Therapeutic Review- A NICE way to optimise prescribing

The Therapeutic Review Steering Group chaired by the Trust Medical Director was established with the aim of embedding a Trust-wide culture of evidence-based practice & identifying high cost drug areas for audit focus including biologic therapies and Disease-Modifying Therapies (DMTs) in multiple sclerosis. The Therapeutic Review Steering Group included the Head of Pharmacy & Medicines Management, Lead Pharmacist Therapeutic Review, Director of Cancer & Specialist Services, Clinical Pharmacologist (Chair of New Drugs Committee) and HSCB Commissioner.

The aim of my role as Lead Pharmacist Therapeutic Review was to conduct a series of audits in 2012-13 working alongside specialist service area leads & multidisciplinary teams to:
- Establish if high cost drug prescribing was in line with evidence-based national standards eg NICE.
- Ensure the Trust has systems in place to record, monitor & audit use of NICE technologies as requested by Northern Ireland Health & Social Care Board (HSCB)
We audited use of:
- Biologics in Rheumatoid Arthritis(RA), Psoriasis & Inflammatory Bowel Disease (IBD) using NICE algorithms & costing tools to ensure audit against robust clinical & cost-effectiveness data.
- Disease-Modifying Therapies (DMTs) in multiple sclerosis against NICE TA 1273 (Natalizumab for treatment of adults with highly active relapsing remitting multiple sclerosis) and Association of British Neurologists guidelines for prescribing in multiple sclerosis 2009.

Standard of patient information provided, starting and stopping criteria, use of cost-effective therapies, record-keeping & monitoring of patient on treatment were audited.

I presented the results to Service Group Managers and Directors alongside Health & Social Care Board (HSCB) representatives and the multidisciplinary team to:
- Highlight good practice
- Identify deviations from evidence-based practice
- Identify & address barriers to change

Action plans agreed with lead clinicians following the audits are in place.
We re-audited use of biologics in IBD & Multiple Sclerosis prescription waste in 2013.

The NHS is facing a significant challenge to improve the quality of healthcare in difficult economic times, and demonstrate that money is being spent wisely, with the best possible outcomes. Belfast HSC Trust delivers integrated health and social care to 340,000 people and provides specialist regional services across Northern Ireland. With an annual budget of approximately £1bn (spending about £3m each day) it is one of the largest Trusts in the UK.

National Institute for Health & Care Excellence (NICE) guidance and Technology Appraisals (TAs) weigh up the clinical and cost effectiveness of treatments based on the best available evidence to set a standard for high quality healthcare.

Belfast HSC Trust Therapeutic Review Steering Group sought to ensure the Trust has in place systems to record, monitor & audit the use of national guidance such as NICE technologies as required by a new process introduced by Department of Health, Social Services and Public Safety Northern Ireland (DHPSSNI) in 2011 and subsequently updated December 2013. The Therapeutic Review Steering Group focused on the high incidence of chronic disease such as multiple sclerosis & Inflammatory Bowel Disease in Northern Ireland and increasing numbers of patients being treated with biologics and Disease-Modifying Therapies.

In the absence of electronic prescribing systems, the Therapeutic Review process assessed managed-entry systems in place for prescribing of these therapies and identified changes to strengthen the process in line with NICE guidance.

Therapeutic Review audits involved baseline data collection on prescribing in 10 cases per consultant audited against evidence-based guidance eg NICE technology appraisals using a clearly defined audit process-see supporting material
I presented therapeutic review audit results to Service Group Managers and Directors alongside Health & Social Care Board (HSCB) representatives and the multidisciplinary team. Deviations from evidence-based practice were highlighted.
The cost associated with the process is funding for the Lead Therapeutic Review Pharmacist post is offset by savings realised by managed-entry systems established eg
- in IBD biologics ensuring use of the most cost-effective agent &
- in multiple sclerosis ensuring that patients meet starting criteria before commencing disease-modifying therapies.
Long term cost-avoidance is realised as a result of identification of significant waste with DMT prescriptions in multiple sclerosis and establishing an action plan to change inefficient systems.

Barriers to change were identified & addressed during the Therapeutic Reviews including:
- Clinicians' lack of ownership & familiarity with NICE guidance:
- NICE algorithms to simplify the process were provided in response to rheumatologists concerns about the complexity of NICE guidance.
- A Trust medicines management intranet page was developed which promotes NICE & national evidence-based guidance and improves familiarity of clinicians with evidence-based guidance.
- Clinicians had a perception that they were adhering to national guidance and challenged the results so I introduced one to one meetings with clinicians to highlight deviations from evidence-based practice.
- Clinicians had a fear there would be a delay in re-instating funding if patient had a trial withdrawal off biologic treatment at 1 year & disease flare occurred eg Crohn's disease. In response, HSCB provided reassurance to gastro-enterologists that biologic funding would be promptly re-instated if Crohn's disease flared for a patient during trial withdrawal.

We audited 60 cases of biologic prescribing in Rheumatoid Arthritis (RA) against NICE RA guidance & highlighted a culture of switching between biologic agents which deviated from NICE guidance on biologics in RA.
The generation of a repeat RA biologic prescription is now linked to attendance at review clinic to prevent repeat prescriptions being issued to patients who have not been reassessed.

We identified potential savings of £55,000 with use of biologics in adult severe active Crohn's (audit cohort n=36) with potential for greater savings if applied to wider patient group. Only 34% of patients were offered written information about their illness & 44% offered written information about the treatment & care they should be offered (n=77). Re-audit June 2013 following introduction of a managed entry checklist showed significant improvement.

We reviewed 61 cases of biologic prescribing in psoriasis. Results were comparable to those from 7 UK dermatology units (Bewley et al 2011). Rigid systems were in place for managed-entry of biologics as Psoriasis Area Severity Index & Dermatology Life Quality Index scores were measured routinely.

We reviewed prescribing of Disease-modifying therapies (DMTs) in 43 cases of multiple sclerosis & identified the need for consistent documentation of how patients meet starting criteria for DMTs & the need to review patients on treatment in line with NICE TA Natalizumab & ABN guidelines. We developed a managed-entry form in agreement with neurologists which records how ambulant the patient is prior to starting DMT, confirms they meet the starting criteria and treatment is reviewed if they meet the discontinuation criteria.
We undertook a regional audit of Multiple Sclerosis prescription waste & identified:
- 155 patients had not collected their MS DMT prescription from hospital pharmacies across NI in over 3 months. - 52% of uncollected DMT prescriptions drug stock had expired at significant cost. - Twenty-eight percent of patients had more than one prescription uncollected. Reasons for waste included poor compliance with treatment, change in device or dose. - An action plan is in place to explore funding options for staff to manage a re-allocation system for uncollected MS DMT prescriptions. Re-audit of uncollected MS Disease-Modifying Therapy prescriptions in December 2013 showed the number of uncollected prescriptions had reduced by two-thirds.

1) Establishment of a Therapeutic Review Steering Group chaired by Medical Director (MD) ensured buy-in from clinicians & budget holders along with commissioners & HSCB representatives to drive change. 2) We established an audit methodology to ensure the process was transparent & enable replication. 3) The MD wrote to lead clinicians ahead of Therapeutic Reviews asking for a high level of engagement in the process to get clinicians on board & promote Therapeutic Review as a Trustwide process as opposed to a pharmacy audit. 4) The appointment of a pharmacist to lead reviews, co-ordinate data collection, undertake one-one meetings, present results & generate action plan was essential to drive the process &cost-effective given savings realized. 5) Initial feedback from clinicians indicated 'lack of ownership' with NICE guidance. Subsequently we developed a Medicines Management page on Trust intranet to demonstrate Trust-wide commitment to NICE. 6) Clinicians will challenge data presented & need to be actively involved in the process. I established 1:1 meetings with individual clinicians to discuss deviations from NICE guidance. This gave clinicians opportunity to check individual data & meant there were no 'surprises' when it came to results. 7) It was important to pinpoint a lead clinician with specialist interest in the topic eg a neurologist with a subspecialty in Multiple Sclerosis to drive therapeutic review for DMTs in Multiple Sclerosis 8) Establish action plans with specific individuals responsible for change & timeline. Agree these with clinicians & service managers to keep up the momentum of the process. 9) The process provided a structured, replicable system to ensure prescribing of high cost drugs is in line with best evidence. It familiarised prescribers, managers &budget holders with up to date guidance & established a network for ongoing process improvement. 10) It's essential to plan ahead for future audit areas & re-audit to progress change.