-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 Clinic
Date:
Release:
Draft/Final
Author:
Owner:
Client:
Document Number:
[Major headings are included in contents list – edit as required]
Contents
Executive Summary
Introduction
Drivers for change that support the need for a
coordinated approach to anaemia management:
Reason, aims and purpose
Expected Benefits & Outcomes
Outcome measures:
Expected Dis-benefits
Timescale
Financial Appraisal
Clinical / Non-Financial Benefits Assessment
Environmental Impact Assessment
1
Risk Assessment and Management
Service Description/Care Pathway
Evidence Base for an IV iron anaemia clinic
Conclusion and approvals
Appendices
Appendix 1: Intravenous iron preparations licensed
in the UK
Appendix 2: Patient Information
Appendix 3: HRG code/tariff
References
Acknowledgements
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-
2
operative setting has been internationally identified as an unmet medical
need.
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 coordination 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
Recommendations
2014
Committee
Patient
Blood
Management
(http://www.transfusionguidelines.org/uk-
transfusion-committees/national-blood-transfusion-committee/patient-bloodmanagement) 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
3
o
Identify and correct the underlying cause of the anaemia
before considering transfusion

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 management
o
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.
4
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.
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
5
guidance on how anaemic patients should be managed by POAC.
BCSH
guidelines are in development.
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
6
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
 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)
7
Cost implications:

Consultant time

Nursing staff time

Secretarial support

Drugs & consumables cost

Investigation costs

Capital costs and variable costs

Transport costs
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]
Intervention
Amount
Cost of Drug per unit/g (£)
time in required hours
band 5 nurse (cost per Hour)
cost of nurse per infusion
Giving set Cost
Cost of Treatment
Current
Situation
Red blood cells
2 units
£243.70
6
£84.00
£504.00
£6.75
£754.45
8
Proposed Iron
Service
Ferinject
1g
£154.23
0.45
£84.00
£37.80
£6.75
£198.78
Day case Payment via HRG
Income to dept per patient
If all patients treated during
audit period
Annual scope for patients
£406.00
(SA13A)
-£348.45
£294.00
(SA04F)
£95.22
[from audit]
[from audit]
[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

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 Assessment
The 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]
9
Risk
Mitigation plan
Other service providers may not feel Collect evidence to provide compelling case for
that this new service is necessary
change,
liaise
closely
with
other
divisions,
develop complimentary service
Trust may feel that activity is being Probable large unmet need – need accurate
diverted rather than genuinely new figures to predict referral patterns and change
activity
in patient flow
Clinical Commissioning Groups may not 1)
support new service
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
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 Person spec: Relevant knowledge, training and
recruit – will require specialist skills experience, competent in assessment of adult
including:
history
taking,
physical patients. Will require supervision by consultant
examination, use of investigations, use until
of treatment modalities etc
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
10
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]
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 as
it has the potential to identify previously undiagnosed disease, reduces the
likelihood of the patient requiring a blood transfusion and therefore avoids
11
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 preoperative 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).
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 nonanaemic 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
12
allogenic blood and associated risk would be reduced (Munoz, GomezRamirez, 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
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]
13
Sign off
Name
Job role
Signature and date
Customer
representative
Transfusion
Practitioner
Consultant
Haematologist
HTC Chair
Pathology Manager
Finance Director
Chief Executive
Medical Director
Pharmacy Manager
Other
approvals
necessary (list)
14
as
Appendices
Appendix 1: Intravenous iron preparations licensed in the UK
[Prices taken from general NHS national prices as of 2014/15. 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
iron

o
Maximum single dose = 1000mg
o
Duration of infusion/bolus injection = up to 15 mins
o
Test dose needed : No
o
Cost: £154.23 (1x100mg), £405.88 (5x500mg)
Cosmofer (Iron dextran) :o
Complex of ferric hydroxide with dextran containing 5% (50mg/mL)
of iron

o
Maximum single dose = 1600mg
o
Duration of infusion = up to 6 hrs
o
Test dose needed : yes
o
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 hr
o
Test dose needed ; yes
o
Cost: £43.52 (5x100mg)
15

Monofer (Iron Isomaltoside 1000) :o
Complex
of
ferric
iron
and
isomaltoside
containing
10%
(100mg/mL) of iron
o
Maximum single dose = 1600mg
o
Duration of infusion = up to 1hr
o
Test dose needed : No
o
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.]

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/
16
Appendix 3: HRG code/tariff
[See local coding department to ensure current and correct codes and
pricing. HRG is the Healthcare Research Group]
HRG: SA04F
Description: Iron Deficiency Anaemia without CC
Sub-Chapter: SA: Haematological Procedures and Disorders
HRG Type: Core HRG
PbRYear: 2014/15
Combined Elective/Day case Tariff: £294
Elective Tariff:
Daycase Tariff:
Non-Elective Tariff:
OPA Procedure Tariff:
Elective Trim:
Non-Elective Trim:
Excess Bed Day Tariff:
Short Stay Emergency Applies?:
Short Stay Emergency Tariff:
Spec Service Top-Ups Apply?:
£813
5
6
£236
No
Yes
HRG: SA04D
Description: Iron Deficiency Anaemia with CC
Sub-Chapter: SA: Haematological Procedures and Disorders
HRG Type: Core HRG
PbRYear: 2014/15
Combined Elective/Day case Tariff: £417
Elective Tariff:
Daycase Tariff:
Non-Elective Tariff:
OPA Procedure Tariff:
Elective Trim:
Non-Elective Trim:
Excess Bed Day Tariff:
Short Stay Emergency Applies?:
Short Stay Emergency Tariff:
Spec Service Top-Ups Apply?:
£1,929
5
22
£236
No
Yes
17
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20
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Acknowledgements
o
Leicester University Hospital
o
Mid Essex Hospital NHS Trust
o
Kate Pendry, Consultant Haematologist, NHSBT
o
Vifor Pharma
o
NHSBT Patient Blood Management Practitioner Team
21