Authors and Institution
Dr Anjan Dhar - Clinical Lead who designed the initiative, discussed and agreed the roles of individual members of the team, monitored progress and analysed outcomes.
Linda Crissop - Lead Gastroenterology Specialist Nurse, responsible for leadership, co-ordinating Biologics MDT and Virtual Clinics and implementation of the project.
Susan Ritchie - IBD Specialist Nurse, member of the Biologics MDT and Virtual clinics, responsible for collating TDM results and organising T2T checks, data collection.
Victoria Fletcher - IBD Specialist Nurse, member of the Biologics MDT and Virtual clinics, responsible for collating TDM results and organising T2T checks, data collection.
Frances Maw - Clinical Pharmacist, responsible for TDM data and member of the Biologics MDT and Virtual clinics, responsible for adverse events, data analysis.
Summary of the service story:
The aim of this initiative was to rationalise the use of high spend biologic drug treatments in Inflammatory Bowel Disease by a bundle of measures including:
- Implementation of therapeutic drug and antibody monitoring in 2016
- Implementing a biosimilar infliximab switch in 2017,
- Starting a virtual biologic clinic and MDT in 2017 and
- Implementing a treat-to-target approach in 2018.
This bundle was designed to reduce the continued use of biologics in patients who were losing response to treatment, and TDM helped us recognise these patients early. It also decreased the cost of biologic treatment with Infliximab by switching to cheaper biosimilar agents; and the Virtual Biologic clinic allowed us to monitor patients remotely using digital tools, which were our Clinical Support manager, and ECDM Web Portal, alongside a secure telephone line.
The virtual biologic clinic was attended by one to two IBD Consultants, one Gastroenterology SpR, two IBD Specialist Nurses and one IBD Clinical Pharmacist. Each phase of the program was implemented over a 12-month period, and its impact audited to confirm efficacy, before moving on to the next phase. The initiative was supported by the appointment of additional IBD Specialist Nurses to the team and a Clinical IBD Pharmacist. We aimed to produce an efficiency benefit of £100,000 annually for the Trust and CCG, which would be reinvested into the IBD Service.z
The first challenge was to develop a business case for starting regular Biologics MDTs and Virtual clinics once a month, as well as to secure funding for Biologic drug and antibody testing. This was obtained through the Biosimilar Infliximab switch to Remsima, allowing for regular TDM checks.
Cost efficiencies required approval by the Trust and CCG, and the money saved from Biosimilar switch funded a weekly Pharmacist IBD clinic to counsel new patients before commencement of immunosuppressant and biologic treatments; review patients started on treatment, monitor response and record any adverse events. The fortnightly Biologics and Virtual MDT was funded as part of a service improvement programme, and job planned into the Consultant weekly timetable for two hours every fortnight.
The second challenge was to get buy in from consultant colleagues and other IBD specialist Nurses to have their patients reviewed at the Virtual Clinic. This, not being usual NHS practice, was quite a tricky process to go through since it made some people quite uncomfortable to have their patients under scrutiny. This challenge needed sensitive lobbying on grounds of patients’ best interests, an independent peer review of clinical practice, and having equitable care for all IBD patients.
Evaluation and Outcomes:
The service had been formally evaluated by a three-month pilot for the IBD Pharmacist run clinic, which saw 20 patients on biologics reviewed, two anti-TNFs stopped, two patients switched, and six patients dose optimised for loss of response (LOR). Calculated savings for the three-month period was £15,000, equating to an annualised saving of £60,000.
The Virtual Biologic and TDM clinics have reviewed 142 patients in the year 2017, with at least 30% patients having a change to their existing treatment (both stopping and optimisation). All biologic patients have had three-monthly CRP, faecal calprotectin and annual ileocolonoscopy and/or MR enterography. This has improved patient care significantly, and we are one of the few non-university hospitals in the country to be doing both TDM and Treat to target.
In 2018, 20 Infliximab, 21 Adalimumab and 19 Vedolizumab patients have been treated to target.
Of 41 patients with either Biosimilar Infliximab (n=20, 13 CD, 8UC) or Adalimumab (n=21, 17CD, 4UC) we have found a 20% secondary LOR for IFX, with very little LOR for Adalimumab. Eighteen patients with Infliximab treatment had colonoscopic assessments; three showed LOR and were switched to Vedolizumab or Surgery. Seventeen patients with Adalimumab had colonoscopic assessments, with good mucosal healing. Only one patient was considered to have possible LOR to Vedolizumab.
Our patient satisfaction survey shows that patients now feel that their IBD care is being managed very efficiently compared to the past, and they have a multi-professional team looking after their treatment instead of a single consultant or Specialist Nurse. Surgical colleagues are also more convinced of the need for an operation when our patients are referred to them since there is a multi-professional team decision of the failure of medical therapy to indicate the need for surgery now.
We have already disseminated some of our work to other colleagues in the country by a presentation by our Pharmacist at the UK Clinical Pharmacist Annual Meeting in 2017, and a poster presentation of our TDM data at the British Society of Gastroenterology Annual Meeting in 2018. We have disseminated our work to regional IBD Specialist Nurses meeting in the North east, and have also presented a poster at the IBD Nurse Education Event in 2018 at Manchester.
We now plan to write up our work for publication in a journal of Gastroenterology and Nursing.