However a number of IV iron preparations can be administered as a total dose infusion/bolus injection. The ability to administer IV iron in the clinic will negate the need for a further hospital visit.

Risk Assessment and Management

[Check other risks that may exist within your Trust. It is important that the service before and after is audited to ensure correct resources are allocated and outcomes expected are being realised]

Risk Mitigation planOther service providers may not feel that this new service is necessary

Collect evidence to provide compelling case for change, liaise closely with other divisions, develop complimentary service

Trust may feel that activity is being diverted rather than genuinely new activity

Probable large unmet need – need accurate figures to predict referral patterns and change in patient flow

Clinical Commissioning Groups may not support new service

1) Iron deficiency is an Ambulatory Care Sensitive (ACS) condition and the case needs to support management of anaemia in the community (including education and training, and availability of expert telephone advice as

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well as rapid access clinic)2) Should meet NHS targets for reduction in emergency admissions and 18 week pathway

Single handed nurse specialist Service co-delivered by consultant haematologist, work as part of transfusion team

Nurse specialist may be difficult to recruit – will require specialist skills including: history taking, physical examination, use of investigations, use of treatment modalities etc

Person spec: Relevant knowledge, training and experience, competent in assessment of adult patients. Will require supervision by consultant until experienced and competent in management of adult patients with anaemia; willing to undertake nurse prescribing course and complete training to allow nurse authorisation of blood components

Service may be underused Develop appropriate communication plan, ensure available on choose and book etc

Service may become overwhelmed Review after 1 year, audit capacity used / available and service demand, make case for additional staff/clinic days as required

Service Description/Care Pathway

[Add brief details of service being commissioned. This could be a new service improvement, redesign or expansion of current anaemia management service. Add in: overview algorithm; below one from the NATA guidelines on detection, evaluation and management of preoperative anaemia (Goodnough et al 2011), location of service, patient access/referral systems patient follow up/review processes, interdependence with other services/providers and administration requirements]

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Evidence Base for an IV iron anaemia clinic

There is strong evidence to show that pre-operative anaemia is a modifiable risk factor for surgery.The identification and management of pre-operative anaemia is important asit has the potential to identify previously undiagnosed disease, reduces the likelihood of the patient requiring a blood transfusion and therefore avoids exposing them to the risks associated with transfusion and allows for the treatment anaemia and modification of associated risks.Both prospective and retrospective studies have looked at the effects of pre-operative anaemia on patient outcome and have consistently shown that patients with pre-operative anaemia have poorer post-operative outcomes than non anaemic patients. Patients who were anaemic pre-operatively had a higher rate of post-operative complications (37% vs. 22%) (Lasocki S et al 2015); reduced admission Haemoglobin levels were shown to have an impact both on functional post-operative recovery and the quality of life of patients. (Lawrence VA et al 2013), (Conlon NP 2008), (Kotze et al 2012).

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Pre-operative anaemia of chronic disease is a strong independent risk factor for surgical site infection (Everhart JS, 2013) with prosthetic joint infection for patients shown to occur at an incidence of 4.3% compared to 2% in non-anaemic patients (Greenky M 2012).Pre-operative anaemia has been shown to be an independent predictor for the need for peri-operative allogeneic blood transfusion (Beattie et al) and has also been found to be strongly predictive of morbidity and mortality. (Sarhane and Flores 2013). This has been found to be true even in mildly anaemic patients, increasing the relative risk of morbidity and mortality by 30-40% (Mussallam et al, 2015). Historically, management of pre-operative anaemia has focussed on the use of blood transfusion. Allogeneic blood transfusions are associated with increased rates of infectious complications, delay in wound healing, renal dysfunction and a longer necessity for mechanical ventilation, all of which lead to increased length of post-operative stays. Preoperative anaemia has been independently shown to be linked to increased patient length of stay regardless of whether allogenic transfusion took place. (Munoz, Gomez-Ramirez, Jose 2014) Bisbe (2015) concluded that there is no increased risk of infection following IV iron treatment based on a randomised controlled trial showing no adverse effects from IV iron (Bisbe et al 2014).Identification and correction of pre-operative anaemia with the use of a well defined Patient Blood Management programme to improve outcomes can lead to a reduction in peri and post-operative complications and improve post-operative recovery. In addition the associated risks to the patient, costs of extended care due to longer stays in hospital and potential requirement for allogenic blood and associated risk would be reduced (Munoz, Gomez-Ramirez, Campos 2014) (Litton 2013) (Carrascal 2010).If allogenic blood components can be avoided by adequately pre-optimising patients pre-operatively, then the cost of blood component usage will be reduced. This will help make better use of resources, the donor pool and ensure that blood is available for those patients where there are no alternatives available (Vetter 2013)Recognising and managing pre-operative anaemia aids overall risk reduction by giving clinicians the opportunity to pre-optimise patients. This gives the chance to reduce allogeneic blood use and potentially improve recovery from

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surgery and reduce length of stays for patients (Clevenger and Richards 2015)

Conclusion and approvals[Set out clearly the recommendation you are making to be approved]

Sign offName Job role Signature and date

Customer representativeTransfusion PractitionerConsultant HaematologistHTC Chair

Pathology Manager

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Finance Director

Chief Executive

Medical Director

Pharmacy Manager

Other approvals as necessary (list)

Appendices

Appendix 1: Intravenous iron preparations licensed in the UK[Prices taken from general NHS national prices as of 2014/15. .There may be some local variance due to individual Trust tenders. Prices will be available from commercial representatives or from Trust procurement frameworks.]

Ferinject (Ferric carboxymaltose) :-o Complex of ferric carboxymaltose containing 5% (50mg/mL) of

irono Maximum single dose = 1000mgo Duration of infusion/bolus injection = up to 15 minso Test dose needed : No

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o Cost: £154.23 (1x1000mg), £405.88 (5x500mg), £81.18 (5x100mg)

Cosmofer (Iron dextran) :- o Complex of ferric hydroxide with dextran containing 5% (50mg/mL)

of irono Maximum single dose = 1600mgo Duration of infusion = up to 6 hrso Test dose needed : yeso Cost: £79.70 (2 x 10ml) £39.85 ( 5 x 2mls)

Venofer (Iron sucrose) :-o Complex ferric hydroxide with sucrose containing 2% (20mg/ml) of

iron. o Maximum single dose = 200mg o Duration of infusion/bolus injection = up to 1 hro Test dose needed ; yeso Cost: £43.52 (5x100mg)

Monofer (Iron Isomaltoside 1000) :-o Complex of ferric iron and isomaltoside containing 10% (100mg/mL)

of irono Maximum single dose = 1600mgo Duration of infusion = up to 1hro Test dose needed : Noo Cost: £339 ( 2 x 10ml) £423.75 (5 x 5ml) £84.75 (5 x 1ml)

Appendix 2: Patient Information [Trust can develop own tailored patient information. Below are examples of what is available for clinical staff to access and give to patients.]

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Commercial iron preparations – contact suppliers for patient information material

NHSBT Patient Information Leaflet – ‘What is Anaemia?’ and ‘Iron in your diet’ http://hospital.blood.co.uk/

NHS Choices – Iron Deficiency Anaemia http://www.nhs.uk Royal College of Nursing – Iron Deficiency Anaemia Nursing Guidelines

(June 2015) http://www.rcn.org.uk/

Appendix 3: HRG code/tariff[See local coding department to ensure current and correct codes and pricing. HRG is the Healthcare Research Group]HRG: SA04FDescription: Iron Deficiency Anaemia without CCSub-Chapter: SA: Haematological Procedures and DisordersHRG Type: Core HRG

PbRYear: 2014/15

Combined Elective/Day case Tariff: £294

Elective Tariff: -Daycase Tariff: -Non-Elective Tariff: £813OPA Procedure Tariff: -

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Elective Trim: 5Non-Elective Trim: 6Excess Bed Day Tariff: £236Short Stay Emergency Applies?: NoShort Stay Emergency Tariff: -Spec Service Top-Ups Apply?: Yes

HRG: SA04DDescription: Iron Deficiency Anaemia with CCSub-Chapter: SA: Haematological Procedures and DisordersHRG Type: Core HRG

PbRYear: 2014/15

Combined Elective/Day case Tariff: £417

Elective Tariff: -Daycase Tariff: -Non-Elective Tariff: £1,929OPA Procedure Tariff: -Elective Trim: 5Non-Elective Trim: 22Excess Bed Day Tariff: £236Short Stay Emergency Applies?: NoShort Stay Emergency Tariff: -Spec Service Top-Ups Apply?: Yes

ReferencesBaron. D, Hochrieser, Posch M, Metnitz B, Rhodes A, Moreno R, Metnitz P. Preoperative anaemia is associated with poor outcomes in non-cardiac surgical patients. British Journal of Anaesthesia 2014 Sep;113(3):416-23doi: 10.1093/bja/aeu098

Bisbe E. Intravenous Iron as Blood saving technique in surgery, what is the evidence? Speaker Presentation ISBT International Congress 2015. Journal of Vox Sanguinis 2015;109 supplement 1

Bisbe E, Molto L, Arroyo R, Muniesa J, Tejero M. A randomised controlled trial comparing ferric carboxymaltose vs oral ferrous glycine sulphate for

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postoperative anaemia treatment after total knee arthroplasty. British Journal of Anaesthesia 2014 Sep;113(3):402-9.

Carrascal Y, Maroto L, Rey J, Are´valo A, Arroyo J, Echevarria R, Arce N, Fulquet E. Impact of preoperative anaemia on cardiac surgery in octogenarians Interactive Cardiovascular and Thoracic Surgery 10 2010; 249–255

Cladellas M, Jordi BrugueraJ et al. Is pre-operative anaemia a risk marker for in-hospital mortality and morbidity after valve replacement? European Heart Journal 2006;27, 1093–1099

Clevenger B, Richards T. Pre-operative anaemia. Anaesthesia 2015;70 (suppl. 1), 20-28

Conlon NP, Bale EP, Herbison GP, McCarroll M. Postoperative anaemia and quality of life after primary hip arthroplasty in patients over 65 years old. Anaesthesia Analg 2008; 106: 1056–61

Curtis L. Unit Costs of Health & Social Care 2014. Personal Social Services Research Unit, University of Kent. ISBN 978-1-902617-89-5

Everhart JS, Calhoun JH. Ohio State University, Columbus, OH Everhart JS, Calhoun JH. Ohio State University, Columbus, OH Preoperative Anaemia of Chronic Disease is a Strong Independent Risk Factor for Surgical Site Infection after Total Joint Arthroplasty. http://www.msis-na.org/annual-meetings/2013-annual-meeting/2013-program/320-preoperative-anemia-of-chronic-disease/

Goodnough L, Maniatis A et al. Detection, evaluation, and management of preoperative anaemia in the elective orthopaedic surgical patient: NATA guidelines. British Journal of Anaesthesia 106 (1): 13–22 (2011)doi:10.1093/bja/aeq361

Greenky M Ghandi K, Pulido L, Restrepo C, Parvizi J. Preoperative anaemia in total joint arthroplasty: is it associated with periprosthetic joint infection? Clinical Orthopaedics and Related Research. 2012 Oct; 470(10): 2695–2701.

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Kotze´A , Carter LA and Scally AJ Effect of a patient blood management programme on preoperative anaemia, transfusion rate, and outcome after primary hip or knee arthroplasty: a quality improvement cycle British Journal of Anaesthesia 108 (6): 943–52 (2012) doi:10.1093/bja/aes135

Lasocki S, Krauspe R, von Heymann C, Mezzacasa A, Chainey S, Spahn DR. PREPARE: the prevalence of perioperative anaemia and need for patient blood management in elective orthopaedic surgery: A multicentre, observational study. European Journal of Anaesthesiology 2015;32:160-167.

Lawrence VA, Silverstein JH, Cornell JE, et al. Higher Hb level is associated with better early functional recovery after hip fracture repair. Transfusion 2003; 43: 1717–22

Litton E, Xiao J, Ho K . Safety and efficacy of intravenous iron therapy in reducing requirement for allogeneic blood transfusion: systematic review and meta-analysis of randomised clinical trials. BMJ 2013;347:f4822

Muñoz M, Gómez-Ramírez S, Campos A Iron Supplementation for perioperative anaemia in patient blood management. European Medical Journal Haematology. 2014;1:123-132.

Muñoz M, Gómez-Ramírez S, García-Erce J Implementing Patient Blood Management in major orthopaedic procedures: orthodoxy or pragmatism? Blood Transfusion 2014; 12: 146-9 DOI 10.2450/2014.0050-14

Miceli A, Romeo F, Glauber M, de Siene P, Capuuto M, Angelini G. Preoperative anaemia increases mortality and postoperative morbidity after cardiac surgery. Journal of Cardiothoracic Surgery 2014, 9:137

Musallam K, Tamim H, Richards T et al. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet 2011; 378: 1396–407

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Otto J et al. Association between preoperative haemoglobin concentration and cardiopulmonary exercise variables: a multicentre study. Perioperative Medicine 2013, 2:18http://www.perioperativemedicinejournal.com/content/2/1/18

Sarhane K, Flores J et al. Preoperative Anaemia and Postoperative Outcomes in Immediate Breast Reconstructive Surgery: A Critical Analysis of 10,958 Patients from the ACS-NSQIP Database PlasicReconstructive Surgery Global Open 2013;1:e30; www.PRSGO.com

Scott Beattie W ,Keyvan Karkouti K et al. Risk Associated with Preoperative Anaemia in Noncardiac Surgery: A Single-centre Cohort Study. Anaesthesiology 2009; 110:574–81

Tian Y, Dixon A, Gao H (2012) Emergency hospital admissions for ambulatory care-sensitive conditions: identifying the potential for reductions (Data Briefing) The Kings Fund. London.

Tinegate H, (2014) National Survey Red Cell Use. NHSBT

VetterT. Tighten Your Belts! Reduce Your Transfusion Costswith Preoperative Management of Anaemic PatientsInternational Anaesthesia Research Society 2013 Review course lectures: 51-57 www.iars.org

Acknowledgementso Leicester University Hospitalo Mid Essex Hospital NHS Trusto Kate Pendry, Consultant Haematologist, NHSBTo Vifor Pharmao NHSBT Patient Blood Management Practitioner Team

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