This example sets out the design and implementation of a Virtual Biologics Clinic (VBC) at the Manchester Royal Infirmary to improve evidence-based prescribing of high-cost biologic drugs in routine clinical practice, to reduce treatment delays and variations in patient experience, and maximise research opportunities for patients with rheumatoid arthritis (RA) and related diseases.
The service includes the use of a MDT review of all new high-cost drugs prescriptions, a biologics database, which is updated in real-time, records core quality data (NICE eligibility and monotherapy rates set out in CG79 & QS33) and the use of systems and procedures to embed the principles of safe and effective prescribing into clinical practice. Using this data, eligibility and response reports can be generated on request and detailed annual audits conducted more easily.
Aims and objectives
The aim of the initiative was to improve all aspects of the biologics service through the introduction of a ‘virtual biologics clinic’ (VBC). We hoped to achieve:
- Successful implementation of a Greater Manchester Biologics Pathway in RA
- A streamlined process of initiating a biologic in order to reduce variation in practice , reduce the number of clinic appointments required, and reduce unnecessary delays for our patients
- Improvements in safe prescribing with strict adherence to a pre-biologics safety checklist for all patients prescribed a new biologic therapy
- Increased recruitment to experimental medicine and translational research studies across all diagnoses within a single academic rheumatology centre
- Cost containment of high-cost drugs in rheumatoid arthritis by following the prescribing pathway
- Improved collection of ‘live’ audit data by which we could monitor prescribing practice and impact of pathway implementation.
Reasons for implementing your project
Biological therapies represent a significant cost to the NHS, which is increasing annually.. Consequently, expenditure on biologic drugs in rheumatology is often amongst the highest pharmaceutical spend within many trusts and rising. Inappropriate and/or inefficient prescribing of these drugs is therefore likely to place a significant financial burden on the NHS.
The process of initiating biologics is complex and varied despite clear NICE commissioning guidelines., and this often results in variation in prescribing patterns and uptake of prescribing guidelines or recommendations. Patients starting a biologic therapy are often a key target population for experimental and translational clinical research studies. Such studies can drive improvements in patient care and offer potential cost savings for CCGs by providing biologic therapies and associated care outside of NHS funding streams. However, many barriers exist that impede recruitment to research, such as lack of opportunity to identify potential recruits.
The rheumatology team at MRI, a large academic teaching hospital, undertook a quality improvement approach to changing the biologics service, and aimed to better understand processes and identify barriers in the existing biologic prescribing system. After mapping the ‘typical patient journey’, for an individual starting on a biologic therapy, the rheumatology clinical team identified several problems with our biologics service including unreliable systems to facilitate efficient prescribing of high-cost drugs, inefficient use of appointments, delays in initiating therapies, missed translational research opportunities, haphazard data collection, and a variation in clinical practice.
How did you implement the project
Plan-do-study-act (PDSA) cycles of rapid change were used in clinical settings to implement and improve changes, that focussed on systems, data collection, and the integration of clinical and research teams.. A detailed measurement strategy was devised to effectively measure the impact of the changes, which included outcomes, processes and balancing measures.
- The VBC was established to review all patients recommended for a biologic to ensure compliance with the regional Greater Manchester Medicines Management Group (GMMMG) biologic prescribing pathway and to integrate research, thereby containing prescribing costs.
- The VBC consists of a weekly 1 hour multidisciplinary team meeting between a consultant rheumatologist, rheumatology specialist nurse, research nurse and specialist pharmacist. New standardised documentation was introduced based on the GMMMG pathway, which included a safety checklist for every patient, the rationale for biologic choice, a new standardised GP letter, and a bespoke biologic electronic ordering screen for screening tests.
- Each patient is reviewed against prescribing checklists to ensure biologics prescribing is compliant with regional pathways, limiting variation in practice and also maximising prescription of the least expensive biologics, unless indicated otherwise. Patients are also reviewed against research study opportunities and invited to discuss entry into a clinical study at a patient education session if appropriate.
- A biologics database, which is updated in real-time, records core quality data (NICE eligibility and monotherapy rates). Using this data, six-monthly reports are produced and annual audits conducted.
A link to the process can be found by clicking here.
Service Performance and Outcomes
- Compliance with the GMMMG biologics pathways for rheumatoid arthritis1 increased from 37% to 97% after the introduction of the VBC.
- The proportion of patients with good or moderate response to biologic therapy (according to the EULAR criteria) has increased; at the most recent audit (2014) 100% of patients had a good or moderate response compared to 82% in 2011.
- A substantial increase in recruitment to research studies was seen after the VBC was initiated; 60 patients were recruited in the year 2012-13 and 98 patients recruited in 2013-2014, the year in which the VBC began.
Financial Performance and Outcomes
- Implementation of the prescribing pathways and increased recruitment into trials resulted in cost-savings to commissioners of £113k in the first 6 months; this was achieved through increased use of cheapest drug options (£23k) and £90k from enhanced CTIMP participation that provided biologic drug for at least 1 year. ,Additional revenue was also generated for the department from enhanced recruitment into clinical trials and other research studies
- The VBC did not required any additional financial investment as no additional staff were required at the outset. Administrative support for the VBC was obtained later, whose funding was based on nurses seeing 6 extra patients per week, who are urgent helpline patients, in place of 6 to 8 hours administration for the biologics service.
Patient Focus and Satisfaction
- The VBC means that the weekly group patient education sessions are up-to-date, based on queries and issues that arise and are discussed by the team in the VBC.
- Nursing staff can act as the patient advocate at the VBC.
- Fewer consultation visits to the hospital are now necessary for the patient prior to biologic initiation, and there has been a reduction in the median treatment delay from 59 days to 16 days after the introduction of the VBC.
When Max was first prescribed a biologic it took 10 weeks between the decision and starting his new treatment, and he needed to return for several appointments to complete all the screening tests and receive education. This time, he only had to attend the group education session after the decision was made to switch his treatment, and he received his new drug in less than 3 weeks.
“.. when we didn’t have the virtual biologics clinic I used to dread the week because I’ve got to collate all of those results, and it nightmare that I’ve got all this paperwork; whereas now I save it for that one hour, I put the problem to bed; so that in that one hour I’m supported, I’m not waiting for annual leave, I haven’t got bits of paper on my desk scattered about, I’ve got admin support; and every patient gets their biologic quicker but it only takes me an hour of my life per week”
Key learning points
Enforcing a similar single model of care onto all rheumatology services is unlikely to succeed as each service and patient population is different. However, offering evidence-based ‘modules’ of service re-development that could be adapted to fit a particular service offers a route to spreading best practice.
We have already shared our experience widely with other units, and several departments have implemented aspects of the VBC. We have also been asked to speak to colleagues in gastroenterology and dermatology, including at an event for the National IBD audit. Implementing up-to-date high-quality research evidence into clinical practice remains a challenge for most clinical teams.
National prescribing guidance does not always reflect the current evidence base and bodies such as NICE cannot be expected to respond rapidly and frequently to new knowledge. This ‘translational block’ inhibits innovation in service delivery and care provision, but can be overcome with the involvement of clinicians, commissioners and patients in locally taken decisions.
The development of a regional biologic prescribing pathway provided the tool to improve prescribing of biologic therapies by utilising recent research knowledge, and the VBC was the mechanism through which this pathway could be implemented and monitored.