IBD Registry: October Update
The final report produced by the UK IBD audit at the Royal College of Physicians has been published and data collection to support audit and quality improvement is moving to the IBD Registry. Teams can participate using a choice of data entry systems including existing local systems. Being part of the IBD Registry will give teams:
- Local data to manage their biologics patients and IBD service more effectively
- The chance to be part of ongoing national audit of the safety and appropriate use of biologics and biosimilars
In time the Registry will become a unique resource for real-world clinical effectiveness and health economic studies in IBD care. The goals for 2016/17 are:
- Transfer data collection from the RCP biological therapy audit web tool, which will be closing, to the IBD Registry.
- Develop a near-complete UK Register of IBD patients on biologics by the end of 2017
- Further information [ 46 kb ]
IBD Registry Update: September 2016
Local value of patient data - the Dorset experience
With the launch of the IBD Registry web tool last month, we're all set for every IBD team in the UK to join in, and to start to benefit from collecting useful local data to help deliver better patient care and support service development. Here Pearl Avery describes the approach she took to entering data on the PMS, involving patients in the process and the value of the information collected in the first ten months. This included being able to achieve CCG funding for the helpline for the first time in 20 years.
- Download full summary [ 168 kb ]
IBD Registry web tool launched
Transition focus on biologics
To deliver local value to teams and patients, the steering group has proposed reporting on a set of 6 key performance indicators on biologics in 2016-17, with the aim of building a UK-wide register of all people receiving biological therapies for IBD by the end of 2017. The combined UK data will become a unique resource for real-world clinical effectiveness and health economic studies in IBD care.
- Download full update [ 43 kb ]
IBD audit transition to IBD Registry
At the BSG annual meeting in Liverpool last week outgoing president Ian Forgacs praised the leaders of IBD Registry and called for all IBD teams in the UK to participate in the new programme for data capture and quality improvement using the IBD Registry.
This new programme is still on the quality accounts list and the national clinical audit and patient outcomes programme (NCAPOP) in England. The aim for the transition year is to report on 6 quality indicators for patients newly started on a biological therapy. This focus will enable the UK IBD clinical community to build the largest biologics registry in the world.
What to do next
If you haven't already done so, please register to be part of the programme using the form at http://ibdregistry.org.uk/wp-content/uploads/2016/05/Registration-Form-for-participating-in-the-IBD-Registry2.pdf.
You can participate using the data entry system that best meets your local needs and arrangements are slightly different in different parts of the UK. If you opt to use the web tool you'll be sent a starter pack once we've received your registration form.
|Northern Ireland, Scotland and Wales||Web Tool||We are awaiting permission for data to flow across NHS England's N3 secure network. Once this is confirmed the IBD programme team will issue registered sites with web tool starter packs|
July data submission
BSG Guidance on the Use of Biosimilar Infliximab CT-P13 in IBD
Introduction: Dr AB Hawthorne, Chair BSG IBD Section Committee
The infliximab biosimilar CT-P13 (Remsima or Inflectra) received marketing authorisation in June 2013.The drug is now widely used in the treatment of inflammatory bowel disease. There is sufficient data from observational studies to show that safety and clinical efficacy of CT-P13 are comparable to the originator drug, with similar immunogenicity.
- Infliximab must be prescribed by brand name (ie Remicade, Remsima or Inflectra) and not by International Non-proprietary Name (INN).
- For patients starting infliximab: Remicade, Remsima or Inflectra can be prescribed, taking into account the evidence showing similar clinical effectiveness. There is evidence that monitoring of patients, including measurement of drug and anti-drug antibody levels, is no different for the biosimilar drugs compared to Remicade. The choice of preparation should take into account the cost of the drug and its administration.
- There is sufficient evidence to recommend that patients who are in a stable clinical response or remission on Remicade therapy can be switched to Remsima or Inflectra at the same dose and dose interval. This should be done after discussion with individual patients, with explanation of the reason for switching (which is usually on the grounds of benefit to the overall service by reduction in costs of the drug and its administration).
- Automatic substitution, (dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber), is not appropriate.
- Pharmacovigilance is essential for any new biological medicine, and patients prescribed Remsima or Inflectra should be followed for safety, in a registry such as the UK National IBD Registry.
This document replaces the previous BSG guidance on Biosimilar drugs - IBD Section Statement on Biosimilar drugs (2014) (View here)
- Download guidance [ 330 kb ]
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