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

Updated guidelinesCommissioning perspective

“Increased clarity regarding patient selection criteria and the need for prescribers to report clinical outcome after treatment are strongly supported” Selection criteria and outcomes

“Effective Immunoglobulin Assessment Panels (IAPs) are important to monitor adherence to these new selection criteria in routine clinical practice” Effective IAPs

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.

“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. Efficacy monitoring

“For most diseases the treatment duration is short term (<3 months). The treatment episode ends at 3 months; treatment re- initiation will be regarded as a new treatment episode, based on a new IAP decision” Stopping criteria

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” Modulating use in large volume indications

The future of the National Immunoglobulin Database and commissioning of immunogobulin

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 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. Enhanced database functionality

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.

Specialised Services National Definition Set Supporting SCG transition & delivery

National Immunoglobulin Database – linking prescribing with payment Timeline of mandated requirements from commissioners 1 st April ‘New treatment episode’ at 3 months to be recorded in short term cases if immunoglobulin is to be continued 1 st April 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

Draft immunoglobulin measures MeasureMeasurement definitionNumeratorDenominator 1 80% of patients confirm that they have been supported in self management as appropriate to their indivdual situation. Patients confirming that they have been supported in self management as appropriate to their indivdual situation. Number of patients confirming that they have been supported in self management as appropriate to their indivdual situation. Total number of patients under treatment with immunoglobulin at the provider. 2 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 At least annual communication with GPs about the care of patients on long term immunoglobulin treatment who are registered with a GP Number of patients on long term immunoglobulin treatment about whom a letter has been sent to the GP in the last 12 months Number of patients who are on long term immunoglobulin treatment 3 Patients on immunoglobulin for PID who are deemed suitable for homecare should be offerred this choice Number of patients receiving immunoglobulin for PID who have been offerred treatment via homecare 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 4 Patients on immunoglobulin for PID who are receiving treatment at home should have been trained by an accredited home therapy centre 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 receiving treatment at home

Draft immunoglobulin measures MeasureMeasurement definitionNumeratorDenominator 5 100% of patients receiving immunoglobulin are entered on the national database Proportion of patients receiving immunoglobulin who are entered on the national database Number of patients receiving immunoglobulin entered on the national data base Number of patients receiving immunoglobulin 6 100% of patients receiving immunoglobulin for grey/black indications entered on the national database have their outcomes reported 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 Number of patients who are receiving immunoglobulin for a grey/black indication who require outcomes to be reported during the quarter 7 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 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 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 8 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 doses of immunoglobulin documented on the national database

Draft immunoglobulin measures OptionsMeasureMeasurement definitionNumeratorDenominator 9 100% of patients receiving immunoglobulin for designated short term conditions must be re- registered on the national database if retreatment is required Number of patients receiving immunoglobulin for designated short term conditions who are re- registered on the national database Number of patients receiving immunoglobulin for designated short term conditions who are re- registered on the database Number of patients receiving immunoglobulin for designated short term conditions who require retreatment 10 Patients receiving immunoglobulin for designated short term conditions should have their outcomes reported on the national database Number of patients receiving immunoglobulin for designated short term conditions who have outcomes reported on the national 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 receiving immunoglobulin for designated short term conditions whose outcomes are due to be documented during the quarter 11 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 Number of patients who are receiving immunoglobulin for a long term condition who have documented evidence of dose reduction and/or increased dosing interval Number of patients who are receiving immunoglobulin for a long term condition who have documented evidence of a dose reduction and/or increased dosing interval Number of patients who are receiving immunoglobulin for a long term condition % 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 Patients receiving immunoglobulin for designated grey and grey unlisted indications who have been reviewed and approved by a multidisciplanary panel before commencing on immunoglobulin therapy Patients receiving immunoglobulin for designated grey and grey unlisted indications who have been reviewed and approved by a multidisciplanary panel that is documented on the national database before immunoglobulin therapy is commenced Patients receiving immunoglobulin for designated grey and grey unlisted indications who have been registered on the national database

Draft immunoglobulin measures OptionsMeasureMeasurement definitionNumeratorDenominator % 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 Number of patients receiving immunoglobulin for designated grey and grey unlisted indications who have had their panel recommendation confirmed for funding by the relevant commissioner before commencing on immunoglobulin therapy Number of patients receiving immunoglobulin for designated grey and grey unlisted indications who have documented evidence that the panel recommendation has received confirmation for funding by the relevent commissioner before commencing on immunoglobulin therapy Number of patients receiving immunoglobulin for designated grey and grey unlisted indications 14 Patients on long term therapy for PID should have trough immunoglobulin levels measured on a quarterly basis Number of patients who are on long term immunoglobulin therapy for PID who have quarterly trough immunoglobulin levels measured Number of patients who are on long term immunoglobulin therapy for PID who have quarterly trough immunoglobulin levels documented Number of patients who are on long term immunoglobulin therapy for PID 15 Patients on long term immunoglobulin therapy for a neurological condition should have objective improvement measured on an annual basis Number of patients on long term immunoglobulin therapy for a neurological condition who have objective measures of improvement documented Number of patients on long term immunoglobulin therapy for a neurological condition

10 minutes to comment on draft measures

How to contact MDSAS about the IVIG Database MDSAS IVIG Support

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