Given the special circumstances putting pressure on IBD teams and wider health services, we have created some in-depth articles below in an easy to read format:
Switchers: Changing originator biologic to biosimilar
Changing originator biologic to biosimilar
With many patients’ biologic treatment being switched to a biosimilar, we would like to remind users of our preferred way of capturing this information. The details below refer to the steps on the Registry WebTool or the IBD PMS – if your site is using a different system please contact us (firstname.lastname@example.org) so we can guide you on the best way to record this on your local system.
- Stopping the originator:
Create a Biologic follow-up for the originator biologic. Enter ‘Ad hoc’ in Type of Review. (On the PMS choose the originator biologic from the Treatment type list, scroll down and click Review button). Record ‘Stop treatment’ in the Treatment plan field, select ‘Other’ as the Reason for treatment plan choice and in If other, please specify box enter ‘Biosimilar switch’. If you are entering this information retrospectively, remember to adjust the Date of Review / Review Date to the date the originator biologic was stopped. Save.
- Starting the biosimilar:
Create a new Biologic initiation for the biosimilar. (On the PMS, choose ‘Initiation’ for the Type of review). Select the new biologic for the Current Treatment type. (On the PMS scroll down to click Initiation button). Record the Clinical indication as before, enter ‘Not indicated’ for the Pre-treatment screening tests, ‘No’ in the Is the patient biologic naïve, ‘Other’ in Reason for stopping and ‘Switch from originator’ in Other reason for stopping. NB: Enter the date the biosimilar was started in the Date initial treatment given. Save
If you are maintaining the patient’s current IBD medications on the system, now update the current medications by marking the originator as stopped and adding the biosimilar (entering the intended maintenance dose in the drug dose fields)
We realise to calculate the complete time the patient has been on the originator plus the biosimilar means both treatments have to be taken into account, but recording the information in this way will enable the Registry to be more informative in its reports on the use of biologic agents in England and Wales. At the suggestion of a user (thank you), we are looking into adding ‘Biosimilar switch’ as an additional option to the Reason for treatment plan choice field. As always, we are hugely grateful to participants for providing information that will help improve the care of people with IBD.
Dataset update to InfoFlex Patient Management System (IBD PMS)
You might recall that we made some small revisions last year to the Registry’s dataset, for the first time since 2015. The significant changes were to enable us to collect information on a patient’s ethnicity, and to enable the ‘Reporting to companies’ consent item and an extended range of biologics/biosimilars to flow to us. WebTool users might have noticed these adjustments towards the end of last year. We are pleased to announce that CIMS are now making these same changes to installations of the InfoFlex Patient Management System, which requires changes at each local site where the PMS is running. No action is needed from users of the PMS, although it would be helpful if PMS users would alert their local IT department that CIMS will be approaching them for permission to make these changes. If you are a user of other systems collecting information to submit to the Registry and are unsure if the dataset changes have been implemented on your system please contact your local system manager or email@example.com
2020-21 Site Agreements including Data Sharing (Registry) and Data Processing (WebTool)
We have been fully revising the formal paperwork (Data Sharing Agreements, WebTool Data Processing Agreements, etc.) that we need teams to complete to participate in the Registry. The goal has been to integrate documents in order to be streamlined.
Tip of the Month #2 – recording the initiation of a biologic
Q: Some biologics have a loading dose/route/frequency of administration that differs from the maintenance regimen. How should I record on my system the dose of biologic that a patient has been prescribed?
A: Please enter the dose, route and frequency of the maintenance regimen in the medication details, BUT the date the biologic started should be entered as the date when the first dose was given. Please record only one initiation visit (even if the patient attends for a number of induction doses)
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