Biosimilar Medicines: all you need to know
Professor Chris Probert, Chair BSG IBD Committee
The announcement by NICE that anti-TNFs may be used, within licence, for patients with ulcerative colitis has coincided with the launch of two biosimilar infliximabs in the UK.
We (BSG) are arranging an educational meeting in conjunction with representatives from the Association of the British Pharmaceutical Industry Biological Medicines Access Group (ABPI BMAG), Hospira and Napp. Our goal is to deliver an educational event with talks from all interested parties as well as from MHRA and NICE. The meetings are on 9th (London) and 16th (Manchester) June and commence at 14:00.
- Download the agenda [ 619 kb ]
- Download the invitation letter [ 619 kb ]
- Download the reply form [ 619 kb ]
IBD Registry Preliminary Data Presented
At BSG 2014, Clinical Lead, Dr Fraser Cummings presented the first data on over 4000 patients from the UK IBD Registry. This presentation gives an idea of the trends that can be observed using Registry data, such as patients' smoking status or medication. One important development is the linkage with Hospital Episode Statistics (HES) data, which shows healthcare utilisation, e.g. the number of outpatient appointments and A&E admissions each year.
Early Adopters' Lead, Dr Matthew Johnson provided practical advice on using the Registry Patient Management System (PMS) to support patient care, and explained how he and his team at Luton and Dunstable University Hospital have successfully used the system to fund an additional IBD specialist nurse.
We also launched our new Registry Information Pack, a step-by-step guide to joining the IBD Registry, including information for clinical teams, IT and Caldicott Guardians as well as an example business case, PMS screen shots and letters.
Setting the Registry within the broader context of raising standards in IBD, the panel also included Professor Mark Baker, Director of the NICE Centre for Clinical Practice, Dr Ian Arnott, Clinical Lead of the UK IBD Audit and David Barker, Chief Executive of Crohn's and Colitis UK and Chair of IBD Standards and Dr Stuart Bloom, Chair of IBD Registry.
Summing up the meeting, Crohn's and Colitis UK Chief Executive, David Barker commented: "The work of the IBD Standards, Audit and Registry are really critical in terms of driving up standards of care for patients."
IBD Nixon Twin and Multiplex Registry
IBD Registry Update
The first of three pilot sites for the UK IBD Registry started trialling the system on Tuesday 15th January. Launching later this year, the Registry will provide the first ever UK-wide repository of anonymised IBD patient data for prospective audit and research. By bringing this data together for the first time, the Registry Board aims to:
- Provide local, regional & national data in order to better define the pattern of ulcerative colitis and Crohn's disease
- Improve understanding of long term outcomes
- Drive continuous improvement in patient care and access to care across the UK
- Inform commissioning and service design
- Support IBD research
Data can be entered either from existing databases, via a web portal, or by means of a new IBD Patient Management System (PMS), which has been developed by Chameleon Information Systems Ltd (suppliers of InfoFlex) under the guidance of Clinical Lead, Fraser Cummings. Fraser and his team have designed the PMS so that data can be easily entered during the consultation. The PMS will also provide real-time benefits such as a clinical summary of each patient at a glance, to save time leafing through paper notes, and work lists to support, for example, azathioprine monitoring, biologics follow-up or MDT meetings. Subject to local IT arrangements, the PMS can also be integrated with local PAS to further minimise data entry.
The pilot stage is due to run till March, and the launch of the Registry is scheduled for the BSG conference in June.
- Further information [ 77 kb ]
IBD Biologics Audit and IBD Registry
The Biologics Audit
Almost half of UK IBD Audit sites have entered data into the biologics audit. Again I am most grateful to sites that have entered the data and I want to encourage those that have not. Firstly I would like to emphasise that this is a purely audit project and is not fulfilling the research aims of any group or individual. This is your data and we hope that by entering cases into the audit that you will get benefit from this.
We will be producing an interim national report on the biologics audit as part of the UK IBD Audit 3rd round which will be launched in June 2012 at the DDF meeting in Liverpool.
UK IBD Registry
The UK IBD Registry is currently being set up; Three areas of work are being progressed in between meetings of a full board containing representatives of all related professional groups:
- Information Group developing the dataset and clinical benefits of the system
- Governance Group looking into issues of confidentiality and consent
- IT Group developing a specification and tender invitation
There has been regular communication with the other IBD projects, particularly the UK IBD Audit, and the importance of coordinating the development of the Registry with the current and next phase of the UK IBD Audit is recognised by everyone. The Registry system will be presented at DDF in June 2012 in Liverpool.
Drs Ian Arnott & Stuart Bloom
- Further information [ 276 kb ]
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