Commissioning view of
immunoglobulin
Malcolm Qualie
Head of Health Policy
East Midland Specialised Commissioning Group
Immunoglobulin prescribing approval
process
Aims of the National
Immunoglobulin Database
Initial aims [in 2007]
• To allow more accurate assessment of immunoglobulin use for
forecasting and tendering
• To provide an accurate picture of prescribing by indication and a
tracking mechanism of individual batches of immunoglobulin for safety
purposes
These aims developed further [in 2008]
• With the publication of the Model Commissioning Policy by the NSCG,
there is now an explicit desire to link immunoglobulin use to payment
at the PCT or SHA level through the records contained in the database
Current position going into 2012.....
Updated guidelines
Commissioning perspective
Selection criteria and outcomes
“Increased clarity regarding
patient selection criteria and
the need for prescribers to
report clinical outcome after
treatment are strongly
supported”
Effective IAPs
“Effective Immunoglobulin
Assessment Panels (IAPs) are
important to monitor
adherence to these new
selection criteria in routine
clinical practice”
Database Information Service
East Midlands Specialised
Commissioning Group
Bespoke immunoglobulin prescribing reports
East Midlands Specialised Commissioning Group has incorporated a
requirement for National Immunoglobulin Database entry as a condition
for payment.
Bespoke immunoglobulin prescribing reports are generated from the
commissioners’ portal on the database, which document the total volume
and cost of each product prescribed per Trust. These data are used to
calculate the ‘spend’ entered onto the database. Payments are
withheld from the Trust if the spend and the actual volume used do not
correlate.
Efficacy monitoring
“The update specifies the
outcome(s) measures, but not
the degree in improvement of
outcome(s) required to
constitute treatment success”
Commissioners will work with
expert clinicians to refine these
outcomes to provide defined
‘treatment success’ measures
where possible.
Stopping criteria
“For most diseases the
treatment duration is short
term (<3 months). The
treatment episode ends
at 3 months; treatment reinitiation will be regarded as a
new treatment episode, based
on a new IAP decision”
Modulating use in large volume
indications
Patients with ongoing ITP
beyond 12 months (chronic ITP)
should not normally be treated
with long-term immunoglobulin
as there are alternative
approaches. To reflect this,
immunoglobulin in chronic ITP
is now a Grey indication
Modulating use in large volume
indications
“For patients on long-term
immunomodulatory doses,
attempts should be made to
reduce the dose, by increasing
the dosing interval or by using
reduced dose, or both, and, for
patients with a high BMI,
adjusted-body-weight dosing is
used”
The future of the National
Immunoglobulin Database and
commissioning of immunogobulin
Enhanced database functionality
Enhanced commissioner reporting tools
will facilitate:
• monitoring of prescribing patterns
• identification of individual cases which
do not meet the selection criteria
• tracking of cases that do not have
(appropriate) outcome measures.
There will be automated email alerts and
automatic stopping rules through database
locking to prevent inappropriate
unsanctioned use.
This will make it possible to link payment
for immunoglobulin to appropriate
prescribing as recorded in the National
Immunoglobulin Database.
Supporting SCG transition & delivery
‘Minimum Take’ specialised services 2012/12
Although the new arrangements for specialised services will not come into
place in full until April 2013, the NHS Transitional Oversight Group (TOG)
for specialised services has agreed to a stepped implementation with a
nationally consistent approach to commissioning for many of the services
from April 2012 (‘minimum take services).
SCGs will commission a consistent sub-set of the Specialised Services
National Definitions Set (‘Minimum Take’ services) from April 2012, with
the remainder being commissioned from April 2013.
Supporting SCG transition & delivery
Specialised Services National Definition Set
National Immunoglobulin Database
– linking prescribing with payment
Timeline of mandated requirements from commissioners
1st April 2012
1. ‘New treatment episode’ at 3 months to be recorded in
short term cases if immunoglobulin is to be continued
1st April 2013
1. Annual review for long-term users
2. Outcome measures reported
Developing a quality dashboard
for immunoglobulin
What is a Quality Dashboard?
 A graphic array of information that demonstrates an
organisation’s performance in a number of
designated areas of quality
 It is meant to be visual, constructed in a way that it is
intuitively meaningful to a variety of readers
 The minimum amount of space is used to
demonstrate the information
 The focus remains on the outcome rather than the
process delivering change
Why is a dashboard useful?
 A dashboard in a car is visualised whilst driving. Changes in
measurement parameters can lead to immediate corrective
action. The aim for a quality dashboard is that it becomes part
of the day-to-day work of service provision. The frontline staff
delivering care should be able to freely see the dashboard to
see the quality benefits of service change.
 The dashboard is a strong tool to facilitate discussion between
commissioners, the organisation, and the clinical team to
focus on interventions that make a measurable change to care
quality.
 The focus is on the delivery of improvement from the
established baseline. This is opposed to the identification of
‘failure’ to meet a fixed critical threshold.
Define measures
 Measures should be meaningful to the clinical staff in the
service and patients experiencing the care
 The outcomes can be compared with nationally established
benchmarks but this is not a requirement
 Outcomes may include critical national initiatives
 Measure variables that relate to the delivery of the improved
outcome
 Variables can include publicly reported data; progress on local
initiatives; patient satisfaction; patient complaints and
potential litigation; significant incidents; workforce issues,
such as retention; and peer review summaries
 A good number of variables for each clinical system is 10 to
20. Each variable should have a meaningful corresponding
number, trend, percentage or a ranking against providers of
comparable size as a way to measure progress
Run Chart
• The most common form of data presentation will be a run
chart of the parameter score plotted over time. As 7 data
points are required to demonstrate a change more frequent
data points are preferred.
Statistical Process Control
• An SPC chart is the preferred method to demonstrate a data
parameter allowing a focus on not only modifying a median
position but on the reduction of variability
Waiting Times for Consecutive Patients Requiring Radical Radiotherapy
Waiting Time
Average
UCL
LCL
120
100
Days
80
U C L :6 8 . 7 1
60
40
M e a n :3 4 . 8 6
3 1 da y s
20
0
1
8
15
22 29 36
43 50 57
64 71 78
85 92 99 106 113 120 127 134 141 148 155 162 169 176 183 190 197 204 211 218
Consecutive Patients
Draft immunoglobulin measures
1
2
3
4
Measure
Measurement definition
80% of patients confirm
that they have been
supported in self
management as
appropriate to their
indivdual situation.
Of patients registered,
there has been a letter
sent to the GP in last 12
months for 90% of
patients receiving
immunoglobulin for long
term conditions
Patients on
immunoglobulin for PID
who are deemed
suitable for homecare
should be offerred this
choice
Patients on
immunoglobulin for PID
who are receiving
treatment at home
should have been
trained by an accredited
home therapy centre
Patients confirming that they
have been supported in self
management as appropriate to
their indivdual situation.
Numerator
Denominator
Number of patients
Total number of
confirming that they have patients under
been supported in self
treatment with
management as
immunoglobulin at the
appropriate to their
provider.
indivdual situation.
At least annual communication Number of patients on long Number of patients
with GPs about the care of
term immunoglobulin
who are on long term
patients on long term
treatment about whom a immunoglobulin
immunoglobulin treatment who letter has been sent to the treatment
are registered with a GP
GP in the last 12 months
Number of patients receiving
immunoglobulin for PID who
have been offerred treatment
via homecare
Number of patients receiving
immunoglobulin for PID who
are receiving treatment at
home who have received
training from an accredited
home therapy centre
Number of patients
receiving immunoglobulin
for PID who are deemed
suitable for homecare that
have been offerred
treatment via homecare
Number of patients
receiving immunoglobulin
for PID who are receiving
treatment at home who
have received training
from an accredited home
therapy centre
Number of patients
receiving
immunoglobulin for
PID
Number of patients
receiving
immunoglobulin for
PID who are receiving
treatment at home
Draft immunoglobulin measures
Measure
5
6
7
8
Measurement definition
Numerator
Denominator
100% of patients receiving
immunoglobulin are
entered on the national
database
100% of patients receiving
immunoglobulin for
grey/black indications
entered on the national
database have their
outcomes reported
Proportion of patients receiving
Number of patients receiving Number of patients
immunoglobulin who are entered immunoglobulin entered on receiving
on the national database
the national data base
immunoglobulin
Patients who are receiving
immunglobulin for a long
term condition must have
an annual review
Number of patients who are on
immunoglobulin for a long term
condition who receive an annual
review
Patients who receive
immunoglobulin should
have any adverse events
documented on the
national database
Number of adverse events
documented on the national
database
Number of patients who are
receiving immunoglobulin for a
grey/black indication who have
outcomes entered on the national
database
Number of patients who are
receiving immunoglobulin for
a grey/black indication who
have outcomes entered on
the national database during
the quarter who require
outcomes to be reported
For those patients due a
review in the quarter the
number of patients who are
on immunoglobulin for a long
term condition who receive
an annual review that is
documented on the national
database
Number of adverse events
documented on the national
database
Number of patients who
are receiving
immunoglobulin for a
grey/black indication
who require outcomes to
be reported during the
quarter
For those patients due a
review in the quarter the
number of patients who
are on immunoglobulin
for a long term condition
who are registered on
the national database
Number of doses of
immunoglobulin
documented on the
national database
Draft immunoglobulin measures
Options
9
10
11
12
Measure
100% of patients receiving
immunoglobulin for
designated short term
conditions must be reregistered on the national
database if retreatment is
required
Patients receiving
immunoglobulin for
designated short term
conditions should have
their outcomes reported on
the national database
Patients who are receiving
immunoglobulin for a long
term condition should have
their dose and/or dosing
frequency reviewed on an
at least annual basis
100% of patients receiving
immunoglobulin for
designated grey and grey
unlisted indications should
have been reviewed and
approved by a
multidisciplanary panel
before commencing on
immunoglobulin therapy
Measurement definition
Number of patients receiving
immunoglobulin for designated
short term conditions who are reregistered on the national
database
Number of patients receiving
immunoglobulin for designated
short term conditions who have
outcomes reported on the national
database
Numerator
Number of patients receiving
immunoglobulin for
designated short term
conditions who are reregistered on the database
Number of patients receiving
immunoglobulin for
designated short term
conditions whose outcomes
are documented on the
national database during the
quarter when outcomes
should be documented
Number of patients who are
Number of patients who are
receiving immunoglobulin for a
receiving immunoglobulin for
long term condition who have
a long term condition who
documented evidence of dose
have documented evidence
reduction and/or increased dosing of a dose reduction and/or
interval
increased dosing interval
Patients receiving immunoglobulin Patients receiving
for designated grey and grey
immunoglobulin for
unlisted indications who have
designated grey and grey
been reviewed and approved by a unlisted indications who have
multidisciplanary panel before
been reviewed and approved
commencing on immunoglobulin by a multidisciplanary panel
therapy
that is documented on the
national database before
immunoglobulin therapy is
commenced
Denominator
Number of patients
receiving
immunoglobulin for
designated short term
conditions who require
retreatment
Number of patients
receiving
immunoglobulin for
designated short term
conditions whose
outcomes are due to be
documented during the
quarter
Number of patients who
are receiving
immunoglobulin for a
long term condition
Patients receiving
immunoglobulin for
designated grey and
grey unlisted indications
who have been
registered on the
national database
Draft immunoglobulin measures
Options
13
14
15
Measure
100% of patients receiving
immunoglobulin for
designated grey and grey
unlisted indications have
had their panel
recommendation confirmed
for funding by the relevant
commissioner before
commencing on
immunoglobulin therapy
Measurement definition
Numerator
Denominator
Number of patients receiving
Number of patients receiving Number of patients
immunoglobulin for designated grey immunoglobulin for designated receiving immunoglobulin
and grey unlisted indications who grey and grey unlisted
for designated grey and
have had their panel
indications who have
grey unlisted indications
recommendation confirmed for
documented evidence that the
funding by the relevant
panel recommendation has
commissioner before commencing received confirmation for
on immunoglobulin therapy
funding by the relevent
commissioner before
commencing on
immunoglobulin therapy
Patients on long term
Number of patients who are on long Number of patients who are on Number of patients who
therapy for PID should have term immunoglobulin therapy for
long term immunoglobulin
are on long term
trough immunoglobulin
PID who have quarterly trough
therapy for PID who have
immunoglobulin therapy
levels measured on a
immunoglobulin levels measured quarterly trough
for PID
quarterly basis
immunoglobulin levels
documented
Patients on long term
Number of patients on long term
Number of patients on long
Number of patients on
immunoglobulin therapy for immunoglobulin therapy for a
term immunoglobulin therapy long term immunoglobulin
a neurological condition
neurological condition who have
for a neurological condition
therapy for a neurological
should have objective
objective measures of improvement who have objective measures condition
improvement measured on documented
of improvement documented
an annual basis
10 minutes to comment on draft measures
MDSAS IVIG Support
How to contact MDSAS about the IVIG Database
0161 277 7917
support@mdsas.com
Thank you for listening and have a great Christmas!
Rob.Hollingsworth@MDSAS.com
0161 277 7917
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